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

Evidence of HarmEvidence of Harm 11

EVIDENCE EVIDENCE OF HARM - OF HARM -

Presentation Presentation 1/11/051/11/05

David KirbyDavid Kirby



THE FAMILIES: KEY TO THIS STORYTHE FAMILIES: KEY TO THIS STORY

THE SCIENCE PART I: CAUSES OF AUTISMTHE SCIENCE PART I: CAUSES OF AUTISM

THE LAW: COMPENSATION, LITIGATION, THE LAW: COMPENSATION, LITIGATION, INVESTIGATIONINVESTIGATION

THE POLITICS: PHARMA & THE FEDSTHE POLITICS: PHARMA & THE FEDS

THE SCIENCE PART II: SEARCH FOR A THE SCIENCE PART II: SEARCH FOR A “CURE”“CURE”


THE SCIENCE: THE SCIENCE:

SEARCH FOR A CAUSESEARCH FOR A CAUSEThe The etiologyetiology of autism of autism


AUTISM BY THE NUMBERS: AUTISM BY THE NUMBERS: US & EUROPE US & EUROPE

USA - 1980’s: 1-2 per 10,000 childrenUSA - 1980’s: 1-2 per 10,000 children USA – Late 1990’s: 1 in 500 (20 per 10K)USA – Late 1990’s: 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)


OTHER POSSIBLE OTHER POSSIBLE ENVIRONMENTAL “TRIGGERS”??ENVIRONMENTAL “TRIGGERS”??

Mercury in fish/air/amalgamsMercury in fish/air/amalgams PesticidesPesticides PCB’sPCB’s Flame retardantsFlame retardants Jet fuelJet fuel Live virus in vaccines (MMR)Live virus in vaccines (MMR) As-yet unidentified virusAs-yet unidentified virus Rampant cell phone use Rampant cell phone use


KNOW YOUR MERCURY (Hg)KNOW YOUR MERCURY (Hg)

TYPETYPE SOURCE SOURCE EXPOSURE EXPOSURE

Elemental HgElemental Hg ThermometersThermometers VaporVaporAmalgamsAmalgamsLights/batteriesLights/batteries

Inorganic HgInorganic Hg Coal power plantsCoal power plants Air pollutantsAir pollutants(hydrophilic)(hydrophilic) VolcanoesVolcanoes

Organic Methyl HgOrganic Methyl Hg FishFish IngestionIngestion(lypophilic)(lypophilic)

Organic Ethyl HgOrganic Ethyl HgThimerosalThimerosal VaccinesVaccines(lypophilic)(lypophilic) Fish(?)Fish(?) OTC TopicalsOTC Topicals


ETHYL VS METHYLETHYL VS METHYL

Main chemical difference: Ethyl form contains extra carbon Main chemical difference: Ethyl form contains extra carbon compound on molecule, making it larger.compound on molecule, making it larger.

Some scientists contend extra carbon compound makes Some scientists contend extra carbon compound makes ethylmercury less likely to cross the blood-brain barrier.ethylmercury less likely to cross the blood-brain barrier.

Methylmercury shown to remain in blood longer than ethyl Methylmercury shown to remain in blood longer than ethyl (1/2 life of 50 days vs. 7 days for ethyl); it accumulates (1/2 life of 50 days vs. 7 days for ethyl); it accumulates more readily in the body. But ethyl converts more readily to more readily in the body. But ethyl converts more readily to inorganic Hg, which appears to remain in brain longer.inorganic Hg, which appears to remain in brain longer.

Despite these differences, FDA researchers assumed that Despite these differences, FDA researchers assumed that the two forms of mercury were equal in toxicity.the two forms of mercury were equal in toxicity.

Arsenic is “less toxic” than cyanide.Arsenic is “less toxic” than cyanide.

99

HOW MUCH Hg IS TOO MUCH?HOW MUCH Hg IS TOO MUCH?

EPA SAFETY LIMIT: 0.1 mcg* per kg per dayEPA SAFETY LIMIT: 0.1 mcg* per kg per day((MethylmercuryMethylmercury))

Avg. 6oz TUNA STEAK Avg. 6oz TUNA STEAK (@17mcg/oz)(@17mcg/oz): 102 mcg : 102 mcg

Avg. 6oz SWORDFISH STEAK Avg. 6oz SWORDFISH STEAK (@30mcg/OZ) (@30mcg/OZ) 180 mcg180 mcg

Avg. VACCINE: 25mcgAvg. VACCINE: 25mcg________________________________

EPA SAFETY LIMIT FOR:EPA SAFETY LIMIT FOR: TunaTuna Swordfish VaccineSwordfish Vaccine

165 lb man = 8 mcg/day165 lb man = 8 mcg/day 12.8x12.8x 22.5x 22.5x 3x3x110 lb woman = 5mcg/day110 lb woman = 5mcg/day 20.4x20.4x 36.0x 36.0x 5x 5x16 lb infant = 0.7mcg/day 16 lb infant = 0.7mcg/day -- -- -- -- 35.7x 35.7x(6 Months old)(6 Months old)

*1mcg = 1 millionth of a gram*1mcg = 1 millionth of a gram

1010

Maximum Hg exposure in 1Maximum Hg exposure in 1stst year of life - US year of life - US Childhood Schedule - 1992-200? Childhood Schedule - 1992-200?

