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1 THE VACCINE-AUTISM DEBATE:NEWDEVELOPMENTS FROM SCIENCE AND POLICY Presentation by David Kirby NYU Law School, New York City June 26th, 2008.

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Presentation on theme: "1 THE VACCINE-AUTISM DEBATE:NEWDEVELOPMENTS FROM SCIENCE AND POLICY Presentation by David Kirby NYU Law School, New York City June 26th, 2008."— Presentation transcript:

1 1 THE VACCINE-AUTISM DEBATE:NEWDEVELOPMENTS FROM SCIENCE AND POLICY Presentation by David Kirby NYU Law School, New York City June 26th, 2008

2 2 A NEW AUTISM VOCABULARY Cause, Effect & Connections of: Immune Activation/Immune Suppression/Autoimmunity Immune Activation/Immune Suppression/Autoimmunity Oxidative Stress/Reactive Oxidative Species (ROS) Oxidative Stress/Reactive Oxidative Species (ROS) Neuro-inflammation Neuro-inflammation Glutathione Depletion Glutathione Depletion Mitochondrial Dysfunction Mitochondrial Dysfunction Impaired Oxidative Phosphorylation Impaired Oxidative Phosphorylation Metal Metabolism/Efflux Disorder Metal Metabolism/Efflux Disorder Activation of Astroglia & Microglia/Gliosis Activation of Astroglia & Microglia/Gliosis Cytokine Imbalance Cytokine Imbalance Methionine Cycle Disruption Methionine Cycle Disruption Impaired Methylation Impaired Methylation Impaired Transulfuration Impaired Transulfuration Demyelination Demyelination

3 3 Types and Causes of Autisms? Types and Causes of Autisms? Types? Types? ClassicRegressive Inborn Environmental Inborn Environmental Genetic Acquired Neuro-Immune NeurodiverseMitochondrial Causes? Inherited nDNA* mutationsMMR (UK) Inherited mtDNA* mutationsThimerosal (US) Spontaneous mutationsMercury etc. in air, food, water EpigeneticsMulti-vaccines: over-stimulation Geeks get luckyPesticides, chemicals, jet fuel Flame retardants, solvents Wireless phones, TV, sonograms *known causesThalidomide*, terbutaline,* rubella*

4 4 IS AUTISM ON THE RISE?

5 5 AUTISM RATES IN THE US

6 6 AUTISM RATES IN THREE EUROPEAN COUNTRIES US 2008

7 7 Is There a Hidden Horde? Is There a Hidden Horde? Reported autism in US – ca1988: 3 per 10,000 Reported autism in US – ca1988: 3 per 10,000 Reported autism in US – ca2008: 66 per 10,000 (40 per 10,000 DSM-IV) Reported autism in US – ca2008: 66 per 10,000 (40 per 10,000 DSM-IV) Did doctors miss 63 out of 66 children with autism, or 95% of all ASD cases, until recent years? Even if 60% of ASD is full blown DSM-IV autism? 95%? 60% DSM-IV 40% PDD- AS DSM-IV

8 8 Autism and the Environment: Challenges & Opportunities for Research - Pediatrics 2008;121;1225 April 2007, IOM Neuroscience workshop on most promising & urgent scientific questions. The environment may play a significant role in triggering autism, probably through a complex interaction with genetic susceptibilities. Evidence points to a large genetic component, but genes alone cannot account for its etiology. Evidence points to a large genetic component, but genes alone cannot account for its etiology. Report praised involvement of parents in the process. Report praised involvement of parents in the process.

9 ARGUMENTS AGAINST A VACCINE/ MERCURY LINK

10 10 VSD: Generation 0 (FOIA)

11 11 VSD: Generation 4 Final Report Vol. 112 No. 5 November 2003, pp. 1039-1048 In no analyses were significant increased risks found for autism or attention-deficit disorder.

12 12 VSD Autism Risk Across 5 Generations 1999-2003

13 13 THIMEROSAL EXPOSURE & AUTISM IN DENMARK Inpatient Only (13%)1981-1994 Inpatient & Outpatient (100%) 1994-2000 SOURCE: Stehr-Green, et al, AMERICAN JOURNAL OF PREVENTIVE MEDICINE, 25, no. 2 (August 2003): 101-6

14 14 DENMARK: Autism Rates DROP in 2000 and 2001

15 15 2004 IOM Report: Preference Given to Epidemiology over Biology Federal Courts: Epidemiology is not acceptable to disprove causation. Federal Courts: Epidemiology is not acceptable to disprove causation. 2004 IOM Report: We cannot rule out, based on the epidemiology, the possibility that vaccines contribute to autism in some small subset. 2004 IOM Report: We cannot rule out, based on the epidemiology, the possibility that vaccines contribute to autism in some small subset. Danish authors: epidemiological expansion of criteria (inpatient-outpatient change) may have spuriously increased the apparent number of autism cases. Danish authors: epidemiological expansion of criteria (inpatient-outpatient change) may have spuriously increased the apparent number of autism cases. Verstraeten: We found no evidence against an association, as a negative study would. Additional study is recommended, which is the conclusion to which a neutral study must come. Verstraeten: We found no evidence against an association, as a negative study would. Additional study is recommended, which is the conclusion to which a neutral study must come.

16 16 2005 - IOM SPECIAL REPORT QUESTIONS CDC METHODS IOM panel said CDCs handling of VSD data suffered from a lack of transparency. IOM panel said CDCs handling of VSD data suffered from a lack of transparency. Original datasets were removed from hard drive, copied to disc, sent to Atlanta and lost. Original datasets were removed from hard drive, copied to disc, sent to Atlanta and lost. Datasets were not archived in a standard manner & are not available for reanalysis. Datasets were not archived in a standard manner & are not available for reanalysis. IOM panel said CDC vaccine officials should seek legal advice about Federal Data Quality Act. IOM panel said CDC vaccine officials should seek legal advice about Federal Data Quality Act. Felony to lose or destroy taxpayer funded records – Possible jail time for violators. Felony to lose or destroy taxpayer funded records – Possible jail time for violators.

17 17 2006 - NIEHS PANEL QUESTIONS VSD FOR FUTURE USE December 2006 - NIH panel identified several serious problems with VSD. Panel Report was signed by NIH Director. December 2006 - NIH panel identified several serious problems with VSD. Panel Report was signed by NIH Director. Several weaknesses and limitations would render a an ecological analysis "uninformative and potentially misleading. Several weaknesses and limitations would render a an ecological analysis "uninformative and potentially misleading. Concern over diagnoses recorded by HMO's, which likely led to an "under-ascertainment" of cases. (CA rates were 3-4 per 1,000, but VSD reported just 1.1 per 1,000). Concern over diagnoses recorded by HMO's, which likely led to an "under-ascertainment" of cases. (CA rates were 3-4 per 1,000, but VSD reported just 1.1 per 1,000). 25% of births were excluded from the analysis. A susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal. 25% of births were excluded from the analysis. A susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal.

