2002 AVIP Update from Buzz -- the truth is in the fine print

[Guest guest]

In the following email I'll update you on the AVIP during the first quater of

2002. The confusing DOD Press Briefings, the Presidential commitment to

develop a new vaccine, the manufacturer's approval with the dramatic changes

in the product label, and the Institute of Medicine report endorsing the

vaccine for US soldiers only -- all show that the truth is in the fine print.

I'll also include some clips at the end and a Process Analysis to put the

entire dilemma in perspective.

Sincerely,

" Buzz "

Major Tom Rempfer

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Confusing NEWS TRANSCRIPT Excerpts from the United States Department of

Defense:

<A HREF= " http://www.defenselink.mil/news/Oct2001/t10122001_t1012sd.html " >DOD

News Briefing -- Secretary of Defense H. Rumsfeld</A>

Friday, October 12, 2001 - 12:15 p.m. EDT

Q: Before September 11, the Pentagon was wrestling with the decision about

whether to invest more money into BioPort, the nation's sole maker of anthrax

vaccine, which so far has had difficulty producing FDA-certified vaccine.

Are you now prepared to put -- invest whatever it takes in that facility to

produce a vaccine, or are you inclined to go in some other direction?

Rumsfeld: The answer is, I think, that I would have to talk to Dr. Chu

and Pete Aldridge. They have been addressing that issue. And there were any

number of issues around that situation which were quite complicated, for a

variety of reasons. And it has been something that I -- preceded us, me,

here as a problem for this department. And to my knowledge, those problems

that have not been worked out. But I would have to talk to them.

-------------------------------------------------------

<A HREF= " http://www.defenselink.mil/news/Oct2001/t10182001_t018sdmy.html " >DoD

News Briefing -- Secretary Rumsfeld and Gen. Myers</A>

Thursday, October 18, 2001 - 2:00 p.m. EDT

Q: Mr. Secretary, I wonder if you can give us an update on the Pentagon's

anthrax vaccine program? ...

Rumsfeld: We're going to try and save it. There have been other efforts that

have failed over a period of years. And it may or may not be savable, but I

met this morning with Pete Aldridge and Chu, and we discussed this at

some length. And they or their representatives are going to be meeting with

people from HHS and Secretary 's office and try to fashion some sort

of an arrangement whereby we give one more crack at getting the job done with

that outfit. It's the only outfit that -- in this country that has anything

underway, and it's not very well underway, as you point out.

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<A HREF= " http://www.defenselink.mil/news/Oct2001/g011025-D-6570C.html " >DoD News

Briefing -- Secretary of Defense H. Rumsfeld</A>

Thursday, October 25, 2001 - 12:14 p.m. EDT

Q: Are you taking the anthrax vaccine, Mr. Secretary?

Rumsfeld: No.

Q: You're not being inoculated, you're not taking a series of tests.

Rumsfeld: No. No.

Q: All right. No vaccine.

Rumsfeld: No, no, no.

-------------------------------------------------------

<A HREF= " http://www.defenselink.mil/news/Oct2001/t10282001_t1028sd.html " >DoD

News Briefing -- Secretary of Defense H. Rumsfeld</A>

Sunday, October 28, 2001 - 11:30 a.m. EDT

: Okay. Mr. Secretary, have you been vaccinated against anthrax?

Rumsfeld: No.

: Okay. Thank you.

Rumsfeld: Have you?

: No. Thank you very much. Thank you for being here.

-------------------------------------------------------

<A HREF= " http://www.defenselink.mil/news/Oct2001/t10302001_t1030sd.html " >DoD

News Briefing -- Secretary Of Defense H. Rumsfeld</A>

Tuesday, October 30, 2001 - 1:35 EST

Q: Mr. Secretary, I have a question to you on the anthrax vaccination program

.. Congressman Shays says the previous administration squandered the vaccine

by giving it out so widely. What is your reaction to that? And a couple of

weeks go you said you were going to try to give BioPort one more chance.

What did you have in mind?

