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 m