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Senate Resolution 278--Expressing the Sense of the Senate Regarding the Anthrax and Smallpox Vaccines

[Congressional Record: November 25, 2003 (Senate)]
[Page S16031-S16034]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
[DOCID:cr25no03-131]                         
SENATE RESOLUTION 278--EXPRESSING THE SENSE OF THE SENATE REGARDING THE 
                     ANTHRAX AND SMALLPOX VACCINES
  Mr. BINGAMAN submitted the following resolution; which was referred 
to the Committee on Armed Services:
                              S. Res. 278
       Whereas military personnel are asked to risk and even
      sacrifice their lives and the well-being of their families in 
     defense of the United States;
       Whereas vaccines are an important factor in ensuring force 
     health protection by protecting the military personnel of the 
     United States from both natural health threats and health 
     threats resulting from biological weapons in overseas 
     conflicts;
       Whereas vaccines offer significant benefits and protections 
     that must be carefully balanced with the reality that 
     vaccines and drugs generally carry rare but serious adverse 
     events and life-threatening risks;
       Whereas in 2002, the insert label for the anthrax vaccine 
     required by the Food and Drug Administration was revised to 
     include approximately 40 serious adverse events with 
     information that ``approximately 6 percent of the reported 
     events were listed as serious.'';
       Whereas in 2002, the Food and Drug Administration also 
     compelled the manufacturer of the anthrax vaccine to 
     substantially revise the package insert and changed the risk 
     to pregnant women from Category C (a possible risk) to 
     Category D (a known risk) because of ``positive evidence of 
     human fetal risk based on adverse reaction data from 
     investigational or marketing experience or studies in 
     humans'';
       Whereas in 2002, the General Accounting Office reported 
     ``an estimated 84 percent of the personnel who had had 
     anthrax vaccine shots between September 1998 and September 
     2000 reported having side effects or reactions. This rate is 
     more than double the level cited in the vaccine product 
     insert. Further, about 24 percent of all events were 
     classified as systemic--a level more than a hundred times 
     higher than that estimated in the product insert at the 
     time'';
       Whereas in June 2003, the Advisory Committee on 
     Immunization Practices of the Centers for Disease Control and 
     Prevention withdrew its support for expanding the smallpox 
     vaccination program for first-responders after finding that 1 
     in 500 civilians vaccinated for smallpox had a serious 
     vaccine event;
       Whereas in 2002, the General Accounting Office found that 
     69 percent of experienced pilots and aircrew members in the 
     National Guard and the Reserve reported that the anthrax shot 
     was the major influence in their decision to change their 
     military status in 2000, including leaving the military 
     entirely;
       Whereas in the war in Iraq that continues as of the date of 
     enactment of this resolution, the British and Australian 
     militaries have conducted voluntary anthrax vaccine programs, 
     and other allies who have been offered the anthrax vaccine 
     have declined;
       Whereas in March 2000, the National Institute of Allergy 
     and Infectious Disease reported in the ``Jordan Report 20th 
     Anniversary: Accelerated Development of Vaccines 2000'' that 
     no data existed to support the effectiveness of the anthrax 
     vaccine against pulmonary (inhalation) anthrax in humans;
       Whereas because anthrax can be prevented and treated with 
     antibiotics and other options are either in clinical trials 
     or development, the current anthrax vaccine is not the only 
     choice for force health protection;
       Whereas in the 2002 State of the Union address, President 
     Bush placed a national priority on developing a new anthrax 
     vaccine and a newer and safer smallpox vaccine is also in 
     development; and
       Whereas the threat of anthrax and smallpox attacks against 
     the deployed troops of the United States has significantly 
     diminished since the overthrow of Saddam Hussein and the 
     disruption of Al Qaeda activity in Afghanistan: Now, 
     therefore, be it
       Resolved, That it is the sense of the Senate that--
       (1) the Secretary of Defense should reconsider the 
     mandatory nature of the anthrax and smallpox vaccine 
     immunization program, pending the development of new and 
     better vaccines that are under development as of the date of 
     enactment of this resolution;
       (2) the Secretary of Defense and Board for Correction of 
     Military Records should reconsider adverse actions already 
     taken or intended to be taken against service-members for 
     refusing to accept the anthrax or smallpox vaccine;
       (3) the Secretary of Defense and the intelligence community 
     should reevaluate the threat of anthrax and smallpox attacks 
     on troops in Iraq and Afghanistan to reflect operational 
     realities as of the date of enactment of this resolution when 
     considering the continuation of a mandatory military 
     vaccination program; and
       (4) the Secretary of Veterans Affairs should assess those 
     adverse events being reported with respect to the anthrax and 
     smallpox vaccines, research causal relationships, and 
     estimate a future cost to the Department to treat these 
     conditions.
