NVIC Vaccine News

What’s Old is New – 1996 Vaccine Safety Research Priorities

By Barbara Loe Fisher
Published May 22, 2018 in Science

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In 1986, the National Vaccine Program Office of the Department of Health and Human Services was created by Congress under the National Childhood Vaccine Injury Act.1 In 1995, the National Vaccine Program Office asked the Institute of Medicine, National Academy of Sciences to conduct a public engagement project to bring vaccine stakeholders together to “examine critical issues relevant to the safety of vaccines used in the United States and to discuss methods for improving the safety of vaccines and vaccination programs.”

Individuals appointed to the Vaccine Safety Forum included representatives from federal agencies responsible for regulating vaccines and implementing vaccine policies; vaccine manufacturers; physicians; academic researchers and parent or consumer groups with an interest in vaccines. I was appointed as a parent group member of the Vaccine Safety Forum and helped to coordinate public workshops and publish reports on vaccine safety issues between 1995 and 1998.

This is a statement on vaccine safety research priorities I gave at the Institute of Medicine more than 20 years ago on behalf of the National Vaccine Information Center at an April 1996 Vaccine Safety Forum public workshop.2

1996: A Parent’s Perspective

In preparing to speak today about Vaccine Research Needs - Perspective From Parents, I thought about how easy it has been to draw a line in the sand to separate the research scientists and government health officials from the parents.

I am a parent, just like many of you. I graduated from college, but unlike most of you, I did not choose to go on to earn a Ph.D. or M.D. degree. Although I came from a family full of doctors, dentists and nurses and grew up with a respect and love for science and medicine, there were other interests and goals I wanted to pursue.

And when my first child, Christian, made me a Mom - I experienced the same kind of joy many of you experienced when you became a parent for the first time. And when Chris, who had begun saying words at seven months, and by the age of two was speaking in full sentences and could identify the upper and lower case alphabet and name every card in the deck by sight; when Chris, the most precocious of my three babies became a totally different child physically, mentally and emotionally at the age of two and a half following a convulsion, collapse shock and six hour state of unconsciousness within hours of his fourth DPT and oral polio vaccinations; and when he later was diagnosed with immune system dysfunction, multiple learning disabilities and attention deficit disorder and placed in a self contained classroom for the severely learning disabled with a 30 point discrepancy between intelligence and performance, suddenly the course of his life and my life changed forever.

Because the doctors could not explain what had happened to my child, I became an investigator out of necessity, not out of choice. I wanted to know why my bright, cheerful, unusually healthy little boy no longer could identify the upper or lower case alphabet or name his beloved cards; why he was constantly sick with otitis media and upper respiratory infections, which he had not had before; why he could not stop having diarrhea and wasted away to a skeleton until he ended up in the hospital with a suspected diagnosis of cystic fibrosis or celiac disease where all tests came back negative; why he never smiled or laughed anymore but would weep inconsolably for no apparent reason; why he spent more time staring into space than talking to people.

I had to find out why my once healthy, cheerful bright little boy was now lost in a confused and painful world so I could find a way to help him, and also prevent this from happening to any other children I would have in the future.

I asked myself the usual questions. Although his father and I did not have severe allergies, was Chris's milk allergy and our extended family's history of severe allergies and reactions to vaccinations important? Was the fact that my mother had rheumatoid arthritis, an autoimmune disease, significant? Was the fact that Chris had a severe local reaction to his third DPT shot a warning sign?

Becoming immersed in the medical literature, pouring through Dorland's 3 and the Physician's Desk Reference4 and Harrison's Principals of Internal Medicine 5 and the 1981 National Childhood Encephalopathy Study6 and then went on to analyzing more than 50 years of literature on DPT vaccine,7 8 9 10 11 12 13 14 I began to realize that I may not have attended medical school but learning how to use the brain that God gave me is not a bad substitute.

And then, when I started systematically collecting records on DPT vaccine reaction cases and interviewing parents of DPT vaccine damaged children, what I was doing didn't seem to be all that different from what Dr. Gordon Stewart referred to in one of his studies as "shoe leather epidemiology" or, as Dr. Georges Peter commented at a meeting we were at in 1983, "If parents describe what happens to their children after vaccination, it is called anecdotal evidence. When doctors do it, it's called clinical observation."15

The Human Face: Listen to the Parents

The reason I am taking the time to tell my personal story is that, while I am not the only speaker who is also a parent on the agenda, I am the only one who has been designated to speak as a parent and so I feel a responsibility to communicate what parents consider to be the most important flaw in vaccine research used to develop vaccine policies. Parents believe that, too often, research scientists forget that behind every vaccine adverse event statistic, there is a real child and a real family who have been hurt just as surely as if polio or diphtheria had visited that house, and claimed a family member as a morbidity or mortality disease statistic.

