Testimony on Maine LD 672 An Act Relating to Exemption from Immunization for Schoolchildren

Below is my written testimony on LD 672 An Act Relating to Exemption from Immunization for Schoolchildren, urging the state of Maine to provide parents with true informed consent in vaccination.

Vaccine information given to parents does not represent true informed consent.

1986 National Childhood Vaccine Injury Act (Vaccine Injury Compensation Act or VICA) http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf:

- Declares all FDA approved vaccines, "Unavoidably Unsafe," which means that they cannot be made safe for their intended use.

"The House Energy and Commerce Committee Report accompanying the Vaccine Act, H. R. Rep. No. 99–908, pt. 1 (1986) (hereinafter 1986 Report), explains in relevant part:

     “ Subsection (b)—Unavoidable Adverse Side Effects; Direct Warnings .—This provision sets forth the principle contained in Comment K of Section 402A of the Restatement of Torts (Second) that a vaccine manufacturer should not be liable for injuries or deaths resulting from unavoidable side effects even though the vaccine was properly prepared and accompanied by proper directions and warnings.

     “The Committee has set forth Comment K in this bill because it intends that the principle in Comment K regarding ‘unavoidably unsafe’ products, i.e., those products which in the present state of human skill and knowledge cannot be made safe, apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system.” Id. , at 25–26."

 - Justice Sotomayor , with whom Justice Ginsburg joins, dissenting, RUSSELL BRUESEWITZ, et al ., PETITIONERS v. WYETH LLC, 
http://www.law.cornell.edu/supct/html/09-152.ZD.html

- Provides blanket liability protection for all involved in vaccine design, production and distribution when injury or death from vaccine occurs.

- Provides that CDC Vaccine Information Sheets (VIS sheets) be provided to patients or their parents before any vaccine is administered so that they have informed consent.  http://www.cdc.gov/vaccines/pubs/vis/

- Establishes the HRSA Vaccine Injury Compensation Program, designed to be a compassionate program with a low burden of proof to provide for vaccine induce injury and death quickly (with in one year) to maintain confidence in the vaccine program. http://www.hrsa.gov/vaccinecompensation/index.html

27 years later the consequences of this well intended law have been devastating untold numbers of families, including mine.

1) The number of vaccines administered has skyrocketed:

• When Pharmaceutical companies realized that they had a product line for which the could not be held liable for injury and death, and that governments would market for them via school mandates, they poured considerable resources into R&D for vaccines and aggressively began to market those vaccines to HHS. 
  
  
  
  
• As a result, the Childhood vaccine schedule, unchanged for nearly 20 years, began to become inflated beginning in 1988, and is now almost three times what it was when the law was passed.
  
  
  
  
• If I were to have a child today, that baby would receive more doses of vaccine by the time it was six months old than I did by the time I went to college.
  
  
  
  
• The current vaccine schedule is untested as a whole, vaccines are recommended in combinations for which there is no safety testing, and doses are being added every year. 

2)  The HRSA Vaccine Injury Compensation Program (VICP) has become a farce.

• Claims were supposed to be processed and paid with in a year, however families languish in the program for ten years or more with out a ruling, reducing pay outs when the injured die before a ruling is made (as death can be capped at $250,000)
  
  
• An arbitrary three year statute of limitations prevents many from being able to take advantage of the program, as most families are never told that a medical condition for which a child (or adult) is being treated may be a vaccine injury and must find out on their own.
  
  
• The VICP which was supposed to be a non-adversarial process is extremely aggressive with families.  DOJ acts as the government's defense council and often treat parents seeking compensation as if they are criminals during hearings.
  
  
• Hearings are secret and petitioners may not bring anyone other than their lawyer into the proceedings.
  
  
• Families council are paid by VICP, so when lawyers are too aggressive in fighting for families, they are 'punished.'  Their billable hours are disputed, the disputes can go on for months or years, and when the fees are settled, VICP may take many more years to actually pay them.  Attny burnout is high and it is difficult to find anyone to take these cases any more.  I don't know of one in Maine who takes VICP cases.
  
