Vaccine Safety Issues: Is the FDA Performing Its Obligated Role of Assuring the Reasonable Safety of Vaccines?

by Harold Buttram, MD

November 21, 2010 http://www.vaccinationcouncil.org

Excerpt from book: [2011] A Commentary on Current Childhood Vaccine Programs by Harold E. Buttram, MD

With the recent rule change [move] of the National Football League to provide greater safety by holding players under a “strict liability” standard for illegal hits to the head and neck, it may be appropriate and timely to examine another area in which safety issues are of growing concern, that of the seemingly uncontrolled proliferation of childhood vaccines with known potential for adverse reactions, an area of supervisory responsibility of the Food and Drug Administration (FDA).

The FDA is the oldest consumer protection agency in the U.S. federal government. Its origins can be traced back to 1848 with its purpose of carrying out chemical analyses of agricultural products, a function that the newly created Department of Agriculture (USDA) inherited in1862. Although it was not known by its present name until 1930, FDA’s regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law one-quarter of a century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.

The FDA and its responsibilities have undergone a vast expansion and metamorphosis since 1906, yet the core public health obligations remain essentially the same. In the area of drugs (including vaccines), it is the obligation of the FDA to provide protection of public safety for the drugs that it approves for commercial use, as required by federal law. This paper addresses the issue of current childhood vaccine programs and the FDA’s supervisory role over those programs.

A. Ominous Health Trends among our Children

Many years ago in this author’s former medical practice we began asking school teachers whether they were observing adverse changes in children. Without exception, they replied that there had been dramatic changes, most notably since the early 1980s. Steadily increasing numbers of children, they reported, were showing autistic-like behaviors, were restless, impulsive, less focused, less able to concentrate, and therefore less able to learn.

Statistically it has been demonstrated that a sharp and persisting rise in childhood autism commenced following the 1978 introduction of the MMR vaccine (measles, mumps, rubella) in the U.S.A [1-2], a time when mercury-laced Hepatitis B and Hemophilus influenza type b vaccines also were introduced. For a number of years previously the measles, mumps, and rubella vaccines had been administered separately with negligible increases in autism. It was only after the three were combined into the MMR vaccine that the incidence of autism began abruptly soaring with one in 150 children up to 8 years being affected, according to a U.S. multi-site study in 2000 [3], as compared with one in 10,000 several generations ago. According to more recent information, the incidence of autism may now be even higher with one in 88 military children in the U.S.A. having autism [4], and one in 86 in the United Kingdom [5]. Considering that the incidence of autism in boys is four times greater than in girls, the relative incidence of autism in boys would be even greater.

In addition to the autism epidemic, in 2004 almost five million children were classified as learning disabled [6], representing a three-fold increase since 1976-7, according to the Digest of Education Statistics [7]. Comparable increases have taken place in attention deficit hyperactive disorder (ADHD), with four-and-one-half-million children between ages 3 and 17 being diagnosed with this condition in 2004 [8].

In a bulletin sponsored by the American Academy of Pediatrics, January, 2004 entitled AUTISM A.L.A.R.M, in addition to an announcement of the increasing incidence of autism, it was announced  that one in 6 American children were diagnosed with a learning disability and/or significant behavioral disorder.

In a similar fashion the incidence of asthma has increased from roughly two-and-a- half million children ages 6-17 years in 1979 to nine million children 0-17 years in 2004 [8], roughly 12 percent of that age group. In the same time period this age-group population increased 114 percent when there was a 360 percent increase in asthma.

As described and documented by Dr. Kenneth Bock, approximately one third of America’s children are afflicted by “The 4-A Disorders: Autism, ADHD, Asthma, and Allergies” [9].

Autoimmune diseases are also increasing, including juvenile diabetes, multiple sclerosis, Guillain-Barre Syndrome, and Crohn’s inflammatory bowel disease. According to the work of Vijendra Singh, who demonstrated marked elevations of brain antibodies in the form of myelin basic protein antibodies in autistic children [10-11]. Autism can therefore be considered an autoimmune disease, at least in part.

As a comparison, during this author’s adolescence, which took place during the 1930s in Oklahoma, I don’t recall ever seeing a child or adolescent with easily recognizable conditions such as ADHD or autism, nor seeing a child, adolescent, or adult whose health was seriously affected by asthma, even though he had fairly broad exposures to different strata of society.

