Neurodevelopmental Disorders Neurodevelopmental Disorders Following Childhood Following Childhood

VaccinationsVaccinations

byby

David A. Geier, B.A.David A. Geier, B.A.

President, MedCon, Inc.President, MedCon, Inc.

Mark R. Geier, M.D., Ph.D.Mark R. Geier, M.D., Ph.D.

President, The Genetic Centers of AmericaPresident, The Genetic Centers of America

Email: Email: mgeier@comcast.net

Phone: (301)989-0548Phone: (301)989-0548

Copyright 2004Copyright 2004

The Great Epidemic The Great Epidemic

Autism was first described in 1943, among Autism was first described in 1943, among children born in the early 1930s.children born in the early 1930s.

By the mid 1980s ~1 in 2,500 was diagnosed with By the mid 1980s ~1 in 2,500 was diagnosed with autism.autism.

By the mid 1990s ~1 in 250 children was By the mid 1990s ~1 in 250 children was diagnosed with autism (most recent studies diagnosed with autism (most recent studies suggest the prevalence of autism maybe as high suggest the prevalence of autism maybe as high as ~1 in 150 children).as ~1 in 150 children).

Autism 5 to 15 times more prevalent in males Autism 5 to 15 times more prevalent in males than females.than females.

US Department of Education DataUS Department of Education Data1992-93 vs 1999-20001992-93 vs 1999-2000

% Increase of Autism in the United States% Increase of Autism in the United States Alabama- 885%Alabama- 885% Alaska- 2,053%Alaska- 2,053% Arizona- 351%Arizona- 351% Arkansas- 1767%Arkansas- 1767% California- 422%California- 422% Colorado- 2,400%Colorado- 2,400% Connecticut- 529%Connecticut- 529% Delaware- 1,533%Delaware- 1,533% Florida- 435%Florida- 435% Georgia- 511%Georgia- 511% Hawaii- 281%Hawaii- 281% Idaho- 513%Idaho- 513% Illinois- 48,600%Illinois- 48,600% Indiana- 442%Indiana- 442% Iowa- 710%Iowa- 710% Kansas- 636%Kansas- 636% Kentucky- 1,845%Kentucky- 1,845%

Louisiana- 152%Louisiana- 152% Maine- 868%Maine- 868% Maryland- 5,439%Maryland- 5,439% Massachusetts- 10%Massachusetts- 10% Michigan- 1,098%Michigan- 1,098% Minnesota- 561%Minnesota- 561% Mississippi- InfiniteMississippi- Infinite Missouri- 306%Missouri- 306% Montana- 535%Montana- 535% Nebraska- 7,125%Nebraska- 7,125% Nevada- 5,360%Nevada- 5,360% New Hampshire- InfiniteNew Hampshire- Infinite New Jersey- 433%New Jersey- 433% New Mexico- 1,106%New Mexico- 1,106% New York- 200%New York- 200% North Carolina- 204%North Carolina- 204% North Dakota- 988%North Dakota- 988%

Oregon- 5,895%Oregon- 5,895% Ohio- 7,055%Ohio- 7,055% Oklahoma- 1,665%Oklahoma- 1,665% Pennsylvania- 683%Pennsylvania- 683% Rhode Island- 1,153%Rhode Island- 1,153% South Carolina- 5,021%South Carolina- 5,021% South Dakota- 367%South Dakota- 367% Tennessee- 169%Tennessee- 169% Texas- 256%Texas- 256% Utah- 350%Utah- 350% Vermont- 2,567%Vermont- 2,567% Virginia- 218%Virginia- 218% Washington- 189%Washington- 189% West Virginia- 159%West Virginia- 159% Wisconsin- 7,928%Wisconsin- 7,928% Wyoming- 453%Wyoming- 453% Total- 435%Total- 435%

US Department of Education DataUS Department of Education Data1992-93 vs 2001-20021992-93 vs 2001-2002

% Increase of Autism in the United States% Increase of Autism in the United States Alabama- 1,229%Alabama- 1,229% Alaska- 2,687%Alaska- 2,687% Arizona- 477%Arizona- 477% Arkansas- 2,480%Arkansas- 2,480% California- 726%California- 726% Colorado- 3,743%Colorado- 3,743% Connecticut- 796%Connecticut- 796% Delaware- 1,860%Delaware- 1,860% Florida- 644%Florida- 644% Georgia- 840%Georgia- 840% Hawaii- 631%Hawaii- 631% Idaho- 813%Idaho- 813% Illinois- 79,940%Illinois- 79,940% Indiana- 1,095%Indiana- 1,095% Iowa- 727%Iowa- 727% Kansas- 904%Kansas- 904% Kentucky- 2,589%Kentucky- 2,589%

Louisiana- 217%Louisiana- 217% Maine- 1,392%Maine- 1,392% Maryland- 8,457%Maryland- 8,457% Massachusetts- 444%Massachusetts- 444% Michigan- 1,538%Michigan- 1,538% Minnesota- 1,005%Minnesota- 1,005% Mississippi- InfiniteMississippi- Infinite Missouri- 481%Missouri- 481% Montana- 885%Montana- 885% Nebraska- 10,275%Nebraska- 10,275% Nevada- 10,260%Nevada- 10,260% New Hampshire- InfiniteNew Hampshire- Infinite New Jersey- 691%New Jersey- 691% New Mexico- 1,556%New Mexico- 1,556% New York- 326%New York- 326% North Carolina- 294%North Carolina- 294% North Dakota- 1,500%North Dakota- 1,500%

Oregon- 7,595%Oregon- 7,595% Ohio- 13,795%Ohio- 13,795% Oklahoma- 2,432%Oklahoma- 2,432% Pennsylvania- 1,047%Pennsylvania- 1,047% Rhode Island- 1,921%Rhode Island- 1,921% South Carolina- 618%South Carolina- 618% South Dakota- 611%South Dakota- 611% Tennessee- 263%Tennessee- 263% Texas- 392%Texas- 392% Utah- 589%Utah- 589% Vermont- 7,033%Vermont- 7,033% Virginia- 339%Virginia- 339% Washington- 314%Washington- 314% West Virginia- 270%West Virginia- 270% Wisconsin- 12,383%Wisconsin- 12,383% Wyoming- 680%Wyoming- 680% Total - 714%Total - 714%

The Great Epidemic IIThe Great Epidemic II Learning disabilities have increased 30-fold from the early 1980s Learning disabilities have increased 30-fold from the early 1980s

to the mid-1990s.to the mid-1990s.

Now ~1 in 6 children in the US has a developmental disorder.Now ~1 in 6 children in the US has a developmental disorder.

Eli Lilly claims that their new drug (Strattera) will be of use in (7 Eli Lilly claims that their new drug (Strattera) will be of use in (7 to 9%) of children.to 9%) of children.

Thimerosal is an Eli Lilly Trademark.Thimerosal is an Eli Lilly Trademark.

Total damage of this apparently iatrogenic Total damage of this apparently iatrogenic epidemic exceeds 2 TRILLION DOLLARS epidemic exceeds 2 TRILLION DOLLARS AND IS RISING.AND IS RISING.

Thimerosal & Vaccines:Thimerosal & Vaccines:Background Information IBackground Information I

Thimerosal is an organic mercury compound that is Thimerosal is an organic mercury compound that is metabolized to ethylmercury and thiosalicylate and has metabolized to ethylmercury and thiosalicylate and has been present since the 1930s as a preservative in some been present since the 1930s as a preservative in some vaccines and pharmaceutical products to prevent vaccines and pharmaceutical products to prevent bacterial and fungal contamination.bacterial and fungal contamination.

Thimerosal & Vaccines:Thimerosal & Vaccines:Background Information IBackground Information I

Thimerosal is an organic mercury compound that is Thimerosal is an organic mercury compound that is metabolized to ethylmercury and thiosalicylate and has metabolized to ethylmercury and thiosalicylate and has been present since the 1930s as a preservative in some been present since the 1930s as a preservative in some vaccines and pharmaceutical products to prevent vaccines and pharmaceutical products to prevent bacterial and fungal contamination.bacterial and fungal contamination.

