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

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

2 Evidence of Harm 2

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

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

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

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

7 Evidence of Harm 7 KNOW YOUR MERCURY (Hg) TYPE SOURCEEXPOSURE Elemental HgThermometersVapor AmalgamsLights/batteries Inorganic HgCoal power plantsAir pollutants (hydrophilic)Volcanoes Organic Methyl HgFishIngestion (lypophilic) Organic Ethyl HgThimerosalVaccines (lypophilic)Fish(?)OTC Topicals

8 Evidence of Harm 8 ETHYL VS METHYL Main chemical difference: Ethyl form contains extra carbon compound on molecule, making it larger. 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. 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. 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. Despite these differences, FDA researchers assumed that the two forms of mercury were equal in toxicity. Arsenic is less toxic than cyanide. Arsenic is less toxic than cyanide.

9 9 HOW MUCH Hg IS TOO MUCH? EPA SAFETY LIMIT: 0.1 mcg* per kg per day (Methylmercury) Avg. 6oz TUNA STEAK : 102 mcg Avg. 6oz SWORDFISH STEAK 180 mcg Avg. VACCINE: 25mcg ________________ EPA SAFETY LIMIT FOR:TunaSwordfish Vaccine 165 lb man = 8 mcg/day12.8x 22.5x3x 110 lb woman = 5mcg/day20.4x 36.0x 5x 16 lb infant = 0.7mcg/day x (6 Months old) *1mcg = 1 millionth of a gram

10 10 Maximum Hg exposure in 1 st year of life - US Childhood Schedule ? AGESHOTSHG CONTENT BIRTHHep B12.5mcg 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 MONTHSHep B12.5mcg HIb25.0mcg DTaP25.0mcg (subtotal for visit): 62.5mcg Avg. weight: 10lbs/4.5kg EPA limit: 0.45mcg = 138 times over 4 MONTHSHIb25.0mcg DTaP25.0 mcg (subtotal for visit):50.0 mcg Avg weight: 14lbs/6.5kg EPA limit: 0.65mcg = 72 times over

11 11 Maximum Hg exposure in 1 st year of life - US Childhood Schedule ? AGESHOTSHG CONTENT 6 MONTHSHiB25.0mcg DTaP25.0mcg (subtotal for visit):50.0mcg Avg. weight: 16lbs/7.3kg EPA limit: 0.73mcg = 68 times over 12 MONTHS HiB25.0mcg DTaP25.0mcg (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 Evidence of Harm 12 Bolus vs. Chronic Exposure FDAs Interpretation FDA totaled 4 large bolus doses at birth, 2, 4, & 6 months (162.5mcg) and divided by 180 days. FDA totaled 4 large bolus doses at birth, 2, 4, & 6 months (162.5mcg) and divided by 180 days mcg divided by 180 = 0.9mcg per day mcg divided by 180 = 0.9mcg per day. This average daily exposure was just above the EPA limit, but below FDA and CDC limits. 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. Analogy: You can take 2 tylenol a day for 60 days and be fine. But 120 tylenol in one day is a lethal dose.

13 13 Safe Minds: Common Symptoms of Autism & Mercury Poisoning IMPAIRMENTS IN SOCIABILITY Mercury PoisoningAutism Social deficits, shyness, social withdrawal Social deficits, social withdrawal, shyness Depression, mood swings; mask face Depressive traits, mood swings; flat affect Anxiety Lacks eye contact, hesitant to engage others Lack of eye contact, avoids conversation Irrational fears Irritability, aggression, temper tantrums Impaired face recognition Schizoid tendencies, OCD traits Schizophrenic & OCD traits Repetitive, stereotypic behaviors

14 Evidence of Harm 14 IMPAIRMENTS IN SPEECH AND LANGUAGE Mercury PoisoningAutism Loss of speech, failure to develop speech Delayed language, failure to develop speech Dysarthria; articulation problems Speech comprehension deficits Verbalizing & word retrieval problems Echolalia; word use & pragmatic errors Hearing loss; deafness in very high doses Mild to profound hearing loss Poor performance on language IQ tests Poor performance on verbal IQ tests