Rumsfeld: I would rather have you talk to Pete Aldridge about what we have in

mind. It involved, as I think I indicated at the time, some complex

negotiations and discussions about how they might find a way forward that

would be useful and constructive from the standpoint of the Department of

Defense. I have not gotten a report back with respect to how that might have

evolved, those discussions.

-------------------------------------------------------

<A HREF= " http://www.defenselink.mil/news/Feb2002/d20020226icwt.pdf " >DoD News

Briefing -- Secretary of Defense H. Rumsfeld</A>

Tuesday, February 26, 2002

Q: Have you reached a decision yet on the future of the Pentagon's

anthrax-vaccine program?

Rumsfeld: No.

Q: You have not. Any sense when you will? I mean, do you plan on starting

it again across the board or limiting it to certain numbers of soldiers? Is

there any sense of that yet?

Rumsfeld: I'm sure that Torie can get you an answer to that from Pete

Aldridge and Chu. I just happen not to be current. And when I said

" No " that quickly, I should've said, " Not to my recollection. " I think they

have -- are reopening that company.

e: Provisional staff -- the company reopened with provisional staff.

We're looking at it in the broader context of all vaccine programs.

Rumsfeld: So it was when the FDA certified that company for operation and

production of that vaccine. Then we have a linkage with HHS and Secretary

. And that is what is being looked at for the total issue with

respect to the vaccine.

-------------------------------------------------------

<A HREF= " http://www.defenselink.mil/news/Mar2002/t03222002_t0322apu.html " >DoD

News Briefing -- C. " Pete " Aldridge, Jr., USD ATL</A>

Friday, March 22, 2002 - 10 a.m. EST

Aldridge: Well, I'm Pete Aldridge, and I'm the undersecretary of Defense for

Acquisition, Technology and

Logistics. It's a pretty broad portfolio, more so than I thought when I first

accepted the job. We deal a lot with certainly the weapon systems; we deal

with all the technology efforts and all the logistics support. And I also

have responsibility for the chemical and biological defense activities

through an assistant to the secretary for Nuclear, Chemical and Biological

Defense Programs. So our activities these days have been quite busy. ...

So with that, I think that's enough. I'll just turn it over to questions.

Q: Can you tell us where you're at on the anthrax-vaccination program?

Aldridge: Yes. As you know, the -- my favorite topic -- (chuckles) -- the

bioport facility was, in fact, approved by FDA for production. It is now

producing vaccine. We're trying to get the contract in place to -- because

we actually had a stop-work contract -- a contract which we actually stopped

work on. It is now being renegotiated to get back on the contract. We're now

looking, and the secretary of Defense is looking at the anthrax-vaccination

policy now that we have production. He has not made his decision on that as

yet. But we are now producing the anthrax vaccine that -- (inaudible) -- in

fact, been approved by the FDA.

Q: Do you expect to start giving shots at some point?

Aldridge: That's being reviewed by the secretary, in fact, almost as we

speak. It will be decided within the next week or so as to how to proceed at

this point in time.

-------------------------------------------------------

AVIP Recommendations to the SECDEF, 10 AUG 02, by Undersecretary of Defense

for Acquisition, Pete Aldridge, and Undersecretary for Personnel and

Readiness, Dr. Chu:

" The current Anthrax Vaccine Immunization Program will continue at a minimum

level (critical personnel and projects only). "

" USD (AT & L) will implement an acquisition strategy to purchase additional

bio-detectors and stockpiles of antibiotics to augment force protection in

the absence of an anthrax vaccine. "

" USD (AT & L) will coordinate with appropriate DOD officials to develop a

coherent institutional process to assess and prioritize biological threats

and approve the use of associated countermeasures. "

" USD (AT & L) and USD (P & R) will continue their inter-agency efforts to develop

a national long-range vaccine that will address the full range of

requirements of the DOD, DHHS, and other stakeholders in this plan. "

(Bottom-line -- the review recommended minimum use of the anthrax vaccine,

because the AVIP was not coherent, and because we knew as early as 1985 that

we need a new anthrax vaccine.)