Why is this important, you may ask, from a scientific perspective? It is important because when the human face is removed, it makes it much easier for the researcher designing and conducting vaccine studies to treat children like a genetically homogeneous group of cattle instead of individual children with a unique genetic heritage subject to unique environmental co-factors. When you forget the human face, it is much easier to stand behind that invisible wall separating science from public policy and be reluctant to design the kinds of studies that will investigate what is really happening to the tens of thousands of babies being born every year, who are eventually developing immune and neurological dysfunction manifested by a wide range of symptoms ranging from medication resistant seizure disorders to learning disabilities to autism to chronic fatigue.

I believe that if you will take the time to listen to what parents have to say about what is happening to their children, who have died and been left immune and neurologically compromised following vaccination, you will know what kinds of studies you need to design to find the answers to the questions parents and scientists alike are asking about the unknown biological impact of vaccines on the human body. The parents are waiting to tell you what happened to their children. They not only want to help you find out why the risks were 100 percent for their children, but they want to help you find ways to develop therapies to make their children whole again.

These, then, are the top five vaccine research priorities that the National Vaccine Information Center and parents who have recently founded other consumer organizations, consider to be most important.

Fill in Knowledge Gaps About Immune and Brain Function After Vaccination

Research Priority Number 1: Set up studies to evaluate, on a molecular biology level, the impact over time of repeatedly manipulating the human immune system with single and multiple antigens.

I remember standing in a lab at the FDA about 13 years ago talking with Dr. Chuck Manclark, who, as many of you know, conducted pertussis vaccine research for many years at the Bureau of Biologics. It was his dream to develop a pertussis vaccine that would be given to pregnant women so they could passively transfer pertussis antibodies to their babies in the womb. In one conversation he pointed out to me that the problem with developing a safe and effective pertussis vaccine was that medical science still doesn't really understand precisely how the pertussis bacterium acts on the human body during the course of the natural disease and so it was difficult to develop a vaccine with the right components in it to both produce protective antibodies while being devoid of toxic effects.16

If you add this basic gap in understanding to science's limited general understanding of precisely how the human immune system functions and how it interacts with the neurological system, a frontier that is being explored by the new neuroimmunologists and molecular biologists,17 18 you have a window for possible past miscalculation of the biological effects over time of repeatedly manipulating the human immune system with single and multiple antigens.19 The fact that each individual is genetically unique adds another confounding variable.

Parents, who are not just being asked - but are now being forced by law - to vaccinate their children with increasing numbers of vaccines, want to see the scientific proof that you know precisely what is happening in the human body at the molecular level when one vaccine or five or ten vaccines are given to their baby.20 They don't want you to just sort of think or assume, that it is OK to grow live viruses for production of vaccines on animal tissue cultures from monkeys21 22 23 24 and cows and chickens. Parents want to know that you know, beyond all reasonable doubt, that vaccines are not carriers of virus particles that can be archived in genes in the wrong tissues, as Dr. Howard Urnovitz talked about, and reemerge later in life to wreak havoc in the body.25 26

Because haunting every new story on mad cow disease27 28 and HIV is the lingering doubt about using calf serum and monkey kidney tissues29 to produce the live poliovirus vaccine or chickens to produce measles vaccine.30 31 And haunting every story of the Gulf War veterans who were given 17 different viral and bacterial vaccines simultaneously and then exposed to environmental toxins,32 33 34 35 36 which left tens of thousands of them with the same kinds of immune and neurological dysfunction that vaccine damaged children and adults are suffering from,37 38 39 and which caused an abnormally high number of them to give birth to catastrophically genetically damaged children,40 is the nagging question about whether we have gone too far too fast in the rush to bring to market and administer to everyone vaccines designed to eradicate all disease from the earth.41

Conduct Biological Mechanism and Clinical Studies Comparing Health Outcomes of Vaccinated and Unvaccinated Children

We briefly discussed in the last workshop the difficulty of setting up a long term study comparing the health of vaccinated children to unvaccinated children, including evaluating over time all morbidity and mortality outcomes, including the difference in rates of immune and neurological disorders such as diabetes, cancer, multiple sclerosis, lupus, epilepsy, chronic fatigue, learning disabilities, attention deficit disorder, autism, asthma, sudden infant death syndrome, otitis media, rheumatoid arthritis, depression, violent behavior and other immune, neurological and psychiatric disorders, as well as genetic birth defects, in their children.42 If you are really going to scientifically evaluate the impact of vaccines on overall health, at the molecular as well as clinical observation level, parents believe the comparison has to be made.

