[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
PREVENTING ANOTHER SV40 TRAGEDY: ARE TODAY'S VACCINE SAFETY PROTOCOLS
EFFECTIVE?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
NOVEMBER 13, 2003
__________
Serial No. 108-127
__________
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
______
92-772 U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2003
____________________________________________________________________________
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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, Chief of Staff
Mindi Walker, Professional Staff Member
Danielle Perraut, Clerk
Richard Butcher, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on November 13, 2003................................ 1
Statement of:
Egan, Dr. William, Acting Director, Office of Vaccines
Research and Review, U.S. Food and Drug Administration; and
Dr. Robert Hoover, Director, Epidemiology and Genetics,
National Cancer Institute, accompanied by Dr. May Wong,
Program Director, Division of Cancer Biology, National
Cancer Institute........................................... 10
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 4
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 61
Egan, Dr. William, Acting Director, Office of Vaccines
Research and Review, U.S. Food and Drug Administration,
prepared statement of...................................... 13
Hoover, Dr. Robert, Director, Epidemiology and Genetics,
National Cancer Institute:
Letter dated January 16, 2004............................ 46
Prepared statement of.................................... 26
PREVENTING ANOTHER SV40 TRAGEDY: ARE TODAY'S VACCINE SAFETY PROTOCOLS
EFFECTIVE?
----------
THURSDAY, NOVEMBER 13, 2003
House of Representatives,
Subcommittee on Human Rights and Wellness,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2 p.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the subcommittee) presiding.
Present: Representatives Burton and Davis.
Staff present: Mark Walker, chief of staff; Mindi Walker
and Brian Fauls, professional staff members; Nick Mutton, press
secretary; Danielle Perraut, clerk; Richard Butcher, minority
counsel; and Jean Gosa, minority assistant clerk.
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. Without objection so ordered.
Today the subcommittee is holding the second in a series of
hearings examining the aftermath of the tragedy of SV40
contamination of America's poliovirus vaccine supply in the
1950's and early 1960's. During the first half of the 20th
century, polio struck down hundreds of thousands of people
leaving many paralyzed, and I knew some of those people, some
in iron lung machines and killing many thousands of others.
The worst year for the disease in the United States was
1952, when more than 57,000 polio cases were reported and at
least 300,000 or 3,000 of those individuals died.
Following the licensure of the Salk polio vaccine in 1955,
the incidence of the disease fell dramatically. The disease was
further reduced by the advent of the Sabin oral polio vaccine
in 1961. In fact, the last cases of paralytic polio from
natural poliovirus in the United States were in 1979 and the
most recent case from outside the United States occurred in
1993. Today polio has virtually been eliminated from the United
States and the entire Western Hemisphere, although it remains a
threat in some developing countries.
There can be little doubt that the invention of the vaccine
immunization to protect children and adults from infectious
diseases, as demonstrated by the success of the anti-polio
campaign, was one of the greatest public health achievements of
the 20th century. Nobody takes issue with that. In fact
immunization as a tool against disease in general has been so
successful that it has now become almost commonplace to use it
against even relative minor diseases such as human influenza.
As a society we have been so confident in the power of
vaccines that we even create government mandates requiring
vaccinations be administered before admitting individuals to
daycare, public schools, college or the military. But what we
perhaps tend to forget is that immunization is very different
than administering a medicine to combat an active illness in a
person. Instead of curing a disease, vaccines instead introduce
a potentially disease causing agent into an otherwise healthy
body in order to stimulate an immune response. Thus, there are
always risks associated with taking any vaccine, and I think
most people realize that.
In some cases vaccines have been known to cause the very
disease they were created to prevent. But the risk can be
greater still. In the earliest days of the polio vaccine
production, laboratory tests were not sophisticated enough to
detect the presence of what became known as Simian Virus 40
[SV40]. At least 26 other Simian contaminants were detected and
eliminated. But SV40 slipped past quality control testing
procedures and into the vaccine pool, potentially infecting
millions of Americans.
Soon after its discovery, scientists also learned that SV40
could cause cancerous tumors in hamsters. So in society's zeal
to combat one disease we as a society potentially risked
exposing millions of Americans to another deadly disease.
As the subcommittee learned at our last SV polio hearing on
September 10th, we are still trying to uncover the true health
impact of the SV40 contaminated polio vaccines. For four
decades Federal Government officials have insisted that there
is no evidence that SV40 is harmful to humans or that polio
vaccines produced after 1963 were contaminated with SV40. But
in recent years dozens of scientific studies have found the
virus in a steadily increasing number of rare brain bone and
lung related tumors, the very same malignant cancers that SV40
caused in lab animals.
The subcommittee's previous hearings in September examined
the intense debate raging within the scientific community
between government scientists who claim that SV40 has had no
effect on the human population and independent researchers from
across the globe who believe SV40 is a human carcinogen.
What the government witnesses testified to at the last
previous subcommittee hearing raised serious concerns about the
National Cancer Institute's handling of research related to the
presence of SV40 in human tumors. The subcommittee subsequently
asked NCI to provide written clarification regarding several
issues of concern to our investigation.
Today we have invited representatives from the NCI to
reappear before the subcommittee in the hope that they might
better explain and clarify the apparent inconsistencies in the
research being supported by the NCI's Division of Cancer
Epidemiology and Genetics regarding the relationship of SV40 to
contaminated polio vaccines. In September we also heard from
Mr. Stanley Kops, a Philadelphia based attorney, regarding
allegations that at least one polio vaccine manufacturer may
have knowingly shipped contaminated vaccine lots after the
FDA's 1961 SV40 screening regime was implemented and that not
only did said manufacturer not submit vaccine safety tests to
the FDA as required, but the FDA regulators failed to hold the
manufacturer responsible for their failure to comply.
In response to these allegations, the subcommittee has
invited representatives from the FDA and several vaccine
manufacturers to present evidence that supports compliance with
safe manufacturing protocols and the assertion that all polio
vaccines have been, are and will continue to be SV40 free.
Regrettably none of the vaccine manufacturing companies chose
to attend today's hearing. And because of the mandatory nature
and risk associated with all human vaccines, government health
agencies have a special duty to exercise the utmost care and
the approval, administration and post-administration
surveillance of vaccines.
The government must always err on the side of caution in
this worthy public health endeavor and to do anything less is a
breach of the public trust.
This subcommittee will continue to pursue the historic
truth in this matter to either reaffirm or, if necessary,
rebuild the public's confidence in vaccines specifically and
our public health service in general.
I look forward to hearing from our witnesses this
afternoon. I think my colleague might have some quick questions
she might like to submit for the record. She is in California
because we are in recess.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. We have the chairman of the full committee with
us. Do you have any questions?
Mr. Tom Davis. No comments.
Mr. Burton. No comments? Thank you.
With that, would the witnesses please stand and be sworn?
Our witnesses today for the record are Dr. William Egan,
Acting Director of the Office of Vaccines Research and Review,
U.S. Food and Drug Administration; Dr. Robert Hoover, Director
of Epidemiology and Biostatistics Program from the Division of
Cancer Epidemiology and Genetics at the National Cancer
Institute. And our other panel I think did not respond. So we
will continue to ask them to be here. And hopefully we will get
them here in the future.
[Witnesses sworn.]
Mr. Burton. Dr. Egan, do you or any of your colleagues have
an opening statement?
Mr. Egan. I do, sir.
Mr. Burton. OK, Dr. Egan, proceed.
STATEMENTS OF DR. WILLIAM EGAN, ACTING DIRECTOR, OFFICE OF
VACCINES RESEARCH AND REVIEW, U.S. FOOD AND DRUG
ADMINISTRATION; AND DR. ROBERT HOOVER, DIRECTOR, EPIDEMIOLOGY
AND GENETICS, NATIONAL CANCER INSTITUTE, ACCOMPANIED BY DR. MAY
WONG, PROGRAM DIRECTOR, DIVISION OF CANCER BIOLOGY, NATIONAL
CANCER INSTITUTE
Mr. Egan. Thank you, Mr. Chairman and members of the
committee. I am William Egan, Acting Director of Vaccines
Research and Review at FDA's Center for Biological Evaluation
and Research. Thank you for the opportunity to testify today.
The availability of vaccines has been one of the most
significant public health achievements of the 20th century.
Many of us can recall the devastation caused by diseases such
as polio in a time when children survived in iron lungs or
walked only with the help of leg braces and crutches. The polio
vaccine and other childhood vaccines have likely saved more
lives and prevented more illnesses than any other medical
intervention.
Unfortunately, a significant number of the early poliovirus
vaccine lots were contaminated with a previously unknown viral
agent designated Simian Virus 40 [SV40]. A tissue culture
procedure to detect SV40 was developed and officials at the
Public Health Service's Division of Biological Standards
notified poliovirus vaccine manufacturers that vaccine lots
would be released for distribution only if test results for
SV40 were negative. This requirement was also codified in
Federal regulations.
Nevertheless, before SV40 was recognized as a problem and
tests were in place, millions were vaccinated with poliovirus
vaccines that contained SV40. Since this unfortunate event 4
decades ago FDA has required that manufacturers perform routine
testing for poliovirus vaccines to demonstrate the absence of
SV40.
Studies in the 1960's showed that SV40 could produce
certain cancers in newborn hamsters. More recent studies
reported finding SV40 genes in several types of human tumors. A
report by the Institute of Medicine, which reviewed this area
last year, concluded, ``The evidence is inadequate to accept or
reject the causal relationship between SV40 containing polio
vaccines and cancers.''
