[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
HEPATITIS B VACCINE: HELPING OR HURTING PUBLIC HEALTH?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY, AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
MAY 18, 1999
__________
Serial No. 106-97
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
63-308 CC WASHINGTON : 2000
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
JOHN T. DOOLITTLE, California (Independent)
HELEN CHENOWETH, Idaho
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
------
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
JOHN L. MICA, Florida, Chairman
BOB BARR, Georgia PATSY T. MINK, Hawaii
BENJAMIN A. GILMAN, New York EDOLPHUS TOWNS, New York
CHRISTOPHER SHAYS, Connecticut ELIJAH E. CUMMINGS, Maryland
ILEANA ROS-LEHTINEN, Florida DENNIS J. KUCINICH, Ohio
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
DOUG OSE, California
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Robert B. Charles, Staff Director and Chief Counsel
Sharon Pinkerton, Deputy Staff Director
Amy Davenport, Clerk
Cherri Branson, Minority Counsel
C O N T E N T S
----------
Page
Hearing held on May 18, 1999..................................... 1
Statement of:
Katz, Dr. Samuel, the Infectious Diseases Society of America;
Dr. Bonnie Dunbar, molecular biologist, Baylor College of
Medicine; Dr. Burton Waisbren, Sr., F.A.C.P.; and Dr.
Barthelow Classen, president and CEO, Classen
Immunotherapies, Inc....................................... 174
Margolis, Harold, Chief of the Hepatitis Branch, Centers for
Disease Control; John Livengood, National Immunization
Program; and Susan Ellenberg, Director of Biostatistics and
Epidemiology Division, Food and Drug Administration........ 125
Moakley, Hon. John Joseph, a Representative in Congress from
the State of Massachusetts; Michael Belkin; Judy Converse;
Marilyn and Lindsay Kirschner; Barbara Hahn; Karen with
PKIDS; and Betty Fluck..................................... 58
Thiel, Thelma, chairman and CEO, Hepatitis Foundation
International; and Barbara Loe Fisher, president, National
Vaccine Information Center................................. 251
Letters, statements, et cetera, submitted for the record by:
Belkin, Michael, prepared statement of....................... 67
Classen, Dr. Barthelow, president and CEO, Classen
Immunotherapies, Inc., prepared statements of........... 226, 238
Converse, Judy, prepared statement of........................ 88
Dunbar, Dr. Bonnie, molecular biologist, Baylor College of
Medicine, prepared statement of............................ 218
Ellenberg, Susan, Director of Biostatistics and Epidemiology
Division, Food and Drug Administration, prepared statement
of......................................................... 128
Fisher, Barbara Loe, president, National Vaccine Information
Center, prepared statement of.............................. 260
Fluck, Betty, prepared statement of.......................... 114
Karen with PKIDS, prepared statement of...................... 108
Katz, Dr. Samuel, the Infectious Diseases Society of America,
prepared statement of...................................... 176
Kirschner, Lindsay, prepared statement of.................... 99
Kirschner, Marilyn, prepared statement of.................... 95
Margolis, Harold, Chief of the Hepatitis Branch, Centers for
Disease Control, prepared statement of..................... 143
Moakley, Hon. John Joseph, a Representative in Congress from
the State of Massachusetts, prepared statement of.......... 61
Thiel, Thelma, chairman and CEO, Hepatitis Foundation
International, prepared statement of....................... 254
Tierney, Hon. John F., a Representative in Congress from the
State of Massachusetts, prepared statement of.............. 56
Waisbren, Dr. Burton, Sr., F.A.C.P., prepared statement of... 200
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 5
HEPATITIS B VACCINE: HELPING OR HURTING PUBLIC HEALTH?
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TUESDAY, MAY 18, 1999
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2247, Rayburn House Office Building, Hon. John L. Mica
(chairman of the subcommittee) presiding.
Present: Representatives Mica, Towns, Tierney, and Waxman.
Staff present: Sharon Pinkerton, deputy staff director; Amy
Davenport, clerk; Cherri Branson, minority counsel; and Jean
Gosa, minority staff assistant.
Mr. Mica. Good morning, I would like to call this meeting
of the Subcommittee on Criminal Justice, Drug Policy, and Human
Resources to order.
This morning, the topic of hearing is ``Hepatitis B
Vaccine: Helping or Hurting Public Health?'' I will begin this
morning's proceeding by reading my opening statement, then I
will yield to the minority for their opening comments and other
Members who may join us. Finally we will proceed to our four
panels this morning, and I am sure into this afternoon.
Public health, including vaccine safety, is critically
important to our subcommittee. Today we are exercising our
oversight responsibility for the Department of Health and Human
Services, and we are committed to ensuring that our national
immunization policies and programs are functioning properly.
The Centers for Disease Control and Prevention, the CDC,
and the Food and Drug Administration are Federal agencies
primarily responsible for immunization policy and safety. They
will be sharing their expertise with us later in this hearing.
There is no doubt that immunizations have greatly improved
public health in our country. Small pox has been eradicated,
and cases of polio, tetanus, and diphtheria are today very
rare. These are great victories for our public health system.
Unfortunately, however, the history of immunization shows
that sometimes vaccinations do injure a child or an individual
rather than inoculating them. That is why Congress created the
Vaccine Injury Compensation Program in 1986 to compensate those
who have been harmed by a vaccine.
My colleague, the ranking member of our full committee, the
gentleman from California, Mr. Waxman, who I hope will be
joining us shortly, and my brother Dan Mica, who was then a
Member of Congress from Florida, worked to successfully enact
that law.
Oversight of that law and program, I believe, is a very
important congressional responsibility. This is the first
oversight hearing on that law held in 10 years. The purpose of
which is not only to protect vaccine manufacturers, but also to
compensate individuals injured from inoculation by a vaccine. I
do have some concerns whether the compensation fund is working
in the way Congress intended, and we will discuss that today
and possibly hold additional hearings.
The Department of Health and Human Services has issued new
rules making it harder to receive compensation, so that while
there is over $1 billion in the fund, only a fraction of that
was awarded last year. The vaccine experience in the early
1980's also demonstrates that when a pattern of injuries from a
vaccine emerges, the vaccine can be made safer.
The crisis in public confidence in diphtheria, tetanus, and
pertussis, DPT as it is commonly known, led to creating the
compensation law and also resulted in the creation of a safer
vaccine. Today what is termed the ``whole cell vaccine'' that
caused the controversy is coming off the market, and has been
replaced by a safer vaccine called ``acellular vaccine.''
Today, we have convened individuals from a variety of
government, academic, professional, and citizens groups in an
effort to provide a structured opportunity for Members of this
subcommittee to ask questions about the Federal Government's
hepatitis B vaccine policy and its impact on our public health.
I want to make very clear at the outset that the purpose of
this hearing is not to scare parents away from immunizing their
children. That should not be the result of today's hearing. The
purpose of this hearing is to examine the effectiveness of the
1986 law, also to learn more about how our Federal agencies are
administering immunization policy and monitoring and analyzing
the safety of the hepatitis B vaccine, and finally to review
evidence of adverse reactions to the vaccine.
The hepatitis B virus is certainly a very serious disease.
We will hear today from witnesses who have experienced the
terrible effects of this disease. In 1996, the CDC reported
10,637 new cases of hepatitis B, 279 cases which affected
individuals below the age of 14. The CDC estimates that 4,000
to 5,000 people each year die from hepatitis B-related liver
disease.
To combat this disease, the CDC issued guidelines in 1991
recommending that every infant receive the hepatitis B vaccine.
In 1995 the CDC recommended the routine vaccination of
teenagers. The FDA first licensed a plasma-derived hepatitis B
vaccine in 1981. In 1986, the FDA licensed the first
recombinant hepatitis B vaccine, meaning the vaccine is the
first genetically engineered one.
Based on CDC recommendations, 42 States mandate that
children be vaccinated before entering kindergarten; 20 million
children a year now receive some type of required vaccine.
Almost 90 percent of all children in this country are now
immunized.
When a parent takes their child in for a vaccine, they are
supposed to be given an information sheet outlining the risks
and benefits of the vaccine. While almost all of the States
mandating childhood vaccinations allow exemptions, the
information sheet does not tell parents that these exemptions
exist.
Recent news reports have questioned the safety of the
hepatitis B vaccine, and have also suggested an association
between the vaccine and multiple sclerosis and other autoimmune
disorders.
I would like to point out a report I have seen from New
Hampshire. The 48 reported adverse reactions to the vaccine in
children aged 1 to 10 in recent years were 16 times greater
than the cases of the disease. There were only three cases of
the disease.
It was reported that there were four times as many child
deaths, 11, as there were cases of the disease. If this is
true, I find the information quite shocking.
We will hear more about these statistics later in the
hearing from some of the researchers that were involved in
analyzing this particular series of cases.
Is it possible that the preventive measure for the disease
is riskier than the disease itself? We must ask ourselves that
question. But our job today is not to prove whether or not this
vaccine causes illnesses or death. Instead, we have created a
forum for asking questions about what scientific evidence does
exist and whether further studies should be completed.
Specifically, I would like this hearing today to examine
some of the following issues. First, what is being done to
study the adverse reactions reported in the Vaccine Adverse
Event Reporting System?
Second, do the benefits of administering the vaccine to
infants outweigh the risks?
Third, what process does the CDC employ to make a
recommendation for a vaccine? What role do pharmaceutical
companies play in that process, and do conflicts of interest
exist?
Fourth, what disclosure is required before the vaccine is
given, and is that disclosure adequate?
With this outline in mind, I would like to now recognize
the ranking member of our full committee. As I mentioned
before, he was one of the individuals very much involved in
passage of the 1986 law. I know he worked with my brother Dan
on this matter, and was very instrumental in reviewing this
whole matter of vaccinations, adverse reactions, and
compensation. So I am delighted that he has joined us, and I
would like to recognize our ranking member, the gentleman from
California, Mr. Waxman, for a statement.
Mr. Waxman. Thank you very much, Mr. Chairman. I appreciate
your recognizing me to make this opening statement and I want
to thank you for the accommodations that you have made in
adding additional witnesses to this hearing.
This hearing today touches on an extremely important public
health issue. Vaccination is an essential weapon against
infectious disease, and I think it is important that we pay
attention to how well we are succeeding in our fight against
infectious disease.
While childhood diseases continue to spread death,
disability, and misery through other parts of the world, the
United States has made tremendous progress against polio,
diphtheria, whooping cough, and other diseases.
Without vaccination, our population would be vulnerable to
devastating outbreaks of these diseases. We cannot be
complacent about our success. Unlike our parents and
grandparents, we are not terrorized every year by the threat of
polio and whooping cough epidemics.
Perhaps that makes it easier to doubt the value of vaccines
and to focus on their potential risk, but if children are
discouraged and parents frightened from the vaccines and do not
take these important vaccines, we will quickly become
vulnerable again to infectious diseases.
No one doubts that there are adverse reactions to some
vaccines. They happen. Children and adults suffer disease or
disability as a result. That is why I sponsored the National
Childhood Vaccine Injury Act of 1986 which established the
compensation program. This program relies upon the best
available science and medicine to provide an alternative to
litigation for individuals who suffered the specific vaccine-
related injuries.
Today, we must continue to rely upon what science tells us
about the benefit and risks of vaccines. We know that hepatitis
B kills 4,000 to 5,000 people in the United States every year.
We know that at least 25,000 children are infected with
hepatitis B each year, and we know hepatitis B is a silent
killer that waits decades before destroying livers and ending
lives.
Everything we know about the hepatitis B vaccine indicates
that its benefits far outweigh its risks. That being said, we
must naturally remain vigilant and continue epidemiological
research into potential side effects of the vaccine.
Today, we are going to hear compelling stories from both
sides of the controversy over hepatitis B vaccines. We will
hear from families who have suffered adverse reactions to the
vaccines or health problems they believe are linked to the
vaccine. We will hear from the families of those who have
experienced hepatitis B, the social stigma surrounding it, and
the fears engendered by this highly infectious disease, and I
am sympathetic to all of our witnesses and look forward to
their testimony.
Mr. Chairman, I wish to submit for the record, along with
this statement, letters and statements supporting hepatitis B
vaccine from leading medical and patient organizations,
including the World Health Organization, the American Medical
Association, the American Academy of Pediatrics, the American
Liver Foundation, Hepatitis Foundation, and the National
Multiple Sclerosis Society.
I think it is important to have in our record what these
public health groups say about this vaccine and their support
of the efforts to continue the vaccination program.
I am pleased that we have Congressman Moakley, who will
tell us from his own experience about the hepatitis disease;
and I welcome all of the other witnesses and look forward to
their testimony.
Mr. Mica. I thank the gentleman. Without objection, the
items that he mentioned will be made part of the record.
[The prepared statement of Hon. Henry A. Waxman and the
information referred to follow:]
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Mr. Mica. Also, since notice of the hearing, we have many
associations and groups from all over the country providing us
with remarks they have requested be entered in the record. I
would like to ask unanimous consent that they also be made part
of the record and without objection, so ordered.
I would now like to recognize the gentleman from
Massachusetts, Mr. Tierney.
Mr. Tierney. Thank you, Mr. Chairman, and thank you for
holding this hearing on the important topic of hepatitis B
vaccine.
Less than 100 years ago, infectious diseases were the most
common cause of death, disability, and disease in the United
States. Polio, pertussis, measles, and diphtheria killed and
disabled millions of people. However, because of the
development and use of vaccines, these diseases are a distant
memory for most Americans. Unfortunately, as old threats fade
away, new threats to public health emerge.
Today hepatitis B, an infectious disease which can be
eliminated with universal vaccination, unnecessarily kills
thousands of people a year in the United States. According to
the CDC, in the United States, 200,000 people contract
hepatitis B each year.
Each year over 11,000 people are hospitalized and 20,000
remain chronically infected. Overall, an estimated 1.25 million
people in the United States have chronic hepatitis B infection;
and 4,000 to 5,000 die each year from hepatitis B, related
chronic liver disease or liver cancer.
Hepatitis B vaccine prevents both hepatitis B infection and
those diseases related to hepatitis B infection. The vaccine
has been available since 1982. The CDC has recommended the
hepatitis vaccine as part of the routine infant vaccination
schedule since 1991.
Prior to the CDC recommendations, approximately 30,000
infants and children became infected with hepatitis B each
year. Hepatitis B vaccines are safe and effective. More than 20
million people have received the hepatitis B vaccine in the
United States and more than 500 million have received the
vaccine worldwide.
Mr. Chairman, I am glad to hear all of our witnesses today,
but particularly honored with the presence of Representative
Joe Moakley, dean of the Massachusetts delegation. We all know
Mr. Moakley as the voice of the 9th Congressional District of
Massachusetts and the ranking Democrat on the Rules Committee.
However, many of us are not aware of his personal
experience with hepatitis B. In the 1980's he was diagnosed
with hepatitis B. For several years he didn't know that he had
contracted the disease. However, in 1995 with only a few months
to live because of the damage the disease had caused to his
liver, he received a liver transplant. Today he is a healthy
man, and he is here to share with us his thoughts about the
hepatitis B vaccine, and I look forward particularly to hearing
his testimony.
Mr. Chairman, thank you again for this important hearing.
Mr. Mica. Thank you again for your opening statement and
also for your comments and introductory remarks about our
colleague, Mr. Moakley.
[The prepared statement of Hon. John F. Tierney follows:]
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Mr. Mica. Our first panel is made up of individuals who
have had some personal experience with hepatitis B, including
our colleague. Let me introduce the panel, and I think Mr.
Tierney has given an introduction to Joe Moakley.
We have Michael Belkin, Judy Converse, Marilyn and Lindsay
Kirschner, Barbara Hahn, Karen with PKIDS, and we have Betty
Fluck.
That is our first panel, and again all of these individuals
have some personal relationship and experience with the problem
of hepatitis B.
Except for Mr. Moakley--we don't swear in our Members of
Congress--this subcommittee is an investigations and oversight
subcommittee, and so we do swear in our witnesses. Again, with
the exception of our Member, if you could all please stand.
[Witnesses sworn.]
Mr. Mica. The witnesses have answered in the affirmative
and I would like to take this opportunity to welcome each and
every one of you for participating and for coming forward and
providing this subcommittee with your important testimony and
personal experience.
Since we have such a large number of requests for
witnesses, we are going to try to adhere pretty strongly to the
5-minute rule. If you have a lengthy statement or additional
information you would like made part of the record, upon
request we will have that entered into the record.
So with those opening remarks and welcome, I would like to
now recognize the distinguished gentleman from Massachusetts
and ranking member, former chairman of the Rules Committee, Mr.
Moakley.
STATEMENTS OF HON. JOHN JOSEPH MOAKLEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MASSACHUSETTS; MICHAEL BELKIN; JUDY
CONVERSE; MARILYN AND LINDSAY KIRSCHNER; BARBARA HAHN; KAREN
WITH PKIDS; AND BETTY FLUCK
Mr. Moakley. Thank you very much, Chairman Mica and
Congressman Waxman and my colleague from Massachusetts,
Congressman Tierney. I thank you very much for allowing me to
testify today and give my perspective on the hepatitis B
immunization.
As Congressman Tierney said, I was diagnosed with hepatitis
B in the early 1980's. The doctors thought I may have gotten it
on a congressional fact-finding trip to China, but they were
not sure.
Mr. Chairman, this is one of the frightening aspects of
hepatitis B. Thousands and thousands of people contract it and
have no idea how they got it. In fact, 40 percent of the people
who get hepatitis B aren't in the so-called high-risk
categories and don't even realize that they have it for many,
many years.
I was sick for years, and had no idea that my liver was
failing. In the spring of 1995, after a thorough examination,
my doctor told me I had 2 months to live. The hepatitis virus
had led to cirrhosis of my liver. I was very sick, had no
strength; and I was severely jaundiced, but I was one of the
lucky ones.
I was put on a waiting list for an organ transplant and
received a donor organ just before it was too late. This July
it will be 4 years since my successful liver transplant, and
there is not a day that goes by that I don't thank God for my
renewed health.
Unfortunately, 1.25 million Americans have hepatitis B and
are potentially infectious to others. Each year 150,000
Americans get hepatitis B and 4,000 to 5,000 die from it. These
are very alarming statistics, made even more tragic by the sad
reality that we have a severe shortage of organ donors in this
country, and many of these people with hepatitis B will
eventually require a liver transplant.
That is why immunization is still the most effective means
of preventing hepatitis B and its consequences. Hepatitis B
vaccines are safe and highly effective in preventing hepatitis
B infection amongst susceptible children and adults.
You say 42 States; I don't know. It is somewhere between 38
and 42, including my own State of Massachusetts, that have
enacted laws requiring children to be vaccinated against
hepatitis B before they enter kindergarten. Immunization is
still the best weapon and by far the most cost-effective way we
have to prevent this devastating disease.
I have heard of the recent reports which question the
safety and the efficacy of the hepatitis B vaccine. Some of
them link the vaccine to multiple sclerosis and other
autoimmune diseases. But, Mr. Chairman, I have some of the same
information that Mr. Waxman has. The World Health Organization,
the American Academy of Pediatrics, and the Multiple Sclerosis
Society have all recommended that the hepatitis B vaccine not
be suspended.
Experts have reviewed the data and determined that there is
no clinical or scientific evidence whatsoever linking the
hepatitis B vaccine with multiple sclerosis or other autoimmune
disorders. The fact of the matter is that the benefits of the
hepatitis B vaccine far outweigh any of the claimed risks.
Hepatitis B infection is still a real threat in this Nation
and throughout the globe. That is why it is so important to
continue with this immunization. These are programs to prevent
the spread of this terrible disease. Hepatitis B is a highly
contagious disease, 100 times more contagious than HIV; and we
have to continue to immunize our infants and children.
The truth is, when immunization rates fall the disease
returns. We saw this a few years ago when there were huge
outbreaks of measles, which everybody assumed was under
control. So even though these reports of people developing
disorders after vaccinations are very, very tragic, we need to
look at the clinical and scientific evidence.
The Institute of Medicine, the World Health Organization,
and the French Government have all conducted studies that
conclude there is no evidence of a causal relationship between
hepatitis B and multiple sclerosis or other disorders. As sad
as these stories are, and I have heard them all, Mr. Chairman,
they should not determine public health policy in this country.
Because, Mr. Chairman, if we suspend immunization programs, we
will only end up with more cases of hepatitis B that could be
even more tragic.
Take it from me. I don't wish this terrible disease on
anyone. There is no reason for anyone to suffer from this
disease. It is totally preventable. So I look forward to the
day that hepatitis B meets the same fate as small pox. Mr.
Chairman, this vaccination will help get us there.
Thank you very much, and I have a conflict of time so if
there are any questions, I would be glad to answer them now,
and then I would like to be excused.
Mr. Mica. Thank you. We would be glad to extend that
courtesy to you.
[The prepared statement of Hon. Joe Moakley follows:]
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Mr. Mica. Mr. Waxman, do you have any questions of Mr.
Moakley at this time?
Mr. Waxman. No. I want to thank you very much for your
testimony. I think you have told us in a very eloquent way,
from your own personal experience, if we can prevent this
disease and how important it would be to do so. Thank you.
Mr. Mica. Mr. Tierney.
Mr. Tierney. I have no questions. Just to thank you and say
that we are glad that the results are as they were.
Mr. Moakley. I am, too. Thank you, Mr. Chairman.
Mr. Mica. Thank you, Mr. Moakley. I don't have any
questions at this time, but I am going to listen to all of the
panels that we have, and I may personally get back with you.
Mr. Moakley. That would be great.
Mr. Mica. And, hopefully, have some more educated questions
at that time.
Mr. Moakley. And I would be willing to present myself to
the panel once again, if necessary.
Mr. Mica. We will now hear from Mr. Michael Belkin.
Mr. Belkin. Thank you for holding this hearing, Mr.
Chairman.
First of all, I would like to submit for the record, the
25,000 adverse reaction reports from the government reporting
system and my recorded testimony which is an investigation of
those reports.
Mr. Mica. I don't know if we will be able to submit all of
those in the record. But what we can do is make reference to
them, and they can be kept with the committee. I think that
would be appropriate. Is that acceptable?
Mr. Tierney. That is fine.
Mr. Mica. We will do that because it is almost impossible
to include all of those in the report. We will make reference
to them, and they will be kept with the committee records.
Without objection, so ordered.
Mr. Belkin. My daughter Lyla Rose Belkin died on September
16, 1998, at the age of 5 weeks, about 15 hours after receiving
her second hepatitis B vaccine booster shot.
Lyla was a lively, alert 5-week-old baby when I last held
her in my arms. Little did I imagine as she gazed intently into
my eyes, with all of the innocence and wonder of a newborn
child, that she would die that night. She was never ill before
receiving the hepatitis B shot that afternoon. At her final
feeding, she was extremely agitated, noisy and feisty and then
she fell asleep suddenly and stopped breathing. The autopsy
ruled out choking.
The New York medical examiner ruled her death sudden infant
death syndrome, but in the notes and in the conversations with
our pediatrician on the day of the autopsy--this is in the
pediatrician's notes--what the coroner said, ``Brain swollen.
Not sure cause yet. Could not see how recombinant vaccine could
cause problem.''
SIDS is a diagnosis of exclusion. It means it is not this,
it is not that. A swollen brain is not SIDS. It turns out in
the medical literature a swollen brain, brain inflammation, is
one of the most common signs of an adverse reaction to a
vaccine.
I set out to do an investigation of this vaccine and
adverse reactions, and these are my conclusions and I urge you
to read them. I have some prepared remarks that are far too
lengthy to summarize here.
First of all, let's look at the vaccination policy in this
country, this Rube Goldberg flowchart that I have. This
committee has oversight over the CDC, which has oversight over
the ACIP, the Advisory Committee on Immunization Practices.
This committee sets immunization policy, and I urge you to
really concentrate on this. I think there is a conflict between
the public interest and the private interest of drug companies
and the interest of the bureaucracy that is violating the
public interest. As an oversight committee, I think this is
something that you should look into.
