SPEAKERS CONTENTS INSERTS
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PLEASE NOTE: The following transcript is a portion of the official hearing record of the Committee on Government Reform. Additional material pertinent to this transcript may be found on the web site of the committee at [http://www.house.gov/reform]. Complete hearing records are available for review at the committee offices and also may be purchased at the U.S. Government Printing Office.
62–560 CC
2000
VACCINES—FINDING THE BALANCE BETWEEN PUBLIC SAFETY AND PERSONAL CHOICE
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
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AUGUST 3, 1999
Serial No. 106–84
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.house.gov/reform
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
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ASA HUTCHINSON, Arkansas
LEE TERRY, Nebraska
JUDY BIGGERT, Illinois
GREG WALDEN, Oregon
DOUG OSE, California
PAUL RYAN, Wisconsin
HELEN CHENOWETH, Idaho
DAVID VITTER, Louisiana
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
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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
C O N T E N T S
Hearing held on August 3, 1999
Statement of:
Kennedy, Ronald C., professor, Department of Microbiology and Immunology, University of Oklahoma Health Sciences Center; Samuel L. Katz, professor emeritus, Department of Pediatrics, Duke University Medical Center; and Marcel Kinsbourne, pediatric neurologist
Nelson, Tonya and Gerald, Indianapolis, IN; Rick Rollens, Granite Bay, CA; Carola Zitzmann, Voice of the Retarded; Antonia C. Spaith, Falls Church, VA; Rebecca Cole, PKIDS, Chapel Hill, NC; and Keith Bergen Van Zandt, M.D., PKIDS, Winston-Salem, NC
Satcher, David, M.D., Surgeon General of the United States
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of
Cole, Rebecca, PKIDS, Chapel Hill, NC, prepared statement of
Davis, Hon. Danny K., a Representative in Congress from the State of Illinois, prepared statement of
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Frenkel, Dr. Lawrence, chairman, pediatrics, University of Illinois, College of Medicine at Rockford, prepared statement of
Katz, Samuel L., professor emeritus, Department of Pediatrics, Duke University Medical Center, prepared statement of
Kennedy, Ronald C., professor, Department of Microbiology and Immunology, University of Oklahoma Health Sciences Center, prepared statement of
Kinsbourne, Marcel, pediatric neurologist, prepared statement of
McHugh, Hon. John M., a Representative in Congress from the State of New York, information from Pasteur Mérieux Connaught
Nelson, Tonya and Gerald, Indianapolis, IN, prepared statement of
Ose, Hon. Doug, a Representative in Congress from the State of California, prepared statement of
Rollens, Rick, Granite Bay, CA, prepared statement of
Satcher, David, M.D., Surgeon General of the United States, prepared statement of
Shays, Hon. Christopher, a Representative in Congress from the State of Connecticut, prepared statement of
Spaith, Antonia C., Falls Church, VA, prepared statement of
Van Zandt, Keith Bergen, M.D., PKIDS, Winston-Salem, NC, prepared statement of
Waxman, Hon. Henry A., a Representative in Congress from the State of California:
Prepared statement of
Various prepared statements
Weldon, Hon. Dave, a Representative in Congress from the State of Florida, prepared statement of
Zitzmann, Carola, Voice of the Retarded, prepared statement of
60208
VACCINES—FINDING THE BALANCE BETWEEN PUBLIC SAFETY AND PERSONAL CHOICE
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TUESDAY, AUGUST 3, 1999
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 2 p.m., in room 2157, Rayburn House Office Building, Hon. Dan Burton (chairman of the committee) presiding.
Present: Representatives Burton, Waxman, Morella, Shays, Mink, Mica, Norton, Cummings, Kucinich, Davis of Illinois, Terry, Biggert, Schakowsky, and Ose.
Also present: Representative Weldon of Florida.
Staff present: Kevin Binger, staff director; Barbara Comstock, chief counsel; Daniel R. Moll, deputy staff director; James Wilson, chief investigative counsel; David Kass, deputy counsel and parliamentarian; S. Elizabeth Clay, professional staff member; Mark Corallo, director of communications; Corinne Zaccagnini, systems administrator; Carla J. Martin, chief clerk; Lisa Smith-Arafune, deputy chief clerk; Phil Schiliro, minority staff director; Phil Barnett, minority chief counsel; Sarah Despres and David Rapallo, minority counsels; Ellen Rayner, minority chief clerk; Jean Gosa, minority staff assistant; and Andrew Su, minority research assistant.
Mr. BURTON. The Committee on Government Reform will come to order. I know we have a big crowd that wants to get in, but we'll have to have the door shut, so we can hear what's going on. Officer, will you shut that door, please? Thank you.
A quorum being present, the Committee on Government Reform will come to order. I ask unanimous consent that all Members' and witnesses' written opening statements be included in the record. Without objection, so ordered.
[The prepared statement of Hon. Doug Ose follows:]
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INSERT OFFSET FOLIOS 1 HERE
[The official committee record contains additional material here.]
Mr. BURTON. We will have more Members here shortly, but everybody is going to different hearings. This is a very, very busy week, as my colleagues all know.
I ask unanimous consent, at this point, that Representative Schakowsky be appointed to the minority vacancy on the Criminal Justice, Drug Policy, and Human Resources Subcommittee. Without objection, so ordered.
I ask for unanimous consent that Congressman Dave Weldon, who is one of the handful of physician Congressmen, join us on the stand and participate in our hearing today. Without objection, so ordered.
Mr. WAXMAN. Reserving the right to object.
Mr. BURTON. The gentleman reserves the right to object. State his reservation.
Mr. WAXMAN. Mr. Chairman, we really need to establish a policy when Members, who are not on our committee, are permitted to come and join us and ask questions. When we were in the majority, the policy we applied, whether it was a Democrat or a Republican, was that if the Member from outside the committee wanted to come and sit with the Members, they were certainly welcome to; but they were not permitted to ask questions because that wouldn't have been fair to other Members. That was the rule we applied, no matter what side of the aisle the Member was from.
I don't know what the policy is now. If the policy is to let any Member who wants to come and join a hearing, join us and ask questions, it could get out of hand. So, we ought to have a policy established.
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Mr. BURTON. Well, I think a gentleman's agreement between you and I would probably suffice, at this point. What I would suggest is if you, Mr. Waxman, have a Member that would like to come and ask questions on a specific topic, I don't think we would have any objection on our side. The reason we have Dr. Weldon here today is because he is a physician. We're talking about issues relating to the health industry and he has some expertise and some background in this area.
Mr. WAXMAN. Well, Mr. Chairman, just to inquire further, and I don't—I'm not talking about this in any way personal to Mr. Weldon, but there are Members who have interest in hearings that this committee will have at one time or another. If you say you're going to let him come and you let someone on our side come, are we talking about one on each side? Or is it anybody who comes can come and—maybe what we could do, rather than work out a policy at this moment, is since we don't have many Members here, have an agreement that we'll let Mr. Weldon ask questions. But, I do think we need to think through this whole question.
We had the issue come up recently with one of our Members who wanted to attend a hearing, and we said, look, if it were a field hearing, that's one thing, if it's in a Member's district. But, since it's a hearing in Washington, we didn't think it was proper to have a Member come and ask questions because other Members then have to wait until they take their turn, either on the first or second round. So, we need to have a policy, apply it, no matter who's involved. And this is an issue that—we had a policy when we were in the majority. I don't know what your policy is, but it sounds like for today, the question is Mr. Weldon.
Mr. BURTON. Well, I think the policy generally has been as the gentleman has stated. That's why I asked for unanimous consent that there be an exception made today. I think that we would make that exception, not as a general policy, but as an exception from time to time and we could do that for the minority. But, I'd be happy to sit down with the gentleman and try to work out some kind of a policy for future hearings.
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Mr. WAXMAN. The only thing I want to point out is that once you've made an unanimous consent exception, then others are going to say why not an unanimous consent exception for me and it gets harder to say no to people. Once you start down that road, just realize that we're sending an invitation out to anybody who wants to show up for any hearing, and it's going to be tough to control in the future.
Mr. BURTON. Well, I understand. And as the chairman—and you may be chairman in the next Congress, who knows. I hope not; but, nevertheless, it could happen. [Laughter.]
But, if you're chairman in the next Congress, I will exceed to your wishes and, likewise, I hope you will mine. I will try not to make this a policy, but I will sit down with you to try to work it out, so that we can work with each other when we have exceptions like this that we'd like to have made.
The gentleman will withdraw his reservation?
Mr. WAXMAN. I'll withdraw my reservation.
Mr. BURTON. Thank you, very much, Mr. Waxman. Then, so ordered.
We're here today to expand upon the work of two of our subcommittees. Both the Subcommittee on Criminal Justice, Drug Policy, and Human Resources and the Subcommittee on National Security, Veteran's Affairs, and International Relations have conducted hearings on vaccine issues. I'm thankful to my two subcommittee chairs, Mr. Mica and Mr. Shays, for being so diligent in pursuing issues regarding safety, efficacy, and the mandating of hepatitis B and anthrax vaccines.
In this country and around the world, we have made a decision to vaccinate the entire population against dreaded infectious diseases. Children are required to receive numerous vaccines before they enter day care centers or schools. Vaccines that we now know contain mercury. Adults in certain professions are required to receive vaccinations for employment. This policy creates an inherent conflict between the interest of the individual and the community.
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The tension between the individual risks and the public benefit is a classic ethical dilemma for public health. Some have described the current mandating of an increasing number of vaccines to children to be a good intention gone too far. Many of you may remember the polio crisis earlier this century. It was through the work of brilliant scientists, like Jonas Salk and Albert Sabin, and their colleagues, that the polio vaccines were developed. It was a mad dash to the finish line of licensing for the manufacturers of these vaccines, while polio, which caused so much illness and heartache, appears to have been eradicated. But, there are still cases of polio today, cases caused by the vaccine, itself. Jonas Salk spent the last months of his life pleading with the government to stop the use of live vaccine, because of the cases of polio that it was causing.
Both the Food and Drug Administration and the Centers for Disease Control have adverse events monitoring systems. The FDA system, the Vaccine Adverse Event Monitoring System, is a passive monitoring system. Medical professionals, the pharmaceutical industry, and the public report adverse events. Over 11,000 adverse events were reported just last year. Over 5,900 adverse events have been reported so far this year, about one-sixth of those are considered serious. In all, 95,103 adverse events have been reported to this system since its inception. The former FDA Commissioner estimated that only 1 in 10 adverse events are reported, which means that we're talking about something close to 950,000.
Now, what is a serious event? It includes events that require hospitalization, events that cause disability, and events that kill. When asked about the safety of their vaccines, one pharmaceutical representative told my staff, everything has adverse events, including aspirin. To the academic or bureaucratic realm, the risk benefit ratio is numbers on a page. But to the parent of a child, who suffered a serious adverse event from a vaccine, that risk becomes a reality.
