June 21, 2008

Ken Stoller's Letter to Pediatrics on the Verstraeten Study

Thimerosal Mea Culpa from the CDC
Kenneth Stoller,Pediatrician
International Hyperbaric Medical Association

Letter sent to Pediatrics:

In 2003, Dr. Eric Coleman (LETTERS TO THE EDITOR: Ethylmercury in Vaccines
Pediatrics, Apr 2003; 111: 922 - 923.) was able to have a letter printed in Pediatrics, undoubtedly because of his affiliation with the FDA, defending the decision to pull the Hep B vaccine until a Thimerosal or ethylmercury free version became available. He said the AAP and USPHS should be commended for this proactive decision for "the fact is, no preclinical or clinical studies were ever conducted to specifically examine the safety of thimerosal (ethylmercury) at the doses found when used in multiple infant and childhood vaccines. Thus, there was no conclusive evidence because there were no studies."

The Coleman letter is of historical importance because of what what took place next.
What followed was insanity. The CDC forced flawed and perhaps fabricated ecological
studies down the throats of pediatricians and the AAP. Pediatrics published the
Verstarten and Madsen studies, to name two, despite glaring methodological errors.

The CDC then used this planted intelligence, if you will, to not only defend the continued presence of Thimerosal, but to obfuscate the rising numbers of children with neurobehavioral disorders, including Autism, and controlled the IOM in the process to make it all but impossible for any one in academic medicine to point out the obvious and still be taken seriously.

Valuable time was lost for affected children and families were destroyed in the ensuing years when legitimate interventions and research could have been taking place.

Thimerosal continues to this day to be given to 3rd world children with the blessing of the WHO and without protest from those that know better within the USA. Meanwhile
the CDC line was all the "new" cases of affected children were but do to better diagnosis.

After numerous unanswered Data Quality Act complaints filed with the the CDC, Director Dr. Julie Gerberding has
produced a report
delivered to the House Appropriations Committee, in which she admits to a startling string of errors in the design and methods used in the CDC's landmark 2003 study that found no link between mercury in vaccines and autism, ADHD, speech delay or tics.

A 2006 report from the National Institute of Environmental Health Sciences (NIEHS),
concluded that the CDC's infamous Verstarten Thimerosal safety study publish in this journal was riddled with "several areas of weaknesses" that combined to "reduce the usefulness" of the study.

"CDC concurs," Dr. Gerberding wrote in an undated confession (see above link) to Congress, (provided to journalist David Kirby through a Capital Hill staffer) adding that her agency "does not plan to use" the database in question, the Vaccine Safety Datalink, (VSD) for any future "ecological studies" of autism.

In fact, Gerberding's report said, any continued use of the VSD for similar ecological studies of vaccines and autism "would be uninformative and potentially misleading."

After Verstarten revealed the link between Thimerosal and neurobehvioral disorders in the report presented to the secret Simpsonwood meeting in June of 2000 (http://www.putchildrenfirst.org/media/2.9.pdf) CDC officials conducted at least five separate analyses of the data. The first analysis revealed at Simpsonwood showed that children exposed to the most Thimerosal by one month of age had extremely high relative risks for a number of outcomes, compared with children who got little or no mercury: The relative risk for ADHD was 8.29 times higher; for autism, it was 7.62 times higher; ADD, 6.38 times higher; tics, 5.65 times; and speech and language
delays were 2.09 more likely among kids who got the most mercury.

Verstarten, who did NOT disclose to this journal that he was now an employee of vaccine maker GlaxoSmithKline (not the CDC) diluted his data five times The relative risk for autism plummeted from 7.62 in the first analysis, to 2.48 in the second version, to 1.69 in the third round, to 1.52 in the fourth, and down to nothing at all in the fifth, final, and this was what was published in November of 2003 (Pediatrics 2003; 112:1039-1048).

The new and improved Verstarten VSD study was the main pillar of a hugely influential 2004 report by the Institute of Medicine, which was essentially ordered to conclude that there was no evidence of link between mercury, vaccines and autism.

The AAP published VSD study has long been held up as the best and brightest of all epidemiology studies(the others were in Sweden, the UK, and two in Denmark).

There is now not a single pediatrician in the USA who can not quote from at least the AAP (Verstarten) study.

In 2005, a group of Senators and Representatives headed by Sen. Joe Lieberman wrote to the NIEHS (an agency of the National Institutes of Health) saying that many parents no longer trusted the CDC to conduct independent minded studies of its own vaccine program. Lieberman et al asked NIEHS to review the CDC's work on the vaccine database and report back with critiques and suggestions.

The final NIEHS report detailed where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel "identified several serious problems," with the CDC's effort, criticism to which the agency had not responded until Dr. Gerberding delived her undated report referenced above.

The NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment.

"CDC acknowledges this concern and recognizes this limitation," the Gerberding reply

The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, "a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal." This strict entry criteria likely led to an under-ascertainment" of autism ases, the NIEHS reported.

"CDC concurs," Gerberding wrote, again noting that its study design was "not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied."

Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could "affect the observed rate of autism and could confound or distort trends in autism rates," the NIEHS warned.

"CDC concurs," Dr. Gerberding wrote again, "that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful."

So, the Director of the CDC is now saying that its most powerful and convincing piece of exonerating evidence for Thimerosal is, in effect, "useless." This after years of
propagandizing the American public in violation of the law, