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Barbara Loe Fisher
Co-Founder & President
National Vaccine Information Center
Institute of Medicine Vaccine Safety Forum
November 6, 1995

In 1982, when Kathi Williams and Jeff Schwartz and I got together with a small group of parents in the Washington, D.C. area and talked about setting up a national organization that would be dedicated to the prevention of vaccine injuries and deaths through public education, one of the first goals we listed was to obtain an improved vaccine adverse event reporting system. All of us had children who had been injured by the DPT vaccine. We knew that if our pediatricians and we, ourselves, had been better educated about vaccine high risk factors and side effects, there was a good chance our children would not have been injured. We believed then, and continue to believe today, that vaccine adverse event reporting and record keeping is the key to increased knowledge, better education and prevention of vaccine associated deaths and injuries.

     So when we helped to create and pass the National Childhood Vaccine Injury Act of 1986, one of the five vaccine safety provisions that we insisted be at the heart of that law was the centralization of the government's adverse event reporting system. Up until that point, private physicians were reporting to the FDA and public health clinic physicians were reporting to the CDC. Our hope was that a centralized system, which in fact became the VAERS system as we know it today, would allow better detection and response to vaccine adverse event reports.

     In order to achieve better detection and response, we also asked for a vaccine safety provision in the law that would legally require doctors to report hospitalizations, deaths and injuries following vaccination. Up until that time, there was a requirement for public health doctors but no formal requirement for private doctors to do that.

     And we supported the provision that doctors give parents information about vaccine benefits and risks prior to vaccination and that doctors keep a permanent record of vaccinations given, including the manufacturers name and lot number. Up until that time, there were no requirements for doctors to do that and we thought that the recordkeeping requirement would be especially helpful in tracing and quickly removing from the market especially reactive lots of vaccines.

     It was our hope that these vaccine safety provisions would mean that all doctors, not just 10 percent of them, would report adverse events following vaccination and that the VAERS system would follow up on each report and we would have a greater understanding of the nature and scope of adverse events associated with vaccination.

     Most of our hopes and dreams for increased reporting, better education and prevention of vaccine deaths and injuries have not been realized through that law. And, again, as I said this morning, I believe that is because adverse event reporting and data collection will continue to remain flawed no matter what mechanism is put in place if there continues to be the presumption, especially by vaccine providers and government officials, that the case reports of deaths and injuries following vaccination are only temporally, not causally related to vaccination. No, I am not suggesting that there be a presumption that every adverse event case report is causally related to vaccination, although if your goal really is detection of vaccine adverse events then it is probably better to prove the vaccine did not play a role rather than to conveniently assume the vaccine did not play a role.

     I believe this is a valid approach because the act of vaccination is a medical intervention that is carried out on healthy children who are required by law to participate. The requirements for adverse event reporting and data collection should be the most stringent and carefully met of all the biological products that are licensed for public use. A well funded, well run, well staffed vaccine adverse event reporting and data collection system should be at the very top of the national disease control strategy plan. And at every step along the way - from pre-licensing to post marketing surveillance - there should be the scientifically responsible presumption, at least, that a new or old vaccine has the potential to cause health problems that have not yet been detected because of the limits of human intelligence and scientific technology.

     These, then, are the steps The National Vaccine Information Center supports to improve vaccine adverse event reporting and data collection:

1. Promote the introduction into medical school curriculums a course on vaccines, risks, benefits, side effects, adverse event reporting and education of parents so physicians can be better partners with parents in preventing vaccine associated deaths and injuries with the goal of raising physician reporting rates from 10 percent to 100 percent.

2. Commit HHHS funds to a public education campaign to educate physicians and the public about the importance of screening children for high risk factors, monitoring children after vaccination and reporting adverse events following vaccination to the government. In 1991 I presented a report to the National Vaccine Advisory Committee detailing 61 cases of death and injury following vaccination. Only 8 physicians out of the 61 cases ever made a report to VAERS, most of them telling parents that vaccines don't cause death or injury because it was all just a coincidence so there is no need to report. Set up an 800 telephone number for parents to report if physicians refuse to report. The National Vaccine Information Center helps parents every week report reactions that their physicians will not report.

3. Make vaccine adverse event reporting a legal requirement for doctors with penalties attached for failing to report. Like mandatory vaccination laws which keep children out of school for failing to be vaccinated, doctors should be prevented from administering vaccines if they refuse to report hospitalizations, deaths and injuries following vaccination.

4. Commit HHHS funds to the more efficient operation of VAERS, including increased staffing so that the VAERS operation is a model for every country in the world to follow. India, which delivers vaccines 25 million children every year, has an adverse event reporting system that includes an on-site investigation and follow-up by a public health team within 48 hours of every death and injury reported following vaccination. If a poor country like India can do it, this country should be able to do it.