  Mr. BINGAMAN. Mr. President, throughout the conflict in Iraq, our 
brave soldiers have carried out their duties with strength, with honor, 
and with courage. They have never faltered in their service to this 
nation or the world. That is why I am so troubled that some of our 
service-members and their families believe that current Department of 
Defense policies may be failing them, with grievous consequences.
  That is why I rise today to submit a Sense of the Senate Resolution 
that asks for reconsideration of the policies surrounding the current 
smallpox and anthrax immunization programs. Specifically it asks the 
Secretary of Defense to reconsider the mandatory nature of its smallpox 
and anthrax vaccine immunization programs pending the development of 
new and better vaccines that are currently under development; 
reconsider adverse actions taken against service-members on the basis of 
refusal to take the smallpox or anthrax vaccines; and reevaluate, with 
the intelligence community, the current threat of anthrax and smallpox 
attacks on our troops, in an effort to reflect current operational 
realities when considering the continuation of a mandatory vaccination 
program.
  It also urges the Department of Veterans Affairs to assess these 
adverse events being reported with respect to the smallpox and anthrax 
vaccines, research causal relationships, and estimate a future cost to 
the Department of Veterans Affairs to treat these conditions.
  Vaccines are an important factor in ensuring protection of our 
nation's military personnel from health threats--both natural or from 
biological weapons--in overseas conflicts. However, the current 
smallpox and anthrax vaccines have real and serious consequences that 
must be weighed against the potential benefits. This is why the 
President has made development of a modern anthrax vaccine a national 
priority in his last two State of the Union addresses and why the 
Institute of Medicine urged the government to do so in March 2002.
  What are the consequences of a policy that makes it mandatory that 
military personnel get the anthrax and smallpox vaccines? First, there 
are a growing number of adverse events reported in conjunction with 
these two vaccines, which is in sharp contrast to other vaccines. 
Second, there is a morale problem in the military associated with the 
mandatory nature of requiring military personnel to take these shots 
that has a serious negative impact on the recruitment and retention of 
our military personnel. Third, the long-term consequences of the 
vaccine programs for the health and well-being of our military 
personnel and our veterans is in question and should be addressed.
  Ensuring the health and well-being of our military personnel before, 
during and after serving our country should always be a top priority of 
our nation.
  The major potential benefit of any vaccine would be force protection. 
Unfortunately, there are major questions that arise with this argument 
concerning the anthrax and smallpox vaccines. First, even if there was 
a threat, such a threat against our troops in the conflicts in Iraq and 
Afghanistan has been significantly diminished. Second, there are other 
mechanisms to address any potential exposure, including post-exposure 
vaccination and antibiotics. This was the effective treatment used in 
the Senate after the anthrax exposure in 2001. Third, we do not even 
know if the anthrax vaccine works at all on inhalation anthrax or 
weaponized anthrax, so the vaccine may be completely ineffective 
anyway.
  For our brave men and women serving in harm's way, all too often the 
first threat they face is not when their boots hit the ground in 
Baghdad, Iraq, or Kandahar, Afghanistan--the first threat many 
service-members believe they face may be in line at the home station 
when they receive their anthrax and smallpox vaccinations.
  There is a growing number of disturbing reports about how some of our 
service-members have contracted health problems shortly after receiving 
the anthrax and smallpox vaccines. These illnesses include mysterious 
pneumonia-like illnesses, heart problems, blood clots, and other 
medical conditions that have stricken otherwise young, healthy, and 
strong military personnel. It has even resulted in death.