18 18 2006 - NIEHS: MORE PROBLEMS WITH VSD Other "serious problems - No consideration of immune globulin (RhoGam) and flu shots during pregnancy. Other "serious problems - No consideration of immune globulin (RhoGam) and flu shots during pregnancy. No accounting for "cumulative exposure to organic mercurials through diet or other environmental sources. No accounting for "cumulative exposure to organic mercurials through diet or other environmental sources. These problems "reduce the usefulness" to prove or disprove a link to thimerosal going into the future - though they can be fixed. These problems "reduce the usefulness" to prove or disprove a link to thimerosal going into the future - though they can be fixed. The VSD wasn't the last word. It was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs.The VSD wasn't the last word. It was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs. Dr. Irva Hertz-Picciotto, NIH Panel Chair, Prof of Public Health, UC-Davis Med School

19 19 2008 – CDC Responds to NIEHS Critiques

20 20 CDC - Detailed Response to Weaknesses Finding: ASD Diagnostic Criteria Too Narrow Finding: Variations in Business Practices

21 21 CDC: More Responses FINDING: No Accounting for Background Mercury FINDING: Low Case Ascertainment CDC: No studies were ecological: Chart reviews, neuro- psychological exams, and parent interviews were done (though not in Verstraeten)

22 22 2006 Cochrane Review: MMR Taylor 1999 - Demonstrates the difficulties of drawing inferences in the absence of a non-exposed population or a clearly defined causal hypothesis. Fombonne 2001 - "The number and possible impact of biases was so high that interpretation of the results is impossible." Madsen 2002 - Interpretation is made difficult by the unequal length of follow up and use of date of diagnosis rather than onset of symptoms." De Stefano 2004 – Probable bias in enrollment; cases may not be representative of the rest of the population of the city." Smeeth 2004 – Only 4-13% unexposed controls - Such a low number may indicate some bias in the selection of controls."

23 23 Other Studies (for Q&A) Miller – UK: Hg protects kids against neuro disorders; (some parents demand Hg in shots). Miller – UK: Hg protects kids against neuro disorders; (some parents demand Hg in shots). Fombonne – Canada: PDD rates rise in Montreal after removal of Hg; (immigrant rate is twice as high). Fombonne – Canada: PDD rates rise in Montreal after removal of Hg; (immigrant rate is twice as high). Pichichero – US/Argentina – Ethylmercury clears from blood quickly (but not necessarily from body) Pichichero – US/Argentina – Ethylmercury clears from blood quickly (but not necessarily from body) NEJM – No neuropsych effects from thimerosal (except for a more than double risk for tics) NEJM – No neuropsych effects from thimerosal (except for a more than double risk for tics) California – Thimerosal came out but ASD still rising (Confounding factors?) California – Thimerosal came out but ASD still rising (Confounding factors?)

24 EVIDENCE TO SUPPORT A THIMEROSAL- MERCURY LINK

25 25 Mercury in US childhood vaccines TRIPLED (75mcg to 237.5mcg) from 1988-1992

26 26 Hg BURDEN AND AUTISM RATES IN CALIFORNIA 1985-98 SOURCE: IOM Immunization Safety Report, 2001

27 27 TYPICAL FLU SHOT INGREDIENT 25 micrograms Hg – EPA Limit: 0.1mcg/Kg/day 110 lb woman = 5 times over EPA daily limit – 14 lb infant = 17 times over limit 1.1 lb fetus = 50 times over EPA daily limit

28 28 Chelation results from child with ASD

29 29 THIOLS MERCURY CAPTURERS Thiol – A class of SULFUR-BASED proteins that bind with heavy metals and help eliminate them from the system. Thiol – A class of SULFUR-BASED proteins that bind with heavy metals and help eliminate them from the system. Thiols include – Glutathione, cysteine, metallothioneine. Glutathione is also a powerful antioxidant. Thiols include – Glutathione, cysteine, metallothioneine. Glutathione is also a powerful antioxidant. Synonym for thiol - mercaptan from the Latin mercurium captans: capturing mercury. Synonym for thiol - mercaptan from the Latin mercurium captans: capturing mercury. Chelation – Also sulfur-based; DMPS = Di-Mercapto- Succinic Acid Chelation – Also sulfur-based; DMPS = Di-Mercapto- Succinic Acid

30 30 ASD kids have low or depleted levels of thiols, including glutathione – a powerful antioxidant. ASD kids have low or depleted levels of thiols, including glutathione – a powerful antioxidant. Low thiols levels are thought to be based on genes - and possible mercury exposure (See: R. Deth). Low thiols levels are thought to be based on genes - and possible mercury exposure (See: R. Deth). 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 with Folinic acid, and Betaine resulted in significant improvement in methylation capacity in children with autism. Targeted nutritional intervention with Folinic acid, and Betaine 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.

31 31 METHYLATION: NEEDED FOR METHIONINE CYCLE AND TRANSULFURATION PATHWAY

32 32 Thimerosal and Immune Cells – UC Davis M.I.N.D. Institute – March 26/06 Tiny amounts (nanomolars) of thimerosal can: Tiny amounts (nanomolars) of thimerosal can: 1) Kill immune (dendritic) cells 2) Cause cytokine imbalances 3) Induce inflammation. THIMEROSAL CAN CAUSE IMMUNE IMBALANCES

33 33 AUTISM ASSOCIATED WITH IMMUNE IMBALANCES Presentation of UC Davis - MIND Institute 2005 IMFAR - International Meeting for Autism Research Compared to typical children, those with ASD were found to have: Increased autoimmunity Increased autoimmunity Extremely elevated levels of certain immune cells and cytokines Extremely elevated levels of certain immune cells and cytokines Imbalances in the TH1/TH2 immune response Imbalances in the TH1/TH2 immune response

34 34 Thomas Bubacher and team at Univ. of Washington Primate Center compared ethylmercury from thimerosal and methylmercury from fish. Thomas Bubacher and team at Univ. of Washington Primate Center compared ethylmercury from thimerosal and methylmercury from fish. Methyl Hg stayed in blood longer, crossed blood-brain barrier more. Methyl Hg stayed in blood longer, crossed blood-brain barrier more. BUT - Ethyl Hg in brain converts to inorganic Hg faster than methyl. BUT - Ethyl Hg in brain converts to inorganic Hg faster than methyl. 2-4 times more inorganic Hg found in brains of ethyl vs methyl group. 2-4 times more inorganic Hg found in brains of ethyl vs methyl group. Over half the methyl-exposed brains had no detectable inorganic Hg. Over half the methyl-exposed brains had no detectable inorganic Hg. Half-life in brain of organic Hg: 30 days; Half-life of inorganic: 20 years Half-life in brain of organic Hg: 30 days; Half-life of inorganic: 20 years

35 35 Changes in astrocytes and microglia in primate brains after long-term methylmercury exposure. Burbacher: Inorganic Hg, presumably from methyl Hg, continued to increase throughout all exposure durations. Both astrocyte and microglial cells had substantially elevated inorganic mercury deposits. Inorganic Hg in the brain may be a toxic form responsible for activation of astrocyte and microglia. Activation of astrocyte and microglial cells was not noted for six months or more, in some cases. Neurotoxicology. 1996;17:127-138.