AGEAGE SHOTSSHOTS HG CONTENTHG CONTENT

BIRTHBIRTH Hep BHep B 12.5mcg12.5mcg

8lb infant (3.6kg)– EPA Hg limit: 0.36mcg = 8lb infant (3.6kg)– EPA Hg limit: 0.36mcg = 35 times over35 times over4lb infant (1.8kg) – EPA Hg limit: 0.18mcg = 4lb infant (1.8kg) – EPA Hg limit: 0.18mcg = 70 times over70 times over

2 MONTHS2 MONTHS Hep BHep B 12.5mcg12.5mcgHIbHIb 25.0mcg25.0mcgDTaPDTaP 25.0mcg25.0mcg

(subtotal for visit):(subtotal for visit):62.5mcg62.5mcg

Avg. weight: 10lbs/4.5kg EPA limit: 0.45mcg = Avg. weight: 10lbs/4.5kg EPA limit: 0.45mcg = 138 times over138 times over

4 MONTHS4 MONTHS HIbHIb 25.0mcg25.0mcgDTaPDTaP 25.0 mcg25.0 mcg

((subtotal for visit):subtotal for visit): 50.0 mcg50.0 mcgAvg weight: 14lbs/6.5kg EPA limit: 0.65mcg = Avg weight: 14lbs/6.5kg EPA limit: 0.65mcg = 72 times over72 times over

1111

Maximum Hg exposure in 1Maximum Hg exposure in 1stst year of life - US year of life - US Childhood Schedule - 1992-200?Childhood Schedule - 1992-200?

AGEAGE SHOTSSHOTS HG CONTENTHG CONTENT

6 MONTHS6 MONTHS HiBHiB 25.0mcg25.0mcgDTaPDTaP 25.0mcg25.0mcg

(subtotal for visit):(subtotal for visit): 50.0mcg50.0mcg

Avg. weight: 16lbs/7.3kg EPA limit: 0.73mcg = 68Avg. weight: 16lbs/7.3kg EPA limit: 0.73mcg = 68 times over times over

12 MONTHS12 MONTHS HiBHiB 25.0mcg25.0mcgDTaPDTaP 25.0mcg25.0mcg

(subtotal for visit):(subtotal for visit): 50.0mcg50.0mcg

Avg. weight: 20lbs/9kg EPA Hg limit: 0.9mcg = Avg. weight: 20lbs/9kg EPA Hg limit: 0.9mcg = 55 times over55 times over

TOTAL Hg EXPOSURE IN FIRST YEAR: 212.5mcg


Bolus vs. Chronic ExposureBolus vs. Chronic ExposureFDA’s “Interpretation” FDA’s “Interpretation”

FDA totaled 4 large “bolus” doses at birth, 2, FDA totaled 4 large “bolus” doses at birth, 2, 4, & 6 months (162.5mcg) and divided by 180 4, & 6 months (162.5mcg) and divided by 180 days.days.

162.5mcg divided by 180 = 0.9mcg per day.162.5mcg divided by 180 = 0.9mcg per day.

This “average” daily exposure was just above This “average” daily exposure was just above the EPA limit, but below FDA and CDC limits.the EPA limit, but below FDA and CDC limits.

Analogy: You can take 2 tylenol a day for 60 Analogy: You can take 2 tylenol a day for 60 days and be fine. But 120 tylenol in one day is days and be fine. But 120 tylenol in one day is a lethal dose. a lethal dose.

1313

Safe Minds: Common Symptoms of Autism & Mercury Poisoning

IMPAIRMENTS IN SOCIABILITYMercury Poisoning Autism

Social deficits, shyness, social withdrawal

Social deficits, social withdrawal, shyness

Depression, mood swings; mask face

Depressive traits, mood swings; flat affect

Anxiety Anxiety

Lacks eye contact, hesitant to engage others

Lack of eye contact, avoids conversation

Irrational fears Irrational fears

Irritability, aggression, temper tantrums

Irritability, aggression, temper tantrums

Impaired face recognition Impaired face recognition

Schizoid tendencies, OCD traits

Schizophrenic & OCD traits

Repetitive, stereotypic behaviors

Repetitive, stereotypic behaviors


IMPAIRMENTS IN SPEECH AND LANGUAGE

Mercury Poisoning Autism

Loss of speech, failure to develop speech

Delayed language, failure to develop speech

Dysarthria; articulation problems Dysarthria; articulation problems

Speech comprehension deficits 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


SENSORY AND MOTOR ABNORMALITIES

Mercury Poisoning Autism

Abnormal sensation in mouth & extremities

Abnormal sensation in mouth & extremities

Sound sensitivity Sound sensitivity

Abnormal touch sensations; touch aversion

Abnormal touch sensations; touch aversion

Impaired visual fixation Problems 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 Unusual postures; toe walking

1616

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

1717

ACRODYNIA (PINK DISEASE)ACRODYNIA (PINK DISEASE)Cause: Inorganic Hg used in teething powders Cause: Inorganic Hg used in teething powders

Afflicted tens of thousands of children in 1930-1950’s.Afflicted tens of thousands of children in 1930-1950’s.