  
• Special Masters have openly bragged in front of families that they are pleased at how quickly and how often they are able to dispense with cases.
  
  
• Families who "win" their cases do not receive money outright, but it is placed in an account for them, and they must apply to use the funds (the program has actually turned down requests, for example, when one little girl grew out of her wheelchair, the family requested a new one.  VICP turned the request down, saying they had already purchased her a wheel chair.)
  
  
• There is no prescient and rulings can contradict each other.
  
  
• Most importantly, when the program rules that a vaccine has caused an illness, disorder or disability, THAT INFORMATION IS NOT ADDED TO THE VIS SHEETS GIVEN TO PARENTS AND PATIENTS AT THE TIME OF VACCINATION.
  
  

3)  Parents and patients are NOT given informed consent as VICA (and LD 672 An Act Relating to Exemption from Immunization for Schoolchildren) intends

A) In the case of the condition that is commonly diagnosed as "Autism":

1. While many public health agencies either give the impression or outright state that vaccines do not cause autism, research into the VICP has found 83 autism cases that were paid by the program under the diagnosis of "Vaccine Encephalopathy," the medical term for brain damage. (http://www.ebcala.org/unanswered-questions)

This was approximately 40% of the sample of VICP Encephalopathy cases that were examined.  If this percentage holds true for the entire 1300+ cases paid by the program, VICP may have paid as many as 500 "autism" cases.

2.  The VICP Vaccine Injury Table actually lists the condition commonly known as "autism" as a outcome of the MMR and DTaP vaccine, but refers to it as "decreased level of consciousness/reduced consciousness."

Refer to Vaccine Injury Table and compare to the information provide to parents on the  DTaP VIS Sheet:

Parents are never told to look for  "decreased or absent eye contact," or told that it is a symptom of vaccine induced brain damage.
3.  HRSA has outright admitted that vaccines can cause the condition that is diagnosed as "autism."

When this legal maneuvering came to light after CNN aired a press conference given by The Poling family about their autistic daughter's VICP ruling, a reporter submitted a question to HRSA asking if this was an admission that vaccines can cause autism.  This is the statement that was issued by the Obama Administration (emphasis mine):

"From: Bowman, David (HRSA) [mailto:DBowman@hrsa.gov]

Sent: Friday, February 20, 2009 5:22 PM

To: 'dkirby@nyc.rr.com'

Subject: HRSA Statement

David,

In response to your most recent inquiry, HRSA has the following

statement:

The government has never compensated, nor has it ever been ordered to

compensate, any case based on a determination that autism was actually

caused by vaccines. We have compensated cases in which children

exhibited an encephalopathy, or general brain disease. Encephalopathy

may be accompanied by a medical progression of an array of symptoms

including autistic behavior, autism, or seizures.

Some children who have been compensated for vaccine injuries may have

shown signs of autism before the decision to compensate, or may

ultimately end up with autism or autistic symptoms, but we do not track

cases on this basis.

Regards,

David Bowman

Office of Communications

Health Resources and Services Administration

301-443-3376"
http://www.huffingtonpost.com/robert-f-kennedy-jr-and-david-kirby/vaccine-court-autism-deba_b_169673.html

Subsequently, other families began to share their VICP rulings with the public.  One such case was that of Bailey Banks, where the wording of the ruling left no question of wavering on the issue:

"The Court found that Bailey's ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey's ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD [an autism spectrum disorder]. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was... a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay." http://big.assets.huffingtonpost.com/BANKS_CASE.pdf

4.  The vast majority of research into the vaccine/autism link DOES find an association between vaccines and what is known as "autism."

I have attached 60 published papers to that effect in the appendix.