36 36 JOHNS HOPKINS: Neurological Activation &Neuro- Inflammation in Brain of Autism Patients Annals of Neurology - Vol 57 No 1 January 2005 Inflammation found in autopsied autistic brains, produced by activation of astroglia and microglia. Inflammation found in autopsied autistic brains, produced by activation of astroglia and microglia. Inflammation apparently associated with activation of the brain s immune system. Compared with controls, autistic tissue showed ongoing inflammation in various sections of brain. Compared with controls, autistic tissue showed ongoing inflammation in various sections of brain.

37 37 HARVARD: Large Brains in Autism: The Challenge of Pervasive Abnormality The Neuroscientist, Volume 11, Number 5, 2000 Neuro-inflammation, oxidative stress & microglia damage found in autistic brain tissue. Chronic disease or external environmental sources (ie, heavy metals) may be the cause. Oxidative stress, brain inflammation, and microgliosis has been much documented in association with heavy metal exposures.

38 38 Blood Levels of Mercury Are Related to Diagnosis of Autism: Reanalysis of an Important Data Set Journal of Child Neurology, Vol. 22, No. 11, 1308-1311 (2007)Blood Levels of Mercury Are Related to Diagnosis of Autism: Reanalysis of an Important Data Set Journal of Child Neurology, Vol. 22, No. 11, 1308-1311 (2007)Blood Levels of Mercury Are Related to Diagnosis of Autism: Reanalysis of an Important Data SetBlood Levels of Mercury Are Related to Diagnosis of Autism: Reanalysis of an Important Data Set We reanalyzed the data set reported by Ip et al. and found the original p value was in error. We reanalyzed the data set reported by Ip et al. and found the original p value was in error. A significant relation does exist between the blood levels of mercury and diagnosis of an autism spectrum disorder. A significant relation does exist between the blood levels of mercury and diagnosis of an autism spectrum disorder. Hair samples offer some support for the idea that persons with autism may be less efficient and more variable at eliminating mercury from the blood. Hair samples offer some support for the idea that persons with autism may be less efficient and more variable at eliminating mercury from the blood.

39 39 Study looked at Texas county levels of emissions, compared to ASD rates and special ed in 1,200 school districts. Study looked at Texas county levels of emissions, compared to ASD rates and special ed in 1,200 school districts. Autism increased as mercury emissions rose. For every thousand pounds of Hg, there was a 61 percent increase in autism rates. Autism increased as mercury emissions rose. For every thousand pounds of Hg, there was a 61 percent increase in autism rates. One county with low mercury emissions but significant autism rates was found to harbor one of the nations largest mercury mines. One county with low mercury emissions but significant autism rates was found to harbor one of the nations largest mercury mines. A potentially important connection between environmental exposure to mercury and the development of autism. A potentially important connection between environmental exposure to mercury and the development of autism. 12 (2006) 203-209 UNIV of TEXAS - 2005: HIGHER RISK OF AUTISM NEAR COAL-FIRED PLANTS - Health & Place - 12 (2006) 203-209

40 40 ENVIRONMENTAL HEALTH PERSPECTIVES – Vol. 114 No. 9, September, 2006 Funded by CDC - 284 ASD children & 657 controls, born in 1994 in SF Bay Area. Assigned exposure level by birth tract for 19 chemicals. Funded by CDC - 284 ASD children & 657 controls, born in 1994 in SF Bay Area. Assigned exposure level by birth tract for 19 chemicals. Risks for autism were elevated by 50% in tracts with the highest chlorinated solvents and heavy metals. Risks for autism were elevated by 50% in tracts with the highest chlorinated solvents and heavy metals. Highest risk compounds were mercury, cadmium, nickel, trichloroethylene, and vinyl chloride. Risk from heavy metals was almost twice as high as solvents. Highest risk compounds were mercury, cadmium, nickel, trichloroethylene, and vinyl chloride. Risk from heavy metals was almost twice as high as solvents. Our results suggest a potential association between autism and estimated metal concentrations, and possibly solvents, in ambient air around the birth residence. Our results suggest a potential association between autism and estimated metal concentrations, and possibly solvents, in ambient air around the birth residence.

41 41 Univ. Of Texas – Study links autism risk to distance from mercury-releasing sources Health and Place – April 2008 Univ. Of Texas – Study links autism risk to distance from mercury-releasing sources Health and Place – April 2008 Hg data from 39 coal plants and 56 industrial facilities in Texas. ASD rates culled from 1,040 Texas school districts. Hg data from 39 coal plants and 56 industrial facilities in Texas. ASD rates culled from 1,040 Texas school districts. For every 1,000 pounds of Hg, there was a 3.7% increase in ASD. Prevalence fell 1-2% every 10 miles from source. For every 1,000 pounds of Hg, there was a 3.7% increase in ASD. Prevalence fell 1-2% every 10 miles from source. 1 st time in scientific literature that statistically significant association between ASD risk and distance from Hg source was identified. 1 st time in scientific literature that statistically significant association between ASD risk and distance from Hg source was identified. Not a definitive study, but just one more that furthers the association. Raymond Palmer. Not a definitive study, but just one more that furthers the association. Raymond Palmer.

42 42 THE SHANGHAI PLUME (Moves up and down Pacific Coast) Lower urban mercury plume. 10-day traverse from South China Sea, ending May 5, 2002. Trajectory calculations by N.O.A.A.

43 43

44 44

45 45 Annals of the School of Medicine, Universidad Nacional San Marcos, Lima An Fac Med Lima 2007; 68(3) Neurotoxic Effects of Thimerosal, At Vaccine Doses, on the Encephalon and the Development of Hamsters at 7 Days After Birth Thimerosal was associated with low body weight, low encephalon weight and smaller stature in hamsters. Thimerosal was associated with low body weight, low encephalon weight and smaller stature in hamsters. Neurotoxic effects also produced in hippocampus, cerebral cortex and cerebellum. Neurotoxic effects also produced in hippocampus, cerebral cortex and cerebellum. Decrease in neuronal density found in exposed group. Decrease in neuronal density found in exposed group. Neuronal necrosis, demyelination and gliosis also found. Neuronal necrosis, demyelination and gliosis also found. Risk in thimerosal group was high and statistically significant. Risk in thimerosal group was high and statistically significant.