The FDA in 1999, under the recommended childhood The FDA in 1999, under the recommended childhood immunization schedule, determined infants might be immunization schedule, determined infants might be exposed to cumulative doses of ethylmercury that exceed exposed to cumulative doses of ethylmercury that exceed some federal safety guidelines established for exposure some federal safety guidelines established for exposure to methylmercury, another form of organic mercury.to methylmercury, another form of organic mercury.

Bernard S, Enayati A, Redwood L, et al. Bernard S, Enayati A, Redwood L, et al. Autism: A novel form of mercury poising. Autism: A novel form of mercury poising. Med Med

HypothesisHypothesis 2001;56:462-471. 2001;56:462-471.

The authors have compared the similar The authors have compared the similar biological abnormalities commonly found in biological abnormalities commonly found in autism and the corresponding pathologies autism and the corresponding pathologies arising from mercury exposure. Distinct arising from mercury exposure. Distinct similarities were found between autism and similarities were found between autism and mercury exposure in their effects upon mercury exposure in their effects upon biochemistry, the immune system, the biochemistry, the immune system, the central nervous system structure, neuro-central nervous system structure, neuro-chemistry and neurophysiology. chemistry and neurophysiology.

Article SummaryArticle Summary

Thimerosal & Vaccines:Thimerosal & Vaccines:Background Information IIBackground Information II

(Institute of Medicine 2001)(Institute of Medicine 2001)

The relationship between thimerosal from The relationship between thimerosal from vaccines and neurodevelopmental disorders vaccines and neurodevelopmental disorders is biologically possibleis biologically possible

Publication IPublication I

Geier MR, Geier DA. Geier MR, Geier DA. Neurodevelopmental Neurodevelopmental Disorders Following Thimerosal-Containing Disorders Following Thimerosal-Containing VaccinesVaccines. . Experimental Biology & MedicineExperimental Biology & Medicine 2003;228:660-664.2003;228:660-664.

Basic premise was to determine whether Basic premise was to determine whether thimerosal-containing DTaP vaccines had a thimerosal-containing DTaP vaccines had a higher incidence of neurodevelopment disorders higher incidence of neurodevelopment disorders than thimerosal-free DTaP vaccines.than thimerosal-free DTaP vaccines.

Results:Results:Thimerosal-Containing vs Thimerosal-Free DTaP VaccinesThimerosal-Containing vs Thimerosal-Free DTaP Vaccines

Type of Type of Reaction Reaction

Relative Relative RiskRisk

Attributable Attributable RiskRisk

Percent Percent AssociationAssociation

Statistical Statistical SignificanceSignificance

Mental Mental RetardationRetardation

6.16.1 5.15.1 8686 p < 0.002p < 0.002

AutismAutism 6.06.0 5.05.0 8686 p < 0.05p < 0.05

Speech Speech DisordersDisorders

2.22.2 1.21.2 6969 p < 0.05p < 0.05

Conclusion:Conclusion:

Overall, an association between Overall, an association between thimerosal & neurodevelopmental thimerosal & neurodevelopmental

disorders was found.disorders was found.

The Centers For Disease Control & PreventionThe Centers For Disease Control & Prevention(CDC)(CDC)

--

Vaccine Safety Datalink (VSD)Vaccine Safety Datalink (VSD)

Thimerosal Dose-Response StudiesThimerosal Dose-Response Studies

Stehr-Green P, et al. Autism and thimerosal-containing vaccines: Lack of Stehr-Green P, et al. Autism and thimerosal-containing vaccines: Lack of consistent evidence for an association. Am J Prev Med 2003;25:101-106. consistent evidence for an association. Am J Prev Med 2003;25:101-106.

Publication II:Publication II:

Geier MR, Geier DA. Thimerosal in childhood Geier MR, Geier DA. Thimerosal in childhood vaccines, neurodevelopment disorders, and heart vaccines, neurodevelopment disorders, and heart disease in the United States. disease in the United States. Journal of American Journal of American Physicians & Surgeons Physicians & Surgeons 2003;8(1):6-11.2003;8(1):6-11.

Study Aims:Study Aims:

1)1) Evaluate the doses of mercury that children received from Evaluate the doses of mercury that children received from thimerosal-containing vaccines as part of their routine US thimerosal-containing vaccines as part of their routine US childhood immunization schedule in comparison to the EPA childhood immunization schedule in comparison to the EPA Safety Guidelines.Safety Guidelines.

2)2) Analyze the relative risk of neurodevelopment disorders for Analyze the relative risk of neurodevelopment disorders for increasing doses of mercury based upon analysis of the VAERS increasing doses of mercury based upon analysis of the VAERS database.database.

3)3) Analyze the US Department of Education data on the number of Analyze the US Department of Education data on the number of children of different ages with various conditions in comparison children of different ages with various conditions in comparison to the dosage of mercury they received from their childhood to the dosage of mercury they received from their childhood immunizations.immunizations.

4)4) Analyze the scientific/medical literature for other reports on the Analyze the scientific/medical literature for other reports on the adverse effects of thimerosal. adverse effects of thimerosal.

Age-MonthsAge-Months Dose(ug)Dose(ug) EPA - PEPA - P0505 EPA - PEPA - P

5050 EPA - PEPA - P9595

00 12.512.5 0.2620.262 0.3300.330 0.4040.404InstantaneousInstantaneous

Relative ExcessRelative Excess -- 4848 3838 3131

              

22 62.562.5 0.4170.417 0.4860.486 0.5580.558Instantaneous Instantaneous

Relative ExcessRelative Excess -- 150150 129129 112112

              

44 62.562.5 0.5520.552 0.6540.654 0.7600.760Instantaneous Instantaneous

Relative ExcessRelative Excess -- 113113 9696 8282

              

66 5050 0.6540.654 0.7800.780 0.8800.880Instantaneous Instantaneous

Relative ExcessRelative Excess -- 7676 6464 5757

              

1515 2525 0.9180.918 1.051.05 1.231.23Instantaneous Instantaneous

Relative ExcessRelative Excess -- 2727 2424 2020

              

6060 2525 1.401.40 1.861.86 2.322.32Instantaneous Instantaneous

Relative ExcessRelative Excess -- 1818 1313 1111

Thimerosal-containing DTaP in comparison to thimerosal-free DTaP IThimerosal-containing DTaP in comparison to thimerosal-free DTaP I

R2 = 0.99

R2 = 0.95

R2 = 0.95

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

0 20 40 60 80 100Mercury Dose (micrograms)

Rela

tive R

isk

Speech Disorders Autism Heart Arrest

Thimerosal-containing DTwcP in comparison to thimerosal-free DTaP IThimerosal-containing DTwcP in comparison to thimerosal-free DTaP I

R2 = 0.98R2 = 0.99

R2 = 0.99

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

0 20 40 60 80 100Mercury Dose (micrograms)

Rela

tive R

isk

Autism Speech Disorders Heart Arrest

US Department of Education Report IUS Department of Education Report I

R2 = 0.97

0

50

100

150

200

250

100 150 200 250 300Mercury Dose per Child (micrograms)

Prev

alen

ce o

f Aut

ism

per

100

,000

C

hild

ren

US Department of Education Report IIUS Department of Education Report II

R2 = 0.96

0

10

20

30

40

50

60

70

100 150 200 250 300Mercury Dose per Child (micrograms)

Pre

vale

nce

of

Sp

eech

Dis

ord

ers

per

1,

000

Ch

ildre

n

Literature ReviewLiterature Review

National Toxicology Program (NTP)National Toxicology Program (NTP)U.S. Department of Health and Human U.S. Department of Health and Human

Services,Services,National Institutes of Health'sNational Institutes of Health's

National Institute of Environmental Health National Institute of Environmental Health Sciences (NIEHS)Sciences (NIEHS)

Statement on ThimerosalStatement on Thimerosal

* * They state that among the They state that among the synonyms of synonyms of thimerosal is merthiolatethimerosal is merthiolate..