The risk was too real for the Nelson's, whose 1-month old daughter, Abbey, born healthy and hearty, died less than 1 month after coming home from the hospital. They later learned from the doctor, who performed the autopsy, that it was a death related to the hepatitis vaccine given to their daughter in the hospital when she was 2 days old.
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To Rick Rollens, whose son acquired autism from a vaccine reaction, the risk was too great. The autism, vaccine linked, is very controversial. But, we have verified with current and former NIH neurologists that any injury to the brain can cause autism, including the shock to the neurological system by a vaccine. They will testify today.
To Michelle Clements, who is not able to be with us today, but who has submitted written testimony, whose son has spent at least 3 years in a coma, as a result of the DPT vaccine, the risk was too great.
We, as the government, can no longer keep our heads buried in the sand like an ostrich, pretending that there is no problem. On the flip side of this discussion is the need to protect the public at large from vaccine preventable diseases. I am not stating or implying that we should not have vaccines, because they are crucial to public health.
We will hear today from Carola Zitzmann, whose son was born in 1964 with severe disability, after being exposed to rubella during her pregnancy. We will also hear from Rebecca Cole, whose child died from chicken pox; and from Dr. Keith Van Zandt, a pediatrician, whose child is living with hepatitis.
In 1997, President Clinton directed Secretary Shalala to work with the States to develop an integrated immunization registry system and to require that all children in federally subsidized child care centers be immunized. This mass tracking of childhood vaccinations has created State registries that are tracking children from birth to grave. With these State systems reporting back to the Federal level, we have instigated something the American people have strongly and loudly opposed, national medical tracking and invasion of the American public's privacy. One report stated that the long-term tracking strategy had three steps: first to notify families with a postcard when their child was late for a vaccine; second, if they did not comply, then a government official would call them on the telephone and remind them; and third, if they still did not comply, a government official would come and visit their home. I think that's going too far.
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And what of attaching immunizations to Federal child care centers? Does this mean if your child has a medical or religious exemption, that he or she will not be allowed to access a federally subsidized facility? In our rush to vaccinate everyone, have we informed members of the public that they have choices? No, we have not. In our rush to vaccinate, do physicians and health care providers keep current in the medical literature, conscientiously reviewing medical histories, read package inserts and the Physician Desk References for contradictions, and clearly discuss these with their patients or their parents? Not very often. Have we become complacent in our protecting of our children, just so that we can meet some kind of a quota?
We will hear today also from Antonia Spaith, a Department of Defense civilian employee, who suffered serious adverse events after taking the anthrax vaccine and other vaccines. The mandating of anthrax vaccine in the military is a great concern to many in the Congress. I have joined my colleagues, Congressman Walter Jones, Ben Gilman, and others, in sponsoring legislation to stop the mandating of this vaccine.
From intense investigations, it has been learned that the decision to use this vaccine is fraught with errors. The adverse event rate is much higher than indicated and the military knows it. The research into its safety and efficacy does not provide any sense of security. We're using a vaccine that does not provide protection against strains of anthrax that would most probably be used, those that come through the air.
As we have learned at the subcommittee level, this issue is adversely affecting military readiness. We are losing a lot of members of our military, who choose to leave the military, rather than take this vaccine. Morale is low, as a result of the misinformation campaign, also on the lack of information on adverse event reports. We learned that there is fear in the ranks about reporting. We learned that the Department of Defense filters these reports before sending them to the FDA. We, also, learned that in complete defiance of regulations, the manufacturing facility was not inspected until 1996.
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That means for 20 years, this manufacturing facility that produces the anthrax vaccine was not inspected, at which time it was learned that the quality control was deplorable. After 20 years of producing this vaccine, they found that the quality control was deplorable. No vaccine has been produced and distributed since that inspection, which means that we've stockpiled vaccines that are likely adulterated and still being given to our service members, while the plant is being updated. Yesterday, a member of my staff reviewed a test video being prepared by the military to show to its members to inform them about this vaccine. It is full of intentionally misleading statements.
Now, in order to keep the pharmaceutical industry in the vaccine development business, Congress created what was supposed to be a no fault system for vaccine victims to receive compensation. There is concern that the Department of Health and Human Services has modified the injury compensation table, and in so doing, excluded those injuries that were most likely to apply to the program.
Now, we're pleased that Dr. David Satcher, the U.S. Surgeon General and Assistant Secretary for Health will be testifying on behalf of the Department of Health and Human Services. We're also pleased that Dr. Marcel Kinsbourne, Dr. Ronald Kennedy, and Dr. Samuel Katz will be testifying today, and we welcome them.
[The prepared statement of Hon. Dan Burton follows:]
INSERT OFFSET FOLIOS 2 TO 7 HERE
[The official committee record contains additional material here.]
Mr. BURTON. The hearing record will remain open until August 16th for all those who wish to make written submissions to the record.
[NOTE.—The information referred to is held in committee files.]
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Mr. BURTON. I now recognize my colleague and ranking minority member, Mr. Waxman, for his opening statement.
Mr. WAXMAN. Mr. Chairman, there are a few triumphs in the annals of medicine like vaccinations. Vaccines have saved more lives than any other medical intervention in history. Today, they protect us from deadly infectious diseases which spread death, disability, and misery in other less fortunate parts of the world. Thanks to universal immunization, the United States has made tremendous progress against polio, diphtheria, whooping cough, and other diseases. According to UNICEF, these diseases kill 2 1/2 million children and cripple 750,000 children worldwide every year. Without vaccinations, American children would also be vulnerable to similar catastrophic epidemics.
I don't think American parents would ever permit their children to be exposed to such extreme risks. But today we are becoming complacent about our success against infectious diseases. Unlike our parents and grandparents, we aren't terrorized every year by paralytic polio and whooping cough epidemics. This makes it easier to forget the value of vaccines and to focus on their potential risks. But, if children are frightened and parents discouraged about vaccines, we will quickly become vulnerable again to infectious diseases.
No one doubts that there are adverse reactions to vaccines. It is unfortunate that they happen and that children and adults suffer as a result. That is why I sponsored the National Childhood Vaccine Injury Act of 1986, which established the National Vaccine Injury Compensation Program. This program relies upon the best available science and medicine to provide an alternative to litigation for individuals who suffered specific vaccine related injuries.
Today we must continue to rely upon what science tells us about the benefits and risks of vaccines. We must continue to educate the public about vaccines, their benefits and risks. While everything we know about childhood vaccines tell us that their benefits far outweigh their risks, we must remain vigilant and continue epidemiological research into potential side effects.
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There is a simple way to illustrate the importance of vaccination. Two hundred years ago, Edward Jenner developed the first small pox vaccine. I was inoculated against small pox; my children, who were born in the 1960's, were also inoculated. But those of you who were born in the 1970's do not have a small round scar that we bear on our shoulders because you didn't need the small pox vaccine. Small pox no longer threatens our children in our beds or whole communities with death. It's just a memory.
Today, we are tantalizingly close to eradicating the second communicable disease in history, polio. But until polio, meningitis, diphtheria, hepatitis, and other diseases are truly memories, our children and our families will continue to be at risk. Vaccination will remain an indispensable public health defense and it will be Congress's responsibility to continue to support and encourage universal vaccination.
Mr. Chairman, we will hear from families today who have suffered either adverse reactions to the vaccine or health problems they believe are linked to the vaccine. We will also hear from the families of those who have experienced the trauma and stigma of infectious disease. I'm sympathetic to all of our witnesses and look forward to their testimony.
Unfortunately, however, there are many witnesses that we will not hear from. The Democrats made a request for witnesses, but only half of those requests were granted. We requested to hear from a doctor who could have talked about efforts to vaccinate worldwide and the ravages of vaccine preventable diseases on children around the globe. We asked for a doctor to testify who has been doing vaccine studies since 1967 and who is an expert on reactions to the pertussis vaccine. And we asked to hear from a member of the board of directors of the American Academy of Pediatrics. But, these requests were denied.
Many other voices are missing from this discussion. For example, there is no representative from the State health agencies who actually mandate vaccinations and administer vaccine programs. There's no representative from the vaccine manufacturers who bear a large responsibility for vaccine safety. I deeply regret that these groups are not here today to provide us with balanced and informed testimony.
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That's what hearings are supposed to be all about. We hear different points of view. And in the course of hearing different points of view, we can try to find out what the truth may be. But I'm sad that at this hearing we're not getting a balanced opportunity to get input from witnesses who have something very important to say.
Now, let me just point out to everybody what that would have entailed. Witnesses are given 5 minutes to testify. The Republican majority on this committee would not let us hear from somebody from the American Academy of Pediatrics for 5 minutes. The Republicans running this committee wouldn't let us hear from a doctor that has been doing vaccine studies since 1967 and is an expert on reactions to the pertussis vaccine for 5 minutes. The Republican leadership did not allow us to hear from a doctor who could have talked about efforts to vaccinate worldwide and the ravages of vaccine preventable diseases on children around the globe for 5 minutes.
But I wouldn't object to a colleague of ours, who is not even on this committee, to be able to ask questions for 5 minutes because I think people ought to be able to have an opportunity to say what they have to say. Although when we get Members who will hear that this is a committee they can all join at any moment to ask questions, we're going to have no time for witnesses, because the Members are going to be the only ones talking.
In conclusion, I wish to submit for the record the positions of leading medical and patient organizations in support of universal vaccination. I want to submit for the record a statement from the World Health Organization and the Pan American Health Organization, the American Medical Association, the Association of State and Territorial Health Officials, the American Nurses Association, the American Public Health Association, the American Academy of Family Physicians, the Children's Defense Fund, the American Pharmaceutical Association, the Partnership for Prevention, the Bill and Melinda Gates Children's Vaccine Program, the Immunization Action Coalition, Every Child By Two, and the National Foundation for Infectious Diseases. So when we have a printed record of this hearing, we'll have a lot of different points of view in that record. It's just today, when the presentations are made to us orally, that we will not have the opportunity to hear from all of the witnesses that we requested.
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I look forward to hearing the witnesses that are here today and I hope that will help us further our understanding about vaccinations and policies that would be best suited to help improve the health and safety of the children of this country.
[The prepared statement of Hon. Henry A. Waxman and the statements referred to follow:]
INSERT OFFSET FOLIOS 8 TO 83 HERE
[The official committee record contains additional material here.]
Mr. BURTON. Well, I just like to say to my colleague, I regret that we were not able to have those additional three people testify, but we had six people on our side that wanted to testify and we have to set some limits. We try to respond and we did let you pick whomever you wanted, up to three people to testify. So, I apologize for not being able to accommodate the additional three witnesses.
Mr. Shays.
