STANDING COURT MARTIAL

for the trial of K72 142 802 Ex-Sergeant Michael Richard KIPLING, Canadian Forces, Regular Force, held at 17 Wing Winnipeg, Manitoba on the 15th, 16th, 17th, 22nd, 23rd, 24th, 25th, 28th and 29th days of February 2000; and the 27th, 28th, 29th, 30th and 31st days of March 2000; and the 26th day of April 2000; and the 5th day of May 2000.

MILITARY JUDGE

F26 089 814 Colonel G.L. Brais, Office of the Chief Military Judge.

PROSECUTOR

N33 788 791 Major D.K. Fullerton, Regional Military Prosecutor Edmonton.

ASSISTANT PROSECUTOR

H40 442 282 Lieutenant(N) M.L. Geiger-Wolf, Deputy Judge Advocate Winnipeg.

DEFENCE COUNSEL

Mr J. Prober, Barrister and Solicitor, 387 Broadway Avenue, Winnipeg, Manitoba.

ASSISTANT DEFENCE COUNSEL

Ms J. Duncan, Booth, Dennehy, Ernst and Kelsch, 387 Broadway Avenue, Winnipeg, Manitoba.

INTERVENERS

Ms D. Miller, General Counsel and Regional Director, Winnipeg Regional Office, Department of Justice, 301-310 Broadway, Winnipeg, Manitoba, Counsel for the Intervener, Minister of National Defence, Mr A. Eggleton.

Mr H. Glinter, Winnipeg Regional Office, Department of Justice, 301-310 Broadway, Winnipeg, Manitoba, Assistant Counsel for the Intervener, Minister of National Defence, Mr A. Eggleton.

Mr W.W.A. Wolf-Reidel, Meighen Haddad and Company, Barristers and Solicitors, Box 22105, 110-11th Street, Brandon, Manitoba, Counsel for the Interveners, General Baril, Lieutenant-General Kinsman and Brigadier-General Jurkowski.

COURT REPORTER

D20 134 200 Master Warrant Officer R.K. Gaudet, Office of the Chief Military Judge.

REASSEMBLY: At 1000 hours, 27 March 2000, the court reassembles and the accused is before it.

ASSISTANT DEFENCE COUNSEL: Good morning, Your Honour, it's Duncan for the record. Our next witness, Your Honour, is going to be Dr Meryl Nass, if she could be called forward, please.

EIGHTH WITNESS

FOR THE

DEFENCE

)))

Dr M. Nass, is duly sworn.

ASSISTANT DEFENCE COUNSEL: Your Honour, it's our intention to have Dr Nass qualified as an expert. She is, we say, an expert in internal medicine with an expertise in bio warfare and in particular anthrax and the anthrax vaccine.

I provided my learned friend with a copy of Dr Nass' CV. I understand from Major Fullerton that he wishes to ask some questions of Dr Nass. So with the court's permission, I'll go through her qualifications.

MILITARY JUDGE: Go ahead.

PROSECUTOR: I can indicate, my friend has provided me with a copy of her CV just this morning, and I would like to hear a little bit of the testimony prior to making a determination.

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL: Perhaps at this point I should file the CV with the court, if I might.

MILITARY JUDGE: Okay, so we'll take this and mark itÐÐwhere are we?

COURT REPORTER: VD number 39, Your Honour.

MILITARY JUDGE: 39.

THE CURRICULUM VITAE FOR DR MERYL NASS IS MARKED EXHIBIT VD39.

Q. Dr Nass, I understand, firstly, that you come todayÐÐor not today, but you come today from Freeport, Maine? A.  That's correct.

Q. I understand that you work in a hospital in Brunswick, Maine? A.  Yes.

Q. Okay. In terms of your past educational background, I understand that in 1974 you received a Bachelor of Science degree in Biology from Massachusetts Institute of Technology? A.  Yes.

Q. And I understand that you received your MD, or your medical doctorate from the University of Mississippi Medical School in 1980? A.  Yes.

Q. I understand as well, Dr Nass, that you completed an internal medicine residency in 1985? A.  Uh-huh.

Q. And that in 1986 you received your diplomate from the American Board of Internal Medicine? A.  That's correct.

Q. And you then have a qualification as an internist? A.  Yes.

Q. Now, in addition to your education, I understand, ma'am, that you have worked as a laboratory technician in the past, as a medical consultant in 1980 to '82, and that you were an emergency physician in '85 and '86? A.  Yes.

Q. You were practising as an internist in 1993 to 1994 in Amherst, Massachusetts? A.  Yes.

Q. 1994 to '95, you practised as an emergency physician? A.  Uh-huh.

Q. And that was at the Franklin Medical Center? A.  Uh-huh.

Q. I understand as well that from 1986 to 1993 and then 1995 to 1997, you practised as an emergency physician and an internist in Palmer, Massachusetts? A.  That's correct.

Q. I understand that you've been in private practice now, essentially, from 1997 to the present time? A.  1999, January 1st, 1999 to the present time.

Q. Okay, 1999 to the present time. From 1997 you were in private practice in Yarmouth, Maine? A.  Yes.

Q. Okay. And you also work as an emergency physician and that's in Brunswick, Maine? A.  Yes.

Q. I understand as well, Dr Nass, that in addition to your education and your work experience, you have teaching experience? A.  Yes.

Q. From 1989 to 1993, you were an instructor in the Department of Internal Medicine? A.  At the University of Massachusetts Medical School.

Q. Thank you. You have a variety of other projects listed on your CV, including being a consultant, member of the Federation of American Scientists Working Group, consultant for the Cuban Ministry of Health, et cetera, and the judge has the CV, so I won't go in to depth in that regard? A.  Yes.

Q. I understand as well, Dr Nass, that in addition to your expertise as an emergency physician and an internist, that you claim expertise in terms of bio warfare and in terms of the anthrax vaccine and the anthrax illness, is that correct? A.  That's correct.

Q. When did you, or how did you outfit yourself with that expertise? A.  In 1989 while I was a member of an organization called "Physicians for Social Responsibility", a group of students and the wife of one of our members approached that organization at a meeting, saying that their class had done research into Pentagon contracts at the University of MassachusettsÐÐthe university part not the medical schoolÐÐand in the town where I lived at the university, of which I was a part-time teacher, and that one of the professor's was doing research on developing a better anthrax vaccine and they were interested in critiquing this. As a result of conversation we had at that meeting in which I said, basically, that I thought vaccines were not related to offensive biological warfare and that I didn't have a problem with a professor developing a new anthrax vaccine and I didn't think we should support the students, the other members disagreed with me and suggested that I review the contract and discuss it at the next meeting. So I did that and learned that the contract, although nominally about development of an improved anthrax vaccine, actually had nothing to do with that but was about genetic engineering of anthrax.

Q. Okay, if I can just sort of interrupt you. That goes back to 1989? A.  Yes.

Q. And that's when you first became interested in anthrax and biological warfare? A.  Approximately, January of 1989.

Q. How did you go about, or did you go about equipping yourself with expertise in this area? A.  As a result of my curiosity about that contract, I decided to review the extant anthrax literature, both on the vaccine and what else was being done.

Q. If I can just interrupt you. What do you mean by "extant"? A.  Existing.

Q. Okay? A.  And so I simply, if you're a physician you just tell your medical librarian to do a literature search for you and get you journal articles about this topic, which is what I did, and I read these articles. In addition, actually simultaneously, these students had developed quite a following at the university and with the Quaker American Friends Service Committee in town and had asked the Board of Health to judge this research as to whether it was dangerous for the town at the town meeting to determine whether it was acceptable within the town. And this became quite a large issue within my town and, actually, eventually wound up in a big demonstration, building takeovers, a hundred and fifty arrests and national news.

Q. Okay, if I can just interrupt you. You indicated that you did a literature search or you had your secretary pull the literature? A.  Yes.

Q. How far back did you go in your search? A.  Well, initially I just looked at the literature on vaccines and on anthrax in general: where was the research and where did this particular professor's research fit in? And then I thought, when I became a little alarmed about it, I thought, well, since everybody's concerned about anthrax as a biological weapon, why don't I go andÐÐI arbitrarily picked 15 years, why don't I go back and do a literature search for the last 15 years, find out what anthrax epidemics have occurred and read about them. So I did that and discovered one epidemic which happened to be the largest ever recorded in humansÐÐit was very large in cattle but there were no numbersÐÐwhich occurred in Rhodesia during its civil war, now Zimbabwe.

Q. And did your search of the literature continue from that point on? A.  Yes. I realized that the epidemic in Zimbabwe, which had affected over 10,000 people, was completely unlike all the other epidemics, that the epidemiology was wrong, that it was likely to have been due to biological warfare. And I was also sort of reviewing the whole issue of biological warfare at that time and acquainting myself with various aspects, reading books and anything really I could get my hands on at that point to try and understand what it was I had stumbled upon. And I, therefore, was aware that there was no means of investigating biological warfare allegations, and there was really no existingÐÐactually, the Canadians have done perhaps more than anybody as far as what should be done to investigate a biological warfare allegation ...

Q. Okay, if I can just interrupt you. Did you restrict your reading to published studies alone? A.  At that point, yes, published medical literature and popular press books and articles: some of the important articles were in Scientific American, Science Magazine, Bulletin of the Atomic Scientists, Bulletin of Far-East Review, something like that.

Q. Okay. And at a certain point, where are we in terms of years? It seems as if from 1989 was the original spark of your curiosity, you proceeded on this study of the literature, how long did that study take? A.  Well, it became an ongoing process. What happened is I wound up feeling theÐÐI also discovered that the United States was doing research that might be construed as transgressing the limitations imposed by the Biological Weapons Convention.

Q. Okay, if I can get youÐÐto stop you there, because I don't want to get too far afield into the evidence itself. But you've given evidence that you've educated yourself to some degree, or to an extensive degree in terms of the literature. At what point did other people begin, if they did in fact begin, to recognize your expertise in this area? A.  Well, let's see, I wrote an article in 1990, which was published in March of '91, about the Biological Weapons Convention and the state of research on anthrax and how it could be looked at in an attempt to take a blurry line between offensive and defensive biological warfare and try to address some medical and scientific thought to make the line less blurred. So that I published, as I say, in early '91. I attended a conference with a lot of DOD, Department of Defense, researchers, most of the people who are the experts at Fort Detrick on anthrax, in April of '91 ...

Q. Okay, if I can just interrupt you now, because we'll probably be hearing more of this place. What is Fort Detrick? A.  Fort Detrick is a Defense Department facility, previously titled, "Camp Detrick", where biological warfare was initiated during World War II, in approximately 1942, and where biological defensive research continues to this day, in Frederick, Maryland.

Q. Okay. If you could continue, then? A.  Okay. Well, I guess, since I started this research for Physicians for Social Responsibility, and because this business at the University of Massachusetts became very large, it became well known what I was doing within that organization and I was asked to present a talk to theÐÐoh, I think it probably was in the fall of 1989, at the American Public Health Association meeting in Chicago, so within six months people became aware of what I knew. And then in 1990, as the Gulf War approached, I actually started trying to contact people at Fort Detrick to tell them I thought there were some additional things they might want to do for troops to protect them from anthrax in the Gulf War.

Q. Okay. In terms of speaking engagements or publications in this area, what was your experience in the early 90s? A.  Well, this national organization, Physicians for Social Responsibility, had made me a national spokesperson on chemical and biological warfare ...

Q. And when was that? A.  That was shortly before the Gulf War when the issueÐÐit was one of those things where I really thought I was in a fringe area, but with the advent of the Gulf War, it became a very interesting area for many people, so I wound up doing a lot of media interviews and being asked to speak at different places, so I had to travel around the country and gave some talks and published more ...

Q. What kind of places were you giving talks? Were you invited to give these talks? A.  Yes, yes, I gave a talk at Stanford Medical School and ...

Q. In this area? The area of bio warfare? A.  Yes, bio warfare, to a physician group in Michigan and to other places, I don't even recall precisely where they were. But I did that, and then I was able to publish my study of the Zimbabwe Epidemic in 1992 and presented that in the summer of '92 at the International Society for Infectious Diseases meeting in Nairobi, KenyaÐÐthe London Times reported on that researchÐÐand then I was asked to present it at the International Anthrax Conference in England in 1995.

Q. And you were invited to attend that conference? A.  Yes. You know, I'd been asked to write other articles about biological warfare, I was asked to comment on the Aum Shinrkyo episodes. And so I did that and basically this was all a hobby on top of my full-time job practising medicine. But I discovered that I was really the only civilian physician who was very knowledgeable about anthrax, and quite knowledgeable aboutÐÐI mean, there are others who knew about biological warfare, but it seemed like the other people were more familiar with the policy aspects, which were less interesting to me than trying to apply science and medicine to solving problems in the field that had not been previously solved.

Q. Okay. Now I understand that you were invited to speak in Zimbabwe? A.  Yes. I have spoken with people in Zimbabwe who have said they'd like to invite me there, and I've been to Zimbabwe and done research there, and I have actually met with people in the government in Zimbabwe, but I have not done any formal presentations.

Q. But you were invited to, I understand? A.  Well, I was invited to, when they got funding, which hasn't happened.

Q. Okay. I understand that you had some involvement with the National Gulf War Resource Center? A.  Yes.

Q. Can you tell us about that? A.  Well, they've invited me the past two years to their national conferences to speak about the possible role of anthrax vaccine in Gulf War illness.

Q. Okay. Is it fair to say that in the last ten years you have spoken extensively across the country regarding anthrax and anthrax vaccine? A.  Yes.

Q. Is that a good summary? A.  Uh-huh.

Q. Has it only been in the United States, ma'am? A.  No.

Q. Where else have you spoken? You mentioned the Zimbabwe invitational, although we're still waiting for funding for that, but ... A.  Right, and I've spoken in Nairobi, Kenya ...

Q. Uh-huh. On anthrax and bio weaponry? A.  Yes. Yes, on the Zimbabwe epidemic. That may be all outside the US.

Q. Okay. Now I understand that you were invited to make a presentation, both I understand verbal and a written presentation, to the House Government Reform Committee, commonly known as the Shays Committee, that was in the United States? A.  Yeah, the Shays Committee is a subcommittee of the Government Reform Committee and it's the National Security Veteran's Affairs and International Relations Subcommittee.

Q. And you were invited to make an oral presentation? A.  Yes.

Q. And, in fact, a written presentation as well? A.  Yes.

Q. And that was specifically on anthrax, anthrax vaccine and all of the associated concerns and areas related to that? A.  Yes.

Q. Have you had a chance to review the Shays report? A.  I have.

Q. Was any of your recommendations or observations incorporated into the Shays report? A.  I've been very gratified that, I think, that they have accepted pretty much everything I told them and have incorporated a number of the things I said into the report.

Q. Okay. Just to refer back to your CV, I know we touched on some of this, but it is apparent that you have published quite extensively in this area: I see in 1991, there is an article, "The labyrinth of biological defense"; an, "Author reply", in '91; 90-92 there was an article entitled, "Can biological toxin, and chemical warfare be eliminated?; '92, we heard about the Zimbabwe research and you published an article on, "Zimbabwe's anthrax epidemic"; it says in 1992 as well "Anthrax epizootic ..."? A.  Epizootic.

Q. Epizootic, what does that mean? A.  That means an illness that is transmitted from animals to humans.

Q. Okay. "... in Zimbabwe" and that was published in 1992; an article in '93, "Germ warfare: ..."; '95 an arms control; in '96 there's a, "Report on the Subgroup on Investigation of Alleged Use or Release of Biological or Toxin Weapons ...". Would anthrax be included in that? A.  Yes.

Q. Then in 1998 there was an article in the ASA Newsletter, "Anthrax vaccine and the prevention of biological warfare?"? A.  Yeah, I think they had actuallyÐÐthat CV is not up to date, so there have been three or four articles in the ASA Newsletter and some others.

Q. Okay. I'll certainly ask that of you. The 1998, the, "Anthrax vaccine and the prevention of biological warfare?", I think I just mentioned that; in The Lancet, and I understand that's a publication with considerable respect in the community, "Biological warfare", that would include anthrax. Is that correct, ma'am? A.  Yes.

Q. 1998 in Autumn, "Will anthrax vaccine help prevent biological warfare?; in 1998, "The anthrax dilemma"; and in 1999, you published an article in the Infectious Disease Clinics of North America, and that article is entitled, "Model of a response to the biologic warfare threat", and I have here a copy of the article. It's a review article, if I can put it that way, in the sense that there's an extensive review of the literature? A.  It is. That's a journal of review articles.

Q. Journal of review articles. And in fact in thisÐÐI can file this, I don't know whether that's necessaryÐÐbut you cite a hundred and two journal articles, is that correct? A.  There are 102 references, not all of them are to journal articles.

Q. Okay. A hundred and two references, obviously you're very familiar with each of these references, of course? A.  Yes.

Q. And, in fact, I see in at least in a few occasions that you actually cite Dr Friedlander's work? A.  That's correct.

Q. And Dr Friedlander, as you are aware, is someone who we may be hearing from in this court martial? A.  Yes.

Q. Okay. Now I understand that your CV is slightly out of date and that there are other publications relating to biological warfare and anthrax that have not been included on this? A.  That's correct.

Q. Can you recall them at this time? A.  I can't even recallÐÐyeah, I'm sorry, I can't recall them all. But there have been about four more publications on the basic issue of anthrax and anthrax vaccine.

Q. Okay. Now going back to the Shays report, I understand that in your involvement with your testimony in Shays, that you were given a certain access to certain materials? A.  That's correct.

Q. What access were you given? A.  The Department of Defense provided Shays Committee with 34 boxes of documents regarding the anthrax vaccine program and I was given access to many of those documents.

Q. Okay. So you certainly reviewed these documents. Were these public documents, or were they just in the ... A.  They were mixed. Most of them are not public documents but some are.

Q. Okay. And in the course of your consulting to Shays, you had a chance to review these documents? A.  Yes.

Q. Okay. There's one other thing I wanted to ask you about, were you involved in the GAO, the General Accounting Office? A.  Yeah, the ...

Q. First of all, if you could tell us what the GAO is? A.  The General Accounting Office, or GAO, is the investigative arm of Congress. So congressional committee and subcommittee members can request the GAO investigate something for them and provide reports and congressional testimony, and this has been done on a number of occasions for anthrax vaccine. And the division of the GAO which did this investigative work used me as a consultant on a number of unpublished studies they were reviewing of the safety and efficacy of anthrax vaccine.

Q. Okay, so in the course of your consulting for the GAO, you were able to review the unpublished literature? A.  Yes.

ASSISTANT DEFENCE COUNSEL: Okay. Thank you, Dr Nass, those are all the questions that I have. Major Fullerton will have some questions for you.

PROSECUTOR: Dr Nass, you are an internist and an emergency room physician?

WITNESS: That's correct.

PROSECUTOR: Okay. And you practice at Parkview Hospital in Brunswick, Maine?

WITNESS: Yes.

PROSECUTOR: And that is a full-time job for you?

WITNESS: I have primarily a private practice, and I work once a week at Parkview Hospital.

PROSECUTOR: Okay, so how many hours a week would you be spending in your private practice and at the emergency room at Parkview Hospital?

WITNESS: That is variable, anywhere from 20 to 40, depending on my other commitments.

PROSECUTOR: And in the course of yourÐÐhow many patients suffering from anthrax have you seen as part of your practice at Parkview Hospital?

WITNESS: Now that's a very good question, because I don't know how many of the Gulf War vets are suffering due to anthrax vaccine. But I see some Gulf War vets and I see patients with chronic fatigue syndrome, fibro-myalgia syndrome, multiple chemical sensitivity as well as standard internal medicine patients.

PROSECUTOR: So how much research of anthrax as a disease do you do in your capacity as an emergency-room physician or in your capacity in private practice?

WITNESS: Well, actually there aren't any physicians who are able to research the disease anthrax within their practices, because there is less than one reported case in humans per year in the entire United States.

PROSECUTOR: So there is actually less than oneÐÐso you're saying that the cases of anthrax as a disease in the United States are really not too common?

WITNESS: Correct.

PROSECUTOR: It's not something that you do in the course of your medical career?

WITNESS: That's correct.

PROSECUTOR: So your interest in anthrax is entirely outside the scope ofÐÐyou described it as a hobby, is that correct?

WITNESS: Let me say this: It used to be entirely outside the scope of my professional work, but to my surprise my professional work and my work on anthrax have dovetailed in that I have learned that anthrax vaccine in some cases is causing the same syndrome that I am treating in patients with Gulf War illness, chronic fatigue syndrome and fibro-myalgia, as well as multiple chemical sensitivity. So I've been gratified that actually my medical expertise in those areas, which are also somewhat arcane, has been perhaps transferable to anthrax vaccine recipients.

PROSECUTOR: You have no degreesÐÐyou took a Bachelor of Science in Biology from MIT in 1974?

WITNESS: Yes.

PROSECUTOR: And you took an MD from the University of Mississippi Medical School in 1980?

WITNESS: That's correct.

PROSECUTOR: And you don't have any degrees or studies related to the manufacture of pharmaceuticals, do you?

WITNESS: No, I don't. But what I did do is I worked at the John Curtin School of Medical Research in Canberra, Australia, in the Immunology Department for 18 months, between university and medical school. So I actually do have some additional experience in the field of immunology.

PROSECUTOR: So that was prior to you becoming a doctor?

WITNESS: That's correct.

PROSECUTOR: That was prior to you going to medical school. And you functioned there, as I understand it, as a laboratory technician?

WITNESS: Yes. But I also was given the scope to review literature and write research proposals in that job and did publish a paper in that capacity.

PROSECUTOR: What was the paper that you published?

WITNESS: It was basically a paper about antibody production in sheep that had been immunizedÐÐI can't recall the name, but it's in my CV.

PROSECUTOR: Have anything to do with anthrax?

WITNESS: It did not, but it did have to do with the issue of immunity.

PROSECUTOR: And you did not occupy a senior position in the Department of Immunology at John Curtin School of Medical Research?

WITNESS: Absolutely not.

PROSECUTOR: No. You were a laboratory technician II?

WITNESS: Yes.

PROSECUTOR: And have you ever worked within a business where they manufacture pharmaceuticals?

WITNESS: No, I have not.

PROSECUTOR: Did you ever work for the Center for Disease Control?

WITNESS: No, I have not.

PROSECUTOR: Did you ever work for the Federal Drug Administration?

WITNESS: No.

PROSECUTOR: Have you ever worked for USAMRIID?

WITNESS: No.

PROSECUTOR: Ever worked for any other investigative or regulatory organization?

WITNESS: No, I have not.

PROSECUTOR: Have you done any original laboratory research with respect to the American anthrax vaccine?

WITNESS: No, I have not.

PROSECUTOR: Now you worked for the Cuban government for a period of time, or were recognized by them, that had nothing to do with anthrax?

WITNESS: No, that was to do with an epidemic of illness that affected 50,000 people in Cuba that was felt to be possibly chemical or biological warfare. And as a result of my developing mechanisms for investigating epidemics, to determine what had caused them, which was the reason I did the Zimbabwe study, I was asked by one of the publishers of an article I'd written to try and look into the Cuban epidemic. And I did that and gave him my thoughts on it, which were that the epidemic was likely due to very small but probably chronic ingestion of cyanide in a setting of nutritional deficiency. And, subsequently, other people have acknowledged that that was in fact the putative cause of that epidemic. So the publisher passed my writings on to, I guess, somebody in the Cuban Embassy, and I was invited to consult for the Ministry of Health back in 1993.

PROSECUTOR: Now there is a branch of medicine called Immunology that is concerned with vaccines and immunization, isn't that correct?

WITNESS: A branch ofÐÐyes, I guess.

PROSECUTOR: You'd agree with me that there's a branch of medicine called Immunology?

WITNESS: Absolutely. But actually, a lot of people get into, yeah, people get into the field of immunology through a lot of different directions. So probably the majority of people in the field have PhDs in different subjects rather than MDs.

PROSECUTOR: Okay. So PhDs in immunology?

WITNESS: In immunology or, yeah, in bio-processing and things like this.

PROSECUTOR: And you don't have a PhD in immunology?

WITNESS: No.

PROSECUTOR: And you are not an immunologist?

WITNESS: No.

PROSECUTOR: And that's a specialized area of study?

WITNESS: Well, the thing is, you see, at least in our country, the MD degree, and certainly training in internal medicine gives you, sort of, a broad overview of a number of subjects, and infectious disease is one of the sub-specialties of internal medicine, and so we all have a bit of training in this area, although it's not extensive. And we are, you know, I am expected to know about vaccines, to administer vaccines, to be cognizant of the side effects and the issues with respect to vaccines, and I'm also expected to be able to review medical literature and make determinations.

PROSECUTOR: So you've described yourself as having a bit of training although not extensive?

WITNESS: That's correct.

PROSECUTOR: You are not an immunologist?

WITNESS: I'm not an immunologist, but I actually know a lot of immunology.

PROSECUTOR: But you're not trained in immunology?

WITNESS: No. But, for instance, with my ...

ASSISTANT DEFENCE COUNSEL: Well, perhaps if my learned friend could phrase it that she's not formally trained, because our suggestion is she is trained, but perhaps not ...

MILITARY JUDGE: Yeah, but what is your objection? What is your objection, really? What do you object to?

ASSISTANT DEFENCE COUNSEL: That Major Fullerton frame it that she's not formally trained, not that she's not trained, because her evidence is she is trained.

MILITARY JUDGE: But your objecting that the question is not proper?

ASSISTANT DEFENCE COUNSEL: Well, that it should be framed more correctly. I'm objecting to the form of the question.

MILITARY JUDGE: Well, I don't see any difficulty with the question the way it was posed to the witness, I'm sorry.

So carry on.

WITNESS: I guess, if I can, for instance, the fellow who asked me to write that article in Infectious Disease Clinics of North America, the editor of that volume, and the volume was called, "New Vaccines and New Vaccine Technology", was an internist with probably some specialty training in infectious disease but it's unlikely that he got any additional training in immunology. Because in the medical field there really isn't any unless you perhaps work specifically at FDA or CDC, there really isn't any formal immunology training that you get beyond what you get in infectious disease, unless perhaps you did a residency in allergy and then you might get some immunology training there. But it's notÐÐthere isn't a lot of formal training in immunology.

PROSECUTOR: Okay, but earlier you said there were PhDs in immunology?

WITNESS: Right. But within the medical, you know, I mean, within the medical branches. If you have a medical degree, you go down a certain track, you do residencies, that's how you get training. And there isn't an immunology residency.

PROSECUTOR: But there are people who have formal training in immunology, who have PhD degrees in that area and you are not one of them?

WITNESS: Right. That's true, and there are also many people who are veterinarians and medical doctors with training similar to my own who enter the field; people who I worked with when I was in the Immunology Department in Canberra with no more formal training but still become physicians withÐÐor a veterinarian with expertise in this area.

PROSECUTOR: So there are veterinarians that develop expertise in immunology?

WITNESS: And medical doctors without any additional formal training.

PROSECUTOR: But there is also a branch of medicine called Immunology?

WITNESS: Yes.

PROSECUTOR: Okay. And you do not share the qualifications the PhD in that branch of medicine?

WITNESS: Absolutely not.

PROSECUTOR: You're not a research scientist?

WITNESS: I would say that I was at one time when I worked in the immunology department, but I am no longer. I'm a physician.

PROSECUTOR: When you worked in the Department of Immunology at John Curtin School of Medical Research?

WITNESS: Uh-huh.

PROSECUTOR: When you were a Lab Tech II?

WITNESS: That's correct, but, as I said, I was given responsibility at that time to develop some research projects.

PROSECUTOR: Relating to sheep and not relating to anthrax.

WITNESS: Relating to immunology, sir.

PROSECUTOR: And you're aware that there are individuals who have studied the researchÐÐor researched the anthrax vaccine over lengthy careers in the United States?

WITNESS: Yes, I am. I know most of them.

PROSECUTOR: You're talking about people like Dr Friedlander?

WITNESS: Absolutely.

PROSECUTOR: And he's an expert in the anthrax vaccine?

WITNESS: Uh-huh.

PROSECUTOR: You'd agree with me?

WITNESS: I certainly would.

PROSECUTOR: Now you indicate that you spent some time studying Zimbabwe's anthrax epidemic?

WITNESS: Uh-huh.

PROSECUTOR: And that took place some 30 years ago, the epidemic?

WITNESS: Twenty years ago.

PROSECUTOR: And you studied it in the early 80s, is that right?

WITNESS: No, it occurred in 1979 and 1980 and I studied it between 1989 and 1992.

PROSECUTOR: Okay. And how did you go about researching it? You just read literature, is that it?

WITNESS: I read the literature, I went to Zimbabwe and went through the case reports and the descriptions of the illness, and I spoke with people who were involved with the epidemicÐÐnever did any lab researchÐÐand wrote a paper that has been widely cited in a variety of countries as a landmark study.

PROSECUTOR: And it was a landmark study. And what exactly was the focus of your landmark study and what were the conclusions?

WITNESS: The conclusions were that the epidemiology of the epidemic did not fit a known pattern and there were a number of aspects of that, and that, therefore, it was likely to be due to biological warfare, and that when one was trying to study an epidemic that there were certain features of the epidemic that should be investigated in order to make a determination of the likelihood of whether it was a naturally occurring or a deliberately created epidemic.

PROSECUTOR: So the focus of your study was really on creating ...

WITNESS: Criteria.

PROSECUTOR: Criteria to determine whether it was naturally occurring, or whether it was weaponized?

WITNESS: Yes.

PROSECUTOR: So where did you publish that study? Or did you publish that study?

WITNESS: That was published in the Physicians for Social Responsibility Quarterly.

PROSECUTOR: Was it published anywhere else?

WITNESS: No, the study itself was only published there, but there were articles about it in articles I wrote which were briefer versions, other places.

PROSECUTOR: Physicians for Social Responsibility Quarterly, is that a peer reviewed journal?

MILITARY JUDGE: Is that what? I didn't hear the word.

PROSECUTOR: A peer reviewed journal.

MILITARY JUDGE: Okay.

WITNESS: To my knowledge it is.

PROSECUTOR: You're not sure?

WITNESS: I would only know if they sent meÐÐI would only know for sure, because it may only be reviewed by the editor, they do not send me comments of reviewers. I wasn't asked to rewrite the article, which is often the case if you get reviewers comments and the request for a rewrite, you know that there were reviewers. But in fact no ones ever done that with any of the articles I've written, so I can't tell you for sure, but I think it's a peer reviewed journal.

PROSECUTOR: But you have no reason to believe that it was reviewed by your peers?

WITNESS: Well, let me say that I know it was reviewed by a number of my peers, certainly after publication, because as a result of that article Peter Turnbull, who was the top anthrax vaccine researcher in England and the person who puts together the only anthrax conference in the world, the International Anthrax Workshops, invited me to present the results of that research at the next conference in 1995.

PROSECUTOR: Now you talked about the Physicians for Social Responsibility Journal and you've talked, the organization Physicians for Social Responsibility. Can you tell the court what the mandate of that organization is?

WITNESS: Yes. I think it's an organization whose thrust is arms control, and I considered myself an arms control advocate and still do; biological, chemical and nuclear arms control.

PROSECUTOR: So the focus of that organization is on arms control and you are a strong advocate of arms control?

WITNESS: I am.

PROSECUTOR: And you were a spokesman for this arms control organization?

WITNESS: Yes.

PROSECUTOR: In your talks at Stanford that you spoke about, were you talking as a representative of Physicians for Social Responsibility?

WITNESS: Probably.

PROSECUTOR: So you were talking as a representative of this arms control group?

WITNESS: Uh-huh. Well, let me say that they got my name through Physicians for Social Responsibility and then they approached me directly and there were noÐÐPhysicians for Social Responsibility has never ever told me what I could or couldn't say or what to say. But they get a lot of requests for speakers and so I was one of their speakers.

PROSECUTOR: And the International Anthrax Conference in England, I think you said it was in 1995, who sponsored that conference?

WITNESS: That's initiated by the group on biological defence at Portondown in England, which is the opposite number as Fort Detrick in the United States.

PROSECUTOR: And did you speak there as a representative of Physicians for Social Responsibility?

WITNESS: I wouldn't be speaking at a professional conference as a representative ofÐÐI would be presenting my data when I go to a professional conference. I was not able to attend that conference, and I attended the subsequent work conference.

PROSECUTOR: So you never actually attended the international conference in England in 1995?

WITNESS: No, I attended in '98, the next one.

PROSECUTOR: And when you attended in 1998, did you speak at that time?

WITNESS: No. They were not having the panel on biological warfare during that conference, so I really didn't have anything special to present there.

PROSECUTOR: So you never attended in 1995 and you never spoke in 1998, you just attended as a member of the conference?

WITNESS: That's correct.

PROSECUTOR: Now have you ever been recognized as an expert in any court in the United States on the issue of anthrax?

WITNESS: Yes, I guess. I mean, a military hearing, would that be a court?

PROSECUTOR: Well, was it a court? What was the focus of the hearing?

WITNESS: The focus of the hearing was a military officer who was being reprimanded, potentially, for refusing the anthrax vaccine.

PROSECUTOR: And did that take place in an officer's office, or did that take place with a judge sitting at the front and lawyers?

WITNESS: Lawyers and three judges.

PROSECUTOR: Three judges. And what was the focus of your testimony at that time?

WITNESS: My focus was the safety and efficacy of the anthrax vaccine.

PROSECUTOR: And did you in fact testify at that time?

WITNESS: I did.

PROSECUTOR: Now this Shays report that you are talking about. Are you talking about the report that was prepared by "the majority staff of the Subcommittee on National Security, Veterans Affairs and International Relations"? I can go on: The "House Committee on Government Reform. By Request of the Subcommittee Chairman, Vice Chairman and Ranking Member". Is that the report you're talking about?

WITNESS: Uh-huh.

PROSECUTOR: Okay. That report, that is not yet out except in draft, is that correct?

WITNESS: No. The full committee on government reform voted unanimously on, I believe, March 12th, to accept that report.

PROSECUTOR: Is that a political report? or is that a scientific report?

ASSISTANT DEFENCE COUNSEL: I don't understand the question.

PROSECUTOR: Is that ...

MILITARY JUDGE: Just a moment. What is your objection?

ASSISTANT DEFENCE COUNSEL: I don't understand the question, and if I don't understand I'm sure that Dr Nass won't understand ...

MILITARY JUDGE: Well, just a moment, just a moment.

ASSISTANT DEFENCE COUNSEL: Well, when my ...

MILITARY JUDGE: Just a moment. An objection has got to be done in accordance with the Rules of Evidence. The fact that you don't understand is not a ground of objection. If the witness doesn't understand, she'll be able to speak for herself and say, I don't understand. But your ground of objection, you've got to tell me first, what is your objection to that specific question.

ASSISTANT DEFENCE COUNSEL: Well, I wish my learned friend would clarify what he means by "a political report". Now this is something that I can deal with in re-examination. But I don't understand a political report versus a scientific report.

MILITARY JUDGE: Well, maybe it'll come clearer when the answer is or isn't given, but that's not a ground of objection, I'm sorry.

PROSECUTOR: Is that a report that was done by scientists analysing their own scientific research? or is that a report that was done by politicians considering the political aspects of various matters?

WITNESS: Neither. It was written by the staff of the subcommittee using extensive information gathered at large hearings of subcommittee and committee hearings, so I believe that there were at least seven or eight committee and subcommittee hearings on the anthrax vaccine. And the General Accounting Office, the group that has been doing the research for Shays Committee includes PhDs with degrees in public health. And so these people certainly have a research scientist background and have presented a lot of scientific evidence to Shays Committee which wasÐÐas well as my own scientific as well as political comments on the utility of the vaccine, and the comments of many others which have included many scientists, physicians, PhDs, public health persons. These hearings, most of which I attended, had people from the FDA, from the General Accounting Office, from the military, medical establishment and civilians such as myself testify. So there is a wide range of political and scientific information in this 120-page report.

PROSECUTOR: And approximately how many witnesses would've appeared at that committee?

WITNESS: I didn't count, but I would say it would be between 50 and 100.

PROSECUTOR: Okay, so you were one of those fifty to a hundred witnesses?

WITNESS: Yes.

PROSECUTOR: Now you talked about, as part of your involvement in the Shays report, you were given 34ÐÐthere were 34 boxes of documents that were given to participants?

WITNESS: No.

PROSECUTOR: Okay. Clarify that ...

WITNESS: They were given to the Shays Committee.

PROSECUTOR: Yeah. And you did not review all of those documents?

WITNESS: No.

PROSECUTOR: And were you excluded from or chose not to review some of those documents?

WITNESS: I didn't have the time to review all 34 boxes.

PROSECUTOR: Okay. So when my friend says you were given access to 34 boxes of documents, in fact you may have reviewed only a very small portion of those documents?

WITNESS: I'm not the only one who's reviewed them, other people that work with me that are in the military and/or have retired from the military, and so we each went through a lot of it; I would say that probably the majority has been reviewed and what we found of interest we shared with each other.

PROSECUTOR: Well, how many of those documents did you review of those 34 boxes?

WITNESS: As I say, what other people found of particular interestÐÐdo you want to know how many boxes of documents I have at home? I'm not sure what you're asking me.

PROSECUTOR: Well, my friend has ...

WITNESS: All I can say is that I've reviewed thousands of pages of documents, including Freedom of Information Act requests that I filed with the FDA myself.

PROSECUTOR: And you indicated that the GAO used you as a consultant at one point?

WITNESS: Yes, that's correct.

PROSECUTOR: Were you the only consultant used by the GAO?

WITNESS: Well, I know that Jack Melling was used as well.

PROSECUTOR: And were you involved in that asÐÐwere you contacted through Physicians for Social Responsibility as part of that involvement?

WITNESS: No, no, this has nothing to do with Physicians for Social Responsibility; that was something I did in the early 90s.

PROSECUTOR: Are you still a member of Physicians for Social Responsibility?

WITNESS: I'm still a member, but any work that I'm doing now has not been under the auspices of Physicians for Social Responsibility.

PROSECUTOR: You described yourself as a spokesperson for Physicians for Social Responsibility?

WITNESS: At the time of the Gulf War and afterwards, I was one of the national spokes-people. Subsequently their staff has changed, my interests have changed and they have not had a strong interest in pursuing the vaccine issue and I haven't really pursued it with them. You have to realize that my life is very busy and I work about a hundred hours a week, probably, 80 to a hundred, and so people call me and ask me to write articles or to do things, and if they're interested, I will often do it for them, but I don't have time to call Congress or to call other organizations and ask them to join a bandwagon. So Physicians for Social Responsibility hasn't evinced any interest in this area and I haven't pursued it with them.

PROSECUTOR: You talked about other retired military members that you work with. What is your involvementÐÐdo you work as part of a formal group together?

WITNESS: There's no formal group, no. Basically, what happened is I wrote an article a little over two years ago outlining what was known in the published literature about anthrax vaccine. And this little article, which I didn't intend to be any big thing, wound up getting a lot of attention and resulted in me receiving thousands of phone calls and letters and emails from many, many people and many requests to write articles and to give talks, and eventually requestsÐÐI did not initiate contact with the Shays Committee, but other people brought me to Shays Committee and asked me to widen my involvement in the issue, and because I was very concerned that they were unable to get the information that I possessed elsewhere, and then subsequently became concerned because so many ill people were contacting me and they didn't have any means of getting treatment or evaluation for their illnesses, I wound up, basically, allowing this issue to take over a large proportion of my time and my professional activity.

PROSECUTOR: This is a letter that you published on the Internet, is that right?

WITNESS: It was a post to an infectious disease mailing list called "Pro-Med Mail", of which I am a member and many of the people who have served with me in Federation of American Scientists are also members and moderators. Actually, the Pro-Med Mail mailing list was set-up by Federation of American Scientists initially as a means of performing surveillance for epidemics for biological warfare. So one of my standard professional activities was to be a member of this mailing list, and when I posted the article on anthrax vaccine to it in late December of 1997, I did so knowing that there were other anthrax experts on the list, and I was trying to initiate a discussion about the usefulness and safety of anthrax vaccine in light of the fact that it had just been announced that 2.5 million people were to get the vaccine and in light of the fact that I knew there was no published evidence as to its safety or efficacy.

PROSECUTOR: So this letter that you published at Pro-Med or on the Internet brought you in to some prominence with respect to the anthrax vaccine?

WITNESS: That's correct.

PROSECUTOR: And this letter that you published on the Internet which brought you in to some prominence with respect to the anthrax vaccine focussed your attention to a certain amount on the AVIP program in the United States, is that right?

WITNESS: That's correct. It was in response to the announcement of the AVIP program that I wrote it.

PROSECUTOR: And what was yourÐÐokay, and your position was that there was no published data on the safety or efficacy of the vaccine?

WITNESS: That's correct.

PROSECUTOR: You've indicated that you worked as a medical doctor, either in your private practice or at an emergency room, some 20 to 40 hours per week?

WITNESS: Uh-huh.

PROSECUTOR: But you work somewhere around a hundred hours per week. Is that with respect to the AVIP program?

WITNESS: That's correct. I get so many requests for information, emails and phone calls every day, and I had to actually develop a web site, which fortunately my teenage son was able to do for me, to put a lot of my writings and other writings on a web site so I wouldn't have to answer all the phone calls and my secretary can refer people to the web site.

PROSECUTOR: So you are the operator of a web site?

WITNESS: That's correct.

PROSECUTOR: Now you had testified that you were an arms control advocate?

WITNESS: Uh-huh.

PROSECUTOR: Would you now characterize yourself as an anti-anthrax vaccine advocate?

WITNESS: No, not at all.

