America’s Healthcare Crisis–Part IV-Vaccine Injury Compensation

“Theoretical Aspects of Autism: Causes—A Review,” (2011)[1] by Helen Ratajczak, PhD, a senior scientist who spent her career in the pharmaceutical industry focusing on immunology and toxicology with special attention to hypersensitivity summarizes the scientific, peer-reviewed literature about autism since 1943.

“This review summarizes evidence of hormones, metabolites, amino acids, and other biomarkers present in significantly different quantities in autistic subjects compared to age- and sex-matched controls. These differences can be measured in the gastrointestinal, immunologic, neurologic, and toxicologic systems of the body, with some biomarkers showing ubiquitous application…The variances of the biomarkers from the norm present the opportunity to create biomarker arrays that when properly developed and analyzed could result in an objective diagnosis with a ranking of the severity of autism for each subject. The contribution of each biomarker to the overall diagnosis could be calculated, thus providing a profile pattern unique to the individual. This profile could consequently provide information for therapeutic interventions on an individual basis.”

Her findings confirm the EPA time frame and correlation between the timing of changes in autism incidence with environmental changes, and they show clear significant increases in the prevalence of autism among children born between 1987 and 1992, when autism prevalence per 10,000 rose by 50% every 2 years:

from 5.3 in 1984; to 7.8 in 1986; to 11.8 in 1988; to 18.3 in 1990. “During that time, there were no changes in prevalence of mental retardation, speech/language impairment, or traumatic brain injury, which suggests that the increase in autism is real.”

Dr. Ratajczak notes that the current recommended immunization schedule for young children from birth to 6 years in the US includes six vaccines at 2 months—a time when the immune system of an infant is compromised. “A challenge by so many vaccines while the immune system is compromised might contribute to an onset of autism.”

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Dr. Ratajczak hypothesizes that the residual human DNA found in the MMR II and Varivax (Chicken Pox) vaccines “might cause autism.”

“It is possible that autism results from more than one cause, with different manifestations in different individuals that share common symptoms…Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis following vaccination. Therefore, autism is the result of genetic defects and/or inflammation of the brain.”

“The incidence and prevalence data indicate the timing of introduction of vaccines and changes in the type and increasing number of vaccines given at one time implicate vaccines as a cause of autism.”

During the same “change-year” period, another environmental factor was introduced—antidepressants, such as Prozac, were being prescribed during pregnancy.

Selective Serotonin Reuptake Inhibitors (SSRI) antidepressants elevate serotonin levels. Studies suggest that an elevated level of serotonin during pregnancy could play an adverse role in brain development. Elevated serotonin levels were observed in autistic children.[2]

A 2009 study, “Serotonin, Pregnancy and Increased Autism Prevalence: Is There a Link?” [3] Suggests that increased serotonin during pregnancy may be the cause of brain dysfunction and abnormal oxytocin levels that underlie features of autism. Since their introduction (1987), SSRI antidepressants have been prescribed for pregnant women. CDC’s epidemiological data shows that Utah ranks highest in depression and in the use of antidepressants:  it also ranks highest in autism prevalence: “while we are lacking specific data on the prevalence of SSRI intake by pregnant women in Utah, the coincidence of highest SSRI intake and top ten autism rates in the same state, given what we have learned from the rodent model, certainly warrants further investigation.”3

A Kaiser Permanente study, “Antidepressant Use during Pregnancy and Childhood Autism Spectrum Disorders,” (2011)[4] compared 298 children with ASD and 1,507 randomly selected control children drawn from the Kaiser Northern California program. They reported a two-fold increased ASD risk for children exposed in utero to antidepressants—with a three-fold increased risk if exposed during the first trimester. There was no increased risk for children whose mothers had a history of psychiatric treatment.

Epidemiological data from CDC provides compelling evidence that autism cannot be attributed primarily to genetic causes—as vaccine promoters have claimed. The data consistently shows varied autism prevalence rates among states in the US. Most notably, Utah consistently ranks as the state with the highest number of prescriptions for antidepressants—and the highest autism prevalence rate among 14 states for which data was collected.

The IOM vaccine safety report (2011) acknowledges: [5]
“that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis”—a severe allergic reaction. The report equivocates about the majority of vaccine-linked adverse effects, claiming “the evidence was inadequate.”

In public pronouncements the claims made by the chair of the IOM committee were bombastic: “The M.M.R. vaccine doesn’t cause autism, and the evidence is overwhelming that it doesn’t. We looked at more than a thousand peer-reviewed articles, and we didn’t see many adverse effects caused by vaccines.”[6]

However, the bulk of those thousand articles were written to support the government vaccine policy, not to find possible causes of adverse effects.