5.  Sanofi Pasteur now lists autism as a reported outcome on the vaccine package insert of their DTaP vaccine "Tripedia," and has since 2005. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM101580.pdf

DESPITE THIS AND MUCH MORE... PARENTS ARE NOT INFORMED THAT AUTISM IS AN OUTCOME THAT THEIR CHILD MAY HAVE FROM VACCINES

B)  Despite the fact that HRSA has ruled that the Hepatitis B vaccine can cause the deadly conditions of Multiple Sclerosis and Lupus, parents are not informed of this on the CDC VIS sheets:

VICP ruled in the case of Tambra Harris, that the deadly illness "she had suffered as a result of receiving a hepatitis B vaccination was systemic lupus erythematosus (SLE)."  (Note that ruling took ten years)
 - Louonia Denice Harris, Administratrix of the Estate of Tambra Harris, V. Secretary of the Department of Health and Human Services, No. 01-499V, March 23, 2011, http://www.uscfc.uscourts.gov/sites/default/files/CAMPBELL-SMITH.HARRIS032311.pdf

"Entitlement; Hep B vaccine; two months later, Devic's Disease (a variant of MS) then death."

- JANE DOE/29, Personal Representative of the Estate of DECEDENT, V. Secretary of the Department of Health and Human Services, No. [redacted]V, January 16, 2009, http://www.uscfc.uscourts.gov/sites/default/files/MILLMAN.DOE012109B_0.pdf

Despite this, CDC's web site claims the following:

"Numerous studies have evaluated a possible relationship between hepatitis B vaccination and multiple sclerosis (MS). The weight of the available scientific evidence does not support the suggestion that hepatitis B vaccine causes or worsens MS."

This leads is to an important question...

Why would HHS not want to disclose accurate risk information to parents? 

C)  HHS does not disclose that it is the patent holder on the HPV vaccine, and receives royalty checks on every dose of Merck's Gardasil and GSK's Cervarix.

HHS owns the patent through NIH, licenses the vaccine through FDA, recommends the vaccine through CDC, and is its own judge in vaccine injury cases through HRSA.

This gives HHS a powerful reason not to investigate Gardasil injury cases like Jenny Tetlock's.

In Conclusion:

The current VIS sheets DO NOT provide informed consent to parents in making vaccine decisions, and giving them to parents does not serve the stated intent of LD 672 "An Act Relating to Exemption from Immunization for Schoolchildren" to "provide to a parent of the child information about the benefits and risks of immunization..."

The Canary Party urges the State of Maine to engage in a thorough and critical examination of the CDC recommended vaccine schedule and undertake a dramatic overhaul of state vaccine policy and recommendations based in the information that has come to light on true vaccine risks in the last decade.

Vaccine policy should not be based merely on the reduction of communicable disease levels, but on overall health outcomes for children, including the true increased risk of autoimmune and neurological disorders that may be caused by an overaggressive and inappropriate vaccine schedule.

Electronic copies of this presentation and all documents can be found at:

Appendix

Research supporting the argument that vaccine induced brain injury can cause autism

1. Metabolic biomarkers of increased oxidative stress and impaired methylation capacity in children with autism

American Journal of Clinical Nutrition, Vol. 80, No. 6, 1611-1617, December 2004

2. Porphyrinuria in childhood autistic disorder: Implications for environmental toxicity

Toxicology and Applied Pharmacology, 2006

3.  Vaccine Safety Study as an Interesting Case of "Over-Matching"

M. Catherine DeSoto and Robert T. Hitlan, University of Northern Iowa, Cedar Falls, USA

4. Uncoupling of ATP-mediated Calcium Signaling and Dysregulated IL-6 Secretion in Dendritic Cells by Nanomolar Thimerosal

Environmental Health Perspectives, July 2006.

5.  Empirical Data Confirm Autism Symptoms Related to Aluminum and Acetaminophen Exposure

Entropy, November 7, 2012

6. Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing Thimerosal

Environmental Health Perspectives, Aug 2005.

7. Increases in the number of reactive glia in the visual cortex of Macaca fascicularis following subclinical long-term methyl mercury exposure.

Toxicology and Applied Pharmacology, 1994

8. Neuroglial Activation and Neuroinflammation in the Brain of Patients with Autism

Annals of Neurology, Feb 2005.

9. Autism: A Brain Disorder, or A Disorder That Affects the Brain?

Clinical Neuropsychiatry, 2005

10.  Activation of Methionine Synthase by Insulin-like Growth Factor-1 and Dopamine: a Target for Neurodevelopmental Toxins and Thimerosal

Molecular Psychiatry, July 2004.