This committee sets mandates which go out to the States and
go to the children, and some small percentage of children have
adverse events which go into this thing called VAERS, Vaccine
Adverse Event Reporting System. From VAERS they go into an
empty drawer, and they pile up and go nowhere and nothing is
done. The CDC and the FDA do studies saying we don't see any
problem with anything.
Can you please change the chart.
First of all, newborn babies are not at risk of getting
this disease. I quote you the risk groups from the CDC
hepatitis B disease fact sheet: injection drug users, sexually
active heterosexuals, homosexual men, infants from disease
endemic areas, low socioeconomic levels, sexual household
contacts of infected persons, infants born to infected mothers,
healthcare workers, chemodialysis patients. Not newborn babies.
Then why do you say are newborn babies infected with
hepatitis B? The vaccine is the first thing that they get in
the first 24 to 48 hours of their lives in the hospital. Here
is the ACIP's original statement from 1991. ``In the United
States, most infections occur among adults and adolescents.
Efforts to vaccinate persons in the major risk groups have had
limited success. In the long term, universal infant vaccination
would eliminate the need for vaccinating adolescents and high-
risk adults.''
And then they say, ``Hepatitis B vaccination is recommended
for all infants. The first dose can be administered during the
newborn period, preferably before the infant is discharged from
the hospital.'' That is where it came from.
I quote you from government statistics, summary of
notifiable diseases, 54 cases of hepatitis B in the 0 to 1 age
group in 1996. And if we compare that, that is that. In the
VAERS reports in that year, there is more than 1,000 adverse
reaction reports, and there are 47 deaths of these reports. So
this needs to be investigated.
I am not saying that every report in VAERS is directly
related to the vaccine, but I have torn apart the VAERS data,
and I am trained in statistics. I am an advisor to some of the
largest financial institutions in the world and a former
proprietary trading strategist at Salomon Brothers.
One of the most striking findings of this data is that
almost 80 percent of the reports of hepatitis B, 77 percent are
in females; only 23 percent in males. More than three times as
many women are having adverse reactions reported in VAERS. No
one is looking at this.
Dr. Chen of the CDC dismisses it and says nurses tend to
over-report. I think that is a big mistake. Independent doctors
with no financial interest should take a look at this.
I would just like to conclude with the way vaccine policy
is set in this country. Dr. Modlin at the ACIP meeting on
February 19, which I attended in Atlanta said--first of all he
said at a debate in New Hampshire: ``How do we decide
something? Is the theory biologically plausible? Has it been
tested by appropriate methods? Is the study well concluded? Are
the results statistically sound?''
Now I read to you from the transcript of the ACIP meeting
regarding the approved rotavirus for premature infants:
``Available data are insufficient to fully establish the safety
and efficacy of rotavirus vaccine in premature infants.'' There
is a section under Adverse Events that details what little
information there actually is with respect to premature
infants. To my knowledge, we don't have data from a clinical
trial specifically. Some bit of information, as I recall,
suggested that there was a relative risk for hospitalization.
Obviously, a situation where we have to make a judgment in the
absence of data and with a vaccine that has not yet been tested
in this group.
They voted 9 to 1 to approve rotavirus vaccine for
premature infants with no scientific statistical studies on it.
I think that is a big problem.
This is my charge to you. I am afraid that this vaccine
policy is dominated by forces that are not in the public
interest and this committee should investigate the 1991 ACIP
recommendation establishing universal hepatitis B vaccination
of newborn babies; and if, as with the rotavirus vaccine
examples were done, no studies were done to prove that this was
safe in a broad sample of racially and genetically diverse
babies less than 24 to 48 hours old when they established this
recommendation, we can find those studies.
We have a Freedom of Information Act request in from the
National Vaccine Information Center. Then the CDC has been
experimenting on babies like guinea pigs, and this committee
should suspend that universal at-birth immunization policy.
Thank you.
Mr. Mica. Thank you for your testimony. We will hold
questions until we have heard from all of the witnesses.
[The prepared statement of Mr. Belkin follows:]
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Mr. Mica. Judy Converse, you are recognized.
Ms. Converse. Thank you for the opportunity to testify. I
regret having a reason to speak here today and have no other
reason to do so except for the sake of truth. I live in
Massachusetts. I wish to state also that I hold a master's
degree in public health and I am a registered dietician, I was
trained to accept and encourage immunization and was in no way
inclined against immunizing my son Benjamin. He is 2\1/2\ now.
I would like to say there is no history of autism or
seizure disorder in my family or my husband's family. If Ben
were here in front of you today, he would seem completely
normal, but I will try to explain a little bit about his
disability which he struggles with every day. He was born full
term, normal in every way. Vaginal birth with no interventions
or drugs. His Apgar scores were 9 and 10, which means that all
of his reflexes were perfect and present.
Before discharge, he was immunized with Recombivax HB
against hepatitis B. Neither I nor my husband recall receiving
informed consents for this vaccine, nor do we recall seeing him
get the shot, but it is in his immunization record. No signed
informed consent specific to this hepatitis B vaccine was
present in the copy of Ben's medical record which we recently
requested.
His fourth night in this world was his first at home. And
about 5 hours after arriving home, he had his first seizure.
Frantic calls to maternity and pediatric staff fell on deaf
ears. The extent of the medical advice we received was to put
him on our clothes dryer and turn it on.
No one mentioned the vaccine. No one expressed concern that
he was turning blue, that he couldn't stop screaming or that he
appeared to be having tremors or full-body spasms. Ben had 3
more seizures, losing consciousness in the next 8 days, as well
as many episodes of arching his spine rigidly without losing
consciousness.
He vomited forcefully every day, had a recurring mild
fever, eczema, was unable to remain asleep, had diarrhea and
cried constantly, but no one thought any of this was out of the
ordinary. I was told these thing are normal for a breast fed
infant which, of course, I knew was not true. He was only 12
days old.
The third time he passed out, he did not resume
consciousness. He was cyanotic. At the emergency room he was
tested for several diagnoses and all were negative or
inconclusive. He was observed overnight, and after nearly
losing him, we were sent home the next day with a shrug.
No one mentioned the vaccine. No one expressed interest or
concern for the events of the previous week and no one advised
us in any way about what appeared to be seizures and a struggle
for his life.
Ben's medical record even states in a gross understatement
that his first days of life prior to this admission were
uneventful. The same doctor who wrote this note privately
admonished me for agreeing with the attending pediatricians to
spare Ben the trauma of another spinal tap.
Convinced Ben had meningitis, he said, ``It is people like
you who cause lifelong mental retardation.'' Ben's discharge
note states only that he had apnea, despite having tested
negative for it. We entered the hospital looking for answers
but left with none. He worsened with the second immunization
for hepatitis B at age 4 weeks.
This was when I realized he had been given the shot at
birth and that was probably causing his problem. I asked for a
delay for Ben's other immunizations at 2 months and was
refused. I knew that accepted pediatric practice dictates that
a sick child should not be immunized, but the doctor refused.
When I persisted, he told me we could either immunize Ben on
schedule, which we had to do because it was the law, or we
could call DSS.
With this threat, Ben was immunized and all of his symptoms
worsened. At 4 months he was immunized again. At 6 months, I
refused further shots and switched doctors. He was seen by
neurologists and developmental specialists, but no one could
explain why he was too floppy to attempt normal developmental
tasks, couldn't sleep, suckled poorly, kept vomiting, why
eczema persisted, despite being breast fed, why he passed out
in shock when he heard Velcro, plastic bags, or aluminum foil.
By age 10 months, he could not pull himself to sitting or
crawling and could not roll over. We sought help from the Early
Intervention Program, and Ben qualified for services based on
his motor delays. For the first time, a formal acknowledgment
of his delays was drafted. Reflexes which were normal at birth
had disintegrated and protective responses inexplicably
delayed.
Ben had two or three seizures a week during his early
infancy and early toddlerhood. The events of these seizures
never vary and Ben had one as recently as 2 months ago. He
cries hard with one breath which seems to empty his lungs; and
he is then silent, mouth open, not breathing and struggling for
air.
Excuse me. As he suffocates, he turns red, blue, and then
purple. His extremities become blue, his limbs flail as if he
is drowning. Often on his left side Ben will have a flapping
tremor of his hand while his arm, neck, and shoulder are
rigidly flexed.
As his asphyxiation is complete, he is gray. His eyes lose
their luster, his pupils dilate and his eyes roll back in his
head and then he is unconscious. He usually regains
consciousness quickly once his muscles are relaxed and he can
breathe again, but these episodes are traumatic, exhausting,
and frightening for Ben. They invariably occur in response to a
stimulus he cannot manage, whether it is auditory anxiety
related or from a fall or bump.
Even though Ben had seizures like this when he was just a
few days old, we were told they were breath-holding spells
which he consciously contrived in response to our
overprotectiveness. The doctors told us we were causing Ben's
seizures, odd behaviors, and delays by bad parenting.
I was told I over-nursed him by one neurologist, and asked
why I needed something to be wrong with my son by a pediatric
developmental specialist. I believe this is a grossly ignorant
assessment of what may be grand mal seizure episodes.
Ben also appears to have petit mal seizures in which he
rolls his eyes back in his head and grimaces, pierces the air
above his head with his left hand, elbow locked, and hand
quivering. Ben was diagnosed with autism recently and sensory
integrative disorder last fall.
He cannot reliably sense, organize, or prioritize
information that he receives about anything in the world. He
cannot be placed in group daycare. He is terrified of his own
peers. These few examples don't describe how profoundly
disabled he is now.
I would especially like to state that our pediatric
providers were very unsupportive, and I do believe my son would
have died if I followed their advice. We have had very little
guidance from them through this journey. His current physician
agrees not to immunize him and has supported our refusals, but
she has not reported his reaction and discouraged me from doing
so.
She told me we would be harassed by the Massachusetts State
Department of Public Health and forced to prove damage from
each vaccine with invasive blood tests. When we asked for a
medical waiver, she gave us only a vague philosophical one.
She acknowledged to me that the hepatitis vaccine is an
unnecessary affront to an infant's well-being and she refuses
to give the younger two or her three children this vaccine
because it is of no benefit.
I have no doubt in my mind that this vaccine damaged my
son, not just because he was normal at birth, full term with a
family history void of these problems, but because the
progression of events after the shot are in keeping with
criteria for a hepatitis B vaccine adverse event listed by the
Vaccine Injury Compensation Program.
The fact that the pediatric community failed to recognize
his reaction in no way exonerates them or the vaccine industry.
It simply means that thousands of healthy newborns will slip
through the cracks with severe reactions and be untreated and
un-acknowledged.
After reading data on hepatitis B in the United States, as
a person trained in public health sciences, it is plain to me
that a program to vaccinate newborns is of no worth to anyone
except those who sell vaccines. The immunity it imparts wears
off before a child is old enough to have sex with an infected
partner or use contaminated needles, which are the foremost
modes of transmission. Therefore, it is my opinion that there
is no benefit and only risk for newborns receiving this
vaccine. Thank you.
[The prepared statement of Ms. Converse follows:]
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Mr. Mica. Thank you for your testimony. We now recognize
Ms. Kirschner and Lindsay Kirschner at this time.
Ms. Marilyn Kirschner. I thank you for having us here
today. I am here with my daughter Lindsay, maintaining a
commitment to pave the way so that other parents can make an
informed choice in regard to the hepatitis B vaccine. Lindsay
is representative of all of the children who fall under the
mandate.
Six months before the vaccine, we had an idyllic life,
reveling in the joy of Lindsay's bat mitzvah, perfect in every
way. Lindsay received the hepatitis B vaccine 2 days before
entering high school.
The next day she seemed flu-like. The day after that, so
dizzy she couldn't stand up without holding the walls. The
following day she passed out. So our life goes since August
1997.
Lindsay has had syncopal and pre-syncopal episodes. Her
ability to stand was compromised for almost 6 months due to
unremitting dizziness. Following our doctor's advice, unknown
the vaccine was the culprit, Lindsay had the series of three.
It was on the third shot Lindsay became so violently ill within
2 hours that I knew the vaccine was the catalyst of her
illness.
At 16, Lindsay should be having fun with friends, dating
and driving. Instead, her days are filled with doctor visits,
15 specialists, MRIs, CAT scans, spinal taps, ER visits, and
hospital admissions. Lindsay is plagued on a daily basis with
headaches of a severe kind, joint pain, seizures, nausea, hair
loss, dizziness, gastroesophogal reflux, and extreme fatigue.
She has been diagnosed with an Acquired Dysautonomia and is
unable to hold food down with frequent retching and vomiting.
She takes a minimum of 10 medications daily; and if she misses
one, her ability to stand is in serious jeopardy for up to a
month.
We have traveled to specialists in four States and will be
traveling to doctors in two more States before July.
Unfortunately, Lindsay is not isolated in her journey. After
WPLG Miami health reporter Kristi Krueger broke Lindsay's
story, the first one to air in the country, I heard from dozens
of people who have themselves been, or have family members,
affected by this vaccine.
Please join me in viewing some clips from the Emmy Award-
winning broadcast that brought national attention to this
issue.
Mr. Mica. Maybe while they are trying to get that working--
--
Ms. Marilyn Kirschner. I will finish my testimony.
Family life as we knew it has been destroyed. This illness
is an emotional and an extreme financial drain, as I am hardly
able to work, depending on my family to support us and feeling
like a beggar for our survival.
As a single parent, this vaccine has ripped out a part of
our lives that can't be replaced. Lindsay, my former National
Junior Honor Society president in 8th grade, is now on a 504
disability plan, missing 70 days of 9th grade and pushing
beyond that in this, her 10th grade year. What about her
future, college, a career?
Will my son David ever forgive me for being so unavailable
last year when he was a senior now that he is 3,000 miles away
in L.A.? The joy of his scholarship offers and prom departure
all took a back seat to Lindsay's illness. Or the fact that he
is spending his birthday on a plane so we could be at this
hearing after just returning Sunday from his first year at USC.
What about Lindsay's puppy, Frisbee, and bird, Boca, who are
boarded almost as much as they are at home?
What about our shattered lives, barely a fragment left of
what used to be? Tragedy is not supposed to be the American
way. Lindsay, nor anyone, should have to live like this because
scientific studies weren't done to determine if this vaccine
was safe to give to every child. My daughter shouldn't have to
suffer like this because government officials and drug company
executives didn't do their jobs. Thank you.
[The prepared statement of Ms. Marilyn Kirschner follows:]
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Mr. Mica. Thank you for your testimony, and now we will
recognize Lindsay Kirschner.
Ms. Lindsay Kirschner. Thank you. I would just like you to
imagine having a life like the one that follows. Your day
starts at 2 a.m., when your body starts jerking uncontrollably
and a burning smell fills the air. After your body relaxes, you
drift back to sleep only to be awakened a short hour later
overcome by nausea.
You reach for the bowl that is always on the side of your
bed because you've had this feeling before, and you know it is
not going to be pretty. Maybe you get another 2 or 3 hours of
sleep, but a soothing voice awakens you at 6:15 because it is
time to get ready for school.
You feel a killer headache approaching on the ride and you
dread the thought of sitting in classrooms for the next 6\1/2\
hours while fighting constant dizziness and nausea.
When you try to take your Algebra II tests, you realize
that you have forgotten the formulas to use, even though you
wrote them more than 25 times in your homework last night.
As the day passes, you look at other kids and long to be
normal like them. And maybe for 10 minutes in between constant
aches and pains, you manage to forget your problems and feel
like you do belong. But then a sudden sharp pain in your arm or
the urge to vomit reminds you how different you truly are.
Let's face it. You haven't made it through one full week of
school in your 10th grade year of high school. You struggle to
keep your head up throughout the remainder of the day and are
relieved when the dismissal bell finally rings.
When you get home, forget watching Rosie or MTV. Your eyes
are already closing, and so you fall into the comfort of your
bed and stay there for the next couple hours. If you manage to
wake up in time to do all of your homework, then you struggle
to finish it because sitting at the computer brings constant
dizziness.
Later, when you start retching, you instantly regret eating
the food you had for dinner, whether it be nachos or pasta, and
you vow never to eat it again, no matter how delicious it
tastes.
Although you are anxious to get more sleep, the thought of
nighttime evokes anxiety because as you lie in bed, you know
that in just a few short hours, the painful cycle will begin
again and your struggle will continue.
To most of you, this would just be a bad dream. But it is
the reality I have faced for the past 2 years; and no matter
how hard I pinch myself, it won't go away. Thank you.
Mr. Mica. Thank you for your testimony.
[The prepared statement of Ms. Lindsay Kirschner follows:]
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Mr. Mica. I don't know if we can get this to restart there.
These are clips that you have provided, Mrs. Kirschner.
[Video shown.]
Mr. Mica. I would like to thank both of you for your
testimony and recognize at this time Barbara Hahn. Barbara, you
are recognized. Welcome.
Ms. Hahn. Thank you. I would like to thank also Congressman
Mica for allowing me to be here to testify today. My name is
Barbara Hahn. I am from the greater Cincinnati area north of
Kentucky. Up until several months ago, I was employed as an
interpreter for the deaf which takes a lot of concentration,
and also I am a chaplain.
In June 1995 I was diagnosed with hepatitis B. That was
about a week before my 25th wedding anniversary. My doctor told
my husband and I that I had a sexually transmitted disease and
that he should be tested and vaccinated.
What the doctor failed to tell me at the time was that
hepatitis B could be spread in many other ways. I had complete
trust in my husband and thank God he had faith and trust in me.
So the suggestion of sexual promiscuity did not harm our
marriage in any way.
Within a week, we were informed that my husband tested
negative as did my children who have all been vaccinated since
this ordeal began. Incidentally, none of them have had any
adverse reaction to the vaccination.
Shortly after my diagnosis of hepatitis B, an employee of
the Cincinnati public schools where I formerly worked informed
me that it was the belief that a student I had worked with had
hepatitis B. This employee and the child's nurse had gotten
themselves vaccinated.
I was furious because no one had bothered to tell me about
the vaccine, and I had worked very closely with this child as
an interpreter. I had even gone to gym class, a place where
children are frequently hurt, with this student. However, I
have since been informed that this child did not have hepatitis
and had only been vaccinated for protection since this student
was in a high-risk group, being that he had multiple
disabilities.
This story caused a great deal of pain to the student's
family, and I deeply regret if they were hurt in any way by my
checking out this rumor. I was eventually told by the
representative of the Cincinnati school occupational safety
department that I probably contacted hepatitis from a dentist
since this is thought to be one of the easiest places that we
can pick up the virus.
I never pursued this possibility any further because my
doctor told me in June 1995, at that same time that I was
diagnosed, that I already had cirrhosis of the liver which
meant that I probably had had the virus for years. I tried for
years to find out how I got this virus.
Had it been from my mother who died of liver cancer as a
result of breast cancer? Did I get it from grade school or
dental work surgeries? Did I get it from one of the hospitals
or clinics where I happened to be an interpreter? Did I get it
from a child who ran into me on the playground or from the
little girl who was upset and bit me while I was working at the
Cincinnati public schools?
Recently, the immigration policies have brought an
increasing number of foreign students into our school systems,
and the incidents of hepatitis are much higher in other
countries. Is that how I got this disease? I am part of the 40
percent of hepatitis B patients who will never, repeat, never
know how we got this chronic, possibly terminal, disease.
I would wish to see no one else go through this. While the
possibility of a liver transplant looms in the future, at
present I suffer from what is called portal hypertension, which
is related to cirrhosis, and chronic fatigue. Portal
hypertension means that I wake up every once in a while feeling
nauseous and throw up great amounts of blood and end up in the
ICU.
It's through repeating bandings of 3 to 6 month intervals
that they are controlled. That's where they put a tube down my
throat and try to tie off these little bulges before they
rupture. I am constantly nauseous, constantly fatigued.
Sometimes I get confused about what I'm going to say, and I
have not been able to fully enjoy my grandchildren.
The only thing that I can be sure of, is I did not get
hepatitis B from sexual contact, drug use, or tattoos. However,
I have now arrived at a place in my life--I accept the fact
that I will never know the path of my transmission. I no longer
search for that answer.
Now I focus on how the virus can be stopped from spreading.
Hopefully, someday our schools will be as worried about
hepatitis as they are with other vaccines. I was required to be
tested for several things before becoming employed by the
school, but no one ever asked me to be tested for hepatitis.
Now, ask yourself how easy it would be for your children to
contract the disease while playing basketball, soccer,
baseball, or track. What about the fights in the school lunch
lines? Or what about the little girls and boys who trade
pierced earrings back and forth perhaps unknowingly infected
with hepatitis B since it is a silent disease that we don't
know about for years.
I don't mean to frighten anyone here with the ease of
contacting hepatitis, but statistics show that it's easier
spread than AIDS, as others will no doubt testify to.
In closing, I make one personal point. I know by being here
today I have added another brick to my wall of isolation
because of the fear some people have of contracting my disease.
I also know that many people will not believe that I have only
had one intimate partner in my life for 29 years, but my
husband does. And you know, that's really all that matters to
us.
Oh, yes, there is one more thing. The best thing my doctor
did tell me is I needed to get my kids and my grandchildren
vaccinated, and I did. So you cannot even imagine the joy when
several weeks ago, I received in the mail my son's blood donor
card. Actually, he received it. I took it. And he is now an
eligible blood donor.
Why am I happy? This means that I have successfully
prevented my son from contracting this terrible disease and he
is safe. So all I'm asking of this committee is to consider and
help me to protect other children the same way I am trying to
protect my own, through vaccination. Thank you.
Mr. Mica. Thank you for your testimony and I will recognize
Karen with PKIDS.
Ms. Karen. Chairman Mica and members of the committee, I
appreciate the opportunity to speak today. I am here today to
talk about my family. I won't add to the list of statistics
related to the immunization issues. I would like to personalize
them to bring them to a level that you can relate to from the
heart, rather than from a business, political, or clinical
standpoint.
My husband and I have three young children. Unfortunately,
I can't bring them with me, but these are the three children.
One of us became infected with hepatitis B and is now a
carrier. One of our twins is the face of this virus. Although
he has no apparent symptoms yet, his liver is dying.
This is an invisible process until the end. Biopsies at
ages 3 and 4 confirmed that he already had cirrhosis, and as
you have heard from other people on the panel that's quite
unusual. It usually takes decades, but at age 3 he already had
cirrhosis, which is permanent scarring of the liver.
He did not respond to a 7-month course of Interferon, which
is a form of chemotherapy, and no other treatment has been
available for him. He has had cirrhosis long enough now that he
must be monitored frequently for liver failure and cancer.
There is a four letter F word which we try to shield our
children from, and it's something they shouldn't know anything
about at such a young age, and that word is fear: fear of
social repercussions, fear of financial ruin, fear of sickness,
death, and loss.
You may have noticed that I have not provided our family
name, and that's because I can't. The first thing hepatitis B
families learn, usually after rejection by friends and family,
is to go to extreme lengths to protect their children's
privacy.
We cannot risk exposing our children's plight on news
programs such as 20/20 to help inform others of the dangers of
this disease. We desperately want to reach out for comfort when
we learn our child has an incurable illness, but we can't.
Local hospitals offer support groups for parents of children
with diseases such as cancer, but not hepatitis.
We, therefore, formed a nonprofit group, PKIDS, or Parents
of Kids with Infectious Diseases. PKIDS is determined not only
to help families with infected children but also to educate the
public about viruses including hepatitis.
My work with PKIDS enables me to accomplish my personal
goal of ensuring that other families are prepared to deal with
the complicated issues related to living with an infectious
disease. Parents feel an overwhelming need to warn day care
workers, teachers, Sunday school teachers, playmates and their
parents of the extra care that needs to be taken if our child
scrapes his knee, bites or is bitten, or has a bloody nose.
We want to tell everyone to get shots, yet we agonize over
the negative consequences of telling. Will our child be treated
fairly? Will he be ostracized on the playground? Will our kids
be singled out as the kids at school that everyone needs to
avoid? Will information given to the school nurse in confidence
wind up as the topic of conversation at a PTA meeting?
