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Hepatitis B




REP. MICA: Thank you for your testimony. And we'll now hear from Barbara Loe Fisher, who is president of the National Vaccine Information Center. You're recognized.

MS. BARBARA LOE FISHER: Thank you, Mr. Chairman. My name is Barbara Loe Fisher. And I am the president of the National Vaccine Information Center, formerly known as Dissatisfied Parents Together, which I co-founded in 1982 with parents whose children have been injured or died from the adverse effect of the DPT vaccine. Our non-profit organization represents tens of thousands of Americans, including families affected by vaccine reactions, healthcare professionals and parents. We're working to prevent vaccine injuries and deaths through public education and to institute safety and informed consent protection in vaccination programs. Some of us worked with Congress in the early 1980s in a bipartisan effort to help create and pass the historic National Childhood Vaccine Injury Act of 1986. One of our main goals was met in 1996, when a less reactive pertussis vaccine was licensed.

I want to thank you, Representative Mica, for having the courage and the vision to hold this hearing. As you have heard, vaccine safety is an issue charged with emotion because whether death or disability is caused by a disease or by a vaccine, the pain is exactly the same. And when children are suffering and their parents are grieving for them, there are no words to make the pain go away.

I think what's important, at the end of the day, is to acknowledge that we are all here because we love our children and we want to protect them from harm. And we need to find ways to protect them from vaccine injury and death while we create public health policies designed to protect them from the ravages of disease. There is no reason why we can't accomplish both of these goals if we embrace the principal that every child's life is important and no child is expendable.

The National Vaccine Information Center has received hundreds of reports of injuries and deaths following hepatitis B vaccination. There is a clear pattern to hepatitis B vaccine reaction symptoms, just as there was a clear pattern associated with DPT vaccine reactions. But unlike DPT vaccine, where most symptoms usually occur within a few days of vaccination, hepatitis B vaccine reaction symptoms can take many days or weeks to develop and include: fevers that come and go, open skin lesions and rashes, severe joint pain and head pain, loss of vision, muscle strength and memory and crushing, debilitating fatigue, which leads to chronic disability.

We have had reports of liver cancer developing in small children following hepatitis B vaccination. There are families with two or three members who have become disabled after hepatitis shots. Tragically, for newborns and babies under two months of age, a hepatitis B vaccine reaction can end in death. When parents look to the medical literature for answers, they find few studies looking into hepatitis B vaccine reaction reports. None deal with newborns. Most of the studies look at vaccine efficacy, not vaccine safety.

A 1994 study by the Institute of Medicine, mandated by Congress under the National Childhood Vaccine Injury Act, found that there have been no large controlled observational studies or clinical trials investigating clinical reports of arthritis, Guillain-Barre Syndrome, transverse myelitis, optic neuritis, multiple sclerosis and other central demyelinating disease, or sudden infant death syndrome after hepatitis B vaccination.

What then will be the scientific criteria used to either award or deny children compensation for their hepatitis B vaccine-associated injuries under the Federal Vaccine Injury Compensation Program? Serious questions remain about the quality and quantity of the scientific evidence used by federal health agencies to license this vaccine for use in children and, in 1991, to recommend that all newborns receive their first dose just 12 hours after they take their first breath.

Last Tuesday, I filed two detailed Freedom of Information Act requests with the FDA and CDC to make this information a matter of public record. We hope this will lead to better public understanding of current standards used to license this first recombinant DNA vaccine and then recommend all newborn infants and children be required to use it.

I will provide copies of what I receive from the FDA and CDC to you. And I submit my FOIA requests as part of the record.

Families with vaccine injured children are trying to cope with the knowledge that they tried to do the right thing. They did what public health officials and doctors told them to do. Most of these children were exceptionally bright, healthy and robust at the time of vaccination. They received a hepatitis B shot and something went horribly wrong. In some cases, they were coerced into having more hepatitis B shots, even in the face of a severe reaction, because the push for a 100 percent vaccination rate has all but eliminated the right to informed consent, when it comes to vaccination in America.

This information sheet on hepatitis B, produced by the Center for Disease Control in compliance with safety provisions in the National Childhood Vaccine Injury Act does not come close to meeting the "informed" part of informed consent. Parents who want to make educated hepatitis B vaccine decisions for their children often are threatened when they even ask to delay vaccination if the child is sick. The lack of informed consent protections in mass vaccination programs is leading to fear and mistrust of the whole vaccination system.

Bottom line: what we are hearing parents tell us is, "Show us the science and give us a choice." So we come before you today to ask for: first, an investigation into federal health agency licensing and policy making standards applied to the recombinant hepatitis B vaccine; and second, consideration of special congressional appropriations to fund non-government, non-industry conducted scientific research to identify genetic and other high-risk factors for reacting to hepatitis B vaccine; and third, the institution of informed consent protections in current vaccine policies.

