Delegation Letter to the Secretary of Defense

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July 20, 1999

The Honorable Cohen

Secretary of Defense

1000 Defense Pentagon

Washington D.C. 20301

Dear Mr. Secretary:

We are writing to you to express our concerns with the Anthrax

vaccination program currently being implemented by the Department of

Defense. As you know, the House Subcommittee on National Security,

Veterans

Affairs, and International Relations has held three hearings on this

subject

and is expected to hold at least two more during the second half of this

year.

The hearings held in March, April, and June have raised a number

of

concerns about the vaccination program including its purpose, its value,

the

manner in which it is being carried out, and its effects on those who

serve

in uniform. These concerns have been heightened by recent media reports

and

information circulating among those affected by the vaccine.

Subsequently,

our offices are receiving an increasing number of contacts from

concerned

constituents, both members of the Armed Forces, as well as their

distraught

parents or relatives.

Mr. Secretary, you had set four specific conditions that had to

be

met before the vaccination program could start; 1) supplemental testing

to

assure sterility, safety, potency and purity of the vaccine stockpile;

2)

implementation of a system for fully tracking anthrax immunizations; 3)

approval of operational plans to administer the vaccine and

communications

plans to inform military personnel; and 4) review of medical aspects of

the

program by an independent expert.

According to the hearing testimony before the Subcommittee, none

of

these conditions was satisfactorily addressed before the vaccine program

was

implemented. While we do not want to duplicate the efforts of our

colleagues who are pursuing their own investigations, we would request

that

you direct your attention to the following issues.

The first of these relates to the overall effectiveness of the

vaccine. The FDA approval cited by the Defense Department was for a

vaccine

that was designed to protect workers in the woolen industry from

cutaneous

contact with anthrax spores. Conversely, the primary anthrax threat

facing

military personnel is not cutaneous, but weaponized versions of the

bacteria, which are inhaled by their victims. There has been little or

no

testing of the vaccine's effectiveness in humans against this form of

anthrax for obvious reasons. Testing results on animals has had mixed

results, with the most promising returns coming from laboratory monkeys.

However, to assume a drug that has achieved successful results in

primates

will have a similar response with humans is only the start of basic

research.

Additionally, we have yet to see any evidence from the Defense

Department that this vaccine would be effective against altered or

multiple

anthrax strains. Given that the Soviet Union placed a high priority on

the

development of the deliverable multiple anthrax strains, this is a

legitimate concern. Analysis of tissue samples from Russians killed in

an

accidental anthrax release from a production facility in the 1970s have

indicated infection from a combination of individual strains. In fact,

the

Russian biowarfare expert, Ken Alibek, has even been quoted as saying

vaccines aren't the answer. Given the extremely poor performance of the

vaccine against even individual multiple strains in the Ft Detrick

guinea

pig studies, does the Defense Department have any evidence that the

vaccine

currently being issued is effective against a combination of multiple

anthrax strains?

We are also concerned about the value of supplemental testing

and

whether such testing can really determine the sterility, potency,

purity,

and safety of the vaccine. Written GAO testimony from the April 29

hearing

left this issue unresolved. They wrote, " . . . quality cannot be

guaranteed

for final tests on random samples but only from a combination of

in-process

tests, end-product tests, and strict controls of the entire

manufacturing

process. " The FDA inspection results from February 1998 already

indicate a

significant lack of quality controls during manufacturing. It would

seem

that any damage done could not really be reversed at this point. Can

you

provide specific details of just how the supplemental testing process is

able to overcome problems already present in the final vaccine product

without remanufacturing the lots?

The second concern relates to the overall safety of the

vaccine. As

with any drug, there are concerns about harmful side effects. Since

1970,

the primary recipients of the vaccine have been several thousand mill

workers and mostly DOD researchers. This limited civilian usage of the

drug

has resulted in limited evidence of adverse reactions. The one

exception to

this was the inoculation of approximately 150,000 Gulf War troops.

However,

the Defense Department's poor record keeping after the Gulf War has made

gleaning any useful information about the vaccine's effectiveness or

harmful

side effects impossible.

Once again, it may be premature to conclude that a drug used on

several thousand individuals with a small incidence of adverse effects

is

safe to administer to 2.5 million military personnel. A simple overall

2%

rate would yield 50,000 adverse reactions each and every year. This is

an

unacceptably high rate (more on the DOD reported reaction rate later).

It

is also completely unknown what will be the effect of cumulative annual

boosters, let alone the combined effects from 15 or so other biological

warfare vaccines under development. What other force protection program

has, as a built-in component, such a high casualty rate and unknown

level of

future risk?

Another source of safety concerns comes from the vaccine plant.

It

is well known that the original manufacturer of the vaccine, Michigan

Biologics Products Institute (MBPI), " voluntarily " closed down in March

1998

in order to make $1.8 million in renovations and a $15 million expansion

which was funded by the Defense Department. Prior to this, MBPI had

been

cited repeatedly by the FDA for quality control problems and

manufacturing

violations dating back to 1990. Will you inform us as to what steps the

new

owner of the manufacturing site, Bioport Corporation, is taking to

improve

the production and testing process for the safety of the vaccine?

The Subcommittee briefing from the April 29 hearing, stated that

the

vaccine " is dangerous enough the manufacturer demanded, and received,

indemnification from the Army against the possibility that persons

vaccinated may develop anaphylaxis or some unforseen reaction of serious

consequences, including death. Private indemnity insurance was

considered

too costly. " If the manufacturer was highly concerned about potential

civil

litigation, why was the Defense Department so quick to convey the

message

that the vaccine was safe for general use?