Mr. WAXMAN. Just to point out, there are nine witnesses——
Mr. BURTON. Yes, I understand.
Mr. WAXMAN [continuing]. In addition to Dr. Satcher.
Mr. BURTON. We gave you more than the limit.
Mr. WAXMAN. You gave us three out of the nine.
Mr. BURTON. Yes, we gave you more than you gave us when you were in the majority. Mr. Shays.
Mr. SHAYS. I think some people got out of bed on the wrong side this morning. I don't think it was me. I welcome Dr. Weldon here and I look forward to others participating, as well.
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The Subcommittee on National Security, Veterans Affairs, and International Relations, which I chair, held four hearings on the Department of Defense [DOD] mandatory force-wide anthrax immunization programs. Questions we consider today about improving the safety and ensuring the efficacy of all vaccines apply with special urgency to the anthrax vaccine. In one subcommittee hearing, a DOD physician stated an important standard: good medical care requires use of the least evasive, lowest risk therapy available. All vaccines should continuously be measured against that standard.
Immunization has been one of the most successful public health interventions in human history. It is undisputed vaccines have afforded remarkable, effective, and efficient protection against diseases that once sickened, disabled, or killed millions, particularly children. But as the number of mandatory vaccines climbs, great care must be taken, least the success begat complacency, or worse, arrogance about the extent of our knowledge about the human immune system. We know very little about the long-term cumulative effects of immunological challenges, both benign and toxic.
Genetic variance may play a role in each individual's immunological response. One size of immunity may not fit all. So, as we look for ways to protect the public health into the next century, today's discussion on ways to improve the safety and efficacy of vaccines is an important one. I look forward to hearing the testimony today from all of our witnesses, those chosen by our ranking member and our chairman. I look forward to other hearings on this, since I know that we can't attempt to cover everything in one hearing. I particularly look forward to Dr. Satcher's testimony. As Surgeon General, he has been outstanding and I appreciate his participation in hearings I had when I chaired the Human Resources Subcommittee. Welcome, Doctor.
[The prepared statement of Hon. Christopher Shays follows:]
INSERT OFFSET FOLIOS 84 HERE
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[The official committee record contains additional material here.]
Mr. BURTON. Thank you, Mr. Shays. I just want to say you have done yeoman service with your hearings and you should be publicly acknowledged for that, and so should your staff.
Are there others, who want to make an opening statement?
Mr. DAVIS OF ILLINOIS. Just briefly, Mr. Chairman.
Mr. BURTON. Mr. Davis.
Mr. DAVIS OF ILLINOIS. Thank you, very much, Mr. Chairman. I want to thank you for holding this hearing, in particular, given the fact that I am in agreement with those, who suggest that our program of vaccination has been the greatest health achievement that we've experienced in the last two centuries. I, too, believe that it should be universal, although there are some concerns, there are some problems, there are some instances, and education must continue to be a real part of the thrust.
In addition to my own opening statement, I am also including in that statement testimony from Dr. Lawrence Frenkel, who is a physician, pediatrician, and immunologist. He's chairperson of the Committee on Infectious Disease of the Illinois Chapter of the American Academy of Pediatrics and co-chair of the Public Affairs Committee of the Greater Illinois Chapter March of Dimes and chairman of Pediatrics at the University of Illinois, College of Medicine in Rockford and has, indeed, been a health advocate for more than 30 years. So, I submit, along with my opening statement, the statement from Dr. Frenkel, and yield back the balance of my time.
Mr. BURTON. Without objection, that will be included in the record.
[The prepared statements of Hon. Danny K. Davis and Dr. Frenkel follow:]
INSERT OFFSET FOLIOS 85 TO 95 HERE
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[The official committee record contains additional material here.]
Mr. BURTON. Mrs. Morella.
Mrs. MORELLA. Thank you, Mr. Chairman. I want to thank you for holding this hearing today, to examine the role and necessary risks of vaccines and immunization. As we listen to the compelling testimony of our witnesses today, I would hope that we keep in mind the remarkable benefits society enjoys because of widespread vaccination. In fact, Mr. Chairman, vaccines and immunization programs have been so remarkably successful in eliminating or controlling many of the more common infectious diseases of childhood, that their use is often taken for granted. It's precisely because of this widespread success that the risks from vaccination, and there are risks, are causing such alarm today. However, we must not forget that vaccinations have been so successful that cases of diphtheria, whooping cough, tetanus, measles, mumps, and German measles is so unusual in the United States, that these infections and their consequences are unknown to most Americans.
To get a clear understanding of the great contributions widespread vaccination has made, we need only listen to the stories from people like Barbara Hahn. In an earlier hearing on the subject, Mrs. Hahn testified about the effects of infectious diseases on millions of American families. I'd like to just read a short excerpt from her testimony to make the point.
She said,
I would like to tell you about my mother and all mothers like her, who suffered through the loss of a child from an infectious disease. Raising a family in the hills of Kentucky, where most people were too poor to pay for the little, if any, medical help available, my mother struggled to keep her family healthy. When one of her babies became serious ill, my mother and her parents did everything they could to try to help her. Despite their efforts, my mother watched her child, Patsy Lynne, die from whooping cough. While making arrangements for Patsy's funeral, my mother learned that another one of her children was gravely ill. Both children were buried on the same day, in the same casket, in the same grave, next to my mother's church.
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Mr. Chairman, childhood diseases like whooping cough and polio have been largely eradicated. As Mrs. Hahn's testimony shows, just a generation ago, the coming of summer brought fears of epidemics of polio. And now, iron lungs can be seen only in museums and dusty hospital storerooms. This has been accomplished through the development and use of safe and effective vaccines in national immunization programs around the world. Small pox was eradicated from the planet in 1977. Polio eradication was defined as a goal for the year 2000. And remarkably, Americans were declared to be free of wild polio myelitis on September 29, 1994.
As we prepare for the 21st century, the promise of vaccines has never been greater. But, a great challenge still remains. I understand representatives of PKIDS, the Parents of Kids with Infectious Diseases, will testify about their children's continuing battle with vaccine preventable diseases. And while vaccines have virtually eradicated the childhood diseases of the last generation, other diseases, such as hepatitis B, baracella, tetanus, and meningitis, are still common and have caused serious illness or the deaths of thousands of children. It's astounding that approximately 1 million preschool American children are not adequately protected against potentially fatal diseases that can be prevented with a vaccine. Therefore, Mr. Chairman, we have to continue to work to increase the awareness of the benefits of disease prevention through vaccination.
Furthermore, if the promise of vaccines is to be fully realized, vaccines must not only be effective in the prevention of disease, they have to be safe. Unfortunately, recent reviews by the Institute for Medicine have identified many gaps and limitations in current knowledge of vaccine safety. Given new technologies for the development, production, manufacture, regulation, and administration of vaccines, the vaccine safety network for the United States must be enhanced to provide appropriate evaluation of new candidates. To ensure continued public acceptance of vaccines, close monitoring of potential adverse effects and adverse reactions, adequate scientific evaluation of associates, and appropriate responses to newly identified risks of vaccines, including research in targeted development of new technologies and vaccines, are critical. So, I guess I'm saying we need to look at a balance, Mr. Chairman.
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I certainly look forward to hearing the testimony from today's witnesses. I welcome them all, beginning with the distinguished Surgeon General, Dr. Satcher. Thank you, Mr. Chairman, for indulging me.
Mr. BURTON. Thank you, Mrs. Morella. Are there further opening comments? If not, Dr. Satcher, Mr. Surgeon General, would you and the people who will be testifying with you from your office, stand, so you can be sworn. Oh, you've brought a lot of people with you.
[Witnesses sworn.]
Mr. BURTON. Let the record reflect the witnesses responded in the affirmative. Dr. Satcher, we recognize you for 10 minutes for your opening statement, sir.
STATEMENT OF DAVID SATCHER, M.D., SURGEON GENERAL OF THE UNITED STATES
Dr. SATCHER. Thank you, Mr. Chairman. I am Dr. David Satcher, Assistant Secretary for Health in the Department of Health and Human Services, and Surgeon General of the United States. I thank you, Mr. Chairman and distinguished members of the committee for your invitation to testify at this important hearing on vaccines. With me today are technical experts from our department and the agencies especially involved in vaccines and immunizations activities. They are: Mr. David Benoir, Office of the General Counsel; Dr. Robert Breiman, who heads the National Vaccine Program Office; Dr. Walter Orenstein from the Centers for Disease Control, where he heads the National Immunization Program; Dr. Kathy Zoon and Dr. William Egan from the Food and Drug Administration; Mr. Thomas Balbier from the Health Resources and Services Administration; and Dr. Regina Rabenovitch from the National Institutes of Health.
As Assistant Secretary for Health and the Surgeon General, I'm called upon to use the best available science to protect and advance the Nation's health. For over 200 years now, the Public Health Service has operated with the understanding that in so much as we care for the needs of the most vulnerable among us, especially our children, we do most to protect the health of the Nation. Throughout our history, the most vulnerable have often been those attacked by various forms of diseases. Thanks to advances in medicine and public health, vaccines have served as a way to offer protection to individuals and communities.
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Vaccines represent a remarkable public health success story. They are perhaps the 20th century's most important medical interventions, having prevented millions of diseases, disabilities, pain, suffering, and death. And from a risk benefit perspective, they are considered by many to perhaps be the safest and most efficacious medical interventions of our time.
During my tenure as Director of the Centers for Disease Control and Prevention, from 1993 to 1998, we made a commitment and were successful at increasing the Nation's immunizations by the age of 2, from 55 percent to 78 percent in 1996. Determined not to allow the barriers of access, cost, lack of insurance, and others to impede us from boosting immunization rates, we went into the community, partnered with organizations, such as the National Council of LaRaza, the Congress of National Black Churches, and others, to help us overcome the barriers to immunization. Today, immunization rates are approaching 90 percent and we're working still to increase that level. But despite our success, disparities in immunization rates still exist for some racial and ethnic groups in this country. Minority children still lag behind their white counterparts, when overall vaccination rates are compared.
However, we in medicine and public health continue to be concerned that some recipients of vaccines suffer injuries, as a result of the vaccine. We recognize how important it is to acknowledge the significance of the problem of vaccine injury.
This administration has made immunizations a priority. Today, immunization coverage among children in the United States is higher than ever before for most vaccines. These high immunization coverage levels translate into record—or near record low levels of vaccine preventable diseases. So, this afternoon, I will briefly discuss issues related to the benefits of vaccines, our concerns for injuries because of vaccines, our progress through the years, what we're doing to ensure that vaccines are as safe as possible, and what we must do to continue to enhance vaccine safety.