There are discrimination and disability laws that guarantee
my child a public education, but there are no laws to protect
his heart. My husband and I attended a school parent meeting
and during casual conversation, a mom mentioned that she had
visited the school superintendent because she had heard there
was a child in the district with hepatitis B. She wanted the
superintendent to identify that child so that she could isolate
her child from him.
My husband and I sat there paralyzed in silence waiting for
everyone to look at us. And all I could think of was if you
wanted to protect your child, get the shots; have him get the
shots.
We supervise our child's play. We watch his soccer games.
We coach his soccer games. We are there as much as possible in
order to protect other people's children. But it's obviously
impossible to continue this vigilance as the children grow
older.
When a neighbor tried to put a bandage on our child's
bleeding cut, I pushed her away; and she thinks I am
overprotective. But what she doesn't realize is that I was
protecting her. No one else should have to live with this virus
because it's preventable.
We worry about our ability to provide the best medical care
for our child. His Interferon treatment cost well over $20,000
and only a portion was covered by insurance. We are self-
employed and we watched our health insurance premiums triple
over a 3-year period. Those premiums now exceed our mortgage
payment.
We wonder if we will ever be able to afford college or
retirement for our children. If no cure or control is found for
hepatitis B in the very near future, our son will most likely
need a transplant, a liver transplant. We have been warned that
transplant and post-transplant care could ruin us financially.
At worst, it's only a temporary solution for him, as the
virus could eventually take the new liver as well. I call this
virus IT, capital I, capital T. Those of you familiar with
Stephen King's Master will understand why. IT invades our
lives, our thoughts, our spiritual beliefs no matter what
defenses we erect.
I watch my happy children playing, and IT reminds me that
we will soon have to tell my son that he has a serious illness.
Whenever he doesn't feel well, I wonder if this is IT. How long
will IT allow him to play the sports he loves? How will IT
affect his school performance? Hepatitis statistics make it
very difficult for us to be optimistic.
You can all look at your children and fantasize about their
senior proms, their weddings, and their careers, but I cannot.
My son is a leader, he is clever, he is creative, he is
charming, and he is very protective of his brothers and they
look up to him. I fear the effect IT will have on his brothers,
and I worry about how they will deal with this illness or
worse.
I fear that I will watch my child die, the worst possible
thing that can happen to a parent. No other family should ever
have to experience this pain because three shots can prevent
IT. Hepatitis B is transmitted primarily through blood and
sexual contact with infected persons.
My child can infect yours by sharing tooth brushes at camp.
He is losing his baby teeth and when children lose their teeth
their gums bleed. And kids share things. A toothbrush is one of
the things they share. He can infect your children through
biting or leaving blood residues on a hard surface.
He has frequent nosebleeds as a result of the virus. It
affects his clotting factor, and the virus lives on hard
surfaces such as tables for up to a week. He doesn't even have
to be there and another person can become infected or through
sports as mentioned by other people.
There are infected kids out there with no symptoms. They
are not reported, no one knows they have it. They have not been
diagnosed yet. Infected children and young adults will be
socializing with and dating your children. It is clear to me
that those who oppose immunizing our children are well informed
about things such as vaccine composition and side effects.
However, I beg you to educate yourselves about the
hepatitis virus and disease progression as well because only
then will you be able to make a truly informed decision
regarding immunizations and help us to protect our children.
Thank you.
Mr. Mica. Thank you for your testimony.
[The prepared statement of Ms. Karen follows:]
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Mr. Mica. And we will recognize our last witness in this
panel, Betty Fluck. You are recognized. Welcome.
Ms. Fluck. I would like to thank you for allowing me to
come before you today to share my experience with you. Never
did I dream that I would have this opportunity. I am a
diagnosed victim of the hepatitis B vaccine. My husband and I
are not antivaccine. Each of our three boys has been vaccinated
per health department guidelines. However, they will not have
the hepatitis B vaccine.
On December 2, 1997, I took my second hepatitis B vaccine
in the series of three. I was required to have the immunization
for my job. I am a registered nurse and have been for 20 years.
I had just started a new job as a public health nurse for the
local health department in Kokomo, IN. Part of my job
description was to give immunizations in the department's
weekly clinic.
Roughly 12 hours after receiving my vaccine, I woke up in
severe pain. I developed a 104 degree fever, nausea, vomiting,
respiratory problems, a rash, severe head, neck and back pain,
swollen joints, and I was unable to move my legs.
When the fever broke several hours later, I regained a
small percentage of my leg strength, but the severe damage had
already been done. I had to use a cane to move around. I had
absolutely no energy, and I had constant joint and leg pain.
I was sleeping approximately 22 hours per day. I continued
to run intermittent low-grade fevers. The first doctor that I
went to said that I had a reaction to the hepatitis B vaccine
but was unable to help. I went from doctor to doctor looking
for help.
I ended up at Indiana University Medical Center in
Indianapolis. I first saw a doctor who was very kind and told
me that he had read about some of the problems with the
vaccine. He promised to do some research into the vaccine's
adverse reactions. He asked me to see one of his colleagues at
IU Med Center, a rheumatologist.
This rheumatologist from IU was simply hostile to the idea
that the hepatitis B vaccine could have caused my problems. He
suggested that some of my problems could be caused by or
attributed to a kidney stone. Please be aware that at this
point, my fingers were so painful that I could not open a soda
can.
I returned to the first doctor at IU Med Center 1 month
later for a scheduled followup. This doctor, who had been
encouraging and sympathetic 1 month ago, now refused to use the
word vaccine and attributed some of my problems to the aging
process.
Unhappy with both of these doctors, I requested a meeting
with a patient advocate and the IU doctors. At this meeting the
first doctor finally told me that I had a ``political problem,
not a medical one.'' My condition continued to deteriorate from
cane to walker to knee braces.
Finally, in September 1998, I was put in full leg braces
that run from my toes to my hips. With the use of the braces
and forearm crutches, I have some mobility. Eight months after
the initial injury, I was able to find an out of State doctor
who was treating people for vaccine damage.
I must now see him every 3 months. The vaccine has caused
nerve damage to my legs and hands. The medical name for my
problem is chronic inflammatory demyelinating polyneuropathy
[IDP]. I also have multiple types of autoimmune disorders, and
I now have an elevated rheumatoid arthritis factor.
I undergo weekly IV treatments that cost several thousand
dollars per week. Although I have more energy now, there is no
real prognosis for my condition. Immediately after I was
injured, I contacted the pharmaceutical company asking them for
help. They told me that they had never heard of this problem
before.
I realized at that point that I was not that unique and
decided to write to the FDA through the Freedom of Information
Act. I requested any reports on file about adverse reactions to
the hepatitis B vaccine for one particular company from 1991 to
present.
Four months later, I received a box containing a 1,045-page
report. On each page, there were summaries of approximately
eight reactions. These 8,000-plus reactions ranged from mild to
death. I made an appearance on ABC's 20/20 in January 1999, on
their story about the hepatitis B vaccine.
Since that show was aired, I have received numerous calls
from adult victims and parents of children who had been injured
after taking the hepatitis B vaccine. One common theme among
the victims is that their doctors told them it couldn't be the
vaccine because it was perfectly safe.
I recently testified before the State senate committee in
Indiana with the intent of removing the mandate for the
hepatitis B vaccine for school entry. The proposed amendment
was designed to give parents the choice to waive the vaccine
for any reason.
On March 2, 1999, it passed the State senate by a vote of
45 to 4. However, the House sponsor of the original bill killed
it rather than bring the bill up for debate. In Indiana, a
doctor from the department of health told the Senate committee
that one of the arguments for the vaccine was that it was the
``first anti-cancer vaccine.''
Fortunately, we were able to show that the ``anti-cancer
vaccine'' theme was taken from the PATH website. PATH is an
organization within the World Health Organization. PATH
suggested that the ``first anti-cancer vaccine'' theme was a
good marketing tool to bring about interest in a ``boutique''
vaccine.
I have minutes from the CDC study group meeting on the
hepatitis B vaccine held in March 1997. The minutes of the
meeting show that it would take at least a 60-day study to show
the onset of MS. Clinical studies done by the two manufacturers
were 4 and 5 days in length respectively.
It should be noted that the afternoon session of this
meeting was chaired by Dr. Robert Sharrar of Merck. This group
was to decide how to identify various types of adverse
reactions, such as MS, and demyelinating disease and to plan
meaningful studies.
When Dr. Sharrar appeared on ABC's 20/20 in January, he
said that he honestly believed that hepatitis B vaccine had not
caused any problems. Can an employee of a pharmaceutical
company that manufactures the vaccine be objective in designing
experiments to show fault in a product that generates close to
$1 billion in sales for his company?
The form that people are given about the vaccine was
written by the CDC. It does not address serious adverse
reactions. When you look at the vaccine insert provided by the
manufacturer, several adverse reactions are noted.
I have since talked to many healthcare professionals who
are also unaware of the potential adverse reactions listed on
the vaccine insert. It makes me wonder why the pharmaceutical
company representative that I talked with earlier, the one who
was unaware of any adverse reactions, was unaware of what their
own company's insert said.
A vaccine that still has so many unanswered questions
should not be mandated for children. It just does not make
sense. The right to decide if it's in the best interests of the
child should be made by the parents. After all, it appears that
for the most part, when a child is severely handicapped by this
vaccine, the parents are on their own.
No one pushing the mandate is there for help or comfort. In
an article on the hepatitis B vaccine that was printed in the
Washington Post, a spokesperson for the CDC said that nothing
unexpected had been observed in the way of adverse reactions.
At first, I thought they meant that their position was that
no adverse reactions had occurred. Now, I really don't think it
was denial. Despite over 20,000 reports to VAERS for the two
manufacturers, nothing unexpected had occurred. I really
believe that the number and type of injuries is no surprise for
the CDC. Maybe the only surprise to the CDC is just how hard
the victims are fighting back. Thank you.
Mr. Mica. Thank you for your testimony.
[The prepared statement of Ms. Fluck follows:]
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Mr. Mica. I would like to thank all of our witnesses for
their testimony this morning. I have a couple of questions, the
first for Mr. Belkin. I believe you testified that you did not
have any notice as to possible adverse reactions before the
immunization?
Mr. Belkin. Yes. We received no warning. Our pediatrician
seemed to think this was like giving an Advil or Tylenol or
something. No warning, no ``watch out, this is dangerous, this
could cause convulsions.'' Nothing whatsoever in any way,
shape, or form.
Mr. Mica. Of course you have experienced a tremendous
personal tragedy. Based on what you know now, do you think
there should be some warning or some signoff by parents, such
as informed consent?
Mr. Belkin. Yes, absolutely. And I think the doctors should
be held responsible. The bureaucracy should be held
responsible. Right now, I have taken about 40 other reports
from other parents where the same kind of thing has happened--
where they found about 10 other SIDS cases, and numerous other
nurses that have the same kind of things as Betty.
In every single case the doctors have denied
responsibility. No, it's not the vaccine. It's happened over
and over. Convulsion, oh, it is not the vaccine. Second time
around, convulsions. No responsibility. As well as disclosure
and choice, the doctors should be held responsible for
reporting adverse reactions so when a dangerous medicine is out
there, it doesn't keep happening. That's my only goal in doing
this.
Mr. Mica. Now, I know that they eliminated some factors for
the cause of the death of your child. Was there a specific
scientific or pathological forensic study that linked your
child's death to this vaccination?
Mr. Belkin. No, not yet. I intend to pursue that. I have
not done that yet. I am going to take the autopsy results. I'm
trying to find someone who knows and will not deny it. What I
found is that the New York City medical examiner and every
doctor, they call up Merck and Merck says, ``you are the first
person that has ever called us, this has never happened
before.'' So then they say, ``well, how can I say this child
died from the vaccine?'' and it turns out there are 400-
something other deaths in VAERS.
So what is happening is, from the top down they are denying
that this is happening. And the people at the bottom, the
pediatricians, the people that are doing the autopsy say
``well, they say it's safe; it couldn't be the vaccine.'' There
has to be some disclosure from the top down to the bottom.
There is a huge body of evidence of brain swelling in
causing encephalitis, which is basically the result which they
are denying. So I still have to go forward with this to
actually go to another neuropathologist, which I intend to do.
Mr. Mica. Thank you. Ms. Converse, your child had reactions
and you stated to the doctor, the physician, that your child
was having reactions. Were you warned in advance that the child
might have adverse reactions?
Ms. Converse. No.
Mr. Mica. Then, after you said that there were problems,
you said that the doctor ignored those and went ahead with the
vaccinations?
Ms. Converse. Right. Because I knew that the pediatricians
would be unsupportive if I mentioned that I suspected the
vaccine, I never told them that.
Mr. Mica. You did not tell them.
Ms. Converse. I simply explained his symptoms.
Mr. Mica. Each time your child was vaccinated, there were
adverse reactions?
Ms. Converse. Yes. But the most profound was with the
hepatitis B.
Mr. Mica. Do you have professional or scientific evidence
that the vaccine has been the cause of your child's condition?
Ms. Converse. The evidence that I am using is that he fits
all of the criteria that the Federal Government describes. We
do not have a blood test which I have just learned that we can
get to--Myelin Basic Protein. I just learned of that.
Mr. Mica. Have you taken advantage of or applied for
compensation under the Vaccine Injury Compensation Program?
Ms. Converse. No, not yet because of the discouraging
comments that my pediatrician gave me in terms of basically
coming out and saying that we have had a reaction. But my
position on that is changing. I think the other reason why we
haven't is we have been very overwhelmed in caring for our son.
Mr. Mica. In the reporting system that we have, the Vaccine
Adverse Event Reporting System, do you know if your child has
been included in that--either through doctors or your report?
Ms. Converse. He has not.
Mr. Mica. What about your child, Mr. Belkin?
Mr. Belkin. Yes.
Mr. Mica. Ms. Kirschner, were you warned in advance that
your child might have an adverse reaction? How old was she when
she had her shots?
Ms. Kirschner. Lindsay was 14. I had no warning at all. In
fact, on the appointment that she was vaccinated, the doctor
didn't even see us. There was no consent form. Nothing. Even
the day after we went back to him when she had flu-like
symptoms, he told me she had the flu. I did not even make the
connection that it was tied into the vaccine. When I called him
every day because she was just getting worse and worse, he
didn't know.
Mr. Mica. Thank you. Ms. Hahn, you contracted hepatitis B
and you said that you didn't know how you contracted it. You
have heard some of the stories today about individuals who had
their child vaccinated under the mandatory program. After your
condition was discovered, you had your family vaccinated. Was
that the case?
Ms. Hahn. Yes, it was.
Mr. Mica. So they hadn't been vaccinated before. You didn't
experience adverse reaction in your family. First of all, what
do you think about the additional requirement for informed
consent before these vaccines are given, particularly for the
parent since of course, the child can't give intelligent
consent to vaccination? And do you think we should have some
other limits on vaccination?
Ms. Hahn. I can't speak for their situation. In mine, I had
my doctors, who are with Group Health Associates of Cincinnati,
and I have always been informed of every vaccination my
children have received. We have had the same doctor all of
their lives. My oldest is 27 and my youngest is 21. I have
always been informed of the risk. My husband was even informed
of the risk.
Mr. Mica. How old were your children when they were
vaccinated?
Ms. Hahn. My youngest son was 16.
Mr. Mica. But if they had been vaccinated--one of the
questions we will get into a little bit later is how long this
vaccine is effective for. So they might have to be vaccinated
again if they were 16 and had it done at birth?
Ms. Hahn. No one has ever informed me of that. I read a
little bit on the Internet of some people suggesting it, so I
can't answer. My doctors haven't seen any need. I believe
before you would do that, from what I understand when I ask my
doctor about that, is that you would do a simple blood test
first to see if they needed to be, you know----
Mr. Mica. Finally, were they given any warning that there
might be an adverse reaction or were you given any warning that
your husband or children might have an adverse reaction to the
vaccine?
Ms. Hahn. Yes. I also encouraged all of my family members,
my grandchildren who are all under the age of 4, my sister, and
my brother to be vaccinated. I don't know of one of my friends
yet that has had a problem.
Mr. Mica. I have additional questions, but I will recognize
Mr. Waxman.
Mr. Waxman. Thank you very much. Let me thank all of the
witnesses and tell you how sorry I am to hear about the
misfortunes all of you have suffered, some from the vaccine
reaction, apparently from the vaccine reaction, and some from
hepatitis itself. We are dealing with a difficult issue. We
want to control this disease, but evidently there are, in some
cases, horrible reactions to vaccines and we want to be sure
that they are minimal and that everything is being done to
prevent those adverse reactions.
Mr. Belkin, you showed us some charts that were pretty
surprising. The question, of course, is one of causation,
whether those lists of reactions were, in fact, caused by the
vaccine itself. Have you conducted controlled research such as
might be peer reviewed and published?
Mr. Belkin. No, and I think that's exactly what should be
done. You cannot go through--I encourage you to go through the
VAERS reports and look at them yourself. I spoke at the New
York City Rotary Club. I was invited to speak on this subject.
A gentleman came up and refuted me and he said he had been sent
by Merck.
He was the chairman of the American Academy of Pediatrics.
It is a major thing when Merck sends the chairman of the local
district of the American Academy of Pediatrics. I asked him
what he thought about VAERS, and he said that it's garbage. I
said, what would you do to improve it? He said, there is no
money for that.
So what is happening is it is just going nowhere.
Mr. Waxman. Let me interrupt you, because we have to have
research done. Any manufacturer of any kind of pharmaceutical
product has got to continually check, in my view, about adverse
reaction reports. One of the concerns I have had is that the
FDA is under such pressure to approve drugs, they get them
approved, and we want to know before they are sending them out
to be used widely that they check for all of the adverse
reactions. And if they are out there and they learned about
adverse reactions, they respond to it.
We are going to hear from somebody from the FDA in a
minute. I'm making that as a general statement. But the charts
that you held up have not been peer reviewed themselves. They
are the list of statistics of people who have had adverse
reactions; is that right?
Mr. Belkin. That's correct.
Mr. Waxman. You haven't had anything peer reviewed or
published in any scientific----
Mr. Belkin. No, I haven't. That needs to be done.
Mr. Waxman. Do you have a dispute with the national
statistics that show that a third of all hepatitis B cases
occur in people who are not in high-risk groups?
Mr. Belkin. Those studies are very interesting. Are they
done on the basis of epidemiological study or are they done by
questionnaires? That's the question. I think that the science
really has not been done. I am not an expert on the subject,
but from what I have heard, those little pie charts showing so
many intravenous drug users, that's the result of
questionnaires.
I'm not absolutely certain about that. I think this whole
area needs to be looked at by independent scientists without
ties to drug companies or the government.
Mr. Waxman. If you have people who are identified as high
risk because of certain activities that they engage in, that's
pretty clear. If you have people who never engage in those
kinds of activities and whom you wouldn't consider high risk
contract hepatitis B, we have to wonder why.
The report that I am referring to indicates a third of all
of the hepatitis B cases occur in people who are not considered
high risk. I am sure it is based on some questionnaire, because
how would you know whether somebody is in a high risk group or
not? But that doesn't invalidate the conclusion. The reason
that I raise this is that it has got to be of concern to all of
us that hepatitis B is a pretty awful disease.
It's not just limited to people who are high risk. If we
can prevent this disease we ought to do so. The question is can
we do it in a way without these costs?
I have a letter from a woman in Santa Monica, which is in
my district. She says,
I understand your committee is hearing from individuals
concerned about the dangers of immunization against hepatitis
B. As a school nurse, I would like to urge you to keep in mind
the devastating effects of this liver infection against which
the vaccine protects both individuals and society in general by
lowering the pool of infected people. It's true that a few
people do suffer adverse reactions to various immunizations.
Nevertheless, although it may seem harsh to say so, the public
health benefits of preventing disease by immunization outweigh
the relatively low risk of harm to the rare susceptible person.
In California, the State requires hepatitis B immunization of
public school students in specific grades, but allows waivers
for individuals with personal beliefs or medical conditions
which render them unwilling or unable to be vaccinated. The
availability of such waivers should allow your vaccine critics
to decline personal vaccinations without depriving other
individuals in society as a whole of this life-saving
protection.
What do members of this panel think of that idea, allowing
waivers?
Ms. Converse. If I could respond to that, Mr. Waxman. I
think it is very interesting to be here today because I am
noticing that victims on both sides of this share a lot of
problems, both the course of their illness--there is some
cross-over, and there is cross-over in terms of isolation and
lack of treatment.
What this is telling me is, clearly we don't understand the
whole picture of transmission and why there is this chunk of
people who we can't identify as to how this is being
transmitted. And the second thing, it is very clear that we
don't understand who reacts adversely and why.
My beef is that unless you profile criteria about who will
react adversely and unless that is very much part of an
informed consent--for instance, if you are of northern European
extraction and you have a history of allergies in your family--
I am making that up. I don't know what the criteria would be--
that you should be informed that you may be adversely affected.
That doesn't exist right now.
Mr. Waxman. Do you think we even know that information?
Ms. Converse. No, we do not know that. My point being that
you cannot mandate this universally for newborns until you know
who may be adversely affected because you will damage thousands
of people.
Mr. Waxman. We know with every immunization that we have
there are going to be some rare cases where there is going to
be an adverse reaction, sometimes horrible and even deadly.
Ms. Converse. I think what is emerging with this one is a
profile, if I might go out on a limb and say. I recently
attended an autism parents support group on Cape Cod where I
live, a small group, 10 parents. All of them had red hair. That
is rare, and I think these are the kinds of things that might
emerge that really should be looked into. That may be different
from other vaccines.
Mr. Waxman. I hope we can find a profile and find a reason
for adverse reactions. We need to have it done, however,
through scientific methods.
Ms. Converse. But until that's done you cannot make it a
law that a newborn get this shot because it's criminal. You
have no way of knowing----
Mr. Waxman. You have no way of knowing, except we do know
that the overwhelming majority of people are not adversely
affected and the disease is prevented. On that basis, most
people want their children to be immunized from polio,
diphtheria, whooping cough, and hepatitis B.
Every single one of those immunizations has an adverse
reaction with some individuals. If we knew why some individuals
react that way, we wouldn't have them take the vaccine. But as
a society, we do require people to be vaccinated. In Santa
Monica, CA, according to this letter that I received, they
allow people to opt out if they have this concern or fear.
Ms. Converse. If I could just interject one more comment
and then I will stop. Our experience--I'm assertive, educated.
I have a public health background and very much accept
immunization. I was persistent and tactful with our providers.
I never told them I think the vaccine caused a problem because
I knew that might be an inflammatory comment for them. They
failed to recognize not just that it was a reaction, but that
my son was even ill.
So this experience tells me that there will be many, many
children who don't get reported. So when you say there are a
few that have a problem, I think it's the tip of the iceberg.
Mr. Waxman. Did you ask your doctor about the possible risk
of the hepatitis B vaccine or about any of the childhood
vaccines that you put your child through?
Ms. Converse. Yes, but we weren't aware that he was going
to be given that shot at birth. It was not discussed at all.
Mr. Waxman. So you were aware that there is a possible
risk?
Ms. Converse. I was aware through my public health
training.
Mr. Waxman. But you didn't talk to your doctor about it
specifically?
Ms. Converse. I wouldn't agree with that. Through my public
health training, I was aware of other vaccines and the risks
associated with them.
Mr. Waxman. My question is, did you talk about it with your
doctor?
Ms. Converse. Yes, absolutely.
Mr. Waxman. Why were you, as a public health person, afraid
to tell your doctor that you thought your child was having an
adverse reaction to the vaccine?
Ms. Converse. Because my training taught me that these are
very rare and there are a few sacrificial lambs for the good of
the whole and that's just the way it goes. I wanted to
encourage----
Mr. Waxman. I thank you very much for your----
Ms. Converse. I wanted to encourage my provider to help us,
and I did not want to discourage them by antagonizing them.
Mr. Waxman. I appreciate what you had to say, and I am
sorry for all of the terrible things that you have gone
through. Did you want to raise a comment? I think my time is
up, but why don't you go ahead.
Ms. Hahn. Chairman Mica and Congressman Waxman, the subject
of the questionnaire about hepatitis--and it only asked
questions. I have had the same health maintenance provider for
over 20 years. He and they are very aware of my medical
conditions. I was told that I would have preventive care and
they would know anything before it happened.