  This is not entirely surprising, in light of the fact that the Food 
and Drug Administration, or FDA, has identified a number of adverse 
reactions associated with these two vaccines. With respect to the 
anthrax vaccine alone, in 2002 the FDA required the anthrax vaccine 
product label be revised and it now includes approximately 40 serious 
adverse events. As it reads, ``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.'' The FDA also raised the rate of systemic reactions by up 
to 175 times over the previous 1999 product label, from 0.2 percent to 
5-35 percent
  Meanwhile, in light of adverse events that exceed those for other 
vaccines and other concerns about the smallpox vaccine, both the 
Institute of Medicine and the Advisory Committee on Immunization 
Practices recently issued recommendations calling for a pause in the 
Federal Government's smallpox vaccination program.
  Meanwhile, both CBS News and UPI have identified a growing number of 
deaths and severe illnesses that they claim point to the anthrax and smallpox vaccines. 
These include the deaths of Army SP4 Joshua Neusche, Army SGT Michael Tosto,
 LTC Anthony  Sherman, Army SP4 Rachel Lacy, Army SP4 Zeferino Colunga, 
Army SP4 Cory  Hubbell, Army SP4 Levi Kinchen, Army SSG Richard Eaton, Jr., 
Army PVT  Matthew Bush, Army SSG David Loyd, and Army SP4 William Jeffries. Eight 
of these 11 Army personnel were under the age of 25.
  As Dr. Jeffrey Sartin, and infectious disease doctor at the Gundersen 
Clinic in La Crosse, WI, said, ``I would say that the number of cases 
among young healthy troops would seem to be unusual.''
  The numbers of those with adverse health events is significantly 
higher. There have been around 700 adverse events reported in just the 
first 6 months of this year and this is as part of a reporting system 
that has been found to significantly under-report adverse events.
  In addition, there are the reports of problems at both Ft. Stewart 
and Ft. Knox with respect to sick and injured soldiers who have been 
waiting weeks and sometimes months for medical treatment. Senators 
Leahy and Bond should be commended for drawing attention to those 
problems and getting the military to move to address it. What remains 
disturbing is that many of those who are ill and on ``medical hold'' 
were never deployed. At Ft. Stewart, Senators Bond and Leahy found that 
one-third of the 650 soldiers awaiting medical care and follow-up 
evaluations were not physically qualified for deployment and therefore 
never deployed overseas.
  At Ft. Knox, according to a UPI story, 369 of the 422 soldiers at Ft. 
Knox did not deploy to Operation Iraqi Freedom because of their 
illnesses. This includes, according to the story, ``strange clusters of 
heart problems and breathing problems, as did soldiers at Ft. Stewart 
and other locations.'' These are health problems that are often cited 
as adverse events accompanying the anthrax and smallpox vaccines. Once 
again, there is a surprising number of such cases in what are otherwise 
a strong, healthy, and young group of people.
  We certainly do not know whether these cases have been caused by the 
anthrax or smallpox vaccines at this point. In fact, these personnel 
desperately await any medical treatment and that must be addressed. 
While the military works to address that problem, they should also 
reconsider the mandatory nature of the anthrax and smallpox vaccines, 
as they may be contributing heavily to the problem.
  In the case of Army SP4 Rachel Lacy, who loved her country and 
volunteered to deploy to the Persian Gulf, she was ordered to take the 
anthrax vaccine and did so without objection. Within days, she started 
to suffer pneumonia and flu-like symptoms. Within weeks, she was dead. 
The coroner listed ``post-vaccine'' problems on the death certificate 
for Rachel Lacy and said, ``it's just very suspicious in my mind . . . 
that she's healthy, gets the vaccinations and then dies a couple weeks 
later.''
  The Army is, according to published reports, conducting an 
investigation of the 100 or more soldiers that have gotten pneumonia in 
Iraq and southwestern Asia. Of those 100, 2 have died and another 13 
have had to be put on respirators.
  According to a story published in both the New York Times and 
Washington Post on November 19, 2003, as part of that investigation, 
the Advisory Committee on Immunization Practices and the Armed Services 
Epidemiology Board said the evidence ``strongly favors'' the belief 
that vaccines led to the death of Rachel Lacy. It was an important 
admission and yet the military immediately said its vaccination 
policies would ``not be changed.''
  Rachel's father, Moses Lacy, has asked, ``Let's stop this, re-
evaluate what we're doing, re-evaluate the risks.'' That is a 
reasonable request and our nation's service-members and families deserve 
it. We owe it to the Lacy family and to all our military personnel and 
their families.
