April 2008

Vaccine Risk Research Priorities

Posted: 4/11/2008 12:00:00 AM | with 3 comments

Vaccine Safety Research Priorities: Engaging the Public

Barbara Loe Fisher
Co-founder & President
National Vaccine Information Center
April 11, 2008
National Vaccine Advisory Committee
Washington, D.C.

     The National Vaccine Information Center is a non-profit educational organization founded in 1982 to prevent vaccine injuries and deaths through public education (www.nvic.org). We represent the vaccine injured as well as families with healthy children and health care professionals united in support of the ethical principle of voluntary, informed consent to vaccination.

     I am the mother of three children, including a son who suffered a brain inflammation within hours of his fourth DPT shot in 1980 and was left with multiple learning disabilities. I worked with parents and Congress on the National Childhood Vaccine Injury Act of 1986, which created the federal Vaccine Injury Compensation Program and vaccine safety provisions, including mandatory adverse event reporting and recording, as well as the Vaccine Adverse Events Reporting System and also mandated the Institute of Medicine’s 1991 and 1994 reviews of the scientific literature for evidence that vaccines can cause injury and death.[1] [2] [3] [4]

     During the past three decades that I have served on committees at the FDA, Institute of Medicine, and CDC, including acting as chair of the subcommittee on vaccine adverse events for the National Vaccine Advisory Committee between 1988 and 1991, the greatest challenge has been to convince public health officials and pediatricians to take seriously the concerns parents have about the quality and quantity of scientific information available to them when making informed vaccination decisions for their children. From the parent’s perspective, as Mark Blaxill, of Safe Minds, and I pointed out in the White Pape[5] we co-authored after the Blue Ribbon Panel on Vaccine Safety in 2004, a comprehensive and transparent scientific examination of vaccine risks is long overdue[6] [7] because, today, the Number One question for many parents raising young children is:

     Why are so many of our highly vaccinated children so sick?

     Vaccination rates with multiple vaccines in America are at an all-time high[8] and, with 1 in 6 vaccinated child in America now learning disabled[9]; 1 in 9 suffering with asthma;[10] [11] [12] 1 in 150 developing autism,[13] [14] and 1 in 450 becoming diabetic,[15] this is a legitimate question. America spends more than 75 percent of the $2 trillion price tag for health care to treat the chronically ill and disabled[16] and it is estimated that, by 2025, 1 in 2 Americans will be chronically ill or disabled.[17]

     The scientific, economic, political and moral imperative for addressing the new epidemic of chronic disease and disability, which has developed in the last quarter century and is compromising more children than were ever harmed by any infectious disease epidemic, including polio, makes the vaccine safety research agenda you are developing the most important federal health research funding priority today. It is a funding priority that must not take money from the vaccine injury trust fund created in 1986 to compensate vaccine injured children,[18] but urgently requires independent appropriations by Congress to support a national research program created in collaboration with those most concerned about vaccine safety to generate evidence-based information the people will trust. With more than 2,000 clinical trials worldwide[19] that will bring dozens of new vaccines to market soon, the first step in securing public trust is to add at least two more well informed consumer representatives critical of vaccine safety to this NVAC Working Group and the general National Vaccine Advisory Committee.

     In 1995, the Institute of Medicine convened a Vaccine Safety Forum of stakeholders to examine and publish reports on vaccine safety issues.[20[ [21][22] During that four year public engagement initiative, a time when autism was affecting 1 in 1,000 children,[23] I provided statements on behalf of concerned parents outlining vaccine research priorities and methods for detecting and responding to vaccine adverse event reports[24] [25] — which I will make available to the Committee for your consideration — and yet again to the 2001 IOM Immunization Review Committee[26] which generated the following statement in their 2002 report on Multiple Immunizations and Immune Dysfunction:

     “The Committee was unable to address the concern that repeated exposure of a susceptible child to multiple immunizations over the developmental period may also produce atypical or non-specific immune or nervous system injury that could lead to severe disability or death (Fisher, 2001). There are no epidemiological studies that address this. Thus, the committee recognizes with some discomfort that this report addresses only part of the overall set of concerns of some of those most wary about the safety of childhood immunizations.” [27]

     Whether you believe vaccines rarely, if ever, cause injury or death and that government should force everyone to take vaccines without exception, or you believe that vaccines are pharmaceutical products that carry risks which are greater for some than others and that government should allow voluntary, informed consent to taking a vaccine risk that is not equal for all, most reasonable people do agree that individuals genetically or otherwise biologically at high risk should be identified so their lives can be spared.