For several reasons, including: Because some researchers
questioned whether the tissue culture tests are sufficiently
sensitive to detect low levels of SV40. FDA researchers
developed a highly sensitive test based on the preliminary
chain reaction technology, or PCR technology, to probe for the
presence of SV40 DNA. When a random sample of oral polio
vaccines manufactured between 1972 and 1996 were tested by this
PCR technology, no SV40 DNA was found in any of the 30 vaccine
model pools or 30 trivalent vaccine samples that were tested.
FDA published these results in 2000.
Like all vaccines, the poliovirus vaccine must meet
stringent standards for safety and effectiveness. Vaccines are
different from most drugs in several respects, and achieving
the highest quality and manufacturing is especially challenging
and critical.
First, vaccines are often produced from or use living cells
and organisms as well as complex growth materials derived from
living sources. Thus, the potential for contamination is higher
than for most drugs, and quality and purity is carefully
monitored.
Second, the production of most vaccines requires growing
and purifying the immunizing agents from living cells. Growth
conditions are complex and subtle changes in materials in the
process itself, in temperature or other conditions can affect
vaccine safety, effectiveness or both.
Third, in light of these differences, we utilize the
mechanism of lot release review to monitor the quality and
potency of the final vaccine before manufacturers can
distribute their product.
Finally, unlike most drugs, which are provided to people to
treat an existing illness, most vaccines are administered to
large numbers of healthy people to prevent infectious disease.
Therefore, even very rare adverse events are a concern and
generally are not viewed as acceptable if they can be
prevented.
With this in mind, FDA's efforts to ensure safety and
effectiveness begin early in the pre-approval process and
continue throughout the post-approval process. As a part of
this process manufacturers must meet the standards established
in FDA regulations, including current good manufacturing
practices [CGMPs].
FDA also uses inspection and surveillance both before and
after granting a license to help assure conformity with current
good manufacturing practices and standards in the
manufacturer's license. Once we license a vaccine, the agency
continues to monitor product safety and effectiveness.
FDA may also perform targeted inspections when, for
example, there are changes to the manufacturing process,
facility or equipment or other significant events.
Finally, when safety concerns arise FDA promptly responds
to address these concerns.
In closing, Mr. Chairman, although scientists have not
reached consensus on the potential risks posed by SV40 and
whether it may
contribute to causing some types of tumors in humans, the one
thing we all agree on is that poliovirus vaccine has provided
an enormous public health benefit and has practically
eradicated this horrible disease.
I am happy to answer your questions. Thank you.
[The prepared statement of Mr. Egan follows:]
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Mr. Burton. Thank you, Dr. Egan.
Dr. Hoover.
Dr. Hoover. I am Robert Hoover, a physician epidemiologist,
currently Director of the Epidemiology and Biostatistics
Program. Accompanying me today is my colleague, Dr. May Wong, a
Program Director from NCI's Division of Biology, and we are
pleased to be here, particularly since NCI has historically
been and continues to be responsible for a substantial
proportion of the research into the role of Simian Virus 40 in
carcinogenesis.
Both my written and oral comments will be brief since NCI
did submit substantial testimony last September.
For several decades the NCI has been supporting research
directed at understanding SV40 carcinogenesis in several areas.
Most of this support has been in the area of laboratory studies
of molecular virology and carcinogenesis, and other efforts
have been focused in epidemiology.
In the past decade multiple investigations from independent
laboratories have identified SV40 in tumor samples, as you
mentioned, from mesotheliomas, brain tumors, osteosarcomas, and
non-Hodgkins lymphoma.
Some research groups have described unique characteristics
of these SV40 DNA sequences and the detection of viral proteins
and tumors, both of which argue against the laboratory
contamination as an explanation. However, when detected, SV40
appears to be present in very low amounts, which has
complicated our understanding of what this detection means.
Additionally, using the same highly sensitive molecular
techniques, other research groups have not detected SV40 in the
same tumor types.
Recognizing some of the difficulties and limitations of
current approaches, the Institute of Medicine recommended the
development of and use of sensitive and specific standardized
techniques for SV40 detection. Meanwhile, those who have found
evidence of SV40 infection in human tumors have also begun the
more difficult task of attempting to discern whether this
infection actually plays a role in the development of these
cancers.
The other line of scientific inquiry is provided by
epidemiologic studies which examine the relationship between
SV40 and exposure or infection and the risk of cancer in human
populations. To date most of these studies have relied on large
population-based cancer registries, such as NCI's SEER program
or the Danish Cancer Registry, to examine the incidence of
cancer in people who had a high probability of receiving SV40
contaminated polio vaccine as children.
Up through the 1990's these studies have failed to detect
evidence of an increased risk of those cancers suggested by the
molecular biology work, indicating that it is unlikely that
there is an epidemic of these cancers that might be attributed
to SV40 contaminated polio vaccine. Nonetheless, as pointed out
by the Institute of Medicine, it has not been possible in these
studies to be certain which individual persons were actually
infected through receipt of contaminated vaccines.
Thus, to answer the question of whether there is any
increased risk and, if so, of what magnitude of cancer from
such exposure will require more epidemiologic research, using
specific data on exposure for individuals. Some attempts have
been made to do this by testing for antibodies to SV40 and
cancer cases and controls. To date these studies have not
indicated an increased risk for those with such antibodies.
However, because of limitations in our current technologies,
these studies cannot be considered definitive. Here again the
development of accurate tests for SV40 infection, in this
instance serologic tests called for by the Institute of
Medicine, will facilitate future epidemiologic research on the
question of whether SV40 causes cancer.
In summary, we agree with the Institute of Medicine that
the evidence is inadequate to accept or reject a causal
relationship between SV40 containing polio vaccines and cancer.
At the moment there is no consensus in the scientific community
on whether SV40 causes cancer in humans. When working at the
cutting edge of science this situation is neither unusual nor
surprising. Different disciplines and different groups using a
variety of approaches and techniques frequently come up with
contrasting results. Indeed, it is in pursuing the scientific
answers for such differences that our knowledge is enhanced and
we are able to move the science forward.
At NCI we are committed to the support and conduct of the
scientific research that will lead to the needed answers. We
are particularly optimistic that improved tools for the
detection of SV40 infection can be developed and thus allow the
power of molecular virology to be combined with the rigor of
the epidemiologic method in addressing these important
questions.
And I would be happy to take your questions.
[The prepared statement of Dr. Hoover follows:]
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Mr. Burton. Thank you very much. Dr. May Wong, do you have
a comment you would like to make?
Dr. Wong. No.
Mr. Burton. OK. Thank you. If you would like to answer--
help answer these questions, we can move that mic back and
forth.
We have had a number of parents before my committee over
the last 4 or 5 years whose children had medulla blastoma and
died, and many of those feel that SV40 could have been the
culprit, could have been passed on through the parent to the
child. We had one case where the father, I think, ultimately
died as well of cancer. So those things are kind of heart
rending. That's one of the reasons why we are very aggressive
in trying to get the answers to these questions.
We also have a former employee of one of our government
research agencies that provided an awful lot of information on
this. I am not at liberty to give his name out right now. But
as you read, I am sure, your agency as you went through the
questions in our letter knew that didn't come out of my brain.
And so we are very anxious to get accurate answers and I know
you want to be as accurate as possible. We don't have a lot of
media here today or anything, but I hope that we will be able
to get as many accurate answers as possible because this is an
issue that, like some of the others we have raised, is not
going to go away, you know, as long as I can hold these
hearings.
Dr. Hoover, you are not specifically an expert on SV40, is
that correct?
Dr. Hoover. That is correct.
Mr. Burton. What is your area of expertise?
Dr. Hoover. Epidemiologic methods. I've studied a variety
of tumors and exposures over my career, applying the
epidemiologic method to that.
Mr. Burton. You're familiar with the subcommittee's recent
exchange and correspondence with the NCI regarding the SV40
research, is that correct?
Dr. Hoover. Yes, I am.
Mr. Burton. Do you have any idea why the National Cancer
Institute did not send somebody who has expertise in SV40?
Dr. Hoover. Well, I'm responsible for the program that does
viral epidemiology. I'm the program director and that branch is
under my direction, so----
Mr. Burton. Yes, sir. Do you have under your jurisdiction
people who have expertise in SV40?
Dr. Hoover. Correct.
Mr. Burton. Why didn't we have one of those come as well?
Dr. Hoover. We sent one last time when it looked like you
were asking for a more global view, or whatever, of the
science.
Mr. Burton. Well, we may want to ask them to come back in
the future if we don't get, you know, all the questions
answered.
In its November 7, 2003 response to this subcommittee the
National Cancer Institute claims that the NCI fact sheet on
SV40 presents a balanced view of the current research
surrounding the connection between SV40 and human cancer. For
example, the NCI fact sheet states that the Institute of
Medicine issued a report in October 2002 which concluded that
the scientific evidence was insufficient, I think you mentioned
that today, to prove or disprove the theory that exposure to
poliovirus vaccine contaminated with SV40 resulted in cancer in
humans. As I said, I think you stated that a while ago.
Do you agree that the fact sheet represents or presents a
balanced view of the current research surrounding the
connection between SV40 and human cancer?