-------------------------------------------------------

New anthrax vaccine product label -- the truth is in the fine print:

SEE:

<A

HREF= " http://www.fda.gov/cber/label/biopava0131022LB.pdf " >http://www.fda.gov/cbe\

r/label/biopava0131022LB.pdf</A>

Excerpted QUOTES from the new FDA-approved label, posted 31 JAN 02:

" WARNINGS "

" Preliminary results of a recent unpublished retrospective study of infants

born to women in the U.S. military service worldwide in 1998 and 1999 suggest

that the vaccine may be linked with an increase in the number of birth

defects "

" Post Licensure Adverse Event Surveillance "

" Through October 2001, VAERS received approximately 1850 spontaneous reports

of adverse events ... Approximately 6% of the reported events were listed as

serious. Serious adverse events include those that result in death,

hospitalization, permanent disability or are life-threatening. "

" Across these studies, systemic reactions were reported in 5-35% of vaccine

recipients ... "

(Note: this compares to " .2% " in the previous label -- therefore, an

increase of anywhere from 25 to 175 fold -- either the old label was

misbranded, which " adulterates " the vaccine under the law, or the new label

reflects that of a " new drug, " which confirms it is experimental under the

law.)

" Reports of fatalities included sudden cardiac arrest (2), myocardial

infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1)

and central nervous system (CNS) lymphoma (1). "

" CLINICAL STUDIES "

" A controlled field study using an earlier version of a protective antigen–

based anthrax vaccine, developed in the 1950’s, that consisted of an aluminum

potassium sulfate-precipitated cell free filtrate from an aerobic culture,

was conducted from 1955-1959. "

(Note - the Federal Food, Drug and Cosmetic Act required that the Anthrax

Vaccine, now called " BioThrax, " be employed in a controlled field study, but

it was not. As you know, this is the basis of the Citizen Petition Russ and

I have filed with the FDA as of 15 OCT 01 -- 01P-0471 Issue the NFR Placement

of Anthrax Vaccine as Category II: <A

HREF= " http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/cp00001.pdf " >Citiz\

en Petition Docket #01P-0471</A>)

(Note -- Adulteration issues concerning the anthrax vaccine's illegal and

unapproved manufacturing changes of fermentors and filters have been omitted

from the new vaccine label. These changes may have caused up to 100 times

increased PA levels, and may be responsible for these over one-hundred fold

increases in adverse reaction rates, deaths and birth defects. These issues

are a matter of the public record via <A

HREF= " http://www.gao.gov/cgi-bin/getrpt?gao-02-181t " >GAO testimony to Congress

on 23 OCT 01</A>

and are addressed in the yet to be acted upon Citizen Petition filed on 15

OCT 01).

-------------------------------------------------------

Presidential Call for a new anthrax vaccine in the State of the Union Address

and in a White House Press Release:

2002 State of the Union Address:

" ... the nation will develop vaccines to fight anthrax and other deadly

diseases ... "

<A HREF= " http://www.whitehouse.gov/news/releases/2002/02/20020205-1.html " >Click

here: Defending Against Biological Terrorism</A> -- For Immediate Release

-- Office of the Press Secretary -- February 5, 2002

" All civilized nations reject as intolerable the use of disease and

biological weapons as instruments of war and terror. "

President W. Bush

November 1, 2001

" The President's Budget for 2003 provides $650 million to carry the process

of enhancing the National Pharmaceutical Stockpile even further through: The

acquisition of the next-generation anthrax vaccine, and the maintenance of

and improvements to the national supply of smallpox vaccine. "

-------------------------------------------------------

IOM (Institute of Medicine) Report endorsing the anthrax vaccine -- again,

the truth is in the fine print:

The IOM report is in conflict with DOD's own critical pre-1997 conclusions

about anthrax vaccine, which are listed at the bottom of this note. DOD has

generated new scientific data to shift the body of evidence on the safety and

efficacy of the vaccine.