15 Evidence of Harm 15 SENSORY AND MOTOR ABNORMALITIES Mercury PoisoningAutism Abnormal sensation in mouth & extremities Sound sensitivity Abnormal touch sensations; touch aversion Impaired visual fixationProblems with joint attention Involuntary jerking movements – arm flapping, ankle jerks, circling, rocking Stereotyped movements - arm flapping, jumping, circling, spinning, rocking Deficits in eye-hand coordination; limb apraxia; intention tremors Poor eye-hand coordination; limb apraxia; problems with intentional movements Gait impairment; ataxia – from incoordination & clumsiness to inability to walk, stand, or sit; loss of motor control Abnormal gait and posture, clumsiness and incoordination; difficulties sitting, lying, crawling, and walking Difficulty in chewing or swallowing Difficulty chewing or swallowing Unusual postures; toe walking

16 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 17 ACRODYNIA (PINK DISEASE) Cause: Inorganic Hg used in teething powders Afflicted tens of thousands of children in s. Afflicted tens of thousands of children in s. Symptoms: weepy rash, peeling skin, lethargy, anemia, sensitivity to light, respiratory distress, general ill health. Symptoms: weepy rash, peeling skin, lethargy, anemia, sensitivity to light, respiratory distress, general ill health. 1-in-500 exposed children developed the disease. 1-in-500 exposed children developed the disease. Years passed before mercury poisoning was gradually accepted as the cause, despite stiff resistance by industry. 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. By 1954, most mercury was eliminated from teething powders. Companies feared adverse publicity and lawsuits. Cases soon fell sharply and then disappeared entirely. Cases soon fell sharply and then disappeared entirely. Today, Pink disease is virtually unheard of. Today, Pink disease is virtually unheard of.

18 Evidence of Harm 18 CHILD WITH ACRODYNIACHILD WITH AUTISM (Mercury poisoning) (Will Redwood)

19 Evidence of Harm 19 INJECTING POISON?

20 : LILLY WARNING ON THIMEROSAL TOXICITY

21 MSDS: Use of chelating agents may be needed to treat ingestion of mercury 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."

22 Evidence of Harm 22

23 Evidence of Harm 23 What is CHELATION? From Greek chele, or claw. From Greek chele, or claw. Developed for lead poisoning by Army. Developed for lead poisoning by Army. Sulfur-based agents bind with heavy metals. Sulfur-based agents bind with heavy metals. Use ONLY under doctors supervision. Use ONLY under doctors supervision. Two main agents currently in use: 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?)

24 Evidence of Harm 24 Chelation results from autistic child

25 Evidence of Harm 25 TOTAL Hg BURDEN AND AUTISM RATES IN CALIFORNIA

26 Evidence of Harm 26 BOYD HALEY – NEUROTOXICITY CHARTS

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

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

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

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

31 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 showed significant delay in weight gain. Sensitive mice had enlarged brains, noted in autistic children, vs. controls. Sensitive mice had enlarged brains, noted in autistic children, vs. controls. Behavioral impoverishment was highly significant the sensitive strain. 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. 40 percent of sensitive mice were self-mutilatory at six months, ie, frantically grooming or biting tails. One mouse groomed through partners skull. One mouse groomed through partners skull.

32 32 AGAINST THE THIMEROSAL THEORY: MAJOR PLAYERS ELI LILLY & CO – Invented product, has license agreements until 2010; defendant in lawsuits. ELI LILLY & CO – Invented product, has license agreements until 2010; defendant in lawsuits. MERCK, GLAXO, ETC – Vaccine makers, lawsuit defendants. 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. 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. 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. AAP-PEDIATRICIANS – Unquestioning support of childhood vaccine schedule; lobbied for Hep.B birth dose; frequent criticism of thimerosal theorists.

33 33 AGAINST THE THIMEROSAL THEORY: MAJOR POINTS No epidemic of autism (the Hidden Horde?). No epidemic of autism (the Hidden Horde?). Hg levels in vaccines very low. Hg levels in vaccines very low. Ethyl Hg less toxic than Methyl Hg (Pichichero, NIAID, Offit). Ethyl Hg less toxic than Methyl Hg (Pichichero, NIAID, Offit). Autism not same as Hg poisoning (Nelson & Bauman). Autism not same as Hg poisoning (Nelson & Bauman). Theory is motivated by greed, emotion, & revenge. 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. 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. No consistent evidence of harm found in five major epidemiological studies: IOM.

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

35 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.

36 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.

