[Avian2005] Forced Use of Anthrax Vaccine

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Pentagon weighs options in anthrax vaccine suit

Time to end anthrax suit

 

The fate of U.S. soldiers, who refused an order to be injected with

the highly reactive anthrax vaccine, is shared by both U.S. District

Judge Emmet G. Sullivan and the Department of Defense (DOD).

Sullivan is the federal court judge in Washington, D.C. who issued

an injunction in October 2004 halting mandatory anthrax vaccination

of all US military personnel without obtaining voluntary, informed

consent.

 

In February 2006, an appellate court asked Sullivan to decide

whether DOD had the legal right to order that the experimental

anthrax vaccine be injected into all troops for 14 years before the

FDA licensed it for use against inhalation (weaponized) anthrax in

December 2005. The DOD was supposed to answer Sullivan's questions

at a scheduled June 27, 2006 federal court hearing but DOD requested

postponement of the hearing.

 

Ever since the Gulf War began in 1991, millions of US soliders have

been forced to get the experimental anthrax vaccine. There have been

tens of thousands of reports of brain and immune system dysfunction,

including death, among soldiers following vaccination. After seeing

many of their colleagues die and become crippled after anthrax

vaccination, more than 400 soldiers refused the vaccine and were

court martialed, dishonorably discharged or otherwise forced to

leave the military. If Sullivan rules that it was unlawful for the

DOD to order troops to take an experimental anthrax vaccine without

their informed consent, the soliders who have been punished for

refusing to take the vaccine will be able to petition DOD for

correction of their service records.

 

In March, 2005, the National Vaccine Information Center joined with

groups representing vaccine injured soldiers and filed an amicus

brief in the lawsuit John Doe et al v. Donald Rumsfeld (Secretary of

Defense) protesting the lack of informed consent protections in the

military's mandatory anthrax vaccination program. The amicus brief

specifically addressed the apparently contrived use of the Emergency

Use Authorization (EUA) under Project Bioshield by the Secretaries

of Health and Human Services and DOD to get around Judge Sullivan's

2004 injunction that required the DOD to give soldiers voluntary,

informed consent to anthrax vaccination. The DOD and DHHS claimed

an " emergency " existed which required supsension of soldiers' right

to informed consent to use of an experimental vaccine or drug.

 

In the amicus brief, NVIC and co-signers, pointed out that " FDA's

history of regulatory malfesance with respect to anthrax vaccine,

combined with the emergency use provision of the 2004 Bioshield Act,

create the scenario for an anthrax vaccine disaster that affects a

much larger segment of the U.S. population, and not just the

military. "

 

Federal legislation passed since September 11, 2001 has set the

stage for forced use of experimental vaccines and drugs in both

military and civilian settings whenever the politically appointed

Secretary of the Department of Health and Human Services (DHHS)

declares an " emergency. " There will be no recourse to appeal the

emergency declaration to anyone, including the courts.. The cavalier

use of the EUA by the Secretaries of DHHS and DOD in the case of

forced anthrax vaccination of soldiers is a chilling example of what

American citizens will face in the future.

 

Americans would do well to remember why the informed consent ethic

is so important to fight for and protect. At the Doctor's Trial at

Nuremberg after World War II, medical doctors employed by the German

state were put on trial for forcing experimental medical

interventions on citizens. Although those medical doctors were tried

for incomparable crimes against humanity, the Nuremberg Tribunal

wisely understood that the only way to deter all forms of medical

exploitation of vulnerable people was to require doctors inside and

outside of government to adhere to the ethical principle of

voluntary, informed consent. At the trial's end, the Tribunal

issued " The Nuremberg Code " to serve as a guide to the ethical

practice of medicine.

 

Vaccination is a medical intervention performed on a healthy

individual which can kill or injure that individual. Therefore,

voluntary, informed consent to vaccination, in either a military or

civilian setting, is a human right.

 

Pentagon weighs options in anthrax vaccine suit

Latest hearing pushed back at government's request

 

Air Force Times (Gannett) July 10, 2006

 

By Gayle S. Putrich Times staff writer

 

The question of whether the Defense Department will be allowed to

resume ordering service members to take the controversial anthrax

vaccine continues to drag on in court.

 

A status hearing, in which the judge would ask questions and hear

arguments from both sides without rendering a decision, was

scheduled for June 27. But that was pushed back indefinitely,

sources say, at the request of the government for reasons that are

unclear.

 

" We're just waiting, " said Mark Zaid, an attorney for the six

anonymous military and federal civilian plaintiffs in the suit, Doe

v. Rumsfeld. " DoD needs to decide what they're going to do. "

 

The vaccine program became voluntary in early 2004 after a federal

judge halted mandatory shots because he said the vaccine was being

used in an unapproved way.

 

After nearly two years of further study, the Food and Drug

Administration issued a " final rule " in December 2005 that the

anthrax vaccine is " safe and effective " as protection against both

the skin and inhalation forms of the disease.

 

Defense officials hoped the FDA's decision would force a reversal of

the earlier court order that made the shots voluntary. The Defense

Department also wanted an appellate court to rule that the

government was within its rights all along to order troops to take

the vaccine. That request, however, was turned down.