It is this contradiction that found many servicemen and women involved in

this dilemma in the first place. The current IOM report only exacerbates

this stark contrast in the scientific record -- essentially a rewrite of

medical history in support of political and bureaucratic inertia, versus

science and fact.

Much relevant testimony questioning the integrity of the scientific reversal

was ignored -- (<A

HREF= " http://www.anthraxvaccine.net/IOMDingle.htm " >http://www.anthraxvaccine.net\

/IOMDingle.htm</A>) -- this research

shows the DOD changed their tune about the vaccine at the exact same time as

the anthrax vaccine program was announced.

Specific evasive language in the report allows the appearance that all is OK,

but in fact acknowledges the less then optimal status of the vaccine:

" AVA should be effective against anthrax toxicity from all known strains ...

AVA is reasonably safe. "

(Refer to the notes at the bottom -- DOD scientists maintained the opposite

view on efficacy, and safety. Simply compare the safety statistics on the

two product labels included in the back of the report -- .2% systemic adverse

reaction rates on the old label increased to up to 35% -- an up to 175 fold

increase -- on the new label. Plus, reported birth defects and deaths are

now on the new label.)

Most important, please note that two years ago the IOM's 30 March 00 letter

to the DOD, which is buried in the back of the report, portrayed a different

scientific story. It stated:

" There is a paucity of published peer-reviewed literature on the safety of

the anthrax vaccine. The committee located only one randomized peer-reviewed

study of the type of anthrax vaccine used in the United States (Brachman et

al., 1962). However, the formulation of the vaccine used in that study

differs from the vaccine currently in use. "

(Ref.: An Assessment of the Safety of the Anthrax Vaccine -- March 30, 2000

<A

HREF= " http://www.nap.edu/html/anthrax_vaccine/ " >http://www.nap.edu/html/anthrax_\

vaccine/</A>)

If the published peer-reviewed literature has changed, it is the result of

data submissions by DOD in the last two years supplementing the scientific

record to make the sum total of the peer reviewed science support the policy,

and the safety and efficacy of the vaccine. This doesn't sound very

scientific, and appears to be the latest post-facto scientific fraud.

-------------------------------------------------------

USA TODAY -- " Anthrax vaccine found safe for troops -- More study needed

before public use " -- the truth is in the double standard, contrary to the

law

<A

HREF= " http://www.usatoday.com/news/nation/2002/03/06/anthrax-vaccine.htm " >Click

here: Anthrax vaccine found safe for troops</A>

" The anthrax vaccine is effective and safe enough to use to protect U.S.

soldiers, says a panel of medical experts. But there are not enough studies

to assure its safety for wide use by the public, and a better vaccine is

needed, according to a report released Wednesday by the Institute of

Medicine. "

(Note -- This statement is an accurate assessment of the IOM's analysis, but

it also defines the ethical dilemma soldiers are engaged in -- i.e., the laws

are no different for soldiers vs. citizens. If the troops receive a vaccine

in a mandatory program that doesn't meet the requirements for use by the

general population, they are by definition being " experimented " upon. We have

laws, executive orders, and DOD directives that deal with these situations,

all which have been violated in the anthrax vaccine program -- 10 USC 1107,

EO 13139, and DOD Directive 6200.2. There is no double standard under the

law unless the President directs one based on an imminent threat or a

national emergency.)

-------------------------------------------------------

News flash: BioPort joined the race for a new anthrax vaccine over one year

ago, while young enlisted men sat in jail over their concerns about the old

anthrax vaccine:

<A HREF= " http://www.lsj.com/news/local/020311_bioport_1a-4a.html " >BioPort

working on new vaccine</A>

The Lansing State Journal reported that the anthrax vaccine manufacturer,

BioPort, has been working on an anthrax vaccine at taxpayer's expense for

over one year. It's also been reported that a modern anthrax vaccine or

nasal application under development by NIH and SAIC could be ready for

clinical trials as early as this summer.

(Note -- that the current anthrax vaccine has also never been employed in a

controlled field trial, which renders it “experimental†under the law.

