U.S. GOVERNMENT PRINTING OFFICE

63–308 CC WASHINGTON : 2000

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

JOHN T. DOOLITTLE, California

HELEN CHENOWETH, Idaho

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

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

BENJAMIN A. GILMAN, New York

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

ASA HUTCHINSON, Arkansas

DOUG OSE, California

PATSY T. MINK, Hawaii

EDOLPHUS TOWNS, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

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

(III)

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

(1)

HEPATITIS B VACCINE: HELPING OR

HURTING PUBLIC HEALTH?

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 Dav- enport, 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 joinVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00004 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
2

ing 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 childVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
3

hood 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

4

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:]

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

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:]

56

57

58

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

59

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

60

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:]

61

62

63

64

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.

65

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.

66

Dr. Chen of the CDC dismisses it and says nurses tend to overreport. 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:]

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

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 21⁄2 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 enVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
86

tered 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.

87

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 unacknowledged.

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:]

88

89

90

91

92

93

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

94

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:]

95

96

97

98

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 61⁄2 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:]

99

100

101

102

103

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?

104

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.

105

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?

106

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

107

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:]

108

109

110

111

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

112

[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

113

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:]

114

115

116

117

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.

118

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?

119

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 prodVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00122 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
120

uct 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 vacVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00123 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
121

cine 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 crossover 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

122

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.

123

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.

124

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

125

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.

126

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.

127

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:]

128

129

130

131

132

133

134

135

136

137

138

139

140

141

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.

142

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:]

143

144

145

146

147

148

149

150

151

152

153

154

155

156

157

158

159

160

161

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.

162

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?

163

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, selflimited conditions, only about 50 percent.

Mr. MICA. Is that a published study?

164

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

165

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.

166

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.

167

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 preventioneffective 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

168

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 duVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00171 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
169

plicates 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——

170

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

171

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 bloodborne 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

172

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.

173

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.]

174

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 IMMUNOTHERAPIES, 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.

175

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:]

176

177

178

179

180

181

182

183

184

185

186

187

188

189

190

191

192

193

194

195

196

197

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 hepVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00200 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
198

atitis 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

199

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:]

200

201

202

203

204

205

206

207

208

209

210

211

212

213

214

215

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.

216

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.

217

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:]

218

219

220

221

222

223

224

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

225

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:]

226

227

228

229

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,

230

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,

231

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.

232

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

233

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 highVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00236 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
234

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.

235

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

236

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 unVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00239 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
237

derstood 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:]

238

239

240

241

242

243

244

245

246

247

248

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

249

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.’’

250

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.

251

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.

252

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.

253

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:]

254

255

256

257

258

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,

259

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:]

260

261

262

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 immuVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00265 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
263

nization 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?

264

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

265

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 deciVerDate 11-SEP-98 13:37 May 17, 2000 Jkt 000000 PO 00000 Frm 00268 Fmt 6633 Sfmt 6633 C:\DOCS\63308.TXT HGOVREF1 PsN: HGOVREF1
266

sion 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

267

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:]

268

269

270

271

272

273

274

275

276

277

278

279

280

281

282

283

284

285

286

287

288

289

290

291

292

293

294

295

296

297

298

299

300

301

302

303

304

305

306

307

308

309

310

311

312

313

314

315

316

317

318

319

320

321

322

323

324

325

326

327

328

329

330

331

332

333

334

335

336

337

338

339

340

341

342

Æ