The latest CDC estimated national average autism prevalence is 11.3 per 1,000 (1 in 88).
In Utah the autism prevalence rate skyrocketed to 21.2 per 1,000
.[7]

“Comparison of 2008 findings with those for earlier surveillance years indicated an increase in estimated ASD prevalence of 23% when the 2008 data were compared with the data for 2006… and an estimated increase of 78% when the 2008 data were compared with the data for 2002.”

Unanswered Questions from the Vaccine Injury Compensation Program (VICP)” by Mary Holland,[8] and colleagues, examined the legal history of the vaccine-autism issue. It was published in the Pace Environmental Law Review (2011).

When Congress enacted the National Childhood Vaccine Injury Act (1986)[9] it provided vaccine manufacturers broad liability protection “for vaccine-related injury or death”—and it shielded manufacturers from the duty to disclose the known risks to parents or guardians. The law deferred disclosure of risks to physicians—the presumed “learned intermediaries.” And it established the VICP to compensate children who had been injured.  At the time the law was passed, the recognized vaccine injuries were: anaphylaxis, encephalopathy, paralytic polio, chronic arthritis, residual seizure disorder, and death. To be eligible for compensation, all the injuries had to occur within 30 days of vaccination.  For injuries not listed on the VICP table, parents would have to prove causation. The VICP has compensated less than 1 in 5 of the total number of vaccine injury claims filed, and its decisions are shown to be inconsistent.

The catalyst for the VICP study was the unprecedented compensation for a child with autism.
A report submitted by HHS to the Court of Claims (2007) conceded for the first time that vaccines—nine doses in one visit—had triggered encephalopathy, developmental regression, and “autism-like symptoms” in Hannah Poling when she was 19 months old.  This landmark concession by the HHS panel of medical evaluators was made public in March 2008, by Dr. John Poling, [10] a practicing neurologist. The concession hinged on the presence of Hannah Poling’s underlying medical condition—mitochondrial dysfunction—which was deemed “very rare.” However, Dr. Poling disputes that it is rare: “mitochondrial dysfunction may be the most common medical condition associated with autism.”

Indeed, in June 2008, the United Mitochondrial Disease Foundation announced a “landmark research finding” published in the American Journal of Human Genetics:[11] Researchers found that “at least one in 200 healthy humans harbors a pathogenic mitochondrial mutation that potentially causes disease.”

The HHS concession—and subsequent compensation of more than $1.5 million—was granted even as the VICP rejected all the other 5,000 cases filed for vaccine-induced autism. The VICP website insists that while one case received compensation from the Omnibus, “HHS has never concluded in any case that autism was caused by vaccination.”[12]   But in an email response to a reporter (2009), an HHS official indicated that the government “may have compensated… some children with autism or autistic symptoms, but we do not track cases on this basis.”[13]  This surely is a perfect example of a deliberate institutional strategy of ignorance.[14]

 The Poling decision was made without any courtroom proceedings or expert testimony10—preventing the public from learning about the facts that led to Hannah’s injury or why her case is unique—as government officials would have us believe. Nevertheless, the concession shakes the ironclad unqualified defense of vaccine safety with regard to autism.

The Poling case and the acknowledgment (en passant) that the government does not track cases of vaccine-induced autism prompted Holland and colleagues to examine the VICP compensated cases.  head_in_sand.jpg

The VICP response to a Freedom of Information request for information and documents about VICP compensated vaccine injury claims was that it would take 4 or 5 years and would cost $750,000.   This is yet another example of an institutional strategy: erecting roadblocks to prevent access to information.

The authors engaged Pace Law School students who searched VICP cases that compensated for vaccine-induced brain damage, including autism.  Their findings revealed that VICP compensation records contradict the official denials. Their preliminary study shows that the VICP has in fact compensated at least 83 cases of children with autism. [8]

The VICP records pull the rug out from vaccine stakeholders who have steadfastly claimed that “no evidence exists linking autism to vaccines”—even in the face of the escalating “national emergency” of autism.

The authors raise the unanswered question: “Are the cases of “autism” that the VICP rejected in the Omnibus Autism Proceeding really different from the cases of “encephalopathy” and “residual seizure disorder” that the VICP compensated before and since?”

The most persuasive argument against awarding vaccine manufacturers total immunity from liability was made by Supreme Court Justice Sotomayor in her dissenting opinion in Bruesewitz v. Wyeth.[15]  Justice Sotomayor argued (and was joined by Justice Ginsberg) that the intent of the 1986 legislation that gave vaccine manufacturers immunity from liability for “unavoidably unsafe” vaccine design, was provisional—intended to indemnify them only for a design defect due to the limited scientific and technological knowledge at the time of manufacture—not intended to shield them from avoidable unsafe design.

