[Congressional Record (Bound Edition), Volume 145 (1999), Part 12]
[Extensions of Remarks]
[Pages 16645-16648]
[From the U.S. Government Publishing Office, www.gpo.gov]



           HALTING THE ANTHRAX VACCINATION PROGRAM, H.R. 2548

                                 ______
                                 

                        HON. BENJAMIN A. GILMAN

                              of new york

                    in the house of representatives

                         Monday, July 19, 1999

  Mr. GILMAN. Mr. Speaker, I rise today to introduce H.R. 2548, a bill 
to halt the implementation of the Department of Defenses' Anthrax 
Vaccination Program. I urge my colleagues to join me in supporting this 
worthy legislation.
  This legislation would halt the continued implementation of the 
force-wide Anthrax Vaccination Program within the Department of 
Defense. As my colleagues may know, this program was the result of a 
decision reached by the Secretary of Defense early last year that 
mandatory vaccination of all personnel in the U.S. Armed Forces was 
necessary.
  Concerns about the program began shortly after its implementation 
earlier this year and have increased as the number of troops receiving 
the vaccine has increased. These problems attracted the attention of 
the Government Reform Subcommittee on National Security, which 
initiated a series of hearings in March. To date, the subcommittee has 
had three hearings, with a fourth scheduled for this week.
  The congressional hearings held in March, April, and June have raised 
a number of concerns about the vaccination program including

[[Page 16646]]

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, my office, and those of 
many of my colleagues, has received an increasing number of contacts 
from concerned constituents, both members of the Armed Forces, as well 
as their distraught parents or relatives.
  The Secretary of Defense set out four specific conditions that had to 
be met before the vaccination program could start: First, supplemental 
testing to assure sterility, safety, potency, and purity of the vaccine 
stockpile; second, implementation of a system for fully tracking 
anthrax immunizations; third, approval of operational plans to 
administer the vaccine and communications plans to inform military 
personnel; and fourth, 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.
  The most prominent concern raised 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 
from 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. Some 
testing has been done on animals with mixed results, the most promising 
returns coming from laboratory monkeys. However, to assume a drug that 
has achieved moderately successful results in primates will have a 
similar response with humans is only the start of basic research, not a 
definitive conclusion based on solid scientific evidence.
  Moreover, Mr. Speaker, there is no 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 1970's have indicated infection from a combination of 
individual strains.
  A second major 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 recordkeeping after the 
gulf war has made gleaning any useful information about the vaccine's 
effectiveness or harmful side effects impossible. In fact, a Senate 
committee studying gulf war illness in the 103rd Congress did not rule 
out the use of the vaccine as a cause of gulf war syndrome.
  Thus, it is 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 
percent 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. I ask, Mr. 
Speaker, what other force protection program has, as a built-in 
component, such a high casualty rate and unknown level of future risk?

  Questions regarding the safety of the vaccine are appropriate given 
the history of the production of the vaccine. The original manufacturer 
of the vaccine, Michigan Biologics Products Institute (MBPI), 
``voluntarily'' closed down in March 1998, in order to make $1.8 
million renovations. Prior to this, MBPI had been cited repeatedly by 
the FDA for quality control problems and manufacturing violations 
dating back to 1990.
  The subcommittee briefing from the April 29 hearing, stated that the 
vaccine ``is dangerous enough that 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? 
This is a question that needs to be addressed.
  There are additional concerns related 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 I 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.
  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, 
there is evidence suggesting 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 percent and .007 percent this year is 
not reassuring. The subcommittee has 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 1970's swine flu vaccine is far below that of civilian rates. 
Given these qualifiers, it seems the DOD-reported reactions rates 
should, at least, be accompanied by reasonable disclaimers.
  There is also some uncertainty with the operational plans to 
administer the vaccine. There appears to be some confusion with 
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, the subcommittee has heard 
that they are met with delays, instructions to not list the vaccine as 
a reason, and even threats of poor evaluation reports. 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.
  Moreover, 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 Corp. is not due to begin distribution of 
new vaccine until next year, and Guard and Reserve units are currently 
being vaccinated, it appears that DOD has rejected this recommendation.
  Lastly, there are serious reservations 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