** They report in their toxicity evaluation of They report in their toxicity evaluation of thimerosal, “thimerosal, “Poison by ingestion, subcutaneous, Poison by ingestion, subcutaneous, intravenous and possibly other routes. An intravenous and possibly other routes. An experimental neoplastigen and teratogen. experimental neoplastigen and teratogen. Experimental reproductive effectsExperimental reproductive effects.”.”

** They report that among the They report that among the symptoms of symptoms of thimerosal exposurethimerosal exposure include include mental retardation mental retardation in children, loss of coordination in speech, in children, loss of coordination in speech, writing, and gait, stupor, and irritability and bad writing, and gait, stupor, and irritability and bad temper progressing to maniatemper progressing to mania. .

Kravchenko AT, Dzagurov SG, Chervonskaia GP. Evaluation Kravchenko AT, Dzagurov SG, Chervonskaia GP. Evaluation of the toxic action of prophylactic and therapeutic of the toxic action of prophylactic and therapeutic

preparations on cells cultures. Communication III. Revealing preparations on cells cultures. Communication III. Revealing the toxic properties of medical biological preparations from the toxic properties of medical biological preparations from the degree of cell damage in continuous cell line L132. the degree of cell damage in continuous cell line L132. Zh Zh

Mikrobiol Epidemiol ImmunobiolMikrobiol Epidemiol Immunobiol 1983;3:87-92. 1983;3:87-92.

““Thus thimerosal, commonly used as a preservative, has been found Thus thimerosal, commonly used as a preservative, has been found not only to render its primary toxic effect, but also capable of not only to render its primary toxic effect, but also capable of

changing the properties of cells. changing the properties of cells. This fact suggests that the use of This fact suggests that the use of thimerosal for the preservation of medical biological preparations, thimerosal for the preservation of medical biological preparations,

especially those intended for children, is inadmissibleespecially those intended for children, is inadmissible.”.”

Cox NH, Forsyth A. Thimerosal allergy and Cox NH, Forsyth A. Thimerosal allergy and vaccination reactions. vaccination reactions. Contact DermatitisContact Dermatitis

1988;18:229-233.1988;18:229-233.

““However, individual cases of severe reactions to However, individual cases of severe reactions to thimerosal demonstrate a need for vaccines with an thimerosal demonstrate a need for vaccines with an

alternative preservativealternative preservative.”.”

Seal D, Ficker L, Wright P, et al. The case Seal D, Ficker L, Wright P, et al. The case against thimerosal. against thimerosal. LancetLancet 1991;338:315-316. 1991;338:315-316.

““Thimerosal is a weak antibacterial agent that is rapidly broken Thimerosal is a weak antibacterial agent that is rapidly broken down to products, including ethylmercury residues, which are down to products, including ethylmercury residues, which are

neurotoxic. Its role as a preservative in vaccines has been neurotoxic. Its role as a preservative in vaccines has been questioned, and the pharmaceutical industry itself considers its use questioned, and the pharmaceutical industry itself considers its use

as historicalas historical.”.”

Forstrom L, Hannuksela M, Kousa M, et al. Forstrom L, Hannuksela M, Kousa M, et al. Merthiolate hypersensitivity and vaccination. Merthiolate hypersensitivity and vaccination.

Contact DermatitisContact Dermatitis 1980;6:241-245. 1980;6:241-245.

““......reactions can be expected in such a high percentage of reactions can be expected in such a high percentage of merthiolate-sensitive persons that merthiolate in vaccines should be merthiolate-sensitive persons that merthiolate in vaccines should be

replaced by another antibacterial agentreplaced by another antibacterial agent.”.”

Heyworth MF, Truelove SC. Problems associated Heyworth MF, Truelove SC. Problems associated with the use of merthiolate as a preservative in anti-with the use of merthiolate as a preservative in anti-lymphocytic globulin. lymphocytic globulin. ToxicologyToxicology 1979;12:325-333. 1979;12:325-333.

““For many years, merthiolate has been known to have anti-For many years, merthiolate has been known to have anti-microbial activity. When it was first introduced as an anti-microbial microbial activity. When it was first introduced as an anti-microbial

preservative, little information about the fundamental biological preservative, little information about the fundamental biological effects of organic mercury compounds was available. effects of organic mercury compounds was available. We would like We would like

to suggest that merthiolate should now be regarded as an to suggest that merthiolate should now be regarded as an inappropriate preservative for anti-lymphocytic globulin inappropriate preservative for anti-lymphocytic globulin preparations and other materials which are indented for preparations and other materials which are indented for

administration to human subjectsadministration to human subjects.”.”

Nelson EA, Gottshall RY. Enhanced toxicity Nelson EA, Gottshall RY. Enhanced toxicity for mice of pertussis vaccines when for mice of pertussis vaccines when preserved with Merthioltae. preserved with Merthioltae. Applied Applied

MicrobiologyMicrobiology 1967;15:590-3. 1967;15:590-3.

““Pertussis vaccines preserved with 0.01% Methiolate are Pertussis vaccines preserved with 0.01% Methiolate are more toxic for mice than unpreserved vaccines prepared more toxic for mice than unpreserved vaccines prepared

from the same parent concentrate and containing the same from the same parent concentrate and containing the same number of organisms…An increase in mortality was number of organisms…An increase in mortality was

observed when Merthiolate was injected separately, before or observed when Merthiolate was injected separately, before or after an unpreserved suspension of pertussis vaccine.”after an unpreserved suspension of pertussis vaccine.”

Conclusion:Conclusion:In light of voluminous literature supporting the In light of voluminous literature supporting the biologic mechanisms for thimerosal-induced biologic mechanisms for thimerosal-induced adverse reactions [i.e. hundreds of articles in the adverse reactions [i.e. hundreds of articles in the peer-reviewed literature], the presence of amounts peer-reviewed literature], the presence of amounts of mercury in thimerosal-containing childhood of mercury in thimerosal-containing childhood vaccines exceeding Federal Safety Guidelines for vaccines exceeding Federal Safety Guidelines for the oral ingestion of mercury {i.e. by > 100-fold in the oral ingestion of mercury {i.e. by > 100-fold in some cases], and previous epidemiological studies some cases], and previous epidemiological studies showing adverse reactions from such vaccines [i.e. showing adverse reactions from such vaccines [i.e. from 3 independent databases], from 3 independent databases], a causal a causal relationship between thimerosal-containing relationship between thimerosal-containing childhood vaccines and neurodevelopment childhood vaccines and neurodevelopment disorders is confirmeddisorders is confirmed..

Additional Epidemiological Additional Epidemiological Publications:Publications:

Geier DA, Geier MR. An Assessment of the Impact of Geier DA, Geier MR. An Assessment of the Impact of Thimerosal on Childhood Neurodevelopmental Thimerosal on Childhood Neurodevelopmental Disorders. Disorders. Pediatric Rehabilitation Pediatric Rehabilitation 2003;6:97-102.2003;6:97-102.

Geier DA, Geier MR. A Comparative Evaluation of the Geier DA, Geier MR. A Comparative Evaluation of the Effects of MMR Immunization and Mercury Doses Effects of MMR Immunization and Mercury Doses From Thimerosal-Containing Childhood Vaccines on From Thimerosal-Containing Childhood Vaccines on the Population Prevalence of Autism. the Population Prevalence of Autism. Medical Science Medical Science MonitorMonitor (in press). (in press).