5. The National Vaccine Information supports the concept of large linked databases for data collection on adverse events only if these linked databases are not used as a club to force vaccinations on individuals, who choose not to be vaccinated, or to exclude these individuals from health insurance coverage or to invade the privacy of individuals by making health information, including vaccination status, a matter of public record. We do not believe that analysis of large linked databases can or should replace the valuable information that can be learned from an efficiently operating VAERS system dedicated solely to the collection and analysis of reports of vaccine adverse events.

     In summary, we believe that improved adverse event reporting and data collection will only occur when it is made an official public health policy priority and government health agencies do more to educate the public and vaccine providers about the importance of reporting and collecting data on adverse events following vaccination.



Barbara Loe Fisher
Co-Founder & President
National Vaccine Information Center
Institute of Medicine Vaccine Safety Forum
November 6, 1995


     I think I can sum up the position of the National Vaccine Information Center on the subject of improving methodologies for detecting vaccine adverse events in two sentences: If you don't believe they occur, you won't look for them. If you don't look for them, you won't find them.

     One handout developed by the National Vaccine Program at the CDC last year suggested to inquiring parents that the biological effects of injecting viral and bacterial antigens into the human body are identical to the biological effects of ingesting milk in the human body for the purposes of calculating the risk of injury or death on any given day. It is difficult to reconcile that kind of unscientific rationalization, used to dismiss the known and unknown biological effects of vaccines on the body and support the nonexistence of vaccine injuries and deaths, with any hope of improving adverse event detection methodologies.

     It is this kind of cavalier attitude which fails to treat the inherent capability of multiple viral and bacterial antigens to have a profound impact on the immune system that I suspect caused the Pentagon to inject U.S. troops heading for the Gulf War with multiple vaccines, including experimental ones, without a second thought. Yet there are signs that vaccine adverse event detection may be heading into a new era as a microbiologist specializing in the immune system prepares to testify at the Presidential Advisory Committee on Gulf War Veterans Illnesses tomorrow that multiple vaccinations did, indeed, contribute to the veterans subsequent health problems by weakening their immune systems and making them more susceptible to chemical and biological agents they were exposed to during the War.

     Likewise, I believe there is hope that vaccine adverse event detection may be heading into a new era because of researchers who are investigating how vaccines may be contributing to the development of autoimmune, neurological and psychiatric disorders in some individuals. The new field of neuroimmunology will no doubt one day give us many answers to questions about how vaccines work in the body but, in the meantime, the success of detection methodologies are entirely dependent upon the willingness of those doing the detecting to believe in the plausibility of cause and effect and explore all possibilities.

So, because efficient detection is inextricably linked with acceptance of the possibility of cause and effect by both reporters and data collectors, it would seem that any efficient detection system would have to first count on a high reporting rate by private physicians, public health clinics and emergency rooms of adverse events occurring within 30 days of vaccination. Parents have to be educated by physicians about how to recognize negative changes in their children's physical, mental and emotional health following vaccination and to seek immediate medical attention as well as report these changes to doctors so doctors can, in turn, report them to VAERS. If causality continues to be erroneously determined by providers at the reporting level, there will be no way to improve detection of vaccine adverse events.

     Once a death, hospitalization or injury is reported following vaccination, data collectors must also be ready to accept the possibility of cause and effect. Ideally there should be a 48-hour on-site follow-up and investigation of the report as occurs in India. If the patient is an adult, he or she should be interviewed. If the patient is a child, the parents should be interviewed. Deaths labeled SIDS, especially when they occur under a month of age, should be suspect and thoroughly investigated. A mechanism should be developed to monitor the outcome of serious events such as seizures with long term follow-up at six months, a year and two years to gather data on permanent damage.

     But mechanisms for detecting adverse events which occur within 30 days of vaccination are different from those which must be set up to detect health problems which have a more subtle or delayed onset or which do not become measurable until children attend school, such as is the case with learning disabilities. This kind of detection would require the kind of retrospective evaluation of historical data that Dr. Barthelow Classen has described as well as the creation of prospective studies which include as controls unvaccinated individuals compared to vaccinated individuals over a period of 10 or 20 years. Expensive? Yes. Logistically difficult? Yes. But not impossible if we really want to find out if vaccines are contributing to the development of immune and neurological damage which does not become apparent until later in life.

     An additional source of information for detection of adverse events is analysis of VAERS data. For example, between May 1993 and September 1994, 482 adverse events were reported following the administration of the newly licensed DPTH vaccine. Most were in children under a year of age and 50 percent of the reported events occurred within 24 hours and more than 80 percent within 48 hours of vaccination. 175 children ended up in the emergency room, 56 had convulsions, 78 were hospitalized, 17 did not recover and 35 died.

     And when you take a closer look at individual reports, you see identifiable patterns of classic vaccine reactions similar to those described in the medical literature for decades, including babies screaming and shrieking uncontrollably for hours and hours. One infant, who had been injected with DPT, HIB, hepatitis B and OPV at six weeks old, screamed every day from the day after vaccination until he died two weeks later and his death was written off as SIDS. Another four month old baby had his first afebrile grand mal seizure within 24 hours of his DPT/HIB/OPV vaccinations just like his sibling did at five months when he was vaccinated. The same patterns are seen throughout the more than 40,000 reports made so far to VAERS — reports that represent only 10 percent of what is occurring.