  As a result of the concerns of service-members and their families that 
these vaccines are having on their health and well-being, it must also 
be noted that the anthrax and smallpox vaccines are having serious 
consequences for our nation's military readiness. In September 2002, 
the General Accounting Office reported that 69 percent of trained and 
experienced pilots and aircrew members in the Guard and Reserve 
reported that the anthrax shot was the major influence in their 
decision to change their military status in 2002, including leaving the 
military entirely.
  Responding to the serious recruitment and retention problems caused 
by the mandatory anthrax vaccine policy, in February 2000, my colleague 
and then Presidential candidate John McCain called for a moratorium of 
this policy. Unfortunately, the safety concerns Senator McCain noted 
then have not been resolved. The military continues to deny problems 
with the vaccine while simultaneously operating a clinic at Walter Reed 
Army Medical Center to treat the illnesses caused by the vaccine.
  Instead of reconsidering its policy, the DOD has, instead, 
aggressively moved against those who have refused the vaccines. After 
his testimony before the House Government Reform Committee, Major 
Sonnie Bates, the highest ranking officer to refuse the anthrax 
vaccination, was charged under article 15 of the Uniform Code of 
Military Justice and the Department of Defense moved to court-martial 
him. After accusations of reprisal came from the Congress, the 
Department of Defense backed down and discharged Major Bates.
  There is also the case of Air Force Captain John Buck, M.D. He was 
court-martialed for refusing the anthrax vaccine in a trial in which 
the judge refused to allow the jury to hear the doctor's views on its 
safety and efficacy. After he was convicted, fined $21,000, and denied 
a promotion he had earned, Dr. Buck deployed to the Indian Ocean after 
September 11th to support U.S. military operations in Afghanistan. He 
was awarded a medal for his service in support of Operation Enduring 
Freedom and subsequently given an honorable discharge.
  In fact, the military has court-martialed soldiers throughout the 
military for refusing the anthrax vaccine, including a case this spring 
in New York of Private Rhonda Hazley who refused the vaccine because 
she was breast-feeding her child. One of the things this resolution 
asks is for the Department of Defense to reconsider adverse actions 
taken against service-members on the basis of refusal to take the 
smallpox or anthrax vaccines. The court-martialing of a woman that 
refused these vaccines because she was breast-feeding is particularly 
disturbing.
  It is important to note that the FDA revised the product label for 
the anthrax vaccine from ``a possible risk'' to a ``known risk'' to 
pregnant women because of ``positive evidence of human fetal risk based 
on adverse reaction data from investigational or marketing experience 
or studies in humans.'' While Private Hazley was no longer pregnant, 
the FDA does believe the ``pregnancy and lactation are a clinical 
continuum.'' Once again, the risks of the vaccine would appear to far 
outweigh the benefit to a mother and mechanic in the Army.
  The DOD's actions in such cases have created a climate of distrust 
and fear within the ranks of the military. This comply or be discharged 
or prosecuted policy is of great concern to our brave young men and 
women in uniform, and in the case of Private Hazley, to her child. 
Again, due to this policy, many soldiers, sailors, airmen and marines 
to reevaluate their commitment to the military.
  The military has argued that we need a mandatory program with respect 
to our nation's military personnel as part of ensuring force 
protection. However, I understand that our allies--both the British and 
Australians--have not made the anthrax vaccines mandatory in the Iraqi 
Freedom Operation. As those two nations weighed the potential 
consequences of requiring all military personnel to get the vaccines 
versus any potential benefit, they came down on the side of making the 
vaccine voluntary.
  In the case of the British military, more than half the armed forces 
personnel deployed in the Gulf have refused to be vaccinated against 
anthrax. The British Ministry of Defense spokesman said that this 
policy would remain voluntary ``in accordance with
long-standing medical practice.'' Of interest, British army units that 
would be responsible for dealing with suspect chemical and biological 
sites are given the smallpox vaccine but still are not required to get 
the anthrax vaccine.
  For those that have agreed to accept the anthrax vaccine among 
British troops, they are reporting a large number of adverse events. 
According to a report by the British National Gulf Veterans and 
Families' Association, they anticipate adverse reaction among ``at 
least 6,000 new cases as a result of the Iraq conflict--about 30 
percent of the 22,000 troops who had the anthrax vaccination.''
  In addition to the policy of our allies that military personnel 
should be able to make their own decisions regarding the anthrax 
vaccine, another reason they have made the vaccine voluntary is that we 
do not even know whether the anthrax vaccine is effective against 
inhalation or weaponized anthrax.