Dr. Hoover. Well, we thought that since it gave evidence
and pointed out the conflicts and the only conclusion reached
didn't reach its own independent conclusion--the only
conclusion reached was the Institute of Medicine's conclusion
with a link to the Institute of Medicine's Web site--we thought
it was reasonably balanced, but as Dr. Von Eschenbach wrote to
you and as you're probably aware from the controversy over our
fact sheet on abortion and breast cancer in the past year,
whenever anyone asks us to review a fact sheet, any responsible
body or person, we do it, and Dr. Von Eschenbach has asked that
fact sheet be reviewed for its balance.
Mr. Burton. So what you're saying is that you think it is a
balanced view?
Dr. Hoover. I thought it was a reasonable view, but it
could stand to be reviewed again.
Mr. Burton. The NCI fact sheet was last reviewed in April
2003, well after the IOM report was issued in October 2002.
That's correct, isn't it?
Dr. Hoover. That's correct.
Mr. Burton. Is it true that the IOM report concluded that
the scientific evidence was inadequate to prove or disprove the
theory because the epidemiological studies like those conducted
by the NCI were too flawed to be scientifically useful?
Dr. Hoover. That was part of their--the reason for their
conclusion, yes.
Mr. Burton. Is it true that the IOM report concludes that
the biological evidence is strong that SV40 is a transforming
or cancer causing virus?
Dr. Hoover. That is correct.
Mr. Burton. Is it true that the IOM report concludes that
the biological evidence is of moderate strength that SV40
exposure could lead to cancer in humans under natural
conditions?
Dr. Hoover. That is correct.
Mr. Burton. Is it true that the IOM report concludes that
the biological evidence is of moderate strength that SV40
exposure from the polio vaccines is related to SV40 infection
in humans?
Dr. Hoover. That is correct.
Mr. Burton. Why does the NCI Web site omit these
conclusions from its discussion of the IOM report?
Dr. Hoover. The Web site is intended to give information to
the general public about issues concerning cancer, and the
bottom line issue in SV40 is does it cause cancer in human
populations. And the bottom line conclusion of the Institute of
Medicine's report was it is unknown at this point, the science
is not adequate to either rule it in or rule it out. And that
was what we tried to convey and presented some of the
contrasting information on either side. We did also provide a
link to the IOM site itself on our site so that people could go
directly to it.
Mr. Burton. The American people would like to have,
especially in the Internet age, as much information as possible
when they're talking about vaccinations of their children and
themselves, and so you omit this from your Web site. And we had
a similar answer from the NCI, not the NCI but the FDA, on
whether or not the mercury in the vaccinations which has a
cumulative effect in the body, in the brain, could cause
neurological problems such as autism in children and possibly
contributed to Alzheimer's in adults. And I can't understand
why they don't put on the Web sites, you know, that this is one
of the things that has not been proven or disproven so that
people can at least have that information that there's a
possibility that cancer is caused by SV40, and that there's a
possibility, very strong, and from scientists around the world,
on these vaccinations that I talked about from FDA that contain
mercury that they could cause neurological problems. And I
can't understand why we don't put on the Web sites that kind of
information.
Dr. Hoover. Well, I think we did try to indicate that there
is the possibility they could cause cancer. That was the whole
reason for the Web site and the presentation of some of the
evidence that has been produced to raise that question and
included the conclusion of the IOM report which indicated that
it couldn't rule it out, and also the link to the IOM Web site
for those who wanted more detailed information so they could
click and go there.
But as I mentioned, we review these all the time when
someone thinks that they don't reflect the appropriate balance
or the appropriate summary, and we will review them and I will
certainly include in that your recommendation that the other
conclusions of the IOM report be considered for inclusion.
Mr. Burton. Thank you. I appreciate that. You know, in the
questions you answered just a minute ago, those epidemiological
studies that were conducted by NCI, according to the IOM
report, were too flawed to be scientifically useful and you
said that's true, that is what the IOM report----
Dr. Hoover. Too flawed to be scientifically useful to
determine whether or not SV40 causes cancer in humans or not.
They are useful, those kinds of studies are useful to frame the
risk, if there is one. And that's why I mentioned in my written
and my oral testimony that it--by not seeing any impact on the
rates in the general population among those age groups that
were most likely to have received the contaminated vaccine does
rule out an epidemic, the classic ones we have seen for tobacco
related diseases, estrogen and endometrial cancer, AIDS, AIDS
virus and Kaposi's sarcoma. All of those show up because they
are so widespread and they are so strong. They all show up
pretty readily in these kinds of epidemiologic investigations.
So we didn't see that.
It does not, however, give you the kind of power that other
kinds of epidemiology do, when you can actually identify people
who have been infected and people who haven't and look at their
cancer experience or look at people who have cancer and
evidence of infection in them and people that don't. Those are
so-called analytic epidemiologic studies, much more powerful.
Those are the ones that people use to support or not support
carcinogenesis for a particular agent. Those actually, we agree
with the Institute of Medicine, those can't be done to the best
of our abilities at this point because the measurement
techniques are not good enough to do that, to validly identify
everybody who got infected and those that didn't. But we
actually are, as I mentioned, very enthusiastic that with
modern molecular technology and all of the research that's
going on that we will actually get those tools in the very near
future and be able to do something about it.
Mr. Burton. That's good. The epidemic of various forms of
cancer that we see in the United States would lead one to
believe that there's some major causes and since SV40 was shown
to be a carcinogenic in laboratory hamsters, it seems that
you'd want to make sure that people had some idea. I'm not
concerned so much about the liability that the pharmaceutical
companies might have unknowingly incurred because we protect
them legislatively in most cases. But the American people I
just think need as much information as possible so that they
can deal with these problems.
Dr. Hoover. I agree.
Mr. Burton. You know I've had people before the committee
who almost blame themselves for their children's brain cancers
or their wife's breast cancer. And of course my wife, as you
know, died from cancers. And it would mentally relieve them of
some of this if they thought that there was a cause that you
could point to.
Dr. Hoover. I agree with you thoroughly, and I believe that
we need to focus on identifying causes and we need to focus on
this particular one. When I have been taking care of patients,
the most difficult time I had was dealing with children who had
cancer. Children aren't supposed to get cancers, and there's no
more driving force in my life than those observations and those
feelings to try and identify causes of cancer.
Mr. Burton. Well, I appreciate that and I do hope that we
will be able to get more information on the Web sites.
Also from the November 7, 2003 response to the
subcommittee, NCI states that in light of a body of evidence
which demonstrates that there may be some SV40 in some rare
human tumors, NCI will review the fact sheet. Is that an
admission by NCI that SV40 is in fact present in human tumors?
Dr. Hoover. There is certainly a large body of evidence out
there indicating that it is.
Mr. Burton. Well, if so, what evidence has come to light
since April that convinced the NCI of that fact?
Dr. Hoover. I think NCI has always been convinced that
there's a large body of evidence and certainly growing all the
time that there is SV40. We support most of that research
actually and--of the people who have identified it. There are
problems interpreting it because we get this wide range of
estimates from 3 percent to 90 percent and not everybody that
looks for it can find it. But those are probably not to be
unexpected in using new technologies and sort of working, as I
mentioned, working at the cutting edge. I think we can, with
time and with more people getting involved in the field, sort
out those issues and those concerns.
Mr. Burton. What explanation or theory does the NCI offer
for SV40 being present in human tumors? I mean, how did it get
in these tumors?
Dr. Hoover. That's a very good question, and I don't think
we know. The only relevant exposures that we know of or the
only exposures we know of happening in this population has been
through contaminated vaccine. There are places in the world
where people have pretty close contact with the monkeys that
are infected with the virus, so perhaps in those locales they
can get it in an epizootic kind of sense. But----
Mr. Burton. Here in the United States we don't have a lot
of people coming in contact with monkeys.
Dr. Hoover. No, we don't. If there are, I think as the
Institute of Medicine pointed out, once the techniques for
measurement get better, they actually think one of the first
things we should do is go back to tumors that occurred in the
40's and early 50's and test them to see if there's evidence of
SV40 in them.
Mr. Burton. Before the vaccines were used.
Dr. Hoover. Before the vaccines.
Mr. Burton. Well, was the SV40--was monkey tissue used in
other vaccines?
Dr. Hoover. Not that I know of. This was their attempt to
see----
Mr. Burton. OK. Was SV40 found in other areas other than
the monkeys and the vaccine that came from the monkey tissues?
Dr. Hoover. Right now the only host that I know of--I'm not
an expert in this area--is the monkeys. But we don't--there's a
lot we don't know about infectious diseases and whether there
might be another source of SV40 infection out there that we
don't know about now I think is what the Institute of Medicine
was concerned that aspect be pursued too, that perhaps this
virus or a very, very highly related virus molecularly may
actually come from somewhere else as well.
Mr. Burton. Come on. You don't believe that. I mean, you're
a very--I'm sure you're a very dedicated scientist and doctor.
But if it's only in the monkey and the monkey tissue is used to
make the vaccine and you know of no other place that SV40 comes
from and people in the United States have SV40 and cancerous
tumors, deductive reasoning would lead you to believe that it
came from the vaccination unless somebody's got a bunch of
monkeys running around their house.
Dr. Hoover. That seems to be the most likely explanation.
But we also agreed with the Institute of Medicine report that
indicated that we should make sure of that by looking at
tissues from people who couldn't have been exposed to that--by
that route to see whether I agree with that.