46 46 What About Al? Al – is a known neuro-toxin Al – is a known neuro-toxin Al – is synergistic with Hg Al – is synergistic with Hg Al – is an immune stimulant Al – is an immune stimulant Al – is damaging to mitochondria Al – is damaging to mitochondria Al – is found in more shots today, maybe in higher concentrations, (to offset Hg removal?) Al – is found in more shots today, maybe in higher concentrations, (to offset Hg removal?) Al – is not your friend Al – is not your friend

47 THE HANNAH POLING CASE

48 48 Poling Concession #1 November 9, 2007 Hannah met all milestones in first 18 months. Hannah met all milestones in first 18 months. At 9 months: Mimicking sounds, crawling, and sitting. At 9 months: Mimicking sounds, crawling, and sitting. At 12-month pediatric visit: Saying Mom & Dad, pulling self up, cruising. At 12-month pediatric visit: Saying Mom & Dad, pulling self up, cruising. July 19, 2000 visit - Hannah spoke well was alert and active, with regular bowel movements and good sleeping habits. July 19, 2000 visit - Hannah spoke well was alert and active, with regular bowel movements and good sleeping habits. July 19, 2000 visit – Hannah received 9 vaccines: D-T-aP, M-M-R, Hib, Varivax, and Polio July 19, 2000 visit – Hannah received 9 vaccines: D-T-aP, M-M-R, Hib, Varivax, and Polio

49 49 Poling Concession #1 July 21, 2000 – Two days later: 102.3 degree fever, lethargic, irritable, and cried for long periods, with intermittent, high- pitched screaming and a decreased response to stimuli. July 21, 2000 – Two days later: 102.3 degree fever, lethargic, irritable, and cried for long periods, with intermittent, high- pitched screaming and a decreased response to stimuli. July 22–31, 2000 - Behavior continued over next ten days. Hannah also began to arch back when crying. July 22–31, 2000 - Behavior continued over next ten days. Hannah also began to arch back when crying. July 31, 2000 – Hannah had 102 degree fever, diminished appetite, red dots on chest and extremely irritable and inconsolable. July 31, 2000 – Hannah had 102 degree fever, diminished appetite, red dots on chest and extremely irritable and inconsolable. September 26, 2000 - Hannah returned to hospital with 102 degree fever, diarrhea, nasal discharge, reduced appetite, and pulling at her left ear. September 26, 2000 - Hannah returned to hospital with 102 degree fever, diarrhea, nasal discharge, reduced appetite, and pulling at her left ear. November 13, 2000 – Hannah presented with more diarrhea, vomiting, diminished energy, fever, and rash on her cheek. November 13, 2000 – Hannah presented with more diarrhea, vomiting, diminished energy, fever, and rash on her cheek.

50 50 Poling Concession #1 December 14, 2000 - Doctor noted Hannah had possible speech delay, was less responsive to verbal direction since July, and lost some language. December 14, 2000 - Doctor noted Hannah had possible speech delay, was less responsive to verbal direction since July, and lost some language. February 8, 2001 – Encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness, following vaccinations of July, 2000. Hannah watched the fluorescent lights repeatedly during the examination and would not make eye contact. February 8, 2001 – Encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness, following vaccinations of July, 2000. Hannah watched the fluorescent lights repeatedly during the examination and would not make eye contact. February 8, 2001 - Hannah diagnosed with regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development. February 8, 2001 - Hannah diagnosed with regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development. May 17, 2001 – Lab results strongly indicated an underlying mitochondrial disorder. May 17, 2001 – Lab results strongly indicated an underlying mitochondrial disorder.

51 51 Poling Concession #1 October 4, 2001 – Hannah found with lactate-to-pyruvate ratio of 28:1, often seen in disorders of mitochondrial oxidative phosphorylation. (Reference ratio is 20:1) Confirmed with muscle biopsy. October 4, 2001 – Hannah found with lactate-to-pyruvate ratio of 28:1, often seen in disorders of mitochondrial oxidative phosphorylation. (Reference ratio is 20:1) Confirmed with muscle biopsy. February 2004 - Mitochondrial DNA analysis revealed single nucleotide change in the 16S ribosomal RNA gene (T2387C). February 2004 - Mitochondrial DNA analysis revealed single nucleotide change in the 16S ribosomal RNA gene (T2387C). April 14, 2006 - Hannah brought by ambulance to Athens Regional Hospital and developed tonic seizure. Diagnosed with complex partial seizure disorder. This epilepsy was NOT related to vaccinations. April 14, 2006 - Hannah brought by ambulance to Athens Regional Hospital and developed tonic seizure. Diagnosed with complex partial seizure disorder. This epilepsy was NOT related to vaccinations.

52 52 Poling Concession #1 Conclusion Nov 9, 2007 Medical personnel at the Division of Vaccine Injury Compensation of HHS have conducted a thorough review and concluded that compensation is appropriate. Medical personnel at the Division of Vaccine Injury Compensation of HHS have conducted a thorough review and concluded that compensation is appropriate. The vaccinations Hannah received significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder. The vaccinations Hannah received significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder.

53 53 Poling Concession #2 February 21, 2008 Amended report from Dr. Zimmerman: The cause for regressive encephalopathy at age 19 months was underlying mitochondrial dysfunction, exacerbated by vaccine-induced fever and immune stimulation that exceeded metabolic reserves. Epilepsy was part of the same pathogenesis that led to autistic encephalopathy. SHORT VERSION: Hannahs autism was caused by a vaccine-induced exacerbation of her underlying mitochondrial dysfunction.

54 54 CNN Worldwide Coverage: Vaccine case draws new attention to autism debate March 6 th - March 6 th - CNN - Live 30 MinuteApril 2 nd - CNN Larry CNN International Press Conference from AtlantaKing Live - and InterviewCourthouse with Polings All Day Coverage

55 55 CDC Director Gerberding Reacts: Cause or Precipitator? The government has made absolutely no statement about indicating that vaccines are a cause of autism. That is a complete mischaracterization of the findings of the case. – Conference Call, March 5 The court (government) apparently made the decision that it is fair to say that vaccinations may have been one of the precipitators. – Press Conference, March 6

56 56 Dr. Gerberding on CNN March 29, 2008 If a child was immunized, got a fever, had other complications from the vaccines, and (is) pre- disposed with the mitochondrial disorder, it can certainly set off some damage. Some of these symptoms can be symptoms that have characteristics of autism." I think we have to have an open mind about this.

57 57 CDC Multiple Vaccine Q&A Source: www.cdc.gov Q: Is simultaneous vaccination with multiple vaccines safe? Wouldn't it be safer to separate combination vaccines? A: The available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system. Q: Can so many vaccines, given so early in life, overwhelm a child's immune system, suppressing it so it does not function correctly? A: No evidence suggests that the recommended childhood vaccines can overload the immune system. Babies are exposed to numerous bacteria and viruses on a daily basis. Q: But are they injected with stimulants like aluminum, Hg etc?