Again, thank you, Chairman Mica and members of the committee for demonstrating leadership by acknowledging these vaccine safety concerns, which is the first important step toward addressing them in a way that will save lives. You have listened. And we are very grateful.

REP. MICA: I thank you for your testimony. Ms. Fisher, you just testified that you felt that the vaccine information sheets handed out on hepatitis B are inadequate, as far as disclosing risks and benefits. What more can we do? Or what more should we do? Or what information should be included would be my first question. And then the second is: there are 16 states now that do allow sort of an opt-out. How would you go about changing that since you have a state- to-state requirement?

MS. FISHER: Well, first I'd just like to read that the mild problems that are listed on this are soreness -- at the injection site -- and mild to moderate fever. The only severe problems listed are serious allergic reactions. And it says, "very rare." There is no description here of the kinds of symptoms that we have heard today.

REP. MICA: So that's all that's on there, as far as severe?

MS. FISHER: Right. Is serious allergic reaction, which is -- they say -- very rare. And they describe serious allergic reaction as, "difficulty breathing, hoarseness, wheezing, hives, paleness, weakness," et cetera. That's a symptom of anaphylaxis. Now anaphylaxis occurs within a very short time period after a vaccination is given. So the people who testified today that told you about these symptoms, they would be candidates for revaccination, according to this vaccination sheet. And in fact, this is part of the problem.

We have heard from so many people who are being forced and threatened that they have to go forward with the hepatitis B vaccinations, even after they've experienced fevers that come and go, skin lesions all over their body, joint -- severe joint pain, symptoms -- autoimmune symptoms and neurological symptoms. And they're being ignored. And they're being -- because there is this push for 100 percent vaccination rate, basically, these people are not being screened out.

And they're not being given full information and the doctors aren't being given full information about what to look for after a hepatitis B vaccination. I mean, the manufacturers, frankly, in their product insert have more of a description about some of the reactions that have been associated with the vaccine than this sheet.

And what I am concerned about is, if this sheet was mandated under this compensation program, and we fought very hard for -- the parents who were involved in the creation of the system fought -- of which I was one -- fought very hard for the safety provisions. And one of the safety provisions was that parents would get proper benefit and risk information prior to vaccination so they would know how to make informed decisions, number one, and also so that they could monitor their children following vaccination for signs of reactions so that revaccination would not take place and more serious reactions would occur that would end in disability and death. And we feel this is woefully inadequate.

REP. MICA: What about the question of inadequate research that has been raised here today? Do you all have a position on that?

MS. FISHER: Well, first of all, there are two kinds of research that need to be done: basic science research that would look at biological mechanisms for hepatitis B vaccine-induced injury or death, which would include looking at what happens at the cellular and molecular level in the human body after this vaccine is given.

The other concern is that this vaccine is often given with other vaccines. And part -- my Freedom of Information Act request to CDC and FDA goes over the different studies that we would like to see that hopefully were done before this vaccine was recommended in 1991 for universal use in all children, particularly newborns. And that would include studies -- include such things as how many children were involved in these studies, the time periods for follow-up of vaccine adverse events.

In the manufacturer's product insert, they list four to five day follow-up for studies that were used to license this vaccine. And yet, the reactions we're seeing are taking sometimes longer than four to five days to occur.

So have we missed in those studies all of these people that testified here today? How good are these studies? Did they include racial diversity of infants and children enrolled in them, particularly in light of what Dr. Dunbar said. If we have genetic predisposition here, if there are certain genotypes who are more susceptible to reaction to this vaccine than others, and we've only done these studies in certain genetic populations, then we don't really know what's going on.

And when we give this vaccine and mandate it and we haven't done the studies prior, it is an experiment. And we can't afford to do that. And so I think these FOIA requests are very important to take a look at not only how was this vaccine licensed and policy made for it, but also is the system that we use good enough? Or should we be raising these standards?

REP. MICA: One of the other questions that's come up in this hearing and also prior to this hearing is a review of the '86 law and the access to compensation through that law for those who have some type of vaccine-related adverse reaction. You were involved in some of that -- the development of that legislation and, I guess, have monitored it, Ms. Fisher.

MS. FISHER: Mmm-hmm. (Affirmation.)

REP. MICA: How do you feel about how that's working?

MS. FISHER: We are extremely disappointed in how this compensation program is being implemented. In fact, it's tragic. Those of us who came to the table in good faith in the early 1980s to work with Congress and work with the vaccine manufacturers and work with the American Academy of Pediatrics feel like we have been betrayed because three out of four children are being turned away from this system and because all the work we did -- for example, set up the table of compensable events for DPT vaccine injury and death -- so that this system wouldn't be like a child and you wouldn't have to show the same kind of proof and it wouldn't be traumatic and it wouldn't be expensive.