Mr. Burton. So there really is no explanation from the NCI
on SV40 being in humans?
Dr. Hoover. Other than from contaminated polio vaccines and
in other parts of the world the contact with monkeys, no, we
don't have another.
Mr. Burton. Well, you know as bright as everybody is over
there I would think that they'd come to the conclusion before
going back to pre-1950 vaccinations and other things that the
SV40 was the culprit. But----
Dr. Hoover. Me personally, and a lot of us, have been
burned too many times by thinking we know something without the
data to prove it and so we are generally in the business of
going out and finding the data to demonstrate that. And I think
that's what the Institute of Medicine wanted to do.
Mr. Burton. Well, parents of kids who died from medulla
blastoma, I think would like to know if there's a strong
possibility that the SV40 was the cause. And if there's no
other avenue that we know of, I think the parents should at
least have that kind of information. It would allay some of the
pain that they've gone through. I mean, you know, to say well,
we don't know, when you know the only source that's known to
man is the monkey and the virus that was in the--and the polio
vaccine, to just keep saying we don't know, I think is--I think
maybe you should reframe that and say it's probable, it's
probable that the vaccine caused it. You've got an out there.
But----
Dr. Hoover. Well, I think it's probable that SV40
contamination of vaccine is responsible for infection in the
U.S. population. The significance of the SV40 in the tumors has
yet to be determined and I'm sure all the molecular scientists
who are working night and day on that issue, the issue of is
that because they get to find the virus in the tumors is the
virus related to that tumor, that's another question and that
is the hardest question of all to answer.
Mr. Burton. You know, I would think there would be a major,
major scientific research project.
Dr. Hoover. It is.
Mr. Burton. Well, I hope so, because my gosh, all the
people that are dying of cancer, my wife, people who are
suffering from breast cancer, medulla blastoma, all these
people, all these various kinds of cancer that 25 years ago you
never saw or very rarely saw, you'd think that if you thought
the culprit might be SV40 that all hell would break loose to
get the research done so that we might stop it in the future if
we can or find a cure that might negate SV40 from killing
somebody.
Dr. Hoover. I think that's why, I know, Dr. Wong's program
is funding probably about $9 million worth of research a year
in SV40 molecular virology.
Mr. Burton. Nine million?
Dr. Hoover. Yes.
Mr. Burton. How much money does our health agency get over
there? NCI, how much do you get over there?
Dr. Hoover. You'll have to tell me. I know what our own
budget is. Several billion.
Mr. Burton. Several billion?
Dr. Hoover. Right.
Mr. Burton. Several billion, and the culprit for cancer in
many cases may be SV40 and you're dedicating $9 million to this
project?
Dr. Hoover. There are very many candidates for what may
cause cancer in human population, an extremely large number,
and we try to keep a balanced portfolio to investigate
everything for which there is a likelihood.
Mr. Burton. I know, Dr. Hoover, but here you know probably
this is, and very strongly possibly, this could be a culprit
because you've found it in cancerous tumors in human beings and
it seems to me that you know it was in laboratory animals. You
know it's showing up in human cancers. It seems that this would
be a top priority and would get more money than $9 million out
of a multi-billion dollar appropriation.
Dr. Hoover. Well, I'm not the one that makes those
decisions, but the people who send in grants do. One of the
problems in making headway in any area where you think you have
something that's worth investigating is do you have the tools
available to you to make--to get the answer. And that's what
the grant mechanism is supposed to determine when people send
in grants and tell their ideas to the study section. People
decide, OK, who's got the best tools to answer this question? I
think we need better tools in the area of viral carcinogens.
Mr. Burton. Could I ask your associate, Dr. May Wong, a
question?
Dr. Hoover. Sure.
Mr. Burton. And this may put you on the spot. Put the mic
real close to you. This may put you on the spot and I don't
want to do that. I mean we're here today not to beat up on
anybody. I have been accused of that in the past. I see you
smiling a little bit there. What we want to do is get the facts
out and try to do something constructive about the possible
cause of cancer.
Would additional funding be helpful?
Dr. Wong. Yeah. I really agree with you. I think we do need
additional research funds. Unfortunately, I guess under the
current fiscal environment, you know, we're obligated with so
many different areas of research not just on SV40, but other
things, but in terms of SV40, yes, I do agree, I think maybe
you or the Congress can set aside or appropriate, you know.
Mr. Burton. You mean dedicate a certain amount of money?
Dr. Wong. Dedicate a certain amount of funds.
Mr. Burton. How much money do you think--and I know this is
a tough one. How much money do you think would be necessary to
do--you don't want to do overkill, but an adequate job of
investigating this?
Dr. Wong. No. No. We have been really actually thinking
about this problem quite a long time and I think what is also
lacking is that cross-discipline area, you know, the
collaborations between, like, from our part is mostly the
molecular virologists, molecular biologists. We need to really
collaborate and work with other parts of disciplines such as
epidemiologists. Currently that's not being really done. That's
why we have a lot of confusion in the area.
Mr. Burton. Well, what I would like to have from you----
Dr. Wong. Is a dollar figure?
Mr. Burton. No, no, not just a dollar figure. And Dr.
Hoover, could you give this subcommittee a recommendation on
how you could come to a conclusion, if possible, quicker? I
mean, she's saying that there needs to be a cross-pollination
between researchers in order to find out, you know, if this is
a culprit and ultimately lead to maybe some kind of a cure or,
like AIDS, maybe a way to prolong life without stopping the
AIDS. You see what I mean? And if we could get from you some
kind of a statement that would say--tell us how that cross-
pollination should take place, in addition to, and in the
letter, or recommendation, in addition to the amount of money
you think is necessary for additional research, I would be very
happy to go to the appropriators and to the authorizing
committees and write a letter directly to your superiors at the
agency saying this is what our subcommittee found should be
done. I don't want to jeopardize you by going to your superiors
and saying, hey, you guys aren't doing your job and here's
what's recommended, but I think it would be helpful if we in
Congress knew what your recommendation is so we could convey
that to the authorizers, appropriators and the people at the
top of the agencies. Could you do that for us?
Dr. Wong. Yeah, I think we can go back and discuss amongst
each other, you know, what is the best approach and then get
back with you.
Mr. Burton. We'd like to do that because then maybe we can
help you get that approach. We'd like to do that. OK.
What explanation or theory does the NCI offer for SV40--
well, you've already answered that question. You don't really
have an answer yet, although you think it's likely that it's
from the SV40.
Who are the experts who will review this fact sheet for
accuracy and balance?
Dr. Hoover. That's up to Dr. von Eschenbach. The fact
sheets are run out of his office, and it's done in different
ways for different times. For the abortion and breast cancer
fact sheet it ended up being an entire conference of experts
from all over the world. That's rarely needed at that level to
respond. But I'm sure he will make a wise decision about who
needs to----
Mr. Burton. Well, the experts have been picked, have they
not, to review that fact sheet?
Dr. Hoover. I don't know.
Mr. Burton. Well, could we make a request here today, and
I'd like to put that in writing, that we have a list of the
experts that are reviewing that fact sheet for accuracy and
balance?
Dr. Hoover. Sure.
Mr. Burton. But you don't know right now?
Dr. Hoover. I don't know.
Mr. Burton. What are the NCI procedures for public and
outside comment on the fact sheet?
Dr. Hoover. Well, as I mentioned, people--most of the fact
sheets that involve--I shouldn't say most. Many of the fact
sheets, when they're developed, are also passed through our
consumer panel, the cancer advocacy groups that are represented
at NCI at the initial stage. Second, when someone has a concern
about our fact sheet, and they e-mail us or they phone us,
almost always if it's a responsible question or a responsible
concern, it ends up in some sort of a review at some level.
Mr. Burton. One of the principal studies cited by NCI
refuting the contention that SV40 is in fact present in human
cancer tumors was a multi-laboratory study conducted by Dr.
Strickler and Dr. Shaw and published in 2001. In 2002, excerpts
from a sworn deposition by Dr. Shaw were published in the
journal Anti-Cancer Research. Those excerpts indicated that Dr.
Shaw was under contract from several pharmaceutical companies
to assist them in litigation against patients with SV40
positive tumors. Dr. Strickler and Dr. Shaw published a
rebuttal in the journal Anti-Cancer Research in 2003. The
subcommittee understands that several NCI scientists sit on the
editorial board of Anti-Cancer Research. When we asked about
their apparent conflict of interest in our letter to NCI dated
October 10, 2003, NCI replied via a footnote that they were
unaware of Dr. Shaw's purported relationship with the
pharmaceutical industry until we mentioned the issue in our
letter.
When Dr. Shaw or any scientists signs a contract with NCI
to conduct research either as grantee or subgrantee, are they
required to disclose their conflicts of interest?
Dr. Hoover. I think the--testifying as an expert witness, I
don't believe it is asked of grantees or contractees, but I
could stand to be corrected if----
Mr. Burton. You know, that's something that needs to be
corrected.
Dr. Hoover. No, no, it's not. It is not.
Mr. Burton. You know that needs to be changed. You know we
had the advisory committees that approve or recommend to the
FDA the approval of a vaccination to be put in the market. We
investigated and found that there was at least one incident, I
believe several, where people on those advisory committees had
stock in companies that were making the very same product. And
that is definitely going to, in many cases, skew somebody's
judgment and is a conflict of interest.