     Parents today are using mass communication and new technology to educate themselves about vaccines. When they evaluate the components of vaccines – from mercury, aluminum and formaldehyde[28] – to animal and human cell substrates that can be contaminated with adventitious agents[29] – they are finding no credible scientific studies proving safety; when they question pediatricians about the safety of giving their babies 8 vaccines on one day, they are being denied medical care instead of being given proof of safety; when they tell their doctor their child regressed after vaccination into autism, they are often told it is all a “coincidence” and so no report is ever made to the Vaccine Adverse Event Reporting System; when their children suffer vaccine reactions and are re-vaccinated again and again, despite deterioration into chronic poor health, they are losing faith in a mass vaccination system that dismisses individual health as unimportant compared to public health when implementing a one-size-fits-all, no exceptions policy.

     We have the technology today to investigate and define the pathology involved in vaccine induced brain and immune system dysfunction at the cellular and molecular level. A 20-year study that prospectively enrolls and compares the health outcomes of two groups of children, one group who will be vaccinated with the CDC recommended 48 doses of 14 vaccines by age six and 60 doses of 16 vaccines by age 12 versus another group, who will remain unvaccinated, will give us preliminary answers in six years about measured pathological changes in immune and brain function in both groups, including information about genetic variability and the development of learning disabilities, ADHD, autism, severe allergies, asthma and juvenile diabetes and other chronic disease and disability.

     In considering the question posed to this panel “How Do We Effectively Engage the Public,” I am reminded of a statement drafted a half century ago by a young group of dissidents who founded a participatory democracy movement in America[30] a progressive concept that I learned about first-hand during a participatory democracy experiment initiated by the CDC between 2002 and 2005 called the Vaccine Policy Analysis Collaborative.[31]

     In calling for a reform of government institutions to be more inclusive and transparent in their operation, the students referred to the great chasm that has developed between those who govern and those who are governed in America. They described the "felt powerlessness of ordinary people, the resignation before the enormity of events” saying:

     “The subjective apathy is encouraged by the objective American situation – the actual structural separation of people from power, from relevant knowledge, from pinnacles of decision-making….the very isolation of the individual – from power and community and the ability to aspire – means the rise of democracy without publics.” [32]

     It is the duty of a government of, by and for the people to listen to the people and act when they are suffering, whether they are in a minority or the majority. Respect for the people and a willingness to share decision-making power with them is an approach that will foster trust in government officials and public policy. Threats and coercion will destroy it.[33]

     What doctors in positions of power in the Department of Health and Human Services need to know at this critical point in time is this:

     Young parents today, who trusted doctors to give them good advice about how to keep their children well, do not understand why their children are never well when they have been given twice as many vaccines as children in previous generations received. They want a full-scale, transparent scientific investigation into all potential environmental causes of autism and other chronic immune and brain disorders conducted by extramural researchers who are not connected to vaccine makers and policymakers with a bias toward existing policy. They want a greater separation of the vaccine risk assessment and safety oversight responsibilities from the vaccine policymaking and promotion activities more in the model of the National Transportation Safety Board. Just as we did a quarter century ago, they are asking you to listen to what happened to their children after vaccination and take immediate steps to modify current vaccine policies to demonstrate a respect for preventing vaccine reactions, biodiversity and the right to informed consent.