37 Evidence of Harm 37 THIMEROSAL EXPOSURE & AUTISM RATES IN SWEDEN:

38 Evidence of Harm 38 THIMEROSAL EXPOSURE & AUTISM RATES IN DENMARK

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

40 Evidence of Harm 40 VSD 5 GENERATIONS

41 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 UNPUBLISHED STUDY OBTAINED THROUGH FOIA

42 Evidence of Harm 42 Generation 1 Verstraeten 2/2000 Verstraeten reruns numbers, risks are lower. Still, significant outcomes just wont go away. Autism RR = 2.48 UNPUBLISHED STUDY OBTAINED THROUGH FOIA

43 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 RRs for outcomes increase with rising exposure. Autism RR = SIMPSONWOOD MINUTES OBTAINED THROUGH FOIA – ACIP MINUTES NEVER POSTED ONLINE

44 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 RRs have been reduced even further. HMO C shows no consistent evidence of harm. Autism RR = 1.52.

45 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. Autism RR: NO LONGER STUDIED.

46 Evidence of Harm 46

47 Evidence of Harm 47 IT JUST WONT GO AWAY

48 Evidence of Harm 48 VSD: Generation Zero

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

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

51 Evidence of Harm 51 VSD Generation 3: Autism (IOM Presentation 7/2001)

52 Evidence of Harm 52 VSD Generation 4: Autism (Pediatrics Article, 11/2003) Vol. 112 No. 5 November 2003, pp

53 Evidence of Harm 53 Generation 4: All Outcomes HMO A: Cumulative exposure at 3 months resulted in a significant positive association with tics (RR:1.89) HMO A: Cumulative exposure at 3 months resulted in a significant positive association with tics (RR:1.89) HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13) and 7 months (RR: 1.07) HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13) and 7 months (RR: 1.07) HMO C, no significant associations were found. HMO C, no significant associations were found. CONCLUSION: No consistent significant associations were found between for neuro- developmental outcomes. Conflicting results were found at different HMOs for certain outcomes. CONCLUSION: No consistent significant associations were found between for neuro- developmental outcomes. Conflicting results were found at different HMOs for certain outcomes.

54 Evidence of Harm Autism Risks Across 5 Generations GEN 0GEN 1GEN 2GEN 3 GEN

55 Evidence of Harm 55 Generation 2: NDDs (Simpsonwood & ACIP 6/2000)

56 Evidence of Harm 56 Generation 2: Language Disorder (Simpsonwood & ACIP 6/2000)

57 Evidence of Harm 57 COMPLIANCE RATES AND OUTCOME RATES AT THREE HMOS HMO BHMO AHMO C (NCK)(GHC)(HP) Population size114,96515,92917,547 Compliance rate15%60%65% (at three months of age) NDD rate1.3%3.9%n/a Speech delay rate2.6%3.9%4.5%

58 Evidence of Harm 58

59 Evidence of Harm 59

60 60 Young Cohort Reduces Signal Over one quarter of the children were under the age of ascertainment for autism - 44 months - causing the signal to disappear. – Mark Blaxill Over one quarter of the children were under the age of ascertainment for autism - 44 months - causing the signal to disappear. – Mark Blaxill There is certainly an under-ascertainment of cases. Some children are just not old enough to be diagnosed. Crude incidence rates are much lower because the cohort is still very young. – Thomas Verstraeten There is certainly an under-ascertainment of cases. Some children are just not old enough to be diagnosed. Crude incidence rates are much lower because the cohort is still very young. – Thomas Verstraeten A CDC official accepted the critics charge that it contained many children too young to be diagnosed as autistic. This is true, said scientist Frank DeStefano, Neil Munro, National Journal A CDC official accepted the critics charge that it contained many children too young to be diagnosed as autistic. This is true, said scientist Frank DeStefano, Neil Munro, National Journal We found no evidence against an association, as a negative study would. On the contrary, additional study is recommended, which is the conclusion to which a neutral study must come. – T. Verstraeten We found no evidence against an association, as a negative study would. On the contrary, additional study is recommended, which is the conclusion to which a neutral study must come. – T. Verstraeten

61 Evidence of Harm 61 THE LAW: COMPENSATION LITIGATION INVESTIGATION

62 Evidence of Harm 62 COMPENSATION: Vaccine Court Created by Congress in 1986 Created by Congress in 1986 VICP – 75 cent per shot tax VICP – 75 cent per shot tax No fault, non adversarial No fault, non adversarial Autism Omnibus Proceedings - DELAYED Autism Omnibus Proceedings - DELAYED 3 year statute of limitations – No window 3 year statute of limitations – No window Low pay out rate Low pay out rate No interim lawyer fees No interim lawyer fees Hard to collect awards Hard to collect awards Adversarial, Govt lawyers fight each case Adversarial, Govt lawyers fight each case In need of reform In need of reform

63 Evidence of Harm 63 LITIGATION: Civil Court PRIVATE SUITS IN PROGRESS PRIVATE SUITS IN PROGRESS Counter, New Orleans, Baltimore Easter Case in Texas now in discovery & depositions (FDA, CDC, IOM) Daubert Hearing in late January Jury trial in March? (If not settled) SUITS PENDING – Redwood, Bono et al SUITS PENDING – Redwood, Bono et al CLASS ACTION SUITS? CLASS ACTION SUITS?

