Past article

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Found this past article - thought is was interesting!

TITLE: Pentagon Breaks FDA Rules

AUTHOR: BIRMINGHAM, KAREN

JOURNAL: Nature Medicine

CITATION: March, 1998: 255.

YEAR: 1998

PUB TYPE: Article

IDENTIFIERS: BIOLOGICAL WARFARE; PERSIAN GULF WAR; BOSNIAN WAR;

ANTHRAX; TICK-BORNE ENCEPHALITIS; GERM WARFARE; FOOD AND DRUG

ADMINISTRATION; VACCINES; IMMUNIZATION

ABSTRACT: The Department of Defense (DOD) has been silent in

response to the Food and Drug Administration's (FDA)

questions as to why deviations in vaccination

standards

for troops in Bosnia occurred. The serum used to

vaccinate 3,981 military personnel against

tick-borne

encephalitis (TBE), a central nervous system disease

that

can lead to brain swelling and coma, had never been

tested in the U.S. The vaccine was administered as

an

Investigational New Drug (IND) to U.S. troops in

Bosnia.

Gulf War troops similarly received immunizations

that

caused the FDA to question the Army's ability to

operate

large-scale immunization programs that are becoming

increasingly necessary due to the growing threat of

biological warfare.

The FDA criticized the Army's recordkeeping

associated with the vaccine's administration

(several

thousand doses were deemed missing), its monitoring

procedures, an unauthorized experimental variance

from

the vaccination schedule, and its failure to

adequately

warn personnel of possible risks associated with the

vaccine under IND standards. The Army countered that

it

was interested in providing protection for its

forces,

not in obtaining safety and efficacy information,

and

accounted for the missing doses as being destroyed.

It is essential that impeccable monitoring of

all

vaccinations be performed to trace any subsequent

illnesses that occur, especially when INDs are

administered. Several new vaccines against

biological

agents are presently in the R & D stage in the U.S.,

and

the military is potentially the initial group to

receive

them. Also, 1.4 million U.S. troops are scheduled to

be

vaccinated against anthrax over a 6-year period;

however,

a professor expert in chemical and biological

warfare at

Rutgers University, New Jersey, is skeptical that

the

3,000 special operations personnel who have already

received the vaccine have yet to be immunologically

challenged with a biological weapon. He argues that

the

Army's poor recordkeeping eradicated any beneficial

effect the recipients of the vaccines may have

realized

during the Gulf War, and that the inoculation

schedule is

too complex (a series of six injections over an

18-month

period). He believes inoculation of a few thousand

military personnel under strict monitoring by a non-

military supervisor is wiser than hasty, mass

inoculation. The Gulf War provided some valuable

lessons

to the Army; however, it is doubtful that it learned

sufficiently about the matter of biological warfare.