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Vaccines offer many benefits to individuals and their communities. When we vaccinate a child, for example, that child becomes protected against a series of illnesses and diseases. But not only does the vaccinated child receive protection from developing a potentially serious disease, the community also benefits when comprehensive vaccination programs are in place. Those programs provide what we call community or herd immunity, which helps to indirectly protect those individuals who cannot be vaccinated, such as those who may be too young for certain vaccinations or who have other health problems that prevent them from being immunized; yet, they're still susceptible to the disease.
For example, babies that are under 1 year of age are too young to receive the measles vaccine, but receive some protection from the vaccination of other individuals. Also protected are children and adults, who cannot be vaccinated with some vaccines for medical reasons, such as children with leukemia. So, the entire community benefits from the reduction of the spread of infectious agents, and healthier communities mean a healthier Nation.
Vaccines not only save lives and eliminate disability, pain, and suffering, they are also cost effective. Immunizations are one of the most cost effective medical and public health interventions we know.
Let me give you an overview of our experience with immunizations and treatment of vaccine preventable diseases. Today, there are far fewer visible reminders of the suffering, injuries, and premature deaths caused by diseases that can now be prevented with vaccines. By now, many Americans have heard my story. When I was 2 years old in Anniston, AL, I came down with a severe case of whooping cough, which led to pneumonia, and a family physician, who came out to the farm to visit me, predicted that I would not live out the week. I was fortunate. I survived. That year, 1943, in the United States over 190,000 children suffered from whooping cough and 3,500 died; 1995, in this country, there were 5,000 cases of whooping cough and 5 deaths. And that's not our best story. In fact, that's one of our worst stories, in terms of where we are today.
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A physician entering practice today may never see a case of meningitis, due to haemophilus influenza type B. Before the introduction of effective vaccines in 1988, approximately 1 in 200 children under the age of 5 developed invasive haemophilus influenza B disease. It was the leading cause of bacterial meningitis in children under 5, accounting for about 60 percent of all such cases. Today, most residents in pediatrics will not see a child with haemophilus influenza meningitis. In fact, whereas in 1988, there were 20,000 cases, today, there are only about 100; and whereas there were almost 500 deaths a year, today, there are very few, if any. By 1998, vaccination of preschool children reduced the number of cases by more than 99 percent.
Finally, in the 1960's, many people witnessed firsthand the terrible effects of rubella, commonly known as German measles. During an epidemic between 1964 and 1965, about 20,000 infants were born with deafness, blindness, heart disease, mental retardation, and other birth defects, because rubella virus infected their pregnant mothers. Today, thanks to nearly universal use of effective vaccines, the rubella virus poses virtually no threat to the children of expecting mothers. So, we can see from our track record that vaccines offer a great many reasons for placing our trust and hope in them, in protecting the health of individuals, communities, and the Nation.
But, we are concerned about vaccine safety. As gratifying and as efficacious as the benefits of immunizations are, we still have serious concerns. Vaccines are not 100 percent safe. They have risk. A small percentage of children still suffer adverse consequences, as a result of vaccines. And as long as there is a risk of injury or illness in even one child, we should not, we will not be satisfied. Our concern for children injured because of vaccines is not without tangible expression. We've developed a compensation system to provide families with financial restitution for vaccine related injuries.
So, how are we dealing with the problem of vaccine injuries today? We're committed to vaccine safety through enhanced surveillance systems, vaccine safety research, adopting safe vaccine administration policies, and educating and providing information to parents, the health care providers, and to the general public. We have a draft proposal for a comprehensive vaccine safety program built upon the cornerstones of surveillance, research, communication, and education. This updated proposal has been reviewed and approved by the National Vaccine Advisory Committee and is now undergoing review within the Department. We're working diligently to ensure that vaccines licensed in the United States are safe and effective as they can be, and we have one of the toughest vaccine approval systems in the world.
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However, even after the extensive studies required for licensure, post marketing research and surveillance are necessary to identify safety issues, which may only be detected following vaccination of a much larger population. This is because very rare events may not even be detected and if noted, not shown to be due to a vaccine. The National Childhood Vaccine Injury Act of 1986, which Congressman Waxman authored and mentioned earlier, led to the creation of a unified national system to collect, manage, and evaluate the reports of possible adverse events. This system, which was initiated in 1990 and jointly managed by CDC and FDA, is a vaccine adverse event reporting system. And recently, the CDC has added to that the Vaccine Safety Datalink to really pursue these cases, to understand the relationship between them and vaccines.
In 1997, we had to make the very tough decision, when I was director of CDC, to switch our polio immunization strategy from primary reliance on oral polio vaccine [OPV], to an inactivated polio vaccine [IPV]. We made the switch to IPV, which never causes polio, even though OPV only very rarely caused it, 1 in 2.4 million doses. So, we estimate that we spend $3 million per injury or a case of polio from oral polio vaccine; i.e., we spend $3 million to prevent one case. And, yet, we think that's well spent. If we can save a single child, we feel that it is worth it.
A good example of how the vaccine safety monitoring system works is in alerting us to and helping address the recent concern about rotavirus vaccines and a type of obstruction, which we call intersusception. Between September 1998 and June 1999, 15 cases of intersusception following rotavirus vaccine were reported to our reporting system. The cases tended to be younger than most cases of intersusception normally occurring in the absence of vaccination. This signal led to special studies, to evaluate whether there is truly causal roles of rotavirus vaccines in intersusception. On July 16th, CDC recommended that vaccination of children scheduled to receive the rotavirus vaccine before November 1999 be postponed, until the studies are completed and findings are available.
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I've adopted, as one of my priorities as Surgeon General, to move this Nation toward a more balanced community health system, which balances health promotion, disease prevention, early detection, and universal access to health care. One of the goals of that health system is to ensure that every child has the opportunity for a healthy start in life. A very definite part of that healthy start is ensuring that children are immunized against vaccine preventable diseases. And we're making great progress.
So, Mr. Chairman, in conclusion, vaccines have given us much for which we can be grateful. They've eradicated small pox. They've eliminated polio myelitis in the Americas and controlled measles, rubella, tetanus, diphtheria, haemophilus influenza type B, and other infectious diseases. And they have saved millions of lives and avoided disease, disability, pain, and suffering, in many people.
The public has a right to and should expect safe vaccines. Although no system is perfect and no medicine or vaccine can ever be guaranteed to be 100 percent free of possible side effects or adverse events, particularly when administered to millions of people, we are still committed to improving the safety of vaccines. The Department and its constituent agencies, who are represented here today, and the scientific community and industry strive to continuous improvement in vaccine safety. As we enter the 21st century, promoting optimum health of people through the development and administration of safe and effective vaccines will continue to be a priority for our department.
Mr. Chairman and committee members, I assure you, in the interest of protecting and promoting public health, we will continue to make policy decisions and recommendations based on the best available science. Vaccines are very safe and effective. They are not perfect and will require continuing vigilance and research. Thank you for this opportunity to testify.
[The prepared statement of Dr. Satcher follows:]
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INSERT OFFSET FOLIOS 96 TO 111 HERE
[The official committee record contains additional material here.]
Mr. BURTON. Thank you, Dr. Satcher. We have to go and vote. It will take about 10 minutes.
[Recess.]
Mr. BURTON. Would everyone please take their seats. We have other Members who will be drifting back in. We had two votes on the floor of the House. I apologize for the delay, but this is a very hectic week. In order to make sure that we keep the hearing moving, I will go ahead and start the first round of questioning. I'm sure Mr. Waxman will be back here shortly.
Dr. Satcher, first of all, I would like to preface my questions by saying we think the Department of Health and the National Institutes of Health, the National Cancer Institute, and the Food and Drug Administration do a great deal of very, very good work. I don't think anybody on this committee or probably in the entire country believes that vaccinations should be done away with. We all believe that vaccinations have provided a quality of life and health in this country that is unparalleled in the annals of world history.
However, there have been some disturbing things that we have been told over the past couple of years. I, myself, have experienced some things that have been of concern to me. My granddaughter, whom I told you about before the hearing, when she was very, very young—she's 5 years old now and doing very well, I might add—she got a hepatitis B shot and within 12 hours, she was in the hospital and not breathing. It was a direct result of a reaction to the hepatitis B shot. She came out of it and the doctors did a good job, but that was of great concern to us.
My grandson—I only have two grandchildren—my grandson got a DPT shot, and he's now been adjudged to be somewhat autistic. We've talked to other people who have had similar problems.
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So, what we want to find out, if we can, if not today, at some point in the future, whether or not these are problems that emanate from these shots, because there are a number of cases like that across the country. We're going to hear from some witnesses today who will talk about that.
So, let me start off with hepatitis B cases. Can you tell us what percentage of hepatitis cases are not from sexual transmission or from blood or needle exchange properties? What percentage is caused by either needle exchanges or blood transmissions or from sexual transmission?
Dr. SATCHER. You want to know what percentage are not from one of those causes?
Mr. BURTON. Yes.
Dr. SATCHER. OK. Well, let me ask Dr. Orenstein to respond.
Dr. ORENSTEIN. Thank you, very much. About 25 to 30 percent of cases have no identified risk factors that are reported.
Mr. BURTON. About 25 to 30 percent have no identified risk factors, that's correct?
Dr. ORENSTEIN. Yes.
Mr. BURTON. When I talk to some other physicians, who are in the Congress, and they thought the percentage was much lower than that. But, is that a scientific fact?
Dr. ORENSTEIN. Those are data collected from both Sentinel Surveillance System, is the main area that information comes from. These are people, who are interviewed and do not admit to any risk factors. And you will hear about cases—or have seen cases in prior hearings that have had no identified risk factors.
Mr. BURTON. How many children under the age of 5 have been infected with hepatitis B from things other than needle exchanges, blood products, or from sexual transmission?
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Dr. ORENSTEIN. I don't have the data broken down by under 5. But under 9, the CDC estimates that about 19,000 infections with hepatitis B virus occur——
Mr. BURTON. What percentage would that be, Doctor?
Dr. ORENSTEIN. Overall, it would be, in the absence of vaccination, about 350,000 infections. So, I'd have to do the math, but it's about——
Mr. BURTON. So, 350,000 infections about. And how many did you say from under the age of 9?
Dr. ORENSTEIN. Under the age of 9, with no known risk factors, there are about 19,000.
Mr. BURTON. So, 20,000 out of—so, it's about one-twentieth?
Dr. SATCHER. For that age group, it would be much higher than that.
Dr. ORENSTEIN. For that age group, it would be——
Mr. BURTON. No, but I mean overall cases.
Dr. ORENSTEIN [continuing]. Higher. But for all cases, it would be, I guess, 6 percent, isn't it—about 6 percent.
Mr. BURTON. OK. But under the age of 5, it would be much, much less than that?
Dr. ORENSTEIN. According to some of our data on serology, the incidence occurs between—often between age 2 and age 5. And so, it's not clear that there is like a continuous level increase up through age 9.