PROSECUTOR: And how would you characterize yourself on the issue of the anthrax vaccine?

WITNESS: Well, I think that whenever you're talking about a medical intervention, any intervention; be it, surgery, pills, vaccine, whatever, one is required to perform risk/benefit analysis. And for this particular anthrax vaccine, the risk/benefit analysis clearly is in favour of not using it unless under the most very limited and extraordinary conditions. And the nitty-gritty as to why I have that position is in that review article, which you may wish to read.

PROSECUTOR: The review article that you've given to my friend?

WITNESS: Yeah, where I've reviewed all the research on anthrax vaccines and, potentially, I would be in favour of a safe and effective anthrax vaccine, but the current one being used in the AVIP is neither.

PROSECUTOR: So in coming to all of your conclusions, you have relied on the research of other individuals, the laboratory research of other individuals?

WITNESS: That's correct.

PROSECUTOR: Individuals like Dr Friedlander?

WITNESS: Actually, when I was speaking to Dr Ivins, who is the primary laboratory researcher on anthrax vaccine ...

MILITARY JUDGE: Doctor who?

WITNESS: Dr Bruce Ivins.

MILITARY JUDGE: Ivins, okay.

WITNESS: He told me that Dr Friedlander actually hadn't done any lab research on anthrax in quite some time.

He told me that Dr Friedlander is probably not being vaccinated with the anthrax vaccine anymore because it's been a long time since he's had to go into the hot rooms.

PROSECUTOR: Well, we will hear.

I have no further questions of this witness.

MILITARY JUDGE: Yeah?

ASSISTANT DEFENCE COUNSEL: Your Honour, if I can have a brief adjournment to consider a re-examination?

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL: Thank you.

MILITARY JUDGE: Ten minutes.

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour, for that longer than expected break. One of the reasons why it was longer is I needed to get a photocopy of the Shays report, which I have and it would be my intention to tender it at this time. The reason why I'm tendering it, Your Honour, is because my learned friend got into the substance of the report when he questioned, for example, whether it was scientific or political. And so it's our opinion that the report speaks for itself and that Your Honour should have a copy so that you can review the report.

PROSECUTOR: I would be objecting to the introduction of this report as irrelevant. I talked a little bit about the Shays report only in response to my friend's comments and the testimony she elicited about the Shays report. The Shays report is really, and you can see right from the first paragraph, it responds to service members with respect to the anthrax vaccination immunization programÐÐthat is a program that we do not have in CanadaÐÐit talks about the universal vaccination of all service members in the United States. It's a very different issue than we face here in this court where we're talking about the vaccination of one individual who is faced with an assessed threat and on a specific operational mission where anthrax is a concern. So I would be objecting to the introduction of this report into evidence, it is simply not relevant to the issues before this court.

ASSISTANT DEFENCE COUNSEL: Your Honour ...

MILITARY JUDGE: Just a moment, I just want to make sure that I understand. What we're doing now is determining whether this court will qualify this witness as an expert, that's all we are doing.

ASSISTANT DEFENCE COUNSEL: Yes, yes.

PROSECUTOR: That's right.

MILITARY JUDGE: So if this, which is not the witness' report, I understand, is not going to assist you in convincing the court that it should qualify the witness or not, then it's useless. I'm not saying it's not going to be useful later on if the witness is qualified as an expert. At this time, though, I wonder why you're trying to put this in evidence on this issue of qualification, okay, that's all.

ASSISTANT DEFENCE COUNSEL: And I appreciate the concern, Your Honour. And while I agree with my learned friend that this report may not be determinative of the issue that's at the heart of the plea in bar, that it does go to the issue of qualifications insofar as my learned friend raises whether Dr Nass was giving scientific or expert evidence, or whether it was a political agenda that was being proffered in this report. And what Your Honour is going to see is that it is, what we say and Your Honour can see the report for yourself, very much a report dealing with scientific expertise and that Dr Nass was testifying as an expert in the science.

And you will be able to see as well, and I suggest that this is relevant in terms of her qualifications as an expert, that there are various footnotes. For example, on page 81, footnote 233, right at the bottom, refers and incorporates the prepared statement of Dr Meryl Nass. So when I ask Your Honour to consider Dr Nass as an expert and I proffer evidence that she has been qualified or she has been accepted by, for example, the congressional hearings as an expert, then I suggest that this document corroborates that assertion, it's ...

MILITARY JUDGE: In that limited sense, yes, I guess it's acceptable.

ASSISTANT DEFENCE COUNSEL: Very well then, thank you.

MILITARY JUDGE: Major Fullerton, in that limited sense, to indicate that, yes indeed, the witness has at times, on occasion, testified as a witness.

PROSECUTOR: In that very limited sense, Your Honour.

MILITARY JUDGE: Yeah. Now the proof that will be offered based on that report and the contents and the conclusion, that reflects something else, that's another issue at this time.

ASSISTANT DEFENCE COUNSEL: Yes.

MILITARY JUDGE: Okay, so we'll mark this just as on this issue of qualification for the very specific purpose that I just outlined. It's an indication that the Doctor, the witness has been, from all appearances, been considered an expert by various bodies and organizations and that's only to add to this issue of qualification.

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour, thank you very much.

MILITARY JUDGE: Okay. So we'll take it, we'll mark it 40. But just for that purpose at this point.

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour.

THE SHAYS REPORT PREPARED BY THE MAJORITY STAFF IS MARKED EXHIBIT VD40.

ASSISTANT DEFENCE COUNSEL:

Q. Just on that point, Dr Nass, if you could clarify: My learned friend asked whether this was a scientific or a political enquiry. You were asked to testify in terms of your scientific knowledge, is that correct? A.  That is correct, that's absolutely correct. I mean, my primary testimony was scientific but at the same time, because I also have a background in biological arms control, there are aspects of things to which I testified which have to do with strategy and necessity of the program.

Q. Okay. You weren't asked, in other words, to testify as a spokesman for any political group or anything like that? A.  No, absolutely not.

Q. I don't think I made it clear in direct examination, Your Honour, I apologize for that. What was the Shays Committee looking at? A.  They looked at actually all aspects of the anthrax vaccine program.

Q. Okay, okay, so it was specific to anthrax? A.  The Shays Committee, yes. And yet the larger committee on government reform, actually, has had hearings looking at, and possibly Shays, I'm not certain, at the issue of other vaccines for biological warfare and other vaccines in general. So although the vast majority of the time I've spent with Shays has been limited to the anthrax vaccine, I have not testified before the committee but I have occasionally spoken with staff on the issue of other vaccines for biological warfare.

Q. Okay. And just so that it is clear that the Shays Committee was a Subcommittee on National Security, Veterans Affairs and International Relations of the House Committee? A.  Yes.

Q. Okay, fair and good. In terms of what my learned friend asked a number of questions regarding formal training, is there any kind of formal training program in anthrax, that you're aware of? A.  No, there is not.

Q. Okay. So the way someone becomes an expert in anthrax is by, for example, studying the literature? A.  Yes.

Q. And that's what you've done? A.  That's correct.

Q. And my learned friend also asked you if you were acquainted with a number of the experts in the field? A.  That's correct.

Q. Is it fair to say that they're acquainted with you? A.  We're acquainted with each other.

Q. And Dr Friedlander knows who you are? A.  Yes, he does.

Q. And it's in the context of work in this area? A.  Yes.

Q. Now my learned friend also asked regarding peer review journals. Is it fair to say that the majority, if not all, of the journals cited in your CV are peer review journals? A.  As I said to him, I think they are but I can't guarantee that. I haven't studied that question.

Q. What about The Lancet? A.  The Lancet is certainly a peer reviewed journal, but I didn't publish an article, I published a long letter at the request of one of the editors of The Lancet.

Q. You were invited to do that? A.  I was invited to submit that.

Q. And throughout, what I would say is extensive publication history, you've never been asked to rewrite your articles? A.  No.

ASSISTANT DEFENCE COUNSEL: If I can just have a moment, Your Honour.

Thank you, Your Honour, that completes my re-examination.

MILITARY JUDGE: Just one last point that was raised. There is no actual formal training in anthrax, by that you mean no formal training at the university level or research? At what level ...

WITNESS: Well, see, anthrax is a very tiny, tiny piece of infectious disease. Being such a rareÐÐnow a hundred years ago that might not have been the case when anthrax epidemics were rampant in Europe and in North America, but now there are very, very few cases, even in animals and certainly in humans, and so there are no courses in anthrax. If you did a PhD focussed on research into anthrax, you would get your training by reading the literature and doing laboratory research. But biological warfare is not aÐÐI've suggested that courses in it be developed, maybe, at the medical school level or the university level, but to my knowledge there are none at this time in North America.

MILITARY JUDGE: Just to make sure that I understand as well, your personal knowledge in relation to the anthrax disease and the anthrax vaccine is the review of literature?

WITNESS: Absolutely.

MILITARY JUDGE: You haven't done any lab work on ...

WITNESS: I have not.

MILITARY JUDGE: So your articles, for example, are your own personal evaluation, review, consideration and opinion on what other people have said about the anthrax disease and vaccine?

WITNESS: Absolutely.

MILITARY JUDGE: Okay, that's the questions that I have for the witness, okay. So we will now consider this issue of expertise. I will ask both counsel to have a few remarks for me, and in order to do that I'm going to ask you to step out. Thank you. And don't go too far, we'll call you back.

THE WITNESS RETIRES.

MILITARY JUDGE: Now before we proceed with your remarks, I'm going to make a few remarks so that we all speak from the same rules, Rules of Evidence being quite essential in the determination of the expertise of a witness.

I draw your attention to Rule 81, okay. So I want to make sure thatÐÐMajor Fullerton is probably more familiar because he's in the system, and I'd like you to make sure you get the Rules, take your time there, no problem. I want to make sure that ...

DEFENCE COUNSEL: Thank you. We've got them here.

MILITARY JUDGE: So go to Rule 81:

that's military judge now,

That's the standard that you have to meet, the defence has to meet in order for the court to qualify Dr Nass as an expert. Having said that, I'm listening to your remarks.

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour. With regard to Rule 81, it's our respectful submission that Dr Nass is necessary to substantially assist the court in terms of understanding the evidence that we're proposing to offer regarding the anthrax illness and the anthrax vaccine. And it's our respectful submission that Dr Nass is more than able to assist the court in that she possesses the specific skill, experience and training in this regard. Specifically, Your Honour, it was clear and uncontradicted, I suggest, by my learned friend that Dr Nass is qualified as a medical doctor and that she has the sub-specialty as an internist, and we heard from that, she has extensive experience in that field, both in private practice and as well as a teacher. I don't expect that my learned friend will be particularly controversial about that aspect of Dr Nass' qualifications.

What I anticipate, however, is that my learned friend will raise objection to Dr Nass' qualifications in terms of her expertise on bio warfare and in particular anthrax and anthrax vaccine. We heard from Dr Nass that there is no formal training in terms of the anthrax vaccine or the anthrax illness. Certainly, my learned friend raised some concerns about whether she had a PhD in immunology or something like that. Dr Nass, however, has indicated that as late asÐÐor as early as 1989, she developed an interest in this area and that she commenced an extensive review of the literature, and I suggest, with respect, that it was during those years that she equipped herself as an expert with the literature. As Your Honour heard in her testimony, she reviewed the published literature as well as the unpublished literature and several thousand pages of documents that were compiled by the DOD.

So we say that through a period of self-study and self-instruction that she equipped herself to be an expert in this somewhat narrow and specific area. And as we heard from Dr Nass as well, that if there was such a program to equip an individual with this kind of expertise, that individual would do exactly what Dr Nass has done, and that is become fully cognizant of the literature and, in fact, she has formed a variety of different opinions and has evaluated the literature.

In that regard, Your Honour, Dr Nass has also established herself as being recognized as an expert by a number of people. She gave evidence that she has testified, certainly extensively, throughout the United States in this area. And in terms of other international locale, she was invited to Zimbabwe to speak; she spoke in Nairobi, for example, all in terms of this specific and narrow area of expertise. We heard from her evidence that she has testified as an expert before a military tribunal before; we heard that she has given a number of speeches and she has attended a number of conferences and associated gatherings where she has been accepted as an expert.

Perhaps a clearer example, Your Honour, is the extensive literature that Dr Nass has produced over the years. As you have seen from VD39, her CV, you will see that since 1991 she has published extensively, and I urge Your Honour to recall that Dr Nass seemed to recall there were three or four further articles that were not specifically written on this CVÐÐit's somewhat out of dateÐÐbut it shows that throughout the 90s that she did publish extensively, and specifically regarding the anthrax illness, for example, in Zimbabwe, and throughout her experience she has talked and written extensively about the anthrax vaccine.

So I suggest that she has equipped herself with expertise and that she has been recognized as an expert both in terms of being invited to speak throughout the country and in fact internationally on the subject and that she has been invited to contribute to the body of literature, and again, this is as an expert in this area. So she has been accepted by those in the field, substantially, over the years.

Perhaps most compelling, however, is that Dr Nass was invited to attend the Shays Committee, the congressional hearings into the anthrax illness and anthrax vaccine. She was invited to testify as an expert, not on any political platform, but to share and assist with the congressional hearing her expertise. And I suggest that it's a very similar situation; we're dealing with a very specific and technical body of scientific evidence, and just as the Shays Committee invited Dr Nass to assist them with the evidence, then I'm suggesting, with respect, that Your Honour can benefit as well from Dr Nass' experience.

And as we can see from the Shays Committee, which has been tendered as VD40, and we heard from Dr Nass as well in her direct evidence, that many of her comments and her observations were directly incorporated into the study report. So I suggest that perhaps more than anything, her expertise was accepted and in fact she was invited to assist at certainly the highest level of scrutiny in the United States.

So going back then to Rule 81, Your Honour, the question is: Is can Dr Nass because of her experience and her training and skill be expected to assist this tribunal? I suggest with respect that she has amply evidenced her expertise and I suggest with respect that she can certainly substantially assist this court in this very difficult and very technical area of evidence. Thank you.

PROSECUTOR: Your Honour, first ...

MILITARY JUDGE: Firstly, Major Fullerton, do you object to this court qualifying this witness as an expert?

PROSECUTOR: I have a few comments to make with respect to her qualifications. Pursuant to Military Rule of Evidence 81, my friend seeks to have this particular witness qualified as an expert with respect to internal medicine, bio warfare, anthrax and the anthrax vaccine, as I understand it. I have no difficulty with respect to her being qualified as an expert and being treated by this court as one who has the qualification, skill, experience, knowledge and training of a doctor with a specialty in internal medicine.

With respect to the issue of bio warfare, I would submit that that is a very broad topic and that there is really here no evidence before this court that this particular witness is in any way an expert in biological warfare. I think she has done one study about the Zimbabwe situation in which she made some concerns or observations about the differentiation between naturally occurring and weaponized anthrax that was published in an article which she cannot even vouch was peer reviewed. So I would submit that the evidence with respect to her expertise and knowledge with respect to bio warfare is scanty indeed.

There is no direct experience or original research with either anthrax as a disease or anthrax as a vaccine. This particular witness has not testified that she has ever even treated a case of anthrax or in any way researched that particular disease. She has simply, what I would call, done aÐÐshe has simply done a literature search and reviewed the literature of others in these particular areas. Again, she has never done any biological or lab research in respect to the vaccine or the disease.

With respect to her publication, she indicatesÐÐwell, I think there are 16 listed on her résuméÐÐthat one of them perhaps was published in a peer reviewed article; the rest she doesn't know, basically. So The Lancet was published in a peer reviewed article. I think she has spoken in Zimbabwe, outside of the United States, and recentlyÐÐand she's attended a conference in England.

So I would submit, Your Honour, that although she may have some level of knowledge about anthrax, she certainly has no skill, experience, or training with respect to biological warfare or the anthrax vaccinations or the anthrax disease. So it is my submission that this witness should really not be allowed to testify, absolutely not be allowed to testify as an expert in bio warfare. She may have some level of knowledge about anthrax and the anthrax vaccine, but to hold her out to this court as an expert in bio warfare is, in my submission, entirely beyond the testimony and qualifications that she has extended to the court.

And that's my submission. I recognize that the standard under Military Rule of Evidence is relatively low, but, nonetheless, I have some real doubts whether she meets that standard and I simply leave that to the court.

MILITARY JUDGE: I notice that you raise this issue of bio warfare, and, indeed, the witness has not testified so far about any special knowledge in bio warfare. She's talked about anthrax and anthrax vaccine, I understand that, and she's also alluded to whether the epidemic in Zimbabwe was natural or was as a result of the use of a biological weapon. Now that doesn't make her an expert in biological warfare, which is something else.

ASSISTANT DEFENCE COUNSEL: No, and I originally prefaced the examination of Dr Nass' credentials that she would be an expert in biological warfare, in particular anthrax and anthrax vaccine to distinguish the anthrax as a biological weapon, as opposed to, for example, we've heard of cutaneous anthrax that mill workers and veterinarians and the, sort of, the domesticated version of the illness. So when I said that she is an expert, or we were proffering her as an expert in bio warfare, it was only ever specifically with regard to the biological use of the anthrax as a weapon in war. So we're not trying to qualify Dr Nass in any other area of biological warfare, only into the anthrax.

And with regard to my learned friend's comment, if I may be permitted, my learned friend has indicated she has merely done a literature search. Certainly, her evidence is, however, that she may have actuallyÐÐshe may have treated individuals, she doesn't know, but she may have treated individuals with the Gulf War syndrome and the chronic fatigue syndrome, which is perhaps something that we'll get into, depending upon what Your Honour rules. So it's not exactly clear that her experience is restricted to a literature search.

And, furthermore, she also indicated that the incidence of anthrax illness, certainly as a biological weapon, is extremely rare, so the fact that it is rare in the field, I suggest, doesn't remove the possibility that Dr Nass is notwithstanding that a witness.

But again, at the heart of the defence's plea in bar, as Your Honour will recall, is, amongst other things, section 7 which is the security of the person, which brings us to the heart of the safety and the efficacy of the vaccine. And in that regard, it's our respectful submission, that she can more than be qualified to testify on the safety and efficacy of the vaccine, and that goes to the very heart of the defence's plea in bar.

Thank you.

MILITARY JUDGE: The court is satisfied under Rule 81 that Dr Nass is able to assist the court and that to a level that is substantial. So the court is prepared to accept that. It's obvious that the many years she's been involved in considering other peoples research and other peoples conclusions and doing what she said to the court, in a question by the court, was essentially a literature analysis of the anthrax disease and the anthrax vaccine, it qualifies her to help the court. Otherwise, the court would have to look at all these documents and I certainly don't have the expertise to understand what is saidÐÐwhat was done by those researchers. So, in that sense, the witness can assist the court as an expert.

And in so doing, as Rule 63 providesÐÐit's amazing how these Rules makes for interesting reading:

How interesting.

So the court will accept Dr Nass as an expert in the anthrax disease, in the anthrax vaccine and the, sort of, limited connection to the anthrax as a biological weapon. So, obviously, and in that sense I agree with the prosecution, that you haven't qualified her as an expert in bio warfare proper. She specialized in internal medicine, so she can certainly testify as a doctor. So we will accept her.

But I want to tell both parties that, as with any other witness, the weight of her evidence will be assessed against the evidence of any other witness, expert or non-expert that will testify or have testified or will testify in this application, plea in bar of trial.

So you canÐÐwell, it's noon now. Maybe we could just be stopping here, it'd be a convenient time, I would say. So she's qualified when we return at, one o'clock?

ASSISTANT DEFENCE COUNSEL: Certainly, Your Honour.

MILITARY JUDGE: One o'clock, okay. So 1300 when we return, she can be seated there and we'll proceed with your interrogation of her as an expert.

THE WITNESS RETURNS TO THE COURTROOM.

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour.

Q. There's different areas regarding your expertise, ma'am, that I'm going to direct you to: the first area I would ask you to consider, however, is the issue of effectiveness of the vaccine, and I will ask your opinion eventually on the effectiveness. But prior to that, I wonder if you could sketch out to us some of the studies covered in the literature upon which you relied on to formulate your opinion? I understand in particular, and if I can direct your attention, ma'am, to the various animal studies regarding the effectiveness of the vaccine, does it work? A.  Uh-huh.

Q. Can you tell us a little bit about what the literature talks about? A.  Yes. There are a lot of animal studies in the literature done in the United Kingdom and the United States using a variety of different animals. But the primary animal has been the guinea pig; by far the largest number of animals and the largest number of experiments have used guinea pigs. But there have also been used rats and mice and rabbits and monkeys. And this literature, which extends back a ways, indicates that there is moderate effectiveness in animals against limited strains of anthrax. And the UK researchers have been very clear at pointing that out, even in the body of the text of their papers, that I would quote Hambleton, for instance, at saying, "The vaccine may be effective."

Q. Okay, if I can just interrupt you, ma'am. You said something about the different strains of anthrax. What did you mean by that? A.  Well, for most bacteria there are different strains. In the case of anthrax most researchers refer to them as strains and some refer to them as isolates, because the taxonomy is not well developed; in other words, every time you isolate anthrax from a newly dead cow, for instance, there will be some slight differences in the DNA of that anthrax bacterium as compared to others that are in anthrax libraries. So since we don't have any way of differentiating between these strains taxonomically or with lab test, every time they isolate a new strain, it's called either an isolate or a strain, and so as you can see there's the potential for an infinite number of anthrax strains.

Q. Do they operate in different ways? A.  Well, it turns out that they do. What happened is that in the early days of anthrax research people generally used a strain called the Vollum strain and derivatives of the Vollum strain. And this showed that the vaccine was moderately effective. You got pretty good survival rates, on the order of 70 to 90 per cent in mice and guinea pigs when they were vaccinated with the currently licenced human anthrax vaccine and subjected to the Vollum strain. What subsequently was learned was that the Vollum strain was actually a defective anthrax strainÐÐand I'm using the term defective as used by Martin Hugh Jones who heads WHO Anthrax Project and is a professor of veterinary medicine at Louisiana State University in Baton Rouge, LouisianaÐÐand so it was realized that in terms of biological warfare, looking at the Vollum strain was really useless. So another strain, the Ames strain ...

Q. If I can just interrupt you there, ma'am, how do you spell Vollum? A.  V-O-L-L-U-M.

Q. Okay, thank you, I'm sorry about that. A.  Another strain which was more virulent than Vollum was used in many early tests, and then for awhile they were calling Vollum a vaccine resistantÐÐsorry, they were calling Vollum a vaccine sensitive strain and Ames a vaccine resistant strain, meaning ...

Q. Now what is Ames? First of all, how do you spell it? A.  A-M-E-S.

Q. Yes? A.  Named after Ames, Iowa, where it was isolated.

Q. And what is it? A.  It is a more virulent strain than Vollum of anthrax. Now let me step back a ways: now if you inject any of these strains into a cow, enough of it into a cow, or lets say into a guinea pig, you will kill it. But if you vaccinate the guinea pig, the guinea pig will probably survive challenge with the Vollum strain but it may not with the Ames strain.

Q. Okay, if I can just, sort of, clarify the situation then: Is it fair to say that a vaccine may work on one strain of anthrax but not as well or not at all with another strain of anthrax? A.  That is precisely correct.

Q. Okay. And in terms of number of strains of anthrax, you said that it's infinite, in essence? A.  That's correct.

Q. Okay. So when we talk aboutÐÐwhen we use the word "anthrax" as a biological weapon, do we know which strain we're referring to? A.  Obviously you don't ...

Q. Or could it be one of many? A.  Well, I mean, any country that's developing a biological weapon is presumably going to choose the most virulent strain or strains to which it has access or which it can create. And so you clearly do not know what strains of anthrax your military forces may be coming up against. And this is a very crucial issue.

Q. So the vaccine that may be developed by one country might not be effective at all against the particular strain of anthrax that that foreign country is using? A.  Yes.

Q. Now I understand you correctly that the various animal studies have been done on different strains of anthrax, some on Vollum and some on Ames? A.  And some on other strains.

Q. And some on other strains. Does the use of a different strain affect the effectiveness of the vaccine in the study? A.  Absolutely.

Q. Can you tell us a little bit more about that? A.  Well, you can choose some strains of anthrax which are almost completely protected against by the vaccine. So you could, for instance, get very close to one hundred per cent survival rates with a strain of anthrax that is not highly virulent. At the same time, you can get survival rates that are close to zero per cent with a very highly virulent strain.

Q. Okay. And that has been shown in the literature ... A.  Yes.

Q. Okay. Is it fair to say that it is a wide span of variability in terms of the efficacy of the vaccine? A.  Yes. Insofar as the published studies show, I mean, there are many strains and I know of studies that have looked at vaccine efficacy against 33 of these strains. One study by Ivins which was presented at that 1998 anthrax meeting, he looked at efficacy against 33 different strains of anthrax in guinea pigs and had widely varying survival rates from zero to 100 per cent depending on the strain.

Q. Okay. Was there a differenceÐÐassuming then that the strain of the vaccine is important in terms of determining efficacy, is there a difference, too, between how various animals react as compared to others? Like, are guinea pigs, do they react the same as mice, et cetera? A.  No. Every animal that has been tested responds differently, so that you give the same vaccine to different species of animals and they will have very different survival rates. And it's very difficult to predict, for instance, what the survival rate is going to be, so that the survival rate in guinea pigs is quite different than what it is in mice or in rats as opposed to rabbits and monkeys. So we have not been able to come up with a way of measuring anything in the blood of the animal which will let us know how well protected they are after receiving a vaccine.

Q. Okay, if I can justÐÐdo you recall, and I can refer you in time to something that might refresh your memory. Do you recall, specifically, how guinea pigs did in terms of their survival rate in some of the studies that have been considered? A.  Well, as I said, depending on the strain ofÐÐwhen they have been vaccinated with the human anthrax vaccine that we're talking about now, the vaccine that's licenced in the US, because they've been tested against other vaccines also, in the Ivins study using 33 different strains of anthrax and 16 guinea pigs per strainÐÐI can pull out the dataÐÐsurvival rates ranged from zero per cent to 100 per cent with 26 of the strains causing 50 per cent or more deaths in guinea pigs.

Q. Okay, let me just focus on that, because I'm not sure I understand that: Twenty-six of the strains ... A.  Of 33.

Q. Okay, so 26 ... A.  I think it was 27.

Q. Twenty-six or 27 strains of the 33 tested, half the animals died? A.  At least half.

Q. So at least there's less than a 50 per cent survival rate for more than two-thirds of the strains? A.  That's correct, 50 per cent or more.

Q. Okay. In terms of mice, do you recall at this junctureÐÐI appreciate I'm asking you off the tip of your headÐÐmice, how did they react to the vaccine in the studies? A.  Mice haven't been tested against as many strains as 33. But when you're using, again, the human anthrax vaccine licenced in the US with mice and not adding any additional adjuvants, your survival rate is usually 10 per cent or less.

Q. Now you used the word "adjuvants"? A.  Well, there are some experiments with mice where they used unlicenced boosters, vaccine boosters ...

Q. Okay, if I can just interrupt you, it's the adjuvant word; first of all, am I ... A.  A-D-J-U-V-A-N-T.

Q. What does that word mean? A.  It means a booster.

Q. Okay, okay. So in this study they used unlicenced boosters? A.  For animals.

Q. Okay, for animals? A.  As a test.

Q. Okay? A.  And you could increase the survival rate in mice and in guinea pigs by using these. This is a side issue, but I'm just mentioning it because that was the only way in theÐÐso, according to the published literature, that's the only way to improve survival rates beyond 10 to 20 per cent in mice.

Q. So without that unlicenced booster, approximately 90 per cent of the animals died, notwithstanding the vaccine? A.  That's correct.

Q. Okay. In terms of the monkey studies, what can you tell us about the monkey studies? A.  The recent monkey studies, the only ones in which monkeys were tested against the US human licenced vaccine have all been done only at Fort Detrick in one lab, and it's been a series of very small studies, I mean, I've been told, I think, by Arthur Friedlander that they're up to about 65 monkeys now.

Q. That's the total number of animals that have been tested, sixty-five? A.  Right.

Q. Okay, just to compare. Approximately how many guinea pigs, for example, have been tested, or mice? A.  Thousands.

Q. Thousands against the 65 for monkeys? A.  Yeah.

Q. Okay. What did the studies show with the monkeys then? A.  Studies in the monkeys showed very high survival rates when they were tested against the Vollum strain and the Ames strain, which were the only two strains against which they were tested. The survival rates were 95 per cent or higher.

Q. Okay, okay. Now in terms of both the guinea pigs, the mice and the monkeys, are those the major three ... A.  Those are the major three.

Q. In terms ofÐÐis it easy to draw a comparison between one of these groups of animals and how men and women would respond similarly to the vaccine? A.  It's impossible to draw a comparison, and that point has been brought out by a number of people as well as in my review article where I review all the literature on this, but it's been brought out by the General Accounting Office and it's been brought out in a number of meetings held to discuss licensure of the vaccine and use. The problem being that the test thatÐÐwe normally do a test to look at immunity. When you get hepatitis B vaccine, for instance, if you're a health care worker and we want to know whether you're immune, we do an antibody test to see what your antibody level is against hepatitis B antigens, and we call that a titre. And if you have a positive titre, you don't need a booster dose of your hepatitis B, but if you have a negative titre, we give you a booster.

Q. A positive titre would mean you had a lot of antibodies? A.  Right, exactly. So there is a comparable test for anthrax which is looking at anti-PA, protective antigen, which isÐÐthe protective antigen is considered to be the main antigen, the main immunizing substance in the vaccine, although there are many substances in the vaccine, and so there is a test, a titre for anti-PA antibodies, and these titres are measured in animals. The problem being that there is absolutely no correlation between the antibody level and the gold standard, which is, you inject the guinea pigs or you have them breath in anthrax and see whether they live or die; that's your gold standard. There's absolutely no correlation between the titre and the survival rate.

Q. Just so that I can understand that correctly then, is that if you hadÐÐis it fair to say that you would expect that a high titre or a high antibody level would correspond with a high survivability? A.  Survivability, yes.

Q. But that wasn't found in the monkeys? A.  But it's never been found. Let me say this: I'm not certain whether it's been found in monkeys. Most of the monkey data hasn'tÐÐsome of it is published but the vast majority is unpublished. So I have to go by what I heard at a conference rather than what I read. So I can't guarantee what the titres show in monkeys. But the issue being that everybody agrees that at this point in time titres have not been shown to correlate or to predict the level of immunity. They haven't in humans. Whether or not they do in monkeys, which I can't say for sure, they don't in mice, they don't in guinea pigs and as far as we know they don't in humans.

Q. So is it fair to say that a monkey with a low titre might survive where a monkey with a high titre might succumb to the virus? A.  Well, I'd rather say guinea pigs 'cause I know that literature very well.

Q. Okay, guinea pigs? A.  Absolutely, in guinea pigs it's clear-cut that those with low titres often survive and with high titres die.

Q. Does that make it difficult to extrapolate between the animal studies and the expectation of how a human would respond to the vaccine? A.  Yes, it does, it makes it impossible, and that has been acknowledged by many people in the field.

Q. Okay. Now in terms of other variables, you've mentioned to us that certain animals responded differently than other animals; you indicated that there are different strains; that one vaccine might work against strain A but not against strain B. Does the, I believe it's the spore challenge, what does thatÐÐfirst of all, what is a spore challenge, that phrase, what does that mean? and does it have any impact on the effectiveness of the vaccine? A.  Well, probably. Spore challenge just means, anthrax is a spore, so it just means the animal is injected with anthrax or is put in a situation where they breathe inÐÐthey have a special mask that may go over the animals head or nose through which relatively measured doses of anthrax are being inhaled.

Q. What is a high spore challenge? What do we mean when we say that an animal has received a high spore challenge? A.  Well, again what it should mean is that the animal is receiving a very high LD50, a dose at which 50 per cent of the animals would die. So you'd like to know what your LD50ÐÐyou know, for a chemical, for a drug, you have an LD50, if a person gets this amount they may well die. And in animals you want to know what the infectious dose is, what is the number of spores required to cause illness. Again, the problem is in the animal studies this is very strain dependant; so an infectious dose for Ames is not going to be the same as an infectious dose for Vollum. And we don't, for the human, know what the infectious dose is, although I once reviewedÐÐit's very debatable what the infectious dose is, so I went through the literature and got everything I could find on infectious doses in different animals. And the infectious dose in generalÐÐusually, in the literature, when they have determined a new infectious dose, it was prior to the researchers realizing that it was strain dependant, so they don't always tell you what strain was used to determine the number. But for the rhesus monkey, I think everybody agrees, the infectious dose or the LD50 is usually about 50,000 spores; this is for a 10-pound rhesus monkey. And for a mouse it might be 10 to 50 spores, and for a guinea pig, you know, let's say, a hundred or several hundred spores. So anyway, if we'reÐÐand for a cow, there have been some studies which show that even a million spores injected into a cow doesn't necessarily cause illness. If you go on the basis of weight, one would assume that the infectious dose for a human is 500,000 or a million spores. But, again, it's strain dependant, so we don't know the answer and we hope that no one has ever done the experiment.

Q. Okay. Now so if I understand you correctly then, what you're saying is, is strain A maybe reacts differently than strain B, correct? A.  Correct.

Q. And then how much of strain A you have will determine whether a vaccine is effective or not? A.  I didn't say that, but you're right.

Q. Okay. I'm sorry, I don't mean to put words in your mouth, if I've overstated things. Now is there any way to evaluate what the "spore challenge", if I can use that word, is going to be in the theatre of operations, in any of them, for example, the Gulf? A.  No, your spore challenge is going to be a function of how far away you are from the epicentre of the attack and by what mechanism the spores are disseminated, whether it be by airplane or exploding a bomb or some other means. So, no, it has always been assumed in military documents, as well as in the published literature, that large spore counts are expected to override any medical protection; by that I mean, antibiotic or vaccine. And for that reason it's always been felt that the mask is the primaryÐÐup until the last two years when people have made other kinds of statements in public, but prior to two years ago, it was pretty much that everybody agreed that the mask was the only thing that was likely to provide very, very high protection independent of spore counts.

Q. So where you are when the attack occurs will affect the effectiveness of the vaccine? A.  The amount you breathe in will affect the effectiveness.

Q. Okay. Now the other variable that may be in existence, and you can correct me if I'm wrong, is the lot to lot quality of the vaccination. Is there any kind ofÐÐdoes that affect the variability of the effectiveness at all? A.  It is expected to. Bruce Ivins, as I said, is the primary, has been for many years, the primary anthrax vaccine researcher at Fort Detrick, and has written in his papers that there is lot to lot variability in potency. And I introduced him to actually the head of QA at the manufacture at this conference ...

Q. "QA", would be? A.  Quality Assurance. And I had to inform this fellow, Bill White, who is the head of QA that the lots varied in potency, which was something he did not know, professed not to know, at any rate. And so I introduced him to Bruce and said, "Bruce, explain to him how your studies of the different vaccine lots show that there is variable potency", and Bruce did this and told us both that actually, according to his studies, the lots vary by a factor of 40 in terms of potency. Now that is not 40 per cent.

Q. Okay, can you clarify ... A.  That is a factor of 40, that means 4,000 per cent. One lot may be 40 times as potent as another, or the reciprocal of that is that one lot may be one-fortieth as potent as you may expect.

Q. Okay. So the use of the animal studies is questionable, correct? as an extrapolation. A.  You're saying the use of animal studies to extrapolate survivability to humans?

Q. Yes? A.  Right. One is unable to extrapolate from the animal studies to the human in terms of protection offered by the vaccine.

Q. And, in addition, there's an infinite number of strains, concentration of exposure and then the lot variation? A.  Let me elaborate a little bit more. I said that the primary immunizing component of the vaccine is believed to be PA. It is believedÐÐwell, in nature all strains of anthrax have PA, in nature. Now there are genetically engineered strains which do not contain PA. These genetically engineered strains, one would assume, would not be protected against by the vaccine because they don't use PA and PA is the primary component of the vaccine. However, theoretically one would assume that here this vaccine contains PA and all these anthrax strains have PA and require PA to be effective, so the vaccine ought to work against all of them. That's a good hypothesis, but unfortunately all the experimental evidence indicates that that hypothesis cannot be corroborated, so that you expect that vaccine ought to be effective, but it isn't. No one has been able to explain that. But in experiments done in England and in the United States by a number of different people, it's been made very, very clear that a solely PA based vaccineÐÐat least, let me put it this way, because there are many vaccines out there that have been developed that haven't been put into practice and I haven't seen the experimental data for all of them, but let me go back and say, the US licenced vaccine is absolutely the weakest in terms of protection compared to the licenced British human vaccine, the Russian live vaccine and the live animal vaccine.

Q. Now what studies have there been undertaken with regard to the effectiveness of the vaccine on human beings? A.  As far as the effectiveness of this particular licenced anthrax vaccine on human beings, essentially there have been none. The only publishedÐÐbecause effectiveness means, when you are actually exposed to anthrax, does it work? So it requires exposure of a human to anthrax. The studies that were done in the late 1950s and early 60s were primarily of an earlier vaccine. The Brachman study is the one published study of human anthrax vaccine efficacy of a killed humanÐÐwe call this a kill vaccine as opposed to the live attenuated Russian vaccine, so there's no live anthrax in this vaccine. There's one published study in the entire world's literature and it is the Brachman study. Unfortunately, the vast majority of people in that study received a vaccine called the Merck vaccine, which was manufactured by Merck, developed by Dr Wright. The study is poorly written up. The body of the study contradicts some of the tables and it's not entirely clear-cut who got what vaccine and how some of the other study parameters were done. But it appears that the majority ofÐÐit was done in mill workers, goat hair mill workers in four mills in New England who were exposed to unknown amounts of anthrax in the ambient air in their mills, and there was some moderate protection conveyed by an earlier vaccine made from a different anthrax strain, using different culture conditions, and the current vaccine has never had a human efficacy trial.

Q. We've heard evidence in this case already that the licenced in the United States anthrax vaccine has been used in the United States since 1970, approximately? A.  Licenced since 1970 and used since approximately 1960.

Q. And except for people in war, who would've received this vaccine? A.  Now that's a very good question because we don't know who received this vaccine. There have been a lot of claims that people have received it but these claims have not been substantiated in most cases. So, for instance, the claim initially was that the vaccine was developed for agricultural and industrial workers and veterinarians. Well, in fact it wasÐÐyou would never develop an anthrax vaccine for any of those people because they get, and it's very rare that they get it, but they get cutaneous anthrax in their line of work ...

Q. And that's, like, infection through the skin as opposed to inhalation of spores? A.  Exactly; forms an ulcer and you take an antibiotic and you get better. So there's no reason for you to go through six doses of a vaccine and yearly boosters to prevent a skin infection that responds to penicillin and occurs in less than one person per year in the United States. And we don't care about skin infections, as I said, nobody dies if you get treated. What we're concerned about is inhalation anthrax which has an 80 per cent mortality rate. The only people who are going to get inhalation anthrax are people who work in laboratories using anthrax or people who are exposed to biological warfare ...

Q. Just going back to the people who apparentlyÐÐor it's claimed they received the anthrax vaccine since 1970. Has there been any follow-up with those individuals as to whether the vaccine was effective for them? A.  Well, the government, this General Accounting Office was charged with looking into: how many people? who they were? what the follow-up was? what happened to them? And all they could come up with in verbal testimony to Shays Committee on April 29th of 1999 was the fact that it appears that between 200 and 2,000 people received this vaccine between 1970 and the Gulf War, and the government has no records of who those people were and there was no follow-up as to any possible medical complications.

Q. Is there anything else that I haven't covered that you relied on in terms of coming to an opinion, and I'm going to invite your opinion shortly, about your opinion about the effectiveness of the vaccine? Is there anything else that I may have missed? A.  No, in terms of effectiveness, because there are no human studies one can only look to the animal studies and then one attempts to make the best sense of them one can, and I think that I have reviewed all the existing published animal studies in the world literature.

Q. What is your opinion then about the effectiveness of the United States licenced anthrax vaccine for human men and women? A.  I think it's moderately effective for exposure to naturally occurring strains in an industrial environment or an agricultural environment, and I think that the likelihood of it being effective when strains are selected or engineered for biological warfare is minimal.

Q. Now in terms of the short-term side effects of the vaccine, I understand there's a variety of different, what we might call "inconsequential side effects" to the vaccine? A.  Well, it's my opinion that any side effect that is short-term, even if it's years, is in the big picture, inconsequential.

Q. Okay, so you might have a redness or a soreness but that's the extent of it. Do you recall what the package insert on the anthrax vaccine, what the package insert estimated as the percentage of short-term side effects for this vaccine? or systemic side effects? A.  Yeah, the package insert estimated a 30 per cent incidence of local reactions and specifically says that these are all considered short-term; and it gave a rate of systemic reactions, which is any reaction far away from the injection site, of 0.2 per cent and doesn't comment as to whether these are short-term or long-term.

Q. Okay, in terms of the systemic reactions, what kind of reactions would that include? A.  May I add something here?

Q. Certainly? A.  Now I told you that there was only one published efficacy study, but there are a series of unpublished studies which are not efficacy studies because people weren't exposed to anthrax, but they were studies of antibody titres and short-term side effects. Having reviewed those studies as well as the Brachman study, and those studies showed systemic reaction rates of from 20 to 44 per cent, and then subsequently the General Accounting Office has identified the Tripler study, which was started in Hawaii in September of 1998, another human study, showing a systemic adverse reaction rate of 48 per cent, I realized that the package insert actually based its reaction rates on the Brachman trial which, of course, is for a different vaccine. So even though the package insert is for the currently licenced vaccine, the side effect rates don't correspond to any of the studies done in humans with this licenced vaccine. I found that surprising. But that appears to be the case. And in Ivins work, he's, sort of, cited the numbers from the package insert. So most people have thought, up until very recently, because they didn't have access to these unpublished studies, that the side effect rates in the package insert were accurate, as they should be. I mean, these are approvedÐÐand everything in the package insert has to be approved by the FDA, although this particular vaccine was licenced by the Division of Biologic Standards before it was moved to FDA. And I've been told informally by a retired FDA regulator that that division was not very good at performing its regulatory function. So although there was supposed to be human efficacy studies for the vaccine in order to licence it, and although the licencing body should have been given appropriate reaction rates for this vaccine, it appears that they may not have been given these numbers.