When I first became a little ill, or rather I was very
ill--I lost 44 pounds--it was looked at first as just chronic
diarrhea and stuff. Within a matter of a couple of weeks,
hospitals. Then they were even telling me possibly cancer. They
were going to remove my spleen for blockage. All of that got
narrowed down after they did some tests.
Then the very last thing they looked at and they said,
Chaplain Hahn, you have a sexually transmitted disease. I
believe that was more for the safety of my husband. They wanted
to make sure that this didn't go any further. So even the best
of prevention, best of care, best of trying to take care, you
don't know.
I worked with your children. I didn't know I had it for
probably 20 years. The only way that I can prevent your
children from getting it and trying to be the best at my
universal precautions is for you to have your children
vaccinated.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Mica. Mr. Tierney.
Mr. Tierney. Thank you. I don't want to prolong this for
any of you. I am really very sympathetic to all that you said,
and I understand how difficult this must be for you.
Particularly Lindsay, I want to say that your courage here
today has been noted by everyone.
Rather than going to a more extensive question, because I
think that you have all been excellent in your testimony and
very informed, I only want to pursue one area. I think, Ms.
Converse, you made the statement, if I am correct, that you
thought the effects of the vaccine wear off within a certain
period of time.
Ms. Converse. That's my understanding.
Mr. Tierney. Could you expand on that a little bit and tell
me where you get that information and that conclusion.
Ms. Converse. I get that information from a Massachusetts
Department of Public Health flyer on hepatitis B for parents,
which says that your child will need a booster by the time they
reach--I think it's either age 11 or 14.
Mr. Tierney. I was thinking that you had excluded the
booster part of it, including that the booster was going to
wear off.
Ms. Converse. Correct.
Ms. Fluck. Can I say something, please?
Mr. Tierney. Absolutely.
Ms. Fluck. In regards to that question, my husband and I
have done a lot of research since I have been stricken with
this. We noted that in India where there is a very high rate of
hepatitis B, that one of the hospitals there recommend
boostering every 4 years for hepatitis B. That's a
recommendation from a hospital in India where hepatitis B is
very rampant.
But what I'm saying is, they don't say how long these
immunities will last for. But some places where they do have a
very high risk, they boost every 4 years.
Mr. Tierney. Are you saying that the entire Nation has a
policy of boosting every 4 years or that single hospital?
Ms. Fluck. In India, they do but that's their policy.
Mr. Belkin. The Merck package insert says that the time is
indeterminate. That's the way they define it on the package
insert.
Mr. Mica. Thank you, Mr. Tierney. One last question, Ms.
Fluck. Your particular affliction has been medically diagnosed
and connected to the vaccination?
Ms. Fluck. Yes, it has.
Mr. Mica. Have you filed a claim in the Vaccine Injury
Compensation Program?
Ms. Fluck. No, not as of yet. Again, part of the reason is,
I guess, one of the things that happened, my husband made some
calls to the CDC and he talked to Dr. Chen. Dr. Chen
recommended that he talk to Dr. Evans. Dr. Evans called our
house, and we had no idea who this gentleman was.
So my husband really didn't want to give him too much
information. We found out eventually that he is among the
people who decide who gets what, and if they get anything from
the claims. He seemed very proud of the fact that they hadn't
paid out anything to any of the victims of hepatitis B unless
they had anaphylactic shock.
Over the phone, without any kind of information about me
whatsoever, except for the fact that I can't walk, he told my
husband, your wife did not have an adverse reaction to
hepatitis B. That's what we are dealing with. I also told you
in my testimony how I was told my problem is a political
problem, not a medical problem. I have gone from doctor to
doctor. It's like they are afraid to say anything.
Mr. Mica. Well, I would like to thank you and all of our
panelists for your testimony today, for coming forward and
providing our panel with your personal experience and
recommendations as we move forward in our oversight capacity.
So I thank each of you, and I will excuse you at this time.
Our second panel today----
Mr. Waxman. Mr. Chairman, just a word to Ms. Fluck. We are
checking about the assertion about the vaccine compensation
system. Don't be so trusting of a comment that you have heard.
There is more data for the anaphylactic shock than any of the
other adverse reactions, but the compensation system does look
at other reactions. So I would urge you to pursue it if you
feel there is a connection----
Ms. Fluck. I am diagnosed. I have all the medical testing
and immunological testing. But what I'm saying is, this doctor
seemed awfully proud to say that they have never paid out
anything to anybody unless they have had anaphylactic shock.
Mr. Waxman. You seem awfully willing to take what he has to
say at face value, and you don't seem to be willing to take
what others say at face value; and I think that you have had
enough reason to be more independent-minded. I'm urging you to
go ahead and pursue this vaccine compensation.
Mr. Mica. Thank you. Again, I appreciate your providing us
with your personal experience--each and every one of you--and
we will excuse you at this time.
I will now call our second panel, which consists of
primarily government officials. Harold Margolis, who is the
Chief of the Hepatitis Branch of the Centers for Disease
Control. We also have Susan Ellenberg, Director of
Biostatistics in Epidemiology Division of the Food and Drug
Administration. If we could have them come forward.
I would like to call the meeting back to order here. Those
who are leaving, please do so and others cease conversation so
we could proceed. Dr. Margolis, you have someone with you. Is
that individual going to testify?
Dr. Margolis. No, he is not. I will introduce him. Dr. John
Livengood from the National Immunization Program.
Mr. Mica. Thank you for identifying him. And as I mentioned
to our other witnesses, this is an investigation and oversight
panel under Government Reform. We do swear in our witnesses, so
those two who are going to testify please, if you are going to
answer questions, I will swear you in.
[Witnesses sworn.]
Mr. Mica. And we have another witness or somebody who may
be answering questions. Could you identify yourself? Dr.
Ellenberg, could you identify the individual?
Dr. Ellenberg. This is Dr. Marcel Salive who is Chief of
the Epidemiology Branch in the FDA's Center for Biologics
Evaluation and Research.
Mr. Mica. Thank you. Again, welcome each of you. If you
have lengthy statements, we would like to make them part of the
record. We do have a number of panelists today. If you have
additional, information we will by unanimous consent make it
part of the record within reason. So I would like to first
recognize Susan Ellenberg, Director of Biostatistics and
Epidemiology Division of the Food and Drug Administration. You
are recognized and welcome.
STATEMENTS OF HAROLD MARGOLIS, CHIEF OF THE HEPATITIS BRANCH,
CENTERS FOR DISEASE CONTROL; JOHN LIVENGOOD, NATIONAL
IMMUNIZATION PROGRAM; AND SUSAN ELLENBERG, DIRECTOR OF
BIOSTATISTICS AND EPIDEMIOLOGY DIVISION, FOOD AND DRUG
ADMINISTRATION
Dr. Ellenberg. Thank you, Mr. Chairman. Good morning. I
appreciate the opportunity this morning to discuss the Vaccine
Adverse Event Reporting System [VAERS], with you. My written
testimony is more detailed, and I'm pleased that you are
willing to include it.
Mr. Mica. Without objection that will be made part of the
record.
Dr. Ellenberg. Before I begin, I would like to say that as
a parent I certainly have the greatest sympathy for those who
have testified today in the previous panel. The job of the
public health service is to investigate and hopefully prevent
all of these kinds of problems. That's what we are dedicated to
do.
Vaccines are among the most significant public health
achievements of all time and have been responsible for saving
millions of lives and preserving health worldwide. They are
extremely safe.
Nevertheless, like all medical treatments, vaccines are not
entirely risk free. Vaccines are unique in that they are
administered to healthy individuals, often children, and in
some instances are required by State law. While serious
complications are extremely rare, they can occur.
Because of the virtually universal exposure of our
population to vaccines, it is important to identify even those
very rare adverse reactions. VAERS was initiated in 1990 as a
joint program of the FDA and the CDC. It receives reports from
vaccine manufacturers, health professionals, State and local
public health clinics, and vaccinees themselves or their
parents or guardians.
To encourage reporting of any possibly vaccine-induced
adverse event, the criteria for reporting to VAERS are
deliberately nonrestrictive. The system accepts and includes
any report submitted, even when there is no obvious connection
to vaccination other than timing. Such reporting systems are
essential to the discovery of potential rare adverse
consequences of medical product that may not become evident
until millions of people have been exposed to them.
There are important limitations, however, as I will discuss
later, but first a brief overview. VAERS receives 11,000 to
12,000 reports a year. About 15 percent of these reports
describe a serious event. Most of the remaining 85 percent of
the reports describe self-limited transient events such as
injectionsite reactions, irritability, prolonged crying, and
fever.
Currently, all reports of serious events and fatalities are
followed up in detail by health professionals. Medical staff
carefully monitor trends in adverse event reporting for
vaccines. VAERS performs a critical function by generating
signals of potential problems that may warrant further
investigation.
This is especially valuable in assessing the safety of
newly marketed vaccines. As an example, a review of reports of
adverse events in infants following the hepatitis B vaccine was
performed by FDA staff several years ago. This comprehensive
review concluded that no new concerns had emerged in the first
few years following the recommendation for universal infant
immunization.
It's important to recognize that VAERS data alone are often
inadequate for drawing firm conclusions or providing any basis
for regulatory actions. Probably the most important reason is
that it is unable to establish causality for most reports of
serious adverse events, the issue that Mr. Waxman had alluded
to.
Most of the types of serious problems reported to VAERS
occur in unvaccinated, as well as in vaccinated, individuals.
With 4 million babies born each year in the United States and
virtually all being vaccinated beginning at birth or shortly
thereafter, almost any adverse experience in a child will
follow a vaccination, and some of these will by chance follow
within a few days of the vaccination.
Thus, even if a vaccine was not the cause of certain rare
medical problems, it is a certainty that some number of these
problems will occur within a short interval following a
vaccination. For this reason, the fact that an event, even a
very serious event such as a death, happens to occur shortly
after a vaccine has been administered cannot by itself lead to
the conclusion that the event was caused by the vaccine.
When the review of VAERS data identifies a signal of a
potential new vaccine associated event, this association,
therefore, must be further investigated in more rigorously
controlled studies before causal conclusions can be drawn.
VAERS data have contributed to our understanding of vaccine
safety and vaccine risks. Several investigations of VAERS data
have uncovered previously unrecognized problems that may occur
rarely in vaccine recipients and examples of these are provided
in the written testimony.
Sometimes VAERS findings which we routinely publish in
medical journals may provide useful and reassuring information
that new problems have not been identified after additional
exposure with a vaccine, as previously noted.
I want to thank the committee and the chairman for this
opportunity to discuss the VAERS system and will be happy to
answer any questions.
[The prepared statement of Dr. Ellenberg follows:]
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Mr. Mica. Thank you. We will defer questions until after we
have heard from Dr. Harold Margolis, Chief of the Hepatitis
Branch of the Centers for Disease Control. You are recognized,
sir.
Dr. Margolis. Thank you, Mr. Chairman, and our written
testimony is submitted for the record.
Mr. Mica. Without objection, that entire statement will be
made part of the record.
Dr. Margolis. I am here with Dr. John Livengood of the
CDC's national immunization program. We are here to discuss the
importance of the hepatitis B vaccination and the prevention of
hepatitis B-related liver disease and cancer and the safety of
the vaccine.
I am both a parent and a pediatrician. Nothing matters more
to me than the health and safety of my children and the
children of others. Based on my 20 years of work in the field,
I have concluded, first, that hepatitis B is a serious risk to
infants, children, and adults; second, we have a safe and
effective vaccine for addressing that risk; and, third, it is
our responsibility to protect the health of our children and
future generations by using this vaccine.
Persons who become infected with hepatitis B either recover
in several months or go on to have chronic infection. In the
United States, one and a quarter million persons are
chronically infected with hepatitis B and are at high risk of
cirrhosis and liver cancer.
Hepatitis B is a silent killer destroying the liver in
someone who thinks they are completely well. When first
infected, two-thirds of adults and more than 90 percent of
young children do not have symptoms of hepatitis. Studies have
shown that each year 20,000 to 25,000 children have been
infected with hepatitis B in the United States. These children
acquire their infections in their households as well as in
their community.
The importance of these childhood infections is illustrated
in figure 1. If infected, 90 percent of infants and 30 to 60
percent of children less than 5 years of age, will remain
chronically infected. Thus a large proportion of adults with
chronic hepatitis B became infected as infants or young
children.
If we do not prevent childhood infections, we cannot
control hepatitis B in the United States. Hepatitis B
immunization prevents greater than 90 percent of infections.
Studies have shown that routine vaccination of infants and
children eliminates transmission of chronic infection and
reduces liver cancer. They have also shown that vaccinated
persons retain long-term immunity.
The CDC vaccine recommendations are made with the advice of
the Advisory Committee on Immunization Practices, or the ACIP.
Hepatitis B immunization issues have been discussed at ACIP
meetings on 20 occasions since 1986. In 1991, a comprehensive
immunization strategy to stop transmission of hepatitis B
infection in the United States was adopted by the ACIP and
recommends, one, prevention of perinatal hepatitis B infection;
two, routine hepatitis B vaccination of infants and
adolescents; and, three, vaccination of high-risk adolescents
and adults.
The decision to vaccinate a child protects that child and
the community. Because hepatitis B produces a chronic
infection, a decision not to vaccinate a child not only puts
that child at risk of infection, but puts others in the
community at risk as well.
The CDC is strongly committed to ensuring the safety of
vaccination. Hepatitis B vaccines are among the safest we have.
Since licensure, the safety of the vaccine has continued to be
monitored. Several reviews have been done and have not shown a
causal association between hepatitis B vaccination and a
variety of severe, neurologic adverse events. In addition,
ongoing studies are investigating whether other alleged adverse
events are associated with vaccination, including multiple
sclerosis.
As the FDA has discussed, case reports of serious adverse
events following vaccination rarely provide a convincing link
between the event and vaccination. Sudden infant death syndrome
is such an example. Because almost 10 million doses of
hepatitis B vaccine are administered to infants each year, some
infants unfortunately will die shortly after vaccination by
coincidence alone. Available scientific data do not support any
causal role for vaccination in SIDS.
As shown in figure 2, 1992 was the first full year that the
hepatitis B vaccine was recommended for routine infant
immunization. Vaccine coverage was 8 percent, and there were
4,800 SIDS death that year.
In contrast, by 1996, when hepatitis B vaccination coverage
had risen to 82 percent, there were only 3,000 SIDS deaths.
These data are reassuring because if the hepatitis B vaccine
was a major cause of SIDS, we would have expected an increase
in cases, not a decrease.
In summary, hepatitis B causes 4,000 to 5,000 deaths a year
in the United States. If exposed to the virus, infants and
young children are most at risk of chronic infection and death
as adults 20 to 40 years later. Fortunately, we have a safe and
highly effective vaccine to prevent the transmission of this
deadly virus and to prevent liver cancer. Immunization of
infants, children and adults is supported by the American
Academy of Pediatrics, the American Academy of Family
Physicians, the American Medical Association, the American
College of Obstetricians and Gynecologists, the Hepatitis
Foundation International, and the American Liver Foundation,
among others. Only by achieving high vaccination rates can we
optimally protect Americans from this serious disease.
Thank you for your attention. Dr. Livingood and I will be
happy to answer questions.
[The prepared statement of Dr. Margolis follows:]
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Mr. Mica. Thank you both for your testimony. I have several
questions.
First of all, Dr. Margolis, you mentioned in your
presentation that studies have shown that at least 25,000
children are infected with the hepatitis B virus each year. Is
this an estimate or are these reported cases?
Dr. Margolis. As I pointed out, infection in young children
is rarely symptomatic. We have looked, using blood tests, at a
very large sample of the United States, and this is an estimate
from that large study called the National Health and Nutrition
Examination Survey, and those estimates come from those surveys
done actually on two occasions 10 years apart.
Mr. Mica. So this is an estimate. If it is an estimate,
what age group are you talking about in children?
Dr. Margolis. The data comes from looking at children down
to 5 years of age. The study didn't go below that, at least for
hepatitis B, but repeated on two occasions, has again shown
consistency of that estimate in terms of those numbers.
Mr. Mica. Did it go below 5 years of age, 5 to what,
teenage or 18?
Dr. Margolis. It actually went through adults. The first
study was done through 2 to 70-year-olds. The second study 10
years later----
Mr. Mica. So the figure is sort of an estimate and it
doesn't deal with those under 5 and it includes adults, so it
does not really deal with children?
Dr. Margolis. No, it is a statistical sample of the United
States. So it represents the U.S. population of children under
5 years of age. That was done in 1970--1979; and then in 1990
it also included children 6 years of age and over. So it is our
best estimate with a valid scientific sample.
Mr. Mica. So these are estimates.
Can you tell me the number of reported cases of hepatitis B
in children under the age of 1, for example, for say the last
year?
Dr. Margolis. Well, I can tell you reported cases. Now, one
of the things, I have to go back 1 minute, from the estimate we
then matched that with our reported cases, and we can put what
we call a correction factor in there that takes into account
that very high rate of asymptomatic infection.
Mr. Mica. Reported cases under 1 in a timeframe like the
last year?
Dr. Margolis. Yes. In 1997 there were 95 reported cases of
children under 2 years of age.
Mr. Mica. Across the entire United States?
Dr. Margolis. Yes. That has been since immunization began
in 1991. So 1997, if we go back to 1990 before immunization
began, there were 266 reported cases of children under 2 years
of age.
Mr. Mica. That is under 2?
Dr. Margolis. That is the way that we have the data put
together.
Mr. Mica. And there were 87----
Dr. Margolis. Ninety-five in 1997.
Mr. Mica. In 1997, there were 95 children reported?
Dr. Margolis. Under 2 years of age.
Mr. Mica. Under 2 years of age, and you are comparing
apples and apples then?
Dr. Margolis. In 1990, which was before immunization of
children began, there were 266.
Mr. Mica. I mentioned, I think, in my opening statement a
study in New Hampshire. For example, there were 48 adverse
reactions to the vaccine in children aged 1 to 10 in recent
years. There were 16 times greater the number of cases of the
disease--16 times more, I guess, adverse reaction than cases of
the disease. There were three reported cases of the disease in
children?
Dr. Margolis. Correct. That is what you said in your
opening statement.
Mr. Mica. Well, is it possible that the preventive measure
is riskier than the disease itself, given these statistics?
Dr. Margolis. The first thing I would like to go back and
readdress is, since an infant or a young child who becomes
infected is very unlikely to be a case, to have symptoms and
thus be reported, as we heard, this is a silent infection. As
we heard today, many people did not know they were infected.
That is the problem with early childhood infections. You can
only discover the magnitude by doing these surveys with the
blood test. So what I would say is, those three cases represent
many infections and, in fact, the multiplier may be as high as
100.
In other words, for a symptomatic case, you may see--90
percent are going to be asymptomatic and not reported.
Mr. Mica. There were 3 cases of the disease and there were
four times as many child deaths, 11 reported; is that correct?
Are you aware of this New Hampshire study?
Dr. Margolis. I am not aware of the New Hampshire data.
Mr. Mica. If there were 11 reported deaths--and this brings
me to the reporting system--what kind of statistics do you have
in children 1 and under, or 2 if we can use 2 as a comparison--
I don't know if you would have the same timeframe--but how many
died from adverse reactions?
Dr. Ellenberg. Well, we cannot tell you from these data how
many died from adverse reactions. What we can tell you is how
many deaths occurring shortly after a vaccination were reported
to our system.
Mr. Mica. Can you give me that figure?
Dr. Ellenberg. Yes.
Mr. Mica. We have 95 reportable cases in children under 2
in 1997, is that correct, across the country?
Dr. Margolis. Correct.
Dr. Ellenberg. If you will give me just a minute--I have
too many folders in here. Find the one with the deaths. We will
give you the exact numbers in a minute, the number of deaths
under a year of age, and you must remember that most of these--
--
Mr. Mica. We want to be fair. I think we are trying to
compare 2 years. Dr. Margolis' statistics are 2 years.
Dr. Ellenberg. The vast majority of the deaths in children
are under age 1 because most of them are attributed to SIDS and
that occurs only in infants, so there are very few deaths in
children over the age of 1.
1997, is that the year?
Mr. Mica. I think that is your year. I am just trying to
get some idea. If, in the case of the New Hampshire data, you
have four times as many child deaths as we have cases of the
disease----
Dr. Ellenberg. Right. I can tell you the numbers, but the
problems are all in the interpretation.
In 1997, VAERS reported 41 deaths in children under the age
of 1; two deaths in children aged 2; and two additional deaths
in other children.
Mr. Mica. So we are looking at about 43 deaths, and we had
95 reportable cases?
Dr. Ellenberg. But it is important to recognize that these
deaths have not been causally attributed to the hepatitis B
vaccine. The bulk of these were reported after children
received multiple immunizations with multiple vaccines. We have
no way of knowing whether any of them had anything to do--this
is simply an association in time that is reported.
The number of deaths has been going down as consistent with
the data that Dr. Margolis showed. In 1994 we had 64; this is,
in age, under 1, we had 64. Then 60 in 1995, 48 in 1996, and 41
in 1997.
The number of childhood deaths is going down, just as the
increase in hepatitis B vaccine coverage in this age group is
going up.
Mr. Mica. Well, again we had the number of deaths that we
think were caused by adverse reactions.
Dr. Ellenberg. No, I have to take exception to that. We
have no idea whether these--there is nothing in the medical
record to indicate or suggest that these deaths were caused by
anything in the vaccine. As Dr. Margolis said, we have 4
million babies a year vaccinated.
Mr. Mica. So basically you are telling me we can't tell?
Dr. Ellenberg. We can't, from what is in the medical
record. The SIDS rate today is 1 in 2,000. Until the Back to
Sleep campaign, the rate was about 1 in 1,000. You don't have
to be a mathematician to see that with 4 million babies and the
rate of 1 in 1,000 per year, you are going to have a certain
number of deaths following vaccination.
Mr. Mica. Well, you said that you also did a study. Was it
in--sometime in the 1990's, about problems with adverse
reactions, possible signals of potential problems, I think you
said, and there was no new consensus as a result of that study
about problems. When was that conducted?
Dr. Ellenberg. We did a thorough investigation. This was
several years ago, actually prior to some of these concerns
being raised. We did a thorough review of all of the adverse
reactions.
Mr. Mica. What year was it?
Dr. Ellenberg. 1996 it was published, so we were doing the
study in 1995 or even earlier. And we have reviewed all of the
data in VAERS from 1991 to 1994 in infants to see whether there
were any patterns, any particular pattern of events that
suggested that they might be associated with the vaccine--this
is what we do with the VAERS data, we review them very
carefully--and there was nothing. Most of the reports, as I
indicated, were of transient, self-limited conditions, only
about 50 percent.
Mr. Mica. Is that a published study?
Dr. Ellenberg. Yes, it is a published report.
Mr. Mica. And peer-reviewed?
Dr. Ellenberg. Yes, sir.
Mr. Mica. There are 42 States that mandate this hepatitis B
vaccination. Can you tell me how many children are getting this
vaccination, say, at birth or how many are getting the
vaccination at a later date? Because if they are not getting
the vaccination, you might have lower figures.
Dr. Ellenberg. I think that would be something that Dr.
Margolis might better answer.
Dr. Margolis. We know that approximately 85 percent of
children are fully vaccinated--that is, as of this last year--
by the time they are 18 months of age. Thirty percent----
Mr. Mica. With the hepatitis B vaccine?
Dr. Margolis. With the hepatitis B vaccine.
And 30 percent of children begin their immunization some
time within the first month of life. So ``near birth'' or ``at
birth,'' the way that the question is asked. The schedule
allows much flexibility to give the vaccine over the first 18
months.
