Legal issues dominate anthrax vaccine battle

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Tue, 22 Mar 2005 19:19:58 EST

 

Legal issues dominate anthrax vaccine battle

 

 

http://www.airforcetimes.com/story.php?f=0-AIRPAPER-727874.php

 

 

March 28, 2005

 

 

Legal issues dominate anthrax vaccine battle

 

 

By Deborah Funk

 

Times staff writer

 

 

Supporters and opponents of the military's anthrax vaccine program are

 

preparing for the latest round of their ongoing battle in Washington,

 

with each side accusing the other of trying to flout a legal

 

requirement.

 

 

The six plaintiffs who sued to stop the mandatory anthrax program

 

allege that the Defense Department and Health and Human Services

 

Department " did nothing less than manufacture " an emergency-use

 

authority for anthrax vaccine so vaccinations could resume in an " end

 

run " around the court order that stopped the shots, according to

 

documents filed in U.S. District Court for the District of Columbia.

 

 

But the government says it is the plaintiffs who are skirting legal

 

requirements by challenging the emergency-use authority without filing

 

a separate complaint in federal court.

 

 

The exchange is among the latest developments in the fight over the

 

mandatory vaccination program, which Judge Emmet G. Sullivan halted

 

Oct. 27, ruling that the government could continue to give shots only

 

with the informed consent of troops or if the president waives informed

 

consent.

 

 

Sullivan ruled that the vaccine was not licensed to protect against

 

inhalation anthrax, the type of disease the military says is a

 

potential threat to troops. He determined that the Food and Drug

 

Administration, which handles licensure, failed to follow its own

 

regulatory procedures in declaring the vaccine safe and effective

 

against all forms of anthrax.

 

 

Since then, the Pentagon has persuaded the Department of Health and

 

Human Services to declare an emergency so that troops again could be

 

vaccinated under a new federal law providing special emergency-use

 

authority for vaccines.

 

 

This is the first time HHS has entertained and granted such a request.

 

 

Unlike the mandatory program, however, the emergency-use authority

 

approved by HHS allows service members to refuse vaccination without

 

punishment.

 

 

Because troops would need to give permission to be vaccinated,

 

government lawyers argue this should satisfy Sullivan's order that the

 

shots cannot be mandatory. They are asking that he change his order and

 

allow the shots to resume on a voluntary basis as outlined in the

 

emergency-use authority, according to court documents.

 

 

As expected, the six anonymous plaintiffs say government plans to allow

 

troops to decline the shots falls short of the intent of the court

 

order that requires stricter legal standards of informed consent.

 

 

They also say the brochure that troops would receive if shots resume

 

under the emergency-use authority is misleading and incomplete in some

 

respects. They say the brochure should be modified to better inform

 

service members of risks, benefits and long-term side effects, and to

 

make clear that troops volunteer for the shots, according to court

 

documents.

 

 

The plaintiffs say the brochure is coercive because it repeatedly

 

tells service members that if they are infected with anthrax, they

 

could cause the deaths of their fellow service members and the failure

 

of the mission.

 

 

The government argues that it does not need to obtain informed consent

 

under the emergency-use authority and that raising this point is only

 

an attempt to confuse the issue, according to court documents.

 

 

Government attorneys also say federal law allows the agency involved to

 

determine what information will be provided, and therefore " plaintiffs

 

have no basis to propose revisions " to the brochure.

 

 

The government soon may face a challenge to its assertions on another

 

front, as some members of Congress also are questioning the

 

emergency-use authority.

 

 

Rep. Christopher Shays, R-Conn., a longtime opponent of the military's

 

mandatory vaccination program, is considering holding hearings to

 

review just how HHS granted the emergency-use authority to the

 

Pentagon.

 

 

Shays said the process was handled " haphazardly " and was insufficiently

 

" transparent. "

 

 

He also said the " emergency used to invoke what was intended to be

 

extraordinary ... authority appears to be the product of preventable

 

legal and regulatory failures by DoD, rather than any validated

 

external threat, " Shays wrote in a March 9 letter to HHS Secretary

 

Michael Leavitt.

 

 

Shays said the approval granted by HHS " unjustifiably expands and

 

distorts the scope of the emergency-use authority " envisioned under the

 

new federal law and " strays well beyond the legislative intent of the

 

provision. "