US Department of Education ReportUS Department of Education Report

R2 = 0.94

0

50

100

150

200

250

300

350

0 50 100 150 200 250 300 350

Average Mercury Dose per Child (micrograms)

Pre

vale

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of

Au

tism

per

100

,000

Ch

ildre

n

Vaccine Safety Datalink ResultsVaccine Safety Datalink Results

Children Receiving 4 Doses of Children Receiving 4 Doses of Thimerosal-Containing DTaP or Thimerosal-Containing DTaP or Thimerosal-free DTaP Vaccines Thimerosal-free DTaP Vaccines

in Various Combinationsin Various Combinations

R2 = 0.99

0

1

2

3

4

5

6

7

8

9

10

0 20 40 60 80 100

Additional Mercury Dose (micrograms)

Rela

tive R

isk

Autism (ICD-9: 299.0)Autism (ICD-9: 299.0)

Publication IV:Publication IV:Bradstreet J, Geier DA, Bradstreet J, Geier DA, KartzinelKartzinel JJ, Adams JB, JJ, Adams JB, Geier MR. Geier MR. A Case-Control Study of Mercury A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Burden in Children with Autistic Spectrum DisordersDisorders Journal of American Physicians & Journal of American Physicians & Surgeons Surgeons 2003;8:76-792003;8:76-79

Aim: EAim: Evaluations of mercury excretion levels valuations of mercury excretion levels among children with autistic spectrum disorders among children with autistic spectrum disorders in comparison to a matched control population in comparison to a matched control population based upon a three-day treatment with an oral based upon a three-day treatment with an oral chelating agent, meso-2,3-dimercaptosuccinic chelating agent, meso-2,3-dimercaptosuccinic acid (DMSA) was undertaken. acid (DMSA) was undertaken.

Results I:Results I:

A summary of heavy metal levels following a 3-day DMSA treatment in A summary of heavy metal levels following a 3-day DMSA treatment in cases matched to control children for age, sex, and vaccination statuscases matched to control children for age, sex, and vaccination status

   Heavy Metal ExaminedHeavy Metal Examined Population ExaminedPopulation Examined Heavy Metal Level Heavy Metal Level (microgram/gram of (microgram/gram of

creatinine)creatinine)

   MercuryMercury 55 Cases55 Cases 6.42 6.42 12.69 12.69

   MercuryMercury 8 Controls8 Controls 1.08 1.08 1.12 1.12

Statistical AssessmentStatistical Assessment       Relative Increase = 5.9Relative Increase = 5.9p < 0.005p < 0.005

95% CI: 1.90 to 8.7995% CI: 1.90 to 8.79

   CadmiumCadmium 55 Cases55 Cases 0.48 0.48 0.42 0.42

   CadmiumCadmium 8 Controls8 Controls 0.36 0.36 0.22 0.22

Statistical AssessmentStatistical Assessment       Relative Increase = 1.3Relative Increase = 1.3p = 0.35p = 0.35

Not SignificantNot Significant

   LeadLead 55 Cases55 Cases 18.2 18.2 43.3 43.3

   LeadLead 8 Controls8 Controls 11.8 11.8 8.6 8.6

Statistical AssessmentStatistical Assessment       Relative Increase = 1.5Relative Increase = 1.5p = 0.34p = 0.34

Not SignificantNot Significant

Results II:Results II:

A summary of heavy metal levels following a 3-day DMSA treatment in vaccinated A summary of heavy metal levels following a 3-day DMSA treatment in vaccinated controls matched to unvaccinated control children for age and sexcontrols matched to unvaccinated control children for age and sex

   Heavy Metal ExaminedHeavy Metal Examined Population ExaminedPopulation Examined Heavy Metal Level Heavy Metal Level (microgram/gram of (microgram/gram of

creatinine)creatinine)

   MercuryMercury 5 Vaccinated Controls5 Vaccinated Controls 0.70 0.70 0.71 0.71

   MercuryMercury 5 Unvaccinated Controls5 Unvaccinated Controls 1.98 1.98 2.40 2.40

Statistical AssessmentStatistical Assessment       p = 0.35p = 0.35Not SignificantNot Significant

   CadmiumCadmium 5 Vaccinated Controls5 Vaccinated Controls 0.42 0.42 0.27 0.27

   CadmiumCadmium 5 Unvaccinated Controls5 Unvaccinated Controls 0.50 0.50 0.27 0.27

Statistical AssessmentStatistical Assessment       p = 0.65p = 0.65Not SignificantNot Significant

   LeadLead 5 Vaccinated Controls5 Vaccinated Controls 14.0 14.0 10.1 10.1

   LeadLead 5 Unvaccinated Controls5 Unvaccinated Controls 16.1 16.1 8.5 8.5

Statistical AssessmentStatistical Assessment       p = 0.73p = 0.73Not SignificantNot Significant

Holmes AS, Blaxill MF, Haley BE. Reduced Holmes AS, Blaxill MF, Haley BE. Reduced Levels of Mercury in First Baby Haircuts of Levels of Mercury in First Baby Haircuts of Autistic Children. Autistic Children. International Journal of International Journal of Toxicology Toxicology 2003;22:277-285.2003;22:277-285.

Aim: EAim: Evaluations of mercury levels in the first valuations of mercury levels in the first baby haircuts of 94 children with autism where baby haircuts of 94 children with autism where compared against 45 age- and gender-matched compared against 45 age- and gender-matched controls. Information on diet, dental amalgam controls. Information on diet, dental amalgam fillings, vaccine history, Rho D immunglobulin fillings, vaccine history, Rho D immunglobulin administration, and autism symptom severity administration, and autism symptom severity was collected through a maternal survey was collected through a maternal survey questionnaire and clinical observation.questionnaire and clinical observation.

BIRTH-HAIR MERCURY OFBIRTH-HAIR MERCURY OFAUTISTIC VS. CONTROL GROUPSAUTISTIC VS. CONTROL GROUPS

0

2

4

6

8

10

12

14

16

18

20

Hair Hg levelHair Hg level(ppm)(ppm)

Female

Male

AutisticAutisticMean=0.47Mean=0.47

n=94n=94

Non-autisticNon-autisticMean=3.79Mean=3.79

n=34n=34

ACTUAL VERSUS PREDICTED BIRTH ACTUAL VERSUS PREDICTED BIRTH HAIR MERCURY LEVELSHAIR MERCURY LEVELS

-5

0

5

10

15

20

0 5 10 15 20

Actual hair Hg level (ng/g)Actual hair Hg level (ng/g)

Predicted hair Predicted hair Hg levelHg level(mcg/g)(mcg/g) Autistics

Controls

Mechanism:Mechanism:

- - Impaired sulphation is observed in autistic Impaired sulphation is observed in autistic spectrum disorders [Alberti et al., spectrum disorders [Alberti et al., Biol PsychiatryBiol Psychiatry 1999], and this biochemical deficit, possibly a 1999], and this biochemical deficit, possibly a pre-existing genetic condition, may contribute to pre-existing genetic condition, may contribute to the observed mercury accumulation, since the the observed mercury accumulation, since the normal mechanism of clearing mercury from the normal mechanism of clearing mercury from the body is thought to involve binding of mercury body is thought to involve binding of mercury compounds to sulfhydryl groupscompounds to sulfhydryl groups

Godfrey ME, Wojcik DP, Krone CA. Godfrey ME, Wojcik DP, Krone CA. Journal of Journal of Alzheimer’s Disease Alzheimer’s Disease 2003;5:189-195.2003;5:189-195.

Godfrey et al. identified genotypes that were Godfrey et al. identified genotypes that were associated with mercury neurotoxicity.associated with mercury neurotoxicity.

The authors also chelated 150 symptomatic The authors also chelated 150 symptomatic patients with 2,3-dimercapto-propane sulfonate patients with 2,3-dimercapto-propane sulfonate (DMPS) in comparison to 10 asymptomatic (DMPS) in comparison to 10 asymptomatic controls, and found that symptomatic patients controls, and found that symptomatic patients had 9-times greater urinary mercury had 9-times greater urinary mercury concentrations than controls.concentrations than controls.

