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EVIDENCE OF HARM - Presentation 1/11/05

EVIDENCE OF HARM - Presentation 1/11/05. David Kirby. THE FAMILIES: KEY TO THIS STORY THE SCIENCE PART I: CAUSES OF AUTISM THE LAW: COMPENSATION, LITIGATION, INVESTIGATION THE POLITICS: PHARMA & THE FEDS THE SCIENCE PART II: SEARCH FOR A “CURE”. THE SCIENCE: SEARCH FOR A CAUSE

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EVIDENCE OF HARM - Presentation 1/11/05

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  1. EVIDENCE OF HARM - Presentation 1/11/05 David Kirby Evidence of Harm

  2. Evidence of Harm

  3. THE FAMILIES: KEY TO THIS STORY • THE SCIENCE PART I: CAUSES OF AUTISM • THE LAW: COMPENSATION, LITIGATION, INVESTIGATION • THE POLITICS: PHARMA & THE FEDS • THE SCIENCE PART II: SEARCH FOR A “CURE” Evidence of Harm

  4. THE SCIENCE: SEARCH FOR A CAUSE The etiology of autism Evidence of Harm

  5. AUTISM BY THE NUMBERS: US & EUROPE • USA - 1980’s: 1-2 per 10,000 children • USA – Late 1990’s: 1 in 500 (20 per 10K) • USA – 2000: 1 in 250 (40 per 10K) • USA – 2004: 1 in 166 (60 per 10K) ------------- • UK – 2004: 1 in 166 (60 per 10K) • Denmark – 2004: 1 in 1,300(7.7 per 10K) Evidence of Harm

  6. OTHER POSSIBLE ENVIRONMENTAL “TRIGGERS”?? • Mercury in fish/air/amalgams • Pesticides • PCB’s • Flame retardants • Jet fuel • Live virus in vaccines (MMR) • As-yet unidentified virus • Rampant cell phone use Evidence of Harm

  7. KNOW YOUR MERCURY (Hg) TYPE SOURCE EXPOSURE Elemental Hg Thermometers Vapor Amalgams Lights/batteries Inorganic Hg Coal power plants Air pollutants (hydrophilic) Volcanoes Organic Methyl Hg Fish Ingestion (lypophilic) Organic Ethyl Hg Thimerosal Vaccines (lypophilic) Fish(?) OTC Topicals Evidence of Harm

  8. ETHYL VS METHYL • Main chemical difference: Ethyl form contains extra carbon compound on molecule, making it larger. • Some scientists contend extra carbon compound makes ethylmercury less likely to cross the blood-brain barrier. • Methylmercury shown to remain in blood longer than ethyl (1/2 life of 50 days vs. 7 days for ethyl); it accumulates more readily in the body. But ethyl converts more readily to inorganic Hg, which appears to remain in brain longer. • Despite these differences, FDA researchers assumed that the two forms of mercury were equal in toxicity. • Arsenic is “less toxic” than cyanide. Evidence of Harm

  9. HOW MUCH Hg IS TOO MUCH? EPA SAFETY LIMIT: 0.1 mcg* per kg per day (Methylmercury) Avg. 6oz TUNA STEAK (@17mcg/oz): 102 mcg Avg. 6oz SWORDFISH STEAK (@30mcg/OZ) 180 mcg Avg. VACCINE: 25mcg ________________ EPA SAFETY LIMIT FOR: Tuna Swordfish Vaccine 165 lb man = 8 mcg/day 12.8x 22.5x 3x 110 lb woman = 5mcg/day 20.4x 36.0x 5x 16 lb infant = 0.7mcg/day -- -- 35.7x (6 Months old) *1mcg = 1 millionth of a gram

  10. Maximum Hg exposure in 1st year of life - US Childhood Schedule - 1992-200? AGE SHOTS HG CONTENT BIRTH Hep B 12.5mcg 8lb infant (3.6kg)– EPA Hg limit: 0.36mcg = 35 times over 4lb infant (1.8kg) – EPA Hg limit: 0.18mcg = 70 times over 2 MONTHS Hep B 12.5mcg HIb 25.0mcg DTaP 25.0mcg (subtotal for visit): 62.5mcg Avg. weight: 10lbs/4.5kg EPA limit: 0.45mcg = 138 times over 4 MONTHS HIb 25.0mcg DTaP 25.0 mcg (subtotal for visit): 50.0 mcg Avg weight: 14lbs/6.5kg EPA limit: 0.65mcg = 72 times over

