[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
THE SV-40 VIRUS: HAS TAINTED POLIO VACCINE CAUSED AN INCREASE IN CANCER
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 10, 2003
__________
Serial No. 108-85
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2004
91-047 PDF
For Sale by the Superintendent of Documents, U.S. Government Printing Office
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
JOHN SULLIVAN, Oklahoma C.A. ``DUTCH'' RUPPERSBERGER,
NATHAN DEAL, Georgia Maryland
CANDICE S. MILLER, Michigan ELEANOR HOLMES NORTON, District of
TIM MURPHY, Pennsylvania Columbia
MICHAEL R. TURNER, Ohio JIM COOPER, Tennessee
JOHN R. CARTER, Texas CHRIS BELL, Texas
WILLIAM J. JANKLOW, South Dakota ------
MARSHA BLACKBURN, Tennessee BERNARD SANDERS, Vermont
(Independent)
Peter Sirh, Staff Director
Melissa Wojciak, Deputy Staff Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Philip M. Schiliro, Minority Staff Director
Subcommittee on Human Rights and Wellness
DAN BURTON, Indiana, Chairman
CHRIS CANNON, Utah DIANE E. WATSON, California
CHRISTOPHER SHAYS, Connecticut BERNARD SANDERS, Vermont
ILEANA ROS-LEHTINEN, Florida (Independent)
ELIJAH E. CUMMINGS, Maryland
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
Mark Walker, Staff Director
John Rowe, Professional Staff Member
Mindi Walker, Clerk
Sarah Despres, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on September 10, 2003............................... 1
Statement of:
Fisher, Barbara Loe, president, National Vaccine Information
Center; Eileen Grabinski, mother of an injured child;
Stanley P. Kops, esq., attorney at law; and Adi Gazdar,
Ph.D., University of Texas Southwestern Oncology, Hamon
Center for Therapeutic Oncology............................ 35
Goedert, Dr. James, Chief of Viral Epidemiology, National
Cancer Institute, accompanied by Dr. Eric A. Engels........ 6
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 4
Fisher, Barbara Loe, president, National Vaccine Information
Center, prepared statement of.............................. 39
Gazdar, Adi, Ph.D., University of Texas Southwestern
Oncology, Hamon Center for Therapeutic Oncology, prepared
statement of............................................... 72
Goedert, Dr. James, Chief of Viral Epidemiology, National
Cancer Institute, prepared statement of.................... 9
Kops, Stanley P., esq., attorney at law, prepared statement
of......................................................... 53
THE SV-40 VIRUS: HAS TAINTED POLIO VACCINE CAUSED AN INCREASE IN CANCER
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WEDNESDAY, SEPTEMBER 10, 2003
House of Representatives,
Subcommittee on Human Rights and Wellness,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:30 p.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the subcommittee) presiding.
Present: Representatives Burton, Watson, and Cummings.
Staff present: Mark Walker, staff director; John Rowe and
Brian Fauls, professional staff members; Mindi Walker,
professional staff member and clerk; Nick Mutton, press
secretary; Sarah Despres, Tony Haywood, and Jeff Baran,
minority counsels; and Cecelia Morton, minority office manager.
Mr. Burton. Good afternoon. A quorum being present, the
Subcommittee on Human Rights and Wellness will come to order,
and I ask unanimous consent that all Members and witnesses'
written and opening statements be included in the record, and
without objection so ordered. I ask unanimous consent that all
articles, exhibits and extraneous or tabular material referred
to be included in the record, and without objection so ordered.
And we may have some other Members that may want to come. I
don't know. We have invited them who are interested in the
vaccination issue. If they come I ask unanimous consent that
they be allowed to participate and we'll enumerate them as they
come assuming they are here.
Immunization to protect people from infectious diseases was
one of the greatest public health advances of the 20th century.
I don't think anybody argues with the fact that it's made us
the luckiest people in the world as far as health is concerned.
However, immunization is a very different medical procedure
than treating an active disease or injury. Immunizations
introduce a potentially disease causing agent into a healthy
body and all experts agree that no immunization is without
risks.
This is a situation where government policy overrides
individual rights. With very few exceptions, immunizations are
mandatory. Infants and young children have absolutely no choice
in the matter and their parents rarely have a choice.
Government mandates require vaccination before admission to day
care, school or college. Just last week, here in Washington
nearly 10,000 children were turned away on the first day of
school because their immunization records were not up to date.
They couldn't go to class until they got their shots.
Those in military service get another battery of shots.
When freedom of choice conflicts with government edicts, the
government nearly always prevails. Because immunizations are
mandatory, government agencies at all levels have a duty to
exercise the utmost care in the approval, administration and
post administration surveillance of vaccines. In fact, the
Public Health Act of 1902 imposed a duty upon the Public Health
Service to, ``ensure the safety, purity and potency of
vaccines.'' ``Ensure'' is a very strong word. However, doing
anything less is a breach of the public trust and could destroy
the public's confidence in vaccines.
The development of the polio vaccines in the 1950's and
early 1960's was especially welcome because of the devastating
toll of death, disability and suffering that polio caused. I
can remember my mother wouldn't let me go outside, was worried
about flies getting in water that might infect you. And I
remember those horrible, horrible machines that children had to
live in for the rest of their lives. It was just tragic. So the
polio vaccine really was beneficial to mankind as well as U.S.
citizens.
However, some parents and a growing number of scientists
now believe that the government did not ensure the purity,
potency, and safety of some of the polio vaccines and that a
breach of the public trust did in fact occur. There is no
dispute that millions of Americans received polio vaccines that
were contaminated with the virus called Simian Virus 40, or SV-
40. There also is no dispute that SV-40 is capable of causing
cancer, but there is a major dispute as to how many Americans
may have received the contaminated vaccine, with estimates
ranging from 4 million to 100 million people. There is also a
major dispute as to when the polio vaccine supply got cleaned
up. In addition, nobody knows how many people got sick or died
because of the contaminated vaccines.
This subcommittee's efforts to give a full and fair hearing
to this important issue today are somewhat impaired by the lack
of participation by some key Federal health agencies. The Food
and Drug Administration informed our staff that they were
having trouble locating FDA staff with sufficient knowledge to
be of much help and that they needed more time to study it.
They promised to submit a statement for the record within the
next 2 weeks. Well, we'll anxiously watch for their statement
and we will give the appropriate FDA personnel the opportunity
to appear before this subcommittee down the road when those
things have been located.
The Centers for Disease Control and Prevention indicated
that they don't keep records on things that happened 40 or 50
years ago and that they could not be very helpful. That in and
of itself raises a serious question in my mind. We're not
talking about the common cold here. We are talking about polio,
the most devastating epidemic of the first half of the 20th
century. We're talking about tainted vaccines that were given
to millions of American children and young adults, and I think
the FDA and CDC need to look a little harder for their records.
The National Cancer Institute has sent a representative in
the person of Dr. James Goedert. Did I pronounce that right?
Dr. Goedert. Goedert. The 'o' is silent.
Mr. Burton. OK. We thank you, Doctor, for your appearing
and we thank your agency for sending you to testify today. I
also want to thank the other witnesses that are here to testify
and I look forward to hearing your testimony. And I understand
Dr. Engels is here with you. We appreciate you coming, Doctor,
and we will accept testimony and answers of questions from you
as well. And I want to thank the other witnesses who are here
and look forward to hearing their testimony.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. Would you gentlemen please raise your right
hands and stand?
[Witnesses sworn.]
Mr. Burton. Doctor, we'll start with you. Dr. Goedert. Go
ahead, Doctor. And we would like to keep our testimony as much
as possible to 5 minutes because we want to get on with
questions and we may have more votes.
