[back]

Testimony of Barbara Loe Fisher
Co-Founder & President  National Vaccine Information Center, U.S. House Government Reform Committee - August 3, 1999  "Vaccines: Finding a Balance Between Public Safety and Personal Choice"

        Thank you, Chairman Burton for calling this hearing on a national health issue which affects the life of every American family.  As the mother of a vaccine injured child and co-founder and president of the parent organization that launched the vaccine safety and informed consent movement in America 17 years ago, I welcome this opportunity to voice the concerns of tens of thousands of parents, grandparents, doctors and health care professionals who have contacted the National Vaccine Information Center during the past two decades to obtain information about diseases and vaccines and to report vaccine reactions.

   We support the development of the safest, most effective vaccines that can be produced and the development of safe, effective vaccine policies.  One of our proudest accomplishments is the role we played in obtaining a safer pertussis vaccine for American babies, which was licensed by the FDA in 1996. Our goal is to prevent vaccine injuries and deaths through public education and through the institution of informed consent protections in the mass vaccination system. We support the right of Americans to have full access to information about the risks and complications of both diseases and vaccines and the right to make informed, voluntary vaccination decisions.

   In 1982, when I joined with Kathi Williams, Jeff Schwartz and other parents of DPT vaccine injured children to begin this work, my first-born son, Christian, was just a toddler. Chris had started saying words at seven months and was speaking in full sentences by age two. At the time of his fourth DPT shot, when he was two and a half years old, he knew the upper and lower case alphabet, numbers up to 20, and was identifying words in the books we read together.  His ability to concentrate was unusual for a toddler and one doctors told me he was gifted.

   Within four hours of his fourth DPT and oral polio vaccinations, I walked into his room and found him sitting in a chair staring straight ahead, his face pale and drawn.  I watched his eyelids flutter, his eyes roll back, and his head fall to his shoulder, and I remember thinking that I had never seen him suddenly fall asleep sitting up before.  Not knowing that what I had just witnessed was a convulsion and collapse shock, two classic DPT vaccine reactions, I also did not know that his deep sleep for nearly six hours that afternoon and into the evening was not just a very long nap, it was a state of unconsciousness.  Like most mothers, I knew absolutely nothing about vaccine reactions and so I did not know that my son was in danger of dying that day.

   And in the days and weeks after that shot, when Chris no longer could identify the alphabet or numbers and had no interest in his beloved books, when he never smiled anymore, could not concentrate for more than a few seconds at a time, would frustrate easily and cry for no reason; when he was so sick with continuous respiratory, ear and throat infections and unrelenting diarrhea that left him so weak and emaciated that one specialist thought he might have cystic fibrosis or celiac disease; when Chris became a totally different child physically, mentally and emotionally, I believed the pediatricians when they told me it was just a stage he was going through and not to worry about it.

   Christian never returned to the child he was before the vaccination that changed his life forever.  Although his physical strength returned after several years of alternative health care therapies, he was eventually diagnosed with minimal brain dysfunction that took the form of multiple learning disabilities and attention deficit disorder. Chris remained in a self contained classroom for learning disabled children throughout his public school education.

   Chris was lucky.  He could have died or been left profoundly mentally retarded; with medication resistant seizures, paralyzed, autistic, arthritic or suffering from more crippling forms of vaccine damage.  And yet, what happened to my son leaves a larger question unanswered:  How many of the nearly three million learning disabled and ADD children filling the special education classrooms in America today, can trace their learning and behavior disorders back to vaccine reactions that were not recognized by their mothers or their pediatricians? How many babies have a vaccine reaction in their cribs in the middle of the night and no one ever knows why they suddenly die, or stop developing normally, or change personality or are one day diagnosed with behavior and learning disorders?

   If I had not walked into Chris's room when I did that day and witnessed the symptoms of a DPT vaccine reaction that I would later find described in clinical detail in the pages of more than 50 years of medical literature, I would never have known why my happy-go-lucky, healthy, precocious toddler changed forever one day in the fall of 1980 after I took him to his pediatrician for routine vaccinations.

