Oral Presentation

Barbara Loe Fisher

Co-founder & President

National Vaccine Information Center

September 10, 2003

Subcommittee on Human Rights and Wellness

U.S. House Government Reform Committee

U.S. House of Representatives, Washington, D.C.

"The SV40 Virus: Has Tainted Polio Vaccine Caused An Increase in
Cancer?"

My name is Barbara Loe Fisher and I am the mother of a DPT-vaccine
injured son and the co-founder and president of the National Vaccine
Information Center. I have spent the last 21 years working with other
parents to prevent vaccine injuries and deaths through public education
and defending the right to exercise informed consent to vaccination.
(Coulter HL, Fisher BL. 1985. *DPT: A* *Shot in the Dark*. New York:
Harcourt Brace Jovanovich.; [Attachment 1]{.underline} -- Allen A. May
6, 2001. A Shot in the Dark. *New York Times Magazine*; Konrad W. and
Ginsburg EH. June-July 2000. Who's Calling the Shots? *Offspring
Magazine.*)

The shocking story you are 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 are dying from
cancerous tumors that contain a monkey virus which appears to have
contaminated that polio vaccine. At the heart of this tragic story is a
violation of the public trust and the informed consent ethic. It is a
story about what happens when the legal and moral duty for industry and
government to insure that a vaccine will not harm individuals is
sacrificed to insure acceptance and mass use of a vaccine by the entire
population. It shows what can happen when Congress, which has oversight
authority over federal health agencies, blindly trusts and fails to
verify.

I began speaking and writing about monkey virus contamination of polio
vaccines ten 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. ([Attachment 2]{.underline}: Kyle, W.S. 1992. Simian
retroviruses, poliovaccine, and origin of AIDS. *The Lancet* 339:
600-601.) Between 1994 and 1997 I submitted several Freedom of
Information Act (FOIA) requests to the government regarding testing of
certain lots of oral polio vaccine for monkey virus contamination
([Attachment 3]{.underline} -- Correspondence between BL Fisher and FDA)
During the course of my research I discovered that it was well known
that the first polio vaccine produced in the 1950's -- the inactivated
polio vaccine created by Jonas Salk -- was made using rhesus monkeys
that were infected with a monkey virus called simian virus 40 or SV40.

It was in 1960 that an 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 SV40 or simian virus 40, the
40^th^ monkey virus to be discovered. (Shorter, e. 1987. *The Health
Century)*

Sadly, the American people were not told the truth about this in 1960.
The SV40 contaminated stocks of Salk polio 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.

Between 1955 and early 1963, nearly 100 million American children had
been given polio vaccine contaminated with the monkey virus, SV40.
(Institute of Medicine, National Academy of Sciences . 2002.
*Immunization Safety Review*: *SV40 Contamination of Polio Vaccine and
Cancer*. Washington, D.C.: National Academy Press)

Today, U.S. federal health agencies admit the following two facts:

1.  Salk polio vaccine released for public use between 1955 and 1963 was
    contaminated with SV40; and

2.  SV40 has been proven to cause cancer in animals.

In fact, at a conference on SV-40 and human cancers held by the National
Institutes of Health in 1997, which I attended, there was no
disagreement among both government and non-government scientists about
these two facts. The only disagreement was whether SV40 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. Non-government scientists working in independent labs
around the world said, "Yes." But the scientists connected with the U.S.
government said "No." (Transcript of FDA, CDC, NIH, NIP, NVPO January
27-28, 1997 *Workshop on Simian Virus 40: A Possible* *Human
Polyomavirus*).

Today, there are scientists associated with the US government who
continue to deny that SV40 causes human cancer or that SV40 associated
cancers have had any effect on cancer rates since the early 1960's.
However, highly credentialed non-government scientists in multiple labs
around the world continue to identify SV40 in human brain and lung
cancers of children and adults and are finding that SV40 is also
associated with bone cancers and Non-Hodgkin's Lymphomas. The majority
of these independent scientists have concluded that, yes, SV40 does
cause human cancers. ([Attachment 4]{.underline} -- Gazdar AE, Butel JS,
Carbone M. 2002. SV40 and human tumours: myth, association or
causality*?* *Nature* 2: 957-964)

And in a report published in 2001, the Institute of Medicine
Immunization Safety Review Committee stated that "in light of the
biological evidence supporting the theory that SV40 contamination of
polio vaccines could contribute to human cancers, the Committee
recommends continued public health attention in the form of policy
analysis, communication and targeted biological research."

Up until this hearing today, the world scientific community has assumed
that the only polio vaccine that was contaminated with SV40 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 oral 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 SV40 infected rhesus monkey kidney
tissues, after 1963 the oral polio vaccine was made using African Green
monkeys, which are rarely infected with SV40. The vaccine manufacturer
and government officials have insisted that the switch from rhesus
monkey to African Green as well as testing protocols to detect SV40
prevented SV40 from contaminating oral polio vaccine after 1963.
([Attachment 5]{.underline}: Statement of Bonnie Brock, Lederle, at Jan.
27-28, 1997 Workshop on SV40, transcript pages 300-307).