     If we can agree that individual health and life is to be valued and that the most vulnerable among us should be protected; if we can agree that when one of us is sick or suffering, we are all diminished if we do nothing; if we can agree that the individual biological differences among us must be acknowledged when making vaccine policies because biodiversity is what strengthens the human race and distinguishes our humanity, then there is no reason we cannot find answers to outstanding questions about vaccine risks and develop public health policies that truly protect the biological integrity, the health and well being, of our individual children, our communities, our nation and the world.


1 Institute of Medicine. Adverse Effects of Pertussis and Rubella Vaccines. Washington, D.C.: National Academy Press, 1991. www.nap.edu [Return]
2 Institute of Medicine. Adverse Effects Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, D.C.: National Academy Press, 1994. www.nap.edu [Return]
3 Institute of Medicine. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington, D.C.: National Academy Press, 1994. www.nap.edu [Return]
4 Institute of Medicine. Research Stategies for Assessing Adverse Events Associated with Vaccines. Washington, D.C.: National Academy Press, 1994. www.nap.edu [Return]
5 Blaxill M, Fisher BL. From Safety Last to Children First: A White Paper on Vaccine Safety. Prepared for the Blue Ribbon Panel on Vaccine Safety, CDC. September 10, 2004. www.ageofautism.com and www.nvic.org [Return]
6 Fisher BL. Statement for Institute of Medicine Committee on National Immunization Program Procedures and Data Sharing Program. August 23, 2004. http://www.nvic.org/Loe_Fisher/blf0804vsd.htm [Return]
7 Institute of Medicine. Vaccine Safety Research, Data Access and Public Trust. Washington, D.C.: National Academy of Sciences. 2005. www.nap.edu [Return]
8 Centers for Disease Control. Press Release: Nation’s Childhood Immunization Rates Remain At or Above Record Levels. August 30, 2007. http://www.cdc.gov/od/oc/media/pressrel/2007/r070830.htm [Return]
9 Centers for Disease Control. Morbidity and Mortality Weekly Report:Percentage of Children Aged 5-17 Years Ever Having Diagnoses of ADHD or Learning Disability by Sex and Diagnosis – U.S., 2003. November 4, 2005. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5443a8.htm [Return]
10 Centers for Disease Control. Press Release: State of Childhood Asthma, U.S. 1980-2005. December 12, 2006. http://www.cdc.gov/nchs/pressroom/06facts/asthma1980-2005.htm Full Report: http://www.cdc.gov/nchs/data/ad/ad381.pdf   [Return]
11 Bloom B, Dey AN et al. Vital Health Statistics: Summary health statistics for U.S. children: National Health Interview Survey, 2005.December 2006.
http://www.ncbi.nlm.nih.gov/sites/ entrez?db=pubmed&uid=17201200&cmd=showdetailview&indexed=google [Return]
12 Centers for Disease Control. Press Release: Nine Million US Children Diagnosed with Asthma, New Report Finds. Summary Health Statistics for U.S. Children: National Health Interview Survey, 2002. March 31, 2004.
http://www.cdc.gov/nchs/pressroom/04news/childasthma.htm [Return]
13 Centers for Disease Control. Morbidity & Mortality Weekly Report: Prevalence of Autism Spectrum Disorders --- Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States, 2002. February 9, 2007.
http://www.cdc.gov/MMWR/preview/mmwrhtml/ss5601a2.htm [Return]
14 Centers for Disease Control. Press Release: New Data on Autism Spectrum Disorders. February 9, 2007 .
http://www.cdc.gov/od/oc/media/pressrel/2007/r070208.htm [Return]
15 Centers for Disease Control. National Diabetes Fact Sheet, U.S. 2003.
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf [Return]
16 U.S. Department of Health & Human Services, Centers for Medicare and Medicaid Services. National Health Expenditure Data. Also, Chronic Disease Overview.