Symptoms: weepy rash, peeling skin, lethargy, anemia, Symptoms: weepy rash, peeling skin, lethargy, anemia, sensitivity to light, respiratory distress, general ill health.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 Years passed before mercury poisoning was gradually accepted as the cause, despite stiff resistance by industry.accepted as the cause, despite stiff resistance by industry.

By 1954, most mercury was eliminated from teething By 1954, most mercury was eliminated from teething powders. Companies feared adverse publicity and lawsuits.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.


CHILD WITH ACRODYNIA CHILD WITH AUTISM(Mercury poisoning) (Will Redwood)


INJECTING POISON?

2020

1991: LILLY WARNING ON THIMEROSAL TOXICITY

2121

1991 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 poisoningmay 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."



What is CHELATION?What is CHELATION?

From Greek From Greek chelechele, or claw., 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 doctor’s supervision.Use ONLY under doctor’s supervision.

Two main agents currently in use:Two main agents currently in use:

DMSA: Di-DMSA: Di-MercaptoMercapto-Succinic Acid-Succinic Acid IV, or more typically in children, orallyIV, or more typically in children, orally

DMPS: Di-Mercapto-Propane-SulfonateDMPS: Di-Mercapto-Propane-Sulfonate Transdermal patch (untested, controversial, more potent?)Transdermal patch (untested, controversial, more potent?)


Chelation results from autistic childChelation results from autistic child


TOTAL Hg BURDEN AND AUTISM TOTAL Hg BURDEN AND AUTISM RATES IN CALIFORNIA 1985-98RATES IN CALIFORNIA 1985-98


BOYD HALEY – BOYD HALEY – NEUROTOXICITY CHARTSNEUROTOXICITY CHARTS

Time (hr) After Treatment

0 5 10 15 20 25 30

Neu

ron

Surv

ival

(% In

itial

Num

ber)

0

20

40

60

80

100

120

Control

50 nM thimerosal

500 nM Al(OH)3

1.75 µg Neomycin/ml

50 nM Thimerosal500 nM Al(OH)3

50 nM Thimerosal1.75 µg Neomycin/ml

50 nM Thimerosal500 nM Al(OH)3

1.75 µg Neomycin/ml

Al:NEOMYCIN:TESTERONE EFFECTS

+ TESTOSTERONE

SYNERGISTIC TOXICITIES

50 NANOMOLAR

DR. MARK LOVELL

COLLABORATOR


BRADSTREET ET. AL. – Autistic BRADSTREET ET. AL. – Autistic kids excrete kids excrete 6 times6 times more Hg more Hg


Mercury is high, cadmium & lead Mercury is high, cadmium & lead levels similar (autistic vs. controls)levels similar (autistic vs. controls)


Holmes, Haley and Blaxill Holmes, Haley and Blaxill Baby Haircut Study 2003Baby Haircut Study 2003

Autistic vs. ControlsAutistic vs. Controls


Holmes, Haley and Blaxill Holmes, Haley and Blaxill Mild vs. Moderate vs. SevereMild vs. Moderate vs. Severe

3131

Mady Hornig – Columbia UniversityMady Hornig – Columbia UniversityHornig used one mouse strain with genetic Hg Hornig used one mouse strain with genetic Hg sensitivity and autoimmunity and two strains sensitivity and autoimmunity and two strains without them, then replicated the immunization without them, then replicated the immunization schedule using thimerosal-containing vaccines.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 Sensitive mice had enlarged brains, noted in autistic children, vs. controls.children, vs. controls.

““Behavioral impoverishment” was highly significant the Behavioral impoverishment” was highly significant the sensitive strain.sensitive strain.

40 percent of sensitive mice were “self-mutilatory” at six 40 percent of sensitive mice were “self-mutilatory” at six months, ie, frantically grooming or biting tails.months, ie, frantically grooming or biting tails.

One mouse groomed through partner’s skull.One mouse groomed through partner’s skull.

3232

AGAINST THE THIMEROSAL AGAINST THE THIMEROSAL THEORY: MAJOR PLAYERSTHEORY: MAJOR PLAYERS

ELI LILLY & COELI LILLY & CO – Invented product, has license agreements – Invented product, has license agreements until 2010; defendant in lawsuits.until 2010; defendant in lawsuits.

MERCK, GLAXO, ETCMERCK, GLAXO, ETC – Vaccine makers, lawsuit defendants. – Vaccine makers, lawsuit defendants.

FDAFDA – “Asleep at the switch” - Failed to add Hg totals; no – “Asleep at the switch” - Failed to add Hg totals; no safety studies; poor lit review (missed articles in own safety studies; poor lit review (missed articles in own library); refusal to recall.library); refusal to recall.

CDCCDC – Conflict in promoting – Conflict in promoting and and monitoring vaccines; monitoring vaccines; aggressive use of immunization schedule; secret analyses aggressive use of immunization schedule; secret analyses of embargoed government data; funding of questionable of embargoed government data; funding of questionable studies; refusal to recommend Hg-free vaccines.studies; refusal to recommend Hg-free vaccines.