64 Evidence of Harm 64 INVESTIGATION: What did FDA Know and When? Europe – 1998; FDA library. Failed to add up Hg Burden. Failed to recall. Patriarca s:. Conversion of % of thimerosal to actual micrograms of Hg involves 9th grade algebra. What took the FDA so long? Perception that FDA, CDC etc were asleep at the switch.

65 65 What did Lilly Know and When? letter to Eli Lilly: Unsatisfactory as a preservative intended for dogs letter to Eli Lilly: Unsatisfactory as a preservative intended for dogs Article received: "It may be dangerous to inject a serum containing [thimerosal] into a sensitive patient Article received: "It may be dangerous to inject a serum containing [thimerosal] into a sensitive patient Article received: Important to determine whether harm results following injection in sensitive individuals Article received: Important to determine whether harm results following injection in sensitive individuals NY Academy of Science: Thimerosal is toxic when injected parenterally and cannot be used in chemotherapy NY Academy of Science: Thimerosal is toxic when injected parenterally and cannot be used in chemotherapy Science department requests that claim "non-toxic" on labels be deleted Science department requests that claim "non-toxic" on labels be deleted Article: Merthiolate in vaccines caused six deaths. The symptoms suggest subacute mercury poisoning Article: Merthiolate in vaccines caused six deaths. The symptoms suggest subacute mercury poisoning Language added to labels: "If pregnant or nursing, seek the advice of a health professional before using Language added to labels: "If pregnant or nursing, seek the advice of a health professional before using.

66 Evidence of Harm 66 SIMPSONWOOD – On The Chatahoochee River June 2000 June 2000 Private meeting between CDC, FDA, AAP, Pharma, etc. Minutes VIA FOIA. Private meeting between CDC, FDA, AAP, Pharma, etc. Minutes VIA FOIA. Unpublished toxicity data discussed. Unpublished toxicity data discussed. Rubber stamp for CDC VSD analysis? Rubber stamp for CDC VSD analysis?

67 Evidence of Harm 67 SIMPSONWOOD: CHOICE QUOTES I was actually stunned by what I saw, because I thought it is plausible... So the bottom line is, okay, our signal will simply not just go away. Thomas Verstraeten

68 Evidence of Harm 68 SIMPSONWOOD: CHOICE QUOTES I was actually stunned by what I saw, because I thought it is plausible... So the bottom line is, okay, our signal will simply not just go away. Thomas Verstraeten

69 Evidence of Harm 69 CDC is not in favor of expressing a preference for thimerosal free vaccines, for fear of alienating other manufacturers and disrupting a free market economy. from Dr. Thomas Saari

70 Evidence of Harm 70 That further brings things down. So you can push, and I can pull. But there has been substantial movement from this very highly significant result, down to a fairly marginal result. Dr. Phillip Rhodes – CDC/NIP Statistician

71 Evidence of Harm 71 You can play with this all you want, but the relationships are linear and statistically significant… Weve got a serious problem. To think there isnt some possible problem here is unreal. Dr. William Weil, Pediatrician - AAP

72 Evidence of Harm 72 It will be a resource to our very busy plaintiff attorneys when this becomes available… this could potentially be a lot of business. The medical and legal findings in this study, causal or not, are horrendous. Dr. Robert Brent, Thomas Jefferson University

73 Evidence of Harm 73 You could readily find a junk scientist who would support the claim with a reasonable degree of certainty. But you wont find a scientist with any integrity who would say the reverse with the data available. Were in a bad position from defending lawsuits. I am concerned. Dr. Robert Brent, Thomas Jefferson University

74 Evidence of Harm 74 What if the lawyers get hold of this? Theres not a scientist in the world who can refute these findings. from Dr. Thomas Saari