   So in 1983 when the U.S. vaccine manufacturers threatened to stop producing vaccines unless they were protected from liability and members of Congress asked us to work in a bi-partisan effort to develop and pass the historic National Childhood Vaccine Injury Act of 1986, we knew it was just as important to institute vaccine safety provisions in the law as it was to create a system for providing financial assistance to families whose children are injured by vaccines.  We fought for and won provisions in that 1986 law to require doctors for the first time to give parents information on vaccine benefits and risks prior to vaccinating a child; and to require doctors to record the vaccine manufacturer's name and vaccine lot number in the child's permanent medical record as well as to record and report hospitalizations, injuries and deaths following vaccination to a centralized federal Vaccine Adverse Events Reporting System. In addition, we won a provision for the Institute of Medicine at the National Academy of Sciences to review the medical literature for evidence that vaccines can cause immune and brain dysfunction.

   In the compensation portion of the law, parents were promised that federal compensation would provide an expedited, no-fault, fair and just alternative to a lawsuit for families of vaccine injured children. We worked hard on a Table of Compensable Events that listed clinical symptoms of a DPT vaccine reaction that would presume the child's disability or death was caused by the vaccine in the absence of compelling evidence to the contrary. The Departments of Health and Human Services and Justice opposed the bill to the end.  Yet, through rule making authority, they were given the most power in the end to change everything after the law was passed.

   Today, the bitter truth is that, although more than one billion dollars has been paid out to some 1,000 families whose loved ones have been harmed by vaccines, three out of four vaccine victims are turned away.  Although parents pay a surcharge on each vaccine their child gets and the money from that surcharge is put into the vaccine injury trust fund, there is more than one billion dollars languishing in the trust fund because DHHS and Justice pay expert witnesses and lawyers to fight every vaccine injury claim. And to make it easier for compensation to be denied to vaccine injured children, under rule making authority these
federal agencies gutted the Table of Compensable Events in 1995 and arbitrarily rewrote the definition of encephalopathy (brain dysfunction) that had been used by medicine decades.

   We tried to stop the destruction of the Table of Compensable Events by bringing suit in federal court, but we lost. So, today, almost no cases of brain damage following DPT vaccination are presumed to be caused by the vaccine. The vaccine injury compensation program has been turned into the trial we were promised it would not be, where causation in fact must be proven in almost every case and vaccine victims and their lawyers are left begging for compensation from federal health agencies holding all the cards. The federal compensation system that we were told would be "simple justice for children," has become a cruel joke, a sad commentary on a national health policy that forces children to take the risk and then leaves many families to cope with the catastrophic consequences on their own when the risk turns out to be 100 percent.

   Under the 1986 law, DHHS was supposed to produce information brochures describing each vaccine's benefits and risks so doctors could educate parents before vaccination of their children took place.  We worked for several years with DHHS on these brochures but DHHS eventually got an amendment to the law to reduce the brochures to a one page information sheet that does not contain enough information to adequately inform parents about vaccine risks or how to monitor their child following vaccination for signs that a reaction is occurring. Many parents report to us that their doctors do not give them these information sheets or any kind of information before vaccinating their children.  In fact, parents continue to report to us that pediatricians get hostile and defensive when questioned about vaccine risks and some families have been denied routine medical care if they attempt to make vaccination choices.

   Under the 1986 law, doctors are supposed to report significant health problems following vaccination and, although about 12,000 reports of hospitalizations, injuries and deaths are filed annually with the Vaccine Adverse Events Reporting System (VAERS), the law provides no sanctions against doctors for not reporting.  The National Vaccine Information Center often assists parents in reporting their child's vaccine reaction to VAERS when doctors refuse to report and for the past decade we have provided independent oversight on vaccine-associated adverse events being reported to VAERS through the Freedom of Information Act.