Q. So the statistics on theÐÐI'll just interrupt myself here, in terms of systemic reactions, can you give us an idea about what those side effects might be? A.  They're widely varying. The syndrome that I hear about the most is fatigue, muscle and/or joint pains, headaches, memory loss, lack of concentration ability and sleep disturbances, with possibly a wide range of other symptoms. But those comprise the primary symptoms of the syndrome. Other symptoms may be rashes, which are recurring and chronicÐÐthese are chronic symptoms I'm talking to about now: ringing in the ears, hearing loss, sometimes visualÐÐsome people say visual loss, respiratory difficulties, chest pain, abdominal pain, diarrhoea, constipation, genitourinary problems.

Q. And the package insert estimates that as .2 per cent? A.  That's correct.

Q. But you've told us that actually that .2 per cent relates to a different vaccine? A.  Yes.

Q. And that the actual incidents of these systemic reactions is quite a bit higher than .2 per cent? A.  Again, it seems to depend on the study you read. You see, when you're looking for side effects, it depends how they're elicited. So if you wait for people to report, maybe only .2 per cent of people will actually come up to you and say, I'm having a problem. That's called passive surveillance. If you go to people and ask them, are you having a symptom? and particularly if you leave it open-ended, has anything happened to you differently since you took this vaccine than was occurring before? Then you're going to getÐÐthat's active surveillanceÐÐyou're going to get a high rate of positive responses. In the first case your rate may be too low; in the second case your rate may be too high. But if you look at the unpublished studies, you have rates of anywhere from 20 to 48 per cent for systemic reactions. Now let me again add a proviso: every one of these unpublished studies looked at side effect rates only up to, at the maximum, 30 days post-vaccination. So I can't tell you whether there are long-term or short-term side effects in these studies. The Tripler study was designed to look for long-term studies (sic) because there were no studies. Even the FDA has said that data on long-term adverse effects has never been submitted by the manufacture or by DOD to FDA on this vaccine. So there's no published literature; FDA has no unpublished literature. So we don't really know what the long-term systemic side effect rates are.

Q. But the short-term systemic rates may very well be 20 to 48 per cent? A.  That's correct. And it's possible, and I would say it's very likely, that it is lot dependent.

Q. And from that I understand one lot of vaccine, I understood from your earlier testimony, may be different than a different lot? A.  Exactly.

Q. Okay, some people getting lot A might get sick; people getting lot B might not? A.  Or the percentages will be likely to be different.

Q. Will be different, okay, thank you. Now ... A.  If the potency varies by 40 times, other molecules in the vaccine which may be inciting reactions also may be varying by a factor of 40 from lot to lot.

Q. Okay. Now moving into the next area that I hope to ask you about, Dr Nass, is your opinion, and again I will ask you after we hear from your foundation of your opinion, regarding the quality of the vaccine, the American licenced anthrax vaccine that was produced by Michigan Biologic Products Institute. Now we've heard evidence that all of the vaccine that was created in the United States was created by this manufacture? A.  Have you heard evidence to that effect?

Q. I think we have from Lieutenant-Colonel Cook.

ASSISTANT DEFENCE COUNSEL: Have we heard that, Major Fullerton?

PROSECUTOR: I don't recall.

ASSISTANT DEFENCE COUNSEL: Okay.

Q. Let me lay a better foundation then: Your understanding, ma'am, is that the licenced vaccine in the United States, is it fair to say, is created by the Michigan Biologic Products Institute? A.  Well, I'm sorry to have to muddy the waters for everybody, but I have a number of government documents in my possession here today that indicate that certainly arrangements were made and contracts were let for other manufacturers to produce this vaccine around the time of the Gulf War, and an indemnification was given by the Secretary of the Army to one of these manufacturers, PRI, a subsidiary of DynPort Corporation. So I know that contracts exists and I know indemnification exists and I know that plans were made to make vaccine elsewhere and ship it to the Michigan manufacturer for testing and bottling and labelling, but I cannot tell you whether that actually took place.

Q. Is your information that the Michigan Biologic Products Institute produced the majority or oversaw the majority of the production of this vaccine? A.  You know, I really don't know. A lot of people have commented on, you know, what is the actual manufacturing capability? Some people think that they've exceededÐÐthat the number of lots available has exceeded what Michigan is able to produce over this period of time. But I'm not privy to enough of the documents to be able to give you an answer.

Q. Clearly, Michigan Biologic Products Institute did manufacture the anthrax vaccine? A.  They certainly have manufactured anthrax vaccine, absolutely.

Q. Okay, okay. Now we've heard evidence from Lieutenant-Colonel Cook that there were some difficulties with the manufacturer? A.  There were serious difficulties at the Michigan manufacturer.

Q. And can you tell us a timeÐÐI understand the difficulties were with the FDA? A.  Well, I can't tell you if they were only with the FDA. I would think thatÐÐapparently the Department of Defense was also inspecting the plant, and I would assume that they also had difficulties with it, but again I'm not privy to that information.

MILITARY JUDGE: Excuse me, Dr Nass, I think I'm going to have to intervene here. Are we really within the level of expertise that this witness was qualified for?

ASSISTANT DEFENCE COUNSEL: WellÐÐI'm sorry.

MILITARY JUDGE: No, just a moment, Major Fullerton, when you want to stand up, you start with the word "objection". Remain seated while I'm speaking.

ASSISTANT DEFENCE COUNSEL: Where I'm going to lead this witnessÐÐor where I would hope to lead this witness is that her evaluation of the inspection of the BioPort or Michigan Biologic Products Institute. We heard from Lieutenant-Colonel Cook that he received certain information regarding the problems at the plant and regarding what FDAs concerns were regarding the production of this anthrax vaccine. And how it relates specifically to the issue, that I believe this witness has been qualified, is that there was a number of supplemental tests that went directly to, for example, the potency of the drug, the sterility of the drug, whether there was any kind of degrading of the drug. So what I'm going to ask this witness is not in terms of manufacturing so much as the difficulties that we say existed in the plant in terms of, did they produce a good quality vaccine?

Because it is our respectful submission that if you don't have a good vaccine, it's not going to be effectiveÐÐthat arguably it's not effective anyway, but if there are problems with, example, potency and sterility, that this witness can qualify as to whether there were difficulties with the quality of the vaccine.

MILITARY JUDGE: Major Fullerton?

PROSECUTOR: Yes, Your Honour, I was just considering very much whether or not this witness was in fact wandering outside her area of expertise. This witness has been qualified as an expert in internal medicine, bio warfare, anthrax and the anthrax vaccine. She specifically testified that she had no training or experience within the manufacturing of this type of drug, or within the manufacturing of pharmaceuticals. So I am wondering, not only that, that this witness has also indicated some doubt as to even the locations in which it was manufactured and indicated that she really hasn't reviewed the evidence or reviewed the documents in any detail in this regard. This is a witness who is here because of the fact that in other respects she has reviewed literature and details. And I would submit that we are getting well beyond the expertise of this particular witness, the areas that she has been qualified as a witness in.

Moreover, I have to question the relevance of this testimony to the issues that are before this court; we're dealing with motions under section 15, 12 and 7, and while there may be some relevance with respect to the finished product, when she goes through talking about, or is asked questions and asked to address question with respect to the manufacturing process, this is really outside the scope of her expertise and it is not, I would submit, clearly relevant to the issues that we are addressing at this point.

So those are my comments.

MILITARY JUDGE: I have a problem, to tell you frankly, with the kind of questioning you're putting to the witness at this point. We're not doing an indictment of the Michigan Biologic Products Institute, okay. They may have been a rotten company. As far as I'm concerned, I don't care; I don't know now, it may show that later. But this witness was qualified, and that's what I was looking for, what the witness was qualified into before, and this is outside the scope that this court accepted that this witness testify about. And we're into hearsay now, very, very severe cases of hearsay, so let's be very careful here.

ASSISTANT DEFENCE COUNSEL: One comment that my learned friend made that is not correct in the sense that Dr Nass has reviewed the FDA report, so she's not talking off the top of her head about this.

The second matter is, is that we already heard from Mr MacKay from Health Canada that the vaccine that was available for the Canadian soldiers did in fact come from Michigan Biologic Products Institute. So while I agree with my learned friend that this witness ought not to testify about other plants, what she has to say about Michigan Biologic does impact upon whether Canada got a safe vaccine or not.

MILITARY JUDGE: Well, I'll put it to you simplyÐÐand that's okay, Major FullertonÐÐI'll put it to you simply: If the question that got the witness here, if the response she gives is not within the field of expertise for which she was qualified and if it's hearsay, you can ask the question but the weight of that evidence is very limited, very limited, to the point of being useless. So I'm saying, you establish the background or leave the subject, either/or, because right now it's not worth very much. I'm trying to help you here, okay.

ASSISTANT DEFENCE COUNSEL: Okay. I appreciate that, thank you, Your Honour.

Q. Perhaps what I'll do then is rather than review extensively the foundation or anything in that regard relating to BioPort, or Michigan Products Institute, do you have an opinion regarding the safety or effectiveness of the vaccine that came out of Michigan Products Institute in the late winter, spring of 1998?

MILITARY JUDGE: And how do you come about with that opinion?

WITNESS: That's what I'd like to tell you. Okay, once I was asked to write a review article on anthrax vaccines, I submitted a Freedom of Information Act request to the FDA. And so they gave me about 2,000 pages of documents on their reviews of anthrax vaccine, and they sent me copies of every inspection report they had done of the plant since 1992. So my expertise derives from going through those documents and then subsequently being given documents that were produced by the Department of Defense, a company called Saic, which the Department of Defense hired to oversee the Michigan manufacturer, and Mitretek, another corporation that the Department of Defense hired to oversee the manufacturer and the supplemental testing at, first, MBPI, Michigan Biologic Products Institute, and subsequently BioPort. So I have spoken briefly with the woman at Mitretek in charge of the supplemental testing; I have reviewed a number of documents on the supplemental testing; and reviewed internal DOD documents. And I certainly can produce any documents anybody wants to be very clear about how my opinions are formed.

ASSISTANT DEFENCE COUNSEL:

Q. Is your opinion based on the kinds of supplemental testing, or how the supplemental testing was undertaken? A.  No. Well, both. I think the supplemental testing wasÐÐI think that Mitretek did an excellent job of overseeing supplemental testing and I think supplemental testing was performed correctly. I think that its scope was limited and I can address that. And I think that for me the very interesting thing was that all the lots of vaccine that were tested with supplemental testingÐÐnot all the existing lots, but 31 lots were selected for supplemental testing. It was very interesting that the majority failed supplemental testing. Supplemental testing consisted of seven of the nine tests required by FDA for release of a lot. So supplemental testing was slightly less stringent than the normal lot release test. Every lot had supposedly passed all these tests previously when the manufacturer supplied the FDA with documentary evidence as to the test results. But once the manufacturer was overseen by Mitretek employees, 25 of the original 31 lots failed supplemental testing.

Q. What kind of things were undertaken for supplemental testing? Like what were they looking at? A.  They did a potencyÐÐwell, I can tell you the names of the tests and then I can tell you what they really did. They did a sterility testing, potency, measured aluminum, Phemerol, sodium chloride and formaldehyde, that's six, and, oh, pfft, pfft, pfft, and then they did a safety test; seven tests. The safety test is a test where they take two mice and two guinea pigs and inject themÐÐno, inject them with the vaccine and watch them for a week. And if they haven't died or lost weight or if they haven't had any gross changes in their behaviour the vaccine passes the safety test. The potency test, well, actually they had three tries, so if the vaccine fails on the first one, they get two more, but ...

Q. What do you mean they got two more? A.  Well, you got two more times where you could repeat the potency test and still keep trying. So if on the third try you passed, even if you failed the first two, it would pass. But, in fact, I'm not sure what potency test they used because that test has been invalidated and BioPort is working on developing a new potency test. Because what happened is that a number of the procedures at the MichiganÐÐI'm calling it the Michigan manufacturer because it had three different names through the 1990s. They had essentially a non-functioning quality assistance unit, quality assurance unit. That unit did not have authority and so their procedures were not validated, so they used a variety of procedures designed to perform certain functions, but in fact they had never justified or demonstrated that those procedures actually could successfully accomplish the functions. And this has been a problem with FDA oversight from the beginning; they weren't able to get the manufacturer to validate their procedures. There were many, many other problems at the plant. I don't know whether you want me to comment on them or not. But there were very serious quality issues with sterility; they would find some lots didn't have the right volume in them and they don't know if they spilled, was there a problem with the caps not being on properly or whether they weren't filled properly or what had happened; there were lots with bits of particles floating in them that were thought to be gasket material, but they were never tested to be proven to be gasket material, at least not in what I've seen; and they used visual inspections to determine which bottles had gasket material and which didn't, and if they had the material they threw them away, and if they couldn't see gasket material floating, the vials were used; they had lots which were produced from sub-lots that had been found to be contaminated; they had lots in which some of the bottlesÐÐeach lot is 200,000 doses or 20,000 bottles, and they had lots in which some vials were found to be unsterile, and if they grossly saw something growing, they would throw them away but used the rest of the lot. So there were some very, very serious problems that I have never heardÐÐI'm not a vaccine expert, but everybody I've shown this to, which is a lot of people, has been very surprised at the level of incompetence at that plant.

Q. On the basis of your reviewing the FDA reports and the information that you have regarding the supplemental testing, what is your opinion regarding the efficacy and safety of the anthrax vaccine that was produced by Michigan Biologic Products Institute and supplied to the Canadian Forces? A.  You know, first of all, based on how terrible the manufacturing was, you still can't say whether it's an effective, efficacious product or not, alright. You also can't say whether it's a safe product or not. You can say that the manufacturing is terrible and I have serious concerns and it should be undergoing some much more rigorous evaluation before being injected into humans, but you can't say, based on the poor manufacturing, that the vaccine is going to be unsafe; you just don't know. Now what I would say is that the appropriate testing wasn't done; I listed seven tests. That safety test is really not adequate to determine whether the vaccine is safe. I mean, the animals didn't die in a week, but they weren't, you know, what happened after two weeks? You know, did they become ill? The sterility test meant that you played it out, vaccine, to see whether it grew bacteria or fungi. But if you had a slow growing bacteria or a slow growing virus or a very slow growing fungus, you would've missed it with the sterility tests. There was absolutely no supplemental testing or FDA release testing looking for the presence of degradents. That, to me, is a very crucial point, because this vaccine was being redated and redated so that many of the vials were nine years old when they were being used, they may have contained sub-lots which were older because the sub-lots have been held for up to several years before being mixed into lots. So the vaccine was old, it was composed of an uncharacterized mix of molecules, and whether any of those molecules in the beginning caused illness, or whether after it had sat around for 10 years caused illness has never been determined. And in fact, the molecules that are present in those vials, they have never been characterized, so we really do not know what is in the vaccine bottle.

Q. Is it safe, the vaccine, in your opinion? A.  The way you determine safety is by looking at the humans that got the vaccine and what happened to them. And here you've really got a very interesting situation, one I haven't previously encountered, which is that the Department of Defense has been able to say that the vaccine is safe because there is no evidence that it's unsafe, and the Department of Defense has made sure to either not collect or to keep hidden any evidence of long-term side effects. There is no evidence, in terms of published statistically valid studies, as to whether this vaccine, over the long-term, is safe or unsafe. They had people in trials for up to two years where you would have to go every two months and they would take blood to measure your antibody titres, but after 30 days they would never ask those individuals, are you having any changes in your health? So the question is: How do you determine if it's safe? Well, the Department of Defense, when all these issues were brought up to them, initiated the Tripler study in Hawaii, in September/October of 1998, and enrolled 603 medical personnel, and the expressed purpose of that study was to look for long-term side effects. They had very, very high initial side effect rates; as I told you, 48 per cent according to the GAO. They had some serious side effects. And they had doctors and nurses composed a lot of the study subjects. A number of people, I mean, missed work; I've seen a memo about one doctor who asked that he be relieved of all his duties because of a tremor. So that study began 18 months ago. Those people should have had now their fourth, fifth and, this month, their sixth shot, but it appears that they haveÐÐand I've talked to Shays Committee and I've talked to the GAO and I've talked to the DOD about this, and the Department of Defense, which for the first month was sharing the data from the Tripler study, stopped after that, and Shays Committee can't get it and the GAO can't get it and I can't get it, so we don't know how sick those people are. But we do know that at a conference last May, held at Fort Detrick to discuss this vaccine, the principal investigator of the study said that this was a problem lot. And by the way, he also said that lots 020 and 030 were problem lots. He gave those three names: lot 017 which was used at Tripler, 020 and 030 were problem lots.

Q. Are you aware of the lot numbers of the vaccine that were administered to the Canadian Forces in Kuwait? A.  Yeah, I just found that out, yes.

Q. And what were those lots? A.  020 was administered and 030 was purchased; I don't know if it was administered.

Q. Going back to the difficulty with the supplemental testing and the quality of the vaccination. Would it be wise to give that vaccination to someone under those circumstances? A.  I don't think it's wise to give it to anyone under those circumstances, particularly in light of the fact that we have other ways of dealing with anthrax if we know that people have been exposed.

Q. What are those other ways? A.  Well, antibiotics which you give and you hope that the anthrax has not been engineered to be antibiotic resistant, so antibiotics are part of the protocol for the Department of Defense; and if you feel it's necessary, post-exposure vaccination which can take over after the antibiotics wear off; and possibly antisera or antibodies which is a treatment that's used in some countries but not in the US and Canada currently.

Q. I just want to take you back to something that you said a couple of sentences ago, you referred to FAV020 and 030 as problem lots. What did you mean by that? A.  I'm sorry, now ...

PROSECUTOR: Objection. This particular witness is here as an expert to talk on the basis of published studies that she has read. In the course of that she is introducing evidence of personal conversations that she has had with particular individuals where they tell her something that apparently pertains to a particular lot or a particular manufacturing process. These are not published studies, they are not peer reviewed. They are not anything other than hearsay by a witness who is brought here as an expert and is introducing personal conversations under the guise of expertise but which are really nothing more than second-hand information passed from others to her.

So if this type of evidence is going to be going in, I would simply ask, and I think I've made this request in this court before: First of all, I would ask that this witness not do that; and second, I would ask that it be given the weight that it deserves, which is zero. It is hearsay.

ASSISTANT DEFENCE COUNSEL: Well, my understanding, Your Honour, is under section 63 (2) that the expert witness is entitled to base the grounds for opinions on the hearsay of another expert, and that's merely what we were trying to elicit from Dr Nass. If it's a basis of weight, then my learned friend can certainly explore that in cross-examination and then ask Your Honour to make the appropriate decision at that point.

MILITARY JUDGE: Uh-huh, indeed. You remember what I was telling you about a half-hour ago about hearsay. So, you know, the context of 63 is very clear, you can quote other authorities, but conversation behind doors, you know, I mean, that's not other authorities, that's not what it means.

ASSISTANT DEFENCE COUNSEL: No, but my understanding is, is the hearsay of another expert, it doesn't have to be a published statement of an expert, that if Dr Nass has this in a professional conversation about ...

MILITARY JUDGE: It becomes a question of weight.

ASSISTANT DEFENCE COUNSEL: It becomes a question of weight. But it seems as if the Rule does say that she can refer to the hearsay, it doesn't have to be a published report or anything of that nature.

MILITARY JUDGE: You can read the Rule, okay, so make the best of it because hearsay is hearsay.

ASSISTANT DEFENCE COUNSEL:

Q. Well, in any event, I think I'd like to move on at this point, Dr Nass, to the next area, and that is the long-term side effects of the vaccine, or what is believed by experts in the field to be long-term side effects of this anthrax vaccine? A.  Well, okay, let me tell you exactly what informs my opinion. Besides the initial data from the Tripler study, there's one published study of Gulf War vets from England who had received the British anthrax vaccine at that timeÐÐthat was published in The Lancet on January 16th of 1999ÐÐand that was really a landmark study done using surveys sent to 4,250 Gulf vets, the same number of Gulf era non-deployed vets, and the same number of Bosnia vets who had not been to the Gulf. For the British vets they were actually given notations in their shot records in many cases of what vaccines they received, unlike the US and Canadian veterans from the Gulf War. And in that study, it was shown that people who recalled or had documentary evidence of receiving anthrax, and they asked about these together, anthrax and plague vaccineÐÐno, they asked separately, excuse me, the text discussed them together but in the tables they're separate. Those Gulf War vets who received anthrax vaccine had statistically significant increased risk of meeting the CDC criteria for Gulf War illness, and that is based on the Fukuda CDC study of Gulf War illness ...

Q. How do you spell Fukuda? A.  F-U-K-U-D-A. But this study, using his definition, this study was done by Catherine Unwin, U-N-W-I-N, and Simon Wessely, W-E-S-S-E-L-Y, and their group. Of interest also, in that study, was the fact that a handful, 32 or 33 Bosnia vets, had documentary evidence of having received anthrax vaccine and they had an even higher risk of developingÐÐof meeting the criteria for Gulf War illness. These were people who had neverÐÐGulf War illness is just a syndrome, it's really not unique to the Gulf, and so these Bosnia vets also, in higher proportion, met the criteria for that syndrome.

Q. What are the symptoms of Gulf War illness or Gulf War syndrome? A.  Well, basically it's very similar to what I told you before about anthrax vaccine, we're talking about ...

PROSECUTOR: At this point I am going to object again, and the objection has to do with the qualification of this witness. And the qualifications of this witness have to do with internal medicine, bio warfare, anthrax and the anthrax vaccine. It does not get into Gulf War syndrome or anything to do with the ethology of Gulf War syndrome. Gulf War syndrome is entirely outside any discussion or evidence that has been called in creatingÐÐor in establishing the qualifications of this particular witness. It is my submission that Gulf War syndrome is not an issue that bears on the issues before this court, nor is it an issue that this particular witness has been qualified in. And I would ask that the court limit or disallow questions respecting Gulf War syndrome and certainly any connection or questions about the ethology of that symptom.

ASSISTANT DEFENCE COUNSEL: Well, this witness was qualified as an expert in the anthrax vaccine, and I invited Dr Nass to consider the long-term side effects, or the considered long-term side effects of the anthrax vaccine, and that's how we got to Gulf War syndrome. That is seen, and as Dr Nass will tell us, that Gulf War syndrome, or the symptoms that are usually associated with that syndrome, are the long-term side effects of the anthrax vaccine. So I would say, with respect, that the side effects of the vaccine is very much within the expertise of this witness.

MILITARY JUDGE: You said that the symptomsÐÐI'm not sure, what did you just say? That the symptoms were the evidence ofÐÐthat the illness is caused by the anthrax vaccine?

ASSISTANT DEFENCE COUNSEL: The symptoms that have been associated with Gulf War illness are ...

MILITARY JUDGE: Are the same as the ones.

ASSISTANT DEFENCE COUNSEL: Are the same as what we say ...

MILITARY JUDGE: Oh, there's quite a difference in what you're saying and what I heard you say a moment ago.

Now, in that context, because of the similarities in the symptoms, I'll allow that question. But, you know, there's a jump here.

ASSISTANT DEFENCE COUNSEL: Okay. That's fair.

MILITARY JUDGE: Okay, so let's be careful to make sure what the witness says and, indeed, if the witness is going to say that the Gulf War syndrome is caused by the anthrax, well, you'd better start qualifying her again because you didn't qualify her that far.

ASSISTANT DEFENCE COUNSEL: Okay.

MILITARY JUDGE: Okay, you didn't go to that extent in qualifying, and I would support the prosecution on that.

ASSISTANT DEFENCE COUNSEL: Okay, fair enough.

Q. Let's then go, in terms of, to specific the long-term effects of the vaccine. What, in your opinion, are there long-term side effects to this vaccine? And if there are, what are they? A.  Yes, I believe there are long-term side effects from the vaccine, and again my opinion is informed by the published study of Unwin and Wessely, by the limited information of the Tripler study, by my contact with hundreds of people who call me and tell me about their symptoms or who have sent me copies of their medical records or whom I have met or whom I've treated, and recently, actually, a very interesting informal study that was done at Dover Air Force Base by a patient, by a pilot. What I have spoken before severalÐÐas I pointed out this morning, I have lectured at two Gulf War conferences, I've spoken before the Institute of Medicine a couple of times on the Institute of Medicine Committee constituted to look at exposures and their relevance to Gulf War illness, and I treat Gulf War veterans. So that's my expertise on that. The illness that many people who have recently received anthrax vaccine are reporting, based on the people I've met, the records are reviewed, the Tripler symptoms, the symptoms in the Unwin/Wessely study which are well delineated, the symptoms from this unofficial study sent to 259 members of the 9th Air Squadron at Dover, all indicate to me that it is not uncommon for people developing anthrax vaccineÐÐor people receiving anthrax vaccine to develop a syndrome consisting of: sleep disturbance, memory loss, muscle and joint pain ...

Q. If I can just slow you down, because we're taking some notes. Okay? A.  Okay. Sleep disturbance, memory loss, muscle and joint pain and fatigue, with many of them have rashes, many have gastro-intestinal disturbances, genitourinary disturbances, emotional liability ...

Q. What does that mean? A.  People seem to have more difficulties maybe controlling their emotions, or there's a higher rate of anxiety and depression. And, again, it's my personal opinion as a clinician, but from my readings, that these emotional, and these are in people who didn't have emotional problems identified, I think that it's part of a syndrome which causes neurological illness and often hormonal imbalances.

Q. Okay, if I can just show you. Is this the Unwin and the Wessely study that you base your opinions on, amongst others? A.  It is.

ASSISTANT DEFENCE COUNSEL: At this time I'd like to tender this as an exhibit.

PROSECUTOR: Maybe I could see that.

ASSISTANT DEFENCE COUNSEL: I have a copy forÐÐcertainly.

MILITARY JUDGE: Yeah, show it to your opponent.

ASSISTANT DEFENCE COUNSEL: This is just to ...

MILITARY JUDGE: No, just a moment.

It's okay?

PROSECUTOR: Yeah, I do have some difficulties with this. And as I understand it, and obviously I haven't reviewed it too extensively, but the Unwood and Irwin (sic) study refers to, I believe, this witness testified, the UK vaccine, where they had different adjuvants and it was a different vaccine. It was one that was manifestly and clearly before this court, based on the evidence before this court, not the vaccine which Sergeant Kipling was ordered to take or which the Canadian service members took as part of OP DETERMINATION.

So I have some difficulties with respect to the relevance of this study. I would suggest, or submit, that this is not the situation that we are dealing with here; we are talking about the American vaccine as opposed to the British vaccine. And I would very much object on the basis of relevance to this particular study going into evidence in support of the issues that are presently before this court which speak to a very different fact situation involving OP DETERMINATION in 1998 and the American vaccine.

So those are my comments.

ASSISTANT DEFENCE COUNSEL: Your Honour, it's a question, I suggest, of weight and that my learned friend can argue the issue when he has the opportunity. But it perhaps might be of assistance if I ask the doctor whether the fact that it's a British vaccine affects the foundation of her opinion, and that if perhaps that foundation is laid then the evidence can go in. It's merely to assist the court. This is a study that is the foundation for Dr Nass' opinion on this issue, and so I present it to the court. Certainly, it's going in as hearsay but it's hearsay that this doctor relied on.

MILITARY JUDGE: And I'll ask you the question, Dr Nass: This is British vaccine. Is it your evidence that the British vaccine, the American vaccines are identical?

WITNESS: No. I have a couple of comments: This whole subject is fraught with great difficulty and it's very controversial. When I first gave a talk on this subject in September of 1998, a Colonel John Graham of the Ministry of Defence of England came up to me right after the talk and saidÐÐand he was very interested in what I had to sayÐÐand he told me that, we used a lot of your vaccine in our Gulf vets. So I said, "Well, that's news to me." And I subsequently was given some information put out by the MOD saying that in England they'd only ever manufactured 100,000 dosesÐÐI don't know if any of this is true because it's a controversial issueÐÐbut said they'd only ever manufactured 100,000 doses of the British anthrax vaccine. And Colonel John Graham, who's an MD and is now a liaison between DOD and the Ministry of Defence and works on Gulf illness, so we've met a few times subsequentlyÐÐactually gave me the numbers of how many people in the British services got how many doses of vaccine, and it added up to, in fact, the British troops used more than 100,000 doses. This is what he told me a year and a half ago. Now I met him again in September of 1999, and at which time he told me that, I gave you the wrong information last year, we actually don't know how many people received the vaccine, we don't know how many doses and we don't think we used the US vaccine. So I don't know what those people received. I've certainly gotten some queries from England which I haven't been able to answer about whether or not they got US vaccine. But that's a side issue. The actual reason why this paper is important is because our Department of Defense has sponsored over 130 studies on Gulf War illness and has spent, I believe, 140 to 150 million dollars studying Gulf War illness. And so far not a single one of the studies they have sponsored, with the exception of this one, looked at the possible relationship between anthrax vaccine and Gulf War illness. So this is the only data that has been collected on that subject and it is British and it is a different vaccine, but it's what we have, and I'm trying to make it clear to the court that we're dealing with very limited pieces of data, and I'm not trying to over-extrapolate them, but just lay out what there is and how I form my opinions.

MILITARY JUDGE: I understand your eagerness to have some reliable studies in order to understand what happens. But this, indeed, is not a study of an American vaccine and the effect on American or Canadian soldiers.

WITNESS: Absolutely.

MILITARY JUDGE: I can't take it, it's that simple. Sorry.

ASSISTANT DEFENCE COUNSEL: Your Honour ...

Q. Is there any other foundation that you then relied on in terms of your decision regarding the long-term effects of this vaccine, ma'am? A.  No. Oh, let me say this: I've also been contacted and been in touch with a number, somewhere between six and ten American non-deployed but vaccinated Gulf War vetsÐÐGulf era vets ...

Q. What does "Gulf era", what does that ... A.  That means that they were to be deployed, were prepared for deployment by being vaccinated and for some reason or another never were deployed to the theatre of operations and, therefore, never had any other Gulf War exposures.

PROSECUTOR: I am going to object at this point. If this witness is going to talk about conversation she had with particular members of the Canadian Forces who have no further expertise other than the fact that they happened to receive the anthrax vaccine and then were not deployed ...

MILITARY JUDGE: Who are we talking about there? Who are we talkingÐÐwho are these people? the eight or nine people.

ASSISTANT DEFENCE COUNSEL:

Q. Well, these are individuals that I assume have contacted you? A.  They've contacted me and I've actually provided some of them with some medical care, and there's only a few and I don't intend to assert that there's any statistical significance, but these people have the same syndrome that I've outlined. And if I may add, the French who did not vaccinate don't have it.

PROSECUTOR: Your Honour, the witness has herself said there's no significance to these impromptu conversations ...

MILITARY JUDGE: Yeah, but that's a question of weight, Major Fullerton, that's a question of weight. There's no statistical significance, it's a question of weight. You objected because this was not relevant. So I'm trying to find out how irrelevant it is to determine whether you're right or wrong.

So who are these people, specifically?

ASSISTANT DEFENCE COUNSEL: Well, if I might, I'll elicit that information.

MILITARY JUDGE: Yeah, establish the background a little bit, because we get the conclusion before we get, really, the background sometimes.

ASSISTANT DEFENCE COUNSEL: Certainly.

Q. Who, then, are these individuals, these people? Were they individuals, firstly, who received the anthrax vaccine? A.  They believe they have received the anthrax vaccine. As I said, it was policy of the Department of Defense not to record the vaccine into the medical records and to classify the master lists of who received the vaccine, so I cannotÐÐand there is no commercially available test, like a titre test, to see whether you received it or not. So we have only peoples assertions that they believe they received it.

Q. And did you find out anything in the course of your investigations that led you to believe that these people did not receive the anthrax vaccine? A.  No. No, I mean, you can't tell one way or the other, based on the unclassified evidence, and I have suggested both at the Gulf War Research Planning Conference that I attended last February that CDC held in Atlanta, I suggested there, and I've suggested to Shays Committee and to other congressional's, that we do know of several thousand peopleÐÐwe do have documentary evidence for several thousand people who did receive anthrax vaccine in the US at the time of the Gulf War, and of some many hundreds that received itÐÐin these unpublished DOD studies, subsequentlyÐÐand that it's absolutely critical that these people be studied to determine what long-term effects, if any, have occurred.

Q. So these people that contacted you, how did youÐÐthese people who believed that they were anthrax vaccinated, do you know why they would contact you? Like, why were they contacting you? A.  Well, some people contact me to ask me for information about, you knowÐÐI mean, they contact me for all sorts of reasons, you can imagine, but a lot of people ask me for advice: how to get treated? what is wrong with me? I have these symptoms, I may or may not have a diagnosis, I may or may not have a doctor who understands what's wrong with me ...

Q. Were there any patterns that you perceived between the symptoms these people complained upon? Were there patterns from one person to the next? A.  Yeah, well, now we're talking to the ...

PROSECUTOR: I'm going to object at this point. We've allowed it to go on for a certain length of time, but we have individuals here who nobody even knows whether they had the anthrax vaccine; we're talking about six or eight people who contacted her, perhaps by phone, perhaps through her Internet site or whatever, to get medical advice or nurturing or advice with respect to their own physicians. I really have some difficulty putting the relevance of this particular line of testimony into the context of the issues that this court is trying to decide. And I would submit that it is irrelevant, there is no foundation for it and that it should not be allowed.

ASSISTANT DEFENCE COUNSEL: Well, this is a question of weight again. This ...

MILITARY JUDGE: Yeah, I agree. But before we reach the issue of weight, we've got to cover the issue of relevance. So could you please respond to that.

ASSISTANT DEFENCE COUNSEL: Certainly. This doctor has been qualified as an expert in the anthrax vaccine. As part of that is her experience and her opinion regarding the possible long-term side effects of the anthrax vaccine. We've heard that she foundÐÐthe foundation of her opinion regarding that vaccine is based on her observations of the literature, both published and unpublished studies, as well as her clinical experience. And this is what she's telling us about is that the, sort of, flesh and blood people who came to her and said that they believed that they received the anthrax vaccine and they were reporting a series of symptoms.

MILITARY JUDGE: Well, that's not quite what the doctor said; the doctor said she couldn't tell one way or the other whether they received the anthrax vaccine or not.

ASSISTANT DEFENCE COUNSEL: She said they reported that they had received the vaccine and that she couldn't ...

MILITARY JUDGE: Is that a fact?

WITNESS: They reported it, yes.

MILITARY JUDGE: They reported that.

WITNESS: Yes.

ASSISTANT DEFENCE COUNSEL: They reported it and they reported a series of symptoms, and so what I'm trying to elicit from Dr Nass is: did she formulate any pattern to these symptoms? and did this clinical experience make a difference in terms of her opinion as to whether there was a clinical post-vaccination syndrome?

MILITARY JUDGE: So, Dr Nass, it's possible they received the vaccination, it's possible they did not, you couldn't tell. There's no test.

WITNESS: That's exactly right. There's no test.

MILITARY JUDGE: I think I will support the objection of the prosecution.

ASSISTANT DEFENCE COUNSEL:

Q. Ma'am, you indicated that there were nine symptoms that you identified as part of a post-vaccination syndrome. On what do you base that opinion? A.  Again, people contacting me. I have met with a number of these people, and I have actually made available to them a questionnaire that I use for my own private patients which helps me to determine whether they haveÐÐyou see, this whole Gulf War illness, Gulf War syndrome, overlaps strongly with chronic fatigue syndrome and fibro-myalgia syndrome and multiple chemical sensitivity syndrome, so they all share common symptoms. The cause of these syndromes has not been determined. My personal opinion is that they are caused by a variety of different things, different kinds of insults which could be vaccines or infectious diseases or toxic exposures. It's my personal opinion that some of the cases, but not all of the cases, of Gulf War illness are due probably to anthrax vaccine. But I only ...

PROSECUTOR: Objection. We have here the witness testifying as to the cause of Gulf War syndrome which is an area which she has not been qualified or accepted as an expert in this court. The ethology of Gulf War syndrome is, as I understand it and I think the witness has said this, very much open to scientific dispute. This is clearly outside her area of expertise as accepted by this court, and I would simply ask that the court not allow her to embark on this particular line of testimony, when this is not the testimony that she was called to this court to give. She was called to talk about anthrax, the disease; she was called to talk anthrax, the vaccine, the safety and efficacy. Well, this is going well beyond that area of expertise, or that delineated area of expertise and now we're moving into the whole quagmire of Gulf War syndrome. So I would submit that this is well outside her expertise as accepted by this court and I would ask that the court not allow this line of testimony to be pursued.

ASSISTANT DEFENCE COUNSEL: Well, I appreciate the court's ruling on the ability of this witness to testify regarding Gulf War illness. What I've been attempting to elicit from Dr Nass ...

MILITARY JUDGE: But there wasn't any.

ASSISTANT DEFENCE COUNSEL: I beg your pardon?

MILITARY JUDGE: There wasn't any.

ASSISTANT DEFENCE COUNSEL: Well, I know that my learned friend objected to the witness giving ...

MILITARY JUDGE: This court did not qualify this witness to testifyÐÐ

ASSISTANT DEFENCE COUNSEL: Oh, no, no, no, no, I ...

MILITARY JUDGE: ÐÐon the Gulf War illness.

ASSISTANT DEFENCE COUNSEL: And I'm saying, Your Honour, I appreciate that, that Your Honour limited the scope of Dr Nass' expertise.

MILITARY JUDGE: That's what you asked me, okay.

ASSISTANT DEFENCE COUNSEL: I appreciate that. But what I'm asking for is the long-term side effects. It may be ...

MILITARY JUDGE: Of anthrax vaccine?

ASSISTANT DEFENCE COUNSEL: Of the anthrax vaccine.

MILITARY JUDGE: Put that question to the witness, get an answer from the witness, that's fine. I've already got 10 things, because I've added fibro-myalgia to the nine first, and I've taken that down, that list, at least three times.

ASSISTANT DEFENCE COUNSEL: Okay.

MILITARY JUDGE: I know it.

ASSISTANT DEFENCE COUNSEL: Okay. Let me put it squarely to the witness then.

Q. Is it your evidence, Dr Nass, that in your opinion the following are the long-term side effects of the anthrax vaccine: "chronic fatigue, dizziness, joint and muscle pain, headaches, memory loss, cognitive disturbances, sleep disorders, peripheral sensory neuropathies, intermittent abdominal pain, intermittent diarrhea, chest pains, recurring rashes, blackouts or seizures"? A.  Yes.

PROSECUTOR: Your Honour, that is extremely directive. I don't think that was the testimony of the witness.

MILITARY JUDGE: There were certainly three or four words I never heard before in that list.

ASSISTANT DEFENCE COUNSEL: I'm referring to Dr Nass' statement regarding ...

WITNESS: That was part of my congressional testimony she read.

MILITARY JUDGE: Yeah, but this is a court martial, not the Congress.

ASSISTANT DEFENCE COUNSEL: Certainly. And if I can, I have a copy of Dr Nass' statement, and if I can file that with the court.

MILITARY JUDGE: Have you seen that?

PROSECUTOR: I haven't. Thank you.

ASSISTANT DEFENCE COUNSEL: And what I was referring to ...

MILITARY JUDGE: Incidentally, you can take this UK thing back, I don't need it.

ASSISTANT DEFENCE COUNSEL: Oh, yes, certainly, Your Honour.

The pages are not marked, this came off ofÐÐthe list I read to Dr Nass' is on the fifth ...

MILITARY JUDGE: This is a document that you completed yourself?

WITNESS: Yes.

MILITARY JUDGE: I think that goes in evidence particularly easily.

PROSECUTOR: I'm not objecting to that going into evidence.

MILITARY JUDGE: We'll mark that 41.

THE STATEMENT OF DR NASS TO SHAYS COMMITTEE IS MARKED EXHIBIT VD41.

ASSISTANT DEFENCE COUNSEL: Thank you.

DEFENCE COUNSEL: 41, I think?

MILITARY JUDGE: 41, yeah.

ASSISTANT DEFENCE COUNSEL:

Q. And the list that I'm referring to, Dr Nass, is a list on the fifth-last page. This document is the, "Statement of Meryl Nass, MD Before the Subcommittee on National Security, Veterans Affairs and International Relations". This is, I understand it, ma'am, the written testimony for the Shays Committee? A.  Yes, it is.

Q. Okay. As I understand it, you orally testified before the Shays Committee? A.  Yes.

Q. You were invited then to prepare a brief? A.  Yes.

Q. And this is the brief? A.  Yes.

Q. And on the fifth-last page are the symptoms that I read to you. And would you agree with me that that's your evidence, that listÐÐand here I'll show you, just to make sureÐÐis the list of the long-term symptoms that, in your opinion, are associated with the anthrax vaccine? A.  That's correct.

Q. And how did you arrive at that opinion? A.  From the many questionnaires I've received back; from the questionnaire now of these people at Dover, they have their own symptom list which is very similar; and from the hundreds of people who have contacted me.