58 58 Commentary: A view from the CDC CNN - April 3, 2008 Some may call it a one size fits all approach, but the recommended vaccine schedule is flexible… parents shouldn't be reluctant to have such discussions with the childs doctor. We're currently conducting the largest study to investigate the potential causes of autism, looking at genetic, environmental and hormonal factors, as well as selected mercury exposures.

59 MITOCHONDRIAL DYSFUNCTION AND ASD REGRESSION

60 60 Mighty Mito Facts MITO - disease in classic form is very rare: 2-per-10K (0.02%) in general population. MITO - disease in classic form is very rare: 2-per-10K (0.02%) in general population. MITO - dysfunction in ASD is more prevalent. Some studies show 10%-20 %, maybe more among regressive cases: 1000 times more common? MITO - dysfunction in ASD is more prevalent. Some studies show 10%-20 %, maybe more among regressive cases: 1000 times more common? MITO - dysfunction can be very mild - many are unaware. Severe forms usually inherited, can be fatal in youth. MITO - dysfunction can be very mild - many are unaware. Severe forms usually inherited, can be fatal in youth. MITO - disease 1 st noted in 1940s: Same decade as autism. MITO - disease 1 st noted in 1940s: Same decade as autism. MITO - dysfunction can cause weak muscle tone, fatigue, poor digestion, other ASD signs. Mito treatments used in ASD. MITO - dysfunction can cause weak muscle tone, fatigue, poor digestion, other ASD signs. Mito treatments used in ASD.

61 61 Three Sources of Mito Disorders Sources: Cleveland Clinic and UMDF 1) Inherited from mother (in Mito DNA) 1) Inherited from mother (in Mito DNA) 2) Inherited from both parents (in nuclear DNA) 2) Inherited from both parents (in nuclear DNA) 3) Sporadic (acquired via medicines and toxins). 3) Sporadic (acquired via medicines and toxins). Sporadic type estimated for 75% of all cases. Sporadic type estimated for 75% of all cases. Mitochondria can be damaged by mercury, aluminum, pesticides, formaldehyde, alcohol, even HIV meds like AZT (which delete large segments of MtDNA). Mitochondria can be damaged by mercury, aluminum, pesticides, formaldehyde, alcohol, even HIV meds like AZT (which delete large segments of MtDNA).

62 62 Developmental regression and mitochondrial dysfunction in a child with autism Journal of Child Neurology. 2006 Feb;21(2):170-2 Poling, Frye, Shoffner, Zimmerman - Johns Hopkins Hospital, Baltimore, MD Described oxidative phosphorylation disorder in 19-month-old. Subtle abnormalities in some enzymes and amino acids. Described oxidative phosphorylation disorder in 19-month-old. Subtle abnormalities in some enzymes and amino acids. Authors looked at records of 159 patients with autism (DSM-IV) and 94 controls with other neurologic disorders. Authors looked at records of 159 patients with autism (DSM-IV) and 94 controls with other neurologic disorders. Aspartate aminotransferase was elevated in 38% of patients with autism compared with 15% of controls. Aspartate aminotransferase was elevated in 38% of patients with autism compared with 15% of controls. Serum creatine kinase level also was abnormally elevated in 22 of 47 patients (47%) with autism. Serum creatine kinase level also was abnormally elevated in 22 of 47 patients (47%) with autism. Metabolic evaluation is indicated in autistic patients and defects of oxidative phosphorylation might be prevalent." Metabolic evaluation is indicated in autistic patients and defects of oxidative phosphorylation might be prevalent."

63 63 Evidence of Mitochondrial Dysfunction in Autism American Journal of Biochemistry and Biotechnology 4 (2): 208-217, 2008 Many cases of autism show evidence of mitochondrial dysfunction (MtD) without classic features associated with mitochondrial disease.Many cases of autism show evidence of mitochondrial dysfunction (MtD) without classic features associated with mitochondrial disease. MtD appears to be more common in autism and presents with less severe signs and symptoms. MtD appears to be more common in autism and presents with less severe signs and symptoms. Exposure to environmental toxins is the likely etiology for mitochondrial dysfunction in autism. Exposure to environmental toxins is the likely etiology for mitochondrial dysfunction in autism. This dysfunction then contributes to a number of diagnostic symptoms observed in autism. This dysfunction then contributes to a number of diagnostic symptoms observed in autism.

64 64 Heavy-Metal Toxicity: Emphasis on Mercury Integrative Medicine Vol. 6, No. 2 Apr/May 2007 Neustadt MD & Pieczenik MD Metal toxicity creates multi-system dysfunction, which appears to be mediated primarily through mitochondrial damage from glutathione depletion. Metal toxicity creates multi-system dysfunction, which appears to be mediated primarily through mitochondrial damage from glutathione depletion.

65 65 Estimates of Mito Dysfunction in ASD 1 ) Oliveiro et al: Markers for Mito dysfunction found in 20% of ASD patients, and muscle biopsy confirmed in 7.2%. 2) Kelley, Zimmerman, Natowicz: Mitochondrial dysfunction may account for 20% of ASD, especially PDD-NOS with language and cognitive regression in 2 nd year. Markers on paternal lines; early testing, may rescue some from more severe brain injury and lifelong disability. 3) David Holtzman, Massachusetts General Hospital, AS Grant: Oxidative Phosphorylation in Cells from Autistic Individuals. Mito dysfunction might be found in up to 30% of ASD cases. 4) Petitioners Steering Committee – VICP – Up to 50% of 5,000 cases filed in Vaccine Court show markers for mild dysfunction.

66 66 Some Markers for Mito Dysfunction And Reported Rates in ASD Kids 47% (elevated serum creatine kinase, Poling et al) 47% (elevated serum creatine kinase, Poling et al) 38% (elevated aspartate aminotransferase, Poling) 38% (elevated aspartate aminotransferase, Poling) 28% (elevated lactate/pyruvate ratio, (Correia et al) 28% (elevated lactate/pyruvate ratio, (Correia et al) 20% (elevated plasma lactate, Oliveiro et al) 20% (elevated plasma lactate, Oliveiro et al) 17% (elevate plasma lactate, Correia et al) 17% (elevate plasma lactate, Correia et al) 13-16% (two hyperlactidemia markers, Oliveiro et al) 13-16% (two hyperlactidemia markers, Oliveiro et al) 65% - Shoffner (certain biomarkers) 65% - Shoffner (certain biomarkers)