The third concern relates to the tracking system being

implemented

with this vaccine. The Gulf War experience illustrated the need for a

comprehensive tracing system to measure the potential side effects of

the

multiple vaccinations often administered to soldiers being deployed

overseas. While we understand that such a tracking system has been

developed for this program, there have been several reports of

individuals

being inoculated with expired lots of the vaccine, to the significant

detriment of their health as recorded in testimony and the media. What

steps are being taken to improve upon this Gulf War experience and what

is

being done to avoid further health impacts with expired lots in this

program?

Moreover, it appears that adverse exclusionary categories, such

as

respiratory conditions, previous reactions, chills and fever, and

pregnancy

are not being adequately reviewed by the personnel in charge of

administering the shots. Rather, the subcommittee has received reports

that

many of those administering the vaccine are simply glossing over

communicating the exclusionary requirements in an effort to inoculate as

many individuals as rapidly as possible. Likewise, we are also

concerned

that the reporting of adverse reactions among troops who have received

the

vaccine, is being discouraged, so as not to cause undue alarm in those

units

which have not received their first round of shots.

In that same regard, the official Defense department's reported

reaction rates of between .0002% and .007% this year is not reassuring

for

several reasons. We have received reports that VAERS forms are not

available to service members, not filled out, or not forwarded. FDA and

JAMA sources indicate extremely low percentages of reactions are ever

reported anyway, and the military's record of reaction reports with the

1970s swine flu vaccine is far below that of civilian rates. Given

these

qualifiers, why are the DOD reported reaction rates not accompanied by

reasonable disclaimers?

The fourth area of concern deals with the operational plans to

administer the vaccine. There appears to be some confusion deadlines as

some units begin their shots and frequent deadline adjustments for unit

personnel to receive their shots. Some of those deadline adjustments

appear

due to commander fear of excessive personnel losses because of the

vaccine.

Additionally, as reserve component personnel express an interest in

transferring or terminating their participation because of the vaccine,

we

are hearing they are met with delays, instructions to not list the

vaccine

as a reason, and even threats of poor evaluation reports. Last we

heard,

this is still a voluntary force. If members are convinced after careful

research that a policy truly threatens their civilian livelihood, they

should be allowed to communicate the truth about their perspective.

What

assurances can you provide that these repressions will not occur in the

future?

Furthermore, the Reserve Officers Association has recommended

that

all National Guard and Reserve units should receive shots from lots of

newly

made vaccine. The ROA is chartered by Congress to review defense

policies

to ensure their adequacy. Since they represent 80,000 current,

experienced,

and retired reservists, their opinion should be considered carefully.

Given

that Bioport Corporation is not due to begin production of new vaccine

until

next year, and we know Guard and Reserve units are being vaccinated, why

has

this recommendation for new lots been ignored?

We would also appreciate data the DOD collected, if any,

regarding

how many and what percent of service members were inoculated to be

protected

prior to deploying to the Allied Force operation in Kosovo. Also, what

percent of members deployed without the vaccine's protection? Given

Russian

support for Serbia, we assume DOD took into account the possible anthrax

supply provided to the enemy for use against our forces or the Kosovars.

Finally, we have serious concerns about the independent review

of

the medical aspects of the vaccination program. The reviewer in

question,

Dr. Gerald N. Burrow, has been cited by the Defense Department as

approving

of the safety and effectiveness of the vaccine. Yet in a letter to the

Subcommittee dated April 26, 1999, Dr. Burrow Stated: " the Defense

Department was looking for someone to review the program in general and

make

suggestions, and I accepted out of patriotism. I was very clear that I

had

no expertise in Anthrax and they were very clear they were looking for a

general oversight of the vaccination program. . . I had no access to

classified information. The suggestions I made were to utilize focus

groups

to be sure the message they wanted to send to force personnel was being

heard, and to use the vaccination tracking system as a reminder for

subsequent vaccinations. I had no further contact after delivering my

report and do not know whether my suggestions were implemented. "

Given that the independent reviewer was admittedly not an expert

in

the field of anthrax, how can the Defense Department stand by his

earlier

claims that the vaccine was safe for distribution and the " best

protection

against wild-type anthrax? " Given past poor credibility in these

issues,

the history with Gulf War Illnesses, and the enormous potential risk to

our

entire population of uniformed defenders, why was this individual, and

not

someone with a background in large vaccination programs or biological

agents

like anthrax, selected for the independent review?

One more specific concern we have relates to the approach of our

allies to the biowarfare issue. We know Britain has a voluntary vaccine

policy which yields only 30% cooperation. We know the French didn't

force

their troops the to take anthrax or other vaccines in the Gulf War and

don't

have the illnesses our service members complain about. We know the

Canadians have faced the same controversies and even more severe

logistics

problems with the vaccine and are not currently administering it to

their

troops. We know Israel, which is conceivably at the greatest risk in

the

Middle East and has received SCUDs attacks, does not rely on vaccines,

but

antibiotics. And the State Department, which arguably has more

personnel

risk because embassies are less well protected than military units, has

only

a voluntary policy. It is almost inescapable that this policy appears

as a

captive research market. Why in light of everyone else's lack of forced

inoculations is it necessary to put U. S. service member trust on the

line

when two surveys have indicated that 80% of the civilian and military

respondents oppose the program?

Above and beyond the specific concerns mentioned here, we are

concerned about the public perception of the anthrax vaccination program

and

its impacts on service member morale. We must ensure that this single

force

protection measure which addresses only one of a myriad of biological

threats is not itself a more real threat to our citizens in uniform.

We welcome your review of this issue, and look forward to

hearing

your response to our specific concerns.

Sincerely,

BENJAMIN A. GILMAN Member of Congress

CHRISTOPHER SHAYS Member of Congress

SUE KELLY Member of Congress

MARK SOUDER Member of Congress

DOUG OSE Member of Congress

JAMES TALENT Member of Congress