During the current year 2010 there are grave general concerns about the U.S. economy with its continually growing deficits. Of much greater concerns are the steadily growing physical and mental health deficits taking place among America’s children, with no end or relief in sight. No nation or society can continue to prosper or even survive with the current rate of health attrition taking place among our children.

Health authorities deny any relationship between vaccines and these adverse health trends, but if current vaccine programs are not causally involved, then what is causing these ominous childhood health trends? Representatives of the FDA (Food and Drug Administration), CDC (Centers for Disease Control and Prevention) and other government health agencies have remained strangely silent about this question.

B. Gross Deficiencies in State-of-the-Art Vaccine Safety Tests

Future times undoubtedly will look back on the series of U.S. Congressional Hearings on issues of vaccine safety (1999-Dec., 2004) as one of the major landmarks in American history. The hearings were called and chaired by Congressman Dan Burton, who had two grandchildren whom he believed had been damaged by vaccines, one of which is autistic. As chronicled by reporter David Kirby in his book, Evidence of Harm, [12] it was during these hearings that gross deficiencies in vaccine safety testing were disclosed, with none of the federal government health agencies able to produce a single safety study which would meet with current scientific standards.

By way of explanation, valid vaccine safety tests are those in which before-and-after-vaccine tests are performed that are designed to test for possible adverse effects of vaccines on the neurological, immunological, hematological, genetic, and other systems of the body, with significant numbers of test subjects and (when appropriate) control subjects so as to be statistically significant. As an example, in a little noted 1984 study from Germany by Eibl et al [13], a significant though temporary drop of T-helper lymphocytes (a class of white blood cell that governs the immune system) was found in 11 healthy adults following routine tetanus booster vaccinations. Special concern rests in the fact that, in four of the subjects, T-helper lymphocytes dropped to levels seen in active AIDS patients. If this was the result of a single vaccine in healthy adults, one must wonder what the results must be from today’s mandatory childhood vaccine programs (over 36 vaccines before school age).

The Eibl study was far too small to be statistically significant, but otherwise it could well serve as a prototype of vaccine safety tests that should be taking place. To the best of the author’s knowledge to date, it has never been repeated. One must wonder why, considering its obvious importance in vaccine safety concerns and immune responses.

As long as this single immune system study remains un-addressed, it by itself discredits and belies any assurance of safety in current vaccine programs.

C. Evidence-Based Medicine and the Quality of Evidence Ratings (QER).

As reviewed in 2003 by Mark om [14], in recent years there has been a clear move towards basing medical practice opinions on the best available medical and scientific evidence in recent years. The process has been termed Evidence-based medicine, which requires a position of objectivity and neutrality in the testing of clinical hypotheses. The process has been placed in four categories:

“Compelling evidence comes from consistent findings in 2 or more well- constructed trials or population-based epidemiologic studies (i.e., level I or II   evidence). By contrast, clinical practice guidelines with level IV evidence (the lowest level of scientific credibility) represent consensus statements of the expert panel according to clinical experience and limited scientific data. Although these (level IV) statements may influence current practice, they are likely to be   modified by further research findings. Data from a single case series without control subjects provide little more than a stimulus for subsequent hypothesis testing.” [14]

During the Congressional Hearings on Vaccine Safety, an FDA panel was asked repeatedly, “Where are your (safety) studies?” The panel could only reply with unsatisfactory answers such as, “They would be very expensive.” However, it was not until January 14th, 2009 that it became evident that the avoidance of meaningful vaccine safety studies has long been an established policy by the National Institute of Health, the primary federal agency responsible for funding health research in America, as reported by the autistic support group, Age of Autism:

January 17, 2009
National Autism Association on IACC Removal of Vaccine Safety Research, a Press Release from The National Autism Association:

“Washington DC – In an unprecedented move on Wednesday, Jan. 14,th 2009 the Interagency Autism Coordinating Committee (IACC) removed previously    approved vaccine safety research from the Strategic Plan for Autism Research objectives. With apparent backing from the CDC representation, committee chair and HIMH director Tom Insel implied that vaccine research conducted by the National Institutes of Health (NIH) would constitute a conflict given the involvement of Health and Human Services with ongoing autism cases filed in the federal vaccine court. The committee’s action is in direct opposition to the majority of its pubic members who support vaccine research, and to the Congressional directive of the Combating Autism Act of 2006 (CAA) which specifically called for research into “potential links between vaccines, vaccine components, and the autism spectrum disorder.

