[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

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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

                              ----------                              


                     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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