STATEMENT OF DR. JAMES GOEDERT, CHIEF OF VIRAL EPIDEMIOLOGY,
NATIONAL CANCER INSTITUTE, ACCOMPANIED BY DR. ERIC A. ENGELS
Dr. Goedert. Mr. Chairman, I appreciate the opportunity to
appear before you. My name is James Goedert. I'm a physician, a
graduate of Loyola University Medical Center, in Maywood, IL,
with training and board certification in internal medicine and
medical oncology. Like everyone here, I have seen suffering and
death from cancer, including close family members. To reduce
suffering and death from cancer I have dedicated my
professional career, over 23 years with the National Cancer
Institute at the National Institutes of Health, conducting
research on the causes and prevention of cancer.
Today we consider two related but scientifically distinct
questions: Is cancer associated with the inadvertent
contamination of the early polio vaccines with SV-40, and do
people with cancer have evidence of SV-40 infection
irrespective of the source? We have and continue to take both
questions seriously. Our current Division Director, Dr. Joseph
Fraumeni, immediately recognized the potential impact of polio
virus contamination with SV-40. In 1963 he studied and found no
difference in cancer risk associated with the use of the
contaminated vaccine. As you know, cancer, can take years to
develop so this study could not be the final word.
During the ensuing 40 years, we and many others have
continued to study populations exposed to SV-40 contaminated
vaccines, including children, the offspring of women vaccinated
during pregnancy, military servicemen and the population of
Denmark. Though some of these studies are ongoing, one point is
clear. They have consistently found that recipients of SV-40
contaminated vaccines do not have an increased risk of cancer.
Turning to the second question of SV-40 in people
irrespective of the source, the reported detection of SV-40 DNA
in two types of brain cancer in children and in mesothelioma
and osteosarcoma tissue prompted us to initiate laboratory
studies. In 48 mesotheliomas from the archives of the Armed
Forces Institute of Pathology we found no SV-40 DNA despite the
use of two laboratory methods, each able to detect 10 or fewer
molecules of SV-40 DNA. Other highly experienced laboratories
also did not detect SV-40 DNA in mesothelioma. Still others
were detecting SV-40 DNA in a wide variety of tumors and at the
same time at extraordinarily high rates in normal blood and
tissue samples.
It should be noted that our studies and those of others use
the PCR technique, a very powerful method for detecting minute
amounts of DNA, but one also prone to false positive results if
handling procedures and negative controls are lacking.
To clarify the disparate results we and our colleagues at
the Food and Drug Administration organized an international SV-
40 working group, including laboratories that had previously
detected SV-40, some that had not and some that were new to the
field. Fundamental to the international working group study was
the development of the study protocol that is included in our
written materials. This protocol is the end product of
extensive in-depth face-to-face discussions and correspondence.
All of the participating laboratories and other collaborating
units contributed to the development of its specification.
Three results from the international working group study
are of note. First, the PCR assays were highly sensitive and
specific in SV-40 positive and negative control specimens
respectively. Second, SV-40 DNA was detected reproducibly in
zero of 25 fresh frozen, optimally handled mesothelioma
tissues. Third, despite what were thought to be adequate
safeguards SV-40 DNA contaminated a batch of normal cells in
one laboratory and SV-40 DNA contaminated the PCR reagents in a
second laboratory. These events illustrate the ease with which
a few DNA SV-40 DNA molecules can creep into an experiment and
be detected by PCR.
The bottom line of the international working group study is
that the SV-40 PCR tests worked well but there was no
reproducible detection of SV-40 DNA in mesothelioma. We also
evaluated the possibility that SV-40 is circulating in people
without cancer. In 166 urine samples from men in Washington,
DC, or New York City we compared the prevalence of the two
human polyoma viruses, called BK virus and JC virus, to the
prevalence of SV-40. We found that 14 percent of these men were
excreting BK virus, 34 percent were excreting JC virus and not
one was excreting SV-40. Even in people with advanced HIV/AIDS
we found no excretion of SV-40. This work and other studies
would indicate that SV-40 does not circulate in the general
population today.
Our results should be considered in the context of the
report of the Immunization Safety Review Committee of the
National Academy of Sciences Institute of Medicine [IOM], as
included in our written materials. This is as prestigious a
body of scientists as can be assembled. Our approaches and
findings are wholly consistent with the IOM's conclusions and
recommendations which we endorse. IOM concluded, ``that the
evidence is inadequate to accept or reject a causal
relationship between SV-40 containing polio vaccines and
cancer.'' The IOM had five research recommendations that are
provided in our written materials and that I will gladly
discuss.
To conclude, we remain committed to identifying the causes
of cancer. If SV-40 was found to cause human cancer tests could
be developed, people could be screened and perhaps even
treatments could be improved. However, our work and that of
excellent research centers in the United States and Europe
currently reveals no association between SV-40 and cancer in
people. We do not consider the matter settled, as new
technologies could afford new insights. Irrespective of new
technology, future studies must adhere strictly to tightly
reasoned, stringently defined research protocols. We invite
others to replicate the international working group study,
including successful masking and sufficient numbers and types
of positive and negative controls.
In sum, on the basis of the available data we do not have
evidence that SV-40 causes human cancer. Only through rigorous,
disciplined and transparent science will we find the insight
and the means to prevent and relieve the suffering of the
cancers being considered by the committee today.
That concludes my statement. I'll be pleased to answer any
questions.
[The prepared statement of Dr. Goedert follows:]
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Mr. Burton. Thank you, Dr. Goedert. And, Doctor, can we
just rely on you for the answering of questions unless you have
something----
Dr. Engels. Yes.
Mr. Burton. OK. Thank you. When did government health
agencies first discover that SV-40 was in the polio vaccine
supply?
Dr. Goedert. The virus itself was discovered in 1960. And
in 1961, Dr. Eddy detected an occurrence of cancer in rodents
that were injected with the vaccine preparation.
Mr. Burton. Hamsters I think, wasn't it?
Dr. Goedert. Newborn hamsters.
Mr. Burton. You're saying that there's no proof that the
SV-40 that was in those vaccines has caused cancer? Is that
what you're saying?
Dr. Goedert. I'm saying that the issue remains open because
essentially the criteria for causality certainly have not been
fulfilled in terms of reproducibility, specificity and many
other criteria, so I think it remains an open question.
Mr. Burton. You know we've had some real problems with the
FDA and other agencies in the past because there's been concern
that there's too much influence exerted by pharmaceutical
companies on our health agencies, and I'm not saying that's the
case with you, Doctor, but it's real troubling because 60
laboratories I understand around the world have done testing
and said that the SV-40 is a cause of cancer, and I can't
understand how 60 laboratories could be wrong and the FDA be
correct.
Can you explain it to me? And these are not fly by nights.
These are some leading scientists. Let me give you just a few
names, OK? Dr. Carbone. He said that they found SV-40 in a
large portion of tumors. Some of the percentages were 60, 63
and 41 percents in three tests. Dr. Cristaudo. He found cancer
in--or SV-40 in 72 and 52 percent of the cancers in two tests.
Dr. DeLuca. He found 86 percent. Dr. Mayall found 45 percent.
However, Dr. Strickler, I guess he worked for you at one time
and is now a consultant or does consulting with the FDA, or
does he have some relationship with the FDA now?
Dr. Goedert. I'm unfamiliar with him.
Mr. Burton. Who's he with now? Albert Einstein Institute.
Does he do any contracting or anything with you?
Dr. Goedert. Dr. Strickler is a former postdoctoral fellow
from my branch who is a--I believe an assistant professor at
Albert Einstein College of Medicine in New York, and we have
until recently collaborated with him on a number of projects
subsequent to his departure from our group.
Mr. Burton. Yes, sir. Well, Dr. Strickler evidently has
done some research on this, and he showed that in 1996 there
was no evidence that the SV-40 was in any tumors and was the
cause of these cancers. And in 2001 he said the same thing.
