Of Evidence, Ethics and EducationRev. Lisa Sykes

“Once Upon a Time…”

1 OUT OF 6 CHILDREN ARE DIAGNOSED WITH A 1 OUT OF 6 CHILDREN ARE DIAGNOSED WITH A DEVELOPMENTAL / BEHAVIORAL DISORDERDEVELOPMENTAL / BEHAVIORAL DISORDER

1 IN 166 CHILDREN ARE DIAGNOSED WITH AN 1 IN 166 CHILDREN ARE DIAGNOSED WITH AN AUTISTIC DISORDER AUTISTIC DISORDER

January 2004January 2004

It wasn’t just Wesley…

a life-long debilitating disorder…

The “Mad” Hatter

Minamata, Japan

Chisso Factory

Protests Against Government

The Caduceus

The U.S. Army Medical Corps Branch Plaque. The 1902 adoption of the caduceus for U.S. Army medical officer uniforms popularized the symbol throughout the medical field in the US.

Mercury’s Wand

Hippocrates, “Epidemics”

“The physician must be able to tell the antecedents, know the present, and foretell the future—must mediate these things, and have two special objects in view with regard to disease, namely, to do good and to do no harm…”

Hippocratic Oath

“I will follow that system of regimen which…I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to any one if asked, nor suggest any such counsel…”

The Right of Informed Consent

Typically should include:

A description of the treatment/procedure

A description of the risks and benefits, esp. disability/death

A description of alternative treatments and their risk

The probably results if no treatment is undertaken

The probability of success, as defined by doctor

Length and challenges of recuperation

Other information generally provided to patients in a similar situation by other qualified physicians

Off-the-chart Mercury

Human Neuroblastoma Cells 24 Hrs Incubation

No Thimerosal

Human Neuroblastoma Cells 24 Hrs Incubation

100 nM Thimerosal[20 ppb Mercury]

↑ ↑

The Dose, Makes the Poison:The Dose, Makes the Poison:

Late 1980s to Early 2000s:Late 1980s to Early 2000s:

• Rh-negative mothers were routinely administered Thimerosal Rh-negative mothers were routinely administered Thimerosal containing Rho(D)-immune globulins at 28 weeks gestation (10.5 to containing Rho(D)-immune globulins at 28 weeks gestation (10.5 to in some instances more than 40 µg mercury per dose).in some instances more than 40 µg mercury per dose).

• Infants may have been exposed a total of 237.5 µg mercury during Infants may have been exposed a total of 237.5 µg mercury during the first 18-24 months of life, if all Thimerosal-containing vaccines the first 18-24 months of life, if all Thimerosal-containing vaccines were administered.were administered.

Early 2000s – Present:Early 2000s – Present:

• All pregnant women to receive flu vaccine anytime during All pregnant women to receive flu vaccine anytime during pregnancy (25 µg mercury / dose).pregnancy (25 µg mercury / dose).

• Infants to receive 3 flu vaccines during first 18-24 months of life Infants to receive 3 flu vaccines during first 18-24 months of life (12.5 µg mercury / dose) = 37.5 µg mercury.(12.5 µg mercury / dose) = 37.5 µg mercury.

• Children from 2 years-old through 18 years-old are to receive Children from 2 years-old through 18 years-old are to receive yearly flu vaccines (25 µg mercury / dose) = 400 µg mercury.yearly flu vaccines (25 µg mercury / dose) = 400 µg mercury.

The Hillman Memo (1991)

“The 25 micrograms of mercury in a single 0.5 mL dose…extrapolated to a 6 lb baby would be 25x the adjusted Swedish daily allowance of 1.0 micrograms for a baby of that size…If 8 doses of thimerosal-containing vaccine were given in the first 6 months of life…to an average size of 12 lbs., (that) would be 87x the daily allowance for a baby of that size…”

The Hillman Memo (cont’d)

“When viewed in this way, the mercury load appears rather large.”

Halsey Memo (1999)

“In the past few days I have become aware thnat (sic) the amount of thimerosal in most hepatitis B, DTaP, and Hib vaccines thnat (sic) we administer to infants results in total dose of mercury that exceeds the maximum exposure recommended by the EPA, the FDA, CDC, and WHO…”

Patriarca email to Myers (1999)

“…I have developed a “quick-and-dirty” pros and cons analysis for the AAP policy statement…

CONS

Will raise questions about the FDA being “asleep at the switch” for decades…

Patriarca email to Myers (cont’d)

CONS

Will also raise questions about various advisory bodies about aggressive recommendations for use. [We have to keep in mind that the dose of ethyl mercury was not generated by ‘rocket science’…(it) involves 9th grade algebra…]”

Etzel Email (1999)

We must follow three basic rules:

(1) Act quickly to inform pediatricians that the products have more mercury than we realized.