Biochemical Differences Between the Three Biochemical Differences Between the Three Most Common Apolipoprotein E Isoforms is Most Common Apolipoprotein E Isoforms is

Reflected in Hg Binding CapacityReflected in Hg Binding Capacity(Source: Dr. Boyd Haley)(Source: Dr. Boyd Haley)

2 Mercury binding sites

1 Mercury binding site

No Mercury binding sites

Westphal GA, Schnuch A, Schulz TG, et al. Westphal GA, Schnuch A, Schulz TG, et al. Int Int Arch Occup Environ Health Arch Occup Environ Health 2000;73:344-8.2000;73:344-8.

The authors determined that the glutathione system was The authors determined that the glutathione system was involved in the metabolism of thimerosal or its involved in the metabolism of thimerosal or its decomposition products (organomercury alkyl decomposition products (organomercury alkyl compounds).compounds).

The authors found that certain genotypes were The authors found that certain genotypes were associated with polymorphisms in the glutathione associated with polymorphisms in the glutathione system, resulting in certain individuals being more system, resulting in certain individuals being more sensitive to thimerosal then otherssensitive to thimerosal then others..

Authors’ Results:Authors’ Results:

Glutathione S-transferase M1 deficiency was Glutathione S-transferase M1 deficiency was significantly more frequent among patient significantly more frequent among patient sensitive to thimerosal (65%, P = 0.013) sensitive to thimerosal (65%, P = 0.013) compared with the healthy control group compared with the healthy control group (49.1%).(49.1%). Glutathione S-transferase T1 deficiency Glutathione S-transferase T1 deficiency in the thimerosal group (19.8%) was barely in the thimerosal group (19.8%) was barely elevated versus healthy control (16.0%). elevated versus healthy control (16.0%). The The combined deletion (GSTT1-/GSTM1-) was combined deletion (GSTT1-/GSTM1-) was markedly more frequent among thimerosal-markedly more frequent among thimerosal-sensitive patients than in health controls (17.6% sensitive patients than in health controls (17.6% vs. 6.1%, P = 0.014).vs. 6.1%, P = 0.014).

Biochemical Markers in Autistics:Biochemical Markers in Autistics:Source: Jill JamesSource: Jill James

The plasma sulfur-group profile observed in the autistic children is The plasma sulfur-group profile observed in the autistic children is severely abnormal. severely abnormal.

** The inability to clear significant levels ** The inability to clear significant levels of mercury is a particular cause for of mercury is a particular cause for concern because it has been determined concern because it has been determined that that the human brain preferentially the human brain preferentially takes up mercury 6-times greater than takes up mercury 6-times greater than the blood.the blood.

[Gilbert SG, et al. [Gilbert SG, et al. Environ Health PerspectEnviron Health Perspect 1995] 1995]

Slikker W. Developmental neurotoxicology of Slikker W. Developmental neurotoxicology of therapeutics: survey of novel recent findings. therapeutics: survey of novel recent findings.

NeurotoxicologyNeurotoxicology 2000;21:250. 2000;21:250.[Authors from the FDA][Authors from the FDA]

““Thimerosal (sodium Thimerosal (sodium ethylmercurithiosalicylate) crosses the ethylmercurithiosalicylate) crosses the blood-brain and placental barriers and blood-brain and placental barriers and results in appreciable mercury content results in appreciable mercury content in tissues including brainin tissues including brain.”.”

Baskin DS, Ngo H, Didenko VV. Thimerosal Baskin DS, Ngo H, Didenko VV. Thimerosal induces DNA breaks, caspase-3 activation, induces DNA breaks, caspase-3 activation,

membrane damage, and cell death in cultured membrane damage, and cell death in cultured human neurons and fibroblasts. Toxicological human neurons and fibroblasts. Toxicological

Sciences 2003;74:361-368.Sciences 2003;74:361-368.

Baskin et al. have examined the toxic effects of micromolar Baskin et al. have examined the toxic effects of micromolar concentrations of thimerosal in cultured human cerebral concentrations of thimerosal in cultured human cerebral

cortical neurons and in normal human fibroblasts. cortical neurons and in normal human fibroblasts. The authors The authors results demonstrated that thimerosal in micromolar results demonstrated that thimerosal in micromolar

concentrations induced membrane and DNA damage, and concentrations induced membrane and DNA damage, and initiated caspase-3 dependent apoptosis in human neurons initiated caspase-3 dependent apoptosis in human neurons and and

fibroblasts. In addition, the authors report that thimerosal fibroblasts. In addition, the authors report that thimerosal toxicity may occur at even lower doses than those utilized in toxicity may occur at even lower doses than those utilized in

their experiments, with longer times of exposure.their experiments, with longer times of exposure.

Synergistic Toxicity of Vaccine Synergistic Toxicity of Vaccine ComponentsComponents

&&

An Explanation of the Male/Female Ratio An Explanation of the Male/Female Ratio inin

AutismAutism

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

++ TESTOSTERONETESTOSTERONE

SYNERGISTIC TOXICITIESSYNERGISTIC TOXICITIES

Source:Source:

Dr. Mark LovellDr. Mark Lovell

Dr. Boyd HaleyDr. Boyd Haley

Waly M, Olteanu H, Banerjee R, et al. Activation Waly M, Olteanu H, Banerjee R, et al. Activation of methionine synthase by insulin-like growth of methionine synthase by insulin-like growth

factor-1 and dopamine: a target for factor-1 and dopamine: a target for neurodevelopemental toxins and thimerosal. neurodevelopemental toxins and thimerosal.

Molecular Pschiatry 2004;1-14.Molecular Pschiatry 2004;1-14.

AUTHORS FROM:AUTHORS FROM:

NORTHEASTERN UNIVERISTY, UNIVERSITY OF NORTHEASTERN UNIVERISTY, UNIVERSITY OF NEBRASKA, UNITED STATES’ DEPARTMENT OF NEBRASKA, UNITED STATES’ DEPARTMENT OF

AGRICULTURE, TUFTS UNIVERSITY, & THE JOHNS AGRICULTURE, TUFTS UNIVERSITY, & THE JOHNS HOPKINS UNIVERSITYHOPKINS UNIVERSITY

AUTHORS’ STATEMENTS:AUTHORS’ STATEMENTS:

““A recent analysis of data from the Vaccine Adverse Event A recent analysis of data from the Vaccine Adverse Event Reporting System maintained by the Centers for Disease Reporting System maintained by the Centers for Disease

Control, found a significant correlation between the use of Control, found a significant correlation between the use of th thimerosal-containing formulation (vs the thimerosal-th thimerosal-containing formulation (vs the thimerosal-free formulation) of Diphtheria, Tetanus, and acellular free formulation) of Diphtheria, Tetanus, and acellular

Pertussis (DTaP) vaccine and autism. The discovery of the Pertussis (DTaP) vaccine and autism. The discovery of the PI3-kinase/MAP-kinase/MS pathway, and its potent PI3-kinase/MAP-kinase/MS pathway, and its potent

inhibition by developmental neurotoxins, including vaccine inhibition by developmental neurotoxins, including vaccine components thimerosal and aluminum, provides a components thimerosal and aluminum, provides a

potential molecular explanation for how increased use of potential molecular explanation for how increased use of vaccines could promote an increase in the incidence of vaccines could promote an increase in the incidence of

autism.”autism.”