Federal Register, 13 December 1985 FDA Product Review and Proposed Rule, CFR

620, “The vaccine manufactured by the Michigan Department of Public Health

has not been employed in a controlled field trial. … No meaningful assessment

of its value against inhalation anthrax is possible due to its low incidence.â€

-- Now, even BioPort is joining the race to develop a new vaccine.

Ironically, since BioPort has been funded 100% by the DOD, to include its

renovations over the past few years, it appears that our DOD was funding

their development of a new vaccine, at the same time as young enlisted men

served out their prison sentences for highlighting the problems of the old

vaccine.)

-------------------------------------------------------

Historical Facts and Qoutes to put this issue in perspective:

1. 1985 US Army RFP, " request for proposal " -- In 1985 the Army solicited a

new anthrax vaccine from the biologics industry and candidly discussed the

safety and efficacy of the MDPH vaccine, its high adverse reaction rate, and

its questionable efficacy against different strains of anthrax:

“There is an operational requirement to develop a safe and effective product

which will protect US troops against exposure from virulent strains of

Bacillus anthracis. There is no vaccine in current use which will safely and

effectively protect military personnel against exposure to this hazardous

bacterial agent.â€

“A licensed vaccine against anthrax, which appears to afford some protection

from the disease, is currently available for human use...The vaccine is,

however, highly reactogenic, requires multiple boosters to maintain immunity

and may not be protective against all strains of the anthrax bacillus.â€

(Ref.: Request for Proposals [RFP] No. DAMD 17-85-R-0078, US Army Medical

Research Acquisition Activity, Fort Detrick, Frederick, MD, 16 May 1985)

2. 1985 FDA Federal Register Product Review:

" Anthrax vaccine … efficacy against inhalation anthrax is not well

documented.â€

“The vaccine manufactured by the Michigan Department of Public Health has not

been employed in a controlled field trial. Brachman employed a similar

vaccine prepared by Merck Sharp & Dohme for Fort Detrick in a

placebo-controlled field trial in mills processing imported goat hair. … No

meaningful assessment of its value against inhalation anthrax is possible due

to its low incidence.â€

(Ref.: 13 December 1985 FDA Product Review and Proposed Rule, CFR 620; <A

HREF= " http://www.house.gov/reform/hearings/healthcare/00.10.03/timeline.doc " >

http://www.house.gov/reform/hearings/healthcare/00.10.03/timeline.doc</A>)

3. 1989 -- Office of the Secretary of Defense (OSD) letter to Senator Glenn.

A 1989 letter from then-Assistant Secretary of Defense B. Barker to

Senator Glenn reiterated the safety and efficacy problems with the

vaccine:

“Current vaccines, particularly the anthrax vaccine, do not readily lend

themselves to use in mass troop immunization for a variety of reasons: the

requirement in many cases for multiple immunizations to accomplish protective

immunity, a higher than desirable rate of reactogenicity, and, in some

cases, lack of strong enough efficacy against infection by the aerosol route

of exposure. "

(Ref.: Letter from former Assistant Secretary of Defense B. Barker to

former U.S. Sen. Glenn, chairman of the Senate Governmental Affairs

Committee, 24 Aug 1989, transcript of Senate Hearing 101-744. The letter and

quotes from Barker to Glenn are on page 474 and 480.)

4. March 1990 -- Army Doctors, Col. (Dr.) Takafuji of the Army Surgeon

General office and Col. (Dr.). Philip K. of Fort Detrick, in an

article titled " Military Immunizations, " describe the anthrax vaccine as a:

“limited use vaccine ... unlicensed experimental vaccine. "

(Note -- This description of the anthrax vaccine by key US Army physicians

means that its use requires informed consent or a Presidential waiver of

informed consent. Yet in the Gulf War and in the current AVIP program DOD

asserts that the vaccine is “FDA-approved†and therefore does not require

informed consent.)

