Subject: Anthrax letter

Date: Thu, 15 Apr 1999 11:58:33 -0700

From: "Meryl Nass" <mnass@igc.apc.org>

To: "Meryl Nass" <mnass@igc.apc.org>

PERSONAL

April 8, 1999

Congressman Walter Jones

422 Cannon House Office Building

Washington, DC 20515

Dear Congressman Jones:

I am writing to you pursuant to our phone conversation earlier today. As I

am aware of your concerns regarding your constituents in the military, I

would like to take this opportunity to provide you with further detail about

the matters we discussed.

There is no evidence for anthrax vaccine efficacy in the setting of

biological warfare.

1. The existing data from multiple studies on mice and guinea pigs

indicates that naturally occurring anthrax strains vary in virulence

and that a number of these strains are lethal for vaccinated animals.

2. It should be expected that when strains are selected for virulence

and/or genetically engineered for virulence, that they will defeat the

U.S. vaccine. The Russians have developed at least one genetically

engineered strain which defeated their own vaccine. Tremendous

resources have been put toward biological warfare in general, and

anthrax research in particular, by the former Soviet Union and other

nations. It is, therefore, very unlikely that the U.S. vaccine,

developed in the early 1960’s, will have much success protecting

troops against a high volume aerosol of virulent anthrax spores.

3. Even if our vaccine were 100% effective, which no one claims, it would

still fail at protecting troops--for an enemy would simply choose a

different biological agent to use. At least 65 naturally occurring

biological threat agents have been identified by DARPA, and the number

of genetically engineered bioweapons is infinite.

There is no evidence of long-term safety for the current U.S. human anthrax

vaccine.

1. No studies have been completed of long-term safety. The Department of

Defense initiated a study at Tripler Army Medical Center in September

of 1998 to begin to collect the kind of data that is necessary. Their

initial results show a side effect rate of 7.9% after the first

injection.

2. Katherine Zoon, the head of FDA’s Center for Biologics Evaluation

and Research, pointed out in a May 1998 letter that no studies of

long-term effects had ever been submitted to the FDA.

3. The January 16, 1999 issue of the British medical journal, The Lancet,

contained an article by Catherine Unwin et al., in which British

soldiers were asked to recall their anthrax and multiple vaccination

status at the time of the Gulf War. This was compared to the

development of subsequent Gulf War Illness. There was a statistically

significant correlation between both anthrax vaccination and multiple

vaccinations and symptoms of Gulf War Illness. This is the only

published study to review data on this question. Other unpublished data

also support an association between vaccination for anthrax and

subsequent Gulf War Illness.

4. In terms of safety of the vaccine during the current round of

vaccinations, which started in March of 1998, DOD has reported an

adverse reaction rate of .007%. This, however, flies in the face of

data generated by DOD in 3 unpublished studies that have been made

available for my review. In these studies, the rate of adverse events

has been as high as 74% for local reactions, and for systemic reactions

as high as 44%.

5. A number of servicemembers have contacted me who believe they have

become ill following anthrax vaccination. Very few of these people have

had documentation placed in the medical record that their symptoms may

be due to the anthrax vaccine. Few of these people have had VAERS

(vaccine adverse event reporting system) forms completed and submitted

to FDA or CDC regarding their illness.

6. The lack of accurate reporting of side effects has further obfuscated

the safety issue.

7. I am aware of an Air National Guard unit from Battle Creek, Michigan,

nearly all of whose members have developed a similar chronic illness

post-vaccination. Four servicemembers have been transferred to Wright

Patterson Air Force Base at the time of this writing, for further

evaluation of their illness. Most of these servicemembers lost a week

of work after receiving the fourth vaccination. Furthermore, they

allege irregularities in recording the expiration date of the vaccine

in their medical records, the dates on which they were vaccinated, and

the lot number of the vaccine they were given. They have been told by

medical staff that they should return their medical records so that the

lot number may be changed.

8. There are significant manufacturing irregularities at Bioport,

previously Michigan Biologic Products Institute (MBPI), where the

vaccine was manufactured for DOD. FDA had not been inspecting the

anthrax line at MBPI until February 1998. However, other irregularities

at the plant led to warning letters from FDA in 1995 and 1997,

threatening to close the entire facility down. After the 1998 anthrax

vaccine inspection, 11 pages of breaches of "good manufacturing

practice" were documented for anthrax vaccine alone.

9. Supplemental testing of vaccine lots, many of which had expired, been

retested, and redated, was instituted. Of the initial 19 lots subjected

to supplemental testing, 11 failed due to concerns regarding potency,

sterility, and adequacy of closure. Only 8 of the initial 19 lots

passed the testing and are now being used on servicemembers. However,

even the lots which passed supplemental testing have been associated

with development of chronic illness.

Given the above concerns, I urge you to support a moratorium on further

anthrax vaccinations unless and until safety, efficacy and necessity are

established.

I will be happy to supply supporting materials for the information presented

above, and would be pleased to assist you in any way I can.

Sincerely yours,

Meryl Nass, M.D.