Now, how do you account for the fact that your scientist, he
was working for you I think at the time, couldn't find any
trace of SV-40 tumors when eminent scientists that I just
mentioned to you and many others from 60 different laboratories
around the world found many cases of its existence? Why is
there that inconsistency? Scientists look at, you know, a lot
of the same data. I mean your scientist says no and 60 other
laboratories say yes and eminent doctors from those
laboratories that have done extensive research say yes. Why
that inconsistency?
Dr. Goedert. Mr. Chairman, I think reasonable people can
disagree, and I'm sure that each individual believes in his or
her own data. But the data are contradictory and the field is
unsettled. There are 11 studies like ours that find no SV-40.
There are four serological; that is, antibody, studies that
find no difference between people with cancer and people
without cancer. The studies that have found SV-40, not all of
them, but many lack the controls and the maskings of specimens
that we require to have confidence in our results. Some of the
others are internally inconsistent and contradictory and they
typically have not been replicated. I mentioned during my
opening statement that our own study with nine laboratories had
two instances, two events where SV-40 contamination occurred. I
think this is the most likely but not the sole explanation for
why SV-40 may be detected but not actually related to the
tumor.
Mr. Burton. You know, sometimes our health agencies and
even the executive branch and other areas come before our
committee and they have what I call selective memory loss or
they use terminology that equivocates on an issue, and I know
you don't want to do that doctor, but I do want to read
something to you.
The institute, the NCI, reassured the medical community
over the years that there was no evidence of cancer caused by
contaminated polio vaccine. However, in referring to study
after study, the Institute of Medicine report of October 2002,
just last year, said, ``weaknesses in the study limit its
contribution to the causality argument.''
Were the National Cancer Institute's reassurances over the
years that polio vaccine did not cause cancer linked to these
now discredited studies?
Dr. Goedert. Mr. Chairman, the Institute of Medicine
concluded that the data are inconclusive with respect to
causality, taking into account all of the available
information. Epidemiologic studies are not perfect and it would
be more challenging if we had found an association with cancer
in a study that was less than ideal.
Mr. Burton. Well, the IOM says that there were weaknesses
in the study and it limited its contribution to the causality
argument. Now that you know that study has been partial--and
those studies have been partially discredited, what is our
health agency going to do to try to fix the problem and is
there any new research methods that you guys are proposing over
there that wouldn't be inherently flawed?
Dr. Goedert. Mr. Chairman, no single study is going to be
perfect. We endorse and are following through with the
recommendations of the IOM panel. The first recommendation, and
we agree it's the most important, is the development of the
serological tests that can more clearly define who is likely to
be infected and uninfected with this virus. We are working with
two university groups on this effort and are following through
with the application of a number of different studies.
That said, we have always maintained that the question
remains open and we do not say that there is no chance
whatsoever that this virus is associated with cancer. We have
said that there is no evidence of an excess risk of cancer
related to exposure to the contaminated vaccines.
Mr. Burton. Let me ask just a couple more questions and
then I'll yield to you and I'll give you as much time as you
like. Eminent doctors, three tests by Dr. Carbone, 60, 63
percent and 41 percent of the cancers they looked at had the
SV-40; 72 and 50 percent by Dr. Cristaudo; 86 percent by Dr.
DeLuca; 45 percent by Dr. Mayall. The IOM report of October
2002 indicates that the biological evidence is strong, strong,
that SV-40 is a transforming virus capable of causing cancer.
Does the NCI agree with that?
Dr. Goedert. Yes, Mr. Chairman, we do. In animals and in
test experiments.
Mr. Burton. In animals?
Dr. Goedert. In hamsters.
Mr. Burton. In hamsters.
Dr. Goedert. Sure.
Mr. Burton. Does the NCI consider a human being an animal?
Dr. Goedert. Mr. Chairman, I'm sorry. Maybe I misunderstood
your question.
Mr. Burton. Well, you said in animals they found that there
was a causality.
Dr. Goedert. I believe the conclusion----
Mr. Burton. In hamsters you said.
Dr. Goedert. I'm sorry, Mr. Chairman. I'm losing it.
Mr. Burton. No, you said in hamsters that the evidence was
strong that the SV-40 was a cause of tumors, and you said in
animals. You said the tests in animals. You were being generic
instead of saying hamsters. You said tests in animals.
Dr. Goedert. Well, I believe that it's not 100 percent
limited to hamsters. I believe there was some lesser evidence
in other rodents.
Mr. Burton. Other rodents. OK. But you're talking about
animals. Or rodents.
Dr. Goedert. Yes, sir.
Mr. Burton. Are human beings animals? Are we considered
animals biologically?
Dr. Goedert. Mr. Chairman, I think that perhaps gets into a
little bit of a philosophical question.
Mr. Burton. Well, I'm talking about from a biological
standpoint. The point I'm trying to make is this. If it causes
tumors and cancers in rodents and hamsters, if you have other
eminent scientists around the world saying that it causes
tumors and cancers in human beings, if 60 well known
laboratories around the world say that they have scientific
evidence that caused cancers and the only one that we know that
is saying that no, it didn't, there's no evidence of it, is Dr.
Strickler, who used to work for you, that would lead one to
believe that there's something wrong. Either the same tests
aren't being utilized by our health agencies, or else they're
not looking at it fairly.
Dr. Goedert. Mr. Chairman, there are 11 studies that have
found no SV-40 in those tumors. There are four studies that
found no difference in antibody between people with cancer and
people without cancer, and the nine laboratories in our
studies, none of those were government laboratories, and
several of those had previously detected SV-40 and were unable
to do so when they met our stringent criteria with respect to
the blinding of the specimens and the reproducibility.
Mr. Burton. Well, let me yield to Ms. Watson and I'll get
back to you in a minute.
Ms. Watson. Thank you so much, Mr. Chairman. Mr. Chairman,
immunizations against infectious disease is undoubtedly one of
the greatest achievements of our public health. As a result of
universal immunization, many diseases that just decades ago
threatened sickness, disability and death to large segments of
the world's population are no longer serious threats to the
public health. Polio is among the greatest examples. Polio
primarily affects children under the age of 3 and results in
the paralysis of the limbs and/or the respiratory system.
Today, because of immunizations, we are on the verge of
global polio eradication. Just seven nations remain polio
endemic, with 99 percent of the cases occurring in India,
Nigeria and Pakistan. Only funding shortfalls for the World
Health Organization's polio eradication initiation stand in the
way of global eradication.
Because of the importance of immunization, it is critical
that the safety of our vaccine supply be protected against
contamination, whether deliberate or inadvertent. With respect
to SV-40 contamination of polio vaccines, the Federal health
agencies maintain that SV-40 has not appeared in either
intravenous or polio vaccine after 1963. Because the vaccine in
current use is free of SV-40, the Institute of Medicine in a
report released last fall stated that it does not recommend a
policy review of polio vaccine on the basis of concerns about
cancer risk for exposure to SV-40. Our hearts go out to the
victims of cancer and their families who have reasons to
believe that SV-40 may have contributed to cancer in their
cases, and it is important that we learn as much as we can
about the risk of SV-40, sources of human exposure to SV-40,
and all biological factors that contributed to development of
cancer in humans.
What should not get lost in this discussion today is how
vitally important it is that all children and adults receive
the vaccinations they need to protect them from the serious
health consequences of infectious disease. According to the
Centers for Disease Control and Prevention, just 65.5 percent
of U.S. children ages 19 to 35 months of age receive all of the
vaccinations they should. Numerous States lag well behind the
national average.
Maintaining the public's trust in the safety and
effectiveness of vaccine is a necessary and important objective
that requires vigilance by our Federal health agencies. It is
unfortunate that we will not hear from the FDA and the CDC and
the Institute of Medicine today. Nevertheless, I hope that
today's hearing will play a constructive role in the effort to
ensure that the public health benefits of immunization can
fully be realized and that vaccines are as safe and effective
as they can be.