Mr. BURTON. If you keep statistical data, for the record, I'd like to have you submit, the number of cases and the percentage of hepatitis B cases under the age of 5. When do we require children to get the hepatitis B shot, at what age?
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Dr. ORENSTEIN. It depends on the State, because it——
Mr. BURTON. Well, most States.
Dr. ORENSTEIN. Most States would be school entry, age 5 to 6.
Mr. BURTON. I think it's very significant, because like I said, my granddaughter had to get it at a very, very young age and there were very severe side effects. I'm sure other parents have that same problem.
Dr. SATCHER. Well, I think the question here is when is it recommended——
Mr. BURTON. Right.
Dr. SATCHER [continuing]. As opposed to when is it required.
Mr. BURTON. It's recommended at what age?
Dr. SATCHER. Well, now—at birth for most children. As you know now, we've at least relaxed that for children of mothers, who have not shown any evidence of exposure. But the requirement relates to day care or school entry.
Mr. BURTON. That's usually 5 to 6 years old?
Dr. SATCHER. Right.
Mr. BURTON. We talked a while ago about the filing deadline of August 6th for hepatitis claims to the National Vaccine Injury Compensation Program. As I understand it, that is statutorily set for August 6th, which is about 3 days from now; is that correct?
Dr. SATCHER. Well, I will ask the person who heads that program, to respond.
Mr. BALBIER. Mr. Chairman, you are correct. August 6th is the deadline for filing claims that are——
Mr. BURTON. Well, there are a number of people, I'm sure, across the country that were unaware of that. I was wondering, would you work with us to try to get that extended for, say, 3 or 4 months, so that people across the country, who may be paying attention to what we're talking about today, would have a chance to file a claim, if they need to?
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Mr. BALBIER. It would require legislation to extend the deadline. I would point out that that did happen once before in the history of the program for claims arising prior to 1988.
Mr. BURTON. Well, what method has been employed to make the public aware of that?
Mr. BALBIER. We have several ways of doing that. We have vaccine information statements that are provided routinely. Every time a child is immunized, it provides information on the Vaccine Injury Compensation Program, including our 800 number and our website, where they can get more information.
Mr. BURTON. Well, unfortunately, we had a problem in our family and I didn't know about it and I'm chairman of this committee. So, I know that it must not have been as far reaching or as effective as it could have been. So, I wish we would work together to try to get an extension and try to inform the public, because I'm sure there are a lot of people who would like to at least make that kind of a claim.
Mrs. MINK. Would the chairman yield?
Mr. BURTON. I'd be happy to yield to my colleague.
Mrs. MINK. I wanted to inquire why we have a statutory deadline? Why did Congress set a deadline?
Mr. BALBIER. The deadline that we're going to reach at the end of this week is the deadline for filing claims that occurred for the 8 years prior to the coverage of the hepatitis B vaccination. Hepatitis B vaccination was covered under the National Vaccine Injury Compensation Program on August 6, 1997, when the excise tax went into effect to cover that vaccine. At that time, the vaccine was covered for any injury that was thought to be related to the vaccine, and people had 2 years to file a claim, for any vaccine administered during the 8 years prior to 1997, and they had 2 years to do so. So, we are now reaching the August 6, 1999 deadline for filing those 8 year retroactive claims. So, it's only for those claims that occurred prior to the coverage of hepatitis B vaccine under the compensation program.
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Mrs. MINK. So, subsequent to 1988, there are no statutory deadlines. Is that what I'm to understand?
Mr. BALBIER. There are deadlines of 3 years for filing an injury claim from the onset of injury and 2 years from the date of death, if a death is thought to be related to the vaccine, or 4 years from the onset of the injury that led to the death from an injury thought to be——
Dr. SATCHER. We wish to point out, Mr. Chairman, that the Secretary has submitted proposed legislation that would extend some of those times.
Mr. BURTON. Well, I would like to work with you and the Secretary, then, to get that extension passed through the Congress, because, like I said, I'm not sure the American people have really been well informed about that.
Dr. SATCHER. I believe it would extend it to 6 years, right?
Mr. BALBIER. That's correct.
Mr. BURTON. Oh, to 6 years?
Mr. BALBIER. It would double the statute of limitations to 6 years for injury requirements.
Mr. BURTON. That would be even better.
Mr. BALBIER. We have already proposed legislation to do that, and we would like very much to see that happen.
Mr. BURTON. We'll work on that. Would you make sure we do that?
The other things that I wanted to ask you about, do you keep records on people's concerns about the side effects of certain vaccines, like hepatitis B and the DTP shot?
Mr. BALBIER. With the compensation program, itself?
Mr. BURTON. Not necessarily the compensation, but where people are making claims that their child or have been making inquiries about their child being affected, they believe, by the shot.
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Mr. BALBIER. We have several ways of tracking that. We have what we call a passive surveillance system, called the Vaccine Adverse Event Reporting System, whereby any provider of the vaccine can report any injury thought to be related to vaccine.
Mr. BURTON. Wait a minute, any provider of the vaccine? You're talking about the pharmaceutical company?
Mr. BALBIER. No, the administrator of the vaccine. That's one way.
Mr. BURTON. Which would be the doctor?
Dr. SATCHER. But, it also could be—it's not limited to the doctor.
Mr. BALBIER. Right. In fact, one of the advantages of the system that was developed, the Vaccine Adverse Event Reporting System, is that it allows anybody to report. The law also requires that physicians give out vaccine information statements to parents before their child is immunized. And on that statement, it gives the parent the number that they can report a case. And that was put in purposely, because some parents were concerned, in the 1980's, that their doctors weren't reporting cases. So, we offer the opportunity for parents to report, as well.
Mr. BURTON. Could we get the statistical data on at least two of those: hepatitis B and the DTP shot?
Dr. SATCHER. There's another point that I think we should probably make and that is the reporting system is one thing. And as you know, there are about 12,000 incidents reported a year. Recently, CDC has initiated what is called the vaccine survey data link. So, we are actually aggressively studying the relationship between the vaccine and adverse events, in about 2 percent of the population?
Dr. ORENSTEIN. It covers about 2 percent of the U.S. population of children. And it allows us to look at when a given illness occurs, how often it's occurring without vaccination, so that we can compare the two.
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Mr. BURTON. If you could provide that information, we would really appreciate it.
Now, regarding anthrax and the anthrax vaccine, we have been told by the General Accounting Office [GAO], in two separate hearings that my colleague, Mr. Shays, held as chairman of that subcommittee——
Mr. SHAYS. Four hearings.
Mr. BURTON. Four hearings, that for 20 years, the person, who was producing this, really wasn't checked thoroughly, as far as the quality control at their facility, I believe it was in Michigan. And when they found out about it, they went up there and checked, and they found that it was way below par and that the serum that was being used, and is still being used, might be, in many cases, tainted. Now, we've had 300,000 people vaccinated in the military with this serum and I just don't understand how we could allow that to happen, if there's some question about the cleanliness of the product, whether or not it might cause side effects simply because it might be tainted and why that product was not inspected more thoroughly over that 20-year period and why the producer of that product is still producing it, to the best of my knowledge.
Dr. SATCHER. I'm going to ask Dr. Kathy Zoon, who is head of the Center for Biologic Evaluation and Research at FDA, to respond. You know that the anthrax program is a DOD program, but your question is still relevant.
Mr. BURTON. I understand. But, I understand that they're talking about expanding the anthrax vaccination program to children. And that troubles me a great deal, because we have had a number of service people, who are not only getting out of the service, but have had severe side effects.
Dr. SATCHER. We have not made that recommendation and that kind of recommendation would come through the Advisory Committee on Immunization Practices.
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Mr. BURTON. Well, maybe it was just for military children; I don't know. But, that's what I've been told.
Dr. ZOON. Thank you, Mr. Chairman. I would like to, one, say that vaccine safety to the FDA is extremely important and with any vaccine, including anthrax, there are four levels, in which we oversee the safety. One is through the review of the data that comes in during the development of a vaccine and then data that comes into the agency, as part of the licensure procedure. That is the beginning of the vaccine and the surveillance that FDA does. Subsequently to that, we do inspections of facilities that produce vaccines. And we, also, are involved in release of lot material and review of protocols for lot release before any product can be distributed. And finally, that we are involved with surveillance, which includes the VAER system and work with the CDC very closely on followup.
With respect to your question regarding the facility producing anthrax vaccine, there have been many inspections of that particular facility over the years. On each inspection, not every part of the facility may be inspected completely at each time. However, many of the records are inspected on each of the inspections. And, in fact, there have been multiple FDA inspectors in the course of the past 10 years in the facility at which you're speaking. So, there has been followup. In addition, FDA reviews all the lot release protocols for this. And right now, the company is not manufacturing and distributing vaccines.
Mr. BURTON. Thank you. I'll followup on that later. Mr. Waxman.
Mr. WAXMAN. Dr. Satcher, you're the head of the Public Health Service, and that Public Health Service in the United States, as I recall, was set up in the last part of the 18th century, 1798. I also recall the reason that we have the Public Health Service in the United States was because of the yellow fever epidemic, which was transmitted by merchant sailors who had wiped out 10 percent of the population of Philadelphia. As a result, we set up the Public Health Service. Isn't that right?
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Dr. SATCHER. Yes, an act of Congress, because at that time, as you know, Congress was located in Philadelphia. President John Adams signed the act of Congress in 1798, giving rise to what we then called the Marine Hospital Service to take care of merchant seamen. But, you're absolutely right, it was in 1793 that this yellow fever outbreak hit Philadelphia and it was felt to have been related to merchant seamen, who were going in and out of the country. It was a devastating experience. As you said, it wiped out over 10 percent of the population; 50 percent of the population of Philadelphia fled because of that epidemic.
We were back there last year, in fact, to begin the 200th anniversary celebration of the Public Health Service, because, later, the Marine Hospital Service became the Public Health Service. So, we went back there in July to begin our celebration. And we retraced the trail of the yellow fever epidemic and it was really quite an experience. But, it was this outbreak that gave rise to the Marine Hospital Service, which would later on become the Public Health Service.
Mr. WAXMAN. I think we shouldn't forget history.
Dr. SATCHER. I agree.
Mr. WAXMAN. And I worry sometimes that the successes that the immunization program has brought to this country and to the world might be a victim of the—the program might be a victim of its own success, when people forget about these dreaded diseases——
Dr. SATCHER. Right.
Mr. WAXMAN [continuing]. That still occur. Right now, as a matter of fact, in certain parts of the world, mainly Russia, according to press accounts, there are over 2,000 reported cases of diphtheria since January 1 of this year. Can you explain how existence of a disease in a foreign country, such as diphtheria in Russia, can threaten unvaccinated children in the United States?