California Environmental Protection AgencyCalifornia Environmental Protection Agency

Office of Environmental Health Hazard Office of Environmental Health Hazard AssessmentAssessment

Response to the petition of Bayer Corporation for Response to the petition of Bayer Corporation for Clarification of the Proposition 65 Listing of Clarification of the Proposition 65 Listing of

“Mercury and Mercury Compounds” as Chemicals “Mercury and Mercury Compounds” as Chemicals Known to Cause Reproductive ToxicityKnown to Cause Reproductive Toxicity

February 2004February 2004

REPORT STATES THAT THIMEROSAL IS BOTH A REPORT STATES THAT THIMEROSAL IS BOTH A REPRODUCTIVE & DEVELOPMENTAL TOXINREPRODUCTIVE & DEVELOPMENTAL TOXIN

Therefore, if a certain segment of the population has a decreased Therefore, if a certain segment of the population has a decreased ability to excrete mercury, as has been demonstrated for several ability to excrete mercury, as has been demonstrated for several different genotypes, there can be little doubt that mercury different genotypes, there can be little doubt that mercury concentrations once administered to children as part of the concentrations once administered to children as part of the childhood routine vaccination schedule resulted in a significant childhood routine vaccination schedule resulted in a significant number of children developing neurodevelopmental disorders. number of children developing neurodevelopmental disorders. This is especially true when a sudden shift in the amount of This is especially true when a sudden shift in the amount of mercury administered, as occurred in the United States when the mercury administered, as occurred in the United States when the amount of mercury administered to children more than doubled amount of mercury administered to children more than doubled as part of the routine childhood immunization schedule in the as part of the routine childhood immunization schedule in the first six months of life (i.e. from 75 micrograms of mercury first six months of life (i.e. from 75 micrograms of mercury generated as a result of three DTwP immunizations to a minimum generated as a result of three DTwP immunizations to a minimum of 187.5 micrograms from three DTwP, three Hib, and three of 187.5 micrograms from three DTwP, three Hib, and three hepatitis B immunizations), since the gene pool will contain many hepatitis B immunizations), since the gene pool will contain many susceptible individuals that under previous environmental susceptible individuals that under previous environmental conditions would have been normal, but under the new conditions would have been normal, but under the new environmental conditions are unable to thrive.environmental conditions are unable to thrive.

Conclusion:Conclusion:

Thimerosal:Thimerosal:

Beyond the ScienceBeyond the Science

The Public Health Service and the The Public Health Service and the American Academy of Pediatrics issued American Academy of Pediatrics issued

a statement in July 1999 “urging” a statement in July 1999 “urging” vaccine makers to reduce or eliminate vaccine makers to reduce or eliminate

thimerosal because of “theoretical thimerosal because of “theoretical potential for neurotoxicity.”potential for neurotoxicity.”

In an internal email written 29 June 1999, by former FDA In an internal email written 29 June 1999, by former FDA scientist Peter Patriarca offered his colleagues a “pros and scientist Peter Patriarca offered his colleagues a “pros and

cons” assessment of thimerosal statement shortly before its cons” assessment of thimerosal statement shortly before its release:release:

““Will raise questions about FDA being ‘asleep at the switch’ Will raise questions about FDA being ‘asleep at the switch’ for decades, by allowing a potentially hazardous compound for decades, by allowing a potentially hazardous compound

to remain in many childhood vaccines, and not forcing to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products. Will also manufacturers to exclude it from new products. Will also

raise questions about various advisory bodies about raise questions about various advisory bodies about aggressive recommendations for use. We must keep in mind aggressive recommendations for use. We must keep in mind that the dose of ethyl mercury was not generated by ‘rocket that the dose of ethyl mercury was not generated by ‘rocket

science’: conversion of the % of thimerosal to actual ug science’: conversion of the % of thimerosal to actual ug [micrograms] of mercury involves 9[micrograms] of mercury involves 9thth grade algebra. What grade algebra. What

took the FDA so long to do the calculations? Why didn’t CDC took the FDA so long to do the calculations? Why didn’t CDC and the advisory bodies do these calculations while rapidly and the advisory bodies do these calculations while rapidly

expanding the childhood immunization schedule?”expanding the childhood immunization schedule?”

Source: Annette Fuentes. Autism in a needle? A toxic tale of vaccinations and mercury poisoning. In Source: Annette Fuentes. Autism in a needle? A toxic tale of vaccinations and mercury poisoning. In

These Times, November 11, 2003. The email was obtained by Rep. Dan Burton (R-Ind.). These Times, November 11, 2003. The email was obtained by Rep. Dan Burton (R-Ind.).

Roger Brenier, of the CDC’s national immunization program, Roger Brenier, of the CDC’s national immunization program, received the email. In a recent interview he explained why the received the email. In a recent interview he explained why the

cumulative amount of mercury was never figured.cumulative amount of mercury was never figured.

““Vaccines tend to be evaluated on an individual basis, the Vaccines tend to be evaluated on an individual basis, the requirements for safety and efficacy on an individual basis,” requirements for safety and efficacy on an individual basis,” Brenier said. “This holistic view of safety was not part of the Brenier said. “This holistic view of safety was not part of the

review.”review.”

Source: Annette Fuentes. Autism in a needle? A toxic tale of vaccinations and mercury poisoning. In Source: Annette Fuentes. Autism in a needle? A toxic tale of vaccinations and mercury poisoning. In These Times, November 11, 2003. These Times, November 11, 2003.

Simpsonwood Meeting (7-8 June 2000) in Simpsonwood Meeting (7-8 June 2000) in Norcross, GA where the findings of the Norcross, GA where the findings of the Vaccine Safety Datalink (VSD) analysis Vaccine Safety Datalink (VSD) analysis

showing a link between Thimerosal-showing a link between Thimerosal-containing vaccines and containing vaccines and

neurodevelopmental outcomes were neurodevelopmental outcomes were discussed in a closed meeting by a discussed in a closed meeting by a

panel of experts.panel of experts.

Dr. Johnston: Page 198: “This association leads me to favor a Dr. Johnston: Page 198: “This association leads me to favor a recommendation that infants up to two years old not be immunized with recommendation that infants up to two years old not be immunized with thimerosal containing vaccines if suitable alternative preparations are thimerosal containing vaccines if suitable alternative preparations are available.“ “Forgive this personal comment, but I got called out a eight available.“ “Forgive this personal comment, but I got called out a eight

o’clock emergency call and my daughter-in-law delivered a son by C-Section. o’clock emergency call and my daughter-in-law delivered a son by C-Section. Our first male in the line of the next generation, and I do not want that Our first male in the line of the next generation, and I do not want that

grandson to get a thimerosal containing vaccine until we know better what is grandson to get a thimerosal containing vaccine until we know better what is going on. It will probably take a long time. In the meantime, and I know there going on. It will probably take a long time. In the meantime, and I know there are probably implications for this internationally, but in the meantime I think I are probably implications for this internationally, but in the meantime I think I

want that grandson to only be given thimerosal-free vaccines.”want that grandson to only be given thimerosal-free vaccines.”

Dr. Weil: Page 207: “The number of dose related relationships are linear and Dr. Weil: Page 207: “The number of dose related relationships are linear and statistically significant. You can play with this all you want. They are linear. statistically significant. You can play with this all you want. They are linear.

They are statistically significant.”They are statistically significant.”

Dr. Brent: Page 229: “The medical legal findings in this study, causal or not, Dr. Brent: Page 229: “The medical legal findings in this study, causal or not, are horrendous…If an allegation was made that a child’s neurobehavioral are horrendous…If an allegation was made that a child’s neurobehavioral findings were caused by thimerosal, you could readily find a junk scientist findings were caused by thimerosal, you could readily find a junk scientist

who would support the claim with ‘a reasonable degree of certainty.’ But you who would support the claim with ‘a reasonable degree of certainty.’ But you will not find a scientist with any integrity who would say the reverse with data will not find a scientist with any integrity who would say the reverse with data

that is available. And that is true. So we are in a bad position from the that is available. And that is true. So we are in a bad position from the standpoint of defending lawsuits if they were initiated and I am concerned.”standpoint of defending lawsuits if they were initiated and I am concerned.”