I must apologize for missing the first part of the
testimony. But I am concerned about the discussion I've been
part of. And that is we have a section of the scientific
community saying that SV-40 can contribute to the onset of
cancer and we have a segment of the scientific community saying
there's no data that concludes that. What I would like to know,
Doctor, what steps do you see needed to be taken to implement a
research agenda that could prove one way or the other? I think
we need to take it out of the realm of guessing and continuing
to use it if there is speculation that it is cancer,
contributing to the onset of cancer. And the tests that have
been taken and that you have noted, were these tests adequate
in your opinion? And can they ensure all the public that polio
vaccine is free of SV-40?
So can you address what is needed down the pike and how we
can ensure the public?
Dr. Goedert. Madam Congresswoman, as I said in my opening
remarks, there's two related but scientifically distinct
questions. One has to do with the risk of cancer in people who
received contaminated polio virus vaccine, and the other is the
association of cancer in people with SV-40 with cancer
irrespective of how they may have gotten it.
You're posing a third question which has to do with the
safety of the current polio virus vaccines. The FDA would be
the people most qualified to answer that. I can tell you
information that I have from my preparations here is that since
1963 every lot of vaccine has been tested and certified as free
of SV-40 and containing no viable SV-40. In addition, using PCR
technology, the FDA itself found no SV-40 DNA molecules in lots
that were released between 1972 and 1996. Comparable data have
been developed by the FDA equivalent in the United Kingdom and
in fact even by Dr. Carbone himself, who the chairman mentioned
earlier was unable to detect SV-40 DNA in the current lots, at
least current as of when they did them, probably the late
1990's, were unable to detect any trace of SV-40 DNA in those
vaccine lots.
With respect to the research agenda, would you like me to
address that?
Ms. Watson. Yes, I would, because I'm hearing conflicting
information. The Chair read off a group of scientists who came
to a different conclusion than the one that you just
reiterated. I possibly would like to see a collaborative
effort. And so do you have any suggestions as to how we could
get on a research agenda where we could combine findings and
come to some final conclusion?
Dr. Goedert. Madam Congresswoman, our nine laboratory study
which we initiated with the FDA and brought together all of the
scientists who had an interest in this field in January 1997
was the--resulted as this SV-40 international working group in
which nine laboratories participated, some who had previously
detected SV-40, some who had not and some laboratories that
were new to the field. This was a very tightly structured
endeavor, highly collaborative and some were very unhappy with
the result in that those who had previously detected SV-40 were
unable to do so in the study that they collaborated in and that
we all collaborated in.
We endorsed the research recommendations of the IOM, of
which there were five. The second of those has to do with
development of sensitive specific and standardized tests for
detection of SV-40 DNA. SV-40 DNA PCR is a highly powerful but
difficult to standardize procedure and similar issues came up
with other PCR assays with previous agents, be it hepatitis C
or HIV and the like. The first recommendation was actually this
antibody test kind of thing, and we endorse that and we are
working with other university laboratories on that. With those
technologies, I think that the third and fourth and fifth
recommendations can be implemented, which has to do with the
evaluation of people and specimens prior to 1955 to evaluate
current populations in terms of transmission and to advance the
question of the vaccine recipients. And I think the weakness
that the chairman was mentioning has to do with the lack of
perfection. We can be very highly confident with respect to the
exposure of the vaccine recipients, but having a blood test
would be helpful.
Ms. Watson. I'm thinking prospectively, and I know that the
field of science is always evolving, and I would think 1997's
results are not conclusive because we are hearing to the
contrary. So what I would like to hear, and maybe you're not
prepared to even comment, is how could we plan a research
agenda that would use specific serologic tests for SV-40, and
maybe you're not prepared to address that. But I would like to
see us use probing minds because there's too much, as I would
think now, inaccuracies, and too much conflict as it addresses
the results of various studies. And so to take it out of the
realm of speculation and this confusion, I would like to see
you come up with a new research strategy that all of you
collaborate on for 2000 and beyond. Well, let's say 2003 and
beyond.
If you're not ready to respond to that, I can understand,
but I'm throwing out a recommendation. I'm just hearing from
too many people. I understand there are some parents that
either have testified or will testify and I think as scientists
we ought to continue to research so that we could once and for
all make conclusions that will hold.
Thank you, Mr. Chairman.
Mr. Burton. Let me just followup. What I would like to do
because we're going to be running short of time. We're going to
have more votes. Could we submit to you questions for the
record to be answered by you and sent back so we can review
them?
Dr. Goedert. Certainly.
Mr. Burton. OK. Well, then we'll do that. Let me just ask,
followup on what the Congresswoman just said. You know, there
were 60 laboratories that conducted tests that showed a
contrary result. We have scientists around the world, eminent
scientists that disagree with the results that you folks base
your findings on, and many of these scientists are every bit as
eminent if not more eminent than Dr. Strickler--is it Strickler
or Stricker? Stricker I guess it is--who as I stated earlier
was working for you. When you're following up on what
Representative Watson suggested, would it be possible for you
to contact those scientific laboratories and those scientists
who had contrary results to take a look at their findings to
find out if there's something that you missed, and we would be
very happy to give you the names of those laboratories as well
as the scientists involved so that you wouldn't rely just on
what you folks found, but also what these other laboratories
and eminent scientists found. Would you be willing to do that?
Dr. Goedert. Certainly, Mr. Chairman. The nine laboratory
study that we did included laboratories, the preeminent ones
that had previously found positive results. They did not when
they----
Mr. Burton. You said nine. There were 60. How come you
didn't talk to the other 51?
Dr. Goedert. Well, some--I'll be happy to if you send me
the names of the other ones.
Mr. Burton. We'll send that to you.
And the other things I'd just like to conclude with is that
many Congressmen and Congresswomen--and I'm not speaking for
Congresswoman Watson, I'm speaking for myself--are a little bit
suspicious of some of the results of tests and other things
that we've seen coming out of FDA and HHS, and I'm not pointing
this at you, Doctor, or Doctors. But we have seen the results
that came back that show results that are unbelievable. And
we've been stonewalled on other issues where there might be
lawsuits filed against pharmaceutical companies that have had
research projects that have worked with, I think, with our
health agencies. And so we're just a little bit suspicious of
those things. That's why when we hear these results, and I hope
you--if you wouldn't mind, I hope you'll stick around a little
bit and hear some of the information from these parents and
other scientists. I think Dr. Gazdar is here, I think he's
going to testify. I think he was on the other side of this
issue at one time. I wish you could just listen to what they
have to say and maybe that would illuminate the issue a little
bit more and maybe help in getting to the bottom of this.
Dr. Goedert. I'll be happy to do whatever I can.
Mr. Burton. Thank you sir, very much. Any other comments?
Ms. Watson. Just before you step away from this panel I
would just like to thank you for being here, and I want all of
you to keep your minds open and I think that our environment,
and I'm talking about comprehensive environment, is so full
today with contaminants. It indeed is affecting our health to
the point that there are new mutations and I'm concerned about
this. More people are coming up with cancer, and we must look
at everything that we spray into our environment, that we put
on our soil, that we ingest, that we use intravenously.
And so I don't want closed minds. We can't depend on
research that was done years ago. We must think about our
future and what we might contribute to it. So I would hope that
you would agree just to keep flexible and we certainly
understand and we know the shortfalls of money and we know
where our focus is. But we would support you in coming up with
a strategy for new studies. We will give you guidance and
direction, I'm sure from the standpoint of this committee, as
to what we'd like to see. And we'll even work for the funding.
So blue sky, if you will. I used to say that to bureaucrats.
You know, if you had all that you needed, what would you like?
And I tell you they were in such little tight boxes they
couldn't even--blue sky. So we're giving you such opportunity
with our support to take another look and work in a
collaborative way to save our people and particularly our
children.