  11. Maximum Hg exposure in 1st year of life - US Childhood Schedule - 1992-200? AGE SHOTS HG CONTENT 6 MONTHS HiB 25.0mcg DTaP 25.0mcg (subtotal for visit): 50.0mcg Avg. weight: 16lbs/7.3kg EPA limit: 0.73mcg = 68 times over 12 MONTHS HiB 25.0mcg DTaP 25.0mcg (subtotal for visit): 50.0mcg Avg. weight: 20lbs/9kg EPA Hg limit: 0.9mcg = 55 times over TOTAL Hg EXPOSURE IN FIRST YEAR: 212.5mcg

  12. Bolus vs. Chronic ExposureFDA’s “Interpretation” • FDA totaled 4 large “bolus” doses at birth, 2, 4, & 6 months (162.5mcg) and divided by 180 days. • 162.5mcg divided by 180 = 0.9mcg per day. • This “average” daily exposure was just above the EPA limit, but below FDA and CDC limits. • Analogy: You can take 2 tylenol a day for 60 days and be fine. But 120 tylenol in one day is a lethal dose. Evidence of Harm

  13. Safe Minds: Common Symptoms of Autism & Mercury Poisoning IMPAIRMENTS IN SOCIABILITY

  14. IMPAIRMENTS IN SPEECH AND LANGUAGE Evidence of Harm

  15. SENSORY AND MOTOR ABNORMALITIES Evidence of Harm

  16. SIMILARITIES ALSO FOUND IN: Unusual Behaviors (Mad Hatters) Cognitive Impairments Visual Impairments Physical Disturbances Gastrointestinal Disturbances Abnormal Biochemistry Immune Dysfunction CNS Structural Pathology Abnormalities in Neurochemistry Neurophysiology

  17. ACRODYNIA (PINK DISEASE)Cause: Inorganic Hg used in teething powders • Afflicted tens of thousands of children in 1930-1950’s. • Symptoms: weepy rash, peeling skin, lethargy, anemia, sensitivity to light, respiratory distress, general ill health. • 1-in-500 exposed children developed the disease. • Years passed before mercury poisoning was gradually accepted as the cause, despite stiff resistance by industry. • By 1954, most mercury was eliminated from teething powders. Companies feared adverse publicity and lawsuits. • Cases soon fell sharply and then disappeared entirely. • Today, Pink disease is virtually unheard of.

  18. CHILD WITH ACRODYNIA CHILD WITH AUTISM (Mercurypoisoning) (Will Redwood) Evidence of Harm

  19. INJECTING POISON? Evidence of Harm

  20. 1991: LILLY WARNING ON THIMEROSAL TOXICITY

  21. 1999 MSDS: “Nervous System and Reproduction Effects; Effects of exposure include fetal changes; Mercury poisoning may occur; Exposure in children may cause mild to severe mental retardation; Hypersensitivity to mercury is a medical condition aggravated by exposure; Hazardous substance, toxic waste disposal." 1991 MSDS: “Use of chelating agents may be needed to treat ingestion of mercury”

  22. Evidence of Harm

  23. What is CHELATION? • From Greek chele, or claw. • Developed for lead poisoning by Army. • Sulfur-based agents bind with heavy metals. • Use ONLY under doctor’s supervision. • Two main agents currently in use: DMSA: Di-Mercapto-Succinic Acid IV, or more typically in children, orally DMPS: Di-Mercapto-Propane-Sulfonate Transdermal patch (untested, controversial, more potent?) Evidence of Harm

  24. Chelation results from autistic child Evidence of Harm

  25. TOTAL Hg BURDEN AND AUTISM RATES IN CALIFORNIA 1985-98 Evidence of Harm

  26. BOYD HALEY – NEUROTOXICITY CHARTS Evidence of Harm

  27. BRADSTREET ET. AL. – Autistic kids excrete 6 times more Hg Evidence of Harm

  28. Mercury is high, cadmium & lead levels similar (autistic vs. controls) Evidence of Harm

  29. Holmes, Haley and Blaxill Baby Haircut Study 2003Autistic vs. Controls Evidence of Harm

  30. Holmes, Haley and Blaxill Mild vs. Moderate vs. Severe Evidence of Harm

  31. Mady Hornig – Columbia University Hornig used one mouse strain with genetic Hg sensitivity and autoimmunity and two strains without them, then replicated the immunization schedule using thimerosal-containing vaccines. • Sensitive mice showed significant delay in weight gain. • Sensitive mice had enlarged brains, noted in autistic children, vs. controls. • “Behavioral impoverishment” was highly significant the sensitive strain. • 40 percent of sensitive mice were “self-mutilatory” at six months, ie, frantically grooming or biting tails. • One mouse groomed through partner’s skull.