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Dr. SATCHER. Let me give another example, measles. Virtually all of the cases of measles that we have seen in recent years have been imported. They've come in from other countries and they've led to, in some cases, outbreaks in this country, when they got into a population that was not vaccinated. The risk to the population of people, who take exemptions for vaccinations, the risk of measles is 35 times what it is in the rest of the population and you know less than 1 percent of the population takes advantage of religious or philosophical exemptions. We're talking 0.64 percent. But even with that small number, there's a 35 time full risk of measles. And most of the measles comes from other countries.
Mr. WAXMAN. So, in the United States, some people don't get vaccinated?
Dr. SATCHER. They take exemption because of religious reasons there are 48 States that allow for religious exemptions, every State except Mississippi and West Virginia.
Mr. WAXMAN. Now, as I understand the chairman's statement, I don't want to attach any policy to it because he has to speak for himself, but it sounds like he and others are saying maybe we ought to leave a choice to everybody, whether they want their kids to be immunized or not. I don't know if that—let me not attribute it to him. Would that make sense as a policy for public health, if we just let people make that choice for themselves?
Dr. SATCHER. I think by definition in public health, we're concerned about the health of the individual; but, we're also concerned about the health of the community, the population. And we make rules to protect the community. In fact, you can't even protect the health of the individual, unless there is a community approach to things like immunization. So, it is true that when we make decisions and recommendations about immunization, we're concerned about the population. That's very basic to public health.
Mr. WAXMAN. What if I say it's my child and I'm willing to take the chance because I heard that there are some adverse reactions. I heard about a congressional hearing that seemed to put a spotlight on those adverse reactions and I don't want to take a chance for my child. My child might be at risk, but am I putting other children at risk?
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Dr. SATCHER. Well, no question about it. I mean, when a child is not immunized—and many States, as I said, allow exceptions—exemptions for religious, and then 15 States, I believe, allow philosophical exemptions. But, we know from much of our experience, and certainly Dr. Orenstein can give more details about outbreaks that have occurred in population for religious reason and others that took exception—I respect people's religion if they decide to take an exemption. But, clearly, if States did not have any rules about what it takes to get into school, many more children would be affected by infectious disease outbreaks.
Mr. WAXMAN. Now that means we've got to be sure that these vaccines are as safe as possible. What mechanisms are in place to assure the vaccines are safe?
Dr. SATCHER. Well, there are quite a few of them, and I'll just give an overview. We have a very tight surveillance system. And I believe the most important thing, of course, is what Dr. Zoon said. We take new vaccines through at least four phases. I mean after the animal studies, there's the phase one study, looking at safety in a small number of individuals. Then there's the phase two studies, which look at dose ranges for vaccines. Phase three studies, like the one that they're beginning now in Thailand for HIV vaccine, really implements the vaccines in a larger population of people, who are at great risk for an infectious disease like HIV. And it evaluates what happens, in terms of safety and efficacy. And only after you've been through that does FDA then approve implementation of that program. And even after that, there's a so-called post marketing phase, in which you really look at what happens when you make this vaccine available to a broader population.
Mr. WAXMAN. That's the Vaccine Adverse Event Reporting System?
Dr. SATCHER. That's right.
Mr. WAXMAN. That's the post-marketing surveillance?
Dr. SATCHER. Post-marketing surveillance is the Vaccine Adverse Event Reporting System, and, in some cases, even some more detail followup. As I mentioned, the Vaccine Safety Datalink, which is primarily with managed care programs, but involves more than 2 percent of the population, looks at these events and sees to what extent they relate to the vaccine.
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Mr. WAXMAN. Mr. Chairman, I appreciate getting a little extra time because I want to ask some questions about the Vaccine Compensation Program, which I am proud to have authored, and I also have a conflict because I'm supposed to be at a conference on another piece of legislation. It has nothing to do with anything we're discussing today.
The Vaccine Compensation System was set up to try to make sure that people didn't have to go to court and go through all the expense of litigation in order to be compensated when they had an adverse reaction from vaccines. And I think it's well worthwhile, Mr. Chairman, for us to use our oversight authority to be sure that program is working.
Now, the administration is proposing that there be a lifting of the time limits for people to come in with their claims. Could you tell us about that?
Dr. SATCHER. We have—and I'm going to ask—where is——
Mr. BALBIER. I'm right here.
Dr. SATCHER [continuing]. In terms of how the litigation process has worked and how well it's worked. But, I think what we're concerned about is making it as easy as possible for people to file claims and to report adverse events. So, the Secretary made some proposals—legislative proposals that would make that process much easier than it is now. And I, also, want to say that when in doubt, we try to give the benefit of the doubt to the petitioner.
Mr. WAXMAN. I sure hope so.
Dr. SATCHER. We do. Without question, we do it in this program.
Mr. WAXMAN. Well, we're going to hear testimony contrary to that and I'm concerned about it, because I think we ought to give the benefit of the doubt.
Dr. SATCHER. I think we can demonstrate that. I can give some specific examples, where the Advisory Committee on Childhood Vaccines, made up, in addition to experts, parents of children, who have suffered events, are members of that committee. And there have been times when that committee has used its authority to override other committees, to make sure that we give the benefit of the doubt to the petitioner.
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Mr. WAXMAN. I want to get more detail on that and I want to get more for the record. The administration is going to propose some legislation. And if Congress is going to deal with legislation, I think we can recognize the fact that there is a lot of money in that vaccine fund at the present time. Mr. Chairman, maybe one area where we can work together is to make sure that if there are excess funds, we devote those excess moneys for more vaccine safety research and surveillance.
I don't know if you're in a position to comment on that, because the administration would have to take its position. But do you think that might make some sense?
Dr. SATCHER. Well, obviously, Congress is going to have to make that decision. I believe there is about $1.4 billion in that trust fund now and there have been various proposals suggested. One proposal would reduce the excise tax from 75 cents to 25 cents. Another proposal would be to use money from that fund to fund safety research. And, you know, obviously, I would—I favor vaccine safety research, because I think, as I said in my testimony, we should do everything we can to make vaccines as safe as possible. But, using the trust fund for that purpose is something the Congress must decide.
Mr. WAXMAN. Yes. Now, you get these reports about adverse reactions. What do you do with them? Do you have any examples of where you've gotten the information and have been able to do something to make vaccines safer?
Dr. SATCHER. Tom, I believe that you——
Mr. WAXMAN. Rotavirus is one issue that I've heard about. Can you tell us——
Dr. SATCHER. Oh, yes, no, that's the one, OK.
Dr. ORENSTEIN. I think there are a number of things to evaluate the reports and to take action when action is indicated and to do further research when signals are generated that there may be a problem with vaccine safety. Vaccine safety is absolutely critical to the immunization program.
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Rotavirus is probably a very good example, because it's a recent example, in which a signal was generated about potential intestinal blockage in children younger than the usual age at which the blockage would have occurred in the absence of vaccine. Because of that, we did two things. It was such a strong signal, and combined with other data we had, that we recommended a postponement to vaccination, at least until November, so we could clarify whether, indeed, rotavirus is causing intestinal obstruction or not. And we are in the process of undertaking a major national study to evaluate that.
There are other signals that have been suggested in the Vaccine Adverse Event Reporting System, such as the relationship of Guillian-Barré Syndrome, a paralytic illness with influenza vaccine. We undertook research to look at that, which suggested that about once in a million doses of influenza vaccine, there could be a problem. There is continuous monitoring. The FDA looks at death reports. It looks at clinical reports. There are meetings regularly with FDA and CDC in order to try to take a comprehensive look at vaccine safety.
Mr. WAXMAN. Let me say if in rare cases there is an adverse reaction, we ought to compensate the victim as best we can for that adverse reaction. But I don't want this country to become lax in the area of vaccinating our kids, because I don't want these diseases to come back and I don't want people looking at a hearing like this and thinking, oh my gosh, more people are hurt than helped when the child's immunized.
Because that isn't any cost benefit evaluation—we always hear we ought to have cost benefit evaluation—but the benefits outweigh the costs enormously to have our children immunized. Do you agree with that?
Dr. SATCHER. Well, a good example is just the followup on what Dr. Orenstein just said about the one in a million risk of Guillian-Barré Syndrome for influenza. The risk of hospitalization from getting the disease influenza ranges from 200 to 1,000 times that. That's the risk of not just having influenza but having to be hospitalized with influenza. It's 1,000 times greater than the risk of getting Guillian-Barré Syndrome.
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Mr. BURTON. Thank you again, and let me just apologize to you for trying to impute some views. I don't know what your views are on the subject so I should not have asked the question in that way.
Mr. SHAYS. Thank you.
Mr. BURTON. But I appreciated the witnesses answering the question.
Mr. SHAYS. Thank you, Dr. Satcher, and your staff for being here. We are not looking at the issue of vaccines for children right now, but my subcommittee is looking at the issue of whether we should have a mandatory program for our military personnel to protect against various biological agents; one is anthrax. But there are many others, and there are questions of different types of anthrax and which you should be protected from. I'm going to focus more on that, and I'm just going to accept as a fact that besides just teaching general cleanliness, which has probably done a world of difference to society, vaccines have been second only to that in terms of their benefit to society.
And so I don't know if this would be Dr. Zoon or anyone else, but I will ask you and you can defer. How long might it take to review and approve a new recombinant vaccine against anthrax? How long would it take, or should it take?
Dr. ZOON. If a biologic license application came in and it was evaluated that a new recombinant anthrax vaccine would presumably be a priority for the FDA, which would probably mean we would review the application within 6 months.
Mr. SHAYS. But overall, from start to the end, review an application, so much more, would have to go in before they could make that application.
Dr. ZOON. Yes.
Mr. SHAYS. What's the sense of the total—it would just take you 6 months, or it would take the Government 6 months, but in addition——
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Dr. ZOON. I think you're asking about the development time?
Mr. SHAYS. Right.
Dr. ZOON. Is that correct?
Mr. SHAYS. Yes, ma'am.
Dr. ZOON. Yes. It varies for a product how long it can take under development. And presumably, once you've discovered it through the time it has all the pre-clinical information, manufacturing information, and clinical information can vary in the timeframe. Generally, the shortest timeframe to collect all that information is 2 years, and sometimes it can take much longer.
Mr. SHAYS. What kind of data would FDA require to demonstrate efficacy of a new anthrax vaccine against aerosol challenges in humans?
Dr. ZOON. At this point in time, there are a number of different opportunities and models that we would look at for both pre-clinical data and data in humans. Because of the seriousness and the ethics involved with doing a challenge study with anthrax, clearly that would not be possible. Also, the incidence of anthrax in the United States is very, very low and therefore a natural history could not be done. What could be, what we would have to look at would be several things, and this is not all-inclusive, but just to give you some sense is, we'd look at pre-clinical data, animal model data, looking at challenge data in good animal models. We'd also look at safety data in humans and we'd look at immunogenicity data in humans as a start.