Mr. Mica. The vaccine hasn't been mandated by the Federal
Government, but the States have instituted a requirement for
entering public school or other public activities, I guess. We
have 42 States, and I am trying to get a picture; was that
instituted in 1991 or 1992, 1993, or has this been a
transitional----
Dr. Margolis. That is correct. It has been transitional and
evolving, and many States actually--now their school entry
requirement is only beginning to happen in 1999, in 2000. As
you see from that coverage data, that yellow line has a higher
proportion of children. Remember, you are vaccinating in the
first 2 years of life, and then they come into school. So the
majority of these States now, by the year 2000 or 2001, will
require a child to be fully vaccinated.
Mr. Mica. The studies or reports indicated an increase in
incidence of adverse reaction as we are having an increase in
vaccination. Maybe you can answer that, Dr. Ellenberg?
Dr. Ellenberg. No, I don't believe there has been any
increase in the total number of adverse events. Well, I should
back up because as a vaccine becomes--as the coverage
increases, you will certainly have increases in the number of
reports. Most of the reports in the system are actually of
things that we can relate causally to vaccines, things like
injectionsite reactions, running a fever, we know that vaccines
can cause these problems.
While we had very few reports involving hepatitis B in
children in 1991 when the recommendation for universal
immunization was first made, the numbers shot up in successive
years because millions of children were then receiving the
vaccine. But over the last few years, there has been a tapering
off and a decrease in the total numbers of reports.
Mr. Mica. So there was an increase in adverse reactions and
reporting in the system, as there was an increase in the
vaccination?
Dr. Ellenberg. That is right. As one would expect.
Mr. Mica. And now you have seen that trailing off?
Dr. Ellenberg. Yes.
Mr. Mica. One of complaints that we heard today is that
individuals, parents or those who were inoculated as adults or
later, did not feel that they had adequate warning about the
adverse reactions. Today we have developed an incredible
warning system. Cigarettes have warning systems on them. Every
time you turn on the television, half the ad is the warning
about the potential of the drug that you may be taking.
From your experience and from seeing the statistics that we
have seen here, it sounds like there are cases of adverse
reaction. Does it not appear that there is inadequate warning
either to the parents or those about to be vaccinated?
Dr. Margolis. Well, I can speak both from the vaccine
information statement that the CDC supplies--and again it is up
to the individual to use that--where we say that a vaccine,
like any medicine, is capable of causing serious problems such
as severe allergic reactions. The risk of the hepatitis B
vaccine causing serious harm or death is extremely small. As a
clinician, when I talk to parents, I advise them of this
potential.
Mr. Mica. Is the warning adequate, given the numbers of
adverse reactions? If we just take the New Hampshire incidence,
we have more deaths from the vaccine than we have deaths from
the disease.
Dr. Margolis. The CDC and the ACIP, whom we go to with
these potential or alleged adverse events, review the data in
terms of association, scientific association and potential
causality, and at this time there are no data that would show
that these deaths, including the SIDS deaths or the other
serious neurologic adverse events that we have heard about, are
associated with the hepatitis B vaccination; and that is why at
this time they are not included in the information statement.
Mr. Mica. Dr. Ellenberg, did you want to respond about
adequate warning?
Dr. Ellenberg. Just to say that the adverse reactions that
are known at the time that a vaccine is licensed are included
in the label for the product. And as we learn new information
about possible risks of the vaccine, those can be added to the
label.
Mr. Mica. Do either of you recommend additional studies?
Another complaint we heard today and something that should be a
concern to us is that we don't have enough data, enough
studies, to find out what is really going on here.
Dr. Margolis.
Dr. Margolis. The CDC has seven studies ongoing at this
time to look at the various types of adverse events which have
been described, to see if there is----
Mr. Mica. What is the sequence of their being initiated? Is
this recent or ongoing?
Dr. Margolis. The first studies with the hepatitis B
vaccine began in the mid eighties, and they were two reviews
looking at neurologic events at that time; and then additional
studies have begun, subsequent--there was an early study
looking, soon after widespread use of the hepatitis B vaccine
in infants in 1993-1994, and then these additional studies in
the last several years for which data collection is still
ongoing and final results are not in.
Mr. Mica. So you think that this does need more study? Is
it getting more study? And you recommend additional study?
Dr. Margolis. Yes. It is part of our keeping vaccines safe.
Mr. Mica. Dr. Ellenberg.
Dr. Ellenberg. Vaccine safety is so important, I don't
think that we can ever have enough studies. It is very
difficult sometimes to uncover very, very rare risks because of
all of the problems in interpreting data. So more studies, yes,
would be very useful.
Mr. Mica. We heard from Mr. Belkin, and he brought a chart
up here that showed the sequence of events as he saw them. And
when it got down to the VAERS study or repository, his chart
indicated that the information went nowhere. What is the case
with the reporting system?
Dr. Ellenberg. Well, we have a staff that review these
reports very carefully. There is more detail----
Mr. Mica. But beyond reviewing them, what happens? Is there
anything happening with that information?
Dr. Ellenberg. Yes. When we review them, when we do a
thorough review, we provide this information to the medical
community in the way of presentations and publications.
If there is a need for making this information--putting
this information on the label, we can work with the
manufacturers to have that happen.
I am not quite sure--that is our job, to see what
information is in there that people need to know in order to
improve everybody's understanding about vaccine safety.
Mr. Mica. Dr. Margolis.
Dr. Margolis. The other things that VAERS do, these case
reports generate--these larger studies, one looks at vaccinated
versus unvaccinated children to see if there is a true
association. So it is fed back into a loop.
Mr. Mica. Do we have information on that as it relates to
hepatitis B?
Dr. Margolis. Those are part of the seven studies that I
described, but we don't have the complete information at this
time.
Mr. Mica. My last question deals with its efficacy, for how
long the vaccines are effective. I have read 7 years in one
report. The manufacturer says--indeterminable was something
that was said, testified to. Someone else said 4 years in
India. It doesn't sound like we know how long these
vaccinations are effective for. Do we, Dr. Margolis?
Dr. Margolis. Unfortunately, when we start out with any
vaccine, we don't know how long it is going to be effective.
Hepatitis B vaccine is one where we started following children
and adults, and we are out now 15 years, to see how long the
immunity will last.
Yes, there has been controversy, and our friends in Europe
and India, some have said we should test everybody and
revaccinate every 4 years. There has been a change as data has
become available. There are studies out 15 years showing that a
child vaccinated either as an infant or a young child is still
protected, including as they have grown up, become sexually
active, and are exposed in settings where there is a high rate
of hepatitis B.
So we feel comfortable that we know about 15 years. We
don't know about the future, but these studies are ongoing.
They are part of CDC's program to follow this vaccine and
determine if we need booster doses.
Mr. Mica. Did you want to respond, Dr. Ellenberg?
Dr. Ellenberg. No, that is a very complete answer.
Mr. Mica. The hearing so far raises as many questions as I
think we have had answers provided, but at this time I would
like to yield to Mr. Tierney.
Mr. Tierney. In that vein, let me say that one of our
colleagues, Rod Blagojevich, asked me to put a question to you
on the record, Dr. Margolis. I think you have answered it, but
in deference to him, I am going to ask it again.
What efforts have been made to compare the overall outcomes
of children who are vaccinated against those who are not
vaccinated?
Dr. Margolis. Again, there have been several long-term
studies in populations. One is among the Alaskan native
children and has shown the ongoing effectiveness of
immunization now for 10 to 15 years.
Mr. Tierney. The second part of his question, are there
clinical trials, control groups or other ways of measuring the
general health of the vaccinated versus the unvaccinated?
Dr. Margolis. These again have been done in these large
population-based studies, and especially where one is looking
for a potential adverse outcome.
Mr. Tierney. I want to pose to you a question one of the
skeptics of the vaccine has published before. The question that
this doctor says is worth asking is, does a baby born of stable
parents in a good environment have enough chance of getting
hepatitis B to warrant subjecting it to what he perceives as an
unknown danger?
Dr. Margolis. When we look at the 20,000 to 25,000
infections that occur in children in the United States, and the
majority don't have a risk factor, there is not someone in
their household who is infected, and so those are a very
important group because if we don't prevent those, they are
going to grow up and have chronic liver disease.
Also, as people may have high-risk behaviors as adolescents
or adults, we have found it very difficult to vaccinate before
you get infected. There is that additional margin of protection
that occurs.
Subjected to a rigorous and peer-reviewed analysis of this,
both in terms of prevention--and we were quite conservative in
our prevention; we only said 60 percent of children would be
vaccinated, we have done better--it becomes both cost-effective
and prevention-effective to do this.
Mr. Tierney. How many manufacturers produce the vaccine?
Dr. Margolis. There are two that are licensed in the United
States. There are many more worldwide.
Mr. Tierney. Dr. Ellenberg, we have--I think you talked
about one study that seemed to document people who use
vaccines, and then looked at the reactions that were claimed.
Do we actually ever do an analysis of VAERS, things that
are claimed, to see if there are any common characteristics
between the individuals who are making those reports?
Dr. Ellenberg. You mean to see whether one could identify
people who are particularly at risk for having reactions?
Mr. Tierney. Yes.
Dr. Ellenberg. We have done that, but we need to do more of
that. It is something that with regard to--for example, the
gender issue that was raised by a previous witness, this is
something that we have studied.
Mr. Tierney. You have studied the gender difference?
Dr. Ellenberg. To some degree; not as intently--we have not
completed our investigation.
Mr. Tierney. Do you have any preliminary results on that?
Dr. Ellenberg. With regard to the hepatitis B vaccine, I
can say that there is a predominance of reports in females in
the adult age group. That is because the largest group of
people who get the hepatitis B vaccine as adults are healthcare
workers, and this is a predominantly female occupation.
When we look at the adverse events in children, there was
no difference, males versus females, in the adverse events
reports. But this is an important issue not just for vaccines,
but for other medical products, and it is something that we
hope to pursue in more detail.
Mr. Tierney. What are we doing exactly to pursue it?
Dr. Ellenberg. Trying to get additional resources.
Mr. Tierney. You have made an application to Congress for
that?
Dr. Ellenberg. Yes.
Mr. Tierney. Let me ask you, Doctor, are there any criteria
for reporting to VAERS? Are there any conditions that have to
be met before a report can be filed?
Dr. Ellenberg. That is correct. Any time anybody feels that
there might have been--a vaccination might have been
implicated, they are encouraged, because we have found things
that nobody would have thought were associated with the
vaccine. And when we have a number of reports, we are able to
see that maybe in some rare cases it is, and some of that
example is in the written testimony.
Mr. Tierney. Can you tell us what your datalink project is
designed to do?
Dr. Ellenberg. The Vaccine Safety Datalink is actually a
program of the CDC, so they may want to elaborate on this. But
it is a collaboration of four health maintenance organizations
where you can link the vaccination history of children with
their medical outcomes. And so we don't have some of the
problems that we have in VAERS in terms of knowing how many
people were vaccinated and how many people had certain kinds of
events.
One can construct rates in a way that you can't do with the
VAERS system. When we identify a signal of a possible problem
in VAERS, we can go to the Vaccine Safety Datalink, which met
last week, and suggest that perhaps these things could be
looked at in the Vaccine Safety Datalink, and that has happened
on numerous occasions.
Mr. Tierney. Has there been a problem with the VAERS system
for double counting?
Dr. Ellenberg. Yes. We get duplicative reports. We have
continued work to develop algorithms to sort these out. We
don't want to discourage--we are more anxious to get the
reports in the first place, but it is problematic. We have more
duplicative reports of the serious events and fatalities; 10 to
15 percent of those are duplicates as compared to the less
serious reports where there is not as much of a problem with
duplicates.
Mr. Tierney. Is there anything that Congress can do with
that particular issue? Is that something that you are working
with within the administrative end of it?
Dr. Ellenberg. The issue of trying to do quality control of
the data base is difficult. Anything that Congress can do to
provide us additional resources to analyze these data bases and
to do followup studies would be most appreciated.
Mr. Tierney. Is it accurate to say that the majority of
people that are contracting hepatitis are, in fact, infants or
adolescents, or do you have it broken down?
Dr. Ellenberg. That, I will have to defer to my CDC
colleagues.
Dr. Margolis. As that pie chart showed, still the majority
who contract it are adolescents and adults.
Mr. Tierney. That is diagnosed or contracted?
Dr. Margolis. Both. If you look at it both in terms of
reported, or if one goes to the surveys and the estimates, you
see it both--you see it as being similar.
Mr. Tierney. So there is no way to tell when someone
contracted it once you have diagnosed it?
Mr. Margolis. That is correct, but the two appear to mirror
each other. You can use acute disease reporting to show you
what happened in the past.
Mr. Tierney. I have no other questions. Thank you.
Mr. Mica. Thank you.
Let me go back if I can just a second. I discussed the
number of cases of children under 2, and we got to 95 reported
cases of hepatitis B nationwide. Was that right, Doctor?
Dr. Margolis. Correct.
Mr. Mica. That was in 1997. Then I asked Dr. Ellenberg the
number of deaths attributed to adverse reactions in the same
period, and we got to about 45?
Dr. Ellenberg. Well, those were deaths reported to VAERS,
but one could not attribute them to the vaccination. They are
associated in time, but there is no way to determine that the
vaccine was responsible for those deaths.
Mr. Mica. They are attributable under some circumstance, in
some way, or does the reporting make any sense if----
Dr. Ellenberg. As I have said, there is no restriction on
reporting. If someone's child----
Mr. Mica. You said there was also underreporting?
Dr. Ellenberg. There is underreporting----
Mr. Mica. And we don't have that causal evidence on other
cases, so we are guesstimating that these 45 would be adverse
reaction deaths, right?
Dr. Ellenberg. No, we cannot draw that conclusion.
Mr. Mica. Do you have any idea what is going on?
Dr. Ellenberg. We have a nonrestrictive system so that
anything that happens after a vaccine we can look at. We might
be able to find some cluster of symptoms that does suggest that
the vaccine was causal. But we don't have that.
Mr. Mica. So our guesstimate is 45 adverse----
Dr. Ellenberg. That is not my estimate. I don't know how
many of these deaths, if any, were related to the vaccine.
Mr. Mica. How many deaths did we have in infants or
children under 2 from hepatitis B, as reported--deaths? Now, if
they have hepatitis B, we can probably get that in a task, and
that would be reportable as a death, OK.
Who can tell me?
Dr. Margolis. Deaths from hepatitis B in children under age
2 or in children in general are very rare.
Mr. Mica. I am trying to get one----
Dr. Margolis. There is----
Mr. Mica. We are looking at children under 2. Is there any
evidence? I know that has to be reported somewhere, because we
can definitely tell who has hepatitis B in children under 2.
Dr. Margolis. I don't have that number. I can tell you----
Mr. Mica. Is it more than 45?
Dr. Margolis. No, it is going to be less than that. That is
again because as you have heard from me and other witnesses,
that the deaths from hepatitis B occur many years later. They
occur from the chronic liver disease. Death from acute
hepatitis B, we estimate there are only 150 to 200 in all of
the United States. That is from the new acute infection;
fomenting hepatitis is rare.
Mr. Mica. That is from hepatitis nationwide in 1997?
Dr. Margolis. Yes.
Mr. Mica. How many were there?
Dr. Margolis. Around 100. That is acute. That is the new
case. If one looks at chronic liver disease, that is the 4,000
to 5,000.
Mr. Mica. Attributable to hepatitis B?
Dr. Margolis. Attributable to hepatitis B. You asked me
about new acute cases. That is what is reported to us or acute
cases. People who get ill with hepatitis acutely, the new
infection.
Mr. Mica. Given some of what we have heard today and some
of what you know, there are--currently 16 States have
conscientious or philosophical exemptions available from the
mandatory vaccination laws. Do you feel we should expand this?
Sixteen States now have it--or redefine it?
Mr. Livingood. This is John Livingood from the National
Immunization Program. The construction and implementation of
State laws for mandatory immunization has been entirely a State
function and not a Federal function.
We have been prepared to support States, however they chose
to enact and implement their State law.
Mr. Mica. We also penalize them----
Mr. Livingood. We do not penalize them for the content of
their State law. States receive incentive funding based upon
the amount of four doses of diphtheria, tetanus, and pertussis
vaccine.
Mr. Mica. So, in effect, they are not being financially
rewarded?
Mr. Livingood. Hepatitis B does not play a role in
incentive funding. It is not included in the formula for
incentive funding. Incentive funding is based on DPT, MMR, and
polio containing vaccines.
A State also measures immunization levels at the time of
school entry, but we don't reward or allocate funds based on
hepatitis B as a component of the immunization program in a
reward or incentive way.
Mr. Mica. So basically no one is going to commit to
anything from this panel as far as any exemptions for
conscientious or philosophical exemptions from the vaccine?
Mr. Livingood. If States implement such a law, we will
support them; and we are in complete agreement with however the
States choose to do their own----
Mr. Mica. There are 16 States that have this exemption.
Have we done any study, if there are any higher or lower
vaccination rates or incidents? Is that part of any ongoing
study, Dr. Margolis?
Mr. Livingood. Not for hepatitis B, but there is an article
that will be coming out in the next several months in the
Journal of the American Medical Association. Not surprisingly,
States that have persons who are allowed philosophic
exemptions, those persons themselves are at increased risk of
disease because they are not immunized compared to the other
population.
There is also a small increased risk that appears for the
general population of those States, but it is not a major
impediment to immunization coverage levels per se, since most
States have rather low levels of philosophic exemptions by the
time of school entry. It is usually in the single digit
percentages.
Mr. Mica. Well, I thank our witnesses. Did you have any
additional questions, Mr. Tierney?
We have been joined by Mr. Towns, the gentleman from New
York. Did you have any questions at this time?
Mr. Towns. I have a couple, Mr. Chairman.
Mr. Mica. Go right ahead. You are recognized.
Mr. Towns. Let me also thank you for holding this hearing.
Today it is fashionable, among teenagers in particular, to
get tattoos and engage in body piercing, and also fraternities
have fraternity brands. Knowing what you know about the
transmission and effects of hepatitis B, what do you think
about this trend from a health standpoint?
Dr. Margolis. Well, anytime one puts a needle into their
body, there is a potential for transporting blood-borne
viruses. I had this discussion with this committee for
hepatitis C and HIV.
However, if you look at persons with acute disease where we
do the surveillance to find out risk factors, we do not see
this as a substantial risk factor. The potential is there and
so we feel that if people choose to do it, they should do it
safely.
Mr. Towns. Don't you think we should be a little more
aggressive about it in terms of getting information out,
because nobody really talks about it? Colleges are doing it and
they are doing it on university campuses. Don't you think some
statement should be coming forth in terms of the possible risk
here?
Dr. Margolis. Actually, the CDC has made that statement as
the possible risk. In information about hepatitis C, there have
been a number of health education materials from non-CDC groups
that point out that potential. And as information--and about
all blood-borne infections, that that potential is there. We
agree.
Mr. Towns. One other question. I am concerned about daycare
workers. Are there any Federal guidelines which require daycare
workers, who have close contact with children by changing
diapers and all of those other kinds of things, be tested for
or immunized against hepatitis B?
Dr. Margolis. In a number of studies----
Mr. Towns. By not doing this, are we jeopardizing our
children?
Dr. Margolis. For hepatitis B, many studies have shown
there is not transmission either from the child to the daycare
worker or from daycare workers to children. And at the time,
the occupational safety and health regulation about blood-borne
pathogens was developed and implemented in 1991, this actually
had been looked at and so that is not considered an
occupational risk and it is really not considered a risk from
the daycare worker to the child. And there have been a number
of studies that have looked at that.
And so again, while this is a blood-borne infection that is
relatively easily transmitted, it has not been transmitted in
the daycare setting.
Mr. Towns. Let me ask you this. Do you have any other
feelings of explanation for that if that is actually true?
Dr. Margolis. Well, we know actually in the hospital
setting that a transmission, again more likely because of
needle sticks and those kinds of sharp injuries, goes from the
patient to the healthcare worker. Transmission from a possibly
infected healthcare worker does not go to the patient. So
again, those blood exposures are rarely there, and they are
even more rare in the daycare setting.
Mr. Towns. I just think that for some reason we are not
paying enough attention to prevention. I could be wrong. In
fact, I hope that I am wrong, but I am willing to bet that I am
not wrong.
Dr. Margolis. I think now children--because of routine
childhood immunization, most children in daycare are
vaccinated. So the potential for transmission between children
or from a child to a daycare worker would even be rarer than it
already is.
Mr. Towns. My other question is, are we requiring this
daycare worker to be immunized?
Dr. Margolis. Not against hepatitis B.
Mr. Towns. OK, I have no further questions.
I just think, Mr. Chairman, that really once we--if we
stressed it at the beginning, I think we might be able to solve
some problems later on.
There is not enough information out. I think that is a big
problem here. Once a person has hepatitis B or C, there is no
treatment for it.
Dr. Margolis. It is largely treatment through interferon
treatments. With end-stage liver disease, a transplantation is
required. So prevention is the thing.
Mr. Towns. Let me ask a question, what is the difference
between B and C?
Dr. Margolis. Two different viruses. Both live in the
liver, but two different viruses in terms of their outcome.
Mr. Towns. Can I say that C is much more aggressive and
much more devastating?
Dr. Margolis. There are more people infected with C, but
they are actually both equally aggressive.
Mr. Mica. Thank you, Mr. Towns.
We did hear today different instances about the effect on
people's lives and some pretty dramatic testimony. You
mentioned in your testimony about some studies that you are
doing, and also I think you mentioned that the British and
French have conducted studies.
I have got a headline from an Associated Press wire story
from October 1998. It says ``French Suspend Hepatitis B
Inoculations,'' and it starts out, ``Faced with a potential
health disaster, France has suspended hepatitis B vaccine
inoculations of school children 4 years after mass immunization
program began.''
I am just wondering if you would like to respond to what
the French have done.
Dr. Margolis. What I would like to do is clarify what
happened in France, and several of us were involved with the
World Health Organization and close to that issue.
The French did not suspend infant, adolescent, or adult
high-risk hepatitis B vaccination. What they suspended was
vaccination of teenagers in schools, and what they said was,
you as a teenager should be vaccinated in your healthcare
providers' office, not in the school. Often in the
translation--that was not there in the early headlines, but
that is in fact the policy in France.
Mr. Mica. I hate to say this, Dr. Margolis, that raises
even more questions because now we have taken--well, we have
questions already about the infant adverse reactions based on
several studies, and we will hear some more about that; but
this raises a whole new area of concern about teenage
vaccination and why one country would suspend that. And it
sounds like you----
Dr. Margolis. They did not suspend teenage vaccination.
They suspended it in the schools. So the recommendation is
still there, as we have in the United States, for routine
vaccination of adolescents.
What the French Minister of Health said is, go to your
physician and have it done, do not come to the school and have
it done. They did not do that because there were any data that
showed that there was an association with adverse events.
Mr. Mica. Well, I guess this is a hearing to be continued.
We have gone on with this panel for some time. I will have
additional questions that I would like to submit to you and ask
that they be made part of the record, without objection. And if
we have any other questions, we will submit them. We will
dismiss you and thank you for your participation and call our
third panel of experts on the subject.
We have a series of doctors who will testify, including Dr.
Samuel Katz, with the Infectious Disease Society of America;
Dr. Bonnie Dunbar, a molecular biologist with Baylor College of
Medicine. Dr. Burton Waisbren, Sr., F.A.C.P., and Dr. Barthelow
Classen, president and CEO of Classen Immunotherapies.
With our witnesses in place, I would like to welcome all
four of you as experts on the subject at hand. I would remind
you that we try to limit your oral presentation before the
subcommittee to 5 minutes, and if you have a lengthy statement,
we will enter it as part of the record.
This is an investigation and oversight subcommittee of
Congress and so if you don't mind, please stand and we will
swear you in.
[Witnesses sworn.]
Mr. Mica. The witnesses have answered in the affirmative.
We are going to recognize Dr. Samuel Katz who is with the
Infectious Disease Society of America. Dr. Katz, welcome. You
are recognized.
STATEMENTS OF DR. SAMUEL KATZ, THE INFECTIOUS DISEASES SOCIETY
OF AMERICA; DR. BONNIE DUNBAR, MOLECULAR BIOLOGIST, BAYLOR
COLLEGE OF MEDICINE; DR. BURTON WAISBREN, SR., F.A.C.P.; AND
DR. BARTHELOW CLASSEN, PRESIDENT AND CEO, CLASSEN IMMUNO-
THERAPIES, INC.