75 Evidence of Harm 75 My gut feeling? It worries me enough. My daughter-in-law (just) delivered a son, and I do not want that grandson to get a thimerosal containing vaccine until we know better what is going on. Dr. David Johnson, ACIP

76 Evidence of Harm 76 Conflicts of interest? Members of the FDA and CDC advisory committees owned stock in drug companies that make vaccines. Members of the FDA and CDC advisory committees owned stock in drug companies that make vaccines. Some owned patents for vaccines under consideration or affected by committee. Some owned patents for vaccines under consideration or affected by committee. 3 members of FDA advisory committee who voted for rotavirus vaccine had conflicts of interest that were waived. 3 members of FDA advisory committee who voted for rotavirus vaccine had conflicts of interest that were waived. 7 of 15 members on FDA panel not present, joined by temporary members who all voted to license the product. 7 of 15 members on FDA panel not present, joined by temporary members who all voted to license the product. CDC grants waivers to member a year at a time; allows full participation in discussions, even if a financial stake in the decision. 700 CDC and FDA waivers granted in CDC grants waivers to member a year at a time; allows full participation in discussions, even if a financial stake in the decision. 700 CDC and FDA waivers granted in CDCs committee has no public members – no parents have a vote. FDAs committee only has one public member. CDCs committee has no public members – no parents have a vote. FDAs committee only has one public member.

77 77 Federal Investigations Office of Special Council (OIC) seeking Federal whistleblowers Office of Special Council (OIC) seeking Federal whistleblowers HHS Office of Inspector General (OIG) and CDC Office of Investigation (OI): Special Agent seeing if officials deliberately manipulated taxpayer funded data (VSD) to eliminate an association. HHS Office of Inspector General (OIG) and CDC Office of Investigation (OI): Special Agent seeing if officials deliberately manipulated taxpayer funded data (VSD) to eliminate an association. HHS/OIG & CDC/OI: Special Agents investigating allegations that CDC officials blocked VSD access and lost, destroyed or did not properly maintain previously analyzed datasets (Verstraeten). A violation of Data Access Law and the Data Quality Act. HHS/OIG & CDC/OI: Special Agents investigating allegations that CDC officials blocked VSD access and lost, destroyed or did not properly maintain previously analyzed datasets (Verstraeten). A violation of Data Access Law and the Data Quality Act. FDA Office of Criminal Investigations – Criminal inspectors investigating withholding and/or misrepresentations made to the FDA by Eli Lilly and the vaccine makers on thimerosal safety data. FDA Office of Criminal Investigations – Criminal inspectors investigating withholding and/or misrepresentations made to the FDA by Eli Lilly and the vaccine makers on thimerosal safety data. FDA Division of Internal Affairs – Special Agent: Did FDA personnel know that vaccines marketed without accurate package insert? Was grievous injury inflicted on kids from negligence and/or conflicts of interest on the part of FDA? FDA Division of Internal Affairs – Special Agent: Did FDA personnel know that vaccines marketed without accurate package insert? Was grievous injury inflicted on kids from negligence and/or conflicts of interest on the part of FDA?

78 Evidence of Harm 78 THE POLITICS: PHARMA $$$ AND PUBLIC POLICY

79 Evidence of Harm 79 Drug Company Influence PHARMA one of biggest political donors in US – 80% to GOP. PHARMA one of biggest political donors in US – 80% to GOP. Lilly among most generous. Lilly among most generous. Donations to Frist, Bush and Congressional Candidates. Donations to Frist, Bush and Congressional Candidates. Soft Money ban helping. Soft Money ban helping. But -- PHARMA money also goes to scientists, media, medical journals and government consultants. But -- PHARMA money also goes to scientists, media, medical journals and government consultants.

80 80 Political Impediments to Compensation and Litigation Frist Vaccine Bill: VICP limitations at 3 years. No look back window. Thimerosal not an additive. Homeland Security Act – 2002; Put Frist bill into statute, later rescinded. Govt lawyers tried to permanently seal all records in Vaccine Court (November, 2002).

81 Evidence of Harm 81 OTHER POLITICAL DEVELOPMENTS Burton Hearings – Mercury in Medicine Report, May, 2003 Burton Hearings – Mercury in Medicine Report, May, 2003 Weldon/Maloney Bill in US House Weldon/Maloney Bill in US House California and Iowa bans passed, other bills in NY, MO, WI, etc. California and Iowa bans passed, other bills in NY, MO, WI, etc. Wrangling over VSD access. Wrangling over VSD access. FDA Product Suit Shield – Bush, Frist and others will push in FDA Product Suit Shield – Bush, Frist and others will push in 2005.