11. Validation of the Phenomenon of Autistic Regression Using Home Videotapes

Archives of General Psychiatry, 2005 


12. Blood Levels of Mercury Are Related to Diagnosis of Autism: A Reanalysis of an Important Data Set

Journal of Child Neurology, Vol. 22, No. 11, 1308-1311 (2007)


13. Developmental Regression and Mitochondrial Dysfunction in a Child With Autism

Journal of Child Neurology / Volume 21, Number 2, February 2006


14. Oxidative Stress in Autism: Elevated Cerebellar 3-nitrotyrosine Levels

American Journal of Biochemistry and Biotechnology 4 (2): 73-84, 2008


15. Large Brains in Autism: The Challenge of Pervasive Abnormality

The Neuroscientist, Volume 11, Number 5, 2005.


16. Evidence of Toxicity, Oxidative Stress, and Neuronal Insult in Autism

Journal of Toxicology and Environmental Health, Nov-Dec 2006.


17. Oxidative Stress in Autism

Pathophysiology, 2006.


18. Thimerosal Neurotoxicity is Associated with Glutathione Depletion: Protection with Glutathione Precursors

Neurotoxicology, Jan 2005.


19. Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice

Neuromolecular Medicine, 2007


20. Environmental mercury release, special education rates, and autism disorder: an ecological study of Texas

Health & Place, 2006


21. Autism Spectrum Disorders in Relation to Distribution of Hazardous Air Pollutants in the SF Bay Area

Environmental Health Perspectives – Vol. 114 No. 9, September, 2006


22. A Case Series of Children with Apparent Mercury Toxic Encephalopathies Manifesting with Clinical Symptoms of Regressive Autistic Disorder

Journal of Toxicology and Environmental Health, 2007


23. Attention-deficit hyperactivity disorder and blood mercury level: a case-control study in chinese children

Neuropediatrics, August 2006 - P.R. Kong [Department of Pediatrics and Adolescent Medicine, The University of Hong Kong].


24. The Changing Prevalence of Autism In California 

Journal of Autism and Developmental Disorders, April 2003


25. Mitochondrial Energy-Deficient Endophenotype in Autism

American Journal of Biochemistry and Biotechnology 4 (2): 198-207, 2008


26. Bridging from Cells to Cognition in Autism Pathophysiology: Biological
Pathways to Defective Brain Function and Plasticity

American Journal of Biochemistry and Biotechnology 4 (2): 167-176, 2008


27. Heavy-Metal Toxicity—With Emphasis on Mercury

John Neustadt, ND, and Steve Pieczenik, MD, PhD


28. Evidence of Mitochondrial Dysfunction in Autism and Implications for Treatment

American Journal of Biochemistry and Biotechnology 4 (2): 208-217, 2008


29. Proximity to point sources of environmental mercury release as a predictor of autism prevalence

Health & Place, 2008


30. Epidemiology of autism spectrum disorder in Portugal: prevalence, clinical characterization, and medical conditions

Developmental Medicine & Child Neurology, 2007


31. Thimerosal induces neuronal cell apoptosis by causing cytochrome c and apoptosis-inducing factor release from mitochondria.

International Journal of Molecular Medicine, 2006


32. Mitochondrial mediated thimerosal-induced apoptosis in a human neuroblastoma cell line (SK-N-SH).

Neurotoxicology. 2005 


33. Possible Immunological Disorders in Autism: Concomitant Autoimmunity and Immune Tolerance 

The Egyptian Journal of Immunology, 2006 


34. Vaccines and Autism: What do Epidemiological Studies Really Tell Us

Coalition for SafeMinds

35. Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink.

Young HA, Geier DA, Geier MR.


36. Glutathione, oxidative stress and neurodegeneration


Eur J Biochem. 2000 Aug;267(16):4904-11.