[[Page 16647]]

independent review? These are questions that the Secretary of Defense 
needs to answer.
  Mr. Speaker, it bears mentioning that several of our allies have 
taken a different approach to this issue. The United Kingdom has a 
voluntary vaccine policy for anthrax, which yields only an estimated 30 
percent cooperation. The Canadians have faced the similar controversies 
to our program, and even more severe logistics problems with their 
vaccine, and are not currently administering it to their troops. 
Furthermore, it should be noted that Israel, which is conceivably at 
the greatest risk in the middle east and has received Scud attacks, 
does not rely on vaccines, but antibiotics.
  Moreover, our own 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 percent 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 myraid 
of biological threats is not itself a more real threat to our citizens 
in uniform.
  This legislation would accomplish this goal by requiring a suspension 
of the anthrax vaccine program until an independent study by the 
National Institutes of Health is conducted on both the safety and 
effectiveness of the vaccine. This study would review the claim being 
made by the Defense Department concerning both the effectiveness of the 
vaccine against airborne anthrax as well as on the low incidence of 
harmful side effects.

  In addition, the legislation would require a second study by the 
General Accounting Office, on the effect of the vaccination program on 
service morale, focusing specifically on recruiting and retention 
issues in National Guard units.
  Should these studies show that the vaccine is indeed effective 
against weaponized anthrax, is produced in a safe, controlled manner 
acceptable to the FDA, and does not have an unacceptably high systemic 
reaction rate, Congress may authorize the resumption of the program. 
Until these questions are answered however, our service men and women 
should not be subjected to a mandatory vaccination program with so many 
unknowns.
  To allow the program to continue without these concerns being 
addressed, would not only be irresponsible, it would be, for those of 
us in Congress, an abdication of our oversight authority. As it 
currently stands, the anthrax vaccination program simply has too many 
unknowns. It may or may not work as advertised, and in doing so, may 
fulfill the old cliche of the cure being worse than the illness.
  Given that our allies have seen fit to either make their programs 
voluntary, or eliminate them altogether, we owe our men and women in 
uniform a closer look at the effects of our program.
  Accordingly I urge my colleagues to join in support of this measure, 
H.R. 2548.

                               H.R. 2548

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Department of Defense 
     Anthrax Vaccination Moratorium Act''.

     SEC. 2. SENSE OF CONGRESS.

       It is the sense of Congress that--
       (1) a single force protection measure such as the mandatory 
     anthrax vaccine immunization program should not be 
     implemented by the Department of Defense without regard for 
     that measure's own effects on morale, retention, recruiting, 
     and budget; and
       (2) an insufficiently proven vaccine should not be 
     advocated as a substitute for research, development, and 
     production of truly effective vaccines and essential 
     antibiotics, adequate personal protective equipment, 
     detection devices, and nonproliferation measures.

     SEC. 3. MORATORIUM OF VACCINATION PROGRAM.

       The Secretary of Defense shall suspend implementation of 
     the anthrax vaccination program of the Department of Defense. 
     After the date of the enactment of this Act, no further 
     vaccination may be administered under the program to any 
     member of the Armed Forces except in accordance with this 
     Act.

     SEC. 4. STUDY BY NATIONAL INSTITUTES OF HEALTH.