HHS came in after that law was passed. And they came in and they gutted it. They gutted the provision to have compensation for DPT vaccine injuries. And there is almost nothing that's now presumed to be associated with DPT vaccine. And we were promised that this would be a fair and expedited system, that it would be a fair alternative to the tort system. And we feel like we have been betrayed.

And the fact that there is $1 billion in the trust fund is a disgrace because there are children out there who need that money because they have done what they were told to do by doctors and public health officials. And they're out there coping and suffering with vaccine injuries. And nobody is helping them because all the resources of HHS and Justice are brought against these plaintiffs. Justice represents Secretary Shalala in these cases. And it's not a level playing field.

And I think it is -- we absolutely oppose the using of any of that $1 billion for anything other than compensating these children. The money for these studies needs to come out of the billions of dollars that's being given to HHS to fund new vaccine development and to set up tracking systems to track children in order to enforce vaccination. And I -- and to promote vaccination.

We have got to do a better job of looking at the existing vaccines we have before we put new vaccines on the market. And we've got to do a better job of taking care of the children who pay the price, who are the casualties of our public health programs. Our children deserve no less.

MS. FISHER: I'd just like to say something to you. (Directed to another member of the panel)

REP. MICA: Ms. Fisher?

MS. FISHER: And I thank you very much for supporting the ethical concept of informed consent. I think this is really, really important because, as you know, as a parent you love your child more than anyone ever could. And when a child dies from a disease or from a vaccine or is hurt, it's you -- it's the mother and the father -- who lives with the consequences of that. And that's why the ethical principle of informed consent that is applied to every other medical procedure in this country that carries a risk of injury or death is so important to be also applied to vaccination.

We're not calling for the elimination of vaccine laws. What we're calling for is flexibility within the laws, a human application of the laws. We're asking for the right to exercise conscious belief exemption if we believe our children are at great risk of having a reaction.

I come from a family of serious autoimmune disorders. My mother has lupus. I have one child who has reacted and has had disabilities from a vaccination.

How can the state possibly ask me to take a risk with another -- a vaccine like this one when I know that my children could either die or have autoimmune disorders from getting this vaccine? Parents have got to have the right to have the information and then make informed decisions for their children.

Every parent wants their child to be healthy. They don't want their child to die from a disease or a vaccine. We've got to give parents more credit. We've got to believe in them. They love their children.

REP. MICA: Ms. Fisher, you had advocated several specific recommendations. One was licensing standards, increased licensing standards. Is that correct?

MS. FISHER: That's right.

REP. MICA: And what are you talking about there, specifically?

MS. FISHER: Well, the reason I filed the FOIAs -- very detailed FOIAs -- with CDC and FDA on this is because I was hoping that we would -- I don't know the answer to that question. And I was hoping that the committee would help us get those answers and do a review of the licensing procedures and of the policymaking procedures.

REP. MICA: The other item you recommended was non-government studies. But if there -- if it's a recommendation to us, it's going to involve government monies. And we have a pretty -- well, we have a pretty complex manner of funding studies that was made that way to keep the studies independent and from outside undue influence. How can we have a non-governmental study financed by government? What -- I mean, do you have something specific?

MS. FISHER: I understand there are -- I am not real knowledgeable.

REP. MICA: And then get an independent study. I think you're questioning the independence of these studies or -- again, I just --

MS. FISHER: Right.

REP. MICA: I don't see how we can accomplish that recommendation since it's government funding the study.

MS. FISHER: I understand that --

REP. MICA: You have some protection and barriers.

MS. FISHER: Right. I'm not knowledgeable about the grant structure at NIH, for example. But I understand there are some grants which are more independent. They are given to scientists and they are more independent from control by the CDC or by NIH. I don't know exactly what they're called. But I understand that there are grants available where you -- the problem, though, is who is going to be on the peer review committee?

Bonnie Dunbar has applied twice for an NIH grant to look at genetic predisposition, the hepatitis B vaccine reactions. I don't know why she was turned down. She has been a vaccine developer for 26 years. She knows methodology. She knows what she's doing.

You don't see these grants being given out to scientists who want to look at adverse effects. The grants are given out to develop new vaccines and to look at efficacy of vaccines, but not to look at clinical reports of adverse events.

And so I don't have all the answers. I only know that we -- the public is very suspicious of having industry and government be in total control of these scientific studies. And so if there was a way to get the funding and then have some autonomy. So yes, of course, to publish you have to be peer reviewed. You have to go through a peer review process.

So that's -- I don't have the answers. But I'd be happy to work with the committee to find one.

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