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The Washington Times
March 30, 2005

Biowar: Informed consent injunction's key?

By Dee Ann Divis
Senior Science & Technology Editor

WASHINGTON, DC, Mar. 30 (UPI) -- The fate of the Defense Department's
anthrax vaccine program appears to hinge on whether Judge Emmet Sullivan
will allow the Pentagon to avoid the notification rules that normally
accompany an informed-consent requirement and the off-label use of a drug.

 On Oct. 27, 2004, Sullivan placed an injunction on the department's
mandatory vaccination program, blocking service personnel from having to
take shots of Anthrax Vaccine Absorbed, a controversial vaccine that critics
said is unsafe.

"Accordingly, the involuntary anthrax vaccination program, as applied to all
persons, is rendered illegal, absent informed consent or a Presidential
waiver," Sullivan said in his injunction.

AVA currently is licensed by the Food and Drug Administration, but only
against anthrax-related skin infections and not the lung infections the
military wants to prevent. The legality of using AVA against inhalation
anthrax was thrown into question after Sullivan ruled FDA had not gone
through all the necessary licensing steps. Under Title 10, which bars such
off-label use without prior consent -- and under a specific injunction
issued by Sullivan -- the military had to stop using the vaccine.

The Defense Department could have continued the program by obtaining the
informed consent of its service members, but officials chose not to.
Instead, they took the controversial step of going to the Department of
Health and Human Services and the Food and Drug Administration for an
Emergency Use Authorization. On the face of it, the EUA allows them to
proceed with the anthrax vaccination program they began in 1997.

Nonetheless, attorneys representing the Pentagon took the odd step of
returning to the U.S. District Court in the District of Columbia to ask
Sullivan to modify the injunction and, specifically, recognize the EUA.

The question is why.

Ostensibly, it is just a housekeeping matter. The EUA did not exist at the
time of the injunction, said Defense Department counsel Brian Boyle. The new
Bioshield Act made an EUA possible and now EUAs should be listed as a third
way to meet the legal requirements set by the injunction.

In a protracted debate, however, Sullivan kept asking if the program would
remain voluntary under the EUA. Boyle said yes, but Sullivan came back to
the question again and again, saying he did not understand why it was
necessary to change the injunction.

Boyle eventually admitted the Pentagon was worried about both requirements
of the injunction -- that the program be voluntary and informed consent be

"Informed consent is not required under the EUA," Boyle asserted.

"It sounds to me like they don't want to do informed consent because then
certain things kick in," said Mac Stewart of the law firm Stewart & Stimmel
in Dallas.

Informed consent is a very specific term. It requires providing a great deal
of background and risk information to anyone receiving a medication for a
reason not originally approved. Informed consent, properly executed, also
protects those administering the medication from liability.

"The requirements come out of the Geneva Convention," said Dr. Patricia
Raymond, a physician in Chesapeake, Va., who has performed and overseen drug

"You need to disclose every side effect that might happen (and) the
possibilities of those side effects," Raymond explained. "You need to fully
disclose what happens to you if you choose not to take it. You've got to
fully disclose ... if the investigators are getting any financial
considerations. You need to do all of that in fifth-grade or sixth-grade
language ... I've got to explain it to you."

There do appear to be negative reactions the Pentagon would have to lay

John Richardson, an opponent of using AVA, told United Press International
there have been some 4,000 adverse-event reports filed so far.

Bioport of Lansing, Mich., AVA's manufacturer, reported that 18 studies back
up the safety of the vaccine and there are no more problems with AVA than
with any other vaccine. Even if there are no more than a usual number of
adverse reactions, they still would have to be described in some detail
under an informed-consent requirement.

"They are trying to get away from two things in my opinion," said Roman
Kupchynski, a partner in the Dallas law office of Gardere, Wynne, Sewell.
"One, (they) don't want to have to go through the whole process of having to
paper and document what this drug is and what it does and the side effects,
et cetera."

Kupchynski suggested, however, there may be more to the Defense Department's
desire to proceed under the EUA. If the EUA gives the Pentagon cover from
liability while reducing the required paperwork, it would constitute an
attractive alternative to resuming the program using informed consent.

It is not clear what liability protections in the many anti-terrorism laws
might be triggered by the emergency nature of the EUA.

"I can tell you that in any other (non-military) setting there is potential
liability for anybody who's in the chain if there is not informed consent,"
said Kupchynski, who made clear there may be other avenues for government

"If I was on the government side," he said, "I would be thinking ... if I
don't really know what this drug is going to do ... I want to be able to
skirt that liability issue."


E-mail: [email protected]

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