Two USAF Reserve JAGs Contend Anthrax Vaccine Program Is Illegal

by Elaine M. Grossman

Inside The Pentagon

April 20, 2000

Two judge advocates general in the Air Force Reserve have concluded in a new legal memorandum that it is illegal for the U.S. military to order service members to submit to the anthrax vaccine because the program is inconsistent with federal law.

The memo, obtained by Inside the Pentagon, was drafted on the initiative of the two attorneys and has been circulating throughout the Air Force's legal community over the past week. The authors "wanted them to look at this [issue] with a careful eye," said one source close to the issue.

The reserve lawyers, Lt. Col. John Michels and Maj. Bruce Smith, hold that for the purposes of protecting against a weaponized, inhaled anthrax threat, the vaccine is properly categorized as an "investigational new drug," or IND. If the vaccine is an IND, service members should not have to take the shots unless they provide their informed consent.

As it stands, though, the program is mandatory for military personnel, with the first phase affecting those deploying to regions around the globe considered at the highest risk for exposure to an adversary's anthrax weapon. To date, more than 400,000 service members have taken one or more shots in the six-vaccine program, which also requires annual boosters after that. By 2005, the entire military is to have received the vaccine.

The Pentagon launched the effort in 1998 as a mandatory program because it does not consider the vaccine an IND for use against inhaled anthrax. The Food and Drug Administration's approved labeling for the drug does not specifically state that "indication," noting only that the vaccine offers protection against anthrax contracted through the skin.

But in March 1997, Dr. Michael Friedman, FDA's lead deputy commissioner, told DOD such a use is "not inconsistent with the current label" (ITP, Feb. 17, p1).

FDA and Pentagon officials continue to cite Friedman's letter as the basis for concluding that the Pentagon's program is not investigational and thus does not require the consent of vaccine recipients in the military.

But Michels and Smith challenge the notion that Friedman's letter -- or any other government document publicly available -- meets legal standards for an FDA decision that can affect the status of the vaccine.

Virginia Stephanakis, a spokeswoman for the Army-run Anthrax Vaccine Immunization Program (AVIP), told ITP on April 19 that "DOD stands by FDA's oft-repeated position that AVA [Anthrax Vaccine Adsorbed] is not an IND."

The two lawyers first drafted the memo when they served on the legal team for Air Force Maj. Sonnie Bates, who refused an order to take the vaccine. Initially, the service pursued court-martial proceedings against Bates. But the officer recently negotiated a settlement with the Air Force in which he paid a fine and left the service.

The "substantive changes in the way the vaccine is used and the purpose for which it is used render the vaccine an IND under current federal law," according to the new legal memorandum. "As an IND, the vaccine may not be administered to service members without their informed consent . . . Accordingly, orders to military personnel to submit to the vaccine without their consent are per se violative of a direct order from the president in his role as commander-in-chief."

The memo cites a 1996 IND application the company that then made the vaccine, Michigan Biologic Products Institute, sent to FDA. The application was for IND status to allow for a new indication on the labeling -- use against inhaled anthrax -- among other changes. MBPI subsequently was bought by BioPort, which is currently the sole-source supplier of the anthrax vaccine.

According to Air Force JAGs who spoke this week to ITP on background, a pending application for an IND suggests the drug in question must be treated as an IND for the purposes in question, and Friedman's letter does not hold the legal power to reverse that. FDA has not yet acted on the IND application.

Earlier this year, a senior program official at AVIP referred a reporter to statements FDA officials have made before Congress indicating the vaccine used by the Pentagon is not in IND status. Kathryn Zoon, director of FDA's Center for Biologics Evaluation and Research, has testified the vaccine is effective against anthrax regardless of the way in which the disease is introduced into the human body, through the skin or the lungs.

Similarly, this week, a Defense Department spokesman referred ITP to a letter that FDA Associate Commissioner Melinda Plaisier sent to Rep. Dan Burton (R-IN), chairman of the House Government Reform Committee, on Nov. 26, 1999. In it, she reiterates Friedman's earlier language with regard to the vaccine labeling, stating, "Use of the vaccine for protection against both cutaneous and inhalation anthrax exposure is not inconsistent with the labeling for Anthrax Vaccine Adsorbed."

Plaisier goes on to note that putting the vaccine into an IND status for this use would not allow for human research to be conducted on inhaled anthrax, as regulations would normally require for a drug to move from the investigational to an approved status. "Requiring the anthrax vaccine to be returned to an investigational new drug (IND) status will not generate more human efficacy data, as inhalation anthrax in humans is not amenable to study, due to the low incidence and sporadic occurrence of disease in natural settings," according to the Plaisier letter.

But in their memo, Michels and Smith reject the notion that either the Friedman or Plaisier memo has the power to legally affect what the attorneys view as the anthrax vaccine's IND status for use against inhaled anthrax. "Both letters are circumspect in their assessment of the status of the AVA as an IND, but indicate that the AVA is not investigational," according to the memo. "However, such letters have absolutely no effect on the legal status of the AVA."

This is because in order to carry the weight of official policy, FDA regulations state such letters must go through a carefully mandated review process, and the letters themselves must state they are being issued in accordance with regulations, according to Air Force JAGs interviewed this week. Lacking that, FDA regulations regard such letters as informal "advisory opinions" that do "not bind or otherwise obligate or commit the agency to the views expressed," the memo cites the regulations as stating.

Even if a letter were issued that does conform with the regulations, the lawyers believe the vaccine the Pentagon is using remains an IND because FDA regulations require two human studies before an IND application can be approved. Such human studies on inhaled anthrax have not been undertaken because of the reasons Plaisier cites in her letter.

"It's not even a questionable issue" as to whether IND status would be required for this use, Smith told ITP in an April 18 interview. "The documents speak for themselves," he said, referring to MBPI's 1996 IND application as well as the various Defense Department briefings and meeting notes that have surfaced recently. In those documents dating back to 1995, government scientists and physicians planning the AVIP program voiced concern that FDA approval -- or informed consent -- may be required for the new usage.

Stephanakis, the AVIP spokeswoman, rejects this assumption. "If we had any questions, we would work with FDA to satisfy them, and to be in compliance with any of their regulations," she told ITP.

Smith, though, is skeptical the FDA has met its obligations in assessing the anthrax vaccine as an IND. "I really believe the DOD solicited that letter from Dr. Friedman as political cover," he said, noting the Defense Department was eager to launch its anthrax force protection program, at the time.

Another Air Force JAG, interviewed on background April 18, voiced similar concerns. "What is most shocking is the absolute failure of executive agencies to police each other," this official told ITP. If the FDA has indeed concluded the vaccine is safe and effective against an inhaled anthrax threat, the agency could issue a formal letter -- according to regulations -- stating it has made that determination, the official said. However, there has not been sufficient human testing to support such a determination, the source added.

"Do I think people should be vaccinated against likely bio-war agents?" the official continued. "You betcha. . . . But under the circumstances we have here, I think it's illegal."