Q. And I understand that you reviewed medical reports as well? A.  I have.

Q. Okay. And you also relied on the Tripler study? A.  I have.

ASSISTANT DEFENCE COUNSEL: Very good.

Your Honour, I'm close to the end of my examination. I'm wondering if we could take a brief adjournment so I can consider my notes. I don't expect to be much longer at all with Dr Nass.

MILITARY JUDGE: You're going to prepare your cross-examination?

PROSECUTOR: I would like to have an opportunity to prepare some cross-examination ...

MILITARY JUDGE: Okay, how about we take until three o'clock? That's 20 minutes. Okay?

ASSISTANT DEFENCE COUNSEL: Yes, thank you very much, Your Honour.

PROSECUTOR: Twenty minutes ...

MILITARY JUDGE: Three o'clock.

ASSISTANT DEFENCE COUNSEL: Thank you very much, Your Honour. I just have a few questions, Your Honour, with regard to Dr Nass. There's a couple of documents that I neglected to put into evidence.

Q. One is a documentÐÐI'll give to my learned friendÐÐit's a two-page document. Ma'am, I understand that you authored this document, it was your report on the problems with the BioPort supplemental testing? A.  No, this is a problemÐÐthis report is a synopsis of the initial FDA report on its inspection of BMPI.

Q. Okay. But you created that document, ma'am? A.  I did.

ASSISTANT DEFENCE COUNSEL: At this point I'd like to tender that into evidence, please.

MILITARY JUDGE: Major Fullerton?

PROSECUTOR: Yeah, I'm not objecting to it going into evidence, Your Honour.

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL: And as well, Your Honour.

Q. Dr Nass, you referred to an article ...

MILITARY JUDGE: 42.

THE FDA REPORT SUMMARY ON MBPI IS MARKED EXHIBIT VD42.

ASSISTANT DEFENCE COUNSEL: Oh, I'm sorry, Your Honour.

DEFENCE COUNSEL: VD42?

MILITARY JUDGE: Yeah.

ASSISTANT DEFENCE COUNSEL:

Q. Dr Nass, you referred to an article that you prepared, you mentioned it a couple of times, it was what you called a review article that you were invited to prepare for the Infectious Disease Clinics of North America? A.  Yes.

Q. I'm going to show you a copy that I believe is a copy of the article that you authored? A.  Yes. That is it.

ASSISTANT DEFENCE COUNSEL: And, if I might then, I'll provide one copy to my learned friend, and if I might tender that as the next exhibit.

PROSECUTOR: And I have no objection to that going into evidence.

MILITARY JUDGE: Okay, so that will be marked VD43.

THE ANTHRAX VACCINE ARTICLE BY DR NASS IS MARKED EXHIBIT VD43.

ASSISTANT DEFENCE COUNSEL: Thank you very much.

Q. Dr Nass, we heard, you'll recall some discussion regarding the Wessely report thatÐÐits report was related to the possible long-term side effects of the British vaccine. And you'll recall that ... A.  British veterans, unclear which vaccine they received, American or British.

Q. Okay. Then I didn't understand you. I had understood ... A.  No, what I said was that Colonel John Graham had come up to me and volunteered the information at one time that the British used a large amount of American vaccine and then a year later came up to me and said he was wrong, he thinks they used British vaccine but he's not sure what they got. So I really don't know. I know they received anthrax vaccine but I don't know the source.

Q. Okay. Assuming that the British veterans ...

PROSECUTOR: Objection.

MILITARY JUDGE: Well, let's wait for the question first, and then you'llÐÐjust hang in there for a moment.

What's the question?

ASSISTANT DEFENCE COUNSEL:

Q. Assuming that the veterans in this article that were the subject of this study received the British vaccine, what are the significant differences between the British, if any, between the British anthrax vaccine and the American anthrax vaccine? A.  They're very similar; similar to the difference between the original Merck vaccine that was used in most of the Brachman subjects and the current vaccine. They're both killed anthrax vaccines; they use different strains of anthrax; they each use an aluminum adjuvant but there is a slight difference, one is alum and one is aluminum hydroxide; and the culture conditions are slightly different. But overall a very similar process.

Q. In your opinion, are the differences between the American vaccine and the British vaccine significant to the degree that you would expect a different post-vaccine profile of symptomatology? A.  Again, I'm sorry to muddy the waters, but the problem is, is that with the American vaccine the manufacturing is such that there is no uniformity of the vaccine. And so when you say, "the American vaccine", it really depends which vial and which lot, and we can't really determine the similarities and differences between them. And so you can't really even refer to the vaccine as "the vaccine", I mean, one lot of the American vaccine might have a similar safety profile to the British and one lot might not. We really don't know why people who receive this vaccine are having problems. I will say thisÐÐbut, I guess, it's hearsay, I don't know what it isÐÐone of the London newspapers reported a few months ago that the British vaccine manufacturer, which is, through the British Government at Portondown, was having similar problems and had to close their plant just like the Michigan manufacturer had to close their plant to upgrade it, and that they also were using many redated lots in England. And that's what I've been told and I had it from Professor Malcolm Hooper that that wasÐÐwho is consulting on Gulf War illness for Parliament that that was in fact the case.

Q. Okay. I guess my point is, Dr Nass, that notwithstanding the differences between, or the apparent differences that there maybe exist between the British vaccine and the American vaccine, in your opinion, is the Wessely study relevant to your opinion regarding long-term side effects?

PROSECUTOR: Your Honour, this is not the first time this question's been asked of the witness, and I think the witness has indicated a number of problems with responding in a manner other than, as she describes it, "muddies the waters", so I would submit that we have asked the question several times, we have an answer, and that it is time to move on.

MILITARY JUDGE: I think the prosecution is right.

ASSISTANT DEFENCE COUNSEL: Very well.

Q. With regard to the Shays report, there's just one thing that I wanted to bring to the attention that I didn't, it's on the fifth-last page, the Shays report isÐÐoh, the statement, I'm sorry, of Meryl Nass, MD, is VD41. On the fifth-last page, you'll recall, and I'll show you, Dr Nass, that I referred you to a list of symptoms? A.  Uh-huh.

Q. And you make there a statement, I just wish to highlight it: "The majority of complaints of illness have been associated with vaccination using lots 020 and 030." Is that correct, that was your opinion? A.  That was my opinion and it was based on reports.

Q. Okay, thank you. Now, Dr Nass, I didn't ask you before about the number of shots that is appropriate, according to the FDA, in terms of the anthrax vaccine. We've heard the notion that there are booster shots and the like. What, in your understanding, is the requisite number of shots of the anthrax vaccination should an individual receive, assuming he should receive any? A.  Well, first of all, the number of shots is a function basically of efficacy, you know, how many shots does it take for the vaccine to be effective? And we don't know whether it's effective with one shot or six shots right now, so you can't really answer the question. But in terms of finding an ideal dosage schedule, what happened when this vaccine was licensed is they began a schedule zero, two and four weeks for the first three shots and then six months thereafter for the next three. And that schedule was chosen somewhat arbitrarily and is probably a poor schedule, because in two weeks you don't have enough time to develop a full immune response, so that the second dose, that two-week booster dose is coming too quickly. And in England they give the injections three weeks apart. And the manufacturer has applied to FDA at DOD's behest to get rid of the second shot, so that there'll be a shot at zero, a shot at four weeks. And then the number of boosters at six monthly intervals is also unclear; they may use one, they may use two. But anyway, the GAO has said in congressional testimony that the number of shots was arbitrary; basically, they were using three doses for awhile and some people getting the three dose regimen developed anthrax, so three more doses were put into place, used in the Brachman trial in the late 50s and early 60s, and that has been the de facto way it's done, but nobody knows whether that's the right way to do it.

Q. Do you know whether the FDA has an opinion regarding the three-shot regime? A.  Well, I don't know whether FDA has an opinion about the three-shot regime yet, but because it's still in INDÐÐthe vaccine is in IND status for that, that mean's that the manufacturer has applied to FDA for an investigational new drug application and has asked to be able to perform studies, to look at different dosing schedulesÐÐthey've already done someÐÐand to supply that data to FDA and ask for a change in the licence. So ...

Q. If I can just slow you down there. IND stands for? A.  Investigational New Drug.

Q. And you say the anthrax vaccine is in IND status right now with the FDA? A.  It is.

Q. And what are any of the consequences, or are there any consequences to the fact that this drug is in IND status? A.  Well, that's again a very controversial issue. The manufacturer would likeÐÐthey've applied for IND status for three things: They want to reduce the number of doses ...

Q. From? A.  Well, they want to eliminate the second dose, and then again, it's not entirely clear yet how many six-month boosters, if any, they will use. But at this point, I think, they've changed what they wanted to do over time. I think that right now they are basically at a dose at day zero, day 28 and then six months later, which is equivalent to the hepatis B injection series.

Q. So if I can interrupt you. They're proposing a three-shot regime? A.  Like I say, they're in the middle of studying it, so that was the latest I saw. But that is not what has beenÐÐthey're still in the process of studying them, they haven't finished the studies, so they haven't asked FDA to grant them a change; they're also studying giving the injection intramuscularly instead of subcutaneously to try and reduce the local reactions, which are very high, somewhere between 50 and 70 per cent of people have local reactions and about 50 per cent wind-up with a knot in the area, and they're hoping to reduce that with a deeper injection; and thirdly, they would like FDA to approve this vaccine for use for inhalation, since it could not be approved for inhalation earlier because the vast majority of people who developed anthrax in the mills were getting cutaneous anthrax.

Q. Are there any clinical implications to administering an IND status drug? "Clinical", what I mean by that is, does a physician's responsibility change at all if the drug is IND status? A.  If it's only IND status and not licensed, you have to collect data and you have to get informed consent from everyone receiving the drug.

Q. Okay, thank you? A.  In other words, this is a very unusual case in that it was already licenced but it was also put back into IND status.

Q. So it was licenced and it's back now into IND status? A.  Yes. And FDA has said that if they give it to service members, according to the originally approved protocol of six shots, that's okay. But if they want to give service members less than six doses, they will need to obtain informed consent. And FDA has basically been wishy-washy about the inhalation indication. They won't give the manufacturer an indication for inhalation, which means this vaccine can't be marketed for inhalation. I mean, if the manufacturer, even though it's only used for inhalation, technically the manufacturer can't market it for inhalation.

Q. So if you wanted to use this drug for inhalation and you wanted to use a three-shot regime, then because the drug was in IND status with regard to those parameters, a physician should obtain informed consent? A.  Is required to.

Q. Required to obtain informed consent. Based, Dr Nass, then on all of your opinions regarding everything back to the animal studies, the different strains, the short-term side effects, the long-term side effects, based on the problems with BioPort and the problems of production and the supplemental testing, would you as a physician prescribe to a patient this vaccine? A.  Under no circumstances. I mean, some of the people I have dealt with haveÐÐI've talked to enough people in enough places and I've seen the Dover study; the Dover study shows at least 30 per cent of people with long-term systemic side effects. I believe that, based on anecdotal evidence from hundreds of people, I believe that the rate of long-term side effects is probably between five and fifteen per cent and possibly higher, because it's lot dependant, and I feel the side effect rate is enormously higher than that for any other vaccine I have ever used or had any experience with or have ever read about, which is basically every other licenced vaccine. This vaccine has, in my mind, an absolutely enormous rate of chronic side effects and I would not use it on anyone.

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour, that completes my examination.

PROSECUTOR: Your Honour, while I realize that we took 20 minutes prior to the completion of my friend's cross-examination, I would be asking for another 20 minutes prior to the commencement of my own ...

MILITARY JUDGE: Ten? Ten minutes?

PROSECUTOR: I would ask for 20, but I will take whatever you grant.

MILITARY JUDGE: Well, you're going to get 12 then, to three-thirty.

MILITARY JUDGE: Go ahead.

PROSECUTOR: Yes, Your Honour.

Q. Dr Nass, you would agree that there are three types of anthrax: cutaneous, gastrointestinal and inhalation, would that be a fair statement? A.  Well, it's a reasonable statement. Some people would say that there is meningeal anthrax also in humans; in humans. There are different syndromes in animals.

Q. And weaponized anthrax is generally inhalational, is that right? A.  That's only inhalational. Well, the kind we're worried about is only inhalational.

Q. Okay. And in that particular type of anthrax illness results from inhaling the anthrax spores? A.  Yes.

Q. And it is about 95 per cent fatal? A.  Well, the two epidemics that we know about in the 20th century were each 80 per cent fatal.

Q. Is that a generally accepted figure, 80 per cent fatal, or would it be closer to between 80 and a hundred per cent? A.  Well, like I said, well, you see these numbers were developed, the 90 per cent, before there was a lot of antibiotic and ICU treatment. So the two recent epidemics are the one at the goat hair mill in Manchester, which was five cases, one survived, and the epidemic in Sverdlovsk, Soviet Union, 1979, and in each of those there was a 20 per cent survival rate. So I'm assuming then that, given our level of medical care now, probably the survival rate's about 80 per cent. It's going to be a function of a lot of things, including virulence, so Sverdlovsk was strains or strain selected for virulence, and the goat hair mill which occurred in about 1960 was not.

Q. When you talk about Sverdlovsk, you're talking about a release of inhalational anthrax that occurred in a major Russian city, is that correct? A.  That's correct.

Q. And you're saying that the rate of survival was roughly about 80 per cent, or thought to be about 80 per cent? A.  As best we have the data.

Q. Sorry, roughly 20 per cent? A.  Right.

Q. Roughly 80 per cent succumbed, so to speak? A.  Right.

Q. But in fact that was a large city and it wasn't clear exactly who had been exposed or who was generally just sick of other things, so that was difficult to say? A.  No. No, actually when someone gets sick with anthrax it's pretty easy to make the diagnosis, all you need to do is look at their blood or their sputum and there are other tests. I mean, it happened in the Soviet Union when it was a closed society, so our information isn't necessarily completely correct. But people I work with, such as Jeanne Guillemin and Matthew Meselson, went and investigated, and there have been articles in the literature and Jean just published a book last year on the epidemic, so that's what we think; 80 per cent. But I admit, in the older literature, and most of the literature, and even in my own article I say 90, because that was before I had actually reviewed the numbers. I wrote that article a year and a half ago ...

Q. Which ... A.  That review article.

Q. The review article? A.  Because most of the literature says 90 per cent fatality rates, but it's based on older data.

Q. So, for example, when I'm looking at an article written by Meryl Nass and posted on Pro-Med, 02 January 1998, and it talks about, "Furthermore, what we would really like to know is the efficacy of inhalational anthrax because it's resistant to standard treatments and high, about 90 percent mortality." You'd agree that you have written in the past that it was higher, as much as 95 per cent, in some articles? A.  That's what I'm saying, I wrote that two years ago and subsequently actually counted the cases.

Q. And antibiotics and standard interventions begun after symptoms begin rarely prevent a fatal outcome, would that be a fair statement? A.  Right. And what I said earlier is, that the important point is, that if you wait till people get sick they're almost certainly going to die. But if you catch them, in let's say a two-day window between being exposed and becoming ill, at least, again based on animal studies, and you treat them aggressively at that point, you can get quite good survivals.

Q. So what you're saying is that if you wait and somehow discover that they have been exposed to anthrax and then start to vaccinate them or give them antibiotics after you've discovered they've been exposed to anthrax but before ... A.  They've gotten sick.

Q. They've gotten sick, that you can get a good survival without the anthrax vaccine? A.  In animal studies, yes.

Q. But you'd agree with me that that's pretty hard to do? A.  Well, actually, you know, when I was at that anthrax meeting in September of 1998, we had four different groups presenting data on their sensor developments, and so it's an area in which there's been a tremendous amount of interest, tremendous amount of research sponsored by the defense department, and I can't tell you at what stage those sensors are right now, but I think we're getting close to reasonably good sensors, and I know they have been deployed at military installations, but I can't tell you how good they are.

Q. Now you have talked earlier about the fact that you didn't see the anthrax as being something that you would ever give to individuals, is that a correct assessment of your testimony? A.  At this point in time, I would never give it because of what I've learned in the last two years with this large program. Because of the consequences of the AVIP, I have a lot more information than I did two years ago when I would have used it.

Q. Well, do you have more information than you had on the 7th of February 2000? Because that's not two years ago? A.  I have some. What are you referring to?

Q. Well, I am referring to an article, "Dissecting Propaganda: Commentary by Meryl Nass, MD February 7, 2000"? A.  Uh-huh, right.

Q. Are you familiar with that article? A.  I wrote it.

Q. Okay. And that's not two years ago that you wrote that article? A.  No.

Q. And in that article you say that, "Once an anthrax attack is detected, there is plenty you can do. You administer antibiotics, passive immunoprophylaxis, and post-exposure vaccination, ..."? A.  Oh, excuse me then, let me put it this way: What I meant was I would not use the vaccine for pre-exposure prophylaxis of anthrax. If someone were in a situation where they were exposed and they had an 80 per cent chance of dying, I would be facing a different circumstance and I would be weighing the benefits of that vaccine perhaps very differently, and I'd be looking at a lot of other issues; such as, if I knew, what was the virulence of the strain? and do I think it's going to work? But, you know, you're absolutely right, if I knew that someone was exposed to a lethal dose of anthrax, I might well use the vaccine in that circumstance, particularly if I thought it was going to work. So I'd be basing my decision on safety and efficacy considerations.

Q. So it's not true to say, as you testified earlier, that in fact you would never give this vaccine to humans? A.  You're right. I wasn't thinking of post-exposure prophylaxis when I said that. By the way, it's not licenced for that use, but it is perhaps a reasonable use.

Q. Okay. Because if you treat people right after exposure survival is likely to be high? A.  Depending on many factors; not necessarily.

Q. Okay. Well, have you made that statement in the past that if you treat people right after exposure ... A.  Remember what I said about the guinea pigs, I mean, in Ivins' study, which was just done a couple of years ago, the majority of the guinea pigs died despite the fact that they were vaccinated.

Q. Okay. Well, on the 7th of February 2000, in your commentary by Meryl Nass, isn't it true that you said, ... A.  I said there's plenty you can do: These are theÐÐI'm not arguing with you, I agree, for post-exposure prophylaxis these are things you can do; can do. It may be a good idea and it may not.

Q. Can I ask you the question, Dr Nass? A.  Go ahead.

Q. Okay. Isn't it true that on the 7th of February 2000, in your commentary to DrÐÐor response to Dr Poland, you said in that article, "If you treat people right after exposure, survival is likely to be high. If you wait until people get sick, the survival rate will plummet. Good detectors are key here."? A.  I did write it and I certainly agree with it.

Q. But in fact you don't know whether good detectors are available, because in fact there are no effective detectors at this point for weaponized anthrax?

ASSISTANT DEFENCE COUNSEL: Well, I don't know whether Major Fullerton is going to be calling evidence on that point, but I would certainly object to him giving evidence in that regard himself.

MILITARY JUDGE: I do intend to call some evidence ...

MILITARY JUDGE: Yeah, okay, what is your objection?

ASSISTANT DEFENCE COUNSEL: Well, Major Fullerton made a statement to Dr Nass that there are no effective detectors ...

MILITARY JUDGE: And your position is?

ASSISTANT DEFENCE COUNSEL: He's giving evidence; he's giving evidence.

MILITARY JUDGE: I thought you were asking a question.

ASSISTANT DEFENCE COUNSEL: No, I was saying that Major Fullerton made a statement to Dr Nass that there are no effective detectors. If he wishes to put it as a ...

MILITARY JUDGE: No, but is that an improper question in cross-examination?

ASSISTANT DEFENCE COUNSEL: Yes, I suggest it is; he's giving evidence.

MILITARY JUDGE: Well, I don't think it is. Objection overruled.

Answer the question, please.

WITNESS: Can you repeat it?

PROSECUTOR:

Q. In fact, there are no good detectors for anthrax? A.  No, I mean, if I were DOD, why would I be deploying detectors on ships and at military bases if they weren't good? I don't agree with that statement. I don't know how good they are. I heard evidence that they were very promising a year and a half ago, and I don't know what has been deployed. I would suggest that a number of people have made the comment that the reason the anthrax vaccine has been given was because the defense department hadn't wanted to put the money into effective masks and effective sensors in the past, and I would hope that they've determined now that this is not a quick fix, not a safe fix, and that money needs to be put into sensors andÐÐas you may, or may not be aware, there was just a big scandal in the last few weeks in the United States regarding the fact that the MOPP gear that people used in the Gulf and subsequently is filled with holes and is not effective. And so it's a real big issue. But what I'm trying to say is that you use vaccines in a context, there are a number of protective measures that could be used or should be used and you look at all of them and see what you have and you see where you're going and you look at the risk and you make a decision and you hope to maximize the safety and the force protection of your people by using as many modalities as possible. Biological warfare is potentially very dangerous and yet, although it's been around for hundreds of years and has certainly been weaponized in a sophisticated fashion for the last 50 years that we know about at least, there really haven't been large outbreak of disease, and I say that as a person who's investigated, you know, perhaps the largest. But there hasn't been a lot of use of biological weapons this century despite their relatively easy availability. And so one has to constantly be making risk/benefit calculations. You can't predict what organisms are going to be used, you know, you can't predict how they're going to be genetically engineered, you can't predict whether your vaccines are going to work. But what you should be able to predict is whether your sensors are going to work and whether your MOPP gear is going to work.

Q. So in response to my question about good detectors, you used the words "promising" and "hopeful", okay.

MILITARY JUDGE: Is that a question?

PROSECUTOR: And she responded, Your Honour.

MILITARY JUDGE: Is that a question? If that was a question, put it in the form of a question.

WITNESS: I think I used thoseÐÐwhatever words I used that ...

PROSECUTOR:

Q. That in response to my questions about the availability of detectors ...

MILITARY JUDGE: No, don't tell me what the answer of the witness is, I can hear that. You have to ask questions of the witness.

PROSECUTOR: I am asking a question andÐÐ

MILITARY JUDGE: You can't state things, you know.

PROSECUTOR: ÐÐthere was an extended answer to my question.

Q. And if I can just focus in on the part that actually answered the question, it was that you are hopeful in respect of good detectors and there are promising indications, is that right? A.  You're the one who qualified me as an expert only for anthrax and I'm not an expert on sensors, and so all I can tell you is what I've heard at a conference 'cause I don't study sensors.

Q. Today anthrax is an almost negligible problem in the developed world, is that right? A.  That's correct.

Q. And there are rare animal outbreaks? A.  That's correct.

Q. And you said that there was less than oneÐÐor there was one human case per year in the United States? A.  Less than one reported.

Q. Okay. So the threat to developed nations is largely a military threat? A.  I would say so.

Q. And you've indicated that weaponized anthrax has been around for an extended period of time, you indicated ... A.  Yes, I did.

Q. So Japan developed weaponized anthrax in the 30s, is that right? A.  Yes, according to the historians who write about it.

Q. Okay. And the US and Great Britain followed in the 1940s with weaponized anthrax? A.  Yes.

Q. And as many as 20 countries may have weaponized anthrax today? A.  I have no idea how many countries have weaponized anthrax, sir.

Q. Okay. But you've written articles on that, have you not, referring ... A.  I have cited, I have used Department of Defense documents which have repeatedly said 10 nations or more, and they have classified information that is not available to me. So I've used their numbers and assumed that they're correct, but I don't have any primary evidence about how many countries have anthrax.

Q. Okay. So when you saidÐÐI'm referring now to an article by Meryl Nass postedÐÐit's entitled, "Anthrax Vaccine, DOD Safety Measures and Chemical-Biological Warfare". Are you familiar with that article? A.  Can I see it?

MILITARY JUDGE: No, just, ma'am, please remainÐÐno, no, excuse me, remain seated.

If you want to show a document to the witness, approach the witness.

PROSECUTOR:

Q. Are you familiar with that article? A.  I've written an awful lot of articles. I've actually never written an article with that title, which is why I'mÐÐsee, this is what happens with some of my articles, theyÐÐoh, I see what happened, okay. This is a talk I gave that was actually published, I found out afterwards it got published, so somebody had published it. But it was a talk that I gave in January of 1998.

Q. Okay, so that's your work? A.  Yeah.

Q. So when it says that the recipes for anthrax or the creation of biological weapons exists in the open scientific literature, that's something that you've said? A.  Yes.

Q. And when you say that there are about 20 countries may possess such weapons, that's something that you have said? A.  Probably. As I say, I think that's a transcript of a tape.

Q. The current US vaccine was formulated in the 1960s, is that right? A.  Yes.

Q. And it was licenced in 1970? A.  Yes.

Q. And the vaccine has been licenced since that time, has it not? A.  Yes.

Q. It's licenced today? A.  Licenced continuously since November of 1970.

Q. Okay. It's never been unlicenced by the FDA? A.  No, it has not.

Q. It's never been de-licenced, it has been licenced continuously since 1970? A.  The FDA has threatened to revoke the licence but has never put the threat into force.

Q. Okay. And the current anthrax vaccine, and I'm looking now at VD1ÐÐsorry VD43, which is the article put into evidence by my friend. It says, at page 189: There are, "Three problems with this vaccine [that] have stimulated interest in an improved human anthrax vaccine ...". And the three problems are the immunization schedule? A.  Uh-huh.

Q. So there's just too many doses of the vaccine required for an individual to receive, is that the problem? A.  If you're reading from my review article there, I think I cite about half a dozen papers that have made that claim.

Q. But I'm asking you about the problems or the present problems of the vaccine? A.  What the researchers say, I mean, there's no other vaccine in existence in the United States that requires six initial doses. So all the researchers have said this is a problem, we need to lower the doses if we want to make this vaccine palatable for more people.

Q. And another problem, cited by yourself, is that it is not protective against all natural anthrax strains in guinea pigs, and that's a problem? A.  True.

Q. And there is a high incidence of local reactions, is that right? A.  Yeah. Where are youÐÐwhich paper are you getting that from?

Q. I'm getting it from VD7? A.  Is that the one you just showed me?

Q. VD43? A.  Okay.

Q. Which is the article submitted by my friend? A.  Can I see? Okay, right, this is the review article. So I was then listing basically the list of problems that Ivins and the researchers at Fort Detrick had identified, and I cite the papers that I'm referring to. So you may realize that when you're citing a number of references you're repeating what the references say, and I agree. But just because I cite those problems doesn't mean that those are the only problems, in my opinion, number one, because I don't have anything to cite regarding the safety because there is no published evidence of safety for the vaccine.

Q. Okay. So when you base your opinion in this court that this vaccineÐÐgive the opinion in this court that the vaccine is not safe, there are no published research papers ... A.  Right. We've discussed how I became informed on that issue, and I told you in fact that the FDA has no data, that the GAO has no data, that the DOD has no data on long-term safety of this vaccine.

Q. And you have done no studies yourself as to the safety of the vaccine? A.  Well, I actually had people send me a questionnaire, so I guess I've done some survey research.

Q. Tell us a little bit about that questionnaire: Was that a statistically valid scientific study? What was the nature of your questionnaire? A.  What I told you before is that I used a questionnaire that I use in my own practice which identifies a lot ofÐÐsimilarly to the Unwin/Wessely study, looks at a lot of different symptoms that may or may not be related to this whole syndrome complex I described earlier as fibro myalgia, chronic fatigue, Gulf War illness, chemical sensitivity, and I got responses from people and I have not had the time to statistically work with that data enough to turn it into a paper. But that's something it's possible I will do in the future.

Q. So that is something that you have impressionistically done on your own and arrived at these conclusions about safety, it's never been published? A.  I thought impressionism was a form of painting.

Q. Pardon me? A.  I'm not sure how the term "impressionistically" relates to me giving questionnaires to people about their symptoms.

Q. Well, you've testified that it hasn't been statistically analysed or evaluated. In fact, you haven't had an opportunity to put it into the form of a paper? A.  Well, ...

Q. I understand that it hasn't been published at this point? A.  I mean, there was actually a doctor who works for the Navy Environmental Health Center who cut the questionnaire down, took it and administered it to his own navy seals and sent me some of that data. But I don't know whether that's statistically accurate. You're right, it's just sitting there right now. I haven't had a chance to do anything with it and in fact people keepÐÐsomebody put it up on the Internet, so now people keep sending me questionnaires and, you know, I don't even know when I'm going to stop collecting them. But you're absolutely right, and I've been very open with you, that a lot of my evidence is purely anecdotal because all we have; all we have, let me say it again, is anecdotal evidence. Although the Department of Defense spent $140 million on studies of Gulf War illness in the US, not one of those studies explored the relationship between anthrax vaccine and the symptoms I'm describing. And they have not done a single study, except the Tripler study, to look at long-term side effects of the current crop of anthrax vaccinees. So we have no data and the question is: Do we sit back and do nothing? or do we try to make the best of what data we have.

Q. But the data that you were using here is anecdotal, as you describe it, in respect of the safety of the vaccine? A.  I would be happy to share with you the informal survey done at Dover, sent to 259 members of the 9th Air Squadron, if you'd like and you could evaluate that for its statistical relevance. I mean, what I'm saying is, we have a problem. We've had many people testify before Congress that they have become chronically ill after getting the vaccine with symptoms that are very similar to each other. We have a defense department that refuses to study the issue and that tries to put the lid on any information coming out about problems, that has attempted to control the reporting to the FDA of side effects. And we're in a very unusual situation, and people in Congress are asking me for my opinion and people in this courtroom are asking me for my opinion and I have only an opinion to provide.

Q. You have only an opinion to provide and you don't have any published studies to back that up with? A.  Right. And there are no published studies as to the fact that it's safe. This vaccine has always been owned by the defense department, it has always been produced under contract to the defense department, it has never been marketed freely to individuals. Essentially, everyone that's ever gotten it has been in the military. The military is the only organization with the ability to study it and has specifically chosen not to study the safety, despite the fact that huge questions have been raised in the Halls of Congress for the last year.

Q. Now isn't it true though that individuals at Fort Detrick have studied the safety of the vaccine? A.  Well, that's a good question. If they have they haven't shared that information with the General Accounting Office or with Congress. Phil Pittman has done some studies of people at Fort Detrick to apparently look at the safety of multiple vaccinations. Now I don't know what he's found, but I have been told, again by Bruce Ivins who's the top anthrax vaccine fellow at Detrick, and also heard through Martin Hugh Jones, that only a very small number of people at Fort Detrick are vaccinated with anthrax vaccine. And Phil Pittman's study is of at least a hundred people and apparently there's only less than 10 that get anthrax vaccine routinely, so I was told. I mean, again, hearsay. So I don't know what they've done at Detrick and I would be delighted to find out.

Q. But you would agree with me that Fort Detrick is studying the anthrax vaccine, various aspects of it? A.  Let me tell you this: Alright, when I was at that anthrax conference in September of '98, I saw Bruce Ivins and I saw Susan Welkos, who are two anthrax vaccine researchers at Fort Detrick, and I had seen them before back in 1991, and I remarked to Bruce on the fact that he looked like he had lost weight, and he told me he had and that he had a blood condition; and that Susan didn't look very good either. And he told me that Susan was down to 90 lbs and he wasn't sure but he thought it might be the anthrax vaccine.

Q. These are researchers at Fort Detrick that you're talking about? A.  Exactly.

Q. Fort Detrick is ...

MILITARY JUDGE: What are the names again?

WITNESS: Susan Welkos, W-E-L-K-O-S, and Bruce Ivins, I-V-I-N-S.

PROSECUTOR:

Q. And Fort Detrick is a research establishment run by the US Army, is that right? A.  Yes.

Q. And that's where in fact Dr Friedlander works? A.  Friedlander.

Q. And these are researchers studying the anthrax vaccine? A.  He was Bruce's boss.

MILITARY JUDGE: Who's Bruce?

WITNESS: Bruce Ivins.

MILITARY JUDGE: I don't know the man, you understand.

WITNESS: Sorry. Arthur Friedlander was Head of Bacteriology at Fort Detrick and Bruce is in the Bacteriology Department, and so Dr Friedlander supervised this vaccine research; he was overall the anthrax vaccine research. Now he is the Assistant to the Commander at Fort Detrick.

PROSECUTOR:

Q. So there's an oversight system in the United States for reporting adverse reactions caused by the anthrax vaccine, is that correct? A.  Yes, there is.

Q. And you're familiar with the VAERS reporting system? A.  I'm extremely familiar with it.

Q. Maybe you could tell the court what the VAERS reporting system is?

MILITARY JUDGE: VAERS?

PROSECUTOR:

Q. VAERS? A.  Yes. It's an acronym, V-A-E-R-S, and it stands for Vaccine Adverse Event Reporting System. It was instituted about nine or ten years ago. It is a passive surveillance system which relies on physicians, people who feel they may have had an adverse effect from a vaccine or their family members to report to the FDA or CDC on the reaction. The VAERS reporting system collects approximately ten to eleven thousand reports yearly for all vaccines, and has collected about 820 reports in the last two years on the anthrax vaccine, for a reporting rate of one in every 500 people who have received the vaccine, which is an extraordinarily high number of adverse reaction reports.

Q. One in every 500 people. And what percentage did you say was reported? A.  It's a passive ...

Q. It's a passive system, it has received how many reports? A.  In the whole United States, you figure how many vaccines are give every year in the United States; I don't know, 50 or 100 million, and they get 10,000 to 11,000 reports per year.

Q. So there were 854 reports? A.  No, no, I said there's about 820 on anthrax.

Q. Eight-hundred and twenty on anthrax. And that works out to one in 500? A.  Yeah, and there are in the low 400,000 people who have received the vaccine so far, some number of doses, so it works out to be approximately one in every 500 recipients has filed a report of an adverse reaction with the FDA.

MILITARY JUDGE: I just want to make sure: Four-hundred thousand have received the anthrax vaccine in the States?

WITNESS: Yes.

PROSECUTOR:

Q. Okay. Now the data from the VAERS reporting system, that goes to the FDA, does it not? A.  It does.

Q. And if the FDA thought the vaccine was unsafe, they could have unlicenced it? A.  That's true.

Q. And they didn't unlicence it? A.  That's true.

Q. If the FDA thought the vaccine was unsafe, they could've stopped its use? A.  They could've.

Q. And they didn't stop its use? A.  That's true.

Q. The anthrax vaccine in the United States was licenced in 1970 and continues to be licenced right up to the present day without interruption, that's true, isn't it? A.  I already told you that.

Q. Okay. And you're aware that when the FDA is concerned about a drug, they haven't hesitated to de-licence or unlicence them? A.  I would actually disagree with that. The roto virus vaccine was on the market for a year last year and caused intussusception, which is a form of small bowel obstruction in infants, and that side effect was identified in the licencing trials, and despite that the FDA licenced the vaccine and allowed it to be used in over a million babies until the reportsÐÐand in fact put it in the package insert that intussusception or a bowel obstruction might be a consequence of this vaccine and allowed it to be used, and there were so many reports of bowel obstruction it was finally looked at. The FDA said, we're not going to stop it but we're going to take a three-month hold, don't use it for three months, let's review our data. And, of course, the manufacturer pulled it at the end of the three months. And that was an interesting vaccine because supposedly there were only 30 to 50 cases of roto virus diarrhoea deaths in the United States per year, not a very large number, so that it appeared that the risk from taking the vaccine was much higher than the risk of dying from roto virus diarrhea. And I would submit to you as well that two drugs were pulled off the market last week by the FDA: Propulcid for having too many potentially fatal drug interactions with other drugs, which has been known about for quite some time; and Reyulin for causing liver failure in a large number of people, which has also been known about for years, and the FDA took its timeÐÐin fact, it was only after a whistle-blower had gone public and had been in the national media that they pulled Reyulin off the market this last week. So I would submit to you that the regulatory efforts of the FDA have left a lot to be desired in the last few years.

Q. So when the FDA has been concerned about a drug they have pulled it off the market? A.  Well, I think, again, I think it's taken them quite some time and I'm not sure that they've pulled all the ones they'veÐÐwhat I'm saying, is that they had reason to be concerned about those drugs for quite awhile and they remained on the market for quite some time. As far as the anthrax vaccine goes, the FDA has been very explicit about only using the VAERS system to look at anthrax vaccine reaction. The FDA has the right, when a drug or a vaccine shows that it's causing too many side effects, the FDA has the right to either demand a post-marketing study of the manufacturer or at least post-marketing surveillance of some kind by the manufacturer. And FDA really doesn't want to do this. Myles Braun, who is a physician and FDA employee said as much at a meeting, that the FDA did not want to set a precedent by requiring extra studies of this licenced vaccine. So the purpose of the VAERS system is really, and I have an article written by Susan Ellenberg, who is the Head of Bio-Statistics at FDA with me, the only purpose of the VAERS system is to be the canary; is to identify that there may be a problem. It doesn't tell you what the problem is or what the magnitude of the problem is, but it says there may be a problem. And then you have to initiate a study to look at the problem. What we need is people who were vaccinated and people who weren't vaccinated and do they get the same illnesses in the same numbers, or are the people who were vaccinated becoming a lot sicker than the people who aren't vaccinated. And that's what you have to have and that's what has not been done. Now if you want more information, I don't have it with me today, but I have emails that indicate that the Department of Defense, specifically the Anthrax Vaccine Immunization Program, was very concerned about the committee of civilian experts that FDA constituted to review the VAERS reports and they made sure to put some of their own people on that committee.

Q. Now these emails, they're not published in peer reviewed articles? A.  No, they came from Shays Committee, those boxes of documents that I told you about.

Q. And this is the type of information that you're using to formulate your opinions here in court? A.  I'm answering your question about the VAERS.

Q. Seldane, that's another drug the FDA de-licenced? A.  Yes, it is.

Q. Can you think of others? A.  Oh, I can think of many, last year there were five or six.

Q. So when they have concerns they de-licence them? A.  Eventually.

Q. The existence of Gulf War syndrome, actually that's controversial in the scientific community, isn't it? A.  It's exceedingly controversial because there is a lot ofÐÐwell, you know, I've worked with Shays Committee; Shays Committee has evaluated Gulf War syndrome, they are the committee that's looked into this in Congress, so I'm very cognizant of these hearings that they've held and I've, you know, been at Gulf War meetings and I've read a lot about it and treat Gulf War vets and all the rest of it. It's like Agent Orange, it's quite controversial, and one of the reasons it's controversial is because a funding agency made sure to fund studies that would confound the results. So any association between, like in Agent Orange ...

Q. Somebody deliberately went out to confound the results? A.  For Agent Orange, you can read Admiral Zumwalt's congressional testimony and see how he told how the actual scientific studies were confounded to dilute the effect of Agent Orange.

Q. But what about Gulf War syndrome? A.  Pardon me?

Q. I'm asking you about Gulf War syndrome? A.  Well, I'm telling you that it looks to me that the same thing happened.

Q. Okay. So it looks to you that somebody has gone out of their way to confound the scientific community? A.  Yes.

Q. Intentionally? A.  Probably.

Q. Okay. Do you have any evidence as to who did that? A.  I would suggest that the Department of Defense, partly through the Office of the Special Assistant for Gulf War Illness and partly through other DOD and VA funding authorities to do research into Gulf War illness, and I would submit that Shays Committee has had hearings on the subjectÐÐthe most recent was last monthÐÐand they were very unhappy at how $121 million was spent. And if you need a transcript of that hearing I'd be happy to provide it for you.

Q. So you're suggesting that the Department of Defense is actively spreading untruths? A.  I would submit that the amount of pensions that they would have to pay if it were shown that exposures that they were responsible for led to illness in more than a hundred thousand veterans, it could be a considerable amount of money, and that that might be a reason to attempt to ...

MILITARY JUDGE: We're really straining, we're really straining. We're into politics now, we're into all kinds of things except and quite clearly outside the realm of expertise upon which this witness was qualified.

PROSECUTOR: I'll move on, Your Honour.

Q. You've testified with respect to the effectiveness of the vaccine, about animal studies in guinea pigs, and you've testified that there was moderate effectiveness of anthrax vaccine against a limited number of strains of the anthrax spores? A.  Uh-huh.

Q. You'd agree with me that there is different effectiveness in respect of different species? A.  Yes.

Q. And that there is better effectiveness in respect of rabbits and monkeys than in respect to the guinea pigs you've talked about? A.  Well, no, that's the problem, we don't know with the rabbits and the monkeys because they haven't been tested against enough strains. It's only the guinea pigs that have had the large number of strains tested against them.

Q. But you are aware of the reports from Fort Detrick of the monkeys immunized with MDPHPA? A.  Right. But they only were tested against Ames and Vollum and nothing else.

Q. Okay. And they were exposed to up to 900 times the LD50 of aerosolized Ames spores, is that correct? A.  Right, right.

Q. And the results were quite positive, is that correct? In fact, all of the monkeys survived? A.  No, not all the monkeys. If you look at the 65, several of them died.

Q. Okay. But nearly every immunized monkey survived? A.  Right.

Q. And all of the controls died? A.  Correct.

Q. So that is evidence of the efficacy of the anthrax vaccine in respect of the rhesus monkeys? A.  The rhesus monkeys and those two strains.

Q. Okay. But you don't actually know what strain a country like, say Iraq, would be using against American troops, do you? A.  Actually, we know a little bit, because we know that the French and the Americans supplied them with some strains.

Q. But you don't know which strain they would use in any given situation?

MILITARY JUDGE: I'll tell you, all of this evidence, I don't know what it's going to do for your case, you know.

PROSECUTOR: I'd simply ask that you bear with me.

MILITARY JUDGE: We've qualified this witness to testify on the anthrax vaccine.

PROSECUTOR: Yes.

MILITARY JUDGE: Now we're hearing things like pensions and the American supplyingÐÐDr Nass, I think you should limit your evidence to your expertise in the anthrax vaccine. Political issues are not really the concern of this court here. This is not the purpose of this trial. I think I have to tell you that.

WITNESS: Right.