  32. AGAINST THE THIMEROSAL THEORY: MAJOR PLAYERS • ELI LILLY & CO – Invented product, has license agreements until 2010; defendant in lawsuits. • MERCK, GLAXO, ETC – Vaccine makers, lawsuit defendants. • FDA – “Asleep at the switch” - Failed to add Hg totals; no safety studies; poor lit review (missed articles in own library); refusal to recall. • CDC – Conflict in promoting and monitoring vaccines; aggressive use of immunization schedule; secret analyses of embargoed government data; funding of questionable studies; refusal to recommend Hg-free vaccines. • AAP-PEDIATRICIANS – Unquestioning support of childhood vaccine schedule; lobbied for Hep.B birth dose; frequent criticism of thimerosal theorists.

  33. AGAINST THE THIMEROSAL THEORY: MAJOR POINTS • No epidemic of autism (the Hidden Horde?). • Hg levels in vaccines very low. • Ethyl Hg “less toxic” than Methyl Hg (Pichichero, NIAID, Offit). • Autism not same as Hg poisoning (Nelson & Bauman). • Theory is motivated by greed, emotion, & revenge. • 4-year CDC study of federal database shows little to no neurological damage from Hg in childhood vaccines. • No “consistent” evidence of harm found in five major epidemiological studies: IOM.

  34. OFFICIAL STATEMENT: US Centers for Disease Control and Prevention (CDC) • “Mercury occurs naturally and is found everywhere in the environment.” • “The level of mercury exposure from vaccines is low.” • “Evidence is accumulating of lack of harm resulting from exposure to thimerosal in vaccines.” Evidence of Harm

  35. OFFICIAL STATEMENT: World Health Organization (WHO) “The latest studies do not support concerns over safety of thiomersal in vaccines. There is no reason to change current immunization practices, since the benefit outweighs any unproven risks.” Evidence of Harm

  36. OFFICIAL STATEMENT:Committee on Safety of Medicines (CSM) –United Kingdom “There is no reliable evidence of neurological adverse effects caused by thiomersal in vaccines. The balance of benefits and risks of thiomersal-containing vaccines therefore remains overwhelmingly positive.” Evidence of Harm

  37. THIMEROSAL EXPOSURE & AUTISM RATES IN SWEDEN: 1980-1996 Evidence of Harm

  38. THIMEROSAL EXPOSURE & AUTISM RATES IN DENMARK 1981-2000 Evidence of Harm

  39. VACCINE SAFETY DATALINK (VSD) • Seven HMOs, including Kaiser. • $25 million in taxpayer funding. • Medical records of 400,000 children, including shots and dx’s. • Source of 4 year CDC study, including unpublished, alarming data. • Currently used to detect bioterror. • Virtually off limits to public. Evidence of Harm

  40. VSD 5 GENERATIONS Evidence of Harm

  41. Generation “Zero”Nov-Dec 1999 Recently rediscovered. First run of the numbers. Very high relative risks for outcomes. Autism RR = 7.6 UNPUBLISHED STUDY OBTAINED THROUGH FOIA

  42. Generation 1 Verstraeten 2/2000 Verstraeten reruns numbers, risks are lower. Still, significant outcomes “just won’t go away.” Autism RR = 2.48 UNPUBLISHED STUDY OBTAINED THROUGH FOIA Evidence of Harm

  43. Generation 2: Simpsonwood - ACIP 6/2000 CDC, FDA, AAP, PHARMA, etc. meet in secret on Hg and NDDs. Verstraeten presents at public CDC meeting, says RR’s for outcomes increase with rising exposure. Autism RR = 1.69. SIMPSONWOOD MINUTES OBTAINED THROUGH FOIA – ACIP MINUTES NEVER POSTED ONLINE Evidence of Harm

  44. Generation 3: IOM 7/2001 Verstraeten presents at IOM on same day he begins work at Glaxo. By this time, more children have been added to study population, and RR’s have been reduced even further. HMO C shows no “consistent” evidence of harm. Autism RR = 1.52. Evidence of Harm

  45. Generation 4: Pediatrics 11/2003 Final version of study published 4 years after it began. Relative risks for all outcomes reduced to null or near null. Autism RR: NO LONGER STUDIED. Evidence of Harm

  46. Evidence of Harm

  47. “IT JUST WON’T GO AWAY” Evidence of Harm

  48. VSD: Generation Zero Evidence of Harm

  49. VSD Generation 1: Autism(Verstraeten – 2/2000) Evidence of Harm

  50. VSD Generation 2: Autism(Simpsonwood & ACIP 6/2000) Evidence of Harm

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