Thank you so much.
Mr. Burton. We will get you the names of the laboratories
and the names of these other eminent scientists who have
differing views and hopefully you can followup with them and
cross-check their results with the results you've had and maybe
additional studies, as Representative Watson suggested, would
be done to make sure that we get to the bottom of this. In any
event, I hope you'll stick around just a little bit and hear
what these other folks have to say. It might be illuminating.
Thank you very much.
Our next panel is my good friend Barbara Loe Fisher. She's
the cofounder and president of the National Vaccine Information
Center. Ms Eileen Grabinski, she's the mother of an injured
child. Mr. Stanley Kops, he's an attorney from Pennsylvania,
and Dr. Gazdar, whom I mentioned a few moments ago, who's a
therapeutic oncology professor, I guess professor, at the
University of Texas Southwestern Oncology in Dallas.
Would you all please stand and raise your right hands?
[Witnesses sworn.]
Mr. Burton. As I said to the first panel, because we are
going to have a whole bunch of votes I would like to try to
keep the testimony to 5 minutes for each one of you so we can
get to the questions, which I think might be a little bit more
illuminating, and let's just go right down the line.
OK, we'll start with Ms. Fisher. I don't know what the
reason is for that but evidently you have more influence with
John than anybody else. Go ahead.
STATEMENTS OF BARBARA LOE FISHER, PRESIDENT, NATIONAL VACCINE
INFORMATION CENTER; EILEEN GRABINSKI, MOTHER OF AN INJURED
CHILD; STANLEY P. KOPS, ESQ., ATTORNEY AT LAW; AND ADI GAZDAR,
PH.D., UNIVERSITY OF TEXAS SOUTHWESTERN ONCOLOGY, HAMON CENTER
FOR THERAPEUTIC ONCOLOGY
Ms. Fisher. My name is Barbara Loe Fisher. I'm the mother
of a DPT vaccine injured son and cofounder and president of the
National Vaccine Information Center. I've spent the last 21
years working with other participants to prevent vaccine
injuries and deaths through public education.
The story you're about to hear involves a pharmaceutical
company which used monkeys to make polio vaccine, government
health agencies responsible for making sure the vaccine was not
contaminated with monkey viruses, and individuals who are now
dying from cancerous tumors that contain a monkey virus which
appears to have contaminated that polio vaccine. At the heart
of this story is a violation of the public trust and the
informed consent ethic.
I began speaking and writing about monkey virus
contamination of polio vaccines 10 years ago when questions
were raised in the medical literature about whether the use of
monkeys infected with monkey viruses to produce oral polio
vaccines was responsible for HIV and the AIDS epidemic. Between
1994 and 1997 I submitted several Freedom of Information Act
requests to the government regarding testing of certain lots of
oral polio vaccine for monkey virus contamination. It was in
1960 that a NIH scientist named Bernice Eddy discovered that
rhesus monkey kidney cells used to make the Salk polio vaccine
and experimental oral polio vaccines could cause cancer when
injected into lab animals.
Later that year the cancer causing virus in the rhesus
monkey kidney cells was identified as SV-40, or Simian Virus
40, the 40th monkey virus to be discovered. Sadly, though, the
American people were not told the truth about this in 1960. The
SV-40 contaminated stocks of Salk polo vaccine were never
withdrawn from the market, but continued to be given to
American children until early 1963 with full knowledge of
Federal health agencies.
At a conference on SV-40 and human cancers held by the
National Institutes of Health in 1997 there was no disagreement
among both government and nongovernment scientists about this
fact. The only disagreement was whether SV-40 was actually
being identified in the cancerous tumors of children and adults
alive today and, if it was, whether the monkey virus was in
fact responsible for their cancer. Nongovernment scientists
working in independent labs around the world said yes. But the
scientists connected with the U.S. Government said no.
As you have already pointed out, Mr. Chairman, the
Institute of Medicine and highly credentialed nongovernment
scientists in multiple labs around the world continue to
identify SV-40 in human brain and lung cancers of children and
adults and are finding that SV-40 is also associated with bone
cancers and non-Hodgkins lymphomas. The majority of these
independent scientists have concluded that, yes, SV-40 does
cause human cancers.
Up until this hearing to date the world scientific
community has assumed that the only polio vaccine that was
contaminated with SV-40 and released for use by millions of
Americans was Jonas Salk's killed polio vaccine, which stopped
being used in 1963 because it was replaced by Albert Sabin's
live polio vaccine. Why? Because the oral polio vaccine
manufacturer and Federal health agencies have told everyone
that while the Salk vaccine was made using the SV-40 infected
rhesus monkey kidney tissues after 1963 the oral polio vaccine
was made using African Green monkeys, which are rarely infected
with SV-40. The vaccine manufacturer and government officials
have insisted that the switch from rhesus monkeys to African
Green as well as testing protocols to detect SV-40 prevented
SV-40 from contaminating oral polio vaccine after 1963.
However, you will be presented with evidence today that
suggests, one, the original seed stocks of oral polio vaccine
were made using the rhesus monkey and were contaminated with
SV-40; two, the major oral polio vaccine manufacturer did not
adequately test their master seed stocks which reportedly
contained SV-40 but used them to produce vaccine released for
use by American children from the 1960's through the 1990's;
and, three, Federal regulatory agencies either did not know or
knew and did not do anything about evidence that SV-40
contaminated oral polio vaccine was released for use by the
public from the 1960's to the 1990's.
If SV-40 contaminated rhesus monkeys were used to produce
original oral polio vaccine stocks, and if these seed stocks
were used to produce oral polio vaccine that was swallowed by
American children through the 1990's, and if SV-40 does cause
human brain, lung and bone cancers, then this could explain why
children today, who were not born before 1963 and never got SV-
40 contaminated Salk vaccines, are now sick and dying from
cancerous tumors containing DNA from a monkey virus that was in
those vaccines. Pediatric brain cancer, once rare, rose during
the past few decades, according to the National Cancer
Institute. But we don't know how many of these children had or
have SV-40 in their brain tumors because nobody checks, how
many of these children are sick and dying because the
manufacturer of oral polio vaccine did not follow the rules and
government health agencies did not enforce the rules.
Since 1999, the United States has discontinued use of the
live oral polio vaccine and American children are now getting a
killed vaccine that is reportedly SV-40 free. So why is it
important today to find out whether or not the oral vaccine
used to eradicate polio was in fact contaminated with the
cancer causing monkey virus and that the vaccine manufacturer
knew it and government health agencies looked the other way?
It is important because if it's true, then a precedent has
been set and that precedent may well be affecting decisions
being made by government health agencies today about what kinds
of animal tissue cultures vaccine manufacturers will be allowed
to use to make new vaccines and what kinds of tests will be
required to ensure that the vaccines do not contain animal
viruses or other contaminants.
I've just ended a 4-year term as the consumer voting member
of the FDA Vaccines and Related Biological Products Advisory
Committee. My service on that committee gave me a new
appreciation for the dedicated work of a number of fine
scientists employed by the FDA who take their regulatory duties
very seriously and are working hard to regulate the vaccine
industry with very limited resources and limited support within
and outside of the government. But there are legitimate
concerns which I and others have voiced in the past and
continue to have about whether government standards for
requiring vaccine manufacturers to prove the safety and
efficacy of vaccines are high enough and whether the tests used
by the manufacturers and the government to ensure the safety of
vaccines are good enough.
I urge this committee and other congressional committees to
carefully review the transcripts of meetings of the FDA
Vaccines and Related Biological Products Advisory Committee,
specifically those which were held in 1998, 2000 and 2001 and
dealt with adventitious agent contamination of vaccines.
