2 aritcles updating the Anthrax Vaccine Immunization Program developments

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State looks to control Guard, vaccinations

Bills introduced in Connecticut House of Representatives

By Deborah Funk

Times staff writer

Some state lawmakers in Connecticut want tighter control of their National

Guard members in the wake of the Pentagon’s controversial mandatory anthrax

vaccination program.Two bills recently introduced in the Connecticut General

Assembly’s House of Representatives launch the attack from different

angles.The first bill would bar the military from requiring members of the

Connecticut “militia or Guard†to take a drug or vaccine used experimentally

unless they are told of the benefits and risks and give their consent.The

legislation would require that before a drug or vaccine could be used without

someone’s consent, it must be licensed by the Food and Drug Administration,

used as instructed by the federal agency and proved safe and effective in

tests on humans.The measure attempts to prevent the Defense Department from

forcing Guard members to take the anthrax vaccine if they either don’t

volunteer for active duty or aren’t called up by the president. Guard members

on active duty, however, could be ordered to take the shot. Anthrax is a

naturally occurring and potentially fatal biological disease found mainly in

other parts of the world in some cattle and other livestock. The FDA licensed

the anthrax vaccine in 1970 after studies on textile workers showed a similar

vaccine protected them against cutaneous anthrax, which is contracted through

the skin.In the studies that led to the vaccine’s licensure, there weren’t

enough cases of inhalation anthrax to determine whether the vaccine worked

against that form of the disease. The FDA’s labeling doesn’t restrict its

use for any particular type of anthrax, however.The Pentagon is using the

vaccine to help protect troops against the biological warfare threat of

inhalation anthrax.Opponents of that program claim the vaccine that was

actually licensed was not the same vaccine tested, and that the tested

vaccine proved effective only against cutaneous anthrax.Either way, they say,

the current vaccine is not licensed for protecting troops against the type of

anthrax they would expect to encounter on the battlefield. They argue that

letters from high-ranking FDA officials saying the Pentagon’s use of the

vaccine “is not inconsistent†with the labeling don’t amount to

law.Connecticut Rep. Toni Boucher, the Republican state lawmaker who

introduced the bill, did not return several phone calls seeking comment.If

members of the Guard are called to active duty, federal law allows the

president to order them to take drugs or vaccines that are not licensed or

are approved only for “experimental†use.A second bill sponsored by state

Rep. Christel Truglia, a Democrat, would restrict who could command the

Connecticut National Guard or Air National Guard. When the Guard is not under

federal service, commanders would have to be commissioned officers of the

Guard. The state’s governor, however, could appoint an active-duty service

member to a command position if state lawmakers are given an explanation

about four months in advance for why no Guard member is qualified for the

post.The bills were introduced at the request of two former Connecticut Air

National Guard pilots who left their jobs rather than take the anthrax

vaccine.The pilots, who could not be reached for comment, say they were

forced out by a federal officer who lacked the authority to give them orders

when they were not on active duty. h Copyright 2001 Army Times Publishing

Company. .    

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Agency Recommends Anthrax Vaccine Curbs

By THOMAS D. WILLIAMS

The Hartford Courant

January 27, 2001 A federal watchdog group has found that the State Department

should not continue to give voluntary anthrax shots to its employees until it

determines whether there is an international terrorist threat of an anthrax

biological weapons attack. The U.S. General Accounting Office's report this

week may undermine the Pentagon's separate, but mandatory, anthrax program.

Former Secretary of Defense Cohen ordered the Defense Department's

six-shot series inoculation program in 1997. He and other Pentagon officials

have argued that service members must take the vaccine or face court martial

because the biological weapons threat from terrorists and enemy nations is so

significant. They insist the vaccine has now been shown to be safe and

effective through tests of monkeys. This week's GAO report says: " Diplomatic

security officials in the State Department and Central Intelligence Agency

analysts agree that they have no clear evidence that U.S. missions or

interests overseas are threatened by foreign state or terrorist attacks using

biological or chemical agents at this time. " The GAO also found that 80

percent of 8,000 doses of the anthrax vaccine at eight overseas State

Department missions had to be destroyed because they were not used before

their expiration date; other doses the State Department tried to give to the

Defense Department before they expired were improperly stored; and none of

the vaccine recipients at one agency site had received all the vaccinations

required. Previous GAO reports have said there is no evidence the vaccine is

effective against airborne anthrax spores. In addition, the GAO has

criticized the Defense Department, as it did the State Department in this

report, for ineffective monitoring of adverse reactions to the vaccine by

those inoculated. State Department spokesmen told the GAO that its inquiry

exaggerated the department{rsquo}s problems and criticized some of its

anthrax operation in a way that was deceiving. They said the

department{rsquo}s program has been harmed by a shortage of the vaccine.

Since a perceived threat of a biological attack existed, the department had

to do the best it could to offer its employees protection, the spokesmen told

the GAO. The State Department did agree to obtain an up-to-date assessment of

the anthrax threat; to better monitor vaccine supplies; to survey its

employees about those truly wanting the vaccine; to improve monitoring of

adverse reactions and to ensure employees are vaccinated with all the

required doses. The vaccine manufacturer has run out of supplies of the old

vaccine, manufactured by a previous operator, and is awaiting approval of its

own lots. In the meantime, the Pentagon is ordering use of the vaccine only

in overseas areas it says are susceptible to biological attacks. The State

Department has discontinued use of the vaccine until new supplies are

available.

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