And the thing that bothers me about--I think it was a
retrovirus. What was that--RotaShield, the RotaShield
vaccination. One of the people, I think it might have been even
the chairman of the advisory committee, had stock in a company
that was going to make that RotaShield vaccine, at least one of
them, and they approved it even though a lot of the members
weren't there. And the FDA went ahead with it. And the FDA
always--we have found no cases where the FDA doesn't approve
the recommendation of the advisory panels, and they put it in
the market. At least one child died and several others were
injured severely by the vaccination and it was withdrawn 11
months later. Now, that is tragic. If there's a conflict of
interest in any of these areas, it must be known because if
not, you're liable to put things into the marketplace and into
people's bodies simply because of money, and that shouldn't
happen.
Dr. Hoover. That's not my area of expertise, but I have
just two comments to make. As you know, if you work for the
government, you have to fill out all those forms about what
stocks you hold and those rules have never been applied to
grantees. My guess is that if you suggest applying those rules
to grantees that there would be a very large outcry from the
academic community that this is something that they don't
believe is necessary. But if that's what you want to suggest, I
can----
Mr. Burton. Well, let me interrupt you just a second, Dr.
Hoover, and I apologize for this. Dr. Shaw, he gets paid to
testify, and his testimony carries a lot of weight because of
his expertise, and he had a conflict of interest. Don't you
think that's something that could skew a report that's very,
very important?
Dr. Hoover. I personally don't. I'm sure that----
Mr. Burton. You don't think so?
Dr. Hoover. I'm sure that in these same cases the people
who have found SV40 in tumors have also probably testified as
expert witnesses because they are experts. And I actually don't
believe that influences the science. One of the great things
about working in the scientific field is that nothing is ever
done based on one person's study or one person's research. The
sine qua non in science is that it has to be replicated and it
has to be replicated multiple times by different people working
in different circumstances. So it is usually readily apparent
if someone found something that cannot be replicated, came to a
finding that can't be supported, it becomes readily apparent
and it doesn't get disseminated. So I think there's actually--
the way science operates, it operates in a way which
irregardless of the personalities involved, guards against----
Mr. Burton. Dr. Hoover, you're a very bright fellow.
There's an old saying. Money talks and baloney walks. I'm being
nice about that comment. The RotaShield virus vaccine I talked
about, it was evident, and there were--the man on the advisory
committee who had a conflict of interest stood to make a lot of
money out of that.
Dr. Hoover. It's possible that being on an advisory
committee--and I know that FDA advisory committees require
people to list conflicts of interest. I'm talking about doing
research.
Mr. Burton. OK. Well, even doing research----
Dr. Hoover. Doing and publishing your research.
Mr. Burton. I think it's important that there be
disclosure, and I don't know that would be a discouragement.
You might have to get another expert or scientist who doesn't
have a conflict in that general area. But it seems to me when
you're talking about something as important as SV40 and the way
our scientific community and our agencies view it, that you'd
want to make sure that the person doesn't have a skewed point
of view because of financial interests.
How did NCI not know about this conflict until our letter
dated October 10 if several NCI scientists sit on the editorial
board of the Anti-Cancer Research? Because it isn't required?
Dr. Hoover. That's correct.
Mr. Burton. OK. So just simply because it isn't required?
Dr. Hoover. Right.
Mr. Burton. What is NCI planning to do to address this
issue in the future, or is it NCI's position that such
conflicts of interest are not serious? I think you've answered
that. You don't think it's a serious problem?
Dr. Hoover. I don't think this is a serious problem. I
believe that we can have conflicts in science that are most
often the results of the science and not because of
incompetence or venality on the part of the investigators.
Mr. Burton. Or money?
Dr. Hoover. Or money, that the weight of the scientific
evidence is based on multiple people finding the same thing,
and the consistency of the evidence, and we have plenty of
safeguards. I think there's--if we ruled out everybody who gave
expert testimony in some of these tort cases, my guess is--and
we ruled out giving money to them from the Cancer Institute of
Research that we would lose many of the most valuable
researchers to both sides of the controversy, and I think that
would be a shame.
Mr. Burton. The Strickler-Shaw study was originally
submitted to Anti-Cancer Research, one of the preeminent cancer
journals, for publication but was rejected; is that correct?
Dr. Hoover. I don't know. That's probably true. It could be
true, I don't know.
Mr. Burton. Well, it was correct. It is correct. Can you
explain why a journal would reject a paper of that type?
Dr. Hoover. A whole variety of reasons. I think I've--
probably half the papers I've published have been rejected by
one first. You usually shoot high to get a paper into a very
high visibility journal because it's good for your career.
They're the most competitive journals or the ones that can
choose from many things and they may make a priority decision
that this isn't of high enough interest for them to publish in
their journal.
Mr. Burton. Well, we also understand that five coauthors of
the study disassociated themselves from the paper's
conclusions, including Dr. Janet Butel, who actually wrote the
last version of the manuscript. Is that correct?
Dr. Hoover. Yes, it is.
Mr. Burton. Is it common for coauthors to disassociate
themselves from their own work?
Dr. Hoover. No, it is not.
Mr. Burton. Well, why is that? It's not common?
Dr. Hoover. It's not common.
Mr. Burton. Given the controversy surrounding this study,
is it appropriate for the NCI to continue to use this material
as the basis for the assertion that SV40 is not present in
human tumors?
Dr. Hoover. I don't think we make that assertion. We say
that study is one that didn't find it; and there's, as you
mention, a whole body of studies out there that don't.
Mr. Burton. Are there other studies that say that SV40 was
not found in human tumors?
Dr. Hoover. There are maybe 10 to 13 that don't find them
in some of the identified tumors. But for that particular
article they submitted a letter to the editor pointing out
their concerns, and Dr. Strickler responded. That is in the--
published in the journal; and I believe that evidence makes it
possible for people to read the article, read the concern, read
the response, and come to their own conclusion of how
scientists can come to their own conclusion about what it is,
about whether the study would be credible and worth
considering.
Mr. Burton. The October 2002, Institute of Medicine report
on SV40 contamination of the polio vaccine recommended that the
Federal Government develop sensitive and specific serologic
tests for SV40. Since it's now been over a year ago that the
IOM issued the report, what steps has the NCI taken to
implement this recommendation?
Dr. Hoover. I do know there are people who are attempting
to develop new serologic tests using viruslike particles and
that Hopkins is one, and you probably know more about it than
I?
Ms. Wong. Gee, Denise Galloway at Seattle and Bob Garcia,
in collaboration with the city, who's with Dr. Shah's group at
Hopkins, they are trying to develop a serological assay, but,
unfortunately, I think there are problems. They could not
detect anything. One possibility is that SV40 cross-reacts with
these human poliomaviruses, J, C, B and K, so that might mask
the detection. So I know several groups are attempting to
further develop this or use other immunological assays to try
to see if they can develop a more sensitive way to detect SV40.
Mr. Burton. So the NCI is taking steps right now to
implement that recommendation?
Ms. Wong. Well, unfortunately----
Mr. Burton. No, no.
Ms. Wong. Oh, OK.
Mr. Burton. Is the NCI taking steps to implement that
recommendation?
Ms. Wong. Well, we're funding it indirectly, let's say.
We're not directly funding that work.
Mr. Burton. Why not?
Ms. Wong. Well, because--one reason is they haven't come in
with a proposal to request for money. That's usually the normal
route of how we fund applications, is people have this idea,
they come in, it gets peer-reviewed, and if this did well and
was with----
Mr. Burton. Well, pardon me for interrupting----
Ms. Wong. Right.
Mr. Burton [continuing]. But what we're trying to find out
is what steps the NCI has taken to implement that
recommendation. Have they let people know this is something
that they're interested in?
Ms. Wong. Yes.
Mr. Burton. Because the IOM in October of last year
indicated, over a year ago, that those tests should be taken.
Ms. Wong. Well, at least, I know, through communications,
not through any funding mechanism, we have our grantee--so-
called extramural investigators are aware that this is what
needs to be done in the community and this is a high priority.
Unfortunately, we are not currently funding any of those
studies.
Mr. Burton. Well, it's been reported over a year ago, and
it doesn't appear that there's real concern over there if over
a year later they still haven't taken steps to implement the
report.
Dr. Hoover. I think what May was trying to say was that
when august bodies make recommendations people that have good
ideas in this area usually immediately submit grants, because
they know--in fact, they reference the recommendation; and
study sections who review that take that quite seriously
because this is recommended in the field. And people who are
out there, who are--who do this for a living--so, usually, when
you don't get a sudden flood of good grant requests, it means
that no one actually has a very good idea right now about how
to do it better.
I suspect what's going to happen--I suspect that with all
the improvement in molecular science that's going on weekly, if
not daily, that somebody will come across a method that they
think they can apply to this; and I would guess that the grant
would come in almost immediately.
Mr. Burton. Do you publish on the Internet or through
medical journals that this is something that you want to see
NCI do? I just wonder how many researchers even know that this
is something----
Ms. Wong. Well, last year I had published a workshop
report. In that workshop report one specific topic was on SV40,
and we did recommend one for future studies in development was
to develop more sensitive assays, and that could be in the
workshop report. But, other than that, I don't think there's
any.
Mr. Burton. Do you think we also need an agreement on
methodologies between intramural and extramural research so
when examining the link between cancer and SV40 all the
researchers and scientists will accept the findings once
they're completed?