Vaccine manufacturers are asking the FDA for permission to use
cells from human and animal cancer tumors; that is, cancer
cells, to make HIV and other viral vaccines in the future that
would be used on a mass basis by the American population. There
has been a Federal ban on the use of cancer cells to produce
vaccines since 1954. But active consideration is now being
given to lift that ban despite the acknowledged risks of
contamination with adventitious agents, including residual DNA
and RNA.
There is frank admission that the limitations of technology
and lack of scientific knowledge means there can be no
guarantee that vaccines will not be contaminated with
substances that could prove harmful to humans 1 day.
Nevertheless, there are discussions about creating allowable
thresholds for adventitious agent contamination of vaccines
being made out of cancer cells that could contain residual DNA
and RNA.
I don't think Congress or the public understands any of
this. There should be a much wider discussion in the larger
scientific community outside of Federal health agencies and the
pharmaceutical industry as well as in Congress and by the
public at large before decisions are made to proceed with
producing vaccines that use cancer cells and have legally
allowable thresholds of adventitious agent contamination.
Mr. Burton. Ms. Fisher.
Ms. Fisher. I know. I'll wrap up here.
Mr. Burton. Well, you can submit the rest of it for the
record, but what I'd like to say is that those hearings that
you were a part of----
Ms. Fisher. I was on the committee.
Mr. Burton. I would like for you to give us copies of those
transcripts if you could.
Ms. Fisher. I have.
Mr. Burton. OK. And with that can you submit the rest of it
for the record?
Ms. Fisher. I will. I just would like to thank you Chairman
Burton for everything you've done to hold these hearings in the
past 2 years, so that we can have a safer vaccine system.
[The prepared statement of Ms. Fisher follows:]
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Mr. Burton. Thank you very much.
Ms. Grabinski.
Ms. Grabinski. Hi. How you doing?
Mr. Burton. You have a child that you feel has been damaged
by the vaccine?
Ms. Grabinski. Yes, I do and I brought him with me. He's
sitting in the wheelchair there.
Mr. Burton. Your son's in the wheelchair over there?
Ms. Grabinski. Yes.
Mr. Burton. OK. Thank you. Mark. OK.
Ms. Grabinski. Right. His name is Mark Marino.
Mark was beautiful, healthy baby when he was born. He was
growing up normally the way you would expect any normal child
to grow up. He wasn't any different than my son Joe. He
received routine care that babies get, including his
vaccinations with the oral polio vaccine known as trivalent.
Shortly before Mark's tumor was found by the doctor he was not
acting right and I knew something was wrong.
Marks' tumor turned out to be a rare tumor. His hospital
stays were nightmares every time he had to stay for surgery. We
always had it in our minds he would never come out alive
because the doctors told us it was a rare tumor. Mark had to
have part of his skull removed to save his life, and now he has
to wear a helmet every day for the rest of his life.
When Mark was born and when tests were done to see his
intelligence, they were pretty good but after his operations
they deteriorated and now he has limited ability. This
limitation lasted from age 5 to now. When he was 5 I was told
he was functioning somewhere between 3 and 5 years old. Nothing
has changed since then.
Mark loves to paint, draw and to go out with other people,
but we cannot go out often because he is in danger of having
epileptic occurrence. Since the first surgery Mark has been a
toddler. He never grew up. He rarely participates in family
functions and when he does he has to be constantly supervised.
I try to keep him busy because he's with me 24 hours a day.
He can do simple chores. He can mix the salads for dinner,
sweep the kitchen floor on his knees. He thinks he cleaned the
whole house. He can put away the cans after shopping. He's so
proud of himself after he does the chores it's the biggest
thrill of the day for him. He talks to his stuffed animals.
They are his friends who he can count on being there for him
every day. He takes them almost everywhere he goes.
He watches TV, but only cartoons. In his mind he believes
that 1 day he will be in a cartoon. He gives his painting and
coloring pages to people he meets to show them he loves them
and he thinks they love him also. You know they love him back.
He paints rocks and sea shells or anything that he can paint
gold. The pirates in his cartoons hunt for gold, so he hunts
for gold. The only difference is he gives his gold away.
He says his prayers at night and has a picture of God on
his wall. He knows that God is his friend and the only one who
can help him. And he never loses his faith. He is convinced
that God hears him and will help him. We have to learn every
day how to cope with every aspect of his life.
I have never been bitter about my son's condition until
recently. Because I cannot go out a lot, I spend a lot of time
on the Internet. On one of the Internet searches, I found out
about there was an issue of SV-40 and childhood tumors.
Eventually I found out that Mark's tumorous material was
available at the hospital where he was treated. The materials
were tested, and I was advised that the SV-40 was found in his
tumor. What I thought was an act of God I know now was what--
I'm sorry, I'm a little nervous--I now learned was an act of
man.
I am not a scientist or a lawyer; I'm just a mother, and I
feel cheated and robbed out of my life, my son's life, our
entire family's life by someone who'd use a childhood vaccine
in an unsafe manner and allow my child, along with many other
children, to be exposed to this virus. I can only hope that
Mark's prayers to God will be answered by the scientists and
maybe there is something that can be done to reverse his
condition.
My reason for testifying here today is for two reasons: to
tell the story of my brave son and to ask Congress to do
whatever is necessary to protect children like my son from ever
having to face what he has faced and from what our entire
family has faced.
Thank you.
Mr. Burton. Thank you, Ms. Grabinski. And I don't think
there is anything that we could say that will help the
situation, but you have our prayers and our gratitude for what
you go through.
Ms. Grabinski. Thank you.
Mr. Burton. Mr. Kops.
Mr. Kops. Good afternoon.
I have represented and still represent individuals who have
suffered injuries from the Orimune oral polio vaccine that was
utilized in the United States from 1962 until 1999 when Orimune
vaccine, oral vaccine, could no longer be sold in the United
States for immunizations.
The history of this negligence of both the vaccine
manufacturer and the government can be found in reported
decisions. The Supreme Court in 1988 in a unanimous decision
written by Justice Marshall, found that if the vaccine
manufacturer and/or the regulator failed to look at the test
results and failed to determine what those test results showed,
the government did not have any permission to do so. They did
not have the discretion to avoid that review. In fact, at oral
argument, I believe it was Justice Scalia who asked the
following question of the Solicitor General: Supposing the
government did not make any examination of the application at
all, or any determination other than some papers have been
filed and now we will issue a license; would this comply with
the regulatory system?
Counsel for the government: No, it would not comply with
the regulation.
Question from Justice Scalia, I believe: It would violate a
mandatory duty wouldn't it?
Counsel: In that extreme instance you are talking about, it
would definitely violate the regulations.
That could be found both in the transcript of oral argument
and at footnote 10 to the opinion.
What I am here to testify today is that's exactly what
happened. They did not look, the regulators, and the vaccine
manufacturer did not submit test results. This is a white-and-
black situation. Either the test results exist and they can be
produced, or they do not exist because they were either not
performed or performed and the results were so horrendous that
they would rather not submit the test results than submit those
that prove the exact points that this committee is
investigating.
There are three types of wild polio. Therefore, there was a
need to create three different vaccines. The IPV, the killed
vaccine, was always a trivalent product. As to the oral polio
vaccine, they were first made as individual monovalent pools
and then later combined as a trivalent vaccine.
Between 1964 and 1967, a single manufacturer in this
country, Wyeth-Lederle had 84 percent of this market. In 1977
it had 100 percent of the market. Up until today, no scientist
has had the complete data to challenge the assertions made by
scientists and by the vaccine manufacturer. In fact, I heard
today in the testimony of the head of the NIH cancer
epidemiology session that all vaccines after 1963 did not
contain SV-40. That is just wrong. They did contain SV-40
because there are test results that I have, which now the
committee has, that show the positive vacuolating agent in
released product. Those were the test results that were shown
to the IOM, the Institutes of Medicine.