 

The injunction that made the shots voluntary ended with the FDA's

Dec. 19 licensing of the drug against inhalation anthrax. A three-

judge panel of the D.C. District Court of Appeals agreed in a Feb. 9

decision that " the injunction is dissolved and this case no longer

presents a live controversy on which we may pass judgment. "

 

However, instead of saying that forcing troops to take the vaccine

was legal all along, the panel kicked the case back to the original

judge, U.S. District Judge Emmet G. Sullivan, " with instructions to

the district court to consider that request. "

 

Sullivan's decision could have an impact on hundreds, perhaps

thousands, of service members who were punished for refusing an

order to take the vaccine when the shots were mandatory.

 

If Sullivan rules that the Pentagon was within its rights to order

people to take the anthrax vaccine even though it had not yet been

properly licensed by the FDA, then the punishments meted out to

those who refused the inoculations will stand.

 

If, however, it is ultimately determined that the Pentagon was wrong

to have forced the shots on troops, those punished for refusing the

drugs will be able to petition for the correction of their service

records.

 

Service members are responsible for their own records; the Defense

Department will not offer to update them, even if they are

inaccurate. And there is a six-year statute of limitations on

changing records in situations involving disciplinary action.

 

The Pentagon's top health affairs official, Dr. William Winkenwerder

Jr., had his own take on the situation when he spoke with Air Force

Times editors and reporters June 12.

 

He indicated the Defense Department got what it wanted from the

appellate court, though he said the program will remain voluntary

for now.

 

" The DoD appeal was not rejected, " Winkenwerder insisted. " The FDA

made a final decision after the federal judge had placed an

injunction on the program. And the final decision from the FDA, the

final rule, allows the department to use the vaccine as we would see

fit. And we are reviewing our program. "

 

He said the Pentagon has made no decision whether to continue the

existing voluntary approach indefinitely or " return to a mandatory

approach or change the target population that we would seek to

protect. "

 

When the status hearing finally takes place, it will be the latest

step in a long legal journey that began in 1998, when the Pentagon

required shots to protect troops against the possible use of anthrax

as a biological weapon.

 

The case, which has become a tangled web of arguments about

scientific research methods, complex statistics and drug safety,

boils down to two questions: Is the anthrax vaccine safe, and does

it work?

 

Government officials contend that scientific data show the series of

six shots to be safe, and that they protect against all forms of

anthrax, including airborne spores — the most probable form of

anthrax that terrorists would use.

 

But opponents say the vaccine, made by a Michigan company that over

the years has endured numerous financial problems and health code

issues at its plant, risks making service members ill.

 

Hundreds of troops have complained of health problems they believe

are linked to the vaccine. Despite congressional requirements that

the Pentagon track the potential health risks of anthrax shots, the

Daily Press of Newport News, Va., reported in December that defense

officials had kept from public view reports of the hospitalization

of more than 20,000 service members following anthrax vaccinations.

 

Defense officials contend there is no evidence that any of those

hospitalizations are linked to the vaccine.

 

Time to end anthrax suit

Editorial

 

Air Force Times (Gannett) July 10, 2006

 

A lawsuit that challenges the military's anthrax vaccine program is

now well into its fourth year in court.

 

It's time for the Pentagon to reach out and settle the case.

 

The vaccine became voluntary in late 2004 when U.S. District Judge

Emmet Sullivan shut down the mandatory program, ruling that the Food

and Drug Administration had failed to properly license the vaccine

for use against the inhalation form of anthrax.

 

The FDA issued a final rule certifying the vaccine for such use last

December. The Pentagon then appealed not only to have Sullivan's

injunction lifted, but to have the courts certify that the mandatory

program had been legal all along. That's a crucial point — if the

courts rule that the old program was illegal, any troops who were

punished for refusing an order to take the vaccine could petition to

have their records corrected.

 

In February, an appeals court dissolved the injunction but sent the

case back to Sullivan to decide whether the mandatory program was

legal.

 

A hearing on that issue was scheduled in Sullivan's court June 27

but was pushed back indefinitely at the government's request,

without explanation.

 

Meanwhile, Dr. William Winkenwerder Jr., the Pentagon's top health

affairs official, seems downright blasé about when, or even if, the

Pentagon might reinstate mandatory shots.

 

" We are reviewing our program, " is all he would say June 12. " No

final decisions have been made. "

 

This is a curious lack of urgency coming from an agency that, until

recently, issued strong and repeated assertions about the dire

nature of the anthrax threat facing U.S. troops.

 

Many service members, both past and present, deserve resolution to

this long, tired saga. Indeed, the Defense Department itself needs

to move ahead one way or another — to settle on how such matters

should be handled in the future.

 

It's time to stop the foot-dragging and resolve this issue, once and

for all.

 

NVIC e-newsletter is a free service of the National Vaccine

Information Center and is supported through membership donations.

 

NVIC is funded through individual membership donations and does not

receive government funding. Barbara Loe Fisher, President and Co-

founder.

 

Learn more about vaccines, diseases and how to protect your informed

consent rights http://www.nvic.org

 

NVIC National Vaccine Information Center

 

 

email: kathi

phone: 703-938-dpt3

web: http://www.nvic.org