AAP-PEDIATRICIANSAAP-PEDIATRICIANS – Unquestioning support of childhood – Unquestioning support of childhood vaccine schedule; lobbied for Hep.B birth dose; frequent vaccine schedule; lobbied for Hep.B birth dose; frequent criticism of thimerosal theorists.criticism of thimerosal theorists.

3333

AGAINST THE THIMEROSAL AGAINST THE THIMEROSAL THEORY: MAJOR POINTSTHEORY: 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 4-year CDC study of federal database shows little to no neurological damage from Hg in childhood vaccines.neurological damage from Hg in childhood vaccines.

No “consistent” evidence of harm found in five major No “consistent” evidence of harm found in five major epidemiological studies: IOM.epidemiological studies: IOM.


OFFICIAL STATEMENTOFFICIAL STATEMENT: : US Centers for Disease Control US Centers for Disease Control

and Prevention (CDC) and Prevention (CDC)

““Mercury occurs naturally and is found Mercury occurs naturally and is found everywhere in the environment.” everywhere in the environment.”

““The level of mercury exposure from The level of mercury exposure from vaccines is low.”vaccines is low.”

““Evidence is accumulating of lack of Evidence is accumulating of lack of harm resulting from exposure to harm resulting from exposure to thimerosal in vaccines.” thimerosal in vaccines.”


OFFICIAL STATEMENTOFFICIAL STATEMENT: : World Health Organization (WHO)World Health Organization (WHO)

““The latest studies do not support The latest studies do not support concerns over safety of thiomersal in concerns over safety of thiomersal in vaccines. There is no reason to vaccines. There is no reason to change current immunization change current immunization practices, since the benefit practices, since the benefit outweighs any unproven risks.” outweighs any unproven risks.”


OFFICIAL STATEMENT:OFFICIAL STATEMENT: Committee on Safety of Medicines Committee on Safety of Medicines

(CSM) –United Kingdom(CSM) –United Kingdom

““There is no There is no reliablereliable evidence of evidence of neurological adverse effects caused neurological adverse effects caused by thiomersal in vaccines. The by thiomersal in vaccines. The balance of benefits and risks of balance of benefits and risks of thiomersal-containing vaccines thiomersal-containing vaccines therefore remains overwhelmingly therefore remains overwhelmingly positive.”positive.”


THIMEROSAL EXPOSURE & AUTISM RATES IN SWEDEN: 1980-1996


THIMEROSAL EXPOSURE & AUTISM RATES IN DENMARK 1981-2000


VACCINE SAFETY DATALINK VACCINE SAFETY DATALINK (VSD)(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, Medical records of 400,000 children,

including shots and dx’s.including shots and dx’s. Source of 4 year CDC study, including Source of 4 year CDC study, including

unpublished, alarming data.unpublished, alarming data. Currently used to detect bioterror.Currently used to detect bioterror. Virtually off limits to public.Virtually off limits to public.


VSDVSD

5 GENERATIONS5 GENERATIONS

4141

Generation “Zero”Generation “Zero”Nov-Dec 1999Nov-Dec 1999

Recently rediscovered. First run Recently rediscovered. First run of the numbers. Very high of the numbers. Very high relative risks for outcomes. relative risks for outcomes.

Autism RR = 7.6Autism RR = 7.6

UNPUBLISHED STUDY OBTAINED UNPUBLISHED STUDY OBTAINED THROUGH FOIATHROUGH FOIA


Generation 1 Generation 1 Verstraeten 2/2000 Verstraeten 2/2000

Verstraeten reruns numbers, risks Verstraeten reruns numbers, risks are lowerare lower..

Still, significant outcomes “just Still, significant outcomes “just won’t go away.”won’t go away.”

Autism RR = 2.48Autism RR = 2.48

UNPUBLISHED STUDY OBTAINED THROUGH UNPUBLISHED STUDY OBTAINED THROUGH FOIAFOIA


Generation 2: Simpsonwood - Generation 2: Simpsonwood - ACIP 6/2000ACIP 6/2000

CDC, FDA, AAP, PHARMA, etc. meet CDC, FDA, AAP, PHARMA, etc. meet in secret on Hg and NDDs.in secret on Hg and NDDs.

Verstraeten presents at public CDC Verstraeten presents at public CDC meeting, says RR’s for outcomes meeting, says RR’s for outcomes increase with rising exposure. increase with rising exposure.

Autism RR = 1.69.Autism RR = 1.69.

SIMPSONWOOD MINUTES OBTAINED THROUGH SIMPSONWOOD MINUTES OBTAINED THROUGH FOIA – ACIP MINUTES NEVER POSTED FOIA – ACIP MINUTES NEVER POSTED

ONLINEONLINE


Generation 3: IOM 7/2001Generation 3: IOM 7/2001

Verstraeten presents at IOM on same Verstraeten presents at IOM on same day he begins work at Glaxo. By this day he begins work at Glaxo. By this time, more children have been added time, more children have been added to study population, and RR’s have to study population, and RR’s have been reduced even further. HMO C been reduced even further. HMO C shows no “consistent” evidence of shows no “consistent” evidence of harm.harm.

Autism RR = 1.52.Autism RR = 1.52.


Generation 4: Generation 4: Pediatrics Pediatrics 11/200311/2003

Final version of study published 4 Final version of study published 4 years after it began. Relative risks for years after it began. Relative risks for all outcomes reduced to null or near all outcomes reduced to null or near null.null.