Evaluate Impact of Vaccination on Evolution of Microbes and Adverse Outcomes for Human Health

Research Priority Number 2: Set up epidemiological studies to evaluate whether the artificial suppression of viral and bacterial diseases by mass vaccination is, in conjunction with the overuse of antibiotics43 and exposure to environmental toxins,44 preventing the human immune system from being naturally challenged and strengthened in childhood as it was in past generations by infectious diseases,45 leaving today's highly vaccinated populations more vulnerable to new and more virulent viruses and bacteria.46 47 48 49

From a global perspective, parents are concerned that there are no scientific studies evaluating the presumption that all disease should be eradicated from the earth with mass vaccination. Just because smallpox vaccine eradicated smallpox from the earth, what scientific evidence is there to presume that it is a good idea to try to eradicate all other infectious disease from the earth with vaccines? Where are the epidemiological studies systematically evaluating the role of worldwide mass vaccination on the etiology and limited ability of the human race to successfully meet the challenge of newly emerging viruses and bacteria, such as HIV, Hantavirus and Ebola?

From an individual perspective, many parents suspect that their children's immune and neurological dysfunction was caused by multiple factors, including an interaction between multiple vaccines, antibiotics and environmental toxins. They want studies to evaluate interactions of multiple toxins in the body, including vaccines, drugs and chemicals so that, for example, if a child receives a live viral vaccine his parents will know whether to keep him temporarily away from immune suppressing environmental toxins such as pesticides.

Investigate Link Between Vaccination and Learning Disabilities and ADD/ADHD

Research Priority Number 3: Conduct studies to investigate the possible link between vaccination, learning disabilities and attention deficit disorder.

There are more than three million children diagnosed with learning disabilities and attention deficit disorder in our school system today.50 51 As Dr. Marcel Kinsbourne will discuss later, there is a scientific basis for the biological plausibility that a vaccine - like any agent inherently capable of causing brain damage - is not only capable of causing brain inflammation leading to catastrophic neurological dysfunction but may also cause brain inflammation leading to milder forms of neurological dysfunction, such as learning disabilities and attention deficit disorder that become more apparent as time passes.52

Investigate Link Between Vaccines and Autism

Research Priority Number 4: Conduct studies to investigate the possible link between vaccines and autism.

Autism affects 1 in 1,000 children and occurs more frequently than childhood cancer, multiple sclerosis or cystic fibrosis.53 In 1943, there were only 11 reported cases of autism.54 In 1989, there were more than 100,000 cases with many of these autistic and borderline autistic children suffering from seizures, chronic autoimmunity or hyperimmunity, and learning disabilities.55 56 57 58 59 60 61

Last year Portia Iverson, a mother whose child was left profoundly immune and neurologically compromised following a severe reaction to vaccinations, founded Cure Autism Now (CAN), a parent organization which has assembled a task force of scientists and physicians involved in cutting edge research in the fields of immunology, neurology, neuroimaging, genetics, biochemistry, metabolics, orthomolecular medicine and pharmacology, who are conducting research with direct clinical implications for the treatment of autism. Among the current studies which CAN, along with the National Vaccine Information Center, is funding is research into the possible role vaccination in the development of autism.

Then there is Cindy Goldenberg, the mother who conducted her own medical research into the link between rubella disease and autism after her son was diagnosed autistic following vaccination with rubella vaccine. Her mastery of the medical literature and basic immunology led her to develop a therapy using immune globulin infusions and a nutritional and dietary supplement regimen, which she employed with the help of an immunologist that cured her son of autism.62 With each gamma globulin infusion her son's sky-high rubella antibody titers went down. As his titers plunged, his autistic behaviors and immune system dysfunction disappeared. Others are using her discovery to cure their autistic children, and we have reports that at least one vaccine damaged child with a medication resistant seizure history has used it and is now seizure free.

And there are other new parent organizations out there, forming alliances with independent researchers, who are developing lab protocols for investigating central nervous and immune system biological markers, including biochemical, metabolic and genetic profiles of developmentally delayed children.

Evaluate Safety of Vaccine Ingredients and Identify Genetic Risk Factors

Research Priority Number 5: Set up studies, which will, on a continuing long term basis, scientifically re-evaluate each of the ten vaccines currently being given to children, including full evaluation of the safety of growth mediums,63 adjuvants,64 65 preservatives and other additives,66 as well as identification of genetic and other high risk factors in order to screen out high risk children.67 68

Anyone who reads the Institute of Medicine's 199169 and 199470 reports evaluating scientific studies in the medical literature, which have actually investigated the cause and effect relationship between mandated vaccines and a wide variety of immune and neurological disorders, is immediately struck by the spectacular absence of studies doing just that. It is stunning that time and again these special IOM committees charged with evaluating the literature had to repeatedly come up with the conclusion that, "there have been no controlled observational studies investigating the association between" a particular vaccine and a suspected immune or neurological disorder. Out of 59 health problems suspected to be associated with different vaccines in the 1994 IOM report, there were no scientific studies to be found that had ever looked at 40 of them.