67 67 Thimerosal Targets Mitochondria Thimerosal induces neuronal cell apoptosis by causing cytochrome c and apoptosis-inducing factor release from mitochondria.Thimerosal induces neuronal cell apoptosis by causing cytochrome c and apoptosis-inducing factor release from mitochondria. - Intl Journal of Molecular Medicine. 2005 Dec;16(6):971-7. Mitochondrial mediated thimerosal-induced apoptosis in a human neuroblastoma cell lineMitochondrial mediated thimerosal-induced apoptosis in a human neuroblastoma cell line - Neurotoxicology. 2005 Jun;26(3):407-16. Biochemical and molecular basis of thimerosal-induced apoptosis in T cells: a major role of mitochondrial pathway - Genes & Immunology. 2002 Aug;3(5):270-8. Inhibition of malate transport and activation of phosphate transport in mitochondria by thimerosal - FEBS Lett. 1980 Aug 11;117(1):149-51. Inhibition of malate transport and activation of phosphate transport in mitochondria by thimerosal - FEBS Lett. 1980 Aug 11;117(1):149-51. Mercurial-induced hydrogen peroxide generation in mouse brain mitochondria - Chem Res Toxicol. 2007 Dec;20(12):1919-26.Mercurial-induced hydrogen peroxide generation in mouse brain mitochondria - Chem Res Toxicol. 2007 Dec;20(12):1919-26.

68 68 Bridging from Cells to Cognition in Autism: Pathways to Defective Brain Function and Plasticity Dr. Martha Herbert, Harvard – Am. Journ. Biochem. & Biotech 4 (2): 167-176, 2008 Autism may begin when an early environmental, infectious, seizure, or autoimmune insult triggers an immune response. This response increases oxidative stress in the brain. Oxidative stress leads to DNA damage (nuclear and mitochondrial) and metabolic (glutathione) enzyme blockage. Inflammatory and oxidative stressors persist beyond early development, producing ongoing functional consequences.

69 69 Bridging from Cells to Cognition in Autism: Pathways to Defective Brain Function and Plasticity In the central nervous system, continued use of damaged mitochondria and impaired metabolic function may generate additional oxidative stress. This oxidative stress causes further activation of the immune system, leading to even more oxidative stress. Such a mechanism would self-sustain and possibly progressively worsen. Mitochondrial dysfunction found in autism would activate both astroglia and microglia. These activated cells can then initiate a broad-spectrum pro-inflammatory gene response.

70 70 Formaldehyde Causes Mito Damage, Oxidative Stress and Glutathione Depletion Chem Biol Interact. 2001 Jan 30;130-132(1-3):285-96. Low dose formaldehyde caused marked decrease in mitochondrial potential and inhibition of mitochondrial respiration, as well as oxidative stress in cells. Low dose formaldehyde caused marked decrease in mitochondrial potential and inhibition of mitochondrial respiration, as well as oxidative stress in cells. Glutathione was also depleted in a dose-dependent manner. Glutathione was also depleted in a dose-dependent manner. Antioxidants & iron chelators protected against cell toxicity. Antioxidants & iron chelators protected against cell toxicity. Toxicity was prevented with cyclosporine or carnitine to prevent opening of mitochondrial permeability pore. Toxicity was prevented with cyclosporine or carnitine to prevent opening of mitochondrial permeability pore. This suggests formaldehyde targets mitochondria. This suggests formaldehyde targets mitochondria. (NOTE: CDC repressed evidence of formaldehyde off- gassing in Hurricane Katrina refugee trailers!)

71 71 Maternal Residence Near Agricultural Pesticide Applications & ASD in Californias Central Valley Environmental Health Perspectives Volume 115, Number 10, October 2007 Environmental Health Perspectives Volume 115, Number 10, October 2007 Environmental Health Perspectives Volume 115, Number 10, October 2007 Calif. women living near farms with organo- chlorine pesticides may be more at risk for children with autism. Calif. women living near farms with organo- chlorine pesticides may be more at risk for children with autism. Autism rates near fields was extremely high - 28% of mothers had children with autism, six times higher than those who did not live nearby. Autism rates near fields was extremely high - 28% of mothers had children with autism, six times higher than those who did not live nearby. 7% of ASD in Central Valley might have been connected to insecticides from fields. 7% of ASD in Central Valley might have been connected to insecticides from fields. Italian scientists in 2005: Pesticides could cause neurological changes that lead to autism. Italian scientists in 2005: Pesticides could cause neurological changes that lead to autism.

72 ASD & PET SHAMPOO PESTICIDE? IMFAR Meeting – London – May, 2008 Chemicals included insecticides, pet shampoos, and weed killers, 3 months before conception until first birthday. Chemicals included insecticides, pet shampoos, and weed killers, 3 months before conception until first birthday. Mothers of ASD kids were twice as likely to report using pet shampoos with pyrethrins vs. controls. Used for flea control, pyrethrins affect pests' central nervous system. Mothers of ASD kids were twice as likely to report using pet shampoos with pyrethrins vs. controls. Used for flea control, pyrethrins affect pests' central nervous system. Strongest association was in second trimester, when ASD mothers were 2.6 times more likely to have been exposed to the chemical. Strongest association was in second trimester, when ASD mothers were 2.6 times more likely to have been exposed to the chemical. In lab, pyrethrins have also been found to affect a part of the brain that protects it from chemicals within the blood. In lab, pyrethrins have also been found to affect a part of the brain that protects it from chemicals within the blood.

73 RECENT DEVELOPMENTS IN U.S. POLICY AND POLITICS

74 74 The NEXT Hannah Poling Case chosen to replace Hannah as 1 st thimerosal test case had SAME mito markers, and was also pulled as test case. Case chosen to replace Hannah as 1 st thimerosal test case had SAME mito markers, and was also pulled as test case. This case will be re-filed outside of Autism Omnibus Proceedings with new theory of causation: Autism can be caused by aggravated mitochondrial dysfunction. This case will be re-filed outside of Autism Omnibus Proceedings with new theory of causation: Autism can be caused by aggravated mitochondrial dysfunction.

75 75 Email from HHS to CBS Here are the numbers of compensable cases for encephalitis / encephalopathy and seizures in our database from October 1, 1988 to March 4, 2008. Here are the numbers of compensable cases for encephalitis / encephalopathy and seizures in our database from October 1, 1988 to March 4, 2008. Encephalitis/Encephalopathy 611 Encephalitis/Encephalopathy 611 Seizure Disorders 711 Seizure Disorders 711 Total 1,322 Total 1,322 There's not much difference in the medical history and outcomes for children that were compensated for "encephalopathy" versus "seizures." There's not much difference in the medical history and outcomes for children that were compensated for "encephalopathy" versus "seizures." Those compensated for encephalopathy often had seizures as part of their clinical picture, and vice versa. Those compensated for encephalopathy often had seizures as part of their clinical picture, and vice versa.