“In addition to the CAA’s mandate for vaccine research, the legislation specifically called for the establishment of key research activities to arrive from meaningful public involvement and advice through the IACC which includes both government and private representatives.

“ ‘Ignoring the Congressional mandate for investigation to links between vaccines and the development of autism is a slap in the face to both Congress and the citizens of this country,’ said National Autism Association board chair and parent Lori Mellwain. ‘Even the most basic studies comparing health outcomes of vaccinated vs nonvaccinated populations are consistently ignored despite the   increasing support for them from legislatures, physicians, and parents.’

“ ‘Dr. Insel’s observation that the NIH is incapable of conducting conflict-free   research supports what a growing number of parents believe,’ commented Ms. Mellwain. ‘While the motivation for refusing to allow this critical research to go forward is likely more related to fear of what such studies would reveal, it is clear that the system managing our vaccine program is corrupt beyond repair and needs a complete overhaul…….’ ”[15].

D. Conclusion

Based on these revelations, the claims of health authorities that there is no proof of a relationship between vaccines have been technically correct, but this is only because the tests that could prove such a relationship have been systematically and knowingly avoided and not conducted by the NIH and other government health agencies over a period of many years, and which is confirmed above by the declaration by the National Autism Association. The time is long overdue for a national referendum and condemnation of this negligence by the FDA, CDC, and HHS.


1. Center for Disease Control and Prevention, California Department of Health and Human Services.

2. Rimland B, The autism epidemic, vaccinations, and mercury. Journal of Nutrition and Environmental Medicine. 2000; 261-266.

3. Prevalence of autism spectrum disorders: Autism and developmental disabilities    monitoring network, six sites, United States, 2000, Morbidity and Mortality      Weekly Report, 2000; Feb. 9, 2007, 56(SS-1): 1.

4. http://www.vapoproject.org/yazbak/1-in-88-20080709.htm  .

5. http://www.vapoproject.org/statistics/autism-statistics.html  .

6. Bloom B, Dey AN,  Summary health statistics for U.S. children: National health   interview survey, 2004, U.S. Centers for Disease Control and Prevention. National Center for Health Statistics.

7. http://nces.ed.gov/programs//digest.d02/dt363.asp.

8. Bloom B, Day AN, Summary health statistics for U.S. children: U.S. Centers for Disease Control and Prevention. National Center for Health Statistics.

9. Bock, K and Stauth C. Healing the New Childhood Epidemics: Autism, ADHD, Asthma, and Allergies.  New York: Ballantine Books, 2007.

10. Singh, VK, Warren RP, Averett R, Ghaziuddin M. Circulating autoantibodies in neural and glial filament proteins in autism. Pediatric Neurology, 1997; 17:88-90.

11. Singh VK, Warren RP, Odell JD, Warren WI, Cole P. Antibodies to myelin basic protein in children with autistic behavior. Brain, Behavior, and Immunology.1993; 7:97-103.

12. Kirby, David. Evidence of Harm. New York: St Martin Press, 2005.

13. Eibl M, Maannhalter JW, Zablinger G. Abnormal T lymphocyte subpopulations in healthy subjects after tetanus booster immunization, (letter), New England Journal of Medicine, 1984; 310(3): 198-199.

14. Donohoe M. Evidence-based medicine and shaken baby syndrome. Part 1.  Literature Review, 1966-1998. American Journal of Forensic Medicine and Pathology. 2003; 24(3): 239-242.

15. http://www.ageofautism.com/2009/01/national-autism-association-on-iacc-removal-of-vaccine-safety-research.

The article is an excerpt from Dr. Buttram’s book entitled A commentary on Current Childhood Vaccine Programs, 2010 publication from The Philosophical Publication Company, PO Box 77, Quakertown, PA 18951. The material is copyrighted and printed here with permission.


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