Dr. Katz. Thank you, Mr. Mica. It is a pleasure to appear
before you and Mr. Towns and Mr. Tierney. I also have submitted
a more lengthy statement.
Mr. Mica. Without objection, that will be made a part of
the record. And if people in the audience have conversations, I
would like them to take them outside so we can hear the
witnesses.
You are recognized, Dr. Katz.
Dr. Katz. I am Dr. Samuel Katz, a pediatrician who has
spent the last 42 years of my life working to develop the best
vaccines in the world to protect the health of infants,
children, and adults. I was privileged to be one of the two
scientists who developed the measles vaccine more than 35 years
ago that has saved tens of millions of lives of children in
this country and around the world.
Today, I was invited to speak on behalf of the American
Academy of Pediatrics, as well as the Infectious Diseases
Society of America and the Pediatric Infectious Diseases
Society, groups whose membership represent more than 55,000
pediatricians and 6,000 infectious disease experts who take
care of patients, do research and teach, and participate in
public health in the United States.
Parenthetically, I would add in relation to an earlier
discussion, that I am currently a member of the Advisory
Commission on Childhood Vaccines, the one that you discussed
that was established by the 1986 National Childhood Vaccine
Injury Act, and the membership consists of parents, attorneys,
and physicians.
Today, we are here to talk about hepatitis B, a
particularly insidious disease, as you have heard, especially
for children who acquire it within the first 5 years of life.
Of those 25,000 hepatitis B-infected children, 30 to 90 percent
are destined to acquire chronic hepatitis, which then leads to
cirrhosis of the liver and liver cancer 30 to 40 years after
they acquire the infection.
However, we can prevent this disease with a vaccine that
has been in use for more than a decade. It is effective and it
is safe. It has been given to more than 500 million people
around the world with the most striking results imaginable. The
benefits of this vaccine are so impressive that more than 100
countries around the world routinely administer it, and in
those countries the incidence of cirrhosis and liver cancer due
to hepatitis B has plummeted.
It is important, Mr. Chairman, to note that everyone is at
risk for this disease. No matter their age, their race, their
lifestyle or their socioeconomic status. As you have heard, at
least 30 percent of people who have the hepatitis B virus have
no idea how they acquired it. It is far more contagious than
the virus that causes AIDS, and in this country it causes at
least 5,000 deaths each year.
The vaccine, like all recommended vaccines, has gone
through rigorous, exhaustive processes of testing for safety
and effectiveness by multiple groups, both within and outside
our government, as well as in countries abroad. The safety
systems currently in place are highly effective, and we persist
in assessment of the safety of the vaccine, continually seeking
new ways to decrease any possible risks.
Parenthetically, Mr. Chairman, let me note that some of the
statements you may hear in the media border on the
irresponsible. The statements are not based on solid scientific
facts, and they serve to shake the public's trust and threaten
to reverse the incredible gains that this vaccine has provided.
When you heard from parents today whose children have
acquired hepatitis B, you can be certain there is nothing they
want more than to turn back the clock so they might have made
this vaccine available to their children.
Parents can continue to have the utmost confidence in their
pediatricians and other health professionals and rest assured
that they are focused solely on providing the best health and
happiness for these children in recommending the vaccine to
prevent hepatitis B.
Let me add, in closing, that I am a grandfather whose eight
grandchildren ages 2 months to 4 years have all received
hepatitis B vaccines, as their parents and their pediatricians
strive to assure them the best in healthy and happy lives.
Hopefully, all American children will continue to receive
these same benefits. Hepatitis B is a serious, often life-
threatening infection. The vaccine is both effective and safe.
Pediatricians will continue to provide parents the most
reliable information regarding all vaccines, including that to
prevent hepatitis B.
Time does not permit my answering many questions you may
pose, but I will be happy to respond to any in the discussion.
Thank you.
[The prepared statement of Dr. Katz follows:]
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Mr. Mica. Thank you. I recognize now Dr. Waisbren. Is that
Waisbren?
Dr. Waisbren. Waisbren.
Mr. Mica. Senior, FACP. Thank you.
Dr. Waisbren. I would like to thank this committee for the
opportunity to share with them my concerns regarding the
vaccination policies of the Centers for Disease Control and
Prevention and the Food and Drug Administration.
I am a physician and clinical investigator who has
practiced internal medicine, infectious diseases, and
immunology in Milwaukee, WI, for 48 years. I am a member of the
Infectious Disease Society of America, and I will point out
that nobody asked me, as a member, my opinion about this
subject. No ulterior motives or special interests are
responsible for my being here.
I am here because I feel an injustice has been done to the
children of the United States. Included among these children
are my 16 grandchildren. I want to make it clear from the onset
that I fully support hepatitis B vaccination for individuals
who have known risk factors for hepatitis B infection.
My involvement in the field of vaccine toxicity began in
1979 when I discovered that central nervous system
demyelination as evidenced by multiple sclerosis had been cause
in some individuals by the swine flu vaccine. My involvement
was heightened when I found the same thing occurred after
hepatitis B vaccination. Incidentally, everything I am saying
is documented in this material that I'm going to submit.
These findings have been confirmed by many others and have
been extended to include other untoward reactions to the
hepatitis B vaccine. Reactions include other autoimmune
diseases such as rheumatoid arthritis, optic neuritis,
postvaccinal encephalomyelitis, which one of the persons who
talked to you has, and possibly juvenile diabetes which you
will hear more about.
An autoimmune disease is defined by the fact that it is
caused by the body's immune system turning against its own
tissue, be it the nervous system, the heart, or the cartilage.
Since the discovery of the autoimmune aspects of vaccine
complications and confirmation by numerous investigators, I
have been searching the medical literature and studying a good
number of patients to try to figure out the mechanism or
mechanisms by which these autoimmune complications occur.
While many explanations have been suggested, the exact
mechanism is still unknown. However, this study of the medical
literature of the patients and a great number of the reports
sent to the Vaccine Adverse Event Reporting System [VAERS], has
convinced me that a serious, probably unique, problem with that
exists in regard to the hepatitis B vaccine.
There are at least 16 articles in the peer-reviewed medical
literature about the occurrence of diseases of autoimmunity,
such as multiple sclerosis, after hepatitis B vaccination. The
editors of these renowned medical journals in which these
articles appear felt that these cases should be brought to the
attention of the medical professions.
There are thousands, yes thousands, of reports by health
professionals to the VAERS that adverse events have occurred
after hepatitis B vaccination. I am aware of dozens of cases
brought against pharmaceutical companies because of damage due
to the hepatitis B vaccination. Many of these cases have been
settled out of court with the proviso that the settlements
remain a secret.
The fact that these well-established adverse reactions to
the hepatitis B vaccine have not been acknowledged or are being
denied by both the CDC and the FDA is the root cause of the
concerns that I am to share with you now. The first concern is
that caused by the experiment, not the strategy, sponsored by
the CDC, which is designed to determine if vaccination at birth
of all babies in the United States will eventually decrease the
frequency of cancer of the liver caused by hepatitis B
infection.
To arrive at the end point of this experiment will take
many years. This experiment is based on the following
assumptions. One, the vaccine is safe and effective. While the
vaccine is effective, we all know that no vaccine is entirely
safe as evidenced by the above mentioned information.
The second assumption: I have read that they say that 5 to
20 percent of the people in the United States will eventually
contract the hepatitis B infection. I doubt these statistics as
I doubt many of the other statistics that have been presented.
They mentioned up to 25 or 30 percent of patients with
hepatitis B infection cannot remember where they got the
disease.
Isn't it understandable that people with risk factors such
as multiple sex partners and injected drug use will not be able
to pinpoint where and when they were exposed to the disease?
The fourth assumption, and they repeatedly say this: There
is no other way to control hepatitis B infection in the United
States. Does anyone in this room agree that there is ever only
one way to accomplish a purpose?
I hope this committee will ask for an independent analysis
of the rationales for the universal hepatitis B vaccination. In
looking at the data, they should remember that the reports by
the CDC are not peer reviewed and are reports, and that much of
the data that is cited were given at symposiums sponsored by
medical journals by invited speakers. Therefore they were not
peer reviewed.
This brings up my second concern, that is, how can an
experiment such as universal hepatitis B vaccinations be
adopted nationwide without congressional involvement or
approval?
Apparently this was accomplished by the joint efforts of an
official of an agency that stood to gain much influence and
power by the program and by an executive of a drug company
which stood to make billions of dollars by the project. The
references in that regard are available to you. What techniques
were used and were conflicts of interest involved? Were the
rights of parents and children infringed upon?
My third concern lies in the fact that the FDA has
apparently not been reacting to the many theories in the
medical literature regarding the causes of neurologic
complications of vaccination. The FDA does not ask if proposed
vaccines exhibit molecular mimicry with human tissue, a
possible cause of the difficulty.
They do not ask if a vaccine exhibits complimentarity with
common viruses that may be in the patients. Again, a possible
explanation. They have not demanded that HLA patterns of
patients who have untoward results be determined. This would
react to the question brought up here today of who would get
reactions.
They have not encouraged the development of synthetic
vaccines that contain only immunogenic antigens and nothing
else. I am very concerned that we may see the same or similar
adverse reactions to new vaccines.
The new Lyme vaccine is a case in point since that vaccine
has more theoretic dangers than does the hepatitis B vaccine
because of the autoimmune nature of the disease itself. When
the material I have presented here is considered en toto, I
believe that it indicates that the present universal hepatitis
B vaccination experiment being conducted in the United States
should be abruptly halted for the following reasons.
It appears likely that serious untoward events,
particularly of the nervous system, involve the vaccine. In
view of this, is it reasonable to suppose that some babies who
have little or no chance of getting hepatitis B will suffer
unnecessary damage to their nervous system?
Three, information regarding the risk-benefit ratio of this
vaccine is not known and therefore cannot be given to parents
in an informed consent.
Four, there is some doubt as to whether the rights of
babies are being violated when they are subjected to an
experiment even with their parents' consent.
France has already at least mediated their program of
hepatitis B vaccine because of reports about multiple sclerosis
following the vaccination. I hope this country will follow
their lead. If not, I'm afraid that public confidence in our
vaccination programs will decrease, and they are excellent as
described by Dr. Katz.
This would be detrimental to the excellent vaccination
programs already in place in the United States. I would like to
thank the committee again for allowing me to share my concerns
with them. Documentation of all that I have said here is
available in the supplemental material that I have given this
committee. Thank you.
Mr. Mica. Thank you for your testimony and that
supplementary material will be made part of the record. Thank
you. We will withhold questions until we have heard from
everyone.
[Note.--Additional information provided by Dr. Waisbren may
be found in subcommittee files.]
[The prepared statement of Dr. Waisbren, Sr. follows:]
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Mr. Mica. Next we will hear from Dr. Bonnie Dunbar,
molecular biologist with Baylor College of Medicine. You are
recognized.
Dr. Dunbar. Thank you, Congressman Mica, for your
invitation to speak to this committee. I also have a full
report and some documentation that I would like to submit.
Mr. Mica. That will be made part of the record without
objection.
Dr. Dunbar. Thank you. I have been a professor at Baylor
College of Medicine for approximately the last 15 years, but I
have been working in vaccine development for 26 years.
I will get to why I am going to be speaking here, but
inasmuch as this is my first time addressing Congress and my
time is limited, I have taken the advice of my lawyer, Mike
Butler, who is a former chairman of the Federal Energy
Regulatory Commission and who has testified on numerous
occasions. He suggested I summarize the detailed report that I
sent you and follow up with some questions.
Mr. Butler and his wife are here at the hearing today, not
as my legal counsel but as concerned grandparents whose
grandchild was vaccinated with the hepatitis B vaccine against
his mother's specific wishes and became subsequently vision
impaired.
With respect to your first question, on the FDA VAERS
reporting system and how it works, I have a few comments. I got
involved in this issue about 5 years ago when I reported
serious and permanent adverse reactions to the hepatitis B
vaccine by two individuals working in my laboratory.
One of those is my brother, Dr. Bohn Dunbar, who is
currently disabled and has been acknowledged by over 12
physicians to have permanent disabilities due to this vaccine.
He could not be here today because of his serious reaction to
one of his treatments.
Despite the seriousness of these reactions, there has been
no followup to my reports to the FDA adverse reporting system.
I have also found that there is no scientific or official
mechanism for research scientists studying these reactions to
communicate with the FDA or to get adequate information.
I did find out, however, that the thousands of reactions
reported to the FDA show the overwhelming correlation with the
reactions that I reported to the FDA. I have received hundreds
of calls from patients and doctors now about their patients
having similar reactions.
What is interesting is that these reactions are also
identical to the over 100 published reports of adverse
reactions that are currently in the literature. Many of these
are in excellent peer review articles, and I have submitted
this for the committee's review.
Finally, and I think a big concern, has come from
communication with my former medical students. I have been
teaching medical students basic sciences for over 15 years. A
student told me in tears, on one occasion, that the supervisory
physicians in the hospitals have told them not to report
vaccine adverse reactions or to get involved.
In one situation, two babies were dying and they were
specifically told not to report it. I feel strongly that this
reporting system needs to be improved so that we can have a
greater impact on vaccine safety.
With respect to the risk benefit issues of infants, you
have heard much about this today and I won't reiterate. But
from a scientific viewpoint, I challenge any of my colleagues,
scientifically or medically, to claim that we understand the
newborn immune system.
Without detailed scientific studies to demonstrate vaccine
safety, efficacy, and duration of protection for an adult
behavior-associated disease, I find it hard to justify wide-
scale immunization. In fact, in our animal models, we can
easily perturb the immune system of the newborn to cause
adverse immune reactions.
With respect to the CDC and pharmaceutical company
interactions in conflict, I as well as other people here have
overwhelming documentation on organizations receiving funds
from drug companies, doctors carrying out clinical trials while
being paid handsomely as expert witnesses and consultants for
promoting the vaccine, doctors who have switched from being
expert witnesses for the plaintiffs that were injured by the
vaccines when they got paid more money to become an expert for
the drug companies.
Lobbyists have been paid simultaneously by healthcare
organizations and drug companies. I recommend strongly that
your distinguished committee investigate and evaluate these
conflicts of interest, and I have documentation on that that I
will be glad to provide you.
Finally, with respect to the informed consent issue, many
of our current and former medical school curricula do not
emphasize details of immunology, a scientific field which has
expanded tremendously within the past two decades. This
expansion includes many of the scientific hypotheses which Dr.
Waisbren just discussed. These could easily explain the
autoimmune problems that are associated with genetic groups of
populations in particular.
They can also explain what has not been brought up today by
any of the speakers, which I find surprising: the fact that
many individuals--depending on the publication as many as 10
percent, and in some reports 30 percent of people--don't even
respond and make antibodies to this vaccine.
Therefore, it may be that if we are not following up who is
a nonresponder, we may not be affecting the incidence of the
disease itself in some genetic populations.
So in summary, no one, especially myself, would ever assert
that the hepatitis B virus is not causing serious health
problems in the world. However, if this or any other vaccine by
nature of the proteins or the parts of that protein, native or
produced from a recombinant cDNA protein, has the ability to
adversely affect the immune system of large numbers of
individuals resulting in severe adverse reactions, even if
restricted to some genetic populations, then all of the public
reaction to all vaccines including those that we don't have
related adverse reactions will be doomed in the public's eye.
This includes the development of vaccines to evolving airborne
viruses that might become a serious threat to the world
population.
Thanks to the success of the Government-funded Human Genome
Project and advances in our computer programs, it may soon be
possible to evaluate potential molecular structures to predict
these problems with the vaccines in advance or in early vaccine
development.
In addition to your investigation with adverse reactions to
this vaccine, I would urge you to help provide research funds,
which are certainly not available now, to study these serious
and what appear to be very common adverse reactions to this
vaccine as well as other vaccines. I thank you for your
attention.
[The prepared statement of Dr. Dunbar follows:]
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Mr. Mica. Thank you for your testimony, and I now would
like to recognize Dr. Barthelow Classen, president and CEO of
Classen Immunotherapies, Inc.
Dr. Classen. Thank you. I am going to talk about the link
between the hepatitis B vaccine and the increased risk of
insulin-dependent diabetes. Vaccine policy in the United States
is based on safety followup of about 30 days or less, that is,
the child is immunized and they are followed for about 30 days
for the development of adverse reactions.
We have been studying the long-term effects of vaccines,
looking at the development of autoimmune diseases. In
particular, our model is insulin-dependent diabetes, a model
for other autoimmune diseases.
This is some of our published peer review data. Shown here
is a 60 percent rise in the incidence of diabetes in New
Zealand following a massive hepatitis B immunization program.
You would expect to see a large or significant rise in
autoimmunity following an immunization program because vaccines
are immune stimulants. They stimulate the immune system. And
then when we expect it to cause a rise in autoimmunity, we see
this as shown here.
The CDC did some studies to verify our findings which are
published. They found, in fact, in their small preliminary
study, that hepatitis B immunization, when given after 2 months
of life, was associated with almost a 90 percent increase in
the incidence of diabetes, very similar to what we found in New
Zealand, so confirming our studies.
They also did some work to confirm another one of our
studies showing that immunization starting early in life was
associated with the decreased risk of diabetes, compared with
getting it later in life. And in their study, they showed that
the immunization before 21 days was associated with a decreased
risk, compared to immunizations starting after 8 weeks of life.
We are doing more studies on the hepatitis B vaccine, but
we now have confirming data from other vaccines including the
hemophilus influenza B vaccine, another relatively new vaccine.
Shown here is one of our studies where we show the incidence of
diabetes more than doubled in the United States following the
introduction of the hemophilus influenza B vaccine in the
Pittsburgh area.
The FDA relies on the VAERS system as well as the Large
Link Data base system to look for adverse reactions. Our
studies, however, showed that vaccine induced diabetes may not
occur until years following immunization as shown here from
some data from Finland. The vaccine was given in the first year
of life, but the extra cases of diabetes occurred many years
later. As shown here, the red curve is higher than the yellow
curve as extra cases of diabetes occurred later in life.
Regarding risk benefits, we characterize this quite for
hemophilus influenza B vaccine in Finland. We show that there
are about three cases of diabetes for every child that would
expect to benefit from the vaccine.
The data is not as clear for the hepatitis B vaccine. We
don't have as much data. It appears that there may be one case
of death from diabetes for every life we save in the hepatitis
B vaccine, from preventing hepatitis B with the vaccine.
However, you have to remember the cases of hepatitis B are
skewed into certain high-risk groups. So, in low-risk groups,
the risk of diabetes, just one autoimmune disease, seem to
exceed the benefit of the vaccine.
Cost effectiveness studies do not involve vaccine-induced
diabetes. We estimate that there may be 10,000 cases of
vaccine-induced diabetes in this country every year costing
over $10 billion a year, with cumulative liabilities reaching
maybe $250 billion.
Now, the U.S. law requires vaccine manufacturers to
demonstrate safety prior to the vaccine being placed on the
market. However, we have proven that safety has never been
demonstrated for this vaccine, yet many kids are being forced
to be immunized. We attribute this to conflicts in interest.
Our proposal is that first of all, there needs to be equal
access to the Large Link Data base. Scientists representing the
parents as well as the established medical community need to
have access to that Large Link Data base. There needs to be
more testing on the effect of vaccines on diabetes and
autoimmunity.
Parents need to be aware of toxicity studies in animals and
in humans linking vaccines to diabetes. Parents also need to be
aware that funds are not available to cover many adverse
reactions and the development of safer immunization technology
that needs to be made a priority above developing new vaccines.
Mr. Mica. Does that conclude your testimony?
Dr. Classen. Yes.
Mr. Mica. Thank you.
[The prepared statement of Dr. Classen follows:]
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Mr. Mica. Dr. Katz, you said that you felt there were some
irresponsible statements being made, either in testimony or
with this hearing. You have just heard several witnesses here
testifying. Would you like to comment on anything they have
said?
Dr. Katz. I hate to be put in a position of being a critic,
but let me give you one example.
Mr. Mica. Go right ahead. That's why we have you here.
Dr. Katz. Thank you. Dr. Classen quoted all of these data,
for example, from Finland. A meeting was held sponsored by the
National Institutes of Health, including the physicians and the
epidemiologists from Finland who had accumulated those data,
including experts on diabetes, experts on vaccines, experts on
immunology, experts on genetics.
There was unanimous agreement that there was no indication
whatsoever that there was any relationship of immunization to
the onset of insulin-dependent diabetes mellitus. Dr. Classen
was a participant in that meeting. If there was a vote, it was
128 to 1, and he was the one.
I am not one who is here to analyze Dr. Classen's
presentation, but only to tell you that the government in the
form of the NIH, and the CDC, the Vaccine Safety Institute of
Johns Hopkins, the Infectious Disease Society's Vaccine
Initiative, all put up the funds to sponsor that meeting.
Everyone was given a chance to present, including Dr.
Classen, and there was absolutely no support for his theory,
his hypothesis. Hypotheses are fine, but you have to accumulate
the scientific data to substantiate your hypothesis. At least
with the diabetes data, Dr. Classen has failed to do that in
the opinion of worldwide experts.
Mr. Mica. I don't want to get into a debate, but I did want
to hear your response on that. One of the things that you just
mentioned is that we rely on data and the need to study and we
had the CDC, Dr. Margolis, we had the FDA representative here.
They said that they felt this whole matter about efficacy,
about adverse effects and others, needs additional study. They
said that there are some number of them going on, have been
going on. I think they said seven, and additional. Do you
support that continued review?
Dr. Katz. Absolutely. I would be the last to say that there
isn't information which we don't yet have regarding vaccines,
regarding the etiology of autoimmune diseases, similarly to the
multiple sclerosis question.
The World Health Organization held meetings to discuss this
very issue. They were attended by immunologists, neurologists,
experts on multiple sclerosis, epidemiologists,
vaccineologists. And they concurred that there was no evidence
that multiple sclerosis was in any way related to the receipt
of hepatitis B vaccine.
Now, I would be very quick to say that if Dr. Dunbar or
others have theories that they can put to scientific test, we
should be supporting that type of experimentation. We don't
ever have the ability to prove the null hypothesis.
What we don't know today we may know tomorrow. I don't mean
that we should be complacent, but until we have some
scientific, concrete evidence to support these hypotheses, I
don't believe that we should be taking actions based on these.
Mr. Mica. In your written testimony, you said there is
absolutely no need to set aside special funds for independent
vaccine safety research, and you felt that there was also
inadequate----
Dr. Katz. I think that you are taking that out of context,
Mr. Mica. What I was saying was that money that is set aside
for safety research should be set aside through the peer review
process; that if the NIH or others have grants submitted to
them to make these investigations that----
Mr. Mica. You felt that that was adequate----
Dr. Katz. That they provide the peer review.
Mr. Mica. Again, I don't want to take anything out of
context, but do you feel there is adequate funding, adequate
opportunity for research for this area? Or is this something
that Congress is neglectful of and that warrants additional
attention?
The reason for this hearing isn't to scare anyone about
vaccines. The reason is to find out if we are doing what we
need to do. I have been in Congress since 1993. I have never
had so many requests to be heard on an issue since I came to
Congress. We merely try to respond and try to do it in a
balanced fashion and then see if we are doing our job.
So my question is, are there adequate funds? Are there
adequate resources? Funds, believe it or not--the NIH is in our
oversight responsibility and legislative responsibility. What
do you think?
Dr. Katz. It's always easy to sit outside of Congress and
tell you how to spend your money. Let me say this: as a member
of the Advisory Commission on Childhood Vaccines--that is the
committee that is the oversight committee for the program, the
National Vaccine Injury Compensation Act--we report directly to
Secretary Shalala.
There is an excise tax that that act put forth which is
levied on every vaccine that is produced and distributed. That
excise tax is used to accumulate the funds to reimburse
families and children who feel that they have, under the
judgment of independent medical review, that these are
legitimate adverse events that have happened due to vaccines.
