Of Evidence, Ethics and Education Rev. Lisa Sykes

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Of Evidence, Ethics and EducationRev. Lisa Sykes
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Once Upon a Time
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1 OUT OF 6 CHILDREN ARE DIAGNOSED WITH A
DEVELOPMENTAL / BEHAVIORAL DISORDER 1 IN 166
CHILDREN ARE DIAGNOSED WITH AN AUTISTIC DISORDER
January 2004
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It wasnt just Wesley
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a life-long debilitating disorder
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The Mad Hatter
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Minamata, Japan
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Chisso Factory
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Protests Against Government
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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.
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Mercurys Wand
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Hippocrates, Epidemics

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

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Hippocratic Oath

• I will follow that system of regimen whichI
  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

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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

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Off-the-chart Mercury
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?
?
Human Neuroblastoma Cells 24 Hrs IncubationNo
Thimerosal
Human Neuroblastoma Cells 24 Hrs Incubation100
nM Thimerosal20 ppb Mercury
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• The Dose, Makes the Poison
• Late 1980s to Early 2000s
• Rh-negative mothers were routinely administered
  Thimerosal containing Rho(D)-immune globulins at
  28 weeks gestation (10.5 to in some instances
  more than 40 µg mercury per dose).
• 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 were
  administered.
• Early 2000s Present
• All pregnant women to receive flu vaccine anytime
  during pregnancy (25 µg mercury / dose).
• Infants to receive 3 flu vaccines during first
  18-24 months of life (12.5 µg mercury / dose)
  37.5 µg mercury.
• Children from 2 years-old through 18 years-old
  are to receive yearly flu vaccines (25 µg mercury
  / dose) 400 µg mercury.

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The Hillman Memo (1991)

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

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The Hillman Memo (contd)

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

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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

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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

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Patriarca email to Myers (contd)

• 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

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Etzel Email (1999)

• We must follow three basic rules
• Act quickly to inform pediatricians that the
  products have more mercury than we realized.
• Be open with consumers about why we didnt catch
  this earlier.
• Show contrition.

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Simpsonwood Meeting (7-8 June 2000) in Norcross,
GA where the findings of the Vaccine Safety
Datalink (VSD) analysis showing a link between
Thimerosal-containing vaccines and
neurodevelopmental outcomes were discussed in a
closed meeting by employees from the CDC, FDA,
the vaccine manufacturers.
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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 oclock 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 thimerosal containing vaccine 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. 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 data and similar
to the neurodevelopmental tox data on other
substances, so that I think you cant accept that
this is out of the ordinary. It isnt out of the
ordinary. Dr. Brent Page 229 we are in a
bad position from the standpoint of defending
lawsuits if they were initiated and I am
concerned.
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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
autismI 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 nations vaccine program and the governments
possibly inadequate response to the growing body
of scientific research on the public health
danger of mercury in vaccines.
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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 the Investigations Committee,
Presidents Council on Integrity and Efficiency
(PCIE). In his letter to this office, Mr. Donohue
expressed concern over your allegation Thimerosal
is being used in order to increase the
manufacturers profit marginsUpon review of the
correspondence you provided to the PCIE, in
conjunction with further research into the
matter, we have determined that 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 Human Services (HHS),
Office of Inspector General (OIG), Office of
Investigations (OI) authority to investigate.
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Formulation of Charges

• 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.

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The test of the morality of a society is what it
does for its
children.
--Bonhoeffer
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A New Metaphor