http://www.cms.hhs.gov/NationalHealthExpendData/ 02_NationalHealthAccountsHistorical.asp#TopOfPage and http://www.cdc.gov/nccdphp/overview.htm [Return]
17 Johns Hopkins University. Robert Wood Johnson Foundation: Chronic Conditions:Making the Case for Ongoing Care. December 2002. http://www.rwjf.org/files/research/chronicbook2002.pdf [Return]
18 National Childhood Vaccine Injury Act of 1986 (PL99-660) http://www.hrsa.gov/vaccinecompensation/statistics_report.htm [Return]
19 U.S. National Institutes of Health. Directory of World Clinical Trials. http://clinicaltrials.gov/ct2/results?term=vaccines [Return]
20 Institute of Medicine. Vaccine Safety Forum: Options for Poliomyelitis Vaccination in the United States. Washington, D.C.: National Academy Press. 1996. www.nap.edu [Return]
21 Institute of Medicine. Vaccine Safety Forum: Summaries of Two Workshops: Detecting and Responding to Adverse Events Following Vaccination and Research to Identify Risks for Adverse Events Following Vaccination: Biological Mechanisms and Possible Means of Prevention. Washington, D.C.: National Academy Press. 1997. www.nap.edu [Return]
22 Institute of Medicine. Vaccine Safety Forum: Risk Communication and Vaccination. Washington, D.C.: National Academy Press. 1997. www.nap.edu [Return]
23 Bertrand J, Mars A et al. Prevalence of Autism in a United States Population: The Brick Township, New Jersey Investigation. Pediatrics 108: 1155-1161. November 5, 2001. http://pediatrics.aappublications.org/cgi/content/full/108/5/1155 [Return]
24 Fisher BL. Vaccine Research Needs: Perspective From Parents. Institute of Medicine Vaccine Safety Forum. April 1, 1996. http://www.nvic.org/Loe_Fisher/blfiom3.htm [Return]
25 Fisher BL. Vaccine Adverse Event Reporting & Data Collection, Detection and Response Methodologies. Institute of Medicine Vaccine Safety Forum. November 6, 1995. http://www.nvic.org/Issues/Institute_of_Medicine.htm [Return]
26 Fisher BL. Presentation for Institute of Medicine Immunization Safety Review Committee. National Academy of Sciences. January 11, 2001. http://www.nvic.org/PressReleases/pr51804iom.htm [Return]
27 Institute of Medicine. Multiple Immunizations and Immune Dysfunction. Washington, D.C.: National Academy Press. 2002. www.nap.edu [Return]
28 Centers for Disease Control. Vaccine Excipient & Media Summary. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf [Return]
29 Khan AS. FDA Vaccines & Related Biological Products Advisory Committee: Adventitious Agent Testing of Novel Cell Substrates for Vaccine Manufacture. November 16, 2005. http://www.fda.gov/ohrms/dockets/AC/05/slides/5-4188S1_3draft.ppt#256,1,Adventitious Agent Testing of Novel Cell Substrates for Vaccine Manufacture Arifa S. Khan, PhD. Division of Viral Products Office of Vaccines Research and Review CBER, FDA November 16, 2005 [Return]
30 Miller R. Toward Participatory Democracy. Summer 2005.
http://www.pathsoflearning.net/articles_Toward_Participatory_Democracy.php [Return]
31 Bernier R. Presentation of Proposal for a Demonstration Project – The Vaccine Policy Analysis Collaborative (VPAC) on behalf of the Wingspread Public Engagement Planning Group. National Vaccine Advisory Committee. June 2003. http://www.hhs.gov/nvpo/meetings/jun2003/bernier.ppt#499,1,Proposal for a Demonstration Project-the Vaccine Policy Analysis Collaborative (VPAC) [Return]
32 Port Huron Statement of the Students for a Democratic Society, 1962. http://coursesa.matrix.msu.edu/~hst306/documents/huron.html [Return]
33 Fisher BL. Promoting Vaccination, Fear, Hate and Discrimination. March 25, 2008. http://vaccineawakening.blogspot.com/search?q=promoting+vaccination%2C+fear%2C+hate+and+discrimination and http://www.ageofautism.com/2008/03/barbara-loe-fis.html#more [Return]

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