Mr. SHAYS. Which leads to the question, what is the status of the FDA regulations on correlating the data on animal immune response to the likely response in humans?
Dr. ZOON. My understanding, there is a proposed regulation that has been drafted. I am not certain as to the status of it right now.
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Mr. SHAYS. And finally, of the most widely discussed biological warfare agents, one is smallpox, another is anthrax, another is the plague. Now there's botulism, glanders and others. How many do we have vaccines against?
Dr. ZOON. Currently there is a licensed smallpox vaccine, of which there is limited quantity. There's one licensed anthrax vaccine.
I thought they—I'd have to get back to you on the rest, sir, because I'm not 100 percent sure.
Mr. SHAYS. But clearly one of the challenges we have is developing vaccines. The military is talking about ultimately vaccinating for a good number of perceived potential attacks against our military. The challenge that we are going to have, it seems to me, is developing a vaccine that we think will do the job given the challenge of how you test it. And it will be interesting to see how you all weigh in on this, because that's the direction our military's going in and it raises gigantic questions. Thank you.
Mr. BURTON. If the gentleman would yield. I think a lot of people who are paying attention to this discussion right now might not understand what kind of questions you're asking, in layman's terms. So I'd just like to clarify a couple of things. As I understand it right now, the anthrax vaccine has been proven effective to a degree against the kind of anthrax that is communicated through the skin and through touching. As far as anthrax being communicated through an aerosol or through a missile that would explode and spray anthrax into the atmosphere where people would breathe it, it has not been proven effective in that. As a matter of fact there was one test, as I understand it, or one case where they had given people the anthrax vaccine in a farm environment, where five people died who inhaled the anthrax bacteria. The thing that a lot of people in the military would like to know is, does the anthrax vaccine work against an aerosol or an aerosol-type dispensing of this, this dread disease? And along with that, if it doesn't—because the most likely way that an enemy would try to attack the U.S. military operation would be through an aerosol-spread bacteria—why are we using this vaccine? If it's not effective against that, and that's the most likely way that an enemy would attack us with it, why are we using that vaccine and mandating it right now?
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Dr. SATCHER. I don't think we're going to try to answer that because—I think it's a very good question, but I think——
Mr. BURTON. It needs to be answered because 300,000 of our troops have been vaccinated, and right now, according to what I've been able to understand, it isn't going to protect them if an aerosol attack with anthrax ensues.
Dr. SATCHER. I just mentioned the question of why because the Department of Defense obviously has risk information that we don't have in terms of terrorism. We can answer the other question you raised. But if you say, why, the Department of Defense made the decision; they certainly have security information that we don't have about the risk that we're facing. And they make decisions based on that. We can answer the question about the relative risk.
Dr. ZOON. Yes, Mr. Chairman——
Mr. BURTON. Would the gentleman yield? Just to clarify the information being provided. If you could, and National Security, Veteran's Affairs, and International Relations Subcommittee would love the answer to the question that you said you would get back to us on. I'm going to have my staff followup on that, so it would be helpful. You may answer, then I'll yield to Mr. Davis. Thank you, Mr. Davis.
Dr. ZOON. Thank you, Mr. Chairman. There is, while be it limited data looking at the ability of the current anthrax, licensed anthrax vaccine to be protective of inhalation anthrax, you are very right, sir, that the primary incidence of the disease in the mills where the study was done on the original anthrax was cutaneous, or skin. However, there were five cases of inhalation anthrax. And when the data was looked at, four of these five cases were fatal cases. When the data was looked at this single-blinded control study, it was discovered that of those deaths from inhalation anthrax, two were in the placebo group and three were in the unvaccinated group, and zero were in the vaccinated group.
Mr. BURTON. So you have none that were vaccinated, that you can tell one way or the other about the aerosol.
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Dr. ZOON. Well, in fact, those people that were vaccinated did not have any cases of inhalation anthrax.
Mr. BURTON. So using deductive reasoning, you say it was effective against that?
Dr. ZOON. Within that limited data base, for that study, we have that information, which would suggest some protection against inhalation anthrax. Subsequently, studies were done in a primate model looking at protection challenge studies that were done by Dr. Ivens. And this was a study where they used a spore challenge in rhesus monkeys. And it was shown to protect against the aerosol challenge.
Mr. BURTON. Mr. Davis.
Mr. DAVIS. Thank you very much, Mr. Chairman. Dr. Satcher, let me thank you for your testimony, and also the advances that I think we're making in public health under your leadership and with the assistance of your team. I agree that the greatest weapon we have, the greatest defense that we have against childhood diseases are vaccinations. According to Evan, Rachel, Brian, David, Katie, Tim, Catherine and Natalie, these are all children who live in Illinois, whose vaccinations produced terribly devastating results for them. They are children who cannot walk, children who cannot play, and they're children whose parents believe that their conditions were caused by their vaccinations. In addition to that, there is a group in my community headed by a woman named Barbara Mallarky, who is the spokesperson for the Illinois Coalition for Vaccine Awareness and a health activist who lives in my community. I see her quite frequently. She believes that strong anecdotal evidence suggests that children are being adversely affected by vaccinations, especially hepatitis B. My question is, what can we tell the parents of these children, and what can I tell Ms. Mallarky and her group?
Dr. SATCHER. Thank you, Congressman Davis. And I appreciate your background in public health, too, so I know I don't have to tell you how we go about making decisions and the struggles that we go through. There are a few issues involved here. And the first one, of course, is that there are adverse events that occur from vaccines. They are very rare. They don't compare with the benefits, but—they are very rare, but they are very significant for the people who are affected. That's the first thing, and we are determined to reduce adverse events to as near zero as possible. The other thing, of course, is that it is sometimes difficult for us to determine when an event occurs temporally related to vaccines, that the vaccine caused the event. And the only way we can determine that to the best of our ability is to investigate. That's why we have a system that allows those kinds of investigations to take place. People can petition, and in many cases it has been found—I believe there have been 1,400 families who have received a little over $1 billion from the system, because they filed complaints about injuries that occurred. I don't believe it is possible to compensate people adequately for the kind of thing that we're talking about. But there is a system set up to investigate and to determine the likelihood that an adverse event was due to the vaccine. And if it is determined that it was, we have a system to attempt to provide some compensation. So the system, I think, is there. The most important system is the one in which we are working night and day to continue to improve safety.
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Mr. DAVIS. So I can assure them that the Public Health Service is doing everything in its power to continue with the research, to investigate, to try and reduce as near to zero as we can, these situations that may occur.
The other question that, that I'd like to ask—we have the injury compensation program, which is publicly funded. Are there any liabilities for the manufacturers of the vaccinations that we use?
Mr. BALBIER. If a petitioner under the program chooses to reject an award or is unsuccessful in obtaining an award, that individual may then sue the manufacturer. So the program is not an absolute protection of the manufacturers by any means.
Mr. DAVIS. So it is the first line of defense for the consumer. Then if people are not satisfied, they can go beyond that in terms of seeking redress.
Dr. SATCHER. That is correct. But there is a very important point here, and I don't know if we've made it yet. Part of the value of this program—sort of a no-fault, where the Government takes responsibility—is that we have been concerned and are concerned that manufacturers are willing to continue to take the risk to develop vaccines. We have been successful in developing effective vaccines because there is a program like this available in which we share the risk of vaccines.
Mr. BENOR. Absolutely.
Dr. SATCHER. I think one of the major benefits of this program is that manufacturers are encouraged to continue to do research. And as Dr. Zoon described, it's an odious process of bringing a vaccine to market.
Mr. DAVIS. So you're really saying that we are co-partners in a way, in trying to make sure that we have available to us the, the medicines or the pharmaceuticals that are needed to address some of the problems. Well, I appreciate that. And let me, Mr. Chairman, thank you, and also just say that, I have studied the public health system for a long time and I can tell you it is so refreshing to see that we are moving toward a public health modality in terms of really trying to move beyond just the individual protections, to the point of protecting our communities, our cities, our States, and indeed our Nation. I thank you very much.
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Mr. BURTON. Before I yield to my colleague, let me just say that we should be concerned about the public health and public welfare. But our country was set up in such a way as to try to maximize the protection of the individual as well. And that's why, one of the reasons we're having this hearing today, because we want to make absolutely sure that people are getting as much information as possible about these vaccines and the possible side affects. Now I don't want to prolong this because I want to yield to my colleague. But my granddaughter had a hepatitis B shot, and within 12 hours, she was in intensive care; she couldn't breathe. One of my daughter's best friends is in the audience, and her child had a hepatitis B shot and died. Now that's 2 people that I know personally. Now this may just be a coincidence, but if those kinds of side-effects occur, then we need to know why. We need to be able to inform people across this country of the risk. Maybe we're giving too many shots in too short a period of time. Maybe, unlike Japan, we're not checking the immune systems of children before we give the shots. Do we check the number of the antibodies? Do we check these really thoroughly before we give our children shots, or do we just indiscriminately give them shots? Twenty-one shots before they're 6 years old. Can their little immune systems stand that much onslaught? Those are the questions that need to be answered. But I know that in my family, I've got an autistic grandchild—out of two grandchildren, one's autistic, the other almost died from the hepatitis B shot, and one of her best friend's child did die from a hepatitis B shot. Now you can call that coincidence if you want to. I kind of think it's more than coincidence. That's why we're having this hearing—not that we don't want to vaccinate, but we need to have an informed population to make sure that parents, while conforming to the rules of society to make sure that the whole population is safe, protects their family and their children as well.
Dr. SATCHER. Chairman Burton, let me just say I agree with you. I think this is a very important hearing. I can't think of any hearing that could be more important. So there's no question in my mind about the importance of this hearing and the importance of this issue.
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Mr. BURTON. I look forward to working with you, Doctor.
Dr. SATCHER. We want safe vaccines.
Mr. BURTON. I think you're a sincere fellow, and from what I can tell, you've done a good job. Of course, I'm a layman; I'm not a doctor. [Laughter.]
Mr. MICA. Thank you, Mr. Chairman, Dr. Satcher. I have a couple of questions. In January I took over a subcommittee that deals with the oversight of HHS and was immediately deluged by people contacting our subcommittee about the need for oversight of some of the vaccine programs, particularly hepatitis B. We did some studies and investigation, and we conducted a hearing on May 18. I'm pleased that you, and the administration, shortly thereafter have taken some actions. You told us today that you have several actions which you are recommending. One is lifting of the time limits; two, I heard about dollars for research—two items that were raised at our hearing. Could you tell me about the specifics of lifting the time limits, what this involves? And then, we now have $1.3 billion in the fund. Are we talking about taking money out of that for additional research purposes?