  Furthermore, even if we had truly thought there was strong evidence 
that the Iraqi government had and was preparing to use biological 
weapons such as anthrax against the United States military, the report 
by Weapons Inspector David Kay in September indicates that threat has 
been found to be lacking or non-existent. There appears to be little 
evidence available that Al Qaeda or Saddam have the capability to 
deliver anthrax or smallpox against our troops in Iraq or Afghanistan. 
Even if there was such a threat, it is likely extremely small at this 
point. Again, if nothing else, this change in the threat to our troops 
requires an immediate reevaluation of DOD vaccination policy.
  Even if you still think there is some potential benefit of these 
vaccinations, it must be further weighed against whether there is 
another mechanism available that would have the same effect. We in the 
Senate, for example, know very well that the treatment of anthrax 
exposure via antibiotics works very well. The Senate was faced with the 
choice of having those exposed undergo a course of antibiotics versus 
getting the anthrax vaccine and the vast majority of those exposed to 
anthrax choose to take the antibiotic treatment rather than volunteer 
to take the anthrax vaccine.
  In fact, the current Majority Leader, Senator Frist, said at the time 
the anthrax vaccine was offered to Senate employees potentially exposed 
to anthrax, ``I do not recommend widespread inoculation for people with 
the vaccine in the Hart Building. There are too many side effects and 
if there is limited chance of exposure the side effects would far 
outweigh any potential advantage.''
  Again, in weighing the potential benefit of the vaccine versus the 
option of antibiotics, the vast majority decided in support of the 
latter option. Our military personnel certainly deserve the option that 
many Senate personnel chose for themselves and what it seems the 
Secretary of Defense chose for himself when he acknowledged on October 
25, 2001--in the midst of the anthrax attacks--that he was not taking 
the anthrax vaccine.
  When the President was running for our Nation's highest office, he 
said with respect to questions posed to him in the September 2000 issue 
of U.S. Medicine, ``The Defense Department's Anthrax Immunization 
Program has raised numerous health concerns and caused fear among the 
individuals whose lives it touches. I don't feel the current 
administration's anthrax immunization program has taken into account 
the effect of this program on the soldiers in our military and their 
families. Under my administration, soldiers and their families will be 
taken into consideration.''
  Some of our nation's service-members and their families believe that 
the current policy of this Administration does not adequately take 
soldiers and their families into consideration. They believe we are, in 
fact, failing to ensure the health and well-being of our military 
personnel and we must do better.
  Before closing, I would like to particularly note the long-standing 
work by Congressman Christopher Shays on this issue. In a report issued 
by the House Committee on Government Reform in April 2000, the report 
states, ``many members of the armed services do not share that faith 
[that the DOD places in the anthrax vaccine]. They do not believe 
merely suggestive evidence of vaccine efficacy outweighs their concerns 
over the lack of evidence of long term vaccine safety. Nor do they 
trust DOD has learned the lessons of part military medical mistakes: 
atomic testing, Agent Orange, Persian Gulf war drugs, and vaccines. 
Heavy handed, one-sided informational materials only fuel suspicions 
the program understates adverse reaction risks in order to magnify the 
relative, admittedly marginal, benefits of the vaccine.''
  Many of the findings by Congressman Shays, such as the concerns by 
military service-members are even more valid today with the introduction 
of the smallpox vaccine to the list of vaccines required by the 
military.
  Consequently, I urge the passage of this Sense of the Senate urging 
the Department of Defense to reconsider the mandatory nature of its 
smallpox and anthrax vaccination programs and to minimize the use of 
these vaccines pending the current development of new and better 
vaccines.
  I also plan to introduce legislation early next year, as the 
Institute of Medicine recommended back in 1999, to establish a National 
Center for Military Deployment Health Research. Our nation's 
service-members deserve our best efforts to assure their health and 
well-being. As the IOM said in making the recommendation to establish a 
National Center for Military Deployment Health Research, ``Veterans' 
organizations were instrumental in developing the idea for a national 
center for the study of war-related illness and post deployment health 
issues, and these organizations continue to support the national center 
concept.'' We owe this to our nation's service-members and veterans and 
I look forward to working with them over the coming months in the 
development of that long-needed legislation.

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