Autism RR: NO LONGER STUDIED.Autism RR: NO LONGER STUDIED.



““IT JUST WON’T GO AWAY”IT JUST WON’T GO AWAY”


VSD: Generation ZeroVSD: Generation Zero


VSD Generation 1: AutismVSD Generation 1: Autism(Verstraeten – 2/2000)(Verstraeten – 2/2000)


VSD Generation 2: AutismVSD Generation 2: Autism(Simpsonwood & ACIP 6/2000)(Simpsonwood & ACIP 6/2000)


VSD Generation 3: AutismVSD Generation 3: Autism(IOM Presentation 7/2001) (IOM Presentation 7/2001)


VSD Generation 4: AutismVSD Generation 4: Autism((PediatricsPediatrics Article, 11/2003) Article, 11/2003)

Vol. 112 No. 5 November Vol. 112 No. 5 November 2003,2003,

pp. 1039-1048pp. 1039-1048


Generation 4: All OutcomesGeneration 4: All Outcomes

HMO A: Cumulative exposure at 3 months HMO A: Cumulative exposure at 3 months resulted in a significant positive association with resulted in a significant positive association with tics (RR:1.89) tics (RR:1.89)

HMO B, increased risks of language delay were HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: found for cumulative exposure at 3 months (RR: 1.13) and 7 months (RR: 1.07)1.13) and 7 months (RR: 1.07)

HMO C, no significant associations were found. HMO C, no significant associations were found.

CONCLUSION: No CONCLUSION: No consistent significantconsistent significant associations were found between for neuro-associations were found between for neuro-developmental outcomes. Conflicting results were developmental outcomes. Conflicting results were found at different HMOs for certain outcomes.found at different HMOs for certain outcomes.

Evidence of HarmEvidence of Harm

Autism Risks Across 5 GenerationsAutism Risks Across 5 GenerationsGEN 0 GEN 1 GEN 2 GEN 3 GEN 4 7.62

2.48

1.691.52

0.00


Generation 2: NDD’sGeneration 2: NDD’s (Simpsonwood & ACIP 6/2000)(Simpsonwood & ACIP 6/2000)


Generation 2: Language Disorder Generation 2: Language Disorder (Simpsonwood & ACIP 6/2000)(Simpsonwood & ACIP 6/2000)


COMPLIANCE RATES AND OUTCOME COMPLIANCE RATES AND OUTCOME RATES AT THREE HMO’SRATES AT THREE HMO’S

HMO B HMO A HMO C(NCK) (GHC) (HP)

Population size 114,965 15,929 17,547

Compliance rate 15% 60% 65%(at three months of age)

NDD rate 1.3% 3.9% n/a

Speech delay rate 2.6% 3.9% 4.5%



6060

Young Cohort Reduces SignalYoung Cohort Reduces Signal ““Over one quarter of the children were under the age of ascertainment Over one quarter of the children were under the age of ascertainment

for autism - 44 months - causing the signal to disappear.” – Mark Blaxillfor autism - 44 months - causing the signal to disappear.” – Mark Blaxill

““There is certainly an under-ascertainment of cases. Some children are There is certainly an under-ascertainment of cases. Some children are just not old enough to be diagnosed. Crude incidence rates are much just not old enough to be diagnosed. Crude incidence rates are much lower because the cohort is still very young.” – Thomas Verstraetenlower because the cohort is still very young.” – Thomas Verstraeten

““A CDC official accepted the critics’ charge that it contained many A CDC official accepted the critics’ charge that it contained many children too young to be diagnosed as autistic. ’This is true,’ said children too young to be diagnosed as autistic. ’This is true,’ said scientist Frank DeStefano,” Neil Munro, scientist Frank DeStefano,” Neil Munro, National JournalNational Journal

““We found no evidence against an association, as a negative study We found no evidence against an association, as a negative study would. On the contrary, additional study is recommended, which is the would. On the contrary, additional study is recommended, which is the conclusion to which a conclusion to which a neutral studyneutral study must come.” – T. Verstraeten must come.” – T. Verstraeten


THE LAW:THE LAW:

COMPENSATION COMPENSATION LITIGATION LITIGATION

INVESTIGATIONINVESTIGATION


COMPENSATION: “Vaccine Court” COMPENSATION: “Vaccine Court”

Created by Congress in 1986Created by Congress in 1986 VICP – 75 cent per shot taxVICP – 75 cent per shot tax ““No fault, non adversarial”No fault, non adversarial” Autism Omnibus Proceedings - DELAYEDAutism Omnibus Proceedings - DELAYED 3 year statute of limitations – No window3 year statute of limitations – No window Low pay out rateLow pay out rate No interim lawyer feesNo interim lawyer fees Hard to collect awardsHard to collect awards Adversarial, Gov’t lawyers fight each caseAdversarial, Gov’t lawyers fight each case In need of reformIn need of reform


LITIGATION: Civil CourtLITIGATION: Civil Court PRIVATE SUITS IN PROGRESSPRIVATE SUITS IN PROGRESS

Counter, New Orleans, BaltimoreCounter, New Orleans, Baltimore

Easter Case in Texas now in discovery & depositions (FDA, Easter Case in Texas now in discovery & depositions (FDA, CDC, IOM)CDC, IOM)

““Daubert” Hearing in late JanuaryDaubert” Hearing in late January

Jury trial in March? (If not settled) Jury trial in March? (If not settled)

SUITS PENDING – Redwood, Bono et alSUITS PENDING – Redwood, Bono et al

CLASS ACTION SUITS?CLASS ACTION SUITS?