76 76 2008 - CDC Studies on MMR www.cdc.gov/ncbddd/autism/documents/vaccine_studies.pdf The Autism and Biopsy Study Can MMR cause autism through persistent measles infection in the intestine? Examination of intestinal tissue of children with autism for the presence of measles virus. Immunizations & Possible Developmental Regression CDC & NIH study of whether the MMR vaccine is linked with developmental regression, which occurs in a subset of children with autism.

77 77 March 11 - CDC Conference Call on Mito Dysfunction, Vaccines and Autism CISA - CDC, vaccine experts and insurance companies – discussed 5-year study of 30 ASD kids w/low cellular energy. CISA - CDC, vaccine experts and insurance companies – discussed 5-year study of 30 ASD kids w/low cellular energy. All 30 had the same abnormalities as Hannah Poling, (who was one of them). All regressed after normal development. All 30 had the same abnormalities as Hannah Poling, (who was one of them). All regressed after normal development. Big surprise: Inheritance pattern" found – When 2 two cousins had autism, genetic link was always through father – clear nuclear DNA inheritance. Big surprise: Inheritance pattern" found – When 2 two cousins had autism, genetic link was always through father – clear nuclear DNA inheritance. DNA mutation may range from 1-in-400 to 1-in-50, or 2%. DNA mutation may range from 1-in-400 to 1-in-50, or 2%. DNA mapping underaway – paternal grandparents tested. DNA mapping underaway – paternal grandparents tested.

78 78 CDC-CISA Conference Call – Contd BUT – is DNA mutation enough to confer MtD? Or is an environmental trigger needed? And what triggers "metabolic decomposition" anyway? BUT – is DNA mutation enough to confer MtD? Or is an environmental trigger needed? And what triggers "metabolic decomposition" anyway? In only 2 of the 30 cases, (6%) regression linked to shots (Hannha was one). In only 2 of the 30 cases, (6%) regression linked to shots (Hannha was one). In other 28 cases, traced to fever-inducing infection. In other 28 cases, traced to fever-inducing infection. But if fever causes 94% of mito reggression, shouldnt there be less today - and less in wealthier countries? But if fever causes 94% of mito reggression, shouldnt there be less today - and less in wealthier countries? (Hannah spoke at 9 months, but had several fevers after that without regression. Now, fevers improve symptoms - reported in Pediatrics). (Hannah spoke at 9 months, but had several fevers after that without regression. Now, fevers improve symptoms - reported in Pediatrics).

79 79 Three-Step, Two-Trigger Path Three-Step, Two-Trigger Path STEP ONE: Child is born with DNA mutation for mito susceptibility. STEP ONE: Child is born with DNA mutation for mito susceptibility. TRIGGER ONE: Child encounters pre- or neo-natal environmental trigger. TRIGGER ONE: Child encounters pre- or neo-natal environmental trigger. STEP TWO: Child develops mild, asymptomatic mito dysfunction. STEP TWO: Child develops mild, asymptomatic mito dysfunction. TRIGGER TWO: Fever and/or immune overstimulation from infection of vaccines exceeds metabolic reserves. TRIGGER TWO: Fever and/or immune overstimulation from infection of vaccines exceeds metabolic reserves. STEP THREE: Encephalopathy, illness, regression, autism STEP THREE: Encephalopathy, illness, regression, autism

80 80 Questions Raised On and From CDC – CISA Confernce Call Do we vaccinate children with known MtD sooner? More slowly? Do we vaccinate children with known MtD sooner? More slowly? Do we develop an efficient test for MtD before vaccination begins? Do we develop an efficient test for MtD before vaccination begins? Do we alter schedule somehow, to lower risk of immune over- stimulation in susceptible children? Do we alter schedule somehow, to lower risk of immune over- stimulation in susceptible children? Do we set a maximum number of vaccine exposures on any one day? Do we set a maximum number of vaccine exposures on any one day? Do we allow MMR to be separated out, on request of parents? Do we allow MMR to be separated out, on request of parents? Do we separate MMR from Varicella on same day? CDC stoped recommending Pro-Quad (MMR+V) because it doubled seizure risk. Do we separate MMR from Varicella on same day? CDC stoped recommending Pro-Quad (MMR+V) because it doubled seizure risk. Do we set new limits on kids playing catch up? Do we set new limits on kids playing catch up?

81 81 April 11, 2008 – Meeting to Discuss Top Vaccine Safety Issues in DC HHS convened first meeting of the national Vaccine Safety Working Group to review CDC's recommended safety research agenda. SOME Specific Questions: Is thimerosal associated with risk for tics and/or Tourettes? Is thimerosal associated with risk for tics and/or Tourettes? Is acellular pertussis vaccine associated with risk for acute neurological events? Is acellular pertussis vaccine associated with risk for acute neurological events? Is combo MMRV vaccine associated with increased febrile seizure risk? Is combo MMRV vaccine associated with increased febrile seizure risk? Are varicella and MMRV vaccines associated with increased risk for clinically important events related to virus reactivation? Are varicella and MMRV vaccines associated with increased risk for clinically important events related to virus reactivation?

82 82 CDC: Clinical Outcomes To Study Autoimmune diseases Autoimmune diseases Nervous system demyelinating disorders Nervous system demyelinating disorders Encephalitis/encephalopathy Encephalitis/encephalopathy Neurodevelopmental disorders, including autism spectrum disorder (ASD) Neurodevelopmental disorders, including autism spectrum disorder (ASD) Clinically important outcomes associated with post-immunization fever. Clinically important outcomes associated with post-immunization fever.

83 83 CDC Also Proposes Mito Research: Q: Is immunization associated with increased risk for neurological deterioration in children with mitochondrial dysfunction? Q: Is immunization associated with increased risk for neurological deterioration in children with mitochondrial dysfunction? CISA has formed a working group to study methods related to mitochondrial disorders and immunization, in collaboration with partners. CISA has formed a working group to study methods related to mitochondrial disorders and immunization, in collaboration with partners.

84 84 Workshop – Mitochondrial Disorders of Childhood: Testing, Potential Relationships to Autism Spectrum Disorders, and Triggers for Neurological Deterioration June 29, 2008 – Indianapolis Sponsored by HHS, CDC, FDA, NIH agencies; and timed around United Mitochondrial Disease Foundation Meeting. HHS: Goals and Objectives - Convene 11 experts in mitochondrial disorders or autism to discuss how the neurology of mitochondrial disorders might inform autism research. HHS: Goals and Objectives - Convene 11 experts in mitochondrial disorders or autism to discuss how the neurology of mitochondrial disorders might inform autism research. UMDF: Address neurological features of mitochondrial disorders, exacerbating factors, and testing and diagnosis. UMDF: Address neurological features of mitochondrial disorders, exacerbating factors, and testing and diagnosis.