Dr. SATCHER. To respond to your last question, we don't have the authority to do that. Any use of those funds other than——
Mr. MICA. Oh, I know. But you're recommending to Congress that we change the law to give you the authority, but to what degree?
Dr. SATCHER. Well, I'm not sure we have made that specific legislative recommendation.
Mr. MICA. You don't have a specific legislative proposal.
Dr. SATCHER. No, we don't.
Mr. MICA. When can we expect that?
Dr. SATCHER. I hate to try to make predictions—because it's been discussed between the administration and Congress.
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Mr. MICA. Can we get a recommendation from you, say by September since we're well into the 106th session? We're going to do a hearing on the compensation fund because it's been brought to light that there were problems, and this is the first time that I've heard of the administration's proposal in this regard. Maybe sometime in September, could we get that?
Dr. SATCHER. Let me say there exists now a set of legislative recommendations from Secretary Shalala to Congress about how to improve this system to improve the benefits to people who are adversely affected by vaccines. Those are in place now. I don't want to say exactly when the administration will submit other proposals because I don't know.
Mr. MICA. Well, maybe we can work with you.
Dr. SATCHER. Yes.
Mr. MICA. One of the things that also came out in the hearing is the frustration with the compensation and that the average length of time to go through the process is 2 years. That's average length, and many of these take more time. Do you know if you have any recommendation about how to deal with speeding up that process for compensation?
Dr. SATCHER. I'm going to ask the attorney but—let me just say, there are times when we compare this system to the regular tort system. As you know, it's been much more efficient, but still we're not satisfied with it—but it's much more efficient than the——
Mr. MICA. Then that would be one area too we'd like to—if we don't have a recommendation. I have a press account that says, that relates to a surprise announcement. It says, a surprise announcement late yesterday. And this was a change in policy relating to mandatory vaccination of children with hepatitis B vaccine. It says, the surprise announcement came late yesterday afternoon, just 7 weeks after a May 18th hearing on the safety of hepatitis B vaccine. The vaccine policies in the U.S. House—our subcommittee conducted—brought out problems with that. And I guess the announcement related to eliminating mercury content in hepatitis B vaccine. It was a joint announcement by the Public Health Service, your folks, and the Academy of Pediatrics. OK. Our hearing was May 18th. When did you have the first information that there might have been a problem relating to the mercury content? Was that after our May 18th hearing and before your announcement, or before our hearing?
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Dr. SATCHER. I can speak to that from the Public Health Service. I was involved in that announcement with the American Academy of Pediatrics, and the announcement was to give pediatricians and parents more flexibility in terms of implementing the hepatitis B vaccine.
Mr. MICA. What I'm interested in, I want to know when you had the information. When did you know——
Dr. SATCHER. I'm going to get to—Dr. Zoon——
Mr. MICA. And was that in your possession before the hearing that we held, or did they come to you after the hearing that we held?
Dr. SATCHER. It was after the hearing that you held.
Mr. MICA. It was.
Dr. SATCHER. In fact, it came to my attention, it came, I believe, less than a week before we made the decision. We—and this included the American Academy of Pediatrics. Now there have been some studies in other countries about thimerasol and its effect. But in terms of FDA looking and getting reports from manufacturers in this country, and the information coming to us, it was a few days or weeks before—Dr. Zoon, do you want to comment?
Mr. MICA. Would you supply the committee and the subcommittee with any communications you had, all communications you had, relating to this particular matter, say, in the last year? Would that be possible?
Dr. ZOON. Yes. Certainly we can provide you—would you like me to give you some background, sir, or would you just like it for the record?
Mr. MICA. I'd just, I'd like to have the information for the record.
Dr. SATCHER. We can say more about that if you'd like.
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Mr. MICA. The last thing—and my time is about up. You are the Surgeon General, the Chief Health Officer of the United States, and I noticed an article that was included here. I don't know if you gave it to us or if it was provided in our packet. But you talk quite a bit about some health issues, particularly smoking, excess, not eating enough vegetables, and not exercising. I chair the Criminal Justice, Drug Policy, and Human Resources Subcommittee, and our concern is, of 14,000 young people and others die every year in drug related deaths.
Dr. SATCHER. Would you like for me to read the Surgeon General's prescription?
Mr. MICA. No. But I just——
Dr. SATCHER. It, includes advice against the use of drugs.
Mr. MICA. Yes, but again, I noticed this. I think you threw away your pipe to set an example.
Dr. SATCHER. That's a good article.
Mr. MICA. My concern is, having survived one of your predecessors, the infamous Jocelyn Elders, that she sent the wrong message out on drugs. And that, to me, is our biggest social and societal problem, with 2 million Americans behind bars, 70 percent of them because of drug-related offenses, and with skyrocketing teen addiction rates and usage rates. Since this administration has taken office—again, people have to look up to folks. And you, as the Chief Health Officer, I would hope, would give us every bit of support relating to hard narcotics—heroin, cocaine, and the methamphetamine addiction that we're facing. I count on you for that.
Dr. SATCHER. Yes, you can. But I would also like to just say that I believe that the program that General McCaffrey is running, dealing with the use of illicit drugs, is the most aggressive in the history of this country, and we're seeing results.
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Mr. MICA. That's only as a result of the predecessor to Mr. Shays' subcommittee, Mr. Hatcher, who came forward to lead the subcommittee and restore the funds and——
Dr. SATCHER. I will be willing to give credit to as many people as possible.
Mr. MICA. Thank you.
Dr. SATCHER. I'm just happy to see that the program is working.
Mr. MICA. But we need you; you're our chief health spokesperson.
Mr. BURTON. The gentleman's time has expired. Ms. Scha-kowsky.
Ms. SCHAKOWSKY. Thank you, Mr. Chairman and Dr. Satcher. It's a pleasure to meet you. As a new Member of Congress, and someone who comes from a State legislature where we have had to make decisions about mandatory vaccination programs, I've been a supporter of those because I think, as we look around at the chief reasons that we've been able to extend life expectancy and improve the general health of our population, that one of the chief public health strategies has been these vaccination programs for polio and rubella and smallpox, et cetera. But I am concerned because under the strong leadership of my subcommittee chairman, Mr. Shays, I have been hearing a lot about the anthrax vaccine. And one of the things that came up is that there was very little research done on the different reactions that women may have to vaccines, that there's a different kind of immune system. And I'm wondering if there are gender-difference studies that are required, and if you're aware of this?
Dr. SATCHER. Let's ask Dr. Zoon from FDA.
Dr. ZOON. The original anthrax vaccine, which is the licensed vaccine we have today, was licensed back in 1970. And at that time there were not guidance documents available in general on inclusion of different populations. Subsequent to that though, there are guidances now that the FDA issues in drug development on the inclusion of different populations, of which women are a significant population. So I think that I cannot give you the breakdown of male and female that were in the original trial, and in fact, we had tried to go back and find some of those data, and they're not as easy to find in terms of the way they were recorded, based on the participants in those studies. But I think I would like to assure that right now, the information we do gather on vaccines do include different populations.
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Ms. SCHAKOWSKY. Well, let me ask you then about another population, which is hyper-reactors. That came up also in the anthrax discussions. And it may refer back to what the chairman was asking, that there are individuals whose bodies do produce adequate immune response with a lower dosage, for whom a higher dosage may pose a real problem. Is there any way to identify these individuals and provide alternative vaccination schedules or lower doses, et cetera, so that in the future we may be able to avoid some of these adverse reactions?
Dr. ZOON. In vaccine and other product development that is done today, there are—as Dr. Satcher alluded to in phase II studies of clinical development, these are generally dose ranging studies, where they look at the immune response, immunogenicity, as well as safety. I would have to go back to look at those original data, and I'm not sure that all that data would be available from the old studies, because those were done in the 1950's.
Ms. SCHAKOWSKY. Well, it seems to me that might be a direction that we need to go in.
Dr. SATCHER. Let me just say that's a very important question, and it is a very important subject of research. We need to be able to better predict how individuals will react to a vaccine much better than we can now. Now in the other medications too, I think you're right—Chairman Burton's example sounded like an anaphylactic-type reaction. I wouldn't know, unless I had the records, but that's what it sounded like. A very dangerous reaction; they can occur with any medication. I've seen them occur with the dye used for renal tests, and people can go into anaphylactic reaction soon after being exposed. We need better ways to predict who will respond in different ways to vaccines and different medications than we have now. That research has to continue.
Ms. SCHAKOWSKY. One other line of questions—let me just ask them, and then you can respond. The VAERS system, which is really a rather passive system of reporting adverse reactions—there were a lot of reasons again, in hearing the anthrax debate and testimony, to doubt the system, not the least of which was, it seemed some people from the Department of Defense were discouraged, some of the people in the Armed Services were discouraged from making those reports. But in a broader sense, how satisfied do you feel that we're getting an adequate representation? Some have projected maybe we only hear about 1 in 10 adverse reactions. And I wonder if you have thought about ways that we can improve the VAERS system so it's more useful to us in making these important decisions.
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Dr. SATCHER. Dr. Orenstein of CDC is here.
Dr. ORENSTEIN. Thank you very much. The VAERS system is really our warning system for problems. It generally can be very helpful, particularly at finding serious problems. The reporting efficiency of VAERS, which is what you're getting at, is how often are events reported. This varies with the severity of the reports. We find, for example, with regard to vaccine-associated polio that about 70 percent or so of the cases that are known get reported to VAERS. With regard to other serious events like seizures, we generally see about 25 to 40 percent of what we would expect to be reported. When we deal with more mild events, or events that require, let's say, a laboratory test to document an abnormality, the reporting efficiency goes down substantially. But it's very difficult with any passive system to get a feel for how much is out there and whether it's causing something, because many of the illnesses that occur after vaccination also occur in the absence of vaccination. For example, in 1990, there were over 5,000 deaths from Sudden Infant Death Syndrome—children who died from Sudden Infant Death Syndrome, children who were well, most of them, and then were found as crib deaths, or may have had some mild illness beforehand. We would expect when we vaccinate large numbers of children—and we're talking about a birth cohort of 4 million children—that you're going to get deaths after vaccination. The real issue is, is the clinical syndrome different, or is it occurring more frequently than expected? And that's when we use our Vaccine Safety Datalink. The Vaccine Safety Datalink is a project where we fund independent researchers in 4 large managed-care organizations, in the Western United States, who have access to all of the medical records, so they can determine the expected incidence in the absence of vaccination to compare with the incidence in the presence of vaccination. We need to do more with VAERS. And I think that we are not satisfied with where VAERS is. Each year we send out a letter to 200,000 individuals to encourage reporting to VAERS. We've put in our standards for pediatric immunization practices that we want reported to VAERS, serious events even if you don't think that it's related to vaccination. We've done a lot; we need to do more. And I think that what you're pointing out is some of the weaknesses to VAERS.
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Mr. BURTON. The gentlelady's time's