MILITARY JUDGE: Carry on.

WITNESS: We actually have a list of the strains that were sold.

MILITARY JUDGE: Yeah, but wait for the questions to come.

WITNESS: Sure.

MILITARY JUDGE: And limit your questions to what this witness was qualified for, please.

PROSECUTOR: Okay.

Q. And you would agree that some strains of anthrax are almost completely protected by the anthrax vaccine? A.  Here's the table: 33 strains, and you can look and see which strains are protected, you know, by the vaccine and which ones aren't.

Q. I will gladly do that. So the table indicates that there is different effectiveness for different strains? A.  Yes.

Q. That would be a rough summation? A.  Yes.

Q. And I'm suggesting to you that in monkeys, are thought to be more closely related to humans than guinea pigs?

DEFENCE COUNSEL: Some humans only.

PROSECUTOR:

Q. Some humans. I'm sure most humans, is that correct? A.  It's clear that monkeys are much closer to humans than guinea pigs are and it's clear that mice are closer to guinea pigs than monkeys, but, you know, why is it that you can only protect 10 per cent of mice? You know, why is it? We don't know the answers to these things and that's the crucial point. And again, GAO and DOD have acknowledged this in plenty of documentary material. Nobody knows.

Q. And one reason is because you can't do this type of testing on human beings, isn't that right? So you're only left with the animal studies? A.  No, no, no, no. Obviously, you can't test inhalation anthrax on humans, or you shouldn't. But, no, the issue is, how do you relate monkeys to humans? Let's say you tested a hundred strains on monkeys, that still bears no relationship to the genetically engineered or the newly discovered strain that Iraq or Russia has. So the problem being is that you've got a jillion potential strains and not only anthrax, they've got other biological weapons; they've got plague and botulism and all the rest. And so you vaccinate against anthrax and against this kind of anthrax and you're doing nothing for your genetically engineered strains that don't use PA, and for all your other weapons and for some of your naturally occurring strains.

Q. But I'm talking to you about the effectiveness of the anthrax vaccine? A.  That's what I'm talking about.

Q. And in respect of the effectiveness of the anthrax vaccine, you spoke about animal studies? A.  Right.

Q. And you spoke about guinea pigs? A.  I'm sorry, what I should've added then was that if there were some way we could draw the blood of a monkey and predict what was going to happen when we exposed that monkey to anthrax, we would then be able to look at that same parameter in humans and draw blood, you know, draw the blood of the monkey and then expose them to anthrax, and if we've got a blood parameter that tells us whether they're going to survive or not, we'd look for that in humans. We haven't been able to find that parameter.

Q. Perhaps I'll leave it with you this way: You're aware that Fort Detrick has done studies in respect of rhesus monkeys? A.  Yes.

Q. And you're aware that we cannot do studies in respect of humans? A.  You can do safety studies; you can't do efficacy studies.

Q. So we're left to extrapolate, in order to determine efficacy, from the studies of animals? A.  Yes.

Q. And you'd agree with me that at least two studies done by Fort Detrick have indicated that the efficacy of the anthrax vaccine is high? A.  In what?

Q. In respect of the those studies, the exposure to aerosolized anthrax in vaccinated rhesus monkeys? A.  Yeah. In vaccinated rhesus monkeys for those two strains of anthrax done in one lab and never repeated anywhere else in the world, yes.

Q. And you'd agree with me that when you're talking about your concerns with respect to other strains, in fact there being an infinite number of strains, you're really talking about a theoretical concern that you have? A.  No, not at all. It was published in the New York Times and in the journal Vaccine in December of 1997 that the Russians constructed a strain of anthrax, which I talked about earlier, which used a protein called cereolysin in place of PA to get the anthrax toxins into the cells it was attacking, and that by using this construct, you basically made anthrax vaccine resistant, because PA is the primary immunizing antigen in the vaccine. So if you're immunized against PA and now you have anthrax which doesn't contain PA, you've got no immunity or very little to the new anthrax. So the Russians did construct this strain, they published an article about it, it's been discussed all over the place, and Fort Detrick says, well, we don't know, we haven't seen the strain, we don't know if it's weaponizable. Well, that's right. But if they made one, they can probably make another that is weaponizable. Then they say, well, it's not anthrax because it doesn't have PA. Okay. Well, then, you know, it's semantics. Basically, you've created something that can kill like anthrax but is not going to be protected against by the vaccine. And if you want a copy of the New York Times article that discusses this or the article from the journal Vaccine in December of '97, I will provide it.

Q. Now you have talked a little bit about the Brachman study, is that correct? A.  I did.

Q. And the Brachman study is really the only study that determined the effectiveness, or considered the effectiveness of the anthrax vaccineÐÐ? A.  An anthrax vaccine.

Q. ÐÐin addressing aerosolizedÐÐin addressing anthrax in humans? A.  That's correct.

Q. And you'd agree with me that Brachman claimed the effectiveness of his study was roughly 92 per cent? A.  Right. And since you read my article on Greg Poland, you've seen that I reran his numbers.

Q. That's right? A.  And I calculated it differently, at about 72 per cent.

Q. Okay, so you calculate the effectiveness of an anthrax vaccine on humans at about 72 per cent? A.  Yes, for unknown doses of anthrax and naturally occurring strains in that setting of the mill, his vaccine appeared to be about 72 per cent effective.

Q. And that's about the best study we got at this point? A.  It was a different vaccine, but it's the only study we've got. It's kind of like the Wessely/Unwin study, you know, it's a different country, a different vaccine and it's not relevant, and that was a different vaccine.

MILITARY JUDGE: You asked the question, you live with the answer.

PROSECUTOR:

Q. We will address that with others. Side effects, with respect to your concerns about side effects, you have brought your concerns regarding adverse reactions to the FDA, is that correct? That's what you testified? A.  I brought my concerns to the FDA?

Q. You have brought your concerns publicly to the American Government? A.  Yeah, I've spoken with the Deputy Commissioner of the FDA on a couple of occasions and I've brought my concerns to Congress and maybe to other bodies.

Q. And they have not seen fit to change the package insert in the anthrax vaccine? A.  Perhaps they've changed a few times, the last time was in March of '99, I'm told.

Q. And did they change it in a way that addressed your concerns? A.  I've never asked anybody to change the package insert, and in fact I was invited by a lawyer to work with him; he was asking the FDA to change the package insert. But it was my believe that it wasn't the package insert that needed to be changed but the vaccine itself.

Q. So when you direct questions or indicate concerns about the package insert, you're not concerned about that? A.  I think that the package insert is inaccurate; I also think that the method of medical practice that is occurring within the United States now is that it's not fulfilling the advice of the package insert. The package insert is a legal document which tells physicians how to practice using that product. And so I think it's important that people read the package insert and be cognizant of what it says. And the package insert says, if you have a systemic reaction you shouldn't get any more doses of vaccine, but that is not being followed, and so I've certainly made that protestation to the FDA and to Congress. The package insert also has the Brachman rates of side effects which were obtainedÐÐI don't think I went into how Brachman got his side effect rates. But Brachman gave his vaccine to mill workers and then went back at 24 hours and 48 hoursÐÐI've heard Brachman say thisÐÐand checked their arms and then got a rate. So he stopped doing active surveillance at 48 hours; that's how he got a 30 per cent rate of local reactions. And probably one or two people from the mills complained to him later that they had some kind of systemic reaction, and that's how he got his 0.2 per cent systemic reaction rate. So, in other words, the local reaction rate was obtained using active surveillance but only up to 48 hours; the systemic reaction rate was obtained using passive surveillance. So that's the rate that's on the package insert, it shouldn't be there but there it is. And I've pointed out to a number of people that the actual systemic side effectÐÐthe local side effect rates, I don't really care about, they go away. But the systemic side effect rates, as I've told you in testimony earlier today, are as high as 240 times the package insert; the Tripler number is 240 times the 0.2 per cent rate listed on the package insert. And I think that FDA is remiss in its duties for not realizing that there is a serious problem there and that this vaccine needs to be looked at very closely, and I've told that to the FDA deputy commissioner who has not, at this point in time, responded.

Q. In your article that I've previously referred you to on, "Anthrax Vaccine, DOD Safety Measures and Chemical-Biological Warfare", it's the article, I think, you said was originally given by yourself as a talk. You say: "Anthrax vaccine probably is safe when administered alone". Are those your words? A.  Yeah, you see, that talk I gave prior to the AVIP, in January of 1998, so nobody, no Canadians, no British, no Americans had gotten any vaccine at that point in time. And so what information I had then was the Brachman study; none of this other information. And it was my belief that although the vaccine was unlikely to be effective, probably it was safe. But subsequently I've been handed all this other information and so I've completely changed my belief about its safety.

Q. So it's only in this year, since February ... A.  Well, it was two years and three months ago.

Q. So it's only in the past two years that you have come to the conclusion that it is unsafe? A.  That's right. That's absolutely right, because I've been given a bunch of unpublished studies from the GAO to read; I've been given internal DOD documents; I have seen some Tripler data; the Dover data; and all these people that have filled-in my questionnaires and called me. So I've seen data on thousands of people now who are suffering adverse effects. I have some of it with me if you want to see it.

Q. Now, that data, was that data available in March of 1998? A.  No. Well, I mean, the unpublished dataÐÐthe GOD (sic) studies was available to DOD, but it's not in the publicÐÐit's not available to the public. I got it because I was asked to critique it.

Q. When were these unpublished studies, when do they date back to? A.  Done? They were done through the 90s.

Q. And hypothetically, in the past you have held the view that the anthrax vaccine would save 50 to 90 per cent of troops if exposed to lethal doses of aerosolized anthrax, is that true? A.  I think there was a caveat in that article, saying if the strains were such that they were susceptible.

Q. If they were the appropriate strains, okay. And that is an opinion that you held in March of 1998? A.  If you read it again, I mean, I just showed you a list of strains. I said: If the enemy chose a strain that was susceptible to this vaccine, I would expect good survival rates. The problem being that it's not that hard toÐÐyou see the Ivins paper that I gave you?

Q. Yeah? A.  Okay. That paper came into my hands in September of 1998, alright. That paper that you're reading from now is from March of 1998, right, or something earlier. So what happened is that even when I wrote my review article, I didn't have Bruce Ivins' paper, I had an earlier study done at Fort Detrick in 1986 which showed that nine out of 27 strains defeated the vaccine and 18 were susceptible. I didn't realize that there was a later study done, which is still unpublished, in which 27 out of 33 strains defeat the vaccine.

Q. So that later study is unpublished? A.  It's unpublished, but Bruce handed it to me.

Q. And its never been put in a peer review article? A.  It was presented at a conference. The abstract is probably in the conference proceedings.

Q. Now at the very beginning of our discussion here, we talked about how fatal aerosolized anthrax would be in weaponized form, and I think you said 80 per cent? A.  Uh-huh.

Q. But you have held the view in the past that it was up to a hundred per cent fatal, is that not correct? A.  I think everything I've written has said either 80 or 90 per cent. But whatever, I mean, we don't know whatÐÐI keep telling youÐÐyou can't say it's this fatal or that fatal, it depends on the strain.

Q. So a survival rate of 50 or 60 or 72 per cent sounds pretty good when you compare it to a fatality rate of a hundred per cent, isn't that right? A.  No, I don't know if it's pretty good, but I guess it's better.

Q. It's a big improvement, you'd agree with me? A.  Yeah.

Q. Okay. I am going to show you an article, "The Department of Defense's Anthrax Vaccine Experiment by Meryl Nass, MD"? A.  Uh-huh, yeah.

Q. If you could look to the fourth paragraph? A.  Uh-huh.

Q. Is that your work? A.  Uh-huh.

Q. And at that time you indicate that aerosolized anthrax in weaponized form would be how? A.  No, again you have to listen to what I say carefully. I'm not trying to give you a hard time, but what I'm saying isÐÐwhat I told you is 80 per cent is the two epidemics that have occurred in recent decades, okay.

Q. Uh-huh? A.  One was in a mill where the strains were not selected for virulence, and one was in the Soviet Union in 1979 when we presumed that they were selected for virulence, and they had 80 per cent fatality rates. It's now the year 2000, do you think we could make a more virulent strain of anthrax between 1979 and 2000?

MILITARY JUDGE: Well, I hope you won't respond to that question.

PROSECUTOR: I won't.

MILITARY JUDGE: Because you ask the questions and you respond to the questions. I'm sorry, this is not a discussion, this is a court of law.

WITNESS: I'm sorry.

MILITARY JUDGE: Okay, please, please.

WITNESS: It's just that I think that the question is: How virulent can you make it? Well, we have very good genetic engineering now and you can make it very virulent. So which country? who made it? you know, how much? But sure, if you use a high, high dose of a highly virulent anthrax, I think it could well be 100 per cent fatal, particularly if you add virulence genes from other organisms.

PROSECUTOR:

Q. You think it could well be. So you're presuming that the anthrax vaccine is increasingly virulent, is that right? A.  No, no, no, I'm saying you can create it to be increasingly virulent given the tools at the disposal of, you know, microbiologists, molecular biologists in the year 2000. And that if you read Alibek, who was in charge of the Soviet anthrax program for a while, that he created, you know, more and more highly virulent strains.

Q. In the article that I've referred you to, you would agree that you write, "Anthrax, used as an agent in biological warfare, is expected to be nearly 100% fatal in those who develop the disease. Therefore, a vaccine which provides only modest protection is still better than nothing, provided it's safe."? A.  That's absolutely true.

Q. Now in Exhibit VD41, at page 21 ...

MILITARY JUDGE: Twenty-one?

PROSECUTOR:

Q. Page 21, I will, because on the one that was entered into exhibit there is no page numbers: it's one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, page 16, you indicate ...

MILITARY JUDGE: What does it say? Because it's hard to follow.

PROSECUTOR:

Q. You indicate that lot FAV020 successfully completed supplemental testing on the 2nd of March 1998? A.  Yes, it did.

Q. The anthrax vaccine was, as I understand it, originally developed as a response to anthrax disease which appeared at Fort Detrick in the 1950s, is that your understanding? A.  Yes.

Q. And so the anthrax vaccine was developed in the 60s and licenced in 1970? A.  From my understanding, Brachman used it at the very end of his trial, which ended in about 62, so it might have been developed in the late 50s, early 60s and was used in a limited way apparently through the 60s.

Q. Okay. And certainly since 1970, it has been used to vaccinate individuals at Fort Detrick, is that correct? A.  Yes. Some individuals at Fort Detrick.

Q. Those individuals who are involved in lab work with anthrax? A.  Anthrax.

Q. And those individuals continue to use it in that environment to this day, isn't that correct? A.  Yes. And I think you're absolutely right, one would think that if it was causing big problems people would've noticed it before. I have a couple of thoughts on that: I think that the question about the lot to lot variability may be important because I think the anthrax vaccine may not have caused all these problems previously, we just don't know. You know, there just isn't the data. But it may have been okay at one time. It may be the fact that the lots have sat around for too long. I don't know the answer to that. There have been some changes in the manufacturing process and not all of which were submitted to the FDA for approval, although they should've been, and it could have to do with those changes.

Q. Now you have expressedÐÐyou talked about the dosing schedule for the anthrax vaccine and you expressed an opinion that it was a poor dosing schedule, is that correct? A.  Like I said, since we can't test efficacy, we don't know for sure. But, you know, on a scientific basis, of course, I'm not qualified in immunology, but basically it takes you longer than two weeks to develop a full antibody response to a dose of vaccine, and so it makes better sense, if you're looking at titre levels, to wait longer than two weeks between doses to optimize your titre increase with additional doses.

Q. So that's what you're basing that opinion on. You're not basing it on studies or reports or published articles? A.  Regarding the dose that's being used?

Q. That's right? A.  Well, I mean, I have a lot of memos and notes, but you're right, there have been no published studies. Some of the unpublished studies I reviewed for GAO looked at different dose ranges, and in fact demonstrated this titre improvement when you increase the distance between the doses. But there are no published studies that look at that.

Q. Now if I can talk to you for a minute about the difference between the British and the American vaccine. Isn't it true that there was difference in the adjuvants, and particularly pertussis? A.  Well, no, you're getting back to the Gulf War. At the time of the Gulf War, based on research that Peter Turnbull had done in guinea pigsÐÐin the guinea pigs, people were very concerned that this was not a good vaccine in terms of inducing a good immune response until you'd had a number of doses. And they didn't have enough vaccine and they didn't have enough time to give all these doses. So Peter Turnbull had done some experiments where he adjuvanted the vaccine with a variety of different adjuvants, one of which was pertussis vaccine, and found that this really strengthened the otherÐÐthe pertussis or the other adjuvants non-specifically revved up the immune response, so you got much higher antibody titres after one dose than you would if you just gave the plain vaccine. So the normal adjuvant in the British vaccine is alum and our normal licenced adjuvant is aluminum hydroxide, or alum; the original, the first vaccine that Brachman used, used alum also. And so anyway, Peter Turnbull found that if he gave the pertussis, he would stimulate greater immunity. Now there are also some questions as to, was he stimulating excess immunity and auto-immunity?

Q. Maybe I can just stop you there and indicate, isn't it true that the American's never used pertussis? A.  I can't say because a lot of vaccines weren't put into the records, so we're not really sure. Some have speculated also that plague was used similarly as an adjuvant and we don't know about that either.

Q. But now you're talking about speculation? A.  Well, there's no vaccine records from the Gulf War. But anyway, that's only the Gulf War. Currently, nobody is getting pertussis with this vaccine, and the MOD has said that in fact the pertussis was not helpful in promoting immunity against anthrax.

Q. Now you have characterized the anthrax vaccine as an investigational new drug? A.  Yes.

Q. Am I mis-stating you? A.  No, you're not.

Q. And what do you base that on? A.  I base it on this Investigational New Drug Application right here.

Q. Are you saying that it's no longer licenced? A.  I didn't say that.

MILITARY JUDGE: I think the witness answered that question before; said, the vaccine was licenced to this date. You asked that question.

PROSECUTOR: No, I believe my friend did.

MILITARY JUDGE: No, no, you did from there, and I could go back to my notes, if you want. Yeah, continuous licencing from 1970s to now, it's a question you put to the witness, Major Fullerton. So that's something I've already heard, I don't want to hear it again.

WITNESS: You can see it's in investigational status for inhalation.

PROSECUTOR:

Q. Oh, so you're not saying that the anthrax vaccine is an investigational new drug, you're saying that it is beingÐÐthere's an application with respect to a different use? A.  It's investigational for three indications here: one, inhalational anthrax; two, change in route of administration; and three, change in vaccination schedule.

PROSECUTOR: If I could just have a moment, Your Honour.

Your Honour, I have no further questions of this witness.

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour.

Q. Just to clear up something that's a bit confusing: the vaccine has been licenced since 1970 by the United States Government, is that correct? A.  Yes.

Q. But it's also in IND? A.  Yes.

Q. Is that unusual for a drug to be licenced and be IND status? A.  I don't know.

Q. When you said that it's IND status for, I believe, three components: one, is to use the vaccine for inhalation; two, was to change the route of administration; and three, to change the dosage schedule? A.  Yes.

Q. Was the vaccine originally licenced for inhalational anthrax, do you know? A.  No, it wasn't.

Q. What was it licenced for? A.  It was licenced for people who would come in contact with the vaccine occupationally, so it was for livestock workers and such, but also those who might come in contact with it occupationally are lab workers.

Q. Okay, so the notion is, is that if you're now going to use the vaccine, or if it's proposed to use the vaccine for inhalational anthrax then it has to go back to FDA and go back into IND status and that's exactly what's happened? A.  That's right.

Q. Okay. Just one little question that I wasn't sure about: we heard about Brockman and we heard about Brachman, are they the same? A.  Yes.

Q. Okay, they're the same. And in terms of whetherÐÐMajor Fullerton asked you about what information was available, what was published prior to March 1998. Are you aware of the Rockefeller report? A.  I am.

Q. Do you know when that was published? A.  1994, I believe.

Q. Do you know whether it was ever distributed on the Internet? A.  Yes, it was.

Q. And do you know when it would've been distributed on the Internet? A.  No, I don't know that ...

Q. Sometime after ... A.  Let me say this: I cited it, it was definitely onÐÐI cited it in that post to Pro-Med that I wrote the end of December 1997, so it was on the Internet probably by that time.

Q. By April 1997? A.  December of '97.

Q. And just very, very briefly, what does the Rockefeller report deal with? A.  The Rockefeller report, which was a Senate Committee report, deals with Gulf War illness and the possible contributors to Gulf War illness. And it makes the comment that anthrax vaccine is a possible contributor for several reasons: One, being that troops who apparently were more likely to get the vaccine also turned out to be more likely to develop Gulf War illness ...

Q. So this was on the Internet at least by January 1998? A.  '97.

Q. '97, okay. Now the ... A.  Oh, sorry, January '98, December '97.

Q. January '98, December '97. Okay, if there is no evidenceÐÐand I think that this was clear but just in caseÐÐif there's no evidence that a drug is unsafe, but there's no evidence that the drug is safe, is it wise to use the drug? A.  No.

ASSISTANT DEFENCE COUNSEL: That's all the questions I have then, thank you, Your Honour.

MILITARY JUDGE: I might have a few clarifications to ask of you, Dr Nass.

QUESTIONED BY COURT

Q. I just want to make sure I understand that when they tested strains of that anthrax bacteria, whatever it is? A.  Bacteria.

Q. Bacteria, on the monkeys, they only tried a couple? A.  That's correct.

Q. The others they didn't? A.  That's correct.

Q. But when they did that with the mice and the guinea pigs then they used all of them? A.  Only a couple of times actually, and it's been relatively recently that they realized that there was this great variability between strains. The first time they looked at multiple strains and published was in '86, and that was from Fort Detrick, and then again in '98, this unpublished study that was presented at the conference. The British have looked at a few different strains also but haven't tried to get as many different strains tested as the Americans.

Q. But when they used the anthrax vaccine for the known strainsÐÐ A.  Yes, some of the known strains.

Q. ÐÐlike, what do you call them? Ames and Vollum? A.  Vollum.

Q. Vollum. It was efficient? A.  It actually depends upon the study. In the monkeys, yes, it wasÐÐin only this series of monkey studies that Dr Friedlander has been involved with it was effective. Those are ...

Q. But only for those two strains? That's what we're talking about? A.  Right, only for those two strains.

Q. Now, obviously, can I conclude from this that if the two strains were the strains that would've been used in a biological warfare weapon that it would've been likely efficient? A.  You can't conclude that.

Q. No? A.  It's very clear in many DOD conferences that peopleÐÐmeetings where Arthur Friedlander was present and the GAO testimony that there is noÐÐthe term is "correlate of immunity"ÐÐthere is no test you can do to see whether people are like monkeys. So we can make the assumption we're like monkeys, but there is no way to prove it for anthrax. And like I said, the mice and the guinea pigs are different; very, very different from each other. So it's possible that the monkeys and the humans are very different also, we don't know and we don't know how to find out.

Q. Do have any data or any knowledge, personal knowledge, of anyone that has been vaccinated exposed to the anthrax bacteria? A.  No. The problem is, is that basically the goat hair mills were the only place left in North America where people were routinely being exposed to anthrax, and they all shut down, so they don't exist any longer in North America. So there is no way to do the studies in humans, I mean, unless you use the lab workers. But we really, you know, again you can't say for sure how much they're exposed to, and they go into the hot suites with anthrax there using a respiratory apparatus so they are not supposed to be exposed to very much anthrax, but they get vaccinated as a precaution anyway. Now not all the researchers apparently have been vaccinated in the past. I remember Hugh Jones said at a talk he gave recently that he only just started getting the vaccine a year or two ago and yet he's had an anthrax lab running for quite some time. I talked to researchers at Duke and they told me they had trouble getting the vaccine, it wasn't available to them, so they were doing their research without it. So we don't know in the United States, don't know whether it protects.

Q. Okay. The Brachman study, the vaccine used at the time had nothing to do with the vaccine we're talking about in '98? A.  Well, it was an anthrax vaccine and it was a killed vaccine, but it used a different anthrax strain, it used a different aluminum adjuvant and a different method for growing it.

Q. But it was not made by the same company? None of this ... A.  It wasn't made by the same company, no.

Q. I'm just trying to make sure I don't confuse companies here. A.  At the very end it looks like Brachman used a little bit of the current vaccine, but in his paper he doesn't differentiate between the two, so there's no data to go by.

Q. Uh-huh. Okay, here's another area that I need to clarify. You said that the supplemental testing that was done by two organizations, MitreTek ... A.  No, actually all the supplemental testing was done by the manufacturer, but MitreTek was contracted to observe it and make sure it was done right.

Q. And you said that the supplemental testing was excellent, it was correctly performed? A.  Yes.

Q. I noted these words when you testified. A.  Yes. I said MitreTek had done a good job, an excellent job at overseeing it and making sure that it was correctly performed ...

Q. But the test were not valid? A.  I think that they were not sufficient to prove what they were supposed to prove. In other words, the potency test itself was not valid and has been junked. The safety test only tells us whether the mice and guinea pigs live or don't lose weight in a week; it doesn't tell us really whether the vaccine is safe.

Q. So the supplemental test, as far as you're concerned, they're not valid? The results are not valid? A.  No. Well, they don't prove stability, they don't prove safety, they don't prove potency.

Q. So they're not valid? A.  I don't think they are.

Q. Well, you'll have to commit yourself there? A.  What I mean is thatÐÐno, what I'm trying to say is that FDA has specified how these tests are supposed to be done, in the original licencing. The manufacturer and the FDA together have agreed certain tests have to be done. Those are the tests that were done. They were performed as they were supposed to be performed correctly. Now the question is, do they actually assess? do they answer the questions they're supposed to answer? They don't.

Q. Now one last area that I want to explore with you is your change, your personal change, your opinionÐÐchange in your opinion in relation to the vaccine, the one we're talking about fabricated in Michigan and which was given to, you said, 400,000 American soldiers? A.  Yes.

Q. And a certain number, few hundreds of Canadian soldiers, I gather. Now you thought it was safe until sometime in '98? A.  That's right.

Q. So you were not alerted to a danger until maybe this summer even, of 1998? A.  That's correct.

Q. And whatever you posted on the Pro-Med, what is it called? Pro-Med? A.  Mailing list.

Q. Mailing list, did not allude to danger. It alluded maybe to a lack of proven efficiency but not to ... A.  No, I did say at that time that the Rockefeller Committee had questioned the safety and so it was something that needed to be resolved. But that was the only thing I really knew at the time.

Q. It's after the summer of '98 that you started getting information that makes you conclude that it was dangerous? A.  Yes.

Q. Early on, when the defence was questioning you about the procedures followed at the Michigan Biologic Products Institute, you alluded to, you know, pieces of gasket found in vials, some vials being infected, not being sterile and so on? A.  Yes.

Q. But these are things you discovered after '98? A.  I believe that that report came into my hands in April or May of '98. The report was conducted in late February of '98, yeah, in '98. At the same time they started vaccinating Americans around March 15th of '98, and so people probably started calling me in April to tell me they were getting sick. And sometime, I would guess in the summerÐÐI'm guessing in the summer, maybe the fall, the GAO gave me the unpublished studies when I became aware of the high side effect rates in the unpublished studies that were completely different than the package insert, whereas previously I thought the package insert was accurate as far as the safety profile went.

Q. Uh-huh. Now on the licencing issue, when the vaccine was licenced, I think that's what I understand your evidence to say, in the 60s, that vaccine was not for the bacteria that's inhaled, it was for contact bacteria? A.  I think thatÐÐthe vaccine was developed at Fort Detick, I think it was developed to protect the workers at Fort Detrick and secondarily maybe for biological warfare protection, and so that is all inhalation anthrax. But in order to get something licenced you have to test it in the appropriate setting, and they were only able to test it againstÐÐthey had five cases of inhalation anthrax, which wasn't enough for statistical significance. Since only 30 per cent of the people in the mills were vaccinated, it didn't really matter that five people got inhalation and all five of them were in the 70 per cent that were unvaccinated. You couldn't draw conclusions as to whether it was effective inhalation. So Brachman says, in his original paper, that no conclusions could be drawn, so the FDA licenced it for cutaneous anthraxÐÐit wasn't FDA, excuse me. The NIA, a division of Biologic Standards, licenced it. Now they probably shouldn't have done that. I mean, they were licencingÐÐI hope they knew that they were licencing it for inhalation use and not for cutaneous use, but they licenced it for people whoÐÐon the package insert it said, had continuing long-lasting exposure to anthrax, because they knew even in 1970 it was a rare disease. You know, we're not all vaccinated against Ebola, for instance, because our chance of getting it is very slim. So in terms of risk/benefit analysis you would have to have a very significant risk to put up with the possible adverse effect of a vaccine.

Q. This new IND, Investigational New Drug program that has nowÐÐthe drug, they're trying to get it licenced anew? A.  Right.

Q. I understand that now. A.  Exactly.

Q. When was that done? That IND one, is it ... A.  Well, there have been a few; this is '96.

Q. No, no, you can stay there and tell me, I can understand? A.  Okay.

Q. So '96 is when they asked for that? A.  When they applied for this, right, this change.

Q. When they applied for this change ... A.  Well, actually it's an application to ask FDA, can they go aheadÐÐit's initial data from a study that's already been done suggesting that there's reason to believe they should have these changes and they're now asking for the ability to do further testing.

Q. When that happens, when that IND system or whatever, or status is given in relation to a drug, the fact that it was used and the way it was used before is not affected by that, unless the FDA would say, now that we're into the IND process you're going to stop producing it? A.  This is a legal question that I can't answer. It's a question that all the legal minds in the United States are very interested in, because the defense department documents indicate that there were some very serious concerns that if they put it back into IND status would they be able to make it mandatory when they gave it. And maybe yes, maybe no. So it's a legal question.

MILITARY JUDGE: Okay. Any questions arising?

ASSISTANT DEFENCE COUNSEL: Just, Your Honour, in terms of the supplemental testing, the document that isÐÐI don't have the number, the document of Dr Nass, if I could, Your Honour, it's the two-page document where Dr Nass is reporting on the FDA inspection.

MILITARY JUDGE: This thing here?

ASSISTANT DEFENCE COUNSEL: Yes.

WITNESS: Uh-huh.

MILITARY JUDGE: A summary of 20 February '98.

QUESTIONED BY ASSISTANT DEFENCE COUNSEL THROUGH COURT

Q. That was an FDA inspection of the Michigan Biologic Products Institute? A.  Yes.

Q. And it was as a result of that inspection that there was the need for the supplemental testing? A.  Yes.

Q. And the FDA inspection of the plant took place on ... A.  Well, no, excuse me, I'm wrong. Questions had already been raised; FDA had been complaining about the plant quality for years and the supplemental testing had actuallyÐÐthey had been discussing it back in 1997 and had MitreTek do a record review of the plant first, and apparently started the supplemental testing in January, a month before this FDA inspection took place. But it was really to answer questions that had been raised in the earlier inspections.

Q. And so, certainly, some significant questions were raised February 20th when FDA did the inspectionÐÐ A.  Yes.

Q. ÐÐof the anthrax aspect of the manufacturing plant? A.  That's correct.

Q. Okay. And as a result of that they went to the next step to do the supplemental testing? A.  No, they had already started the supplemental testing, but they went to the next step of shutting the plant down.

Q. Okay. The plant was never closed, was it? A.  It closed. Now the question is, who initiated the plant closure and a tremendous rebuilding, rehabilitation of the plant? The defense department says that the FDA never ordered it and there's no evidence that the FDA ordered it, but it's coincidental that the plant shut down in February of '98 and the FDA inspection took place in February of 1998, and they basically razed the plant to the ground and doubled the capacity. And DOD owns all the equipment and DOD paid for the whole renovation of the anthrax specific portion of the plant.

Q. In your opinion, is it sort of a situation that Michigan Biologic quit before it got fired, is that a fair way to say it? A.  I don't know.

PROSECUTOR: Object.

ASSISTANT DEFENCE COUNSEL: No, okay, that's fine, I'll just leave that then.

Thank you, Your Honour.

Q. Oh, it's reopened now, the plant now operates under the name of BioPort? Well, it's been extensively renovated, is that correct? A.  It's been renovated, it has been rebuilt, they have been making vaccine and the FDA inspected them again in November and they had many, many of the same problems that they had before and FDA will not allow them to distribute any of their product. They're not re-licenced.

Q. As of today? A.  As of today.

ASSISTANT DEFENCE COUNSEL: Thank you.

PROSECUTOR: I have no further questions of this witness.

MILITARY JUDGE: Just one small clarification. It's 20 February '98 that report, that summary by yourself?

WITNESS: No, the report was 20 of February, but I think that my summary is probably May.

MILITARY JUDGE: 19 May '98.

WITNESS: May, yeah.

MILITARY JUDGE: It says, 19 May '98.

WITNESS: Yes.

MILITARY JUDGE: So that's when that was raised?

WITNESS: Yes, and I'm thinking that I wrote that summary within a week after, I think, receiving a copy of the report.

MILITARY JUDGE: Thank you very much, Dr Nass.

THE WITNESS WITHDRAWS.

PROSECUTOR: Thank you for that additional extra 15 minutes there. The prosecution at this point would be calling Doctor Friedlander.

THIRD WITNESS

FOR THE

PROSECUTION

)))

PROSECUTOR: Your Honour, I can indicate that this witness has been called and it is my intention to have him qualified as an expert in internal medicine, infectious diseases and in respect of anthrax as a disease, as a biological weapon and the anthrax vaccine.

I have a copy of the curriculum vitae which I provided to my friend and which I would tender to the court.

MILITARY JUDGE: No objection?

ASSISTANT DEFENCE COUNSEL: No, Your Honour.

MILITARY JUDGE: Thank you.

Where we at now?

COURT REPORTER: VD46, Your Honour.

MILITARY JUDGE: 46.

THE CURRICULUM VITAE OF DR FRIEDLANDER IS MARKED EXHIBIT VD46.

Q. Can you state your name? A.  Arthur Friedlander.

Q. Okay. And, Dr Friedlander, you presently work where? A.  I work at the US Army Medical Research Institute of Infectious Diseases, otherwise known as USAMRIID, at Fort Detrick in Frederick, Maryland.

Q. Okay, and you are qualified to practice medicine in the state of Maryland, is that correct? A.  Correct, uh-huh.

Q. And you did your undergraduate training at Harvard College in 1961? A.  Yes.

Q. And you received your MD from the University of Pittsburgh in 1965, is that correct? A.  Uh-huh, correct.

Q. Okay. And I understand, Dr Friedlander, that you have held a number of academic and other professional positions and that you did your medical internship at Downstate Medical Center in SUNY, Brooklyn, New York? A.  Uh-huh.

Q. And you were a medical resident at Downstate Medical Center in SUNY, Brooklyn, New York, as well? A.  Uh-huh.

Q. I understand that you were a research associate at the National Cancer Institute, and subsequent to that you did a postdoctoral research fellowship in infectious diseases at the University of California School of Medicine? A.  Yes.

Q. Okay. And you're a clinical instructor of medicine and research at the University of California School of Medicine? A.  Uh-huh.

Q. And subsequent to that an assistant professor of medicine at the University of California School of Medicine? A.  Right.

Q. And since 1979 you've worked at USAMRIID? A.  Correct.

Q. And you have held a number of positions in that organization including Research Investigator; Chief, Airborne Diseases Division; Chief, Department of Pathology; and Chief of the Bacteriology Division, until you held your present position, is that correct? A.  Right, yes.

Q. Okay. Dr Friedlander, I'm not going to go all through your clinical teaching and administrative positions, but I would like to highlight a couple of them: I understand that you were an attending physician in internal medicine at the University of California Medical Center from '72 to '79? A.  Uh-huh.

Q. And that you were an attending physician in infectious diseases at the University of California Medical Center from '72 to '79; and that you also worked as an attending physician infectious diseases at Walter Reed Army Medical Center? A.  Correct.

Q. Now from 1998 to the present you were an adjunct professor of medicine. Where were you an Adjunct Professor of Medicine? A.  This is at the School of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.

Q. Okay, an adjunct, what is that? A.  I'm not full-time on the staff there, my full-time job is at USMARIID, and so that's why I'm in the adjunct series.

Q. Okay. Is that a full professor? A.  Un-huh.

Q. And I understand that you were the Director of the AMEDD course on Medical Defence Against Biological Weapons and Infectious Diseases from '84 to '91. What is the AMEDD course? A.  That's the Army Medical Department course on biological warfare, defence, and infectious diseases.

Q. And you subsequently, or you continued to lecture on that course up until 1995? A.  Right, and to the current time, actually.

Q. And at the current time? A.  Uh-huh.

Q. And you're a member of the Infectious Diseases Society of America Committee on Emerging Infections and Bio-Defense? A.  Yes.

Q. And I understand as well you're a member of the Working Group of Civilian Bio-Defense? A.  Correct, at Johns Hopkins.

Q. And you have a number of honours and fellowships listed on your curriculum vitae, I'll refer simply to one, and that is a Fellow of the Infectious Diseases Society of America? A.  Uh-huh.

Q. And I understand that you have a number of patents filedÐÐtwo patents filed: one involving plague vaccine and the other in respect of the anthrax vaccine. What is that patent in respect of? A.  This is a patent that deals with the development of a next generation anthrax vaccine.

Q. And I understand that you've spoken at a number of international meetings on anthrax? A.  Yes, uh-huh.

Q. And which international meetings on anthrax have you spoken at? A.  Well, all of the recent since 1990, the international anthrax meetings. I mean, I've been involved in the organization of the last two international meetings and the subsequent meeting, the next meeting in 2001, we're going to be sponsoring in Annapolis, Maryland.

Q. Okay. So you've been involved in the organization of a number. If I can just turn to the articles that you have written on the area of anthrax, and I see that there's some 60 articles many of which have to do with anthrax, and I'm just going to refer to a couple of the more recent ones. I understand that you wrote an article on anthrax as a biological weapon, Medical and Public Health Management, which was published in JAMA in 1999. What's JAMA? A.  That's the Journal of the American Medical Association, and that actually is a consensus paper by the civilian group on bio-terrorism defence at Johns Hopkins. This one is on anthrax.

Q. And you published a paper on vaccination against anthrax with attenuated strains of bacillus anthrax that produced protective antigens and that was published in Infection and Immunity? A.  Yes.

Q. And you published an article on the pathology of experimental anthrax in rabbits exposed by inhalation and subcutaneous inoculation? A.  Uh-huh.

Q. And that was published in 1998 in the Arch., what is that? A.  Archives.

Q. Archives of? A.  I think it's of pathology.

Q. Pathology, okay? A.  Of clinical pathology.

Q. And you published an article on comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus monkeys in vaccine? A.  Uh-huh.

Q. And I'm going to go throughÐÐoh, and anthrax as a potential biological warfare agent in Arch. Int. Med., is it? A.  Archives of Internal Medicine, I think, is ...

Q. Okay. Are all these peer reviewed articles? A.  Uh-huh.

Q. And you've published quite a number of others, I'm not going to go into them, obviously the judge can read them. But are all of these published in peer reviewed articles? A.  A few of them are in abstracts of meetings where the selected articles are published in detail.

Q. And those meetings were meetings of? A.  The International Anthrax Meetings, for example.

Q. And I note that you have published, or written chapters on anthrax in a number of textbooks, and you wrote The Anthrax Toxins, in the textbook, in Trafficking of Bacterial Toxins; and you wrote the chapter on Anthrax, in Textbook of Internal Medicine; and you wrote the chapter on Anthrax, in Textbook of Military Medicine; and you wrote the chapter on Anthrax, in the book, Vaccines? A.  Uh-huh.

Q. And you wrote the chapter on Anthrax, in Hunter's Tropical Medicine. Are all these textbooksÐÐstandard textbooks that are used to teach medical doctors? A.  Yes. Most of those that you cited, yes.

Q. Okay. And how long have you been interested in the topic of anthrax for? A.  Well, a few years after I arrived in 1979, I began working on anthrax.

Q. And when you say you began ... A.  In the laboratory.

Q. Okay. When you say you began working on anthrax in the laboratory, what did you begin doing? A.  Well, our lab, we were examining the effect of the anthrax toxins on different cell models, essentially, and we actually discovered its effect on certain types of cells. That was from a fairly basic research perspective of how these toxins cause damage to human cells, the organism makes toxins that are damaging. And that was the work that I did initially, and over the last ten years it's been more focussed on the vaccine.

Q. You have, as I understand it, two primary interests: one is anthrax, and the other isÐÐwhat is it? A.  I've been working on plague also. The ...

Q. So you're dealing with anthrax ... A.  That's right.

Q. Would it be fair to say that these have been your primary research focus over the past, what period of time? A.  Yes, about 20 years; 15/20 years.

Q. And you work in USAMRIID. What is USAMRIID? A.  USAMRIID, it's the Department of Defense's, the US Department of Defense's primary biological defence research institution. It's run by the army but it has people from all the services, and it's where the developmental research for medical countermeasures against biological warfare is centred.

Q. And you supervise or work in a group that is focussed primarily on what area? A.  On anthrax.

Q. On anthrax. And the information and advice and the knowledge you've gleaned there, that is primarily focussed on ... A.  The development, as I said, of medical countermeasures of oneÐÐand that's primarily focussed on vaccines: the evaluation of vaccines, the development of new vaccines, studies of how the organism causes disease, to begin with, so that we can develop additional approaches to treatment and diagnosis.

Q. And your work in internal medicine is primarily from what areas? A.  My work, at the present time I don't do work in internal medicine, I did in the past.