   Former FDA Commissioner David Kessler estimated in a 1993 article in the Journal of the American Medical Association that fewer than 1 percent of all doctors report injuries and deaths following the administration of prescription drugs. This estimate may be even lower for vaccines. In one survey that our organization conducted in New York in 1994, only 1 doctor in 40 reported to VAERS.

   So, instead of the 12,000 reports that VAERS receives every year, there could be more than 1.2 million vaccine-associated health problems following vaccination every year and no way to evaluate how many of these are causally related to vaccinations or end in death or disability.  Even with substantial underreporting, one of the newest vaccines - hepatitis B - has generated more than 25,000 reports to VAERS with 1 in 3 adverse events ending in a trip to the emergency room, a life-threatening episode, hospitalization or permanent disability. For children under 14, one in two hepatitis B vaccine adverse event reports fall into this serious category.

   The task of properly evaluating the possible negative impact of a given vaccine on the public health is complicated by the CDC policy of recommending simultaneous administration of multiple vaccines to children, a policy which has also been applied to adults, including soldiers heading for the Gulf War.  As was illustrated by the recent rollback of the CDC policy of vaccinating all newborn infants with hepatitis B vaccine at birth, the cumulative effects of mercury contained in many childhood vaccines is just one possible safety hazard connected with the practice of multiple vaccination of babies whose immune and neurological systems are still developing.  Just two weeks ago, a vaccine manufacturer announced it was ready to market a 5 in 1 shot - five vaccines in one shot. When a reaction occurs after that shot, who can tell which vaccine it was?

   While our grandparents were required to get only one vaccine to control one deadly and highly infectious disease - smallpox - children today are required by law to receive 33 doses of 10 different viral and bacterial vaccines before entering kindergarten.  Unlike smallpox, which was the deadly, highly contagious disease that set the precedent for mandatory vaccination, children today are being required to be vaccinated for hard-to-catch adult diseases like hepatitis B and forgenerally mild diseases such as chickenpox.   And there are 200 morevaccines being created, including an AIDS vaccine that one federal
vaccine policymaker said will be targeted for use by all 12 years olds.   Because public health and safety is measured not just by the absence of infectious disease but also by the absence of chronic disease, there are new questions being raised about how much we really know about the cumulative impact of mass vaccination policies on the public health. We know that the achievement of a 98 percent vaccination rate among all five year olds over the past three decades has dramatically suppressed infectious diseases such as polio, pertussis and measles, but we know very little about whether mass vaccination with multiple vaccines has played a significant role in the doubling of cases of asthma and learning disorders; the 273 percent increase in autism; the tripling of diabetes or the unexplained increases in arthritis, chronic fatigue or other autoimmune disorders in the baby boomer generation.

   Because studies used to license vaccines only require a limited follow-up period to evaluate for adverse events (in some cases only a few days); because vaccine studies are often conducted in populations which do not reflect the genetic diversity of the US population; because once a vaccine is licensed, it is often administered at the same time as many other vaccines without credible corroborating scientific evidence to prove it is safe to do that; and because no case controlled, long term studies have been conducted to measure for all morbidity and mortality outcomes over time, mass vaccination with multiple vaccineshas become, in effect, a national medical experiment on our children as well as on our men and women serving in the armed forces.

   This fact became more apparent after the Institute of Medicine at the National Academy of Sciences, in compliance with the 1986 law, published three reports in 1991 and 1994 after convening committees of independent physician experts to review the medical literature for evidence that vaccines can cause injury and death. Their reports confirmed that the DPT vaccine can cause acute brain inflammation and permanent brain damage; the DT vaccine can cause Guillain-Barre syndrome, including death, as well as brachial neuritis; the rubella vaccine can cause acute and chronic arthritis; the live oral polio vaccine can give polio to the person being vaccinated or to someone who comes into contact with the person's body fluids; and the MMR vaccine can cause shock and death from measles vaccine strain viral infection. But because there were so few scientific studies investigating vaccine-induced immune and brain dysfunction in the medical literature, the Committees were not able to properly evaluate a long list of vaccine-associated health problems. One of their most dramatic conclusions was:

   "The lack of adequate data regarding many adverse events under study was of major concern to the committee.the committee encountered many gaps and limitations of knowledge bearing directly or indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series.and inadequate size or length of follow-up of many population based epidemiologic studies."

