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.