Dr. Clements: Page 247: “I am really concerned that we have taken off like Dr. Clements: Page 247: “I am really concerned that we have taken off like a boat going down one arm of the mangrove swamp at high speed, when a boat going down one arm of the mangrove swamp at high speed, when in fact there was not enough discussion really early on about which way in fact there was not enough discussion really early on about which way

the boat should go at all. And I really don’t want to risk offending the boat should go at all. And I really don’t want to risk offending everyone in the room by saying that perhaps this study should not have everyone in the room by saying that perhaps this study should not have been done at all, because the outcome of it could have to some extent, been done at all, because the outcome of it could have to some extent,

been predicted, and we have all reached this point now where we are left been predicted, and we have all reached this point now where we are left hanging…I know how we handle it from here is extremely problematic.” hanging…I know how we handle it from here is extremely problematic.” “But nonetheless, we know from many experiences in history that the “But nonetheless, we know from many experiences in history that the

pure scientist has done research because of pure science. But that pure pure scientist has done research because of pure science. But that pure science has resulted in splitting the atom or some other process which is science has resulted in splitting the atom or some other process which is

completely beyond the power of the scientists who did the research to completely beyond the power of the scientists who did the research to control it. And what we have here is people who have, for every best control it. And what we have here is people who have, for every best

reason in the world, pursued a direction of research. But there is now the reason in the world, pursued a direction of research. But there is now the point at which the research results have to be handled, and even if this point at which the research results have to be handled, and even if this

committee decides that there is no association and that information gets committee decides that there is no association and that information gets out, the work that has been done and through the freedom of information out, the work that has been done and through the freedom of information that will be taken by others and will be used in ways beyond the control of that will be taken by others and will be used in ways beyond the control of

this group. An I am very concerned about that as I suspect it is already this group. An I am very concerned about that as I suspect it is already too late to do anything regardless of any professional body and what they too late to do anything regardless of any professional body and what they

say…” say…”

Mercury in MedicineMercury in Medicine––

Taking Unnecessary RisksTaking Unnecessary Risks

A report prepared by the staff of the Subcommittee A report prepared by the staff of the Subcommittee on Human Rights and Wellness,on Human Rights and Wellness,

Committee on Government ReformCommittee on Government Reform

Unites States House of RepresentativesUnites States House of Representatives

Chairman Dan BurtonChairman Dan Burton

May 2003May 2003

““There’s no question that mercury does not belong in There’s no question that mercury does not belong in vaccines. There are other compounds that could be used as vaccines. There are other compounds that could be used as

preservatives. And everything we know about childhood preservatives. And everything we know about childhood susceptibility, neurotoxicity of mercury at the fetus and infant susceptibility, neurotoxicity of mercury at the fetus and infant

level, points out that we should not have these fetuses and level, points out that we should not have these fetuses and infants exposed to mercury. There’s no need of it in the infants exposed to mercury. There’s no need of it in the

vaccines.”vaccines.”

““Mercury is hazardous to humans. Its use in medicinal Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be products is undesirable, unnecessary and should be

minimized or eliminated entirely.”minimized or eliminated entirely.”

““Manufacturers of vaccines and thimerosal (an ethylmercury Manufacturers of vaccines and thimerosal (an ethylmercury compound used in vaccines), have never conducted compound used in vaccines), have never conducted

adequate testing on the safety of thimerosal. The FDA has adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety never required manufacturers to conduct adequate safety

testing on thimerosal and ethylmercury compounds.” testing on thimerosal and ethylmercury compounds.”

““Studies and papers documenting the hypoallergenicity and Studies and papers documenting the hypoallergenicity and toxicity of thimerosal (ethylmercury) have existed for toxicity of thimerosal (ethylmercury) have existed for

decades.”decades.”

““The amount of ethylmercury to which children were exposed The amount of ethylmercury to which children were exposed through vaccines prior to the 1999 announcement exceeded through vaccines prior to the 1999 announcement exceeded

two safety thresholds established by the Federal Government two safety thresholds established by the Federal Government for a closely related substance – methylmercury. While the for a closely related substance – methylmercury. While the

Federal Government has established no safety threshold for Federal Government has established no safety threshold for ethylmercury, experts agree that the methylmercury ethylmercury, experts agree that the methylmercury

guidelines are a good substitute.”guidelines are a good substitute.”

““The FDA and CDC failed in their duty to be vigilant as new The FDA and CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to vaccines containing thimerosal were approved and added to

the immunization schedule. When hepatitis B and the immunization schedule. When hepatitis B and Haempohilus Influenza Type B vaccines were added to the Haempohilus Influenza Type B vaccines were added to the recommended schedule of childhood immunizations, the recommended schedule of childhood immunizations, the

cumulative amount of ethylmercury to which children were cumulative amount of ethylmercury to which children were exposed nearly tripled.”exposed nearly tripled.”

““The CDC in general and the National Immunization Program The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the in particular are conflicted in their duties to monitor the

safety of vaccines, while also charged with the responsibility safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting of purchasing vaccines for resale as well as promoting

increased immunization rates.”increased immunization rates.”

““To date, studies conducted or funded by the CDC that To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and purportedly dispute any correlation between autism and

vaccine injury have been of poor design, under-powered, and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC’s rush to support and promote such fatally flawed. The CDC’s rush to support and promote such research is reflective of a philosophical conflict in looking research is reflective of a philosophical conflict in looking

fairly at emerging theories and clinical data related to fairly at emerging theories and clinical data related to adverse reactions from vaccinations.”adverse reactions from vaccinations.”

Kelly Patricia O’Meara. Vaccines may fuel autism epidemic. Insight Kelly Patricia O’Meara. Vaccines may fuel autism epidemic. Insight on the News, 24 June – 7 July, 2003, Volume 19, pgs 24-27.on the News, 24 June – 7 July, 2003, Volume 19, pgs 24-27.

““According to Len Lavenda, a spokesman for Aventis Pasteur, ‘The According to Len Lavenda, a spokesman for Aventis Pasteur, ‘The current package insert does not accurately reflect what is being current package insert does not accurately reflect what is being

marketed.’”marketed.’”

““The Indian Congressman [Dan Burton] continues, ‘One reason The Indian Congressman [Dan Burton] continues, ‘One reason this isn’t getting the attention it needs is that the Food and Drug this isn’t getting the attention it needs is that the Food and Drug

Administration has very close ties to the pharmaceutical Administration has very close ties to the pharmaceutical companies, as does the Department of Health and Human Services companies, as does the Department of Health and Human Services

[HHS] and the Centers for Disease Control and Prevention. I’ve [HHS] and the Centers for Disease Control and Prevention. I’ve said in the past that in some cases it appears that it’s a revolving said in the past that in some cases it appears that it’s a revolving

door and people leave government health agencies and go to work door and people leave government health agencies and go to work for the pharmaceuticals, which I think have undue influence on our for the pharmaceuticals, which I think have undue influence on our

health agencies. Of course, they may not want to look at this health agencies. Of course, they may not want to look at this because there’s a possibility that large claims would be filed and because there’s a possibility that large claims would be filed and

the pharmaceutical companies would have to cough up the money the pharmaceutical companies would have to cough up the money to take care of these kids who have been damaged.’”to take care of these kids who have been damaged.’”

Rep. Dr. Dave Weldon (Fla-R)’s letter of Rep. Dr. Dave Weldon (Fla-R)’s letter of 31 October 200331 October 2003

ToToDr. Julie Gerberding, Director, CDCDr. Julie Gerberding, Director, CDC

““I have read the upcoming Pediatrics study and several earlier versions of I have read the upcoming Pediatrics study and several earlier versions of this study dating back to February 2000. I have read various emails from Dr. this study dating back to February 2000. I have read various emails from Dr.