INVESTIGATION: What did FDA INVESTIGATION: What did FDA Know and When?Know and When?

Europe -1986 – 1998; FDA library.Europe -1986 – 1998; FDA library.

Failed to add up Hg Burden.Failed to add up Hg Burden.

Failed to recall.Failed to recall.

Patriarca emails:. “Conversion of % of thimerosal to Patriarca emails:. “Conversion of % of thimerosal to actual micrograms of Hg involves 9th grade actual micrograms of Hg involves 9th grade algebra. What took the FDA so long?”algebra. What took the FDA so long?”

““Perception that FDA, CDC etc were ‘asleep at the Perception that FDA, CDC etc were ‘asleep at the switch.’”switch.’”

6565

What did Lilly Know and When?What did Lilly Know and When? 19351935 - letter to Eli Lilly: “Unsatisfactory as a preservative - letter to Eli Lilly: “Unsatisfactory as a preservative

intended for dogs.”intended for dogs.”

19471947 - Article received: "It may be dangerous to inject a - Article received: "It may be dangerous to inject a serum containing [thimerosal] into a sensitive patient.“serum containing [thimerosal] into a sensitive patient.“

19481948 - Article received: “Important to determine whether - Article received: “Important to determine whether harm results following injection in sensitive individuals.“harm results following injection in sensitive individuals.“

19501950 - NY Academy of Science: “Thimerosal is toxic when - NY Academy of Science: “Thimerosal is toxic when injected parenterally and cannot be used in injected parenterally and cannot be used in chemotherapy.“chemotherapy.“

1967 1967 Science department requests that claim "non-toxic" Science department requests that claim "non-toxic" on labels be deleted.on labels be deleted.

19721972 Article: Merthiolate in vaccines caused six deaths. Article: Merthiolate in vaccines caused six deaths. “The symptoms suggest subacute mercury poisoning.““The symptoms suggest subacute mercury poisoning.“

19831983 Language added to labels: "If pregnant or nursing, Language added to labels: "If pregnant or nursing, seek the advice of a health professional before using.“seek the advice of a health professional before using.“


SIMPSONWOOD – On The SIMPSONWOOD – On The Chatahoochee RiverChatahoochee River

June 2000June 2000

Private meeting between CDC, FDA, AAP, Pharma, Private meeting between CDC, FDA, AAP, Pharma, etc. Minutes VIA FOIA.etc. Minutes VIA FOIA.

Unpublished toxicity data discussed.Unpublished toxicity data discussed.

Rubber stamp for CDC VSD analysis?Rubber stamp for CDC VSD analysis?


SIMPSONWOOD: SIMPSONWOOD: CHOICE QUOTESCHOICE QUOTES

““I was actually stunned by what I saw, I was actually stunned by what I saw, because I thought it is plausible... So the because I thought it is plausible... So the bottom line is, okay, our signal will bottom line is, okay, our signal will simply simply

not just go away.”not just go away.”

Thomas VerstraetenThomas Verstraeten


SIMPSONWOOD: SIMPSONWOOD: CHOICE QUOTESCHOICE QUOTES

““I was actually stunned by what I saw, I was actually stunned by what I saw, because I thought it is plausible... So the because I thought it is plausible... So the bottom line is, okay, our signal will bottom line is, okay, our signal will simply simply

not just go away.”not just go away.”

Thomas VerstraetenThomas Verstraeten


““CDC is not in favor of expressing a CDC is not in favor of expressing a preference for thimerosal free preference for thimerosal free

vaccines, for fear of alienating other vaccines, for fear of alienating other manufacturers and disrupting a free manufacturers and disrupting a free

market economy.” market economy.”

Email from Dr. Thomas SaariEmail from Dr. Thomas Saari


““That further brings things down. So That further brings things down. So you can push, and I can pull. But you can push, and I can pull. But

there has been substantial there has been substantial movement from this very highly movement from this very highly

significant result, down to a fairly significant result, down to a fairly marginal result.”marginal result.”

Dr. Phillip Rhodes – CDC/NIP StatisticianDr. Phillip Rhodes – CDC/NIP Statistician


““You can play with this all you want, You can play with this all you want, but the relationships are linear and but the relationships are linear and

statistically significant… We’ve got a statistically significant… We’ve got a serious problem. To think there isn’t serious problem. To think there isn’t

some possible problem here is some possible problem here is unreal.”unreal.”

Dr. William Weil, Pediatrician - AAP Dr. William Weil, Pediatrician - AAP


““It will be a resource to our very busy It will be a resource to our very busy plaintiff attorneys when this becomes plaintiff attorneys when this becomes available… this could potentially be a available… this could potentially be a lot of business. The medical and legal lot of business. The medical and legal findings in this study, causal or not, findings in this study, causal or not, are horrendous.”are horrendous.”