I have been lucky to have had the honor to represent people
like Eileen and Mark and others, and during that representation
when it was only about polio, I was given the actual test
results of various products which show that they were positive
for SV-40. You could see that in exhibit 21. The use of Rhesus
monkeys, something that this vaccine manufacturer guaranteed
the entire scientific world that it never used in manufacture,
is in fact exactly what they used.
If you look at exhibit No. 11, there is a released
monovalent pool of this manufacturer. It shows that the monkeys
utilized were Rhesus. It shows in a subsequent exhibit, No. 13,
that on January 15, 1990, American Cyanamid requested from the
regulators permission to release five monovalent pools, all
made in Rhesus monkeys. The pool numbers 263, 265, 283, 501,
and 509. I see I'm over my time so----
Mr. Burton. Can we get into this a little bit more, Mr.
Kops, in the question section?
Mr. Kops. Certainly.
Mr. Burton. This is a pretty voluminous bit of information
you sent from Lederle Laboratories, and I think we're going to
have to digest this over a period of time, but we have some
questions we'd like to ask you about that.
[The prepared statement of Mr. Kops follows:]
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Mr. Burton. Dr. Gazdar.
Mr. Gazdar. Mr. Chairman, members of the committee, I
welcome this opportunity to address you on the subject of SV-40
contamination of the polio vaccine and the role of the virus in
the causation of human cancers. I've spent more than 35 years
my entire professional life studying the cause of human
cancers. Twenty-three of those years were spent at the National
Cancer Institute.
As you have heard, several reports from laboratories around
the world have demonstrated the presence of footprints of SV-40
virus in a certain select group of human tumors. You've also
heard that approximately 10 percent of these reports have been
negative. The virus has been associated with four types of
human tumors, approximately 40 to 50 percent of these four
types. These four types are brain tumors, bone tumors,
mesotheliomas, and lymphomas. Three of these are very rare or
relatively rare tumors; however the incidence has been
increasing. Of great interest, injection of the virus into
hamsters results in an identical tumor spectrum.
It defies belief that this is a coincidence that three of
these rare tumors are caused by injection of the virus into
hamsters and the same rare tumors in humans have also been
associated with this virus. I estimate from published data that
approximately 113,000 Americans will suffer from these tumors
this year and 64,000 will die from their disease. Thus,
approximately 50,000 tumors that occur in this country this
year will contain evidence of the virus in their tumor tissues.
SV-40 is one of the most potent cancer-causing agents
discovered for human cells. It's--because of--perhaps it's the
most potent transforming agent, cancer-causing agent for human
cells. It is widely used in laboratories, raising the spectrum
that it may--its presence in human tumors is due to laboratory
contamination. I was highly skeptical of the reports, and
finally I decided I had the tools to investigate and, what I
thought, settle the matter.
Using a technique of microsection, taking single glass
slides of tumor and adjacent nonmalignant tissue, I could
selectively remove the tumor cells from that glass slide as
well as the nonmalignant tissues from the very same slide and
analyze these independently. To my amazement, I found the virus
in approximately 50 percent of human mesotheliomas and its
almost complete absence in adjacent nonmalignant tissues. These
experiments, in my opinion, ruled out the possibility of
contamination of laboratory artifact.
I went from a skeptic to a believer. My assessment was
supported by a review conducted by a panel of scientists of the
National Cancer Institute chaired by Dr. Pagano and May Wong.
This panel concluded that it is proven that SV-40 is present in
some human tumors, and it ruled out the possibility that these
were caused by laboratory artifacts. An international meeting
of scientists, 80-odd scientists, held in Chicago in 2001 and
chaired by two eminent scientists who never worked in this
field, came to the same conclusions.
However, the presence of virus in the cancer does not prove
causation because the virus may be an innocent bystander or it
may be one of the causes of the tumor. To link a given agent
with the cancer, one relies on both epidemiology and molecular
tests demonstrating not only the presence of virus but some
effect of it. The epidemiology studies, as you've heard and the
Institute of Medicine has investigated, have been flawed.
They're flawed because we cannot identify in these studies
which subjects receive vaccination in the years under study.
Also, we don't know which batches of virus were contaminated,
whether the batches contained high marks of virus or low marks
of virus.
For these reasons, the Institute of Medicine has declared
that all epidemiology studies have been flawed and, in fact,
suggest that no further epidemiology studies be performed until
these deficiencies can be corrected. They did conclude that the
biological evidence is strong that SV-40 is a cancer-causing
virus and that the biologic evidence is of moderate strength
that SV-40 exposure could lead to cancer in humans under
natural conditions.
Recent molecular studies from my laboratory have
convincingly demonstrated that the virus-positive tumors have
different biologic properties than similar tumors that lack the
virus. These studies I believe demonstrate that the virus is
not just a bystander in these tumors but is having an important
biologic effect, in all likelihood contributing to the
causation of these tumors.
Why have we failed to make greater progress in this field?
Why are we sitting here before this committee arguing whether
this virus plays a role in cancer or not? It is because we have
failed to make--to make progress because of a complete lack of
funding, because of lack of direction from our government
agencies to fund these very important issues.
Never once has the National Cancer Institute and National
Institutes of Health issued a request for proposals that
specifically address these issues. This lack of major funding
has hampered progress and needs to be addressed. And I thank
you for this opportunity.
[The prepared statement of Mr. Gazdar follows:]
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Mr. Burton. You say there's no funding done to followup and
to really study this issue?
Mr. Gazdar. There's been no targeted funding. There's been
a very minimal amount of funding to a handful of investigators.
Mr. Burton. That raises the issue of whether or not the
pharmaceutical companies, Lederle that produced these vaccines
that may have caused these cancers, doesn't want that explored
because of the possible liability that might ensue from
lawsuits. And I think Mr. Kops is probably familiar with that
since you were involved in litigation.
What paper were you talking about there?
There was a study, a paper on the absence of Simian Virus
40 in human brain tumors from northern India and that paper
states, ``Our results do not support a role for SV-40 in human
brain tumors in northern India.'' And as I understand it,
several of the people that supported that study, five of the
co-authors of that paper have disassociated themselves from
that. And is that correct and why would they do that?
Mr. Gazdar. I believe you are perhaps talking about the
study that Dr. Goedert talked about, the multi-lab study.
Those--that----
Mr. Burton. That's not the India study?
Mr. Gazdar. No.
Mr. Burton. Is this the one that Dr. Simpson was involved
in?
Mr. Gazdar. Strickler.
Mr. Burton. Strickler.
Mr. Gazdar. He's been involved--I'm not sure he was
involved in the Indian study. Dr. Engels, who was here, was the
lead author on the Indian study. He can address that issue. But
it's the multi-laboratory study that Dr. Goedert spoke about
which has been attacked as flawed--being highly flawed in both
public and in writing, and several members of that nine-lab
panel have withdrawn their association because they felt----
Mr. Burton. Of the nine people, five have withdrawn their
names as I understand it.
Mr. Gazdar. I'm not sure of the exact number.
Mr. Burton. Dr. Lednicky, Butel, Gisani, Jones, and Gibbs.
Does that happen very often?
Mr. Gazdar. Not to my knowledge.
Mr. Burton. It's highly unusual, isn't it?
Mr. Gazdar. That study took several years to get written up
and published, partly because the members of that committee
could not agree on the study design, how it was carried out, on
the interpretation, etc.
Mr. Burton. But you believed after, Doctor, and you say you
were very skeptical at the outset on whether or not this SV-40
virus was a possible cause of tumors and cancers in people.
Your attitude has changed dramatically since you actually did
all this study yourself?
Mr. Gazdar. That's right. In fact I call myself a skeptic,
but frankly I simply could not believe that a monkey was
suddenly turning up these rare human tumors.
Mr. Burton. But now you believe that it can?
Mr. Gazdar. I am firmly convinced that it not only is that
but it's playing a role in the causation of tumors.
Mr. Burton. It's causing tumors?
Mr. Gazdar. Yes.