“[The Court’s] decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products….neither the [Vaccine] Act nor any other provision of federal law places a legal duty on vaccine manufacturers to improve the design of their vaccines to account for scientific and technological advances. Indeed, the FDA does not condition approval of a vaccine on it being the most optimally designed among reasonably available alternatives, nor does it (or any other federal entity) ensure that licensed vaccines keep pace with technological and scientific advances.  Rather, the function of ensuring that vaccines are optimally designed in light of existing science and technology has traditionally been left to the States through the imposition of damages for design defects.

(“ ‘[T]he specter of damage actions may provide manufacturers with added dynamic incentives to continue to keep abreast of all possible injuries stemming from use of their product[s] so as to forestall such actions through product improvement’ ”)

Taxpayers are shouldering the burden of compensation–close to $2.5 billion for liability for vaccine-induced harm. The US Health Resources Administration reports that 2,999 vaccine injury claims have been compensated since 1989—and 9,445 were dismissed. Compensation for petitioners was $2.3 billion and $91.5 million was paid for attorney’s fees.[16]

The question that must be addressed: “How many cases of autism have vaccines caused and how can we prevent new injuries from occurring?”

Vera Sharav

This is Part IV of V

See Part I: The Whole System is Broken

Part II: What Do We Get for All That Money?

Part III: The Untouchable Third Rail of Healthcare: Vaccine Controversy

Part IV: Vaccine Injury Compensation

Part V: FDA the Duplicitous Gatekeeper

 

 



[1] Ratajczak, HV, Theoretical aspects of autism: Causes—A review, Journal of Immunotoxicology, 2011; 8(1): 68–79.  http://www.rescuepost.com/files/theoretical-aspects-of-autism-causes-a-review1.pdf Dr. Ratajczak waited until her retirement to write about vaccine safety and autism—because the issue is so contentious.

[2] Whitaker-Azmitia PM. Behavioral and Cellular Consequences of Increasing Serotonergic Activity During Brain Development: A Role in Autism? International J Developmental Neuroscience, 2005, Vol 23 cited by Hadjikhani.

[3] Hadjikhani N. Serotonin, pregnancy and increased autism prevalence: Is there a link?. Medical Hypotheses (2009).

[4] Croen LA, Gether, JK, Yoshida, CK, Odouli, R and Hendrick, V. Antidepressant Use During Pregnancy and Childhood Autism Spectrum Disorders, Archives of General Psychiatry, 2011

[5] “The committee finds that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis.” “However, for the majority of cases, the evidence was inadequate to accept or reject a causal relationship. Overall, the committee concludes that few health problems are caused by or clearly associated with vaccines.” See, Institute of Medicine. Report, Adverse Effects of Vaccines: Evidence and Causality, 2011

[6] Harris, G. “ Vaccine Cleared Again as Autism Culprit,” The New York Times, August 25, 2011.

[7] CDC. Prevalence of Autism Spectrum Disorders—ADS Monitoring Network, 14 Sites, US, 2008. MMWR Report, March 2012.

[8] Holland, M, Conte, L, Krakow, R and Colin, L. Unanswered Questions from the Vaccine Injury Compensation Program Pace Environmental Law Review, vol. 28, no. 2, 2011

[9]  National Childhood Vaccine Injury Act (1986) PL 99-660 shields vaccine manufacturers from  product liability: “No vaccine manufacturer shall be liable…if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

[10] Jon Poling: Mitochondrial Dysfunction Not Rare In Autism. Adventures in Autism Blog.  April 11, 2008. http://adventuresinautism.blogspot.com/2008/04/jon-poling-mitochondrial-dysfunction.html

[11] Elliott, HR, Samuels, DC, Eden, JA, Relton, CL, Chinnery, PF. Pathogenic Mitochondrial DNA Mutations Are Common in the General Population, The American Journal of Human Genetics, Vol.  83(2): 254-260, July  31, 2008.

[12] See, Vaccine Injury Compensation Program. Statistics Report (February 2011). US. DHHS, Health Resources and Services Administration (HRSA). http://www.hrsa.gov/vaccinecompensation/statistics_report.htm

[13] HRSA e-mail reprinted [p. 144] in: Vaccine Epidemic  See, Ref. 55

[14] McGoey, L The Logic of Strategic Ignorance, British Journal of Sociology, 2012, Vol. 63:533-76.

[15]  See Dissenting Opinion. Justice Sotomayor joined by Justice Ginsberg:  562 U. S. (2011) Supreme Court of the US Russell Bruesewitz, et al . v.Wyeth Laboratories, [February 22, 2011]  Dissenting.  http://www.law.cornell.edu/supct/html/09-152.ZD.html

[16] See, Vaccine Injury Compensation Program. Statistics Report (February 2011). US. DHHS, Health Resources and Services Administration (HRSA). http://www.hrsa.gov/vaccinecompensation/statistics_report.htm