Dr. Robert Brent, Thomas Jefferson University Dr. Robert Brent, Thomas Jefferson University


““You could readily find a junk scientist who You could readily find a junk scientist who would support the claim with ‘a reasonable would support the claim with ‘a reasonable degree of certainty.’ But you won’t find a degree of certainty.’ But you won’t find a scientist with any integrity who would say scientist with any integrity who would say the reverse with the data available. We’re the reverse with the data available. We’re in a bad position from defending lawsuits. I in a bad position from defending lawsuits. I am concerned.”am concerned.”

Dr. Robert Brent, Thomas Jefferson UniversityDr. Robert Brent, Thomas Jefferson University


““What if the lawyers get hold of this? What if the lawyers get hold of this? There’s not a scientist in the world There’s not a scientist in the world who can refute these findings.”who can refute these findings.”

Email from Dr. Thomas SaariEmail from Dr. Thomas Saari


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

Dr. David Johnson, ACIPDr. David Johnson, ACIP


Conflicts of interest?Conflicts of interest? Members of the FDA and CDC advisory committees owned stock Members of the FDA and CDC advisory committees owned stock

in drug companies that make vaccines. in drug companies that make vaccines.

Some owned patents for vaccines under consideration or affected Some owned patents for vaccines under consideration or affected by committee.by committee.

3 members of FDA advisory committee who voted for rotavirus 3 members of FDA advisory committee who voted for rotavirus

vaccine had conflicts of interest that were waived. vaccine had conflicts of interest that were waived.

7 of 15 members on FDA panel not present, joined by temporary 7 of 15 members on FDA panel not present, joined by temporary members who all voted to license the product. members who all voted to license the product.

CDC grants waivers to member a year at a time; allows full CDC grants waivers to member a year at a time; allows full participation in discussions, even if a financial stake in the participation in discussions, even if a financial stake in the decision. 700 CDC and FDA waivers granted in 2003.decision. 700 CDC and FDA waivers granted in 2003.

CDC’s committee has no public members – no parents have a CDC’s committee has no public members – no parents have a

vote. FDA’s committee only has one public member.vote. FDA’s committee only has one public member.

7777

Federal InvestigationsFederal Investigations

Office of Special Council (OIC) seeking Federal whistleblowersOffice of Special Council (OIC) seeking Federal whistleblowers

HHS Office of Inspector General (OIG) and CDC Office of Investigation HHS Office of Inspector General (OIG) and CDC Office of Investigation (OI): (OI): Special Agent seeing if officials deliberately manipulated Special Agent seeing if officials deliberately manipulated taxpayer funded data (VSD) to eliminate an association.taxpayer funded data (VSD) to eliminate an association.

HHS/OIG & CDC/OI: HHS/OIG & CDC/OI: Special Agents investigating allegations that CDC Special Agents investigating allegations that CDC

officials blocked VSD access and lost, destroyed or did not properly officials blocked VSD access and lost, destroyed or did not properly maintain previously analyzed datasets (Verstraeten). A violation of maintain previously analyzed datasets (Verstraeten). A violation of Data Access Law and the Data Quality Act.Data Access Law and the Data Quality Act.

FDA Office of Criminal Investigations FDA Office of Criminal Investigations – Criminal inspectors – Criminal inspectors investigating withholding and/or misrepresentations made to the FDA investigating withholding and/or misrepresentations made to the FDA by Eli Lilly and the vaccine makers on thimerosal safety data.by Eli Lilly and the vaccine makers on thimerosal safety data.

FDA Division of Internal AffairsFDA Division of Internal Affairs – Special Agent: Did FDA personnel – Special Agent: Did FDA personnel know that vaccines marketed without accurate package insert? Was know that vaccines marketed without accurate package insert? Was “grievous injury” inflicted on kids from negligence and/or conflicts of “grievous injury” inflicted on kids from negligence and/or conflicts of interest on the part of FDA?interest on the part of FDA?


THE POLITICS:THE POLITICS:

PHARMA $$$ AND PHARMA $$$ AND PUBLIC POLICYPUBLIC POLICY


Drug Company InfluenceDrug Company Influence PHARMA one of biggest political PHARMA one of biggest political

donors in US – 80% to GOP.donors in US – 80% to GOP. Lilly among most generous.Lilly among most generous. Donations to Frist, Bush and Donations to Frist, Bush and

Congressional Candidates.Congressional Candidates. Soft Money ban helping.Soft Money ban helping. But -- PHARMA money also goes to But -- PHARMA money also goes to

scientists, media, medical journals scientists, media, medical journals and government consultants.and government consultants.

8080

Political Impediments to Political Impediments to Compensation and LitigationCompensation and Litigation

Frist Vaccine Bill:Frist Vaccine Bill:VICP limitations at 3 years.VICP limitations at 3 years.No “look back” window.No “look back” window.Thimerosal not an additive.Thimerosal not an additive.

Homeland Security Act – 2002; Put Homeland Security Act – 2002; Put Frist bill into statute, later rescinded.Frist bill into statute, later rescinded.

Gov’t lawyers tried to Gov’t lawyers tried to permanentlypermanently seal all records in Vaccine Court seal all records in Vaccine Court (November, 2002).(November, 2002).