37. Hepatitis B triple series vaccine and developmental disability in US children aged 1-9 years

Journal Toxicological & Environmental Chemistry, Volume 90, Issue 5 September 2008 , pages 997 - 1008


38. Induction of metallothionein in mouse cerebellum and cerebrum with low-dose thimerosal injection.

Cell Biology and Toxicology. 2009 Apr 9. [Epub ahead of print]


39. Mercury induces inflammatory mediator release from human mast cells

Journal of Neuroinflammation 2010, 7:20 doi:10.1186/1742-2094-7-20


40. Influence of pediatric vaccines on amygdala growth and opioid ligand binding in rhesus macaque infants: A pilot study

Acta Neurobiol Exp 2010, 70: 147–164 Polish Neuroscience Society - PTBUN, Nencki Institute of Experimental Biology


41. Cultured lymphocytes from autistic children and non-autistic siblings up-regulate heat shock protein RNA in response to thimerosal challenge.

Neurotoxicology. 2006 Sep;27(5):685-92. Epub 2006 Jun 16.


42. Hepatitis B Vaccination of Male Neonates and Autism

Annals of Epidemiology , Vol. 19, No. 9 ABSTRACTS (ACE), September 2009: 651-680, 
p. 659 


43. Neonatal administration of a vaccine preservative, thimerosal, produces lasting impairment of nociception and apparent activation of opioid system in rats.

Brain Res. 2009 Dec 8;1301:143-51. Epub 2009 Sep 9.


44. Sorting out the spinning of autism: heavy metals and the question of incidence

Acta Neurobiol Exp 2010, 70: 165–176


45. Urinary Porphyrin Excretion in Neurotypical and Autistic Children

Environ Health Perspect. 2010 Oct;118(10):1450-7. Epub 2010 Jun 24.

 46. Mitochondrial dysfunction in autism spectrum disorders: a systematic review and meta-analysis

Molecular Psychiatry advance online publication 25 January 2011;doi: 10.1038/mp.2010.136


47. Sensitization effect of thimerosal is mediated in vitro via reactive oxygen species and calcium signaling.

Toxicology. 2010 July - August;274(1-3):1-9. Epub 2010 May 10.

Migdal C, Foggia L, Tailhardat M, Courtellemont P, Haftek M, Serres M.


50. Theoretical aspects of autism: Causes—A review

Journal of Immunotoxicology, January-March 2011, Vol. 8, No. 1 , Pages 68-79


51. A Positive Association found between Autism Prevalence and Childhood Vaccination uptake across the U.S. Population

Journal of Toxicology and Environmental Health, Part A: Current Issues
Volume 74, Issue 14, 2011, Pages 903 - 916


52. Ancestry of pink disease (infantile acrodynia) identified as a risk factor for autism spectrum disorders.

J Toxicol Environ Health A. 2011 Sep 15;74(18):1185-94.
Shandley K, Austin DW.


53. Do aluminum vaccine adjuvants contribute to the rising prevalence of autism?

J Inorg Biochem. 2011 Nov;105(11):1489-99. Epub 2011 Aug 23.
Tomljenovic L, Shaw CA.


54. Lasting neuropathological changes in rat brain after intermittent neonatal administration of thimerosal.


55.  Hepatitis B vaccine induces apoptotic death in Hepa1-6 cells

Apoptosis. 2012 Jan 17.  Hamza H, Cao J, Li X, Li C, Zhu M, Zhao S.


56.  Risk Factors for Autistic Regression: Results of an Ambispective Cohort Study.

J Child Neurol. 2012 Jan 30. [Epub ahead of print]


57.  Adverse events following 12 and 18 month vaccinations: a population-based, self-controlled case series analysis.

PLoS One. 2011;6(12):e27897. Epub 2011 Dec 12.


58.  Administration of thimerosal to infant rats increases overflow of glutamate and aspartate in the prefrontal cortex: protective role of dehydroepiandrosterone sulfate.

Neurochem Res. 2012 Feb;37(2):436-47. Epub 2011 Oct 21.


59.  Neonatal Administration of Thimerosal Causes Persistent Changes in Mu Opioid Receptors in the Rat Brain

Neurochem Res. 2010 November; 35(11): 1840–1847.

60.  Unanswered Questions: A Review of Compensated Cases of Vaccine-Induced Brain Injury

Pace Environmental Law Review, vol. 28, no. 2, 2011