Dr. Hoover. I think that the ideal would be to find methods
that are robust enough that everyone can use them and everyone
can get the same answer when they use them. That's been the
history of when we advance.
Cervical cancer field's a good example. Back in the early
1980's, it was Dr. zur Hausen and others developed papilloma
virus in the vast majority of cervical cancers, maybe 80, 90
percent. The next question was, well, how does that compare in
different populations and how does it compare to people who
don't have cervical cancer?
The first study that was done was to look at the--at
something called block analysis, which was considered the gold
standard, and looked at it in multiple labs and found there was
no consistency--people couldn't replicate each other very
well--and probably explained why some of the studies in
humans--in human populations were giving conflicting results.
Shortly thereafter, two new assays were developed, PCR-
based and a hybrid-capture-based assay, that, when used by
multiple people, everybody got the same answer; and it
catapulted that research forward. So now we, in fact, know that
papilloma virus is the major cause of certain invasive cervical
cancers. So as the field advances and as techniques get better
what we try to find is a technique that everyone can use and
end up getting the same answer and, hopefully, that's the right
answer, that's the valid answer, as well.
Mr. Burton. So I presume that's a yes.
OK. The October 2002, Institute of Medicine report on SV40
contamination of the polio vaccine recommended that the Federal
Government develop sensitive and specific serologic tests for
SV40. Since it's now been over a year ago that the IOM--oh,
excuse me. I'm getting punchy here. The IOM report also
recommended the development and use of sensitive and specific
standardized techniques for SV40 detection. What steps has the
NCI taken to implement that recommendation?
Dr. Hoover. Once again, that would probably be done through
the molecular virology community; and I'm unaware of what new
efforts are going on.
Mr. Burton. If you don't have that answer, can you submit
that to me?
Ms. Wong. Yeah.
Mr. Burton. I mean, can you find that out?
Ms. Wong. Yeah, we can get back with you later.
Mr. Burton. We want to find out if there are sensitive and
specific standardized techniques for detection, and I'd like to
know if they've implemented that recommendation, and, if not,
why they haven't and when they intend to do so. Can we get that
information from you?
Dr. Hoover. Sure can.
Mr. Burton. Thank you.
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Mr. Burton. The IOM report further recommended that no
additional epidemiological studies be performed because of the
uncertainty of knowing which individuals were exposed to SV40
made interpretation of the data problematic.
The IOM report was issued in October 2002. Yet, in 2003,
the NCI released a new epidemiological study based on data from
Denmark. Was this study begun before or after the IOM released
its recommendation, the Denmark study?
Dr. Hoover. Yeah, that was certainly begun before; and that
was actually presented to the IOM committee. They asked for
people to come who had unpublished information; and we
presented that plus two others, actually, another one that was
published in December as well. So they had that body of
knowledge in hand when they made their recommendation.
Mr. Burton. Can you confirm that NCI has no other
epidemiologic studies currently in the works?
Dr. Hoover. We have none of the kind that the Institute of
Medicine was concerned about, following populations where you
can't identify who's been exposed to vaccine, who hasn't.
Mr. Burton. Should peer review data protocols be agreed to
before further studies are funded and released?
Ms. Wong. I'm sorry?
Mr. Burton. Should peer review data protocols be agreed to
before further studies are funded and released?
Ms. Wong. No, peer review should also be reviewed, and they
are.
Mr. Burton. Excuse me just 1 second.
I think you can relax for a little bit. Now I get to go to
Dr. Egan.
The U.S. Food and Drug Administration first learned about
SV40 problem with the polio vaccine in 1960, is that correct?
Mr. Egan. That's correct.
Mr. Burton. Starting in 1961, the FDA stipulated that no
lots of polio myelitis vaccine would be released in the absence
of negative results of a valid tissue culture for SV40; that's
correct?
Mr. Egan. That's correct, sir.
Mr. Burton. Prior to the requirement, millions of Americans
were vaccinated with SV40 contaminated polio vaccines; that's
correct?
Mr. Egan. That's correct.
Mr. Burton. Once the FDA released there was a problem with
the polio vaccine, did the agency issue any type of recall?
Mr. Egan. No, they did not, sir.
Mr. Burton. Why?
Mr. Egan. OK. Well, at this time this would have been the
Division of Biological Standards at the National Institutes of
Health. At that time they took this question about recall or
leaving material on the market to the Polio Myelitis Vaccine
Committee, their advisory committee to the NIH; and the
committee weighed the risks and benefits, the risks of polio,
the risks of not having the polio vaccine virus out there and
the potential risk that might result from SV40 and they
concluded that, on balance, from the risk benefit analysis,
that it was much better to leave the vaccine on the market and
not to recall it.
Mr. Burton. Once the FDA released there was a problem with
the polio vaccine, did the agency ever issue a notice to
health-care providers not to use contaminated vaccine, even
though it wasn't recalled?
Mr. Egan. Yeah, I do not have any knowledge of that, sir.
Mr. Burton. Can you find out for me?
Mr. Egan. I will try, sir.
Mr. Burton. Because I know, since I was a child, at that
time, everybody was very concerned about polio. We knew about
iron lungs and all that sort of thing, and our parents wouldn't
even let us get around water outside or flies or anything.
Mr. Egan. I shared the exact same experience. I was 12
years old when the vaccine came out.
Mr. Burton. I understand that. But when they found out the
SV40 was a possible cause of cancer in the hamsters, couldn't
the--I mean, there was other ways to make the vaccine other
than using that contaminated SV40 vaccine; wasn't there?
Mr. Egan. I'm not aware of another method that was known at
that time. But once the issue came to the fore, the FDA--the
Division of Biological Standards did require that all vaccine
be free of SV40, that it be tested for SV40, each lot of
vaccine be tested for SV40, be found free of SV40 prior to
release to market.
Mr. Burton. I think we know the answer to this question
from Dr. Hoosier, but SV40, if it was discovered in a major
vaccine today, what would the FDA's response be and how would
it differ from your response in the 1960's?
Mr. Egan. If SV40 was found in the vaccine today?
Mr. Burton. It would not be put on the market?
Mr. Egan. It would not be put on the market, no, sir.
Mr. Burton. FDA testing from the 1972 to 1976 polio vaccine
questions I'd like to ask you next.
In your testimony, you mentioned that the FDA has tested
live supplies of polio vaccine between 1972 and 1976 and that
you found them free of SV40; is that correct?
Mr. Egan. That's correct.
Mr. Burton. The subcommittee understands that the FDA
tested no samples prior to 1972 because no pre-1972 samples of
the polio vaccine still exist; is that correct?
Mr. Egan. They were not in our possession. I don't know
whether they exist or not, but the retention samples that we
had went back to 1972.
Mr. Burton. Well, would any of the laboratories that had
produced the vaccine have that?
Mr. Egan. I don't know what their retention policies are.
They might.
Mr. Burton. Could that be requested from them so that we
could be testing those?
Mr. Egan. Yes, I'll do that.
Mr. Burton. So, since you didn't have any of that, the FDA
has no way to independently test if the polio vaccine was SV40-
free from 1955 to 1972; that's correct?
Mr. Egan. Well, that's correct. Certainly the vaccine--many
of the lots of vaccine from 1955 through the early 1960's was
certainly contaminated. I don't think there's any question
about that.
Mr. Burton. That it was left on the market.
How about up to 1972?
Mr. Egan. That vaccine was tested for SV40 and found to be
free.
Mr. Burton. But the vaccine that contained the SV40 was
still on the market, was it not, in 1972, or was it?
Mr. Egan. It should not have been.
Mr. Burton. Should have been exhausted by then?
Mr. Egan. Exhausted. I'll have to look at what the
expiration dating period was, but it was probably no more than
a year or 2, couple of years----
Mr. Burton. OK.
Mr. Egan [continuing]. And everything released after 1961
would have been SV40 free, found to be SV40 free, so----
Mr. Burton. If after 1961 you required the vaccines to be
SV40 free, why didn't they recall the vaccines that were
contaminated before that?
Mr. Egan. OK. Again, that was the--I was not there at those
discussions, but my understanding is that the--they had
discussions of the risks of polio versus----
Mr. Burton. I understand, but----
Mr. Egan. Yes.
Mr. Burton. I'm sorry to interrupt. Go ahead.
Mr. Egan. That in determining--in going over those risk-of-
benefit determinations, they felt it was better to leave the
market--leave the vaccine on the market to prevent polio,
rather than withdraw it, which would have resulted in a
shortage.
Mr. Burton. I know, but I'm saying if there's a vaccine
that is SV40-free coming on the market, is being produced, you
still have contaminated vaccine in the marketplace. Why didn't
they recall what was left at that time? Why run the risk of
infecting additional people when you have an SV40-free vaccine?
Mr. Egan. I mean, I could only, you know, speculate, not
being there, but----
Mr. Burton. Could you check?
Mr. Egan [continuing]. I think there was an issue of supply
of vaccine, how much would be available. But I mean that's
speculation.
Mr. Burton. Could you check for the record and give us an
answer to that? Because it seems to me that the manufacturers
would move pretty quickly to jam up supply of free SV40 vaccine
as quickly as possible; and if that's the case, they would
have--it seems to me our health agencies would have said, let's
get this contaminated vaccine off the market.
I understand the rationale about weighing it and saying do
we want to stop polio or run the risk of possible cancer down
the road. I can understand that rationale if you don't have the
alternatives. But once you have the alternative why would you
keep that out there? That's what I would like you to answer, if
you could.
