Air Force Times - article and editorial on anthrax vaccine (July 10 edition)

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ARTICLE

Air Force Times (Gannett)(subscription)

_http://www.airforcetimes.com/story.php?f=0-AIRPAPER-1919368.php_

(http://www.airforcetimes.com/story.php?f=0-AIRPAPER-1919368.php)

July 10, 2006

Pentagon weighs options in anthrax vaccine suit

Latest hearing pushed back at government’s request

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.â€

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.â€

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.â€

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. 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.â€

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.â€

Zaid said the plaintiffs will file a challenge if the Pentagon moves to

reinstate a mandatory program, but “we have no complaints with a voluntary

program — we never have.â€

The issue, he said, has been that up until the FDA properly approved the

drug in 2005, it was illegal to administer it, which means the order to take it

was unlawful and troops should not have been punished for refusing to obey.

At that time, “the vaccine was unlawful,†he said. “We have very strict

rules, and if you are not in compliance with the FDA, it is unlawful to

administer a drug, whether it’s a DoD drug or a Merck drug. And that is what

this

case has always been about.â€

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.

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EDITORIAL

Air Force Times (Gannett)(subscription)

(this editorial also appeared in Army Times, Navy Times, and Marine Corps

Times)

*

_http://www.armytimes.com/story.php?f=0-ARMYPAPER-1920850.php_

(http://www.armytimes.com/story.php?f=0-ARMYPAPER-1920850.php)

July 10, 2006

Editorial

Time to end anthrax suit

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. 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.â€

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.