Parents think this is unacceptable, just as they think it is unacceptable that little effort has been made to identify genetic and other markers to screen out high-risk children. Some of the presentations given today give us hope that there is a move in the direction of developing studies to identify high risk children, and this is welcome because it is long overdue.

It is unfair to leave the funding of cutting edge vaccine safety research to the families of vaccine victims, when many millions of dollars are being spent by DHHS to develop and promote new vaccines and little money has been allocated to evaluate vaccine adverse events.71 It is even more disturbing to parents to watch independent medical researchers, who are trying to pursue vaccine adverse event research, be denied DHHS funding and be forced to risk their careers because they are conducting what is still sadly stigmatized as a politically incorrect line of research.

Will You Be Ready for Them?

I became an investigator 14 years ago because I was driven by my love for my child. Today other young mothers and fathers in America and in countries around the world are being driven by the same love for their children to conduct research after their children's lives have been forever changed by vaccines they were required by law to use. And, increasingly parents of healthy children are following the same path because they don't want their children to become vaccine reaction statistics.

I think you will be surprised at the depth of knowledge that the smart young parents coming on the scene today have in the areas of immunology, epidemiology and even molecular biology. Some of them are writing books; some are joining with independent researchers and funding vaccine research; some are becoming vocal consumer advocates and others will make their impact on Capitol Hill. They will be the ones to help take the vaccine safety issue into the 21st century.

Will you be ready for them?

This video was recorded in March 2018, more than 20 years after parents asked for well designed studies to find out why so many children born healthy in America become chronically ill and disabled after vaccination.

  • In 1976, 1 child in 30 was learning disabled.72 Today, 1 child in 6 is learning disabled.73
  • In 1980, 1 child in 27 had asthma.74 75 Today, 1 child in 9 has asthma.76
  • In the 1996, 1 child in 1,000 developed autism.77 Today, 1 child in 50 develops autism.78 79
  • And millions more are suffering with other kinds of inflammatory brain and immune system disorders.80 81 82 83

The biggest public health emergency in America today is the unexplained epidemic of chronic disease and disability among vaccinated children.84 85

How many more years will go by before quality scientific research into vaccine risks and failures is made a national priority?


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30 Brown D. Unexpected protein found in measles-mumps vaccine. Washington Post Dec. 9, 1995.

31 Khan AS. Investigating Viruses in Cells Used to Make Vaccines; and evaluating the Potential Threat Posed by Transmission of Viruses to Humans. FDA Feb. 2, 2018.

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34 Butler D. Admission on Gulf War vaccines spurs debate on medical records. Nature 1997; 390: 3-4.

35 Urnovitz HB, Tuite JJ et al. RNAs in the Sera of Persian Gulf War Veterans Have Segments Homologous to Chromosome 22q1.2. Clinical and Diagnostic Laboratory Immunology 1999; 6(3): 330-335.

36 Baker L. Genes May Determine Who Developed Gulf War Syndrome, UB Researchers Find. University of Buffalo: Aug. 9, 2004.

37 Rook GAW, Zunia A. Gulf War syndrome: is it due to a systemic shift in cytokine balance toward a Th2 profile?The Lancet 1997; 349(9068): 1831-1833.

38 Science Daily. Brain Scans of Gulf War Veterans Show Brain Damage. May 26, 2000.

39 Nordqvist C. Proof Gulf War Illness Does Exist. Medical News Today June 15, 2013.

40 U.S. Senate Committee on Veterans Affairs Hearing. Reproductive Hazards and Military Service: What Are the Risks of Radiation, Agent Orange and Gulf War Exposures? Aug. 5, 1994.

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43 Davies J. Vicious Circles: Looking Back on Resistance Plasmids. Genetics 1995; 139: 1465-1468.

44 Luster MI, Rosenthal GJ. Chemical Agents and the immune response. Environmental Health Perspectives 1993; 100: 219-226.

45 Strachan DP. Hay fever, hygiene and household size.BMJ 1989; 299: 1259-1260.

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48 Bart MJ, van Gent M, van der Heide HGJ et al. Comparative genomics of prevaccination and modern Bordetella pertussis strains . BMC Genomics 2010; 11: 627.

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