Let me get back to the pre-1972. So the FDA had no way to
independently test whether the polio vaccine was SV40 free from
1955 to 1957; is that correct? They had no way to test it?
Mr. Egan. No, they were testing after 1960 or 1961. It was
the period in between----
Mr. Burton. 1955 and 1960.
Mr. Egan. 1955 and 1961 where it was unsuspected. Because
the virus didn't harm, you know, kill the cells in which it was
growing.
Mr. Burton. Excuse me, just 1 second.
My right arm here indicated that they were getting SV40
polio vaccine off--not off the market but produced after 1961,
but he tells me that there was no test to test the vaccine up
to 1972; is that correct?
I'm going to let you ask this question. I want to make sure
I get this correct for the record.
Mr. Fauls. I think you've already answered the first
question, is that you--when studies first came out that showed
SV40 in cancerous tumors, FDA went back and tested all of the
samples it had of polio vaccine in its possession, which only
went back to 1972, to verify again those were free of SV40.
That's correct?
Mr. Egan. One minor change. We tested a sampling of the
retention samples that we had. We tested 30 monopools, and we
tested 30 trivalent vaccine lots. It wasn't 100 percent.
Mr. Fauls. So you didn't test 100 percent of all the lots
produced from, say, 1961 to 1972 or what you had in your
possession?
Mr. Egan. No, what we had in our possession were a number
of lots that were kept in as retention samples that represented
lots that were manufactured between 1972 and 1996. Of them, we
chose the large sampling, which was 60 samples in total; and
each and every one of those was negative to a highly sensitive
chain reaction, preliminary chain reaction testing methodology
that we developed. We did not have any samples that predated
1972 in our possession.
Mr. Fauls. OK.
Mr. Egan. But there was, for every lot of vaccine, lot
release testing from 1961 onward; and this was the tissue-
culture-based testing.
Mr. Burton. So in the absence of this independent testing,
the possibility existed that pre-1972 polio vaccine could have
been contaminated with SV40; is that correct?
Mr. Egan. I do not believe so, because each lot of vaccine
was tested in the tissue culture test, which is rather
rigorous, testing in sub-culturing, looking for a cytopathic
effect in the African green monkey tissue, and this was done
for every lot of vaccine since 1961.
Mr. Burton. But the FDA doesn't have any samples of the
vaccine that was manufactured prior to 1972; is that correct?
Mr. Egan. No, we did not have any in our possession. If we
did, we would have gone back further.
Mr. Burton. The samples that were tested by the FDA were
under--were they under the FDA's supervision since their
manufacturer was supplied by individual manufacturers at the
FDA's request in 1996?
Mr. Egan. I'm sorry. I don't understand the question? Would
you mind repeating it?
Mr. Burton. I'm going to let you ask that question.
Mr. Fauls. OK, sir. Very good.
The question gets at--and I think you answered this
earlier--that the samples that you tested back to 1972 were in
the FDA's possession; is that correct?
Mr. Egan. That's correct.
Mr. Fauls. OK, so you have a clear chain of custody of
those samples so that you know that they were, in fact,
produced in 1972 and they weren't--they weren't, say, produced
in 1996 specifically because you were going to do some
retesting?
Mr. Egan. It's a different office within the--within FDA
that handles these, but they come in. They're logged in and
then stored in the freezer.
Mr. Fauls. OK, but since the time of the manufacturer
they've been stored there?
Mr. Egan. Yes. Whenever the samples are submitted, along
with the lot release protocol, every lot of vaccine that's
released to market must be released by FDA before the
manufacturer can send it out. What they will send in to the FDA
after they've manufactured a lot is a lot release protocol that
contains all of the testing that was done so this can be
reviewed by FDA scientists to see whether it's satisfactory or
not. The manufacturer, at the time that they send in this
protocol, will also send in physical samples in the event that
FDA wishes to do any testing on that lot, so they're sent in
prior to the release of the vaccine by FDA.
Mr. Fauls. And stored at FDA?
Mr. Egan. And stored at FDA.
Mr. Burton. And they're still there in frozen status?
Mr. Egan. Yes.
Mr. Burton. And you have documentation to verify that the
vaccine was actually produced when the manufacturer said it was
produced?
Mr. Egan. Well, it would come in----
Mr. Burton. Come in with it?
Mr. Egan [continuing]. With the lot release protocol at
that time. So the vaccine that was manufactured, for example,
in 1982 would--that vaccine would come in with the lot release
program.
Mr. Burton. What we're trying to get at is something that
was produced in 1972 is there as a 1972 product and not
something that was manufactured later in 1994?
Mr. Egan. No.
Mr. Burton. OK. Thank you.
Mr. Egan. No, that would not be an issue.
Mr. Burton. Has the FDA required the polio vaccine
manufacturers to produce results showing that their seed stocks
are SV40 free?
Mr. Egan. The two vaccines that are currently in use--you
know, we've switched, a number of years back, to IPV--and the
two major IPV's that are in use at the moment----
Mr. Burton. Are SV40 free.
Mr. Egan. They're SV40 free, but the manufacturers also
demonstrated that the seeds that are used to produce the
vaccine are SV40 free by PCR technology, and I'm referring to
the recently licensed Pediarix and the Ipol.
Mr. Burton. So the manufacturers are required to submit
their polio vaccine lots to a 14-day tissue culture procedure
to test for the presence of SV40?
Mr. Egan. OK, the procedure that I think--I think the
procedure that you're referring to is, for example, the one
that was in the Code of Federal Regulations. If I look at the
one, for example, for OPV, they hold the seed--they hold the
part of the production for a number of days--I forget how many
it is, exactly--and then there are two subcultures of 14 days
and 14 days. So from the beginning to the end of that entire
process with the control production cells is about 50 days.
For the part of the harvest with the monkeys just prior to
the inoculation with polio virus, they also hold those cells
and then subculture them for one or two periods of--I think
it's one period of 14 days. They observe the cultures in 14
days. Then there's a third one with the actual harvest itself
where they neutralize the polio virus with specific anti-sera
and then culture and subculture again. So they are actually
three very--three independent sets of cultures and subcultures
that go out for, you know, 28 plus days.
Mr. Burton. So that would be considered three independent
tests?
Mr. Egan. They're independent tests in the sense that
they're done on different parts of the process, yes. They are
not independent in the sense--they're independent tests, yes.
They are coming from the same tissues, though. I would be happy
to outline that for you.
Mr. Burton. My counsel says that your original answer was
they are not part of the same test.
Mr. Egan. They are three independent tests on the same
monkey kidney cells. Yes, they are three independent--they are
independent tests. For clarity, I would be happy to submit to
you what is done.
Mr. Burton. I wish you would do that.
Mr. Egan. Sure.
Mr. Burton. I think that might help.
Mr. Egan. I think we can diagram that.
Mr. Burton. Like I said, we have somebody who used to be--
work on this in the health department of the government, and we
want to, you know, discuss this with them in some detail.
Mr. Egan. It's very, very complicated and hard to
understand.
Mr. Burton. That's why we go to an expert. You folks tell
us, and then we talk to them to find out if there is additional
information we need.
Mr. Egan. Sure.
Mr. Burton. So we appreciate that.
Well, I think this is important. There's evidently one
scientist who claims to have discovered a second strain of SV40
that takes longer than the 14 days to develop in the culture
testing. You said that you actually go beyond the 14 days?
Mr. Egan. That's correct.
Mr. Burton. If a polio vaccine lot fails that 14-day test
and the subsequent tests that are part of the testing process,
does the manufacturer automatically destroy it or can they
attempt to clean the vaccine and retest it for SV40?
Mr. Egan. I will double-check this, but my understanding is
that if SV40 is in the vaccine they are not permitted to clean
it up.
Mr. Burton. If they want to get rid of it, they destroy it.
Mr. Egan. Yes, if SV40's in the vaccine, yes.
Mr. Burton. Can you double-check that for us?
Mr. Egan. Yeah, but that's my interpretation, my
understanding.
Mr. Burton. Well, one of the accusations against one of the
major drug manufacturers of the product is that they went back
and scrubbed it and used the same vaccine, so we'd like to
check that if you could for us.
Mr. Egan. Yeah, I'd be very happy to. I do not believe
that's allowed.
Mr. Burton. Would you know if they did that?
Mr. Egan. It would have to be part of the manufacturing
record, yes. Any reprocessing----
Mr. Burton. One of the accusations we have been told is
that they--that this rescrubbing process did take place. Could
that have been done without the FDA's knowledge?
Mr. Egan. Anything is possible. The only reprocessing that
I'm aware of is related to the viral inactivation, and that's
described in the CFR.
Mr. Burton. OK.
Mr. Egan. That's the polio virus inactivation.
Mr. Burton. I guess if we were to find out that a
manufacturer did clean and retest they'd be subject to
penalties by the FDA, severe penalties; wouldn't they?
Mr. Egan. I cannot really respond to the compliance side of
that, what those penalties would be.
Mr. Burton. Is there any way we can find out what those
penalties would be if that was the case?
Mr. Egan. Yes.
Mr. Burton. So you will let us know the maximum penalty for
violating those regulations. And the manufacturers are required
to, by the FDA, to keep records on all testing of vaccine prior
to releasing it to the public; that's correct?