85 85 6/19/08 -Should I vaccinate my baby? 1. Delaying the first hepatitis B shot 1. Delaying the first hepatitis B shot 2. Not doing some shots at all 2. Not doing some shots at all 3. Checking for 'titers' before giving booster shots 3. Checking for 'titers' before giving booster shots 4. Spreading the vaccines out over a longer period of time 4. Spreading the vaccines out over a longer period of time 5. Splitting up combined shots 5. Splitting up combined shots /health

86 86 Hillary Clinton on Autism: Campaign Questionnaire Feb. 2008 Yes, (autism is epidemic). I am committed to make investments to find the causes of autism, including possible environmental causes like vaccines. Yes, (autism is epidemic). I am committed to make investments to find the causes of autism, including possible environmental causes like vaccines.

87 87 Barack Obama on Autism: Campaign Trail, Pennsylvania April, 2008 We've seen just a skyrocketing autism rate. Some people are suspicious that it's connected to the vaccines. The science right now is inconclusive, but we have to research it. We've seen just a skyrocketing autism rate. Some people are suspicious that it's connected to the vaccines. The science right now is inconclusive, but we have to research it.

88 88 John McCain on Autism: Campaign Trail, Texas March, 2008 It's indisputable that autism is on the rise amongst children, the question is what's causing it. And we go back and forth, and there's strong evidence that indicates that it's got to do with a preservative in vaccines. It's indisputable that autism is on the rise amongst children, the question is what's causing it. And we go back and forth, and there's strong evidence that indicates that it's got to do with a preservative in vaccines.

89 89 Dr. Bernadine Healy on CBS News May, 2008 Officials have been too quick to dismiss the hypothesis as 'irrational,' without sufficient studies of causation, without studying the population that got sick. Officials have been too quick to dismiss the hypothesis as 'irrational,' without sufficient studies of causation, without studying the population that got sick. Never turn your back on any scientific hypothesis because you are afraid of what it might show."

90 90 Healy on CBS News The IOM concluded there is no link based mostly on population studies. But, Populations do not test causality they test associations. The IOM concluded there is no link based mostly on population studies. But, Populations do not test causality they test associations. I am a member of the IOM. I love the IOM. But a report from 2004 basically said, 'Dont pursue susceptibility groups. Don't look for those children who may be vulnerable.' I really take issue with that conclusion." I am a member of the IOM. I love the IOM. But a report from 2004 basically said, 'Dont pursue susceptibility groups. Don't look for those children who may be vulnerable.' I really take issue with that conclusion."

91 91 Dr. Healy on Don Imus Radio Show May, 2008 The issue is really almost one of ideology or religion, more than it is of science. It is the sense that vaccines are critically important. The issue is really almost one of ideology or religion, more than it is of science. It is the sense that vaccines are critically important.

92 92 THE END: Remember the kids!

93 93 6/19/08 -Should I vaccinate my baby? Story Highlights Parents have concerns about possible vaccine and autism link Parents have concerns about possible vaccine and autism link Doctors from CDC say vaccine schedule is flexible Doctors from CDC say vaccine schedule is flexible Sears Schedule recommends spreading vaccines out over time Sears Schedule recommends spreading vaccines out over time Looking at family history can give clues as to whether your child is at risk Looking at family history can give clues as to whether your child is at risk

94 94 Evidence of Harm – Introduction First Words in Book: Does mercury in vaccines cause autism in children? A definitive answer has proven elusive, and it remains so to this day. No one can say with certainty that thimerosal helped fuel the explosion in cases of autism, attention deficit disorder, speech delay and other disorders over the past decade.

95 95 EOH – Introduction Several potential culprits beside thimerosal have been mentioned, though there is no hard evidence to link any of them to autism. Possible environmental triggers include: mercury in fish, pesticides, PCBs, flame retardants, jet fuel, live viruses in vaccines or some as-yet unidentified virus, and even rampant cell phone use. It is plausible that any combination of the above, with or without thimerosal exposure added into the mix, might cause harm to some fetuses and infant children. At the very least, the thimerosal debate has compelled the scientific community, however reluctantly, to consider an environmental component to the disorder, rather than looking for a purely genetic explanation.

96 96 EOH Introduction Some parents, fearing harmful effects, have been tempted not to vaccinate their children. Most people would agree that this is foolhardy and dangerous. Few of us are old enough to remember the great epidemics of influenza, pertussis, smallpox, polio, diphtheria and measles that once swept entire populations - until the advent of vaccines reduced those maladies to abstract, unthreatening concepts, at least in America. These diseases, all of them preventable, can kill children. When vaccination rates fall, disease rates rise.

97 97 WHAT ABOUT CALIFORNIA?

98 98 Possible Confounding Factors Hg in vaccines and Rho-Gam until 2003. Hg in vaccines and Rho-Gam until 2003. Flu shot for infants and pregnant women. Flu shot for infants and pregnant women. Early intervention – More 3-5 y/o counted. Early intervention – More 3-5 y/o counted. Rising aluminum exposures. Rising aluminum exposures. Rising Hg levels in air and soil. Rising Hg levels in air and soil. Immigration from countries that still use Hg. Immigration from countries that still use Hg. Expanding criteria in 2008? Expanding criteria in 2008?

99 99 The flu shot may matter A pregnant woman receives 25mcg, fetus is also exposed. Much is absorbed by fetal brain stem in rats. Human maternal/cord blood ratio is 1:2). A pregnant woman receives 25mcg, fetus is also exposed. Much is absorbed by fetal brain stem in rats. Human maternal/cord blood ratio is 1:2). 1lb fetus exposed to 25mcg is 500 times over EPA limit. 1lb fetus exposed to 25mcg is 500 times over EPA limit. At 6 months, a 7kg baby receives 12.5mcg – or 17 times over limit. At 7 months, baby receives 12.5mcg. At 6 months, a 7kg baby receives 12.5mcg – or 17 times over limit. At 7 months, baby receives 12.5mcg. At 18 months, a 10kg infant receives 25mcg – or 25 times over At 18 months, a 10kg infant receives 25mcg – or 25 times over Other shots contain 5+ mcg in residual Hg. Other shots contain 5+ mcg in residual Hg. Total by 18 mos: 80 mcg UK exposure until 2004: 75 mcg Total by 18 mos: 80 mcg UK exposure until 2004: 75 mcg

100 100 California autism: increase in DDS cases by ethnic group: 2003-2007

101 101 Montreal School Boards: PDD Highest in English Speaking (Immigrant) District

102 102 PDD rates in Lester B. Pearson School Board (LBPSB) Montreal

103 103 -June 6, 2007- Canadian Broadcasting News Autism rates higherAutism rates higher in immigrant families in immigrant families Health-care specialists in Montreal are trying to understand why such a high number of autistic children come from immigrant families, a phenomenon seen in major cities across North America. Health-care specialists in Montreal are trying to understand why such a high number of autistic children come from immigrant families, a phenomenon seen in major cities across North America.


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