       (a) Study.--
       (1) In general.--The Director of the National Institutes of 
     Health shall require the appropriate national research 
     institute to conduct or oversee an independent study of the 
     effectiveness and safety of the vaccine used in the 
     Department of Defense anthrax vaccination program.
       (2) Matters to be studied.--The Director shall include in 
     the study under paragraph (1) determination of the following 
     with respect to that vaccine:
       (A) Types and severity of adverse reactions.
       (B) Long-term health implications, including interactions 
     with other (existing and planned vaccines and medications.
       (C) Efficacy of the anthrax vaccine for protecting humans 
     against all the strains of anthrax pathogens members of the 
     Armed Forces are likely to encounter.
       (D) Correlation of animal models to safety and 
     effectiveness in humans.
       (E) Validation of the manufacturing process focusing on, 
     but not limited to, discrepancies identified by the Food and 
     Drug Administration in February 1998 (especially with respect 
     to the filter used in the harvest of anthrax vaccine, storage 
     times, and exposure to room temperature).
       (F) Definition of vaccine components in terms of the 
     protective antigen and other bacterial products and 
     constituents.
       (G) Such other matters as are in the judgment of the 
     Director required in order for the Director to make the 
     determinations required by subsection (b).
       (3) Limitation.--The Director may not use for purposes of 
     the study any data arising from the experience of inoculating 
     members of the Armed Forces with the vaccine studied because 
     of the lack of informed consent and inadequate recordkeeping 
     associated with such inoculations.
       (b) Report.--Upon completion of the study, the Director of 
     the National Institutes of Health shall submit to the 
     Committee on Government Reform of the House of 
     Representatives and the Committee on Governmental Affairs of 
     the Senate and to the Secretary of Defense a report setting 
     forth the results of the study. The report shall include the 
     Director's determination, based upon the results of the 
     study, as to each of the following:
       (1) Whether or not the vaccine used in the Department of 
     Defense anthrax vaccination program has an unacceptably high 
     systemic reaction rate.
       (2) Whether or not the vaccine is effective with respect to 
     noncutaneous transfer of anthrax.
       (3) Whether or not the vaccine will be produced in a manner 
     acceptable to the Food and Drug Administration.

     SEC. 5. GENERAL ACCOUNTING OFFICE STUDY.

       (a) In General.--The Comptroller General shall conduct a 
     study of the inoculation program referred to in section 3 and 
     of the effect of the use of contractor-operated facilities 
     for that program. As part of the study, the Comptroller 
     General shall study the following with respect to the 
     inoculation program:
       (1) Effects on military morale, retention, and recruiting.
       (2) Civilian costs and burdens associated with lack of 
     military medical care and loss of civilian sick leave and 
     work capacity for members of the reserve components who 
     experience adverse reactions while not in military status.
       (3) A system of accurately recording medical conditions of 
     members of the Armed Forces and other patients before and 
     after inoculation, including off-duty reactions and treatment 
     of reserve component members and including screening for 
     allergens and contraindication, to include prior adverse 
     reactions.
       (b) Public Comments.--The Comptroller General shall publish 
     the study under subsection (a) for public comment.
       (b) GAO Review.--The Comptroller General shall review the 
     Secretary's written report and provide comments to Congress 
     within 75 days after the Secretary files the report.

     SEC. 6. BOARDS FOR CORRECTION OF MILITARY RECORDS.

       The Secretary of Defense shall direct that the respective 
     Boards for Correction of Military Records of the military 
     departments shall, upon request by individual members or 
     former members of the Armed Forces, expedite consideration of 
     applications for remedies for adverse personnel actions (both 
     voluntary and involuntary) that were a result of the 
     mandatory anthrax vaccine immunization program, to including 
     rescission of administrative discharges and separation, 
     rescission of retirements and transfers, restoration of 
     flying status, back pay and allowances, expunging of negative 
     performance appraisal comment or ratings, and granting of 
     physical disability certificates.

     SEC. 7. CONTINGENT RESUMPTION OF VACCINATION PROGRAM.

       (a) Contingent Authority for Resumption.--If the Director 
     of the National Institutes of Health determines in the report 
     under section 3(b) that the vaccine used in the anthrax 
     vaccination program of the Department of Defense meets each 
     of the criteria stated in subsection (b), the Secretary of 
     Defense may resume the Department of Defense anthrax 
     vaccination program. Any such resumption may not begin until 
     the end of the 90-day period beginning on the date of the 
     submission of the report under section 3(b).
       (b) Criteria for Program Resumption.--the criteria referred 
     to in subsection (a) are the following:

[[Page 16648]]

       (1) That the vaccine used in the Department of Defense 
     anthrax vaccination program does not have an unacceptably 
     high systemic reaction rate.
       (2) That the vaccine is effective with respect to 
     noncutaneous transfer of anthrax.
       (3) That the vaccine will be produced in a manner 
     acceptable to the Food and Drug Administration.
       (e) Requirement for Use of New Vaccine.--If the anthrax 
     vaccination program is resumed under subsection (a), the 
     Secretary of Defense may only use newly produced vaccine for 
     vaccinations after the resumption of the program.

     

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