OTHER POLITICAL OTHER POLITICAL DEVELOPMENTSDEVELOPMENTS

Burton Hearings – “Mercury in Burton Hearings – “Mercury in Medicine” Report, May, 2003Medicine” Report, May, 2003

Weldon/Maloney Bill in US HouseWeldon/Maloney Bill in US House California and Iowa bans passed, California and Iowa bans passed,

other bills in NY, MO, WI, etc.other bills in NY, MO, WI, etc. Wrangling over VSD access.Wrangling over VSD access. FDA Product Suit Shield – Bush, Frist FDA Product Suit Shield – Bush, Frist

and others will push in 2005.and others will push in 2005.


THE SCIENCE: THE SCIENCE:

SEARCH FOR A CURESEARCH FOR A CURE


KNOW YOUR KNOW YOUR THIOLSTHIOLS

ThiolThiol – A class of sulfur-based – A class of sulfur-based proteins that bind with heavy metals proteins that bind with heavy metals and eliminate them from the system.and eliminate them from the system.

Thiols include – Glutathione, cysteine Thiols include – Glutathione, cysteine and metallothioneine. and metallothioneine.

Synonym for thiol = “mercaptan” Synonym for thiol = “mercaptan” from the Latin from the Latin mercurium captans: mercurium captans: literally “mercury capturer.”literally “mercury capturer.”


MERCAPTANS AT WORKMERCAPTANS AT WORK

Two main chelating agentsTwo main chelating agents::

DMSA: Di-DMSA: Di-MercaptoMercapto-Succinic Acid -Succinic Acid

IV, or more typically in children, orally.IV, or more typically in children, orally.

Most commonly used.Most commonly used.

““Safest?”Safest?”

DMPS: Di-Mercapto-Propane-Sulfonate DMPS: Di-Mercapto-Propane-Sulfonate

Transdermal patch.Transdermal patch.

Controversial and untested.Controversial and untested.

Anecdotal evidence shows great potency.Anecdotal evidence shows great potency.

““Miraculous” recoveries reported by parents and doctors.Miraculous” recoveries reported by parents and doctors.


METHYLATIONMETHYLATION Occurs billions of times a day within cellsOccurs billions of times a day within cells Transfer of a “methyl group” (1 carbon & 3 Transfer of a “methyl group” (1 carbon & 3

hydrogen atoms) from one molecule to another. hydrogen atoms) from one molecule to another. Why important? Every cell contains the same Why important? Every cell contains the same

DNA and can do same things. DNA and can do same things. Methyl groups shut down genes that aren’t Methyl groups shut down genes that aren’t

supposed to be active.supposed to be active. Methylation critical to normal DNA function and Methylation critical to normal DNA function and

gene expression.gene expression. Also needed for fatty acids for nerve development Also needed for fatty acids for nerve development

& myelin sheath. & myelin sheath. Essential for glutathione and thiol productionEssential for glutathione and thiol production Greatly impaired by thimerosal in test tube Greatly impaired by thimerosal in test tube

through inhibition of methionine synthasethrough inhibition of methionine synthase


METHYLATION: NEEDED FOR METHIONINE CYCLE AND TRANSULFURATION PATHWAY


Results:Results: Children with autism had Children with autism had significantly lower concentrations of significantly lower concentrations of methionine, homocysteine, cysteine, methionine, homocysteine, cysteine, and total glutathione vs. controls. and total glutathione vs. controls. This metabolic profile is consistent This metabolic profile is consistent with impaired capacity for with impaired capacity for methylation and proper sulfation.methylation and proper sulfation.

JILL JAMES: AMERICAN JOURNAL OF CLINICAL NUTRITION

8888

JAMES: RebuildJAMES: RebuildMetabolic Profile? Metabolic Profile?

Methionine “metabolites” (methionine, Methionine “metabolites” (methionine, cysteine, glutathione) in 20 children with cysteine, glutathione) in 20 children with autism compared vs. controls revealed autism compared vs. controls revealed severely abnormal profiles.severely abnormal profiles.

Targeted nutritional intervention for three Targeted nutritional intervention for three weeks with Folinic acid, and Betaine (1000 weeks with Folinic acid, and Betaine (1000 mg. BID) resulted in significant improvement in mg. BID) resulted in significant improvement in methylation capacity in children with autism.methylation capacity in children with autism.

Addition of methyl B-12 to “cocktail” brought Addition of methyl B-12 to “cocktail” brought all autistic children within normal levels of all autistic children within normal levels of methionine, cysteine and glutathionemethionine, cysteine and glutathione


Thimerosal’s Legacy?Thimerosal’s Legacy?

Autism rarely reported outside industrialized countries until Autism rarely reported outside industrialized countries until recently.recently.

China: Merck and Glaxo-SmithKline have aggressive China: Merck and Glaxo-SmithKline have aggressive

pediatric marketing campaigns.pediatric marketing campaigns.

Xinhua: Autism suddenly skyrocketed from nearly nothing Xinhua: Autism suddenly skyrocketed from nearly nothing to 1.8 million in 2004. BETTER DIAGNOSIS?to 1.8 million in 2004. 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 What if the profitable export of our much vaunted medical technology has led to the poisoning of tens of thousands of technology has led to the poisoning of tens of thousands of children? children?

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

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