Q. But you have worked internal medicine in the past? A.  Uh-huh.

Q. In which locations? A.  Well, at the University of California and in the army as well.

Q. Okay. And you've worked in the area of infectious diseasesÐÐ A.  Uh-huh.

Q. ÐÐas well in both in academic and a working environment? A.  Both from a clinical perspective in terms of dealing with patients, and that's been primarily in the past, and all throughout my career in the research of infectious diseases.

Q. And the work that you've done, has that given you a body of knowledge in respect of internal medicine, infectious diseases, the anthrax disease. Would it be fair to say that you have a ... A.  I believe so.

Q. And are you familiar withÐÐhas it given you a body of knowledge in respect of anthrax as a biological weapon? A.  Yes.

Q. And are you familiar with anthrax as a vaccine? Would it be fair to say that you've devoted yourself to these areas? A.  Uh-huh, yes.

PROSECUTOR: Those are the questions that I would be asking this witness.

ASSISTANT DEFENCE COUNSEL: I just have a couple of questions, Your Honour.

Sir, with regard to the vaccine that you developed or that you have a patent for, "attenuated strain of Bacillus ..."ÐÐhow do you ...

WITNESS: Anthracis.

ASSISTANT DEFENCE COUNSEL: Anthracis.

WITNESS: Uh-huh.

ASSISTANT DEFENCE COUNSEL: That's not the vaccine that's licenced for use right now in the United States, is it?

WITNESS: No.

ASSISTANT DEFENCE COUNSEL: Okay. And, sir, I'm a littleÐÐobviously, I'm not a scientist. I see in the large number of articles that peoples names are ordered in different ways. Why would someone be named first rather than third or fourth in terms of authorship?

WITNESS: Well, let me preface that by saying almost all of this research is a collaborative effort that involves several people, usually. As you look through there, it's only very rarely that a single person is involved in the study these days. There are some where that's the case. And so the primary investigator is the first author, and then the people that have contributed in some way to the design of the experiment, to carrying out the experiment, some aspects. It's very rare that a single person, it's almost unheard of, actually carries out all the experimentation involved in aÐÐthat results in a publication. And that's why there are multiple authors there.

ASSISTANT DEFENCE COUNSEL: And are they listed according to the degree of contribution to the study?

WITNESS: That's an interesting question. In general, I think it's fair to say, traditionally the individual who actually does the experiment and who writes the manuscript is the first author. Often the head of the laboratory is the last author, and the overall director of the research effort often is the last author.

ASSISTANT DEFENCE COUNSEL: Does that mean that any work that comes out of your lab, you would be given an authorship because you're the head of the lab?

WITNESS: No. Not necessarily. It depends on how thatÐÐthe culture of the laboratory.

ASSISTANT DEFENCE COUNSEL: Okay. Okay.

WITNESS: And how much youÐÐI mean, just for being there, you should not be given an authorship, you should have some significant contribution.

ASSISTANT DEFENCE COUNSEL: Okay. And I note in your CV that you're listed as a first author at number 12, that's a 1986 article; and then at 21, 24 and 25. So there's four articles in this CV where you're listed as the prime investigator?

WITNESS: I haven't seen it, so ...

PROSECUTOR: I would simply indicate that the first four articles he's listed as the primaryÐÐthe first individual ...

ASSISTANT DEFENCE COUNSEL: Oh, I'm sorry, that only relate to anthrax. The first four articles, sir, I'll just show you and maybe you can correct me.

WITNESS: Sure.

ASSISTANT DEFENCE COUNSEL: But I had understood that the first four articles didn't relate to anthrax?

WITNESS: That's correct.

ASSISTANT DEFENCE COUNSEL: So then with regards to the articles about anthrax, there's what, four or five articles where you're the chief investigator?

WITNESS: Uh-huh. I wouldn't quite put it that way. In the evolution of scientific and research careers, when you're doing the actual experiment, the person who is running the laboratory is usually not the first author, as I said, often the person who's running the entire program is the last author, and in some instances that's not the case but often that is the case.

ASSISTANT DEFENCE COUNSEL: But if you were the main investigator, you would always be the first?

WITNESS: That's correct.

ASSISTANT DEFENCE COUNSEL: Thank you, sir, I have no further questions.

MILITARY JUDGE: So the area was: internal medicine, infectious disease andÐÐ

PROSECUTOR: And in respect of anthrax as a disease.

MILITARY JUDGE: ÐÐanthrax as a disease, a biological weapon vaccine.

PROSECUTOR: And a vaccine.

MILITARY JUDGE: Any objection to ...

ASSISTANT DEFENCE COUNSEL: I only have one comment. In terms of the infectious disease qualification that my friend is seeking, I'm not exactly sure whether my learned friend is seeking a scope of evidence beyond anthrax. Are we going to get into other illnesses? Because it seems to me that if he's qualified as an expert to give anthrax, then that occupies the field. I'm just wondering whether my learned friend is seeking to tender evidence about other infectious diseases?

MILITARY JUDGE: I don't know.

PROSECUTOR: I wasn't intending to tender evidence about other infectious diseases. I'm simply saying that this is a medical doctor ...

MILITARY JUDGE: Anthrax as an infectious disease.

PROSECUTOR: Anthrax is an infectious disease.

ASSISTANT DEFENCE COUNSEL: Okay. Then on the proviso that he be qualified certainly as an internist and as an expert in anthrax disease and vaccine as an infectious disease, I have no objection.

MILITARY JUDGE: Okay, so the court will accept this witness as an expert.

PROSECUTOR:

Q. Dr Friedlander, I would like to draw your attention, first, to the areaÐÐfirst of all, I'd seek your opinion as to whether anthrax is in factÐÐyour bare opinion as to whether anthrax is an efficacious and safe vaccine? A.  I believe it is.

Q. Okay. I want to draw your attention to anthrax as a disease? A.  Uh-huh.

Q. Can you indicate to the court how many different forms anthrax takes as a disease? A.  Anthrax exists and has existed, so far as we know, forever and causes three forms of disease in humans under natural circumstances; that is, not a biological warfare or a terrorist scenario: The most prevalent form of the disease is when it enters the skin giving rise to cutaneous anthrax. That occurs under conditions where people are handling through direct contact either the tissues, the hides of an animal that was infected with anthrax and usually slaughtered, or products that have been produced from such animals; such as, their hides, their hair, the wool from sheep that have died of anthrax, because of the contamination of these substances with the spores of anthrax which are very, very persistent. That's the most common form of the disease that occurs; a farmer slaughters an animal that's sick. The other form of the diseases, which are much less common, are: one, the gastrointestinal form which occurs when you eat under-cooked meat from an animal that died; and the other form, also very, very rare under natural circumstances, is inhalation anthrax when you are in an environment where you're breathing in spores. And under natural circumstances, that actually occurredÐÐbecame apparent in the last century in England and in Germany and Austria; particularly in England where it was called "wool sorters disease". From a biological warfare perspective or terrorist perspective, the disease that we're concerned about is inhalation anthrax from the specific aerosolization of anthrax spores, the intentional aerosolization, and that causes inhalation anthrax where it comes in through the lungs.

Q. Okay. How many different strains of anthrax are there? A.  Well, the word "strain" has some scientific meaning and let me see if I can explain that. When a cow dies in Manitoba, or wherever, of anthrax, the carcass is cultured in the laboratory and the organism is grown, an anthrax strain or isolate is grown. Another cow dies in Florida or in Kansas in the US, or in France, and another isolate or strain is identified. That's what we call strains or isolates, and there have been strains or isolates that have been collected from all over the world. This disease exists all over the world.

Q. How many strains? A.  So when you say, "How many strains?", there are thousands. Now what we know, and this is from evidence that's been generated only in the last five years or so when people look at this genetically, it turns out that anthrax, in distinction to almost all other organisms, is very monomorphic.

Q. And what does that mean? A.  That means that the organisms look very, very similar whether they're isolated in Bolivia or whether they're isolated in Canada or they're isolated in Italy. They're genetically very close together. Much more so than say, salmonella, that causes food poisoning or gastroenteritis or staphylococcus. It appears to be a fairly uniform organism, genetically, not identical, but veryÐÐthere's not much diversity among the different isolates.

Q. Okay. The fact that there's not much diversity among the different isolates, is that important when you're talking about creating vaccines for them? A.  Yes. Although just because there's diversity doesn't mean that a vaccine could not be uniformly effective, but if there's less diversity one wouldÐÐit would suggest that there's even less likelihood that a vaccine would not be effective. And that depends upon the organism and it also depends on what the vaccine is targeted to in the organism, that is, if I can give an analogy: If the code of an organism, say, varies, that's not a good vaccine target because you may have to make five, or different coats. But if there's a part of the organism that doesn't vary, that's constant, even though the coat varies in different strains or isolates, that's a good target for a vaccine because that is an invariable part of the organism. And we think that this vaccine targets an invariable part of the organism that is absolutely crucial for it to cause disease.

Q. If I can just clarify a little bit. Are you saying that the vaccine is thought to work against a multiplicity of strains? A.  Yes.

Q. What are the most common strains? A.  I can't answer that. I don't think that's an appropriateÐÐthere are strains that have beenÐÐeach one is different: a different cow that died, a different goat that died, a different person that died, so there have been strains isolated from little outbreaks, little epidemics in animals, but I don't think you can say that one is more common than another.

Q. Would you be able to talk a little bit about the Vollum strain or the Ames strain, because we've heard some testimony about these? A.  People working in the laboratory during research develop animal models to study the disease and choose organisms to study because of reproducibility or for varying reasons. The Vollum strain, which is from the United Kingdom, was one of the strains that was used for many years in studying the disease, in evaluating vaccines. It's been carried in the laboratory for many, many, many years. The Ames strain from Ames, Iowa, in the US, was a strain that was isolated, I think from a cow in Iowa, and it came to be developed in the 80s mainly at our institution as the prototype strain that we were studying, as opposed to the Vollum strain.

Q. Yes. And why did you develop a new strain? A.  There were a couple of reasons, I think: One, was that the Vollum strain had been carried for a long time in the laboratory and we know that that can cause changes in the organism such that it's further away from what actually killed that cow. So the Ames strain was a fresher isolate, if you will. The other reason had to do with the fact that there was some evidence in some animal models, in the guinea pig model, that it was easier to protect against Vollum than against Ames, as well as some other strains, isolates. For that reason, when we looked into other animal models, we chose the Ames strain because it appeared to be more difficult to protect against in a guinea pig model. And there were a few other strains as well. So the Ames strain became the strain that we used because it would be a more effectiveÐÐone, it was closer to a dead cow; and two, it might be a more severe test of any vaccine, if you will.

Q. How easy is it to genetically engineer new strains? A.  These days, as well as in old, in years ago, it's easy to do some things. Now with genetic manipulation it's much easier to do things, but it wasn't that difficult to do, to select organisms, even before genetic engineering for certain types of characteristics, like, antibiotic resistance. Just by growing the organism in the presence of an antibiotic, often you can select an organism that is resistant to it without doing any genetic manipulation. Nowadays you can do genetic manipulation and convert an organism from sensitive to resistance.

Q. Does the American anthrax vaccine, does it still offer protection against a wide variety of strains? A.  Uh-huh.

Q. What impact does this have on vaccine resistance? A.  Antibiotic resistance per se doesn't have anything to do with vaccine resistance. In fact, it's the feeling, I think it's fair to say, when you genetically manipulate something you often don't necessarily retain its virulence, you may lose some virulence. This organism was selected to kill animals, I mean, in a Darwinian sense, its job is to kill animals. It does it very well. It's not clear that you can make it do it better.

Q. Okay. As I understand it, you said it's relatively easy to create an antibiotic resistance strain? A.  Yes.

Q. Am I misstating you if I say, if I indicate that you've testified that it's more difficult to create a vaccine resistant strain? A.  That's correct.

Q. And how difficult would it be to create a strain that, you know, that the American vaccine; for example, the presently used American vaccine, would have no effect on, would have no ... A.  I think oursÐÐas you know, I mean, there's a publication in the literature describing a strain that's resistant to the Russian vaccineÐÐour feeling isÐÐmy feeling is, it's a very, very difficult undertaking to design something that would specifically subvert the way in which this vaccine works. It's not a trivial undertaking at all. Because this protein, as I said, is absolutely necessary. Now ...

Q. When you talk about "this protein", what protein are you talking ... A.  There's a protein that the organism makes, that the bacillus makes, that is the protective component of the current vaccine. So that antibodies that develop against this protein are crucial, that's the way we think this vaccine works, it induces antibodies against this protein. This protein we don't think you can vary that protein much. Now you might be able, as this Russian report suggested and it's not been confirmed, you might be able to add in other things. Whether that could cause something to subvert a vaccine is not clear. There's one report that suggests that it subverted the Russian vaccine, which is a different vaccine. That becomes essentially a different organism, if you will; it's not anthrax, it's acting through some other mechanism, it's a genetically engineered new strain. We think it would be extraordinarily difficult to alter this protein to overcome the vaccine. It's not a trivial thing. And then even making genetically modified organisms, to make it a weapon, it's got to be stable, there are some physicalÐÐjust because you've done it in a laboratory doesn't mean it's something that's going to be aerosolizable. That's not a trivial track to go from making something in the laboratory to something that's weaponizable.

Q. So even if you could do it in a lab, it's one thing to do it in a lab, it's even more to turn it into a nuclearÐÐsorry, a ... A.  A biological weapon.

Q. A biological weapon? A.  Yes.

Q. And your opinion in this respect, what's that based on? A.  Because some of these may be genetically unstable, they may beÐÐit may effect its ability to sporulate, you have to get it into a form where it's in spore. When you start genetically manipulating something, that doesn't mean that it's going to be aerosolizable, for example, and all of those characteristics have to be retained. It's not something that's going to be done easily, at least that's my opinion.

Q. How lethal is anthrax? A.  About as lethal as it gets.

Q. What does that mean? A.  We're not talking about the flu here, we're not talking about a runny nose and we're not talking about diarrhoea; we're talking about a disease. Inhalation anthrax if you get it and it's unrecognized and it's untreated, you will die, I think that's fair to say.

Q. And what kind of time period will you die? A.  The incubation period is usually within a week. Once symptoms develop, which are non-specific, like the flu, nothing particular about it, which is part of the problem, you've probably got three to four days, a window in there of that time frame, about three days.

Q. And what are the options to address, from a military commander's, what are the options to address in a weaponized anthrax threat? A.  There are, in general with anthrax as well as other agents, there are a series of medical countermeasures that one could envision using: one, is physical protection; that is, a mask. From a bio-warfare scenario or terrorist scenario, we're concerned about the respiratory tract. So a mask, a high efficiency filtered mask, could protect you. The problem with a mask is knowing when to put it on and when to take it off.

Q. And why is that? A.  Because there are no detection systems currently available to say when an attack has occurred, because you need to have the mask on, obviously, before you're exposed. And this type of weapon is such that you don't know it's happening until somebody's dead a week later. So the episode has occurred, the plane passed over, we're exposed in this room or it's in the duct over there, and everybody feels fine and doesn't know anything about it. The question is, how do you know when something is going to occur? And there are no currently available detection systems to say when to put a mask on.

Q. What other options are available to military commanders to address this type of a biological threat? A.  The other approaches are vaccination and antibiotics, and there are also, theoretically, antiserum that could be used. The latter's not available. But vaccination before the event, just as we do for the prevention of other infectious diseases ...

Q. Well, why can't you vaccinate after the event? A.  There are very few infections where you can vaccinate after the event. It takes a finite amount of time for the vaccination to induce protection. Usually, I mean, it depends on the vaccine, but it takes a finite amount of time to induce immunity. By that time you're dead. Because this incubation period, as I mentioned, the whole course of the disease is a week from exposure usually, so for some diseases where there's an extraordinarily long incubation period, like rabies, for example, you may be able to vaccinate after the event. But for most infections you cannot vaccinate after exposure. So you must vaccinate, just like measles and mumps and chicken pox and whooping cough, you vaccinate before exposure so that you're immune upon any subsequent potential exposure. And that is the ideal way that you deal with infectious diseases ...

Q. Okay. I didn't mean to interrupt you, you were going to talk about vaccination before the event as an available method? A.  Well, that's what I was starting to say, the ideal way of dealing with infectious agents is to prevent them. That's what we do in medicine, we vaccinate our children, we vaccinate throughout our lives, we vaccinate old adults against diseases, to prevent them, so that upon subsequent exposure you will be immune.

Q. Now you also mentioned antibiotics? A.  Uh-huh.

Q. And how effective would they be as a medical countermeasure? A.  There are two problems with antibioticsÐÐthere's three problems with antibiotics: One, the organism could be antibiotic resistant. We know people have made antibiotic resistant strains. That is a horrifying scenario but one that could exist. Two, at least in experimental animals, in most infectious situations the patient becomes ill, you go see the doctor, he gives you antibiotics. In this disease, if you wait until you're ill with inhalation anthrax, we think the chances of survival are not very good. What exactly they are, we don't know: 20 per cent, 50 per cent, 70 per cent, I don't know. But it's not going to be very high. There's going to be very significant mortality even in the face of antibiotic and intensive care, which doesn't exist certainly in a battlefield. So to wait until someone was ill to treat there's going to be significant mortality. The ideal situationÐÐnot ideal, the better situation is to treat before anybody is sick. That also requires knowing when someone was exposed; detection, again. You can't keep people on antibiotics forever.

Q. And what are the problems with keeping people on antibiotics for extended periods? A.  The problems with keeping on antibiotics are: One, side effects from the vaccine, the fact that people are not going to continue ...

Q. When you say "side effects from the vaccine" ... A.  I'm sorry, from the antibiotics. And the other problem that is somewhat unique to anthrax is that you have to treatÐÐat least this is based upon data in experimental animals which is the only data we haveÐÐif you in fact treat animals right after exposure, or a day after exposure, before they're sick, which from an antibiotic perspective is the ideal situation and, as I said, one that in practice probably doesn'tÐÐyou're not going to have that opportunity because you're not going to know when the attack occurred, but if you do that in an animal, you have to treat for very prolonged periods of time ...

Q. What kind of periods of time are you ... A.  Well, we did an experiment where the animals are actually exposed to a very low dose and treated them for 30 days.

Q. And what was the result of that ... A.  And the result of that was that while you were on the antibiotics none of the animals died; this is 30 days on antibiotics. When you stopped the antibiotics, animals started to die. So about overall maybe 20 per cent of the animals died when you stopped the antibiotics. This was a low dose. The reason for that is that when you inhale spores of anthrax, the spores, this tough, hard little nut that can burst, change into an actively growing bacillus or organism and that's what does its business. The spore, it turns out, can sit in your lung for months. Most of 'em start to change early on, but some of 'em will sit for months. If you don't have antibiotics onÐÐif you stop the antibiotics and there's still enough spores in there, they'll change and start growing and kill you. And that's what this experiment showed, that 30 days with a low dose challenged there were animals that still died. So the recommendations that came out from the CDC and from ...

Q. The "CDC", what is that? A.  I'm sorry, theÐÐwhat is it called?ÐÐthe Center for Disease Control and Prevention in the US, which is the civilian public health centre, actually, as well as the Johns Hopkins Center on Civilian Bio-terrorism Defense, they wrote consensus papers about how to deal with civilians who might be exposed to anthrax; they recommended 60 days of antibiotics for this reason. So that antibiotics while they act, they can treat infections, they're not ideal, by any means. So that's the reason that pre-exposure vaccination is the optimal way to deal with the threat of anthrax as a weapon. And that's why our efforts have been focussed on vaccines predominantly.

Q. I think you referred to one other possible method of dealing with this, it was antiserum? A.  Antiserum, right. Before antibiotics, antiserum was used against anthrax as well as other things. It has some effectiveness in experimental animals. There's no commercially available antiserum available in the US or in Canada, so far as I know. There are some serums available in other parts of the world, in the countries of the former Soviet Union, I believe in China. When antibiotics came in, basically antiserum went away. It's possible they may offer some adjunctive effect. They can have some effect in experimental animals, particularly if they're given before exposure. Again, once the disease starts, they don't do anything and they're not available.

Q. How resistant or hardy are anthrax spores? A.  The answer is very and it depends. In the laboratory situation, sitting on a shelf, they'll last for decades; up to 50/60 years, and that probably just depends on the lifetime of the person that was studying it. They've been isolated from bones 200 years old in graves from animals that have died. So they're very hardy.

Q. Can you talk a little bit about perhaps the history of the anthrax vaccine? A.  Sure.

Q. And I'm talking about the American anthrax vaccine? A.  Okay. So far as I know, efforts began aroundÐÐin the offensive biological weapons program of the US and the UK to study anthrax, around the Second World War, after the Second World War. And efforts began to develop a vaccine against anthrax, certainly in the 50s, again both in the US as well as in the UK and they were studied experimentally. And that continued and through successive advances in the development of vaccines that led to the licensure of vaccines both in the UK as well as in the US against anthrax. The US vaccine was licenced in 1970; I'm not exactly sure when the UK vaccine was licenced. But there were parallel efforts in both countries that resulted in licensure of vaccines, quite similar vaccines, in both countries.

Q. Okay, you say the US vaccine was licenced in 1970? A.  Uh-huh.

Q. Can you tell the court whether it's still licenced today? A.  Yes.

Q. Has it been licenced continuously throughout that period? A.  Yes.

Q. Can you indicate whether it is presently experimental with respect to inhalation anthrax? A.  No, no. There's nothing experimental about the vaccine, it's a licenced product that's available for use and has been used continuously since that time.

Q. I would draw your attention to the question of vaccine efficacy? A.  Uh-huh.

Q. And how do we establish the efficacy of the anthrax vaccine? A.  Well, perhaps I can preface that by telling you how we establish efficacy under ideal situations for any vaccine, and the vaccines that all of you are familiar with, again, for your children, for yourselves: diphtheria, tetanus, pertussis, measles, mumps, all those vaccines, rubella ...

Q. How do you establish their efficacy? A.  Well, the disease exist obviously, that's why we develop vaccines, we want to prevent illness. And in fact younger people than myself don't even know about these illnesses anymore and often question why we still vaccinate people, and that's because of the high effectiveness of these vaccines these diseases don't exist. How do you test for a vaccine? Well, you identify a population in which the disease exists, say it's children, you're checking measles vaccine, so you develop a certain number of individuals who are going to get the vaccine. You then look for a control group, which is a group of individuals which are as closely matched to the group that receives the vaccine in terms of age, in terms of socioeconomic level, in terms of gender, all the parameters; so you might take one sibling and another sibling, the best way you could match them up. You vaccinate one group, you give the other group a placebo; something that's essentially the same as the vaccine except it doesn't have the vaccine. And you don't tell anybody who got what; you don't tell the investigators who got what. You vaccinate them and you observe them over time for the incidence of the disease that you are evaluating: measles. You follow them very closely and at the end of a year, two years, five years, depending on the incidence of disease and the size of the group, which sometimes may be 20,000 kids in each group, at the end of the two years, you say: What's the incidence in the group that got the vaccine? What's the incidence in the group that got the placebo?

Q. Have these kind of studies been done with respect to the anthrax vaccine? A.  No. And the reason that they haven't been doneÐÐso that's the gold standard, that's the gold standard. The problems with diseases like anthrax is the extraordinarily low incidents of this disease under natural circumstances; that is, inhalational anthrax, cutaneous anthrax, is a very rare disease, particularly the inhalational forms. There have been about 18 cases in North America in the twentieth century of inhalational anthrax. There's not a population to test it in. The other way we evaluate vaccines is by small human challenge studies.

Q. Have there been any human studies done? A.  No, because it would be unethical. With this disease, with its extraordinarily high mortality, to subject someone to anthrax to see whether a vaccine workedÐÐwe do that with other vaccines: we do it with diarrhoeal vaccines, we do it with flu vaccines, we do it with malarial vaccines, we take volunteers, we vaccinate some, we don't vaccinate the others and we give them malaria. But that's a treatable disease. You can't do that with anthrax. And that's why we'll never have an opportunity, hopefully, to test this vaccine or any subsequent vaccine.

Q. Have any human studies of any kind been done with respect to the anthrax vaccine? A.  Yes, there's been a study that was done in the 50s by a precursor in the development of this current licenced vaccine. In the development of the vaccine, as I said, since the early-50s, various vaccine candidates were evaluated in experimental animals. One of these, in the progression toward the current licenced vaccine, was evaluated in mill workers in New Hampshire in the 1950s where cutaneous disease, which I said occurs from people who handle contaminated product, this is a goat hair mill, and they had cutaneous disease in this mill over the previous, I don't know, 20 years, and it had been a problem in the United States, and I don't know the data in Canada, but it certainly had been a problem in mill workers throughout the century, mainly cutaneous disease, very rarely inhalational disease, and it was evaluated in that population in a placebo controlled study. So one group got the vaccine, one group got a placebo, and then they observed them over time to see whether there was any effect. And what happened as an intercurrent event, about four months into the study, was that while there was continuing cutaneous disease, there was a little epidemic of inhalation anthrax; there were five cases that occurred, a little point epidemic. The results of the study showed that the vaccine was 93 per cent effective against mainly cutaneous anthrax, based upon the criteria that were established for evaluating the vaccine. So the conclusion of that study was the vaccine was effective. Now there was one case in the vaccinated group and, I believe, 15 cases in the placebo group.

Q. Are we talking about cutaneous? A.  Thirteen were cutaneous; two were inhalational, okay. So one versus fifteen; thirteen cutaneous, two inhalational in the placebo group. There were three other cases of inhalational anthrax that occurred. These were in people that were not part of the study, and so they could not be evaluated because they weren't a part of the study, but they didn't get the vaccine. So the conclusions, as I said, were: the vaccine was effective against predominately cutaneous disease; however, there were five cases of inhalational anthrax, all of them were in people who did not get the vaccine, none were in people who got the vaccine. That difference was not statistically significant, so you could not come to a conclusion based on that study with a precursor vaccine, which, I might add, was one-fourth as potent; one-fourth as potent as the current licenced vaccine, based upon animal tests. So the conclusion they drew was that it was protective against cutaneous disease, not sufficient cases statistically to say whether it was effective, in that setting, against inhalational anthrax because there weren't enough cases. There was a suggestion it was, but not any proof that it was. That's the only data that exists in humans in any study.

Q. Is this the Brachman study that ... A.  This is the Brachman study.

Q. Okay. And is the BrachmanÐÐwhat conclusions would you draw from the Brachman study that might be relevant to, you know, to the licenced vaccine today? A.  I think I'll just summarize what I said: One, this was a precursor in the development of the vaccine. It was said to be, based upon animal testing, only one-fourth as potent as the vaccine that currently is licenced; in other words, this was developed in the 50s, it was during the 60s that they got additional strains, growth conditions so that they made a more potent vaccine which was the one that was eventually licenced. It looked like it was effective against cutaneous disease. There were two cases of inhalational anthrax in there, so it actually was a combination of both, but predominantly cutaneous disease. What that says is this vaccine is effective against the anthrax. There's no definitive evidence that it's effective against inhalational anthrax, but there is suggestive evidence that it is, and, I think, that's all that you can say about that.

Q. Okay. You've told us how we don't test the efficacy of the anthrax vaccine, how do we test the efficacy of the anthrax vaccine? A.  Well, it's a tough, tough question and one thatÐÐwe don't have this gold standard that I mentioned to you, and, I think, unfortunately the only way that we're going to know something is if this dark scenario that we have that if somebody did something, for example, in Washington, DC, and released a cloud, that the people in the Pentagon are there to remember what happened and the civilians are not. And I say that only half facetiously; that is to say, we will never hopefully be able to determine in humans whether this vaccine or any other vaccine is effective, and it's only in that kind of a scenario we're going to know something about it. So what are we left with? We're left with looking at the best animal models that we have to evaluate a vaccine like this that we can't test in humans and basically to extrapolate that data as best we can, with the best evidence that we have, to demonstrate whether or not it's effective in humansÐÐto argue that it's effective in humans.

Q. I understand there have been some studies using mice? A.  Uh-huh.

Q. Can you indicate what the mice studies indicate about the efficacy of the anthrax vaccine? A.  Well, this vaccine and other vaccines that are based upon this protective protein don't work very well in mice; they don't protect. It's almost impossible to protect the mouse with this vaccine.

Q. And we're talking about the American anthrax vaccine? A.  The American anthrax vaccine, or the UK vaccine. And it appears, and this is not uncommon in other infectious models that different animals behave differently in terms of how the organism causes disease, one; and two, how they respond to a vaccine. And in this instance we're evaluating really the response to a vaccine and trying to ask the question: Which animal model best reflects how the human would react? As well as, what the pathology of the disease looks like in an animal model?

Q. Well, I understand that there have been guinea pig studies. Can you indicate what the guinea pig studies have shown us about the anthrax vaccine? A.  Well, the guinea pig againÐÐdifferent animal models have been used over the years, the guinea pig is one animal model that's been used. The vaccine in the guinea pig is a fairly good vaccine against inoculation through the skin or into the muscle; it's not a very good vaccine for an aerosol exposure. And much has been said about vaccine resistant strains in the guinea pig, and this is based upon data that was published back in the 60s where people were looking at different isolates and different animal models, and it'd been known since that time. And more recently studies that we've done have essentially confirmed this, that some strains are more difficult to protect using the licenced vaccine in the guinea pig than other strains. This Ames strain is one of these strains. This is just against an intramuscular challenge. So there was known to be this variability. Now the best study that actually was done comparing these two strains showed a statistically significant difference between the Vollum strain and the Ames strain in the guinea pig in a very carefully controlled study; there was about 80 per cent survival with the Vollum strain and, I think, about 50 per cent overall, the way the experiment was designed, for the Ames strain. So it was more difficult to protect against the Ames strain. Um, go ahead.

Q. We've heard testimony that the guinea pig is regularly used with respect to testing the anthrax vaccine, perhaps the most commonly used. Can you indicate why that might be? A.  In the testing of a vaccine there's a potency test, and that potency test is to answer the question: Is this lot of vaccine that I made the same as the previous lot that I made? It's to look for consistency in lots. And one tries to get as simple a test as you can. The one that is used for the current vaccine is a guinea pig potency test. And what it does is it asks the question: Is this lot comparable to that lot? So it doesn't require, for example, that you have to get optimal protection, okay. It just requires that you have a reproducibleÐÐit's to measure the comparability of one lot to another. So it's not quite the same thing as an efficacy test.

Q. Are you saying that that's to test to a certain standard of potency? A.  That's correct. To a certain level of potency that each lot must meet; the criteria.

Q. So how does a lot pass that test? A.  I don't remember the exact details of the test, but basically you inoculate a guinea pig and in different dilutions of the vaccine, and then I think 10 days later, so they just get a single dose, so it's not the way you would actually use a vaccine, it's just to quickly determine potency, and then you challenge them with a standard inoculum and show a certain amount of survival. And that's the potency test. So each lot has to pass that to show that it basically meets this standard for lot release.

Q. That is something different than efficacy, though? A.  That is something different than efficacy.

Q. Okay, and what's the difference between potency and efficacy? A.  Well, they're related, but you could also measure the potency, for example, by measuring the antibody responseÐÐit's not in this vaccine but in fact in subsequent vaccines it probably will beÐÐyou'll measure the ability of each lot of vaccine to induce a certain antibody response, and that will give you some idea of, again, its potency. You could also measure other characteristics. You're looking for consistency between lots to meet a certain release criteria.

Q. And can you talk a little bit about the rabbit studies? A.  Certainly. The rabbit has also been used as a model over the years, and in fact in the older studies that I mentioned where guinea pigs were found to be, quote, "there were some strains that could overcome a vaccine"; there were also studies that are not mentioned then that were done in rabbits that showed that did not occur in the rabbit. Now, these were the experimental designs of both of those studies, are perhaps less than optimal in terms of the way we might design them today, but that's the data that exists. Now, we had done some experiments in primates and we were looking for additional models and we looked again at this rabbit model in terms of trying to address this question of the significance of different strains we re-looked at this issue, in the guinea pig and then in a rabbit model as well as in primates.

Q. What animal is thought to best reflect the results in humans? A.  Well, we think that the non-human primate, the monkey, that's the rhesus monkeyÐÐnot, we think, I think there's a consensus in the scientific literature over the last 40 years that the non-human primate is closest to the human both in terms of what the disease looks like as well as in terms of its immune response. We feel, I think that's intuitively obvious to most of us, that we're more closely related to monkeys than we are to mice or guinea pigs or rabbits. And so both pathologically as well as immunologically the standard has been the non-human primate.

Q. And how effective is the American anthrax vaccine, how effective is it in the non-human primate, the rhesus monkey? A.  We looked at that, and as I said, we chose to use the strain that weÐÐthe first experiment, actually, that we did was with Vollum, but all subsequent experiments have been done with this Ames strain, which is a guinea pig so-called "vaccine resistant" strain.

Q. And why did you use the Ames strain? A.  Again, because this was a strain that could partially overcome the immunity induced by the US vaccine in the guinea pig, this was one of the strains, and so that became the strain that we used in all subsequent primate studies. We didn't know the significance of that; in other words, we know a little bit more about the guinea pig now, but we chose that strain for that reason, to test it. And we've tested it now in some 65 monkeys.

Q. And how effective has the US anthrax vaccine ... A.  Sixty-two out of sixty-five of those monkeys survived. That's a 95 per cent survival limit, where all the controls die. So this strain, which is a guinea pig vaccine resistant strain, is not vaccine resistant in the monkey model against the licenced vaccine. And I should point out that these experiments were done, in 55 of the animals there were two doses of the vaccine given; in 10 animals there was a single dose of the vaccine given.

Q. And how effective were those two doses and how effective was that single dose? A.  We can break it down: fifty-two out of the fifty-five animals given two doses survived otherwise lethal doses; all the controls die. Of those animals given two doses of the vaccine, there was one group that was challenged at two years after two doses of the vaccine; seven out of eight of those animals survived after two doses, at two years.

Q. After two doses given two years previous to the challenge? A.  Correct.

Q. And how large a challenge was given to them? A.  In these monkey experiments it's usually hundreds of lethal doses, except for the one-dose challenge where it's actually, I think, it was about a hundred times the lethal dose, and 10 out of 10 of those animals survived. So we feel, on the basis of just that data that I told you, that this is a spectacular vaccine for a monkey, not a spectacular vaccine for a guinea pig.

Q. Dr Friedlander, if it's a spectacular vaccine for a monkey and if a monkey is the most proximate to a human, why don't we just do monkey experiments? I understand you've done rabbit experiments? A.  Yeah, we have done rabbits. We don't do monkey experimentsÐÐI mean, we do monkey experiments, but we don't do as many because they cost an awful lot of money. I mean, a single monkey is, I think, $3,000 or something, or $4,000, plus keeping him alive for a year is, I don't know, a couple of dollars a day or something, like 10 bucks a day. So they're very expensive as well as it's very difficult experiments to do. But that's part of the reason that we went to look for another small animal model.

Q. And what small animal did we find? A.  And that's why we looked at the rabbit again, because we were, based in part upon this older data, we looked at the rabbit model again because we can't do hundreds of monkeys, I mean, it's also a matter of space as well as cost. And so we looked at the rabbit in terms of how it responded to the vaccine and whether it looked like a guinea pig or whether it looked like a monkey. And what we ...

Q. You mean immunologically looked like? A.  In terms of how it responds to the vaccine, right, immunologically, right. And what we found is that the rabbit looks like the monkey not like the guinea pig. So in terms of preliminary experiments or screening experiments or evaluating this type of vaccine, it looked like the rabbit was predictive of what would happen in the monkey, and that is, we looked in this experiment, we've now done something like 117 rabbits and 114 of them survived.

Q. Survived what kind of a challenge? A.  An aerosol challenge again, a few hundred LD50s; that is, a few hundred times the lethal dose. None of 88 control animals survived. So the differences in this vaccine are 114 out of 117 versus zero out of eighty-eight. We did now looking at multiple strains. What we did was we re-looked at this guinea pig with the different isolates and pickedÐÐwe again identify about a quarter of the strains that were like Ames. We took those strains and we challenged, and I should say, that in the guinea pig they're all intramuscular challenges. It's more difficult to protect against an aerosol challenge. We took those same strains and we used them to challenge rabbits that were vaccinated and there was 90 to 100 per cent survival among these different strains against an aerosol challenge. So we can protect a rabbit against all the strains that we've tested.

Q. So what conclusions do you draw about the efficacy of the anthrax vaccine from the rabbit model? A.  Again, what the conclusions we draw for the rabbit is that the rabbit is predictive of what happens in the monkey; that is, that the vaccine works in the monkey, which is our gold standard other than humans; that the rabbit looks like the monkey; that the guinea pig is difficult to protect particularly against an aerosol challenge; and that the mouse with this vaccine is almost impossible to protect. So there's a spectrum of effectiveness of the vaccine. And we don't know all the details of the immune systems but we think that the immune system of the monkey is closer to that of the human and that how it reacts to the vaccine is the best predictor we have baring studies in humans.

Q. And, Dr Friedlander, in your opinion, does the anthrax vaccine work? A.  In my opinion it works; it certainly works in one primate and we have reason to believe, based upon the one study that was done in conjunction with the primate data, that it'll work in the human primate. I mean, I think that's a reasonable conclusion.

Q. Is this a generally accepted conclusion amongst the scientists who study this type of thing? A.  You know, I can't talk forÐÐI mean, I think it is, but I don't, you know, I don't thinkÐÐthere's not been a consensus group essentially. I mean, that's the data that I've told you that exists.

Q. And is this efficacy in respect of weaponized and naturally occurring? A.  Yes.

Q. And I'd like to draw your attention more to the vaccine safety side of these issues?

MILITARY JUDGE: Are we going to embark on something very long now?

PROSECUTOR: We're going to embark on the second branch of it, yes.

MILITARY JUDGE: I know it's still early for lunch but, I mean, we've been going at it for close to an hour and a half, maybe ...

PROSECUTOR: I would submit that it would be an appropriate time to take a break.

MILITARY JUDGE: Maybe we could stop there and resume maybe around quarter to one or something like that, or even one o'clock, give everybody a rest.

Is that okay with you?

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour, that would be appreciated.

MILITARY JUDGE: So we'll start back at one o'clock.

ASSISTANT DEFENCE COUNSEL: One o'clock, sir?

MILITARY JUDGE: Yeah.

ASSISTANT DEFENCE COUNSEL: Thank you.

MILITARY JUDGE: Carry on.

PROSECUTOR:

Q. Dr Friedlander, at this point I'd like to turn your attention to the issue of vaccine safety. Do you have an opinion as to the safety of the vaccine? A.  Yes, I think, based upon what I know as well as my own personal experience, that it's a safe vaccine.

Q. Can you talk a little bit about some of the common side effects. What are some of the common side effects of the American anthrax vaccine? A.  Well, reactions to vaccines in general are in two categories: one, is the reactions potentially at the local site of the injection; and secondly, a possible systemic reactions, that is, reactions characterized by generalized symptoms of fatigue, muscle aches, fever, if they occur.

Q. Okay. And what kind of local reactions occur with the anthrax vaccine? A.  Well, the data on this was developed during the licensure of the vaccine, and in the course of licensure of a vaccineÐÐthis was again in 1970ÐÐyou have to demonstrate that it's safe to the licencing authority, what is now the FDA, the Food and Drug Administration in the US; was the Bureau of Biologics before that, and was the Bureau of Biologics, now associated ...

PROSECUTOR: If I can just get you to hold for a moment.

WITNESS: And this data comes from testimony recently given, my awareness of this, the source of this information is from testimony recently given by Dr Kathryn Zoon, the head of the FDA, the Food and Drug Administration in the US, before congressional testimony this past year. And she reported on 16,000 doses of the vaccine given to 7,000 individuals. This was the data that was accrued before the vaccine was licenced to demonstrate whether or not it was safe for human use. And these were on four different lots of the vaccine that were made, and the reactions that were seen there were local reactions at the site consisting of redness, swelling or a thickening of the skin of varying degrees. Those are the predominant local symptoms.

PROSECUTOR:

Q. And how common are those local symptoms? A.  What they reported was that reactions, say less than say an inch or so, inch and a half to two inches, were in about up to 20 to 30 per cent of people; redness, some swelling. Those greater than, and the characteristics in different studies change in terms of the size, but in general, say greater than two inches were up to anyplace from one to three per cent reported in those studies. And reactions greater than, say five inches, were less than one per cent, much less. Those are the local reactions that were described. So greater than, say an inch and a half to two inches, up to three per cent. They also described, and this I should say, this is actively analysed data; that is, there are two different general ways that you could look for reactions: one, is by having an independent observer examine the arm and ask the patient: Do you have any symptoms and so on? And that's obviously much more accurate. The other is for the patient to report themselves if they have any local reaction or symptoms. That's passive reporting. So these studies that I mentioned, 16,000 doses; 7,000 individuals were active surveillance. Now they also reported that systemic symptoms of malaise and fatigue occurred in less than half a per cent.

Q. Okay. And by "malaise" you mean ... A.  Not feeling well, feeling achy, feeling like you have the flu, those type of symptoms.

Q. Okay, and those occurred in less than half a per cent? A.  Correct. In that study of 16,000 doses. That's the data that was used, to my understanding, to support the safety of the vaccine for licensure.

Q. Have there been any Canadian studies ... A.  There's one study I'm aware of.

Q. And what is that? A.  And that was in, I think, about 540 some odd people.

Q. And where were these people drawn from? A.  It was in the armed forces, this is from information from Lieutenant-Commander Souter.

Q. Is Lieutenant-Commander Souter is the author of this study? A.  No, I don't think he's the author of the study. I don't know what his official position is, but he's in the Embassy, I don't know exactly what his position is.

Q. When you talk about the armed ... A.  But he has to do withÐÐI interface with him in terms of agreements; this Canadian, UK, US military has some medical interactions and that's how I know him.