Those funds are managed very wisely and very judiciously to
the extent that there has now accumulated over $1 billion in a
trust fund which is apparently inviolate unless you do
something in Congress to make that available. Those billion
dollars could very well be used to fund a number of studies
such as those you are hearing requested today.
Mr. Mica. That's your suggestion. Now, Dr. Dunbar, you were
very specific in your testimony when you advocated additional
studies and research and funding.
Dr. Dunbar. Well, first of all, I would like to make two
comments about the studies that we have heard about all day
including those I think a lot of scientists are calling, the
``phantom WHO meeting'' studies.
For 5 years I have been asking questions of people and I
have been quoting these studies. None of us scientists could
get that data. If this committee could get that data for us,
many of us would appreciate that. The other thing is that, in
many of those studies, it has become a semantics game. For
example, where everyone is saying that this is not multiple
sclerosis. Most of these cases, thousands of cases, we are
looking into are not MS.
We have to look at the broad range of autoimmune diseases.
Most importantly, from the grant funding point of view. I
myself have been a standing member of NIH subcommittees and I
am well aware of the politics right down the road here. When
you send in a grant on this topic, it goes to one of the
vaccine committees where everybody on the committee develops
vaccines.
Most of those people are working with the pharmaceutical
companies. There is a great prejudice by many scientists on
those committees against anyone saying anything negative about
a vaccine. I believe strongly and so do my other colleagues,
such as Ron Kennedy in Oklahoma and Willy Hildebrand, who is
head of the National Bone Marrow Association Program, who are
helping us, that funding is needed.
Now, fortunately we have private funding for this. But I
find it sad that we have to get private funding, and that
government funding is not supporting this, particularly when
there are so many vaccine mandates out there.
Dr. Waisbren. May I just make a comment?
Mr. Mica. Dr. Waisbren.
Dr. Waisbren. I think we all agree there have to be more
studies. But I think we have to admit that people like the
vaccine advisory groups, the CDC, and the FDA have a conflict
of interest. They have been pounding the drum for universal
vaccination for 10 years, and they have made every attempt to
denigrate results to the otherwise.
They have used institutions, such as the Institute of
Medicine, as their evidence that nothing has happened. I think
that the hope would be that a committee such as yours would be
able to have an independent investigation of the statistics
upon which the universal hepatitis B vaccination experiment is
based to see if you can believe that they are adequate by a
statistical group that has no conflict of interest.
Mr. Mica. Dr. Katz, we heard from some folks before in a
panel, one lady in particular, who I think medically has been
able to verify that through the vaccination she has suffered
adverse reaction and it has caused some problems.
Dr. Katz. Are you talking of Ms. Fluck?
Mr. Mica. Yes. She has not applied to the fund account that
was set up.
Dr. Katz. I asked her husband why she hadn't.
Mr. Mica. One of my concerns--and again I hope that we are
not acting irresponsibly, but it's 13 years since we passed the
legislation that provided compensation for those that are
adversely affected. We have $1 billion in the funds, and we are
getting complaints that people aren't getting compensated or
feel that they have access to be compensated. That's one
problem.
The other problem is that they are saying they are having
difficulty in determining the causal relationship and verifying
that it is a result of the immunization.
Maybe you could comment on this. Is the fund operating
properly? And then the problem of getting access to the fund
and verifying cases.
Dr. Katz. I think it would be very helpful to you if you
talked to the people who run the fund. The committee of which I
spoke is actually called a commission, not a committee, and is
chaired by a gentleman whose child was the victim of an adverse
event. The parents who sit on that committee are all of that
ilk. The attorneys who sit on that committee are the attorneys
who pursue these cases on behalf of plaintiffs who feel that
they have been injured.
So, if it is a biased committee, it's biased in favor of
those who feel that they have been adversely affected. There
are only 3 of us out of 10 on the committee, actually 2 out of
10, who are physicians. So it's not a physician-dominated
committee. There is only one from the pharmaceutical industry
on the committee, one representative. So the majority are the
very people from whom you heard today.
I would urge you to talk to Dr. Geoffrey Evans and Mr. Tom
Balbier who are the two people who run that program. They issue
a regular report every 3 months documenting the number of cases
heard, the adjudications, and the awards made. I think that the
program is working very well.
There is one problem, and that is, sometimes people aren't
aware of it. Every effort is being made to promulgate the
information so that families who feel that they have had an
adverse event will know how to file before this committee. They
have cutoff the grandfather clause. It used to be that you had
to report within X number of years. They have extended that to
longer and longer durations so that families that hear about it
late are not cutoff because it's too late. I don't want to bore
you with all of this.
Mr. Mica. No, that's exactly what we wanted to hear. We set
up the fund and want to know if it was working.
Dr. Katz. I think it is working wonderfully well.
Mr. Mica. And you have made some changes that you described
at length in the eligibility. You also cited through your
testimony that the fund has accumulated more funds than
anticipated, and one of your recommendations--and I don't want
to take words out of your mouth--is possibly some of these
funds could be used for research. Is that correct?
Dr. Katz. That's exactly what I hoped to say, yes. I think
that the issues relating to the whole area are reviewed
regularly. Dr. Waisbren mentioned the Institute of Medicine.
The Institute of Medicine isn't funded by the pharmaceutical
industry or by any other conflict. It is part of the National
Academy of Sciences, which you and Congress set up under
Abraham Lincoln, a Republican President, to provide advice to
the government about unbiased scientific issues.
Mr. Tierney. I just thought that he and Abe were working in
tandem at the same time.
Mr. Mica. I know him well.
Dr. Katz. That group is one that reviews regularly the
issue of vaccine-associated adverse events. It's so strict in
its membership that any of us, if you will, us in an editorial
fashion, who work with vaccines can't be members of that
committee because they don't want to have the bias that Dr.
Waisbren feels is exerted.
There are immunologists, there are epidemiologists, there
are people who are knowledgeable about science but who aren't
biased by being proponents of vaccines.
Mr. Mica. I want to give the others an opportunity to
respond. Dr. Dunbar.
Dr. Dunbar. Well, obviously, I am not a lawyer and neither
is my colleague, Dr. Katz, but there are clearly some issues on
the Vaccine Compensation Act, and there are some lawyers in the
room who I know can deal with that issue. One point is, I
believe, there is some problem with the fact that after this
summer, people who had the hepatitis B vaccine are going to be
restricted from even filing. So, there clearly are some
problems. I am not familiar with that, and I think that might
be a good subject for a whole other hearing.
Mr. Mica. Dr. Waisbren, did you want to comment?
Dr. Waisbren. I just wanted to make one comment about the
Institute of Medicine. I have gone over their material
carefully. They have said often, we cannot prove that the
vaccine causes any difficulty. They also mention that they
can't prove that it doesn't. So the question is open.
But time and time again, I hear people saying the Institute
of Medicine says that the vaccine doesn't cause any trouble. So
they cover themselves with the fact that they haven't proved
that it does occur. All their study is, if you read in their
books, is they have not proven that it doesn't hurt anybody.
In view of that, I think that the jury is out. As far as
the members of that committee, I beg to differ. I corresponded
with them, and there are vaccine proponents in Seattle and
other places in the country.
Mr. Mica. Dr. Katz, I see you nodding.
Dr. Katz. I keep prolonging this. The Institute of Medicine
task force categorizes vaccine-associated injuries in several
ways. One is what Dr. Waisbren has said, that is, that we can't
prove that this is associated or not. Those are obviously the
ones where a red flag goes up and where further investigation
is needed.
There are others where they say, yes, definitely. This
association is correct. Thrombocytopenia after measles and
rubella vaccine is an example. There are others where they say,
we can state definitively there is no association. So, they
don't just categorize things one way or the other. They have a
gradation.
Mr. Mica. Thank you. I'm going to yield now to Mr. Tierney,
the gentleman from Massachusetts, for questions.
Mr. Tierney. Thank you, Mr. Chairman. Thank you to the
members of this panel for their testimony. Let me ask generally
just to get a feel for your opinions on this. Assuming there
were studies or studying whether or not the hepatitis B vaccine
might cause other types of issues or problems, are you all of a
mind that we should stop giving this vaccine in the interim
period while waiting for the results of these studies?
Dr. Classen. I believe very strongly. I am a physician. I
have been immunized with the hepatitis B vaccine, and in
certain high-risk categories I agree with Dr. Waisbren that, in
fact, it may have some utility.
However, I think the forced immunization of children which
is going on when, in fact, the risk may exceed the benefit as
some of the data suggest, that again, I think there is a real
problem there with forcing people to be immunized.
Mr. Tierney. Thank you. Dr. Dunbar.
Dr. Dunbar. I concur. I think there are some high-risk
groups, particularly as we are looking into the genetic
populations where in some particular parts of the world
genetically, some people are more likely to have a reaction to
the vaccine and others in other countries or parts aren't.
But certainly for high-risk categories I see no problem.
But we need to have more studies to find out who is going to be
in the high-risk categories.
Mr. Tierney. Thank you.
Dr. Waisbren. I believe very strongly that my
grandchildren, who aren't as yet sexually active or alcoholics
or any of those categories, do not have a significant chance of
getting hepatitis B. And I think that the data that suggest
that they are, when you examine it, is not there.
If, at the age of 12, they are wild, I would have no
objection to them getting it. But to assume that they are going
to have trouble these first few years of life I think is
fallacious.
Mr. Tierney. Just before I left Dr. Katz, are you saying,
Dr. Waisbren, that those are the only people that can contract
hepatitis B?
Dr. Waisbren. I say that the figure of this 30 percent is a
red flag that cannot be established. I think it is done by a
questionnaire of people who are blood donors. I suggest that a
statistician go over the paper in which the CDC claimed that in
30 percent of hepatitis B cases, there is no evidence that risk
factors are involved. The data in this regard appears to come
from a questionnaire sent to hepatitis B patients in only four
counties in the country. In my opinion, there is no credible
evidence that what we call lateral spread of this disease
occurs in any but extremely rare instances.
Mr. Tierney. Thank you. Dr. Katz, could you respond to both
of those questions?
Dr. Katz. Obviously, I disagree with my three colleagues.
Let me see if I can remember the questions. First of all,
regarding the use of the vaccine in very young children: I
think I find Dr. Classen inconsistent. On the one hand, he is
saying we should give the vaccine before 21 days of age. We
give it to newborns. That's well before 21 days of age! I don't
know how that adds up. That's apples and oranges.
Second, I think the issue of the 30 percent is a very real
one. You heard one parent today. But that's only one parent.
There have been very good studies to which Dr. Margolis
alluded. In Alaska, children under the age of 10 have a very
high rate of carrying the hepatitis B virus before they were
sexually active. They had no injectable drugs. There were no
apparent causes other than close living quarters where there
were a lot of people who were chronic carriers.
Since the institution of the hepatitis B vaccine program in
Alaska, which is 1 of our 50 States, there has been no child
under the age of 10 in the 10 years since that program has been
in place in the seven villages that they monitored, who has
acquired hepatitis B carrier state.
I think that the vaccine as it is currently available and
utilized is appropriate. I do not say that we shouldn't
continue to study, but I think to halt the program at this
point, which is eminently successful, would be a serious
mistake.
Mr. Tierney. You mentioned, Dr. Katz, that the system to
assure the vaccines are safe and effective is always improving.
I think you said that during your testimony. What
recommendations do you have to make to us about improving the
system further?
Dr. Katz. I think there is a vaccine branch of the National
Institute of Allergy and Infectious Diseases of the National
Institutes of Health. I think they have a vaccine study section
to which Bonnie alluded. I think that an infusion of funds that
were deliberately aimed and targeted--I know that you don't
like to target funds at NIH--but if you spoke to Dr. Varmus and
to Dr. Fauci and explained to them what you saw as to the
severity of this problem, never mind its magnitude but just the
severity of concern on the part of the people that we have
heard today, that there has to be an acceleration of research
aimed to investigate these hypotheses. Individuals who are
proven investigators can conduct peer-reviewed research. Then
you would get some further action much more rapidly.
Mr. Tierney. Thank you. Dr. Dunbar, am I correct in
understanding that you believe, or have a belief, that
Caucasians may be susceptible to the side effects of the
hepatitis B vaccine?
Dr. Dunbar. We are actually doing some genetic studies to
try to nail this on the head, as it were. But of the literally
hundreds and thousands of people who have contacted me or
doctors, so far they are all Caucasians.
I feel that if this is just vaccine hysteria, we wouldn't
be seeing this kind of relationship. And they are all of the
same types of people that I am studying. In particular, of the
hundreds we have, they were perfectly healthy and they took the
vaccine and now they are debilitated for life.
The other concern is not just the people that are having
the adverse reactions. Dr. Katz has alluded to the group in
Alaska where there is a high group of chronic carriers. We also
know in Asia, where a lot of the clinical trials were done, you
don't see adverse reactions. But this is a different population
that we know ``genetically'' responds differently to the virus
itself.
In fact, another point that was not brought out today is
that 95 percent of the people that get the virus don't even
have the flu or don't even know they are sick. So a lot of
people respond normally without having any long-term side
effects.
What we don't know about the whole vaccine itself, which
Mr. Mica referred to this morning. We don't know a lot about
why the different genetic populations respond differently with
respect to the disease itself, let alone why the people with
adverse reactions that we are seeing are responding with
respect to the genetics. It was curious to me at the Institute
of Medicine meeting at which I was invited to speak that, when
we asked about all of these new studies that are being done, I
said ``great,'' we have the genetic data so we can break this
out. They said, oh, no, we can't ask those questions.
So even though these studies are ongoing, we are not going
to get the data we need. We need to have those studies where we
can take into account the genetic populations in what we are
seeing. So from what I could see of what they outlined at the
Institute of Medicine, the studies that are in the works or are
being planned are not going to be sufficient to evaluate these
serious adverse reactions.
Mr. Tierney. Thank you. In the testimony there was
reference to a molecular mimicry hypothesis. Could somebody
there explain to me the relevance that that hypothesis has to
the hepatitis B vaccine safety?
Dr. Waisbren. When you look back as we developed--and I
will try to make this brief--is that all living things have
certain proteins that are of advantage to them whether they be
viruses, bacteria, or humans.
So we have to assume that certain proteins are held in
common by humans and bacteria and viruses. If those proteins
are similar enough, when you inject a virus into a person the
body will mistake that protein for itself and make antibodies
or T-cells against the body itself, rather than the proteins in
the virus.
It has been shown that in the hepatitis B virus, for
instance, there is molecular mimicry between myelin, which is
involved in multiple sclerosis, and the hepatitis B vaccine.
There are studies that should be done and have been done by
the people of Harvard in which if you give a vaccine, you can
find out whether or not antimyelin T-cells are circulating.
This would be one easy way of studying vaccine toxicity. I
recommended that to the Institute of Medicine 3 years ago at
one of their meetings, and it just fell on deaf ears. So those
sorts of things should be done.
Mr. Tierney. Thank you.
Dr. Classen. Can I add one point, though? Molecular mimicry
is only one hypothesis. In fact, there are probably several
mechanisms of reactions. We are seeing increases in diabetes
with many different vaccines which suggest that, in fact, there
are other mechanisms as well.
Just giving Interferon, plain Interferon, to patients who
are diseased increases the risk for autoimmunity including
diabetes. Vaccines are known releasers of Interferon. So just
by generally stimulating the immune system you would expect to
see a wide range of autoimmune diseases following immunization.
Mr. Tierney. Thank you. Dr. Katz, would you like to say
something?
Dr. Katz. I was only going to say that there is no doubt,
as Dr. Dunbar has pointed out, that there has been enormous
advance in the field of immunology. There are now very large
grants from the National Institutes of Health to diabetes
centers around the country to look at the question of
autoimmunity and what are the inductive factors.
In other words, diabetes, childhood juvenile diabetes,
insulin-dependent diabetes may be an autoimmune disease. What
is not understood is what is the trigger that sets off that
autoimmune disease.
We are being besieged day and night by things that you
inhale, by things you ingest. It isn't just what you inject
with a vaccine. There are all sorts of proteins and
carbohydrates, all sorts of antigens to which you and I are
subject day and night.
To single out vaccines as the only target is being somewhat
parochial. I assure you that these study programs that the NIH
is now funding on diabetes will be looking at vaccines, at
acquired infections and many other possible stimuli. To date
there is no evidence that vaccines are the culprits.
Mr. Tierney. Thank you.
Dr. Waisbren. There have been official pronouncements by
the National Diabetes Association and by the Multiple Sclerosis
Society that juvenile diabetes and multiple sclerosis do not
occur after the hepatitis B vaccination. You wonder what
influences these national organizations to make these
statements in view of information discussed here and in the
world literature.
Dr. Dunbar. Just one quick comment, if I may. My medical
student who has just taken her exam and is graduating today
said that they had to learn an answer for the exam this year.
The question in the study guide was, ``what is the safest
vaccine ever made?'' and the answer was the hepatitis B
vaccine.
So it's already infiltrated. Even without saying we haven't
done these studies, the medical students are already being told
in their minds that this is the safest vaccine ever made, yet
we don't have any long-term followup clinical trials.
Dr. Classen. I would like to make one point. I submitted
additional testimony, written testimony, which I hope you will
accept, and also I hope that you will look into the conflict-
of-interest issues, as well, as described in my testimony.
[The prepared statement of Dr. Classen follows:]
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Mr. Tierney. Thank you. Thank all of you.
Mr. Mica. Thank you. Dr. Katz, I have a question. In your
testimony you said that hepatitis B--and I think I wrote this
down--is far more contagious than AIDS?
Dr. Katz. HIV, the virus that causes AIDS, absolutely.
Mr. Mica. I am not a scientist. I am just a Member of
Congress and it is pretty scary, isn't it? I just wonder. We
had Ms. Hahn here. She has hepatitis B. She lives with her
husband and four children and yet none of them tested positive.
I'm not sure if that same thing would happen with AIDS.
Maybe it would. I don't know.
Dr. Katz. I think that it's inappropriate to compare HIV
and hepatitis B. I was only using that as an example of the
contagiosity of hepatitis B. HIV is much more constrained in
the way that it is passed by blood, by semen, by sexual
encounter, by injectable drugs.
Hepatitis B, I was trying to point out, doesn't need any of
them. I think it was Ms. Hahn who pointed out how long the
virus survives if you spill it on a table top. HIV is very
fragile. In a very short period of time if you were to have an
accident, it is no longer infectious. That was the gist of what
I was trying to express.
Mr. Mica. I'm not trying to put you on the spot, just a
layman's question.
Ms. Hahn. I will answer that. I praise the Lord.
Mr. Mica. Maybe that has something to do with it, too. The
other thing is based on the information that you all have. Do
you think that we should provide additional warnings of adverse
potential reactions based on your knowledge, Dr. Katz?
Dr. Katz. I was a little bit chagrined and disappointed in
listening to some of these presentations. Not in the
presentations, but in what was said about physicians who had
administered vaccines. We are required to provide the so-called
vaccine information statements to parents and guardians or
individuals who are old enough to read them for themselves.
If physicians are failing to do that, then we have failed
in getting the message across to them that this is important.
Those statements are clear. They do outline both the benefits
and the risks of the vaccine, and they should be given to
parents before they even bring their child in so they have time
to digest this at home and not in the rush of 5 minutes in the
waiting room of the office.
Dr. Dunbar. But these vaccines are being mandated. They are
even being given by schools and school nurses. Once it's
mandated by the States, you take away that liability.
Dr. Katz. They cannot give them in school without the
parents' permission.
Mr. Mica. Again, is there adequate notice regarding the
possible adverse effects, Dr. Waisbren?
Dr. Waisbren. I would say that the fact is that the vast
majority of babies are immunized in the hospital without the
parents being consulted. This is based on my personal
experience with my patients, my grandchildren, and so on.
I think that one of the solutions to advising parents is to
make their physician become responsible for any adverse
reactions that happen even in the hospitals. They say, well--
the American Association of Pediatricians or someone said that
it's OK, so it's OK.
But I think if doctors have to take the responsibility for
adverse results that perhaps they will look into the
possibility and warn their patients more adequately.
Mr. Mica. Dr. Classen, I didn't give you an opportunity to
respond.
Dr. Classen. Yes. I think absolutely more warning needs to
be made, both in animal toxicity studies. You have a lot of
epidemiology data and people who are always going to say, well,
maybe it's not the causality.
But animal toxicity data, I think, is crucial; and there is
a lot of animal data, for example, with vaccines on different
autoimmune diseases that they can exacerbate it. In that case
it's clearly that the vaccines are causing and exacerbating
autoimmunity in animals.
I think that the parents should be warned of that. I do
believe that there is a real problem with physicians not
notifying the patients. I had one classical example where I saw
a patient with a vaccine adverse reaction. I didn't immunize
the child. It was clear to me it was a vaccine adverse
reaction. It was shingles following the chicken pox vaccine.
So I sent the patient back to the physician who had
administered the vaccine for followup; and the physician who
followed up, who administered the vaccine, denied that it was a
vaccine adverse reaction. The parent had to go to a third
physician to verify my diagnosis. And even when the result was
overwhelming, the physicians want to avoid liability by never
admitting they could have possibly harmed a child.
I think this is a big problem. This is probably why vaccine
adverse reactions are not reported to VAERS, because the
physician doesn't want to admit that they may have harmed one
of their patients.
Dr. Katz. But under the National Vaccine Injury
Compensation Program the physician is not liable. That's the
whole point of the program, to take it out of the adversarial
position of having to sue in a tort system. If the case is
presented, it is sent to the Vaccine Injury Compensation
Program.
They have experts, whether they are neurologists or
epidemiologists or pediatricians, depending on the particular
type of case. They review it, and it is presented to a master.
There is not the controversy. That was the whole point--not the
whole point, but one of the points of the whole act, to take it
out of the tort system and put it into something where parents
and children would be treated fairly, whether they could afford
a lawyer or not and whether they could get into the court
system or not.
Dr. Waisbren. This is the fatal error in your bill, if you
will pardon me for telling you.
Mr. Mica. It wasn't my bill. Mr. Waxman.
Dr. Waisbren. Your brother's bill. The point is, when you
take the responsibility away from the doctor and the hospital,
the doctor is not forced to really think the thing over and he
says, ``It's not going to hurt me.''
I would suggest that the bill be kept in, but that it
should be clearly stated that the person could go to court. And
I think it is in the bill to get justice if he feels the system
did not work correctly.
Mr. Mica. Dr. Katz is determined to get the last word in.
Dr. Katz. Thank you, Mr. Mica. The physician is liable if
what he commits is an act which is not within the
recommendations of his State, his vaccine program. So that the
physician can be sued if he has transgressed what is the
recommended approach.
On the other hand, the idea that the system allows the
physician to get off stark free is inappropriate. If the case
is heard before the Vaccine Injury Compensation Board and
rejected, the family still has recourse to the tort system. It
is just that they have to go to the compensation program first.
Mr. Mica. I want to thank each of you for your testimony
today. We have tried to conduct this in a responsible fashion.
We have heard from representatives from the CDC, we have heard
from representatives from the FDA. We have heard from Dr. Katz
who is representing several very prestigious organizations. And
we have heard from others.
However, I do want to announce that I will keep the record
open for at least--I'm going to keep the record open for 30
days, which is unusually long, for additional information. I
know there are some controversial matters in this, but we want
to make certain that the record is complete and balanced, and
that we hear from folks.
The reason for this hearing is not to excite anyone or as I
said at the opening, to discourage anyone from vaccinating
their children or anything of that sort. It's to, one, review
the entire process. The law was passed in 1986. I wasn't here.
I didn't pass the law. I didn't author the law.
Once every 13 years we may look at these things whether we
need to or not and then responsibly see that we are doing our
job. Is the proper research being done? Is proper notice being
given? Is the system working?
And then also to hear from citizens. When a certain number
of citizens want to be heard in a congressional process--and we
do oversee the FDA and the CDC and MOPP--we have that
responsibility.
Without objection, I will leave the record open for 30 days
for additional testimony or for input for the record. I thank
each of you for your testimony today and excuse you at this
time. Thank you.
We have one final panel. That panel consists of Thelma
Thiel, chairman and CEO of the Hepatitis Foundation
International.