     This is valuable data. It could be used to not only identify patterns which need further investigation but also to help identify categories of high risk children who should be screened out of the mass vaccination program. The rush to develop and recommend for universal use multiple viral and bacterial vaccines to be given simultaneously should make the development of failsafe detection methodologies a priority in any credible mass vaccination program.


Barbara Loe Fisher
Co-Founder & President
National Vaccine Information Center
Institute of Medicine Vaccine Safety Forum
November 6, 1995

Once the vaccine associated adverse event has been detected, there can be no prevention unless the system responds in appropriate ways. For those of us whose children have paid the price for sometimes dangerous vaccine policies that have failed to identify and screen out high risk children, the issue of how the system has refused to appropriately respond to the reality of vaccine deaths and injuries is a very painful one.

   In our view, there can be no greater responsibility on the part of doctors and public health officials than for them to fulfill their promise to care about and protect the health of all the people. We do not expect them to play politics with our lives and implement official policies that place a higher value on the life of a child who suffers from a disease than is placed on the life of a child who suffers from a vaccine reaction. And we don't expect them to lobby Congress for money to be spent on promotion of vaccination and enforcement of mandatory vaccination laws while no money is obtained or spent to detect and prevent vaccine injuries and deaths. And we don't expect them to participate in the kind of destructive action which, last year, resulted in the gutting of the federal vaccine injury compensation program which we fought so hard to provide for victims of vaccine damage.

     No matter how hard you try to make parents believe it was our patriotic duty to sacrifice our children in the war on disease, you will never succeed because you have failed to respond to what happened to our children as either caring physicians or good scientists.

     Because it is too late for our children, the hope that we can do something to prevent this from happening to others is all we have left. And so parents of vaccine injured children will continue to come forward and demand that public health officials respond appropriately to vaccine injuries and deaths so that other children won't have to suffer like ours have.

     We sincerely hope that this Vaccine Safety Forum will mark the end of protection of the status quo and the beginning of meaningful responses to the detection of vaccine adverse events.

1. Make the funding of credible vaccine adverse event research a priority. There is more than enough taxpayer money being spent on vaccine development and promotion. Where are the government funded independently run studies to detect vaccine adverse events or identify high risk individuals or develop therapies to help vaccine injured individuals recover their health?

2. Review and update FDA regulations for vaccine safety screening to reflect the state of the art in scientific technology so that vaccines are being tested for adventitious agents as well as toxicity that may be related to additives such as aluminum and formaldehyde;

3. Create large prospective studies to evaluate the impact of multiple vaccines on the human immune system over time by comparing groups of vaccinated individuals against groups of unvaccinated individuals. Prove these vaccines are safe and effective so an Institute of Medicine committee evaluating proof of cause and effect in the medical literature doesn't have to come up with the unfortunate conclusion time and time and time again that there is not enough evidence in the medical literature to make a determination whether a vaccine does or does not cause a particular health problem.

     In summary, simply be good scientists and physicians and, when there are clear indications that vaccines either singly or in combination may be causing health problems that have not yet been evaluated, don't turn away and pretend it isn't happening. Please do everything in your power to respond appropriately to protect children and adults from suffering vaccine associated death and damage. As public health officials that should be as much a part of your mission as preventing infectious disease-associated death and damage.

     We will be watching you and making sure that if you don't, the public will know about it so they can take steps to protect themselves. Because that is our mission.


Barbara Loe Fisher
Co-Founder & President
National Vaccine Information Center
Institute of Medicine Vaccine Safety Forum
November 6, 1995

     With the advent of 45 new vaccines, particularly the new supervaccine that reportedly will contain raw DNA from 40 different kinds of bacteria and viruses that will be squirted into the mouths of all newborn infants and time released in the body throughout life, we must be absolutely sure that the vaccine policies which we endorse today do not weaken the immune and neurological systems of and cause negative genetic changes in whole generations of children tomorrow. We must be scientifically certain that it is safe and effective to vaccinate babies or military recruits or pregnant women or sick people in nursing homes with so many live viral and killed bacterial simultaneously – or that it is safe and effective to vaccinate sick children or children with family histories of vaccine reactions or immune system disorders, which is the current policy.

     The only way we can effectively detect and respond to vaccine adverse events is to have the will and the commitment to ask the hard questions and find out the truth about how vaccines impact on the body. And then we must have the will and commitment to act responsibly on our conclusions in order to protect the public health. To do anything less, in our view, is morally unacceptable.

     Those of us who have worked for the past 14 years for meaningful reform of the mass vaccination system to make it safer, stand ready to work with you in any way we can to achieve that goal as long as we know that what is being done is not simply window dressing or maintaining the status quo or playing politics as usual. The time has come to take action before it is too late for many other children, who have no choice and have no voice, in a war on disease that is supposed to save lives and not take them.

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