Q. Do you know whether he's a doctor? A.  I believe he is, yeah.

Q. And what was that study? A.  And that study was, again, active surveillance, and what they found there was a somewhat lower incidence, actually, of reactions greater than two inches in, I believe, about one per cent of the cases; less than the three per cent that were seen ...

MILITARY JUDGE: You said greater than one inch or two inches?

WITNESS: Greater than two inches.

MILITARY JUDGE: Greater than two inches. And what's the percentage again?

WITNESS: I think it was 0.5 per cent.

MILITARY JUDGE: Okay.

PROSECUTOR:

Q. When you referred to the armed forces in that case, were you referring to the Canadian Armed Forces? A.  The Canadian Armed Forces, yeah.

Q. Are you familiar with the VAERS reporting system? A.  Somewhat.

Q. What is the VAERS reporting system? A.  I'm not an expert on this, but in the development of vaccines, as I mentioned, there's an initial safety evaluation done on thousands to maybe ten thousand individuals to try to get some assessment as to the safety of the product before licensure. So that will pick up reactions of a certain incidence; that is, if it occurred in one out of a hundred individuals you definitely will see it if you have thousands of people. And that is the ballpark range of individuals, as I understand it, for safety for licensure; ten thousand, something in that range; thousands. The product then gets licenced, or the drug, just like a drug gets licenced. And then there's a post-marketing surveillance, because an assessment has been made that it's safe enough for use for its indicated purpose based upon these thousands of individuals. After that time, there are systems to look for lower incidence reactions that might not have been picked up when you looked at thousands of individuals because there are very low incidence. And that's done in post-marketing, post-licensure. And the VAERS system, as again as I understand it and I'm not an expert, was introduced, I think, I'm not exactly sure when, but it was introduced to look for pediatric vaccines, and more recently has it been now extended to all vaccines, all ages. And it's a surveillance system to look for adverse events associated with vaccination to try to see whether or not there are any untoward, unanticipated adverse events that were not picked up in the initial thousands of individuals in whom it was studied. So if there's a reaction, for example, that occurs in one of every five-hundred thousand doses, you would not see that until you got to that number of individuals, and that's what VAERS is designed to detect.

Q. Would it be fair to say it's designed to more meticulously scrutinize the incidents? A.  I don't know meticulously, if that's the right word. By its design it's geared to be a monitor of any unexpected side effects that were suddenly occurring at a higher incidence than would be anticipated, or any unanticipated side effects; in other words, if these local reactions for some reason now appeared in 50 per cent of individuals for a vaccine as opposed to what was seen before, it would pick that up, or if there were very serious side effects at a low incidence, it would pick that up also.

Q. And has the anthrax vaccine been subject to that type of VAERS scrutiny? A.  Yes, it has. And again, the results that I'm aware of, and I don't sit onÐÐthis is done by the Food and Drug Administration and the Centre for Disease Control, they jointly run the VAERS program.

Q. Are you aware of what the results of that show? A.  What I'm aware of, again, is testimony that was given on two occasions by the FDA in congressional testimony, two occasions last year, and this was on the basis then, at that point in time, of something over a million doses of the vaccine that have now been given, most of that to the Armed Forces, and something like 350,000 individuals now. So now we're getting up into significant numbers of individuals who've taken this vaccine and numbers of doses. And their assessment of thatÐÐI think at that point in time there were some 20 odd serious reactions. Their assessment of it at that time was that the vaccine was safe and effective and that the VAERS reporting to date did not raise concerns about the safety of the vaccine; that is, the incidence of these serious reactions, and I should point out, the local ones are clearly associated with the vaccine. But systemic reactions, it's often difficult to know whether they're associated with the vaccine because they occur in the normal incidents in a population of 300,000. But the incidence was not higher than what they would anticipate, basically is what they're saying. There was no reason to think, based upon the reporting that was done, to raise doubts about the safety of the vaccine.

Q. Can you indicate whether there is a substantiated medical link between the anthrax vaccine and Gulf War syndrome? A.  Not to my knowledge, no.

Q. Do you take the anthrax vaccine? A.  Yes.

Q. How long have you been taking the anthrax vaccine? A.  A little over 20 years.

Q. And when did you get your last shot? A.  I think about two months ago.

Q. I understand your son is entering the armed forces? A.  Uh-huh.

Q. You're aware that he's going to be subject to the anthrax vaccine? A.  At some point, that's correct.

Q. Does that give you any cause for concern? A.  No.

Q. Are there any studies of the long-term effects of the American anthrax vaccine on individuals? A.  The only studies that I'm aware of, and I have not been involved in these studies, there were some studies published by a group at Hopkins and perhaps the University of Maryland, I don't remember, over the years looking at individuals who had multiple immunizations, workers at Fort Detrick, that included the anthrax vaccine, but they'd had other immunizations, so it wasn'tÐÐone couldn't distinguish whether this was anthrax or not, there were multiple immunizations they received. And my understanding of the results is that they could not come to any conclusion that there was any significant evidence of altered health effects because of this. There were some blood chemistry changes, but the significance of that was not clear. And I understand that there are studies planned to look at long-term effects of the vaccine.

Q. What is the policy with respect to immunization by the anthrax vaccine at Fort Detrick? A.  Anybody who works in a laboratory where the organism is used, whether they work with it directly or not, if they're in that environment, they must be vaccinated in order to be in that environment.

Q. At Fort Detrick, the workers at Fort Detrick, how long have they been vaccinated with the American anthrax vaccine? A.  I can't speak for sure, but, I mean, I've been there since '79, my assumption is that since the vaccine has been licensed that that vaccine has been used. Certainly, that I'm aware of, since I was there, and I know that they were vaccinating with the precursors of these vaccines in workers there also. So my best assessment is that this vaccine has been used since it was licenced there.

Q. Is there any recognized medical data that indicates that workers at Fort Detrick who are subject to the anthrax vaccine are experiencing health risks? A.  No. But, I think, there are plans to try to assess this retrospectively again, but there's no data that I'm aware of to suggest that at all.

Q. Is it surprising, the lack or the deficit of long-term health studies? A.  I don't think so. Because in the licencing of a vaccine, one doesn't waitÐÐyou're licencing a vaccine and using a vaccine for an immediate need. You identify logically thoseÐÐyou must make sure that the vaccine is safe before licensure. But you're trying to prevent against a disease so that you never accrue before licensure long-term safety data. It would take you 10, 20 years to do that, and you're using the vaccine to prevent against a disease where's the threat of a disease. So that data accrues, if there are any long-term affects, and I must say, in terms of these types of vaccines, there's not been significant long-term effects that have been described in the literature, so there's not a great deal of reason to suspect there would be significant long-term effects. For example, we have all had here since childhood, diphtheria, pertussis, tetanus vaccines, that's part of routine vaccination. These vaccines started to be used generally since the 40s; we've got now a 50 year history of the use of these vaccines. And unless there's a significant decline in our mental abilities over time, we haven't seen it yet. So there is a body of information to give us some comfort. So this kind of information is only accrued after the fact, is what I'm saying. You would not wait, if you were trying to protect someone against diphtheria, you're not going to wait for a 50-year long-term safety study before you licence the vaccine, unless you had some reason to think otherwise.

Q. And would it be fair to say that that's the same situationÐÐis this situation unique in anyway to the anthrax ... A.  Not at all. All of the vaccines are evaluated this way, and that's why it was licenced based upon the safety data that was presented.

Q. And your opinion, based on all of this knowledge or these facts that you have laid out before the court, your opinion is that the vaccine is safe, is that a good summary? A.  Yes.

Q. I'm wondering if you are familiar with the work of Meryl Nass? A.  A little bit.

Q. Do you understand her work to be generally accepted within the scientific community? A.  Ah, ...

ASSISTANT DEFENCE COUNSEL: Well, I don't know whether this gentleman can answer what is generally accepted. He can give his opinion about what he thinks about Dr Nass' work, but I don't know whether he can speak for others.

PROSECUTOR: I'm not asking him to speak specifically for others. He is a part of the scientific community, I'm asking him simply to comment on his general understanding of her acceptance within the scientific community.

MILITARY JUDGE: I think it's a fair question.

Answer the question, please.

WITNESS: Okay. I would say, at least from what I've read of her writings, that it's geared not really towards the scientific community but more towards the lay community in trying to address issues about vaccines. It's not really geared so much towards the scientific community audience.

PROSECUTOR:

Q. Can you comment at all on her approach and conclusions? A.  Well, I think, again from what I've read in some of the articles, I think there's a selection of the data, that's fairly evident to me, in some of her writings in terms of not being presenting data on both sides of an issue.

Q. I understand that you brought with you the article, "ANTHRAX VACCINE Model of a Response to the Biologic Warfare Threat", that is VD43 before the court. Do you have a copy of that with you? A.  Yes, yes, I do, yeah.

Q. Do you have any comments with respect to her writings in respect of that particular article? A.  Well, I do. I think, perhaps in some instances, there are some examples of what I was trying to refer to in terms of presenting an unbiased, if you will, in presenting all the data. I don't know if you want me to give you an example or ...

Q. Maybe you could just give one or two? A.  Well, there's a paragraph that deals with the Brachman study that we alluded to.

MILITARY JUDGE: Where is that?

WITNESS: This is on page ...

MILITARY JUDGE: Help the witness, show him, so that I can follow.

PROSECUTOR: Maybe I could show you a copy.

WITNESS: It's on page 189, on the bottom, the last paragraph on the bottom of the page.

MILITARY JUDGE: Yeah, I'm with you.

WITNESS: "The only human field trial ... ÐÐ

MILITARY JUDGE: Yeah, okay.

WITNESS: ÐÐwas conducted by Brachman ...", and so on. So it starts to give a discussion of the Brachman trial, which we went over, and it says that: "During the 4-year study ... there were 26 cases ... of which 21 were cutaneous ... 5 were due to inhalation. One case ... occured ...", and such and such. "The five inhalation cases were too few to draw any conclusion about vaccine efficacy with regard to inhaled organisms." That's the end of the discussion about the Brachman study. Now the major conclusion of the Brachman study is not mentioned here. The major conclusion of the Brachman study was that it was designed to test the efficacy of the vaccine against cutaneous disease, and the conclusion was that it worked. That's not mentioned here at all; in other words, that's what the study was for. There's no mention of what the conclusion of the study was. And to me that's eliminating some of the data.

Q. I'm not going to ask you to go through the article bit by bit or piece by piece, I just asked to give an example. Can you talk to the issue of whether the anthrax vaccine is safe in comparison to other vaccines? A.  I'm not an expert on all the vaccines but I know some of the vaccines, and perhaps I can give you some data, again, on some of the vaccines. The vaccine, for example, this childhood vaccine that we've all taken ...

Q. And which one are you referring to? A.  Diphtheria, pertussis and tetanus, was a vaccine, as I said, was used for 50 years. And that vaccine has been associated with about a 50 per cent local reaction rate, this is in children, and 50 per cent had temperatures greater than a hundred degrees. Now over the years there's been more recently the development of a modified pertussis vaccine and that's the vaccine that's now used, except in third-world countries, and that was done to try to lower this incidence; 50 per cent with fever. Fever is a very, very, very rare reaction to the anthrax vaccine.

Q. Would that be considered a systemic reaction? A.  Systemic reaction, yes. The current licenced vaccine, which is an improvement, now has a 19 per cent rate of temperature greater than a hundred degrees. That's given to every kid in North America. The pneumococcal vaccineÐÐanybody here over 65? No, okay, well, we're getting close, a few people. Well, actually they're now starting to recommend it for people down to 50, okay. This is to prevent pneumonia and it's recommended for everybody over 65 and now they're trying to lower that because of its presumed effectiveness. That causes ...

PROSECUTOR: I'm just going to get you to hold for a moment.

MILITARY JUDGE: There's no war going on, it's just the airport.

WITNESS: They started re-vaccinating people, because it's felt that you have to give a booster because immunity wanes. And what they started noticing, in one of the reports, was the local reactions in people who had already had the vaccine and then were boosted, there was a 25 per cent incidence of local reaction greater than two inches; 25 per cent. I mentioned that it was three/four per cent with anthrax. If you take it on the first shot, the first time you take the vaccine, it's still 10 per cent of individuals that have that degree of reaction. So there are some vaccines where the local reactions are worse; there are some vaccines probably where the reactions are less. The hepatitis vaccine that adults take, hepatitis B, has local reactions of about 17 per cent; the meningococcal vaccine, which is given to all US ArmyÐÐI don't know about the Canadian ArmyÐÐand is now starting to be given toÐÐis it given? Somebody's shaking his head.

AUDIENCE MEMBER: Yeah, I've had it.

PROSECUTOR: In any event, I'll just ask that you continue on.

WITNESS: I'm sorry, I'm sorry. Sorry.

MILITARY JUDGE: Excuse me, excuse me. No, just a moment, Major Fullerton, please.

PROSECUTOR: Absolutely, sir.

MILITARY JUDGE: We will not have any discussions between the witness and members of the audience. This is a court of law, not a board of inquiry. Please, this is very important.

WITNESS: The meningococcal vaccine is used in the US military forces and is now being used by some college students, and some universities are requiring it, because of the dangers of meningococcal meningitis, and that's associated with swelling at the local site and hardness in some places between 25 and 30 per cent. So there are vaccines that have reaction rates higher and vaccines that have reaction rates that are lower than the anthrax.

PROSECUTOR:

Q. Dr Friedlander, what would be the ideal anthrax vaccine? What characteristics would the ideal anthrax vaccine have? A.  Well, we like to, in science fiction, have these visions of what the ideal situation would be and the ideal situation would be, obviously, to take a vaccine that would be effective in a single dose; we're talking about any vaccine now, generically, and that you could swallowÐÐeverybody would like to take that vaccineÐÐand that would cause no reactions. From a practical perspective, the major disadvantage of the current vaccine, as I see it, is the number of doses that are required. And I think the ideal vaccine that we could envision would be one that would be given in a few doses, say, two doses, as opposed to the current six doses over 18 months and would be just as effective, that would be the ideal, and if it had no reactions at all.

Q. I understand that you're working towards a new anthrax vaccine? A.  Yes.

Q. Can you indicate to the court what the primary motivationÐÐwhat's motivating you to work towards a new anthrax vaccine, primarily? A.  The motivation is to reduce the number of doses, that's the primary motivation.

Q. Dr Friedlander, I'm going to show you an article that is written byÐÐor appears to be written by yourself, Mr Pittman and Gerald Parker, are you familiar with that article? A.  Yes, yes.

Q. Can you just generally describe what that article is? A.  Well, this was an article that was written to disseminate information about the anthrax vaccine, the licenced vaccine, to both civilian and military physicians who are unfamiliar with its use, because of the fact that the Secretary of Defence in the US had made the decision to vaccinate the Armed Forces against anthrax, this was a vaccine with which most civilian and military physicians were unfamiliar, and so it was meant to review the information that was available about the vaccine, its safety and efficacy and, to some extent, the reasons for using the vaccine.

Q. Would it be fair to say that in a brief and short form it encapsulates the knowledge as you understand it respecting safety and efficacy? A.  Yes.

Q. Is that an accurate and true copy of that document? A.  Yeah.

PROSECUTOR: And I'd simply be asking to have this tendered as an exhibit, Your Honour.

ASSISTANT DEFENCE COUNSEL: No objection, Your Honour.

MILITARY JUDGE: So VD47.

THE ANTHRAX VACCINE EVIDENCE FOR SAFETY AND EFFICACY AGAINST INHALATIONAL ANTHRAX ARTICLE IS MARKED EXHIBIT VD47.

PROSECUTOR: Your Honour, if I could just have a brief moment?

MILITARY JUDGE: Yeah.

PROSECUTOR: Your Honour, I have no further questions of this witness.

MILITARY JUDGE: Ms Duncan?

ASSISTANT DEFENCE COUNSEL: Your Honour, if I can just have a few minutes, I just want to take a look at VD47, I haven't seen it prior to a couple of minutes ago. I don't need a lengthy adjournment, I'm ready to proceed with this witness, but I'd just like to review the article.

MILITARY JUDGE: Well, it's okay, we can certainly take a 10-minute break.

ASSISTANT DEFENCE COUNSEL: Thank you very much.

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour.

MILITARY JUDGE: Incidentally, Ms Duncan, I understood that Mr Prober was supposed to be back here this afternoon and I haven't seen him yet.

ASSISTANT DEFENCE COUNSEL: He's actually here. I spoke to him when we broke at approximately 11:35 and he had been delayed downtown and told me that he would be coming shortly after lunch. My understanding is, is that he did arrive after lunch but that he spent the time interviewing, or taking the opportunity to interview the prosecution's next witness, Dr Ward. So he has been busying himself with the preparation of that witness. I understand as well, he was in the courtroom just a minute ago, I understand he made another telephoneÐÐor went to telephone Herfst, I believe is the name, the witness that we've heard about recently, in a couple of days, to try to talk to him. So he is here, he's just on active duty elsewhere.

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL: So with the court's permission then I'll proceed with Dr Friedlander.

MILITARY JUDGE: Go ahead.

Q. Sir, I understand that you are employed by the Department of Defense? A.  Correct.

Q. And I understand as well, sir, that you are a member of the American military? A.  Uh-huh, the Army.

Q. Of the Army. Is there a reason, sir, why you have been referred today as Dr Friedlander as opposed to by your rank, Colonel Friedlander? A.  Not that I know.

Q. Is there a reason why, sir, you're not wearing your military uniform? A.  No.

Q. Even though you're here in your professional capacity, sir? A.  I don't know. I mean, I'm here as a physician and as an expert on anthrax, is my understanding of it.

Q. Would you describe yourself as being presently on active duty with the ... A.  I am on active duty.

Q. And yet you're not uniformed? A.  Correct.

Q. Is it possible, sir, that you're trying to distance yourself from the Department of Defense? A.  Not at all.

Q. Okay. Now we've heard, sir, from your curriculum vitae that you have a patent filed with the developmentÐÐand just for the sake of the record, this is VD46ÐÐyou have a patent filed for the development of an attenuated strain of the anthrax vaccine. Is that your personal patent, sir, or is that ... A.  No, there are several people on that patent.

Q. But you share the patent. Is that something thatÐÐwould you benefit from that patent should that drug become licenced for use? Benefit financially, sir? A.  I don't think so. The Government owns the patent. I mean, the patent has not been issued, a patent has been filed, a filing has been put in for a patent. There are both military as well as civilian peopleÐÐindividuals, rather, on that patent.

Q. And if the patent is issued, do you stand to gain financially? A.  I really don't know, I don't think so.

Q. Is it possible, sir? A.  It's possible, sure.

Q. And if that was the case, then certainly that financial interest would be benefited by the military's continued use of the anthrax vaccineÐÐor the new anthrax vaccine? A.  Perhaps.

Q. Okay. Now we've heard, sir, and I know that you referred to Dr Nass' articleÐÐand Dr Nass' review article is VD43, Your HonourÐÐand she cites, for example, I believe it was on 189: "The only human ...", I'll let you find it? A.  Yes.

Q. "The only human field trial of an anthrax vaccine in the West was conducted by Brachman et al in goat hair mills in New England in the late 1950s." You would agree with me, sir, that that's accurate, that that is the only human field trial? A.  Correct.

Q. Okay. And I believe, if we read down further and also from your testimony, that in four years there were only five cases of inhalational anthrax? A.  Correct.

Q. And you'll agree with me, sir, I believe that that number is not statistically significant? A.  Correct.

Q. And if it's not statistically significant, then, sir, I suggest to you that we can't draw any kind of conclusion about the effectiveness of the vaccine against inhalational anthrax? A.  I think that was my statement previously, correct.

Q. Okay. So when, for example, you mention that Dr Nass didn't mention the thrust of the study, the thrust of the study wasn't inhalational anthrax, it was cutaneous anthrax? A.  Correct.

Q. Okay. So Dr Nass' failure to add in the sentence that you say is missing doesn't change the fact that we can't tell anything about this study in terms of inhalation anthrax? A.  Correct.

Q. Also I understand, sir, that the Brachman study used a different vaccine than the one that's currently used? A.  Uh-huh.

Q. Incidentally, sir, has the vaccine changed at all since its licensure in 1970? A.  No. Not to my knowledge.

Q. Now, sir, my understanding is, is that the vaccine in 1970 was licenced for cutaneous anthrax? A.  The product insert says for exposure to anthrax spores.

Q. Is your information, sir, that it was licenced only for cutaneous anthrax in 1970? A.  No.

Q. Is it your understanding, sir, that it was licenced for inhalation anthrax as well? A.  I don't think that distinction was clearly made in theÐÐso far as I understand, from the product licence in terms of the package insert: it says for individuals who come in contact with anthrax spores. That contact, as I mentioned, could be from cutaneous, from gastrointestinal, from aerosol exposure. The workers in mills are exposed by the cutaneous route and the aerosol route.

Q. If I'm going to suggest to you, sir, that the drug was licenced for cutaneous anthrax only and that there has been a subsequent amendment for coverage for inhalation anthrax, would you agree with me or disagree with me? A.  I'm not aware of that.

Q. Okay. I'm going to show you something, sir, that seems to suggest at leastÐÐI'll give you a copy. A.  Uh-huh.

ASSISTANT DEFENCE COUNSEL: Oh, I've given you the copy for the judge. I'll just refer, Your Honour, if I might to where I want the witness to attend to and then I'll show it to Your Honour.

MILITARY JUDGE: Yeah, but I'd like to know what it is first, before you have the witness ...

ASSISTANT DEFENCE COUNSEL:

Q. It's off of the web and it indicates that it's an article from the Belleville News-Democrat newspaper, March 27th, the year 2000? A.  Uh-huh.

Q. Have you seen this newspaper article, sir? A.  No, no.

Q. In particular, the fifth paragraph, it says that the office, and this is referring to the Joint Program Office for Biological Defense, quote: "'managed and funded efforts leading to the submission of a Biologic Licensure Application amendment to the FDA,' including data to support its proposal 'to license the vaccine to provide protection against aerosol exposure to anthrax.'". Is that something you're familiar with, sir, or would you disagree with that statement? A.  I'm not sure the details of this. I do know that there were questions that were raised, since there are no direct studies in humans with this vaccine, and that a statement was made by the FDA that the use of the vaccine in the Gulf War against the threat of aerosol use of spores was not inconsistent with the product licence.

ASSISTANT DEFENCE COUNSEL: Okay. I don't know whether my learned friend has any objection to tendering this into evidence; the witness has referred to it.

MILITARY JUDGE: Well, you've, sort of, put the cart before the horse. But, you know, I mean, I wanted to see the document before you questioned the witness on it. I guess there was no objection, so now it's done.

PROSECUTOR: Your Honour, I would object to this. He has responded to ...

MILITARY JUDGE: Well, it's too late, its done, I've heard it. I've heard it, now it's a question of weight.

PROSECUTOR: Well, ...

ASSISTANT DEFENCE COUNSEL: Okay, I'll proceed then. This is not a document that was offered by this gentleman, so I'll just leave it at that.

Q. But, sir, when you say that it's not inconsistent with inhalational anthrax, that's something slightly different than saying it was licenced for inhalational anthrax, wouldn't you agree? A.  I can read to you what it says in the product insert about anthrax, and I think that the question is what you mean by "contact".

Q. Okay. Well, my question to you actually, sir, was: To say that it's not inconsistent with inhalational anthrax is different than saying this drug isÐÐor this vaccine is for inhalational anthrax? A.  That's for the person who wrote that statement toÐÐI mean, the interpretation of that, I'm not here to interpret that statement, I didn't make that statement.

Q. If I was to suggest to you, sir, that we've heard evidence that the vaccine was licenced for cutaneous anthrax and that there was an application placing the drug into IND status with the FDA for three reasons: one, is to change for inhalational anthrax; two, was to change the route of administration; and, three, to change the scheduling of the drugs, would you agree with that or do you know? A.  I know that there have been studies dealing with trying to reduce the number of doses and to look at the route of administration.

Q. So are you saying, sir, that you're not familiar with what I've said, or you disagree with it? A.  No, no. I don't know thatÐÐI'd have to look back at the documents that you're referring to.

Q. Okay. So you're not saying the drug is not in an IND status for those three variations? A.  You know, I'm not clear what you're saying in terms ofÐÐI mean, I'm not quite clear what that means, in other words. There are studies that have been done, that I'm involved with, looking at reducing the number of doses and changing the route of administration.

Q. Okay. That's not actually what I'm asking, sir? A.  Yes.

Q. Okay. Maybe if I can make myself clearer: We've heard evidence that the drug was licenced for cutaneous anthrax and that it's now been proposed, presumably by DOD, to make three changes: one, is make it a countermeasure for inhalational anthrax as opposed to cutaneous; two, change the route of administration; and, three, the schedule of dosages, and that because it's an amendment, the drug has gone into IND status for that purpose? A.  You know, I can't answer that question. You have to talk to the people actually directing that study.

Q. So you're saying you're not sure? A.  That's right.

Q. Okay. Now, sir, we've heard quite a bit of testimony regarding the effectiveness of this vaccine, and, as you have indicated and I think everyone accepts, there's obviously no human trials of this drug? A.  Correct.

Q. And so we have to look at the animal studies? A.  Uh-huh.

Q. Now, you will agree with me, sir, I think, that the results of the effectiveness studies varied widely depending on which animal you use? A.  Uh-huh.

Q. And we heard: guinea pigs, rabbits, mice. Mice, the survival rate, and I think you said this morning, they don't survive very well, it's 10 per cent? A.  Yeah.

Q. Something like that? A.  Uh-huh.

Q. And will you agree with me, sirÐÐI'm not sure that you willÐÐthat the results vary depending upon the strain of the anthrax used? A.  For some animals that's the case; not for the monkey or the rabbit.

Q. Okay. Because I had understood you to say two things, sir, this morning: one, is I had understood you to say that there are numerous strains but that they're not significantly different from each other? A.  So far as we know.

Q. Okay. Then I heard you to say that there were different studies and different study results depending upon which strain you used? A.  Uh-huh.

Q. So, for example, Vollum, it was easier to protect an animal against Vollum than against Ames? A.  Correct.

Q. I feel that there's a bit of an inconsistency there, sir? A.  Uh-huh.

Q. Because on one hand you're saying they're not different, on the other hand you're saying that they are different? A.  Well, maybe I can clarify that. First of all, this issue of the vaccine resistance in the guinea pig is probably a function not of the protective component but of the immune system of the guinea pig; that is to say, if you take the protective component in the anthrax vaccine and use it with a different adjuvant, you now can protect the guinea pig against Ames strain, for example. So the problem with the guinea pig is not the protective component but the fact that the guinea pig does not respond to this aluminum adjuvant; that's what the data suggests.

Q. Okay. Well, if Vollum was the same as Ames for every other animal except the guinea pig, why were the monkey studies initially done on Vollum but then you changed it to have it with Ames? A.  The initial studies were done on Vollum because that had been historically the strain that had been used for many years. And in fact the virulence between Vollum and Ames is only slightly different in a non-immunized animal; very slightly different. And it was in part based upon, as I said, the guinea pig data that we selected that strain to use in the primates, and the fact that this strain had been carried for many years in the laboratory, that we were concerned that it was notÐÐin fact, Vollum appears to be distinct from, in terms of vaccine efficacy, even from other strains.

Q. Okay? If I ... A.  We think that's due to the fact that it's been carriedÐÐwe don't know the reason for that, but we think it's due to the fact that it's been carried in the laboratory many years.

Q. I guess my question, though, sir, was, if there's no big difference between Vollum and Ames, then why change the monkey studies to use Ames rather than Vollum? A.  Well, it depends what you mean by "no big difference". There was a difference in the guinea pig between Vollum and Ames and we chose the most stringent organism at the time that we thought we could evaluate vaccines with.

Q. So there was a big difference between the Ames and the Vollum? A.  Not a big difference, a difference.

Q. Okay. Well, I understand, for example, with the guinea pig, for example, in a study by Dr Ivins who I believe is in your lab, is he not? A.  He's at the institute, right.

Q. Okay. And what I'm referring to is VD43, just for the sake of reference, is that the guinea pig against Ames was only 23 per cent survival? A.  Uh-huh.

Q. So some of the studies against guinea pigs and Vollum was close to a hundred per cent? A.  Uh-huh.

Q. So that's approximately a seventy per cent difference? A.  Uh-huh.

Q. I would suggest that's pretty significant survival rate difference, depending on which strain used? A.  Ah, well, I would refer you to a more definitive study that was done, and this was a very carefully done study to really specifically address this issue, and that was a study that's referenced in this paper, where overallÐÐthis is looking at defined doses of Vollum and Ames in the guinea pig, at three different dosage levels, and the overall survival for Vollum was 89 per cent and for Ames was 63 per cent. Now there are always differences between experiments, that's the nature of it. This was done specifically to address this issue of the differences. When we talk about differences between strains in terms of virulence, we are talking about orders of magnitude, not two-fold differences, or less than two-fold differences. So a significant difference would be if one organism, for example, could be protected zero per cent and another a hundred per cent or 90 per cent, or if the number of organisms required was a thousand-fold difference. A two-fold difference in terms of animal experiments is not a very big difference.

Q. You're not saying, sir, that the Ivins study wasn't carefully done? A.  No, I'm not saying that. I'm saying that this study was done with defined numbers of lethal doses at three different dosage levels. And it was not part of a larger study, it was done specifically to address this issue. So there are differences, but ...

Q. And there's just not these two cases thatÐÐor two studies ... A.  No, there are other strains that behave like the Ames strain.

Q. Okay? A.  Uh-huh.

Q. Now the other question about the effectiveness of the vaccine is the spore load, of course, it depends on how much of the bug you get as to whether the vaccine will be effective, is that correct? A.  Yes.

Q. Okay. Now, sir, with regard to the monkey studies, I understand there's only been two monkey studies, studying a total of 65 monkeys? A.  Actually, it's more than two studies where the 65 monkeys are addressed. I believe there were altogether four studies. Some of these animals are as part of other studies, but there were, I believe, four different studies.

Q. And do you see a reference to these four studies, sir? A.  It's in this paper.

Q. I see you're looking at ... A.  Yeah, I'm just trying to see here.

Q. You're looking at VD47? A.  I believe so. This JAMA article.

Q. Okay. Where are the four studies referenced? A.  Well, if you look on page 2105.

Q. Yes? A.  "... 20 of 21 animals vaccinated at 0 and 2 weeks ...".

Q. Where on the page? A.  I'm sorry, the last paragraph on the page, down a few lines, about five lines down. This describes all the primate studies.

Q. Was that a published study? A.  Yes, that was published after the international meeting in 1994 or -5.

Q. Is it an abstract? A.  It was more than an abstract, it was two pages that described in detail the methodology and the results of the experiment.

Q. I'm sorry, sir, I'm still not able to see where the footnote is, the quote? A.  Reference ¹⁶.

Q. Uh-huh? A.  "In 1 study, 20 of 21 animals vaccinated at 0 and 2 weeks survived."; reference ¹⁶.

Q. Is the footnote indicated for the ... A.  It's a superscript, yes, ¹⁶ is the reference. Are we looking at that ...

Q. Okay, and that's one study? A.  That's correct. In the second study, "... 9 of 9 animals vaccinated at 0 and 4 weeks survived.", that's reference ¹⁷.

Q. Okay, and where are the other two studies, sir? A.  "As part of an unpublished study, 5 animals vaccinated at 0 and 4 weeks all survived ...".

Q. And then the fourth study, sir? A.  And the fourth study, "... 18 of 20 animals ...", and that's described below. That study was just completed a few months ago.

Q. Okay. Is it published, sir? A.  It's not published yet. There's a manuscript in my briefcaseÐÐit's not quite in my briefcase, but I have to read it when I get back.

Q. Okay, I guess then maybe I should've been more specific: there's only two published studies for monkeysÐÐ A.  Correct.

Q. ÐÐand that's 65 monkeys? A.  No. No, no. The 65 is all four of the studies.

Q. Oh, all four of the studies. So the two published studies are even less than 65 monkeys? A.  Uh-huh. They're not "even less", they're less than sixty-five. The total of the four studies is 65 monkeys.

Q. Okay. Now I understand with these two published studies that only two strains were examined, is that correct, sir? A.  In the two published studies, that's correct. Actually, that was one strain, those are all with the Ames strain, the so-called vaccine resistant strain in the guinea pig.

Q. So there's only one strain that was studied with the monkeys? A.  In those two studies. In this 18 out of 20, there are two additional strains that were tested.

Q. My understanding, sir, is that in the first study, the vaccine was given on day one and day 15 after challenge and that the vaccinated monkeys did no better than the unvaccinated controls? A.  Alright, let me try to clarify that. The study that was published that I just alluded to, there's a difference between vaccinating before exposure and after exposure and I think the testimony before described some of the differences there. We don't expect that a vaccine against anthrax will ever be effective alone when it's given post-exposure. What you just referred to is yet another study that was published in 1993 which looked at antibiotic and vaccination with or without vaccination post-exposure in a group of animals that were not vaccinated before exposure. So as a control, in that experiment, a group of animals were vaccinated post-exposure on days one and 15, that's what you're referring to. That is not the study here at zero and two weeks. To go back to the study that you're referring to, when they were vaccinated post-exposure, the animals died as we expected. In fact, it was a control group for a group of animals that were given antibiotics and vaccine post-exposure compared to just vaccine alone post-exposure. Just vaccine alone post-exposure, the animals died.

So this experiment that was published, the animals were vaccinated, in fact, at zero and two weeks and challenged at various times up to two years post-exposure.

Q. And it showed that the vaccine essentially didn't work, which was pretty well expected? A.  No. It showed that the vaccine did work, which was pretty well expected.

Q. I'm sorry, sir? I had misunderstood, my understanding was is the post-exposure vaccine ... A.  No, the post-exposure does not work; the pre-exposure, correct.

Q. No, that was what I was referring to? A.  Okay.

Q. Okay. Now, sir, I understand that there are similarities, I suppose, between monkeys and human beings, but it's not necessarily certain that the connection or the extrapolation can be made between the vaccine, how it relates to primates and how it relates to humans? A.  Not unless we had human trials, that's correct.

Q. And so when you say that the monkey is the best model, that's different than saying we can draw theÐÐwe can make definitively the extrapolation? A.  That's a matter of interpretation. That's a matter ofÐÐwe take the best evidence that we have and we make decisions based upon that evidence.

Q. And we know, I would presume, that there are sometimes that monkeys don't behave in the same way as people do, human beings do? Sometimes a drug will work with a monkey and not with a human and vice versa? A.  It depends on the situation, you know.

Q. That happens? A.  I can't speak to that, I can speak to what happens with this anthrax vaccine.

Q. Okay. But certainly in terms of whether we extrapolate the monkey evidence or not, you have to make, as you say, your best judgment, but that's different than saying that it's a proving connection? A.  That's correct.

Q. Now I also understand that ... A.  It's only a proving connection if we had data in humans.

Q. Okay. Which, of course, we don't and can't? A.  That's right.

Q. Okay. Now I understand as well, sir, that one of the problems with extrapolating the monkey evidence is that we don't know how closely the response parallels the human response in that there's no reliable chemical correlates of immunity? A.  There is a correlate of immunity in a rabbit, in the rabbit model. And that data was presented at the last anthrax vaccine international meeting in 1998 and a manuscript is being drafted for that data ...

Q. Do I takeÐÐI'm sorry, sir, I didn't mean to interrupt you. A.  No, that's fine. So there is a serologic marker in the rabbit; there is none to date in any other species.

Q. So that further adds to the difficulty as to extrapolation? A.  No, I don't know if it adds. It's the same issue as toÐÐit doesn't necessarily resolve an issue. If you have a correlate in an animal that does not necessarily mean that the correlate will be the same in humans.

Q. And I understand that the serum levels of anti-PA which isÐÐwhat does PA stand for? A.  It stands for protective antigen.

Q. Protective antigen, that the serum levels, which is, I guess, the blood levels, of anti-PA antibodies are not predictive of immunity in animals? A.  In the rabbit they are.

Q. In the rabbit, but not in guinea pigs? A.  There's insufficient data about that. It's not been established yet.

Q. Not in mice? A.  No.

Q. Not in monkeys? A.  Insufficient data.

Q. Okay. And there have been a number of ... A.  We believe there will be.

Q. But there isn't yet? A.  That's correct.

Q. And there's been a number of authors who have noted this, that the serum levels are not predictive, including Dr Ivins? A.  Uh-huh.

Q. Okay. And I have a Dr Broster, Dr Turnbull and a variety of different quotes, okay? A.  And that's why this finding in the rabbit is very significant.

Q. Okay. How many rabbit studies have there been, sir? Just approximately? A.  Well, in total, as I mentioned, there were about 117 rabbits; actually, there's somewhat more.

Q. So if there is no correlate between monkeys and people ... A.  Whoa, whoa ...

Q. No chemical correlates in immunity between monkeys and people, but there is between rabbits, why isn't the rabbit the better choice for the model? A.  Wait, wait, wait, we're mixing something up here.

Q. Okay? A.  You're talking about a correlate between one animal and another. What I said is, is there's a correlate between the antibody level in the rabbit and protection in the rabbit, that's all. To go from that to humans, one would need a great deal more data.

Q. So there's maybe some connection between the rabbit evidence and humans, but ... A.  Not in humans, I mean, all we know is that in the rabbits to date; we don't know what a given level in the human means.

Q. And just so that it's clear, as I understand that sentence, and you can see I'm referring to my writing here, just so I don't mess it up: The serum levels of anti-PA antibodies are not predictive. What that means is that if you test the blood of an animal they might have very high antibody levels and not survive, or they could have very low antibodies and survive and everything in-between, is that fair, sir? A.  That's what that statement means, but I think that some of those studies are mixing apples and oranges and they weren't carefully analysed. And when this study was done in the rabbit in an appropriately designed study, there was a clear association between antibody levels to protective antigen and survival and we would hope we would be able to do that in the primate as well.

Q. Well, I have the studies: there was a '91 by Dr Broster; Dr Ivins published this in '94, '96, '88, '92; Turnbull in '88 and Turnbull in '72, and you're saying that there's one study now that contradicts all of those other studies? A.  It doesn't contradict it. I think these studies were not designed to answer that question.

Q. Okay. So there's maybe only one ... A.  I think ...

Q. I'm sorry, sir. A.  That's right. These studies were not designed to answer that question. They were a compilation of experiments where people post hoc, after the fact were trying to show an association, with different vaccines in fact.

Q. So there really has only been one study on this issue? A.  There actually, at the last anthrax meeting, there was a study actually in guinea pigs from Thailand that suggested similar data.

Q. Okay. I had understood you to say, though, that guinea pigs were not a good model? A.  They're not a good model in terms of showing comparison to the primate. There's a certain amount of protection in the guinea pig and there was a publication showing a correlation in fact in the guinea pig.

Q. Do we know whether we're more like the monkey or more like the mouse or more like the guinea pig? Do we know that? A.  It depends on how you're comparing. I think, again, intuitively we're genetically closer to primates, to other primates. And in terms of our immune system, it's my understanding that, yes, that we are closer to monkeys than we are to mice or guinea pigs.

Q. Okay. Certainly mice and guinea pigs are in the same family? A.  They're rodents.

Q. And they react very differently to each other, though, with regards to the anthrax vaccine? A.  Differently, yes.

Q. So the fact that we're in the same family as monkeys doesn't mean that we won't react very differently than the monkeys? A.  We don't know that for sure.

Q. Okay. Now my learned friend talked a little bit this morning about this notion of there are many strains and then introduced the notion of genetic engineering. You're not saying that it can't be done; you can't genetically engineer an anthrax vaccine resistant strain? I think I understoodÐÐand I wrote it down, I'll check my notesÐÐyou said it wasn't a trivial undertaking? A.  Not at all.

Q. But that's not to say it can't be done? A.  Until it's done, no, I can't say it can't be done.

Q. You don't know whether it's been done yet, sir, or not, do you? A.  No, the only thing I know about it is this one publication.

Q. Okay. But what is happening in the Iraqi laboratories, we don't really have a good idea? No. Do you agree with me, sir? A.  I don't have any idea what's going on.

Q. Okay. And, of course, you will agree with me, sir, that if Saddam wanted to select an anthrax strain as a biological weapon, it's not beyond the realm that he would pick one that was strain resistant. There's no reason why he would pick a strain that was very reactive to the anthrax, for example? A.  It depended on what, you know, there are other issues besides that. Certainly, if one were picking a weapon, you'd pick the best weapon you could, given what was available and the constraints and everything else.

Q. And the best weapon that you could would be perhaps a vaccine resistant strain? A.  It depends on what your intent was, yeah, assuming that it was a weapon and weaponizeable, uh-huh.

Q. Okay. Now, sir, I think no matter how you slice it, the body of the evidence does say that there's some effectiveness to the vaccine. Now we may disagree on how much, but there's obviously some effectiveness. But you'll agree with me, sir, that the vaccine as it's designed presupposes that it's manufactured in a sound and good way? A.  Say that again.

Q. You have to manufacture the vaccine the way it was supposed to be manufactured in order for it to be effective? A.  Certainly.

Q. Okay. Because the best vaccine if it's messed up in the lab won't work, correct? A.  Correct.

Q. You understand, sir, that the anthrax vaccine is produced by the Michigan Biologic Products Institute, now known as BioPort? A.  Uh-huh.

Q. And you understand, sir, that MBPI has had somewhat of a checkered history with FDA in terms of its inspections? A.  I know some of it, I'm not intimately familiar with it, no.