However, you will be presented with evidence today that suggests
([Attachment]{.underline} [6]{.underline}: Kops SP. 2000. Oral polio
vaccine and human cancer: a reassessment of SV40 as a contaminant based
upon legal documents. *Anticancer Research* 20: 4745-4749. and Oral
Testimony, Stanley Kops, Esq. Subcommittee on Human Rights and Wellness,
US Government Reform Committee, September 10, 2003):

1.  the original seed stocks of oral polio vaccine were made using the
    rhesus monkey and were contaminated with SV40;

2.  the major oral polio vaccine manufacturer did not adequately test
    their master seed stocks which reportedly contained SV40 but used
    them to produce vaccine released for use by American children from
    the 1960's through the 1990's;

3.  Federal regulatory agencies either did not know or knew and did not
    do anything about evidence that SV40 contaminated oral polio vaccine
    was released for use by the public from the 1960's through the
    1990's;

If SV40 contaminated rhesus monkeys were used to produce original oral
polio vaccine seed 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 SV40 does cause human brain, lung and bone cancers, then
this could explain why children today, who were not born before 1963 and
never got the SV40 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 SV40 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 didn't enforce the rules?

Since 1999, the US has discontinued use of the live oral polio vaccine
and American children are now getting a killed polio vaccine that is
reportedly SV40 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 a cancer causing monkey virus, and that the vaccine manufacturer
knew it, and that government health agencies looked the other way?

It is important because if it is 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 insure that the
vaccines do not contain animal viruses or other contaminants.

Drugs and vaccines are very different. Drugs are used to cure sick
people while vaccines are required by law in this country to be given to
healthy people, primarily children. The standards for proof of safety
and efficacy of vaccines should be higher than for any other
pharmaceutical product we use.

I have just ended a four 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 government.

However, 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 insure the safety of vaccines are good enough.
([Attachment 7]{.underline}: National investigative news reports,
including Wechsler P. November 11, 1996. A Shot in the Dark. *New York
Magazine.*; Rock, A. December 1996: The Lethal Dangers of the Billion
Dollar Vaccine Business. *Money Magazine.;* Bookchin D, Schumacher J.
June 1997. The Lonely Crusade of Walter Kyle. *Boston Magazine;*
Bookchin D., Schumacher J. February 2000: The Virus and the Vaccine.
*Atlantic Monthly Magazine.)*

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; 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
use of cancer cells to produce vaccines since 1954 but active
consideration is being given now to lift that ban despite the
acknowledged risks of contamination with adventitious agents, including
residual DNA and RNA. .(Attachment 8: Excerpt from November 19, 1998 FDA
Vaccines and Related Biological Products Advisory Committee meeting,
transcript pages 29-52).

There is frank admission that the limitations of technology and lack of
scientific knowledge means there can be no guarantee the vaccines will
not be contaminated with substances that could prove harmful to humans
one day. Nevertheless, there are plans to set allowable threshholds for
adventitious agent contamination of vaccines being made out of cancer
cells that would contain residual DNA and RNA. ([Attachment
9]{.underline}: Excerpts from May 12, 2000 FDA Vaccines and Related
Biological Products Advisory Committee meeting transcript and
[Attachment 10]{.underline}: Excerpts from May 16, 2001 FDA Vaccines and
Related Biological Products Advisory Committee meeting transcript)

I do not 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 threshholds of adventitious agent contamination.

Past is often prologue. So much can be learned from understanding the
mistakes of the past so that the same mistakes are not made in the
future.

Outstanding questions about the links between vaccines, government
vaccine policies and the epidemic of chronic disease in our children,
including autism, learning disabilities, ADHD, asthma, diabetes and, as
we have discussed today, cancer are not going away. Questions about the
links between vaccines that US military soldiers are required to take,
including anthrax and smallpox vaccines, and the subsequent death or
permanent health problems being suffered by those previously healthy,
young recruits are not going away. They will never go away when the main
defense of industry and government health officials is that when
anything bad happens after vaccination it is just a coincidence. I can
tell you, the American public, especially parents, are not buying it.
And they shouldn't buy it, especially when the kind of evidence that you
will hear today suggests official government and industry denials are
simply a way of avoiding taking responsibility for failing to do
everything they can to minimize the risks of vaccines.

We owe it to our children and grandchildren to do everything we can to
find out the truth about vaccine risks and make the mass vaccination
system as safe as it can be. I believe that can only be done if Congress
exercises more oversight authority over federal health agencies
responsible for vaccine research, development, regulation, policymaking,
promotion and monitoring of vaccine side effects. Conflict of interest
legislation is urgently needed to separate government health agencies
from financial and other ties with the vaccine industry so that
government health officials can be free to do the job they are supposed
to do: protect the health and well being of every American and not
simply protect the vaccine supply. ([Attachment 11]{.underline}:
Investigative news report by UPI reporter Mark Benjamin. July 20, 2003.
*Chicago Sun Times,* *Washington Times*)

Before I conclude, I would like to thank you, Chairman Burton, for all
you have done during the past three years to investigate and bring to
the attention of Congress and the American people the fact that our
nation's mass vaccination system must be reformed to make it safer. You
have had the courage to stand up for those who suffer greatly when a
vaccine's risks turn out to be 100 percent for them or their child and
you have done it against great opposition from powerful special interest
groups with vested interests in protecting the status quo. Your tireless
efforts on behalf of so many will not be in vain because the truth will
shine bright and clear in the end no matter how long it takes.