82 Evidence of Harm 82 THE SCIENCE: SEARCH FOR A CURE

83 Evidence of Harm 83 KNOW YOUR THIOLS Thiol – A class of sulfur-based proteins that bind with heavy metals and eliminate them from the system. Thiol – A class of sulfur-based proteins that bind with heavy metals and eliminate them from the system. Thiols include – Glutathione, cysteine and metallothioneine. Thiols include – Glutathione, cysteine and metallothioneine. Synonym for thiol = mercaptan from the Latin mercurium captans: literally mercury capturer. Synonym for thiol = mercaptan from the Latin mercurium captans: literally mercury capturer.

84 Evidence of Harm 84 MERCAPTANS AT WORK MERCAPTANS AT WORK Two main chelating agents: DMSA: Di-Mercapto-Succinic Acid IV, or more typically in children, orally. Most commonly used. Safest? DMPS: Di-Mercapto-Propane-Sulfonate Transdermal patch. Controversial and untested. Anecdotal evidence shows great potency. Miraculous recoveries reported by parents and doctors.

85 Evidence of Harm 85 METHYLATION Occurs billions of times a day within cells Occurs billions of times a day within cells Transfer of a methyl group (1 carbon & 3 hydrogen atoms) from one molecule to another. Transfer of a methyl group (1 carbon & 3 hydrogen atoms) from one molecule to another. Why important? Every cell contains the same DNA and can do same things. Why important? Every cell contains the same DNA and can do same things. Methyl groups shut down genes that arent supposed to be active. Methyl groups shut down genes that arent supposed to be active. Methylation critical to normal DNA function and gene expression. Methylation critical to normal DNA function and gene expression. Also needed for fatty acids for nerve development & myelin sheath. Also needed for fatty acids for nerve development & myelin sheath. Essential for glutathione and thiol production Essential for glutathione and thiol production Greatly impaired by thimerosal in test tube through inhibition of methionine synthase Greatly impaired by thimerosal in test tube through inhibition of methionine synthase

86 Evidence of Harm 86 METHYLATION: NEEDED FOR METHIONINE CYCLE AND TRANSULFURATION PATHWAY

87 Evidence of Harm 87 Results: Children with autism had significantly lower concentrations of methionine, homocysteine, cysteine, and total glutathione vs. controls. This metabolic profile is consistent with impaired capacity for methylation and proper sulfation. JILL JAMES: AMERICAN JOURNAL OF CLINICAL NUTRITION

88 88 JAMES: Rebuild Metabolic Profile? Methionine metabolites (methionine, cysteine, glutathione) in 20 children with autism compared vs. controls revealed severely abnormal profiles. Methionine metabolites (methionine, cysteine, glutathione) in 20 children with autism compared vs. controls revealed severely abnormal profiles. Targeted nutritional intervention for three weeks with Folinic acid, and Betaine (1000 mg. BID) resulted in significant improvement in methylation capacity in children with autism. Targeted nutritional intervention for three weeks with Folinic acid, and Betaine (1000 mg. BID) resulted in significant improvement in methylation capacity in children with autism. Addition of methyl B-12 to cocktail brought all autistic children within normal levels of methionine, cysteine and glutathione Addition of methyl B-12 to cocktail brought all autistic children within normal levels of methionine, cysteine and glutathione

89 Evidence of Harm 89 Thimerosals Legacy? Autism rarely reported outside industrialized countries until recently. Autism rarely reported outside industrialized countries until recently. China: Merck and Glaxo-SmithKline have aggressive pediatric marketing campaigns. China: Merck and Glaxo-SmithKline have aggressive pediatric marketing campaigns. Xinhua: Autism suddenly skyrocketed from nearly nothing to 1.8 million in BETTER DIAGNOSIS? Xinhua: Autism suddenly skyrocketed from nearly nothing to 1.8 million in BETTER DIAGNOSIS? 20% growth rate, higher than world average of 14%. 20% growth rate, higher than world average of 14%. Other increases in Indonesia, Argentina, India and Nigeria. Other increases in Indonesia, Argentina, India and Nigeria. What if the profitable export of our much vaunted medical technology has led to the poisoning of tens of thousands of children? What if the profitable export of our much vaunted medical technology has led to the poisoning of tens of thousands of children?


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