[NVIC] Protesting the Anthrax Vaccine

[Guest guest]

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

#9119

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" Protecting the health and informed consent rights of children since 1982. "

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K Note: Things seem to be coming to a head with the forced use of

the Anthrax vaccine by the military and informed consent is at the heart of

the issue. Tomorrow, NVIC will participate in a press conference with the

heavy metal band, Anthrax who are reuniting to tour and to protest the use

of the vaccine. To read more go the NVIC website: www.NVIC.org

http://www.washtimes.com/upi-breaking/20050330-085257-3105r.htm

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 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

obtained.

" 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 of the law firm & 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.

, a physician in Chesapeake, Va., who has performed and overseen drug

trials.

" You need to disclose every side effect that might happen (and) the

possibilities of those side effects, " 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

bare.

, 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

immunity.

" 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. "

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Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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Doctors destroy health, lawyers destroy justice, universities destroy

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