Q. You know, sir, I suggest, perhaps in 1997 and 1998, there were persistent quality control problems cited by the FDA? A.  No, I mean, I just know what I know ...

Q. I'm sorry, I didn't mean to ... A.  No, I just know, you know, essentially by word of mouth. I've not been involved in that in dealing with the issues that the FDA is dealing with, with Michigan.

Q. Do you know, sir, that the FDA threatened to revoke MBPI's licence? A.  No.

Q. Do you know, sir, that there were substantial problems regarding standardized testing and contamination and degradation of the product in February '98? A.  I know that there were problems at Michigan, I'm aware of that, yes.

Q. Have you seen, sir, the FDA inspection report of the MBPI lab? A.  No.

Q. Okay. Do you know, sir, about the fact that there were supplemental testings undertaken by MBPI? A.  I believe the Department of Defense instituted supplemental testing.

Q. And do you know, sir, that in fact there were supplemental testings done but they didn't, for example, study degradation of the product? A.  No, I'm not aware.

Q. Didn't review volume of ... A.  I'm not aware of the details of those issues.

Q. Okay. Do you know, sir, that of the 31 lots reviewed by the supplemental testing, 25 lots failed? A.  No, I'm not aware of it.

ASSISTANT DEFENCE COUNSEL: Okay, I'm moving on.

MILITARY JUDGE: Do you have an objection? Don't just stand up, start with the word "objection". If you don't have an objection remain seated.

PROSECUTOR: She has said she's moving on, Your Honour.

ASSISTANT DEFENCE COUNSEL:

Q. You'll agree with me, sir, that all of the studies that you have cited today and have referred to and relied on is on the assumption that there weren't quality control problems on the vaccines that you tested? A.  No.

PROSECUTOR: Your Honour, I object. This quality control issue is one that the witness has clearly said he doesn't know anything about the details, and my friend indicated she would be moving on and now she is talking again about these quality control issues. So I'd object to this line of questioning, the witness has no idea.

MILITARY JUDGE: Okay. How do you get your evidence on the quality control? What do you know?

WITNESS: All of these lots of vaccines that we've ...

MILITARY JUDGE: No, no, how did you get that information?

WITNESS: I'm sorry, about the quality?

MILITARY JUDGE: About the quality control and ...

WITNESS: I don't know anything about the quality control of the production.

MILITARY JUDGE: In that sense then, I think the answer is clear.

ASSISTANT DEFENCE COUNSEL: Okay. If I can ask itÐÐmaybe rephrase it.

Q. Obviously, sir, and I think I've asked you this already, but I don't mean to flog a dead horse, you're assuming that the quality of the vaccine is sound? A.  I take the vaccine. These are all lots that have been released. All of the lots that are used in all of these animal experiments are lots that have been released for human use, including lots that I personally have taken. So clearly, I think that, so far as I know, these lots are acceptable, they've been released for human use. None of the lots that have been used in animals, to my knowledge, are other than those released for human use.

Q. Okay. Now I understand, sir, that there have beenÐÐmy learned friend reviewed the evidence regarding short-term side effects. You'll agree with me, sir, that no oneÐÐit doesn't make sense for anyone to refuse this vaccine on the basis of concerns over short-term effects? A.  Correct.

Q. The effects that you're talking about is redness to the arm, maybe a bit of soreness, nothing to get too excited about? A.  Uh-huh.

Q. However, you'll agree with me, sir, that there have been reports, at least in the media or in the scientific community, that there are concerns about long-term side effects? A.  I'm not aware in the scientific literature of concerns about long-term side effects.

Q. Is that just with regard to the United States vaccine, or does that include the United Kingdom vaccine as well? A.  I'm just aware of the studies about the United States vaccine.

Q. Are you aware of any studies in the United Kingdom?

PROSECUTOR: Objection. This seems to be irrelevant. The evidence before this court is clearly that the Canadians, including Sergeant Kipling, were being given the American vaccine. The issues before this court are about the American vaccine. The witness has testified and indicated knowledge about the American vaccine. There's no issues before this court with respect to the British vaccine 'cause it simply wasn't given.

ASSISTANT DEFENCE COUNSEL: Except this gentleman did say that they were similar, that the UK and the US vaccine were similar. Now he ...

MILITARY JUDGE: Yeah, but we're dealing with the American vaccine in this case. I ...

ASSISTANT DEFENCE COUNSEL: But if they're similar, then perhaps the concerns regarding the long-term side effects are similar. The gentleman can tell me that there's no connection between the UK vaccine and the US, but he has testified this morning that they are in fact similar.

MILITARY JUDGE: And you're suggesting that because they are similar, the side effects or the long-term effects of one could be relevant to the long-term effects of the American vaccine.

ASSISTANT DEFENCE COUNSEL: Possibly.

MILITARY JUDGE: Okay.

PROSECUTOR: Your Honour, they're different as well, and what we have here is an issue that focusses clearly on the American vaccine. And the British vaccine has been differentiated in a number of witnesses' testimony before this court as being different, it had different things, it had different concerns and different components and different ways of creating it, and what we're talking about in this case, in these issues, is the American vaccine. And nothing that my friend has said changes that. These are the issues before the court.

MILITARY JUDGE: The objection is sustained.

ASSISTANT DEFENCE COUNSEL:

Q. Sir, there are no studies that prove that there are no long-term side effects to this vaccine, are there? A.  That prove that there are no long-term, not to my knowledge, no.

Q. Okay. And we heard that individuals who have taken this drug, has been licenced since 1970, and that there were a variety of people who would take this vaccine, such as mill workers and veterinarians, et cetera, there have been no studies regarding the health of those individuals, have there? A.  Except for the studies of the individuals, as I mentioned, at Fort Detrick who've taken multiple vaccines including the anthrax vaccine.

Q. And which study is that? I know, sir, that you mentioned it ... A.  Yeah, I mean, there have been multiple studies, I think three publications over the years have followed individuals who have had multiple vaccinations.

Q. Do you know how many individuals were followed, sir? A.  I don't know for sure, no.

Q. Can you give an estimation? Was it thousands of individuals? A.  No, I don't think it was thousands, I don't think there were that many. I would guess hundreds.

Q. Hundreds. Okay, and you ... A.  But I don't have those and I haven't reviewed those recently.

Q. Okay. And you're saying that, because originally I had understood you to say that there were no studies proving that the vaccine was safe, or no long-term side effects to the studies. Now you're saying there are these Fort Detrick studies? A.  No. Say again what you're ...

Q. I had understood you to say, sir, that there were no studies proving that there were no long-term effects, and I believe you agreed with me? A.  These individuals had multiple vaccines and it's my understanding from the results of the those studies, which I've not reviewed carefully recently, is that the conclusion of those studies was that there were no significant identified health effects other than for some biochemical abnormalities, which they did not make a great deal of, in people who had had multiple immunizations, and I believe they included the anthrax vaccine. So these were not people that just had the anthrax vaccine. But that would suggest that there were no long-term effects from those, as I understand it, relatively small studies of individuals.

Q. You're not sure that those individuals had received the anthrax vaccine, though? A.  I'd have to go back and look. I believe they did.

Q. But you're not sure of that for sure? A.  That's correct.

Q. Okay. Now I think my original question, sir, was that the mill workers, et cetera, who took the vaccine from 1970, there hasn't been any studies regarding their health? A.  Not that I know of.

Q. So they may all be dead from side effects from that, we wouldn't know that one way or the other? A.  Yeah, or they may be all, you know, living forever, they all may be octogenarians.

Q. We just don't know? A.  That's correct. I don't know.

Q. Are you familiar with the Shays report, sir? A.  No.

Q. You've not reviewed it? A.  No.

Q. Have you heard of it? A.  I've heard of it.

Q. What do you understand it to be? A.  I don't know the details of it. I know the Shays committee has had meetings and hearings, that's about all I know about it.

Q. And you haven't reviewed the report at all? A.  No.

Q. Even though it bears directly on anthrax and the vaccine? A.  No, I haven't seen it yet.

PROSECUTOR: Objection. Asked and answered.

MILITARY JUDGE: I guess, the witness has said he hasn't, so I guess he hasn't.

ASSISTANT DEFENCE COUNSEL:

Q. Why, sir, haven't you read a congressional report on the very drug that you specialize on? A.  I'm not in charge of the anthrax vaccine immunization program for the Army. My job relates to doing research on anthrax. That includes some aspects, although I don't direct these studies that are involved in, for example, reducing the number of doses, that study is now being actually done by the CDC, so it hasn't come to me yet. I suspect I'll get it, but I haven't seen it yet.

Q. Are you aware, sir, that they made a variety of different recommendations? A.  Again, I haven't seen the report ...

PROSECUTOR: Objection. He's already testified that he has not read it, he doesn't know what it's about.

ASSISTANT DEFENCE COUNSEL:

Q. Do you know, sir, anything of the substance ofÐÐjust for foundation. If he knows nothing of the substance, then I won't continue asking these questions

MILITARY JUDGE: Well, I think the witness has answered that many times; he hasn't seen the report, he hasn't read the report, it hasn't come to him. Those are all things that seem to indicate he doesn't know the report.

ASSISTANT DEFENCE COUNSEL:

Q. And you don't know anything in the report? A.  No, I ...

PROSECUTOR: Objection. That's the same question.

MILITARY JUDGE: Okay. I think that issue has been flogged to death.

ASSISTANT DEFENCE COUNSEL: Very well.

MILITARY JUDGE: Any more questions?

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour, I'm just referringÐÐreviewing my notes. If I just ...

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL:

Q. Sir, you talked about the antibiotics and whether that can be used as a countermeasure against the anthrax, and I understood that you had two concerns: one, was the side effects of the antibiotics; and the second, is that you would have to take the antibiotics for some considerable period of time. If an individual, however, wanted toÐÐdidn't mind the side effects or wasn't affected by them and was prepared to take them on a long-term basis, would that be an effective countermeasure? A.  It would confer some protection if it were given before the development of symptoms.

Q. Okay, so if someone was in the field, and as soon as they went into, for example, the theatre, commenced an antibiotic regime and continued it for some considerable period of time, that would offer some degree of protection? A.  Some degree of protection, if it were an antibiotic sensitive organism.

Q. Are you aware, sir, of whether there is any lot to lot variation in the vaccine? A.  I am aware that in that there is some variation in terms of the quantities, at least there were of some lots, of the quantity of protective antigen, that there's some variation, yes.

Q. So one lot might be more effective than another? A.  Might contain more of the protective antigen than the other.

Q. Do you know why there would be a variation? A.  I don't know that much about the details of the growth conditions, why specifically there would be. But the reason for the potency test is to establish a level of potency of each lot and that each lot then meets that standard.

Q. The study that you referenced, Dr Zoon? A.  Yes.

Q. There were 16,000 doses of vaccine to 7,000 individuals? A.  Yes.

Q. That would've been a little bit more than two shots per person? A.  I don't know how it was distributed, I don't know the details, but that's what it would come out to be.

Q. Okay, the regime for this drug, though, is six shots? A.  Uh-huh.

Q. So if we examine individuals who received less than six shots, that's maybe not the whole picture in terms of side effects? A.  Perhaps. I don't know, as I said, the distribution, whether there were a thousand people who got six doses and some people that just gotÐÐI don't know the distribution of that.

Q. Okay. So it's hard to draw any conclusions from that study? A.  I think just in terms of doses, not necessarily; based upon the information that I have, as to how many people had all six shots, right.

Q. In talking about the VAERS, I believe you indicated that it was a passive reporting system? A.  That's correct.

Q. And I believe you said that a passive reporting system was less accurate than an active reporting system? A.  Uh-huh.

Q. And certainly, individuals who ...

MILITARY JUDGE: Excuse me, you responded to that question ...

WITNESS: I'm sorry, yes, correct.

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL:

Q. I understand thatÐÐif I can just have a momentÐÐyou published an article in a book, Vaccines, I believe it is, 1994, the editor was Plotkin S? A.  Uh-huh, yes.

ASSISTANT DEFENCE COUNSEL: And in that study, sirÐÐperhaps I'll just show you a copy that I'm referring to.

The annotations are not mine, Your Honour, it was on the copy that I was given.

Q. This is the article, sir, or the book chapter? A.  Uh-huh.

MILITARY JUDGE: You're going to put this in evidence?

ASSISTANT DEFENCE COUNSEL: Yes, please.

PROSECUTOR: I have no objection, Your Honour.

MILITARY JUDGE: So that's 48, VD48.

THE ANTHRAX BOOK ARTICLE BY DR FRIEDLANDER IS MARKED EXHIBIT VD48.

ASSISTANT DEFENCE COUNSEL: VD which? I'm sorry, sir.

MILITARY JUDGE: VD48.

ASSISTANT DEFENCE COUNSEL: Thank you.

Q. From this article, sir, you wrote, sir, "The vaccine is composed of an ...", ...

MILITARY JUDGE: Lead me to where you are so I can follow with you, please.

ASSISTANT DEFENCE COUNSEL: I'm sorry, I had in a different place. It's page 737, it's the last full ...

MILITARY JUDGE: Under "UNRESOLVED PROBLEMS AND FUTURE DEVELOPMENTS"?

ASSISTANT DEFENCE COUNSEL: No. The last full paragraph on the right margin, the last full paragraph.

MILITARY JUDGE: Okay.

ASSISTANT DEFENCE COUNSEL:

Q. It says here, sir: "The current vaccine ... ", and you're referring to the vaccine that was licenced in 1970? A.  Uh-huh.

Q. "The current vaccine against anthrax is unsatisfactory for several reasons. The vaccine is composed of an undefined crude culture ..."ÐÐI can't pronounce the word? A.  Supernatant.

Q. ... supernatant adsorbed to aluminum hydroxide. There has been no quantification of the protective antigen content of the vaccine or of any ... other constituents, so the degree of purity is unknown. Standardization is determined by an animal potency test. The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed." Reactogenicity is the number of side effects? A.  Yeah.

Q. And then: "The vaccine is also less than optimal in that six doses are required over 18 months, ...". Did you write that, sir? A.  Yes, indeed.

ASSISTANT DEFENCE COUNSEL: Your Honour, if I can just have 10 minutes at this time just to make a final review of my notes. I don't expect to be much longer with this witness.

MILITARY JUDGE: And you will prepare your re-examination, if any.

PROSECUTOR: Absolutely, Your Honour.

MILITARY JUDGE: The court's adjourned for 10 minutes.

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour, thank you for the break. There's just two very brief questions.

Q. Sir, with regard to that book chapter that I referred you to, VD48, it's not on your CV, is it? A.  It's not on my CV?

Q. I don't think so, unless I missed it. Here I'll show you a copy? A.  I think you probably missed it.

Q. You missed it, okay? A.  Look on the chapters there, it's not a research paper, it's a review, so it should be in the book chapters.

Q. Oh, that's where I looked, sir. Did I miss it? I didn't think I ... A.  I don't know.

ASSISTANT DEFENCE COUNSEL: Did you find it, Major Fullerton?

PROSECUTOR: Number 8, I believe.

WITNESS: Here, number 8.

ASSISTANT DEFENCE COUNSEL:

Q. Oh, okay. Thank you, I ... A.  In fact, there's a more recent addition, 1999.

Q. Well, what I was asking about was the 1994 edition? A.  Yes, what about it?

Q. That's not on your CV? A.  You don't usually list the same reference twice. It's basically an updated version, it's the first edition versus the second edition.

MILITARY JUDGE: Show me ...

ASSISTANT DEFENCE COUNSEL: Yes, sir.

WITNESS: You have a copy of the 1994 ...

ASSISTANT DEFENCE COUNSEL: It's number 8, sir, on the book chapters, the last page, reference is a 1999 version of this book.

MILITARY JUDGE: Yes.

ASSISTANT DEFENCE COUNSEL: Okay.

Q. Sir, there's an article that I have, and I'm just going to direct you to one aspect of it, you're obviously aware of The New England Journal of Medicine, of course? A.  Yes.

Q. There's an article that I have here, a Terry Dixon? A.  Uh-huh.

Q. The date is September 9th, 1999, have you seen this article? A.  Yes, I have.

Q. You have seen this? A.  Uh-huh.

Q. Just to ... A.  Yeah.

Q. Sir, would you agree with me, the observation that the author makes on 822, quote: "The ability of any vaccine to protect humans in the event of aerosol attack, as in biologic terrorism or warfare, cannot be tested directly and therefore must remain a concern." Do you agree with that, sir? A.  Uh-huh.

ASSISTANT DEFENCE COUNSEL: Thank you, sir, nothing further.

Maybe this should go in ...

MILITARY JUDGE: It's usually better.

ASSISTANT DEFENCE COUNSEL: It's usually better. Unfortunately, sir, I didn't make a copy of it, I wasn't expecting to refer to it. So I'm wondering if I could provide it to the court staff, and once it's copied I can tender it at that time.

MILITARY JUDGE: No problem with that.

PROSECUTOR: Maybe my friend could tender it to us as well.

ASSISTANT DEFENCE COUNSEL: Certainly.

That completes my examination then, Your Honour, save for filing that article.

PROSECUTOR: I do have a few questions in re-direct.

Q. With respect to the document, VD48, and the paragraph that my friend referred you to, starting: "The current vaccine against anthrax is unsatisfactory for several reasons.", on page 737, in the last paragraph. Can you indicate whether that is the most recent copy of that? A.  No, as I mentioned, there is a 1999 version.

Q. Okay. Does that statement appear in that version as well? A.  Yes, it does.

Q. And what do you mean by that statement? A.  Well, this was in reference to an ideal vaccine, and I think we discussed this before, but it's also probably the last sentence of that paragraph which summarizes what one would like when an ...

Q. Do you have a copy of that? A.  I actually have the 1999, so I don't know what it says there.

Q. Well, maybe I can show it to you? A.  But it shouldn't be substantively different. It says: "Clearly a vaccine that is completely defined, that is less reactogenic, and that requires one or two doses to produce long-lasting immunity would be highly desirable." That's an ideal vaccine as we discussed previously. And the major concern with this vaccine is in fact the number of doses that are required by the current licence. So an ideal vaccine would be effective in one or two doses, and that is the context in which a current state-of-the-art vaccine would be made. The current licenced vaccine was made with the state-of-the-art technology that was available in the 60s, and that's what it was at that time.

Q. So when you make that statement that's what you're referring to, the concept of an ideal vaccine? A.  Yes.

Q. My friend referred you to the question regarding the use, or whether it was licenced for the use of aerosolized anthrax, and you started to talk about the product insert and what it said? A.  Uh-huh.

Q. Would you be able to tell us exactly what the product insert says that this is used for? A.  I could pull it out, I mean, I have it here. It says: "Immunization with Anthrax Vaccine Adsorbed is recommended for individuals who may come in contact with animal products such as hides, hair, or bones which come from anthrax endemic areas and may be contaminated with Bacillus anthracis spores; and for individuals engaged in diagnostic or investigational activities which may bring them into contact with ... [anthrax] spores ...". That's basically what it says.

Q. Can you indicate whether there's any distinction between cutaneous and aerosolized anthrax made on that document? A.  Not in this product insert.

PROSECUTOR: Your Honour, I have no further re-direct.

QUESTIONED BY COURT

Q. When the question was put to you regarding the use of antibiotics instead of vaccination, you referred to a finite amount of time to induce immunity when you take the vaccination? A.  Uh-huh.

Q. You didn't give us any time. Can you put a figure on that? A.  I don't think we can put a figure onÐÐthe evidence that we have is that within six weeks, in the primate, immunity develops against aerosol infection. There were in the literature previous studies done in primates with precursors of the vaccine which suggested, I think, that, I believe, by a month there was immunity developed. To my knowledge it's not been looked at earlier, but it would take, my estimate is, something like a month from the start of the vaccination.

Q. In comparison to other vaccines, does this finite amount of time vary a lot? It varies with each vaccine? A.  Yes. But with this type of vaccine, I think that's a reasonable time frame, a month to two months, three months.

Q. But you would doubt the efficiency of the vaccine within a month, though, within the first month? A.  Oh, absolutely.

Q. When the CDC and the Johns Hopkins Center on civil defence, I think that's what you were referring to, they had a recommendation of taking antibiotics for a period of 60 days, I think you said that? A.  Yes.

Q. This was of people knowingly infected, or in order to protect people? A.  No. After an exposure.

Q. After exposure? A.  After exposure.

Q. That's actually what I wanted to know? A.  Right, yes.

Q. So a minimum of 60 days is what they recommended? A.  Correct.

Q. Of consecutive days of consuming antibiotics? A.  Yes.

Q. On these studies of rabbits, my question is, I hope simple: Do you personally, as a result of, maybe, being involved in or reviewing those studies on the rabbits, do you feel confident that the protection afforded the rabbit because of whatever: serologic marker or correlation or all these words that were put to you and that you understood, seemingly, would provide any indication of what would happen to humans? A.  We hope that that will give us an approach to take to try to get to the point where we can predict in humans, based upon some test, whether or not someone is immune. That does not exist now for anthrax. It exists for, I don't know if it's a minority, but for many licenced vaccines such a blood test that predicts immunity, is not known for licenced vaccines. For some it is known, but for some it is still not known even though they've been licenced and in use for many years.

Q. Now on this document that you read that seemed to be the information sheet that comes with the vaccine? A.  Yes.

Q. What is it called? A.  The product insert.

Q. The product insert. I heard you read what you read and it doesn't say the word "aerosol"? A.  No.

Q. But it speaks of contact with hides and contact with skin, contact with wool? A.  Uh-huh.

Q. Do I conclude from this that you're saying that these contacts could be an aerosol contact? A.  Absolutely.

Q. Something could come from these hides via inhalation? A.  We know that's the case.

Q. Ah, okay. A.  The wool sorters disease was from the processing of wool.

Q. But it was in the air that it is truly inhalation? A.  You generate aerosol when you're handlingÐÐif you're in a factory where wool is processed, this disease became apparent in the 19th century in England when for the first time on an industrial scale, in a factory, contaminated wool was processed; it generated aerosols. So when you're working in a mill we know that people are exposed to aerosols.

Q. By opposition to cutaneous? A.  As well as by skin, both.

Q. But those are two different mediums? A.  Two different ...

Q. Two different ways, okay? A.  Yes. And in a mill you'd be exposed to both.

Q. And my last question will be related to that paragraph that you wrote in '94 and that apparently is repeated in '99? A.  Yes.

Q. And I understood your explanations. I still want to question the meaning or why you used the word "reactogenicity". What did you mean by that? A.  The local ...

Q. I know it means long-term, or did it mean local effect? A.  Local, reactogenicity.

Q. So that article, or that paragraph does not relate to long-term effects? A.  No, not at all. There are no known long-term effects.

MILITARY JUDGE: I think I heard that a couple of times. Thank you.

Okay, those are my questions. Any questions arising?

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour.

MILITARY JUDGE: No, just first, I think was that the witness for the prosecution?

ASSISTANT DEFENCE COUNSEL: Oh, I'm sorry, Your Honour.

PROSECUTOR: I have no questions arising, Your Honour.

MILITARY JUDGE: Okay. Now your turn.

ASSISTANT DEFENCE COUNSEL: Firstly, Your Honour, if I enter this article in as an exhibit; this is the Dixon article from 1999..

MILITARY JUDGE: Yeah, that's the one that you were supposed to bring in a moment ago.

ASSISTANT DEFENCE COUNSEL: The one that we were getting copied.

MILITARY JUDGE: So that's going to be 49.

THE NEW ENGLAND JOURNAL OF MEDICINE ARTICLE IS MARKED EXHIBIT VD49.

QUESTIONED BY ASSISTANT DEFENCE COUNSEL THROUGH COURT

Q. Sir, the judge asked you about antibiotics and there's a paragraph I want to see whether you agree with this, on page 822? A.  Of?

PROSECUTOR: I understand at this point we're really talking about clarity and clarifying from questions that arose from your questions, Your Honour. I would be objecting to her putting to the witness new portions or new documentary evidence at this point. If there's some clarification or confusion that arose out of your question, I wouldn't object to her seeking clarification of that.

ASSISTANT DEFENCE COUNSEL: Yes, Your Honour, I was just going to refer to a statement regarding antibiotics and the length of time that there's prophylaxis.

MILITARY JUDGE: But the question that I put to the witness was about that, so you can ask him that. But we're not going to makeÐÐbring in new evidence, you know, like ...

ASSISTANT DEFENCE COUNSEL: No, I just wanted to ask him whether he agrees with the statement regarding prophylaxis.

MILITARY JUDGE: Well, give him the statement. If it's related to antibiotics and how long it takes, that's fine.

ASSISTANT DEFENCE COUNSEL: Thank you.

MILITARY JUDGE: Because that arises.

PROSECUTOR: Perhaps I could see the statement that she is making so I can ...

ASSISTANT DEFENCE COUNSEL: It's in the article at page 822, right underneath, "PREVENTION AND TREATMENT".

MILITARY JUDGE: Yeah, go ahead.

ASSISTANT DEFENCE COUNSEL:

Q. Sir, would you agree with this statement: "Prophylaxis for asymptomatic patients with suspected exposure to anthrax spores can be achieved with a six-week course of doxycycline or ciprofloxacin. If the suspected dose of spores is high, a longer course of antibiotics is warranted."?

MILITARY JUDGE: Yeah?

PROSECUTOR: I would object to this, because this is really introducing a whole newÐÐwhile it is tangentially related to your question, your question was more to clarifying whether it was before or after and the length of time, but this is a whole new paragraph, a whole new written portion that she's putting to this witness. If she has questions about what you have asked and the confusion that that may have arisen or caused in her mind, that's one thing. But to open up the topic in this way again and to put whole new statements to him is really, I would submit, not appropriate at this stage.

MILITARY JUDGE: Okay, let me consider that for a moment.

No, I think it's a proper question. I personally raised the issue of the 60 days of antibiotics and I find that's related. Go ahead.

ASSISTANT DEFENCE COUNSEL:

Q. Why don't I just show you the statement, sir, it just might be easier than me reading it again. It's the statement right here, that's in the pink? A.  Uh-huh.

Q. Would you agree with that statement? A.  We're talking about the difference between six weeks and eight weeks in terms of what's recommended?

Q. Yes? A.  I think the consensus statement was of a large numbers of people was that 60 days would be recommended.

ASSISTANT DEFENCE COUNSEL: Thank you, Your Honour, that completes my questions.

MILITARY JUDGE: Thank you very much.

MILITARY JUDGE: In this plea in bar of trial the defence asks that the proceedings against the accused be stayed for the reason that his rights under section 7, 12 and 15 of the Charter of Rights and Freedoms have been infringed. It is submitted, generally, that by imposing vaccination against anthrax upon all soldiers participating in OP DETERMINATION, including the accused, the military authorities have effectively infringed the accused's right to life, liberty and security of the person by not affording him the right to informed consent, his right not to be subjected to a cruel and unusual treatment and his right to the equal protection and equal benefit of the law without discrimination.

These arguments are based on the premise that the anthrax vaccine which the Canadian Forces obtained from an American manufacturer through the Health Canada Special Access Program was an unlicensed, hazardous and unsafe substance, the effects of which were unknown and apparently remain unknown in the long term. Many witnesses, including a number of experts, have been heard by the court and have testified for and against the vaccine. Many documents were also tendered through these witnesses.

In order for the defence to establish any infringement of any of the already enumerated rights of the accused they had to show, first, on the balance of probabilities that the vaccine was in fact unlicensed, hazardous and unsafe. Then, secondly, they had to show how the inoculation of a vaccine presenting such characteristics could be shown to affect the life, liberty and security of the person of the accused, or constitute cruel and unusual treatment, or prevent the accused from enjoying the equal protection and equal benefit of the law without discrimination.

The defence has spoken at length on the issue of the anthrax vaccine not being licensed in Canada. Witnesses confirmed that the anthrax vaccine was indeed not licensed for use in Canada, but they also appraised the court as to how it could be used through the Health Canada Special Access Program like many other types of unlicensed drugs and medicine used by other Canadian physicians to treat their patients every year. This has been an important aspect of the defence's submissions on the issue of informed consent.

At this point in time, however, the court believes that it must first address the hazard and safety concerns raised by the defence. As it isÐÐbefore the court can consider section 126 of the National Defence Act and the connection the defence is making between the concepts of reasonable excuse as a defence and informed consent, or consider the issues of the inoculation of any substance as a cruel and unusual treatment, or of equality before the law, the court must consider whether the substance which was used in Kuwait City on 12 March 1998 was safe.

As it has been confirmed by the Ontario Court of Appeal decision in Fleming, reported at 82 D.L.R. (4th) 298, one can read at page 312:

And further:

Where a law or a mandatory vaccination program, based on an operational order, purports to impose vaccination on a group of Canadian Forces members, the end result is that these individuals are being deprived of their right to bodily integrity and personal autonomy as part of their section 7 constitutional right to life, liberty and security of the person. Non-consensual vaccination under the threat of disciplinary proceedings amounts to an invasion of the bodily integrity and personal autonomy of a person. And, as is required, no such deprivation is permissible unless done in accordance with the principles of fundamental justice and demonstrably justified under section 1 of the Charter as a reasonable limit prescribed by law in a free and democratic society.

However, before the court considers the application of the principles of fundamental justice and any limit placed on individuals by such a mandatory vaccination program, the court must consider whether the subject matter of the program, the anthrax vaccine, was safe; in other words, if it did not constitute a hazard for the OP DETERMINATION soldiers because of a danger associated directly with the contents of the vials, or because of short or long term effects.

Should the court conclude on the balance of probabilities that the anthrax vaccine generally, or the anthrax vaccine contained in lot 020 which was used in OP DETERMINATION was unsafe and hazardous, then it would find not only that the Charter right of the accused to life, liberty and security of the person was infringed by making vaccination with such unsafe substance mandatory, but it would have to consider whether mandatory vaccination with an unsafe substance could ever be justified in the current state of Canadian constitutional and statutory law.

This court is of the view that in enacting section 1 of the Charter, any limits to the rights and freedoms guaranteed by the Charter, such as the right to security of the person, which includes the right to bodily integrity and personal autonomy, can only be justified where it can be demonstrated that it is being imposed for the benefit, for the good of people. In the same vein, in enacting section 126 of the National Defence Act which, in essence, permits the mandatory vaccination of people, albeit as long as they do not have a reasonable excuse, Parliament could not have intended in enacting that section that this obligation placed on soldiers could include vaccines which are demonstrably dangerous and unsafe. This court does not believe that it can ever be reasonable and demonstrably justified to impose on any Canadian citizen to accept a breach of his or her bodily integrity by the inoculation of any known unsafe substance.

Before the court reviews any of the defence and prosecution theories, including any relief that the prosecution may seek by way of section 1 of the Charter, the court must first deal with the issue of the safety of the vaccine.

Through the testimonies of Lieutenant-Colonel Cook, Dr Nass, Dr Friedlander, Dr Ward and the hearsay statements, oral and written, of a number of other people, groups and organisations, the court has been able to consider the issue of the safety of the anthrax vaccine.

The court has concluded that, for the most part, these witnesses have testified truthfully and to the best of their abilities. The evidence tendered was carefully reviewed, and where justified proper weight was ascribed to it. Some pieces of evidence could not be given the weight that the parties may have wished, like the report marked VD 20 which was signed by a Dr Gilbreath and forwarded to Lieutenant-Colonel Cook. It was introduced as part of the cross-examination of that witness by the prosecution. It could not be given the weight that it might have otherwise deserved had the good doctor and others who were involved in the supplemental testing of anthrax vaccine lots been called to testify and been subjected to cross-examination. The same goes for many hearsay statements which were reported by Dr Nass and Dr Friedlander throughout their testimony and which could not be properly introduced under Military Rule of Evidence 63, or by Lieutenant-Colonel Cook in reporting some of the assurances he was provided by persons in the Pentagon or elsewhere in the US Department of Defense. So, in short, the court relied mostly on the evidence of Dr Nass and Dr Friedlander which was based on their knowledge and powers of observation in order to determine whether or not the anthrax vaccine was safe.

Generally speaking, Dr Friedlander testified that the anthrax vaccine, which has been licensed in the US for more than 20 years, is safe. He said he has taken the vaccine and so has his son. His expert opinion is based on the results of years of positive and promising testing performed on a number of laboratory animals: mice, guinea pigs, rabbits and monkeys, and on the fact that many American workers exposed to the anthrax bacteria, disease, including the personnel in the Fort Detrick laboratory have been receiving this vaccine for years without any noticeable negative long-term effects.

Now Dr Friedlander provided no evidence on the safety of the vaccine in lot 020 which was used by Dr Ellis to vaccinate all members of 435 Squadron Detachment, to the exclusion of the accused. If it were not for the article that he wrote in 1994, which is marked VD 48, and specifically the last paragraph on page 737, a view that he still held in 1999, where he affirms that the degree of purity of the vaccine is unknown and the undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed, one would be tempted to give the anthrax vaccine a general blessing. And even though Dr Friedlander tried to explain and somewhat water down the tone and obvious meaning of his article, the fact remains that the only expert with so-called hands on experience with the anthrax vaccine manufactured by the Michigan Biologic Products Institute has attested to the lack of purity and the presence of undesirable constituents in the vaccine.

The prosecution could possibly have been able to buttress the evidence of Dr Friedlander by using the evidence supplied by Dr Micheal Gilbreath who provided Lieutenant-Colonel Cook with the Mitretek report on the supplemental testing of lot 020, or by using the evidence of a Mr or Mrs R. Taylor from Mitretek who observed the supplemental testing of the safety aspect of the vaccine contained in lot 020. The prosecution did not do so. And having regard to what Dr Nass would later say on the value of the supplemental testing of that lot in respect of safety, potency and efficacy, the court cannot disregard that part of Dr Nass' testimony in favour of hearsay statements, the value and reliability of which have not been tested and cannot be assessed by the court, notwithstanding that Lieutenant-Colonel Cook may have relied on these reports to recommend the use of the anthrax vaccine to Brigadier-General Jurkowski.

In short, the evidence of Dr Friedlander pretty well stands alone in support of the general safety of the anthrax vaccine; that is to say, to the exclusion of lot 020.

On the other side, the evidence which questions the safety of the anthrax vaccine and specifically of lot 020 is to say the least quite impressive. Dr Nass was qualified as an expert in the field of the anthrax vaccine in spite of the fact that she herself was never directly involved in its development and testing. She testified that she completed a thorough research and study of published material, including laboratory testing results as well as some anecdotal knowledge gleaned from treating a number of patients with symptoms which could be linked to the anthrax vaccine and the Gulf War illnesses equally. The parties will remember the long list of symptoms reported, which included sleep disturbance, memory loss, muscle and joint pain and fatigue, rashes, gastro-intestinal disturbances, genitourinary disturbances, emotional liability; i.e., higher rate of anxiety and depression. She bases her opinions on this material including the conclusions drawn by other experts in this area.

According to Dr Nass, and without actually repeating her testimony which lasted one whole day, the anthrax vaccine produced by the Michigan Biologic Products Institute and released to the US, to the United States and Canadian Forces in March 1998 fell short in terms of safety, potency and efficacy in front of weaponized strains of anthrax. After her review and analysis of, amongst other things, some 2,000 documents supplied to her by the US Government under the Federal Access to Information program, she observed that reports of contaminated and unsterile vials, vials with an inaccurate volume of vaccineÐÐa fact that was confirmed by Dr EllisÐÐvials which had things growing in them or pieces of gaskets indicating a lack of sterility, vials containing vaccine produced from contaminated sub-lots, vials which were redated and were in fact some nine years old, made it virtually impossible, in her view, to confirm the safety of the vaccine. She confirms that there was no quality assurance control at the Michigan Biologic Products Institute. In fact, in his 1994 and 1999 articles Dr Friedlander confirms what Dr Nass said to the effect that, "we really do not know what is in the vaccine bottle".

She came to that conclusion in spite of the supplemental testing conducted at the Michigan Biologic Products Institute under the supervision of an independent contractor, because as she explains, on the specific issue of safety, one of seven separate tests, the way in which the safety test was conducted could not adequately determine whether the vaccine was safe, and that in spite of the fact that the testing was done correctly. In fact, she reports that of the 33 lots supplementally tested, 25 apparently failed the tests. She reports also that in the Tripler study, conducted in the fall of 1998, where a high initial serious side effects rate of 48 per cent among the 603 medical personnel enrolled in the study, the principal investigator reported in that study that the anthrax vaccine lot 017, used in the Tripler study, as well as lots 020 and 030 were problem lots.

Dr Nass then goes on to say that she believes, based on her analysis of the Unwin and Wessely and the Tripler studies and her contacts with hundreds of people who report their symptoms to her, that there are long-term side effects to the vaccine which, in her view, present some similarities with the symptoms reported by those who allegedly suffer from Gulf War illnesses. She confirms that in her statement before the committee chaired by Christopher Shays, at page 27, she submitted that the majority of complaints of illness have been associated with vaccination using lots 020 and 030. She states: "this vaccine has an absolutely enormous rate of chronic side effects and I would not use it on anyone", except, as she admits in cross-examination, in the case of a person who had knowingly been exposed to the anthrax disease and had an 80 per cent risk of dying. It might then be that last thing that could be done to save a life.

If the court were to conclude that the defence has failed on the balance of probabilities to show that the anthrax vaccine and specifically lot 020 was unsafe, it would mean that the court would have given more weight to the evidence of Dr FriedlanderÐÐwho, I repeat, did not testify about lot 020ÐÐto the hearsay evidence of Dr Gilbreath and R. Taylor, and to the hearsay evidence of those people in the Department of Defense, US DOD, and the Federal Drug Administration, or FDA, who assured Lieutenant-Colonel Cook that the vaccine was safe, as well as the fact that after approximately two years, long-term side effects have not yet been reported to any marked degree. Mind you, Dr Ward testified that the side effects could, in some instances, take as many as four to five years to occur. To consider that the anthrax vaccine was safe would mean that the court had disregarded a body of evidence presented by Dr Nass, and through her by Dr Ellis who confirmed that the vials were not full, and by the numerous studies, especially the Tripler study and the Fukuda CDC study of the Gulf War illness, as well as the somewhat contradictory evidence in Dr Friedlander's testimony on the lack of quality and purity of the current anthrax vaccine.

Before pronouncing its ruling in this plea in bar of trial a couple of matters require commenting upon. One issue which was not commented upon by the parties in their final remarks is the matter of the knowledge on the part of the accused about lot 020 and its lack of safety. The accused was not questioned on that particular lot, but he testified that through readings of various publications and the gathering of information on the Internet he had acquired extensive knowledge about the problems associated with the manufacture of the anthrax vaccine and its earlier use in the Gulf War in 1991. He has even testified as to his belief that the vaccine may be related to, if not the possible cause of, the so-called Gulf War syndrome. Contrary to what would likely be material in the main trial on the issue of knowledge as part of the mens rea, at this stage of the trial this court believes that an absence of evidence of knowledge on the part of the accused as to the safety of the vaccine in lot 020 is not essential to the issue before the court.

Even where it was shown that the accused was unaware that the vaccine he actually refused to take was unsafe and hazardous, even if it were shown that except for lot 020, the anthrax vaccine was generally safe and was not related to any potential disease, it would not affect the principle whereby the right of the accused to bodily integrity and personal autonomy cannot be limited for the purpose of inoculating him with a proven bad vaccine. In other words, assuming the court is satisfied on the balance of probabilities that only the vaccine in lot 020 was shown to be unsafe and hazardous and that the accused was not aware of this specific situation, its mandatory inoculation could not be saved by section 1 of the Charter or any other societal or operational objective that could be pursued by the Canadian Forces or the Canadian Government.

It is necessary also to comment on the issue of the decision of the Deputy Chief of the Defence Staff, then Lieutenant-General Crabbe, to go with a mandatory anthrax vaccination program during OP DETERMINATION in 1998. This court is satisfied that the evidence of both Brigadier-General Jurkowski and Lieutenant-Colonel Cook demonstrates that they truly and honestly believed on the basis of information received from the United States that the anthrax vaccine was safe and efficacious and on the basis of intelligence reports that there existed a real, albeit low, threat of weaponized anthrax in the area of operation which would require special protection for our soldiers. In other words, no evidence has shown any malice or negligence on the part of the Canadian Forces authorities in deciding to go with the mandatory anthrax vaccine program on the basis of their knowledge in 1998.

Now back to the issue of the plea in bar of trial itself. It is necessary to confirm here that the court has based its ruling in this plea in bar of trial on the evidence that was presented to the court and which was used as worthy of consideration. There was no requirement to show that the vaccine was deadly or would've caused irreparable or incurable physical or psychological damages to our soldiers. It was sufficient and the court is satisfied on the balance of probabilities that the defence has successfully demonstrated that the anthrax vaccine contained in lot 020 was unsafe and hazardous and could be responsible for the important symptoms reported by so many persons who received that vaccine.

In those circumstances, the court concludes that the accused's right to life, liberty and security of the person in section 7 of the Charter of Rights and Freedoms were infringed. And as the court stated earlier, the government, through its Department of National Defence and the Canadian Forces, could never be justified to impose inoculation of soldiers with an unsafe and dangerous vaccine as a limit of their rights under section 7.

Having so concluded, it will not be necessary, I believe, to comment on the arguments presented by the defence pursuant to sections 12 and 15 of the Charter.

The plea in bar of trial of the accused is allowed and as requested by the defence it is hereby ordered that the proceedings in respect of charge 1 be stayed. Thank you very much.

CERTIFICATION BY THE MILITARY JUDGE

I certify that the proceedings against the accused were terminated when the plea in bar of trial was allowed and that the court directed a stay of proceedings on the charge.

I further certify that the minutes of proceedings accurately reflect any decision rendered by the court.

G.L. Brais

Colonel

Military Judge