(Ref.: Infectious Disease Clinics of North America, 3/90, p. 156)

5. 1994 -- Senate Report 103-97. In February 1994 MG Blanck (later

Army Surgeon General) acknowledged a possible link between the anthrax

vaccine and Gulf war Illness to Congressional investigators:

“Although anthrax vaccine had been considered approved prior to the Persian

Gulf War, it was rarely used. Therefore, its safety, particularly when

given to thousands of soldiers in conjunction with other vaccines, is not

well established. Anthrax vaccine should continue to be considered as a

potential cause for undiagnosed illnesses in Persian Gulf military personnel

.... because many of the support troops received anthrax vaccine, and because

the DOD believes that the incidence of undiagnosed illnesses in support

troops may be higher than that in combat troops.â€

(Ref.: Maj. Gen. Blanck, Commanding General, Walter Army

Hospital, to Committee staff, 414 Senate Office Bldg., Washington,

DC, 4 Feb 1994, from Senate Report 103-97, 8 DEC 94, page 35.)

The Senate Veterans Affairs Committee concluded in their DEC 1994 report:

“Records of anthrax vaccinations are not suitable to evaluate

safety...However, the vaccine's effectiveness against inhaled anthrax is

unknown. Unfortunately, when anthrax is used as a biological weapon, it is

likely to be aerosolized and thus inhaled. Therefore, the efficacy of the

vaccine against biological warfare is unknown. … The vaccine should therefore

be considered investigational when used as a protection against biological

warfare.â€

(Ref.: Senate Veterans Affairs Committee staff report 103-97, 414

Senate Office Bldg., Washington, DC, 4 Feb 1994, from Senate Report 103-97, 8

DEC 94, Note 61-63.)

6. 1994 and 1999 -- Medical textbook Vaccines: In 1994, Col. (Dr.) Arthur

Friedlander, the Army's chief anthrax vaccine researcher at Ft. Detrick,

co-authored a chapter on the anthrax vaccine in a medical textbook,

" Vaccines, " and acknowledged the shortcomings of the vaccine used for AVIP,

including its high reactogenicity:

“The current vaccine against anthrax is unsatisfactory for several reasons.

The vaccine is composed of an undefined crude culture of supernatant adsorbed

to aluminum hydroxide. There has been no quantification of the protective

antigen content of the vaccine or of any of the other constituents, so the

degree of purity is unknown. Standardization is determined by an animal

potency test. The undefined nature of the vaccine and the presence of

constituents that may be undesirable may account for the level of

reactogenicity observed. The vaccine is also less than optimal in that six

doses are required over 18 months, followed by annual boosters. There is

also evidence in experimental animals that the vaccine may be less effective

against some strains of anthrax. Clearly a vaccine that is completely

defined, that is less reactogenic, and that requires on or two doses to

produce long-lasting immunity would be highly desirable.â€

(Ref.: A.M. Friedlander and P.S. Brachman, " Vaccines, " ed. Plotkin and

Mortimer, 1994 edition chapter 26, pg. 737)

7. 1995 -- SAIC Corporation contracted to develop an Army plan to obtain FDA

approval for a license amendment to include aerosolized anthrax exposure. In

September 1995 the Army contracted SAIC Corporation to submit a plan to the

Army that would enable them to obtain FDA licensure of the vaccine for

inhalation anthrax. SAIC's plan clearly identified the legal status of the

vaccine -- which inferred a substantial informed consent obstacle for DOD

unless scientific tests were developed to satisfy federal regulatory

requirements pertaining to the safety and efficacy of the vaccine:

“This vaccine is not licensed for aerosol exposure expected in a biological

warfare environment.â€

(Ref.: SAIC Corporation plan, 29 Sep 1995, enclosure to memorandum from Dr.

-Winegar -- US Army -- to Dr. Myers [MDPH], US Army

Medical Research and Material Command, Fort Detrick, Frederick, MD, 5 Oct

1995.)

8. 1996 IND (Investigational New Drug) Application submitted by MBPI, the

anthrax vaccine manufacturer, to obtain inhalation anthrax approval. This IND

application is still pending with the FDA.