We also have Barbara Loe Fisher, president of the National
Vaccine Information Center. This is our fourth and final panel
today. I would like to welcome both of our witnesses.
As I mentioned to our previous panelists, this is an
investigation and oversight subcommittee of Congress. We do
swear in our witnesses which I will do shortly, both Ms. Thiel
and Ms. Fisher. We also ask that if you have a lengthy
statement or additional information that you would like made
part of the record, we will do that upon request. I would also
ask you to limit your oral testimony to approximately 5
minutes.
Again, I am pleased to welcome both of you, and if you
could stand at this time and be sworn.
[Witnesses sworn.]
Mr. Mica. The witnesses answered in the affirmative and I
am pleased to welcome to our subcommittee today our witnesses.
First of all, we will hear from Thelma Thiel--I hope that I am
pronouncing it right--chairman and CEO of the Hepatitis
Foundation International. You are recognized.
STATEMENTS OF THELMA THIEL, CHAIRMAN AND CEO, HEPATITIS
FOUNDATION INTERNATIONAL; AND BARBARA LOE FISHER, PRESIDENT,
NATIONAL VACCINE INFORMATION CENTER
Ms. Thiel. Thank you, Mr. Mica, for giving me this
opportunity to share our concerns with you. I am representing
50,000 victims of hepatitis in this organization, plus 300
support groups with thousands of people who are concerned about
this disease.
I am also a registered nurse who lost a precious 4-year-old
son 29 years ago to cirrhosis. I thought I would like to share
with you some of the things that he endured with his cirrhosis.
Because his liver was so badly damaged, even a bloody nose
was a hemorrhage. When he tripped over a toy, he broke his hip,
not once but twice. His tummy was terribly distended because he
had an enlarged liver and spleen and excess fluid.
His little arms and legs were scrawny because he couldn't
metabolize proteins to build muscles. He was extremely
jaundiced, almost to the point of looking green, but worst of
all, he itched from head to toe, night and day.
Can you imagine being in a body cast with a fractured hip
and itching constantly? He asked me one day if I could take his
foot off because it itched inside.
Most people don't know that the liver is their internal
chemical power plant, a very complex and noncomplaining organ
that detoxifies everything that we eat, drink, breathe, and
absorb through our skin. It helps us digest our food, stops
cuts from bleeding and fights off infection. It makes hormones
and muscles and maintains over 5,000 vital functions to keep us
alive and alert.
When this hepatitis virus gets into the blood stream
through an open cut, a scratch, or a puncture with a
contaminated sharp needle or an instrument such as those used
in body piercing or tattooing that was previously used by an
infected person, even in an abrasion of the mucus membrane or a
splash of blood in the eye that could happen in the dentist's
office, this virus makes its way to the liver.
It quietly kills liver cells replacing them with scar
tissue which is called cirrhosis. This virus can continue to
assault the liver until there are so few good healthy liver
cells remaining that the impact on body functions and healthy
problems is devastated.
I had a woman who called me because she had two children.
She needed to put them in a daycare center. One of them had
hepatitis B. When she told the daycare center, they wouldn't
allow her to enter the child in the school.
This mother had to go to work; and it was important that
she get this child in daycare. She went to another daycare
center, and didn't bother to tell them that the child was
infected.
Now, every time that child gets a bloody nose or scratch,
everyone in that daycare center will be exposed to this
insidious disease.
I had a call the other day from a father who was very upset
about his 13-year-old son, Rob. He had developed a severe case
of diarrhea. There had been an E. coli outbreak, and he took
him to a hospital. They did a thorough examination and found
out that he had hepatitis B. He also had advanced cancer of the
liver at the age of 13.
The father was terribly distressed, however, because he
wanted to know whether his child who was on the wrestling team,
might possibly have infected other children. Occasionally they
get bloodied up during a wrestling match. We advised him to
tell the school. We also found out that his mom had hepatitis B
and was a carrier and did not know it.
Unfortunately, Rob had not been vaccinated at time of
delivery. He had no signs or symptoms for 13 years with the
potential to infect other children and now he was facing death.
Hepatitis B is an insidious disease often called a silent
killer largely because the liver is a noncomplaining organ.
Individuals can have serious liver damage without any signs at
all. With the estimated one and a quarter million carriers of
hepatitis B in this country, how many of them are sitting in
the classroom with your child or your grandchildren?
Could a cut finger or a smear of blood on a page in a book
shared with a classmate be a threat to your child? A little
known fact is that the only treatment available for hepatitis B
is chemotherapy. I can't imagine the guilt I would feel if my
child became infected when he could have been vaccinated. If
infected, he would have to go through chemotherapy given by
injection for 6 months to a year, with only a 40 percent chance
that he would have a positive response.
If the treatment fails, they can develop cirrhosis and
cancer of the liver, going through many of the horrible things
that my son went through. The other option, of course, is a
liver transplant. However, organs are in very short supply, and
we also know that the virus that remains in the body attacks
the new liver with a vengeance.
Researchers are trying desperately to develop ways of
controlling that virus, with limited success this process is
very costly.
Losing a child to an incurable liver disease is a heart-
wrenching tragedy, but I can't imagine the overwhelming guilt
that I would feel if my child became infected and I had had an
opportunity to protect him and didn't.
We who are well informed are aware of the risks that
children can take. We don't always know when they are going to
become sexually active. We have heard about children doing body
piercing in the back room. We don't always know what risks they
are taking. Many are not informed because there has been very
little education to encourage our children to take
responsibility for their own behaviors. Often their parents are
uninformed.
We have a long way to go, and we are depending on you to
make certain that you weigh the scientific facts and the lives
that will be saved by this vaccination against the
unsubstantiated reports that we have heard today. Thank you for
giving me this opportunity.
Mr. Mica. Thank you for your testimony.
[The prepared statement of Ms. Thiel follows:]
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Mr. Mica. And we will now hear from Barbara Loe Fisher, who
is president of the National Vaccine Information Center. You
are recognized.
Ms. Fisher. Thank you, Mr. Chairman. My name is Barbara Loe
Fisher, and I am president of the National Vaccine Information
Center, formerly known as Dissatisfied Parents Together, which
I cofounded in 1982 with parents whose children had been
injured or died from the adverse effects of the DPT vaccine.
Our nonprofit organization represents tens of thousands of
Americans, including families affected by vaccine reactions,
healthcare professionals, and parents. We are working to
prevent vaccine injuries and deaths through public education
and to institute safety and informed consent protections in
vaccination programs.
Some of us worked with Congress in the early 1980's in a
bipartisan effort to help create and pass the historic National
Childhood Vaccine Injury Act of 1986. One of our main goals was
met in 1996 when a less reactive pertussis vaccine was
licensed.
I want to thank you, Representative Mica, for having the
courage and the vision to hold this hearing. As you have heard,
vaccine safety is an issue charged with emotion because whether
death or disability is caused by a disease or a vaccine, the
pain is the same. And when children are suffering and their
parents are grieving for them, there are no words to make the
pain go away.
I think what is important at the end of the day is to
acknowledge that we are all here because we love our children
and we want to protect them from harm. We need to find ways to
protect them from vaccine injury and death while we create
public health policies designed to protect them from the
ravages of disease.
There is no reason why we cannot accomplish both of these
goals if we embrace the principle that every child's life is
important and no child is expendable.
The National Vaccine Information Center has received
hundreds of reports of injuries and deaths following hepatitis
B vaccination. There is a clear pattern to hepatitis B vaccine
reaction symptoms, just as there was a clear pattern associated
with the DPT vaccine reactions, but unlike DPT vaccine where
most symptoms usually occur within a few days of vaccination,
hepatitis B vaccine reaction symptoms can take many days or
weeks to develop and include fevers that come and go, open skin
lesions and rashes, severe joint pain and head pain, loss of
vision, muscle strength and memory and crushing, debilitating
fatigue which leads to chronic disability.
We have had reports of liver cancer developing in small
children following hepatitis B vaccinations. There are families
with two or three members who have become disabled after
hepatitis B shots. Tragically, for newborns and babies under 2
months of age, a hepatitis B vaccine reaction can end in death.
When parents look to the medical literature for answers,
they find few studies looking into hepatitis B vaccine reaction
reports. None deal with newborns. Most of the studies look at
vaccine efficacy, not vaccine safety.
A 1994 study by the Institute of Medicine, mandated by
Congress under the National Childhood Vaccine Injury Act, found
that there have been no large controlled observational studies
or clinical trials investigating clinical reports of arthritis,
Guillain-Barre Syndrome, transverse myelitis, optic neuritis,
multiple sclerosis, and other central demyelinating disease or
sudden infant death syndrome after hepatitis B vaccination.
What, then, will be the scientific criteria used to either
award or deny children compensation for their hepatitis B
vaccine-associated injuries under the Federal Vaccine Injury
Compensation Program?
Serious questions remain about the quantity and quality of
the scientific evidence used by Federal health agencies to
license this vaccine for use in children and, in 1991, to
recommend that all newborns receive their first dose just 12
hours after they take their first breath.
Last Tuesday, I filed two detailed Freedom of Information
Act requests with the FDA and the CDC to make this information
a matter of public record. We hope this will lead to better
public understanding of current standards used to license this
first recombinant DNA vaccine and then recommend all newborn
infants and children be required to use it. I will provide
copies of what I receive from the CDC and the FDA to you, and I
submit my FOIA requests as part of the record.
Families with vaccine-injured children are trying to cope
with the knowledge that they tried to do the right thing. They
did what public health officials and doctors told them to do.
Most of these children were exceptionally bright, healthy, and
robust at the time of vaccination.
They received a hepatitis B shot, and something went
horribly wrong. In some cases, they were coerced into having
more hepatitis B shots, even in the face of severe reactions
because the push for a 100 percent vaccination rate has all but
eliminated the right to informed consent when it comes to
vaccination in America.
This information sheet on hepatitis B produced by the
Centers for Disease Control in compliance with safety
provisions in the National Childhood Vaccine Injury Act does
not come close to meeting the informed part of informed
consent.
Parents who want to make educated hepatitis B vaccine
decisions for their children often are threatened when they
even ask to delay vaccination if the child is sick. The lack of
informed consent protections in mass vaccination programs is
leading to fear and mistrust of the whole vaccination system.
Bottom line, what we are hearing parents tell us is: show
us the science and give us a choice. So we come before you
today to ask for, first, an investigation into Federal health
agency licensing and policymaking standards applied to the
recombinant hepatitis B vaccine; and, second, consideration of
special congressional appropriations to fund nongovernment,
nonindustry conducted scientific research to identify genetic
and other high-risk factors for reacting to hepatitis B
vaccine; and, third, the institution of informed consent
protections in current vaccine policies.
Again, thank you, Chairman Mica and members of the
committee, for demonstrating leadership by acknowledging these
vaccine safety concerns, which is the first important step
toward addressing them in a way that will save lives. You have
listened and we are very grateful.
[The prepared statement of Ms. Fisher follows:]
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Mr. Mica. I thank both of you for your testimony.
Ms. Fisher, you just testified that you felt the vaccine
information sheets handed out on hepatitis B are inadequate as
far as disclosing risks and benefits. What more can we do, or
what more should we do, or what information should be included
would be my first question?
The second is, there are 16 States now that do allow sort
of an opt-out. How would you go about changing that since you
have a State-to-State requirement?
Ms. Fisher. First, I would just like to read that the mild
problems that are listed on this are soreness at the
injectionsite and mild to moderate fever. The only severe
problems listed are serious allergic reaction, and it says very
rare.
There is no description here of the kinds of symptoms that
we have heard today.
Mr. Mica. As far as severe, that is all that is on there?
Ms. Fisher. Right. Serious allergic reaction they say is
very rare. They describe serious allergic reaction as
difficulty breathing, hoarseness, et cetera, which are symptoms
of anaphylaxis. Anaphylaxis occurs within a very short time
period after a vaccination is given.
So the people who testified today, who told you about these
symptoms, they would be candidates for revaccination according
to this vaccination sheet; and, in fact, this is part of the
problem.
We have heard from so many people who are being forced and
threatened that they have to go forward with hepatitis B
vaccinations, even after they have experienced fevers that come
and go, skin lesions all over their body, severe joint pain,
symptoms that--autoimmune symptoms and neurologic symptoms, and
they are being ignored.
Because there is this push for a 100 percent vaccination
rate, these people are not being screened out. And they are not
being given full information, and the doctors are not being
given full information about what to look for after a hepatitis
B vaccination.
The manufacturers, frankly, in their product insert, have
more of a description about some of the reactions that have
been associated with the vaccine than this sheet.
What I am concerned about, this sheet was mandated under
this compensation program, and we fought very hard--the parents
who were involved in the creation of the system, of which I was
one, fought very hard for the safety provisions.
And one of the safety provisions was that parents would get
proper benefit and risk information prior to vaccination so
they would know how to make informed decisions and also so they
could monitor their children following vaccination for signs of
a reaction so that revaccination would not take place and more
serious reactions would occur that would end in disability and
death; and we feel this is woefully inadequate.
Mr. Mica. Ms. Thiel, do you want to respond?
Ms. Thiel. Physicians have access to the drug insert. If
they are giving the vaccination, they should be aware of those
reactions.
Also, the CDC puts out a publication called MMWR which
identifies the fact that there should have been informed
consent. There has been a great deal of effort on the part of
the hepatitis B immunization programs and on the Internet to
identify the fact that they should be asking the parents to
sign consent forms.
The Hepatitis Foundation International created a booklet
that would go home with the consent forms to identify the
importance of the liver, the importance of the vaccine, and
some things parents should be concerned about. This has been an
effective way of informing the parents of the benefits of the
vaccine.
Mr. Mica. What about the question of inadequate research
that has been raised here today? Do you all have a position on
that, Ms. Fisher?
Ms. Fisher. First of all, there are two kinds of research
that need to be done: basic science research that will look at
biological mechanisms for hepatitis B vaccine-induced injury or
death, which would include looking at what happens at the
cellular and molecular level in the human body after the
vaccination is given.
The other concern is that this vaccine is often given with
other vaccines. Part of my Freedom of Information Act request
is that the CDC and the FDA go over the different studies that
we would like to see that hopefully were done before this
vaccine was recommended in 1991 for universal use in all
children, particularly newborns. That would include such things
as how many children were involved in these studies, the time
periods for followup of vaccine adverse events. In the
manufacturers' product insert, they list 4 to 5 day followup
for studies that were used to license this vaccine, and yet the
reactions we are seeing are taking sometimes longer than 4 to 5
days to occur. So have we missed in those studies, all of the
people who testified here today? How good are those studies?
Did they include racial diversity of infants and children
enrolled in them?
Particularly in light of what Dr. Dunbar said, if we have
genetic predisposition here, if there are certain genotypes who
are more susceptible to reacting to this vaccine than others
and we have only done these studies in certain genetic
populations, we don't really know what is going on. And when we
give this vaccine and we mandate it and we haven't done the
studies prior, it is an experiment and we cannot afford to do
that.
I think the FOIA requests are important to take a look at--
how was this vaccine licensed and policy made? But also, is the
system that we use good enough or should we be raising these
standards?
Mr. Mica. Ms. Thiel, has your group taken a position as far
as opting out of these vaccinations?
Ms. Thiel. We feel very much if a person has an objection
to being vaccinated, they have that right. Of course, it is
going to be a problem if you get a lot doing that. You are
going to have more exposure to other children if they are not
vaccinated.
Mr. Mica. But your group has basically supported the opt-
out ability?
Ms. Thiel. Right.
Mr. Mica. One of the other questions that has come up in
this hearing and also prior to the hearing is a review of the
1986 law and the access to compensation through that law for
those who have some type of vaccine-related adverse reaction.
You were involved in some of that, the development of that
legislation, and I guess of monitoring, Ms. Fisher?
Ms. Fisher. Yes.
Mr. Mica. How do you feel about how that is working?
Ms. Fisher. We are extremely disappointed in how this
compensation program is being implemented. In fact, it is
tragic.
Those of us who came to the table in good faith in the
early 1980's to work with Congress and work with the vaccine
manufacturers and work with the American Academy of Pediatrics
feel like we have been betrayed because three out of four
children are being turned away from this system. And because
all of the work we did, for example, to set up the table of
compensable events for DPT vaccine injury and death so that
this system wouldn't be like a trial and you wouldn't have to
show the same type of proof and it wouldn't be expensive and
traumatic--HHS came in and they gutted it.
They gutted the provisions for awarding compensation for
DPT vaccine injuries, and there is almost nothing now presumed
to be associated with DPT vaccine.
We were promised that it would be a fair alternative to the
tort system, and we feel like we have been betrayed. And the
fact that there is $1 billion in the trust fund is a disgrace
because there are children out there who need that money
because they have done what they were told to do by doctors and
public health officials; and they are out there coping and
suffering with vaccine injuries, and nobody is helping them
because all the resources of HHS and Justice are brought
against these plaintiffs.
Justice represents Secretary Shalala in these cases, and it
is not a level playing field. I think it is--we absolutely
oppose the using of any of that billion dollars for anything
other than compensating these children. The money for these
studies needs to come out of the billions of dollars that are
being given to HHS to fund new vaccine development and to set
up tracking systems to track children in order to enforce
vaccination and to promote vaccination.
We have got to do a better job of looking at the existing
vaccines that we have before we put other vaccines on the
market, and we have to do a better job of taking care of the
children who pay the price and are our casualties of our public
health programs. Our children deserve no less.
Mr. Mica. Thank you. Ms. Thiel, have you observed the
operation of the compensation fund, and do you have any
comments?
Ms. Thiel. Well, I think it could be improved. I think we
have to look at the fact that we have saved so many children
and adults from the tragedies of this disease by having this
vaccine that I think we have to continue.
When you understand that we have given 10 million doses of
the vaccine this year with a small number of adverse reactions
that are very serious. I think we have to weigh the benefit to
the masses against the unfounded concerns expressed.
For years we were promoting vaccination for high-risk
populations, mentioned earlier. This was an abysmal failure
because we were not reaching those at high risk, many in urban
areas.
These are the children that are probably going to
participate in high-risk activities. How can we protect them?
We have to protect them when they are accessable, which is in
the school system or requiring immunization before entering
school. Otherwise, they will be missed. People continue being
infected, with many developing serious cirrhosis of the liver
and cancer.
Children as young as 8 years of age have developed cancer
of the liver having acquired this disease from their mothers,
at the time of delivery. The baby's mucus membranes, in their
eyes, nose, mouth, and genitals are exposed to infected blood
through the birthing process. Because their immune systems are
not fully developed, they have a 90 percent chance of
developing the serious consequences of hepatitis B.
There are major social factors related to hepatitis B
infection. If, as a teenager, they become infected and go
through the chemotherapy treatment and fail, they are going to
remain infectious for the rest of their life. They must be
concerned about infecting their sex partners if their partners
are not vaccinated or immune.
I think Barbara Hahn was very fortunate that her family did
not become infected, because she was very careful of any blood
or body fluid exposure that she had for her family. We also
know that families living in the household with someone who is
chronically infected is at higher risk of acquiring hepatitis
B.
I use the analogy in 1 teaspoon of blood for the AIDS
virus, there are about 5 to 10 particles of the AIDS virus
compared to 500 million of the hepatitis B virus. This gives
you an idea of how infectious this disease is. Even blood on a
dry surface can cause the transmission of hepatitis B to
others.
Ms. Fisher. I would like to say something to you Ms. Thiel,
and I thank you very much for supporting the ethical concept of
informed consent. I think this is really, really important
because as you know, as a parent, you love your child more than
anyone ever could. And when a child dies from a disease or from
a vaccine, it is you, the mother and the father who lives with
the consequences of that, and that is why the ethical principle
of informed consent that is applied to every other medical
procedure in this country that carries a risk of injury or
death is so important to be applied to vaccination.
We are not calling for the elimination of vaccine laws. We
are calling for flexibility within the laws, a humane
application of the laws. We are asking for the right to
exercise conscientious belief exemption if we believe our
children are at great risk of having a reaction.
I come from a family of serious autoimmune disorders. My
mother has lupus. I have one child who has reacted and has
disabilities from a vaccination. How can the State possibly ask
me to take a risk with another--a vaccine like this one--when I
know that my children could either die or have autoimmune
disorders from getting this vaccine?
Parents have got to have the right to have the information
and then make informed decisions for their children. Every
parent wants their child to be healthy. They don't want their
child to die from a disease or a vaccine. We have to believe
that parents love their children.
Ms. Thiel. I believe that we also have to receive informed
consent. We also have to give them the information so they know
how serious this disease can be to help them make an
appropriate decision and not just respond emotionally to some
of the misinformation they have been hearing about the adverse
reactions.
Ms. Fisher. I totally agree with you.
Mr. Mica. Ms. Fisher, you advocated several specific
recommendations. One was increased licensing standards; is that
correct?
Ms. Fisher. That's right.
Mr. Mica. What are you talking about specifically?
Ms. Fisher. The reason that I filed very detailed FOIAs
with the CDC and the FDA on this was I was hoping--I don't know
the answer to that question. I was hoping that the committee
would help us get those answers and do a review of the
licensing procedures and of the policymaking procedures.
Mr. Mica. The other item you recommended was nongovernment
studies. But if it is a recommendation to us, it is going to
involve government moneys and we have a pretty--well, we have a
pretty complex manner of funding studies that was made that way
to keep the studies independent from undue outside influence.
How can we have a nongovernmental study financed by
government--I mean, do you have something specific in mind?
Ms. Fisher. I am not really knowledgeable----
Mr. Mica. And then get an independent study. I think you
are questioning the independence of these studies? Again, I
don't see how we can accomplish that recommendation since it is
government funding, the studies--unless you have some
protection and barriers.
Ms. Fisher. I am not knowledgeable about the grant
structure at NIH, for example; but I understand there are some
grants that are more independent. They are given to scientists,
and they are more independent from control by the CDC or the
NIH.
I don't know exactly what they are called. But I understand
that there are grants available where the--the problem is who
is going to be on the peer review committee? Bonnie Dunbar has
applied twice for an NIH grant to look at genetic
predisposition to hepatitis B vaccine reactions. She has been a
vaccine developer for 26 years. She knows what she is doing.
You don't see these grants being given out to scientists
who want to look at adverse effects. The grants are given out
to develop new vaccines and look at the efficacy of vaccines,
but not to look at clinical reports of adverse events to
vaccines.
The public is very suspicious of having industry and
government be in total control of these scientific studies. And
so, if there was a way to get the funding, and then have some
autonomy. So yes, of course, to publish you have to be peer
reviewed. I don't have the answers, but I would be happy to
work with the committee to find one.
Mr. Mica. Thank you. In conclusion, did either of you have
any final recommendations, anything additional legislatively or
administratively that we can promote to help address some of
the problems we have heard described today? Ms. Thiel.
Ms. Thiel. In response to----
Mr. Mica. This is additional.
Ms. Thiel. The advisory committees that review the grants
that are coming through have lay people on them--they are not
just physicians who are reviewing these grant requests. They
have very strict criteria to assess whether they are qualified
and worthy of the funding that they receive. I think that there
is a good review system there.
Mr. Mica. Ms. Fisher.
Ms. Fisher. We just touched on a few of the problems with
the compensation program, the implementation of the National
Childhood Injury Act, and I would just hope that we would have
another opportunity to look at that program and talk about the
issues surrounding that program.
Mr. Mica. Thank you.
Well, I would like to thank both of our panelists and
everyone who participated today, our various witnesses, for
their participation.
As I said, we will leave the record open for 30 days. I
have never extended the record that long; but since there is so
much interest in this subject, we will accommodate additional
interest for the record, and anyone interested should contact
the subcommittee on Criminal Justice, Drug Policy, and Human
Resources with their submission. Without objection, so ordered.
There being no further business before the subcommittee, I
will call this meeting adjourned, and I also will make an
announcement here. There was a request for press availability
after the hearing, and I will make a very brief statement here
rather than go out to the Triangle.
This meeting is adjourned.
[Whereupon, at 2:34 p.m., the subcommittee was adjourned.]
[Additional information submitted for the hearing record
follows:]
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