Mr. Burton. What do you think we ought to do as a Congress
to deal with this problem if our health agencies continue to
stonewall and say we've had all kinds of tests and nothing
shows up and eminent scientists have said no and there's just
nothing to it? What would you suggest we do?
Mr. Gazdar. I feel you have a part to persuade our
government agencies to take a more proactive role in this issue
and certainly to supply targeted funding to settle the issues.
Three different committees, one convened by the NIH, by the
Institute of Medicine, and this international meeting I
mentioned in Chicago, have all recommended greatly increased
funding to settle not only these issues but to develop new
methodologies so some of our deficiencies can be corrected.
Mr. Burton. Do we have copies of those?
We'll take a look at those and we'll write a letter to our
health leaders urging them to follow that and to do that
funding. But I will tell you I am convinced that our
pharmaceutical companies have undue influence over our health
agencies because of the liability exposure, and you can bet
your bottom dollar that there will be every reason thrown up
against us to try to stop us from getting to the bottom of
this. Because we've had other cases--Ms. Watson and I have had
cases involving mercury in vaccines, and the amount of
opposition that's thrown up because of the possibility of
lawsuits is just phenomenal. But what I'd like to do is have
from you any recommendations that you can make so that we can
submit those to HHS, FDA, and CDC to try to get them to fund
that, and we'll try to keep the pressure on them to make sure
that happens.
Mr. Gazdar. I'll be glad to do that, Mr. Chairman.
Mr. Burton. Mr. Kops, you had a lawsuit that evidently did
not prevail. Can you tell us a little bit about that and what
happened?
Mr. Kops. Yes. That is a lawsuit involving a young boy who
died at the age of 2. Dr. Gazdar testified in that lawsuit
unequivocally that the child died from SV-40. The court had a
hearing to determine whether or not there was evidence,
sufficient evidence given by Dr. John Lednicky, one of the
world famous scientists who is one of the scientists that the
chairman has quoted from, testify that he too was under the
medical certainty that this boy died from SV-40. The problem
was could we prove that the given dose that this child received
from an individual fill was SV-40 contaminated? We proved that
the monovalent harvest were positive, positive for an
adventitious agent. When the drug company reported it to the
government, they said, We know what that adventitious agent is,
it's a phony virus, not SV-40. Of course, they forgot to
produce nine other tests which proved it couldn't possibly have
been a phony agent. But the judge, hearing the arguments made
by the lawyers for the drug company claiming that Dr.
Lednicky's opinion was faulty because he did not do a test on
the same trivalent product, therefore he would not accept his
testimony.
I believe the judge was wrong. The method that this doctor
used, world famous, was the identical method that the drug
company uses to determine the presence or absence of SV-40.
Also, the court failed to take into consideration the fact that
other monovalent pools failed for specifically SV-40 and were
released. The test results show it there, and the product goes
out the door.
Mr. Burton. Can we get a summary of that case from you with
the relevant aspects of it so that we can take a hard look at
that as well?
Mr. Kops. Yes, I will be happy to do so.
Mr. Burton. Ms. Grabinski, I think your testimony was
sufficient, so we won't ask you any questions.
And Ms. Fisher, you and I will talk privately later because
you know we work on this.
Ms. Watson.
Ms. Watson. I just want to associate myself with something
that the Chair said. I'm sitting here right now and I have a
ring on, supposedly gold, and I'm having a reaction in my mouth
because I have mercury amalgams, Mr. Chair, in my mouth and I'm
going through the process of having them removed. It's quite a
long process. I have to go out of the country to have it done,
and I've already made two visits. I have four more to go.
The reason why I mentioned that is because mercury in your
system, I don't care what the ADA says, is a contaminant and
places those who have it at tremendous risk. I am intent on
getting back to the bottom of this thing, and I do have a piece
of legislation that the Chair has so kindly co-sponsored with
me, and we expect to be successful.
I want to continue to take a look at those kinds of toxic
materials, fluids, substances, particles or whatever that we
put into the human body. Now, the question was raised do we
consider ourselves to be animals? Well, biologically,
physiologically, there's an answer to that. We test on animals
and apply those tests to humans. So I am absolutely 100 percent
committed to further research because I do think there is a
connection, Mrs.----
Ms. Grabinski. Grabinski.
Ms. Watson [continuing]. Grabinski, to your son's current
condition and something that went into his system. I see more
and more of that. My background is as a school psychologist. I
had to test youth, and I can tell you we keep a record of
inoculations. We keep a record of those who are in special
education. I tested them to establish an IQ, make
recommendations. So I'm a continuing researcher. I mean I've
been in politics, took a different direction, but I'm hoping to
continue that as we struggle to find the truth.
And so my question to you, Mr. Kops, is as you represent
the parents and the victims, have you been able to establish
legally a course of action that we can take? And I have had
various industries in front of my committee when I was in the
Senate because we found that silicone in breast transplants
indeed were harmful to many women's health. We found also, and
it was in the early 1980's, that the testing on breast cancer
was done on men. How ridiculous. And so there's a continuing
evolution that I mentioned. And so we had to go to court and we
put companies out of business because the jury found on behalf
of the victims. And we had to--we took case law and then we
made it into legislative policies, and I want you to know from
the cases you've had--I want to know from the cases you've had
where do you see us going with this.
Mr. Kops. Well, I've had two different types of cases, one
where the individual received the polio vaccine themselves and
became paralyzed, and where their parents changed a child's
diaper and became paralyzed. Those cases ended up in the
Berkovitz and Sabin cases where the court held that the
regulator did not enforce the regulations and the vaccine
manufacturer, the same one, did not comply with the
regulations.
As to the cancer issue, the problem is that no one has gone
back and looked at the records. I have said in a published
peer-reviewed article that appeared in the year 2000 that there
are no test records. Dr. Engel was at a conference or a hearing
at the IOM and he asked me a question. I was one of the people
who were allowed to present a power point. He said, ``Do you
mean to say that all the epidemiological studies that we have
conducted up to now are flawed?'' I said, ``Absolutely. Just go
back and look at the records. You will see positive proof that
SV-40 was not removed from the seeds, was not removed from the
product, and released product contained the vacuolating agent
SV-40.'' I offered to send Dr. Engels this material after the
hearing.
I can tell you as of this day I have not received a request
from Dr. Engels for that material, but it's now before this
committee, some of it.
Mr. Burton. You know, you hate to point fingers at any
individuals because government service is a real high calling
as far as I'm concerned, and most times they're not paid enough
and they work long hours and they do a lot of work that the
people on the street don't know about. But, you know, when our
health agencies stonewall Members of Congress and keep us from
getting information, it sure raises a lot of questions.
You know, this Dr. Strickler, he--one of the favored labs
that he uses for the tests that he does is funded in large part
and does a lot of work with Merck, Pfizer, and Wyeth, and while
that doesn't apparently look like a conflict of interest, it
certainly does raise some questions.
So, you know, I don't know that we can conclude a lot more
from this hearing today, but what I'd like to do is have our
staff contact you and get as much information as possible and
we will followup on this and we will have more hearings on
this, I promise you, and we will try to get from our health
agencies information that they say does not exist or is hidden
in the archives someplace. And we will be prepared to, if
necessary, issue subpoenas to get that information.
Mr. Kops. Thank you very much, sir.
Mr. Burton. Do you have any final comments before we
adjourn? Any additional information that you have, be sure to
get that to us.
Mr. Kops. I have submitted a written document which
contains much more information and I would ask that it would
become part of the record.
Mr. Burton. Without objection, so ordered.
And we will take a hard look at this and probably get back
to all of you before long.
Mr. Kops. Thank you very much.
Mr. Burton. Thank you very much. We stand adjourned.
[Whereupon, at 4:01 p.m., the subcommittee was adjourned.]
[Additional information submitted for the hearing record
follows:]
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