IND Summary: The IND application was submitted following an Army, Joint

Staff, and OSD staff process in which there was concurrence that it was

necessary to obtain FDA approval of a new licensed indication for inhalation

anthrax before DOD could start mass anthrax vaccinations.

(Ref.: LTC Danley, " Minutes of the Meeting on Changing the Food and

Drug Administration License for the Michigan Department of Public Health

Anthrax Vaccine to Meet Military Requirements, " held on 20 Oct 1995 meeting;

Joint Program Office for Biological Defense memorandum, 13 Nov 1995.)

That consensus was reversed within a month of Mr. Cohen being confirmed as

SecDef, following DOD pressure on FDA to give permission to begin use of the

anthrax vaccine for inhalation anthrax without obtaining a new licensed

indication or completing the scientific investigation proposed by the Army in

the IND application.

(Ref.: Dr. C. ph, DoD ASD/Health Affairs, letter to FDA Lead

Deputy Commissioner Friedman, 4 Mar 1997)

9. 1993 - 1999 FDA inspections: DOD and the Army have long been aware of the

anthrax vaccine's significant shortcomings, and the FDA began its reporting

of problems with a series of inspections in the post-Gulf War era that

continue to this day. According to the GAO, the FDA did not inspect the

anthrax vaccine manufacturing facility from 1970 when the vaccine was

licensed until 1993. Both the former and current anthrax vaccine production

facility have consistently failed FDA inspections with " significant

deviations " from current good manufacturing practices (CGMPs) required by FDA

regulations on the following inspection dates:

· May 4 - May 7, 1993

· May 31- June 3, 1994

· April 24 - May 5, 1995

· Nov 18 - Nov 27, 1997

· Feb 4 - Feb 20, 1998

· Nov 15 - Nov 23, 1999 (current facility)

Before the announcement of the AVIP policy, FDA had communicated the

seriousness of these deficiencies to the manufacturer (MDPH, MBPI and

Bioport) and to the US Army in:

· An FDA letter dated 22 DEC 1993.

· An FDA Warning Letter dated 31 Aug 1995

· An FDA Notice of Intent to Revoke (NOIR) MBPI's license dated 11 Mar

1997.

· 20 Feb 1998 FDA inspection report begins: “The manufacturing process

for Anthrax Vaccine is not validated. "

(Ref.: FDA/CBER Office of Compliance and Biologics Quality, inspections of

Bioport)

10. 3 April 2000 Congressional Report – After multiple Congressional

hearings concerning the AVIP controversy, the full Committee on Government

Reform adopts the National Security Subcommittee report, " Unproven Force

Protection, " recommending suspension of the experimental anthrax program.

· House Government Reform Committee Findings:

" AVIP is a well-intentioned but over-broad response to the anthrax ...

represents a doctrinal departure over emphasizing the role of medical

intervention ... vulnerable to supply shortages ... logistically too complex

to succeed. ... Safety of the vaccine is not being monitored adequately. ...

Efficacy of the vaccine against biological warfare is uncertain. "

· House Government Reform Committee Recommendations:

" The force-wide, mandatory AVIP should be suspended until DOD obtains approval

for use of an improved vaccine. To accomplish this: DOD should accelerate

research and testing on a second-generation, recombinant anthrax vaccine;

and, ... a shorter anthrax inoculation regimen; and, ... enroll all anthrax

vaccine recipients in a comprehensive clinical evaluation and treatment

program for long term study.... While an improved vaccine is being developed,

use of the current anthrax vaccine for force protection against biological

warfare should be considered experimental and undertaken only pursuant to FDA

regulations governing investigational testing for a new indication. "

(Ref.: House Committee on Government Reform, " Unproven Force Protection, " 17

Feb 2000 <A

HREF= " http://www.house.gov/reform/ns/reports/anthrax1.pdf " >http://www.house.gov/\

reform/ns/reports/anthrax1.pdf</A>)

Process analysis of the Anthrax Vaccine Immunization Program,

approved for posting by the Office of the Secretary of the Air Force:

<A

HREF= " http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html " >http://w\

ww.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html</A>