Verstraeten and coauthors. I have reviewed the transcripts of a discussion at Verstraeten and coauthors. I have reviewed the transcripts of a discussion at Simpsonwood, GA between the author, various CDc employees, and vaccine Simpsonwood, GA between the author, various CDc employees, and vaccine

industry representatives. I found a disturbing pattern which merits a industry representatives. I found a disturbing pattern which merits a thorough, open, timely, and independent review by researchers outside of the thorough, open, timely, and independent review by researchers outside of the

CDC, HHS, the vaccine industry, and others with a conflict of interest in CDC, HHS, the vaccine industry, and others with a conflict of interest in vaccine related issues (including many in University settings who may have vaccine related issues (including many in University settings who may have

conflicts.”conflicts.”

““A review of these documents leaves me very concerned that rather than A review of these documents leaves me very concerned that rather than seeking to understand whether or not some children were exposed to harmful seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s, there may have been a levels of mercury in childhood vaccines in the 1990s, there may have been a

selective use of data to make the associations in the earliest study selective use of data to make the associations in the earliest study disappear.”disappear.”

““This study increases speculation of an association between TCVs This study increases speculation of an association between TCVs [Thimerosal-containing vaccines] and neurodevelopmental outcomes. I [Thimerosal-containing vaccines] and neurodevelopmental outcomes. I

cannot say it was the author’s intent to eliminate the earlier findings of an cannot say it was the author’s intent to eliminate the earlier findings of an association. Nonetheless, the elimination of this association is exactly what association. Nonetheless, the elimination of this association is exactly what

happened and the manner in which this was achieved raises speculation. The happened and the manner in which this was achieved raises speculation. The dialogue at the Simpsonwood meeting clearly indicates how easily the dialogue at the Simpsonwood meeting clearly indicates how easily the

authors could manipulate the data and have reasonable sounding authors could manipulate the data and have reasonable sounding justifications for many of their decisions.”justifications for many of their decisions.”

Thimerosal:Thimerosal:

Still in Vaccines ??Still in Vaccines ??

Pediatric Diphtheria-Tetanus (DT)Pediatric Diphtheria-Tetanus (DT)

VaccineVaccine

Aventis Pasteur Aventis Pasteur

5 mL Vial - 0.5 mL Dose5 mL Vial - 0.5 mL Dose

Expires 19 February 2004Expires 19 February 2004

1:10,000 [25 Micrograms Mercury] Thimerosal1:10,000 [25 Micrograms Mercury] Thimerosal

Tetanus-Diphtheria (TD) VaccineTetanus-Diphtheria (TD) Vaccine

Massachusetts Public Health Biological Massachusetts Public Health Biological LaboratoriesLaboratories

For Children > 7 years-oldFor Children > 7 years-old

7.5 mL Vial – 0.5 mL Dose 7.5 mL Vial – 0.5 mL Dose

Expires 4 November 2004Expires 4 November 2004

1:30,000 [8.3 Micrograms Mercury] Thimerosal1:30,000 [8.3 Micrograms Mercury] Thimerosal

Tetanus-Diphtheria (TD) VaccineTetanus-Diphtheria (TD) Vaccine

Massachusetts Public Health Biological Massachusetts Public Health Biological LaboratoriesLaboratories

For Children > 7 years-oldFor Children > 7 years-old

7.5 mL Vial – 0.5 mL Dose 7.5 mL Vial – 0.5 mL Dose

Expires 21 May 2005Expires 21 May 2005

1:30,000 [8.3 Micrograms Mercury] Thimerosal1:30,000 [8.3 Micrograms Mercury] Thimerosal

Influenza Virus VaccineInfluenza Virus Vaccine

FluzoneFluzone

Aventis PasteurAventis Pasteur

5 mL Vial5 mL Vial

Expires 30 June 2004Expires 30 June 2004

1:10,000 [25 Micrograms Mercury] Thimerosal1:10,000 [25 Micrograms Mercury] Thimerosal

Japanese Encephalitis Virus VaccineJapanese Encephalitis Virus Vaccine

JE-VAXJE-VAX

Aventis PasteurAventis Pasteur

3 x 1 mL Vial3 x 1 mL Vial

Expires 15 February 2004Expires 15 February 2004

0.007% [35.7 Micrograms Mercury] Thimerosal0.007% [35.7 Micrograms Mercury] Thimerosal

Additional Vaccines Still Containing Additional Vaccines Still Containing ThimerosalThimerosal

**** Meningococcal Polysaccharide VaccineMeningococcal Polysaccharide Vaccine

Aventis Pasteur, 10 Dose Vial (25 Micrograms of Mercury per Dose), Lot Aventis Pasteur, 10 Dose Vial (25 Micrograms of Mercury per Dose), Lot UB505AA - Expires 17 Jun 05UB505AA - Expires 17 Jun 05

** Td Vaccine** Td Vaccine

Aventis Pasteur, 10 Dose Vial (25 Micrograms of Mercury per Dose), Lot Aventis Pasteur, 10 Dose Vial (25 Micrograms of Mercury per Dose), Lot U1014AA - Expires 2 Sept 05U1014AA - Expires 2 Sept 05

** Tetanus Toxoid Absorbed Vaccine** Tetanus Toxoid Absorbed Vaccine

Aventis Pasteur, 10 Dose Vial (25 Micrograms of Mercury per Dose), Lot Aventis Pasteur, 10 Dose Vial (25 Micrograms of Mercury per Dose), Lot U1048BA - Expires 8 Sept 05U1048BA - Expires 8 Sept 05

** Tetanus Toxoid Vaccine** Tetanus Toxoid Vaccine

Aventis Pasteur, 15 Dose Vial, (25 Micrograms of Mercury per Dose), Lot Aventis Pasteur, 15 Dose Vial, (25 Micrograms of Mercury per Dose), Lot U0775AA - Expires 19 Mar 05U0775AA - Expires 19 Mar 05

Other ConsiderationsOther Considerations

Adopted by the 53Adopted by the 53rdrd meeting of the WHO meeting of the WHO Expert Committee on Biological Expert Committee on Biological

StandardizationStandardization

17-21 February 200317-21 February 2003

Labeling:Labeling:

““Preservative-free does not necessarily mean Preservative-free does not necessarily mean a thiomersal – free product. Thiomersal could a thiomersal – free product. Thiomersal could by used during production as an inactivating by used during production as an inactivating agent, resulting in traces of thiomersal in the agent, resulting in traces of thiomersal in the final product, which are not intended to be final product, which are not intended to be have a preservative function.”have a preservative function.”

Memos About KeepingMemos About Keeping

ThimerosalThimerosal

InIn

VaccinesVaccines

WHO Information Meeting on Removal of Thiomersal From VaccinesWHO Information Meeting on Removal of Thiomersal From Vaccines

& Its Implications For Vaccine Supply& Its Implications For Vaccine Supply

May 21May 21stst 2002 2002 WHO HG GenevaWHO HG Geneva

•““DEVELOP A STRONG ADVOCACY CAMPAIGN TO SUPPORT ONGOING DEVELOP A STRONG ADVOCACY CAMPAIGN TO SUPPORT ONGOING USE OF THIOMERSAL”USE OF THIOMERSAL”

•““LOBBY MINISTRY OF HEALTH AND SENIOR REGULATORS”LOBBY MINISTRY OF HEALTH AND SENIOR REGULATORS”

• RECOGNIZING THE IMPORTANCE OF MAINTAINING USAGE OF RECOGNIZING THE IMPORTANCE OF MAINTAINING USAGE OF MULTIDOSE VACCINES IN GLOBAL MARKETS THAT ARE MULTIDOSE VACCINES IN GLOBAL MARKETS THAT ARE

EFFECTIVELY PROTECTED AGAINST FIELD CONTAMINATION, THEY EFFECTIVELY PROTECTED AGAINST FIELD CONTAMINATION, THEY SUPPORTED WHO’S PLANS TO RECOMMENDED THE CONTINUED USE SUPPORTED WHO’S PLANS TO RECOMMENDED THE CONTINUED USE

OF THIOMERSAL IN VACCINES.OF THIOMERSAL IN VACCINES.