Mr. Egan. Yes. I believe that they are required to keep
those records for--it's either 5 years or 10 years after the
date of manufacture. I don't know--I think it is one of those.
They are required to keep them for either 5 or 10 years after
the date of manufacture. We're going to have to look it up and
get back to you on the exact length of time they're required to
keep them.
Mr. Burton. I appreciate that.
Are experimental monkeys ever allowed to be used as donor
tissue for vaccine growth cultures?
Mr. Egan. Monkeys that had been used in experiments?
Mr. Burton. Mm-hmm.
Mr. Egan. No.
Mr. Burton. I guess that's another accusation that's been
made, and we'd like to verify that, and we would probably--you
would have to go to the manufacturer to get that information;
would you not? How would the FDA know about that?
In 1986, I think it was Wyeth-Lederle wrote to the FDA,
talking about a herd of monkeys that they had, that they wanted
to, I guess, reuse. Can you see if there's any correspondence
or any information on that we can get about that?
Mr. Egan. 1986 was reuse of monkeys from Wyeth?
Mr. Burton. Wyeth Lederle material, yeah. I presume that if
that was done that also would be subject to review and penalty
by the FDA, if they were doing that?
Mr. Egan. Again, I'll have to check this, but I think that
the Code of Federal Regulations states that monkeys that had
previously been used in some fashion----
Mr. Burton. Can't be.
Mr. Egan [continuing]. Cannot be used.
Mr. Burton. Well, you will let us know the maximum penalty
of what it would be if it did occur?
Mr. Egan. Well, yeah. I won't personally, but I'll ask the
compliance, yes.
Mr. Burton. Thank you.
Mr. Egan. Because I don't know that part of this.
Mr. Burton. How often does the FDA conduct site visits to
inspect vaccine manufacturing facilities?
Mr. Egan. Those are generally biennial.
Mr. Burton. Biennial?
Mr. Egan. Yes, sir.
Mr. Burton. Every 2 years?
Mr. Egan. Yes, sir.
Mr. Burton. Are they usually announced or not announced?
Mr. Egan. They are at least now unannounced. I don't know
if in the past what the policy was, but they're unannounced.
Mr. Burton. Is there any way we can find out what the
policy has been and what it is now?
Mr. Egan. Yes.
Mr. Burton. And when it was changed?
Mr. Egan. Yes.
Mr. Burton. Thank you.
How often does the FDA review their regulations to be sure
they conform to the most current good manufacturing processes?
I presume you do that periodically; don't you? Review your
regulations to make sure that----
Mr. Egan. Well, the current good manufacturing practices
regulations that exist are, let me say, more philosophical.
They state how things should work as opposed to what exactly
everything is. For example, like a housing code may say you
have to use exactly this kind of wire, you know, in a co-axial
cable. It doesn't say that. It says that, you know, records
must be maintained, personnel must be trained, etc., and that
this is constantly evolving.
Mr. Burton. So it's a flexible approach?
Mr. Egan. It's a flexible system.
Mr. Burton. But records are kept?
Mr. Egan. Oh, yes.
Mr. Burton. OK.
How often are the FDA inspectors retrained in inspecting
for good manufacturing practices or are they retrained? I mean,
you know, if you're an insurance man or a lawyer or real estate
guy, a lot of the professions, they have an educational
process, because they have that for the inspectors.
Mr. Egan. Yeah. The inspectors for good manufacturing
practices facilities and inspections, these are actually done
by a different part of the agency than the Office of Vaccines,
so I'll have to get back to you on that answer, but I believe
that they are given training in the beginning and that there's
continual updating.
Mr. Burton. Continuing education?
Mr. Egan. Continuing education.
Mr. Burton. Well, if we could get that, that would be
helpful.
If a manufacturer is found to be in violation of FDA
regulations, what can the agency do to the manufacturer? Can
they close them down or penalize them? What do they do?
Mr. Egan. I'll have to get the lawyers to----
Mr. Burton. OK.
Mr. Egan [continuing]. To give you exactly what those are,
but we can certainly suspend or revoke the license.
Mr. Burton. I did know we were talking about the
vaccination for anthrax, and the major manufacturer was shut
down for a while because of some problems like that. We'd just
like to know what the rule of--that you follow to deal with
that.
Has the FDA ever taken any action against any of the FDA's
licensed polio vaccine manufacturers? If you don't know----
Mr. Egan. I don't know.
Mr. Burton. OK.
In May 2000, the FDA's Public Health Service and the Center
for Biological Study and Evaluation held an advisory board
meeting to review vaccines and other biologically related
agents. At the board meeting, advisory board Chairman Harry
Greenberg admitted that there's no way to ensure absolute
purity in the vaccine manufacturing process. Is that a pretty
accurate statement?
Mr. Egan. Yes.
Mr. Burton. Chairman Greenberg also stated there was no way
possible to eliminate all infectious adventitious agents, which
SV40 would be one example of. Is that a correct statement as
well?
Mr. Egan. Well, you know, if we want to talk about, you
know, adventitious agents' molecules, ensuring that something
is out to the last possible molecule or the last, you know,
virion is essentially impossible.
What one does is, you know, as the case with SV40 for the
best available technology, that the materials are negative to
that testing. It's impossible to go beyond the limits of
scientific testing.
Mr. Burton. I will guess this is a tough question----
Mr. Egan. And the same, for example, if you had, you know,
water and you wanted to say that the lead content of water must
be, you know, approved, that there isn't one single lead
molecule in the entire reservoir. It's impossible.
Mr. Burton. Well, has the FDA ever established a threshold
level for contamination for vaccines? I mean, is there a
maximum level of contamination that you would accept or is that
a flexible thing? Is that a judgment call?
Mr. Egan. Right. It would be flexible, depending on the
situation, vaccine materials.
Mr. Burton. That's the way it sounds when SV40 was first
found.
Mr. Egan. With SV40, when it was first found they developed
very sensitive tissue culture tests that were developed, and
the answer was that there could be no SV40 demonstrated by that
testing.
Mr. Burton. So they were almost 100 percent sure there was
no SV40 in those?
Mr. Egan. We can make estimates of what the most could have
been, there would have been, and it's very small.
Mr. Burton. Is there some kind of standard that you're
considering developing that would set a minimum level
acceptable for these contaminants or can you do that?
Mr. Egan. For SV40?
Mr. Burton. No, for any kind of a contaminant.
Mr. Egan. Well, I mean, we certainly have, you know,
standards for a lot of things. For example, the amount of
residual DNA in vaccines or in biological products, you know,
cannot be above a certain number of picograms. So these
standards are developed and used all the time.
Mr. Burton. The bottom line is you can't be 100 percent
free of contamination, you can't guarantee that, just do the
best you can?
Mr. Egan. Yes, sir.
Mr. Burton. OK. Thank you.
What else do we have? Anything else?
We're almost finished here, and I appreciate your patience.
Mr. Egan. You're very welcome, sir. This is a very
important issue.
Mr. Burton. It is, it is, and you know there's lawsuits
pending on some of these issues.
Mr. Egan. Yes, I'm aware of that.
Mr. Burton. There are people who worked at the health
agencies who take issue with some of the statements I've
admitted, and we just wanted to make sure we clear it up.
Mr. Egan. We have disagreements all the time.
Mr. Burton. The IOM's SV40 report issued in October 2002--
and this is a question for any of you--recommended that the
appropriate Federal agencies develop a vaccine contamination,
prevention, and response plan. The plan should identify the
steps already in place of those that need to be developed to
prevent contamination of vaccines and to respond to concerns
about possible contamination. The plan should include
strategies for routine assessment of vaccine for possible
contamination, notification of public health officials, health
care providers and the public if contamination occurs,
identification of recipients of contaminated vaccine and
surveillance and research to assess health outcomes associated
with contamination. What have either of you or your two
agencies done to implement that recommendation?
Mr. Egan. That's being handled by the National Vaccine
Program Office and specifically something known as the
Interagency Group within that office, which has representatives
from each of the Federal agencies that's involved with
vaccines. So that plan is--that part of the recommendation of
the IOM is handled by the National Vaccine Program Office.
Mr. Burton. How far advanced is that plan; do you know?
Mr. Egan. I'm not the representative to it, so I don't
know.
Mr. Burton. Do we need to request that information from
them or could you request it for us?
Mr. Egan. I can ask the initial vaccine program where they
stand on that program.
Mr. Burton. The last thing is, also, it's important--if a
plan is developed, is there a communication program that's
being formulated to inform the public and medical practitioners
about it?
Mr. Egan. That should be part of the plan. I think that is
part of the recommendation of the IOM.
Mr. Burton. OK.
Mr. Egan. And I certainly concur with that.
Mr. Burton. We'd like to know about that, as well.
Is there anything else we need, right now?
I want to thank you very, very much for your patience. I'm
sure we'll be talking in the future, but you're very helpful,
and we appreciate it.
I would really like to get from the two of you, you know, a
proposal or whatever you want to call it that would help in
getting additional funding and the cross-pollination of the
agency so that we could maybe get to the conclusion a little
bit quicker on cancer.
OK, hey, thanks a lot. We appreciate it.
Mr. Egan. You're very welcome, Mr. Chairman.
Mr. Burton. We stand adjourned.
[Whereupon, at 4:45 p.m., the subcommittee was adjourned.]
[The prepared statement of Hon. Elijah E. Cummings
follows:]
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