CONCLUSION
   Without the basic science research to define at the cellular and molecular level the biologic mechanism for vaccine-induced injury and death, no pathological profiles have been developed to distinguish a vaccine-induced health problem from one that is not.  This has also impeded the indentification of genetic and other high risk factors that could be used to screen out and spare the lives of many children and adults. And so, federal health officials can continue to claim that almost all health problems following vaccination are merely temporally associated with the vaccination and not caused by it. In other words, in each individual case, the a priori assumption is that the vaccine did not cause the health problem when, in fact, in most cases no one knows.

   The policy of forced vaccination in a vacuum of scientific knowledge has placed many American parents in the difficult position of having to choose between obeying their conscience or obeying the law. This is especially true for parents who have concluded that one-size-fits all vaccination policies do not take into consideration the fact that each child is an individual with a unique genetic heritage, personal and family medical history and socio-economic environment that can impact the vaccine benefit risk equation.

   The National Vaccine Information Center is concerned about the inherent conflict of interest that exists when the same federal agencies responsible for the development, licensing, regulating and promotion of mandatory use of vaccines are also responsible for the monitoring and investigation of adverse events associated with vaccines. We are particularly concerned about the use of large linked databases by the CDC to conduct vaccine adverse events investigation and publish studies about vaccine risks, which consist of using data in closed HMO medical databases which are not open to public oversight in the same way that the VAERS system is open to public oversight.

   NVIC supports congressional appropriations earmarked for independent scientific investigation into possible links between mass vaccination policies and the substantial increases in autism, learning disabilities, attention deficit disorder, diabetes, arthritis, asthma and other chronic brain and immune dysfunction in our children during the past four decades, during which time more eight vaccines joined DPT on the federally recommended childhood vaccination schedule that includes DPT (live oral polio; measles, mumps, rubella, Hib, hepatitis B, chicken pox and rotavirus) and national vaccination rates increased from 60 to 80 percent in 1967 to 80 to 95 percent in 1996 for children entering kindergarten.  We oppose the suggestion by federal agencies and vaccine manufacturers to raid the trust fund and use the one billion dollar surplus in that fund for this purpose, as that money belongs to the children who were promised compensation for their catastrophic vaccine injuries.

   NVIC also supports a congressional investigation into the operation of the mass vaccination system by federal and state health agencies including a review of:

· federal vaccine licensing and policymaking standards;· implementation of the National Childhood Vaccine Injury Act of 1986;
· the erosion of privacy and informed consent protections in mass vaccination programs; and
· why the whole cell pertussis vaccine has not been removed from the market three years after a safer pertussis vaccine was licensed.

  We hope that Congress will take immediate emergency action to extend the August 6 deadline for children and adults, who have suffered Hib, chicken pox and hepatitis B vaccine-related injuries on or before August 6, 1997 to file for compensation under the National Childhood Vaccine Injury Act or they will never be able to apply for financial assistance to cope with their vaccine injuries.

   We believe that vaccines and national vaccine policies can be made safer and that this will enhance, not jeopardize the health and welfare of our nation.  The balance between public safety and personal choice can only be achieved when the lives of a minority are not written off as expendable in the name of the majority. Until then, public trust in the mass vaccination system will continue to erode.

    We are very grateful to you, Congressman Burton and the members of this Committee, for having the vision, courage and compassion to address this politically sensitive but critical health care issue which touches the life of every American family.  We stand ready to work with you and other members of Congress for as long as it takes to help make the mass vaccination system safer for every child.

***************************************************************
[Burton]  [Vaccination]