(2) Be open with consumers about why we didn’t catch this earlier.

(3) Show contrition.

Simpsonwood Meeting (7-8 June 2000) Simpsonwood Meeting (7-8 June 2000) in Norcross, GA where the findings of the in 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 discussed in a closed meeting by

employees from the CDC, FDA, & the employees from the CDC, FDA, & the vaccine manufacturers.vaccine manufacturers.

Dr. Brenier: Page 113: “We have asked you to keep this information confidential…”Dr. Brenier: Page 113: “We have asked you to keep this information confidential…”

Dr. Johnston: Page 198: “Forgive this personal comment, but I got called out a eight Dr. Johnston: Page 198: “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. Our first 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 grandson to get a male in the line of the next generation, and I do not want that grandson to get a thimerosal containing vaccine”thimerosal containing vaccine”

Dr. Weil: Page 207: “The number of dose related relationships are linear and statistically 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. They are statistically significant. You can play with this all you want. They are linear. They are statistically significant. significant. The positive relationships are those that one might expect from the Faeroe The positive relationships are those that one might expect from the Faeroe Islands studies. They are also related to those data we do have on experimental animal Islands studies. They are also related to those data we do have on experimental animal data and similar to the neurodevelopmental tox data on other substances, so that I think data and similar to the neurodevelopmental tox data on other substances, so that I think you can’t accept that this is out of the ordinary. It isn’t out of the ordinary. you can’t accept that this is out of the ordinary. It isn’t out of the ordinary. ””

Dr. Brent: Page 229: “…we are in a bad position from the standpoint of defending Dr. Brent: Page 229: “…we are in a bad position from the standpoint of defending lawsuits if they were initiated and I am concerned.” lawsuits if they were initiated and I am concerned.”

“The Office of Special Council (OSC) today forwarded to Congress hundreds of disclosures alleging public health and safety concerns about childhood vaccines that include a mercury-based preservative known as thimerosal, and its possible link to

neurological disorders, including autism. Notwithstanding a new Institute of Medicine study released yesterday that concludes there is no link between

thimerosal and autism…I hasten to add, however, that based on the publicly available information, as discussed briefly below, it appears there may be

sufficient evidence to find a substantial likelihood of a substantial and specific danger to public health caused by the use of Thimerosal/mercury in vaccines

because of its inherent toxicity… I believe these allegations raise serious continuing concerns about the administration of the nation’s vaccine program and the government’s possibly inadequate response to the growing body of scientific

research on the public health danger of mercury in vaccines.”

This letter is in response to you April 3, 2004 correspondence, which arrived at This letter is in response to you April 3, 2004 correspondence, which arrived at our office from Mr. Kenneth M. Donohue, acting in his capacity as Chairman of our office from Mr. Kenneth M. Donohue, acting in his capacity as Chairman of the Investigations Committee, President’s Council on Integrity and Efficiency the Investigations Committee, President’s Council on Integrity and Efficiency (PCIE). In his letter to this office, Mr. Donohue expressed concern over your (PCIE). In his letter to this office, Mr. Donohue expressed concern over your allegation Thimerosal is being used “in order to increase the manufacturer’s allegation Thimerosal is being used “in order to increase the manufacturer’s profit margins”…profit margins”…Upon review of the correspondence you provided to the PCIE, Upon review of the correspondence you provided to the PCIE, in conjunction with further research into the matter, we have determined that in conjunction with further research into the matter, we have determined that your above allegation represents a potential conflict-of-interest issue which may your above allegation represents a potential conflict-of-interest issue which may be criminal in nature and therefore falls within the Department of Health and be criminal in nature and therefore falls within the Department of Health and Human Services (HHS), Office of Inspector General (OIG), Office of Human Services (HHS), Office of Inspector General (OIG), Office of Investigations’ (OI) authority to investigate.Investigations’ (OI) authority to investigate.

Formulation of Charges

I. FDA: Criminal Negligence in failure to regulate safety and effectiveness of biological products

III. FDA: Criminal negligence in not instituting a Class I recall of all vaccines administered to infants containing thimerosal in July of 1999 and again in June of 2000 when the results of the VSD were discussed at Simpsonwood.

““The test of the morality of a society is what it does for its The test of the morality of a society is what it does for its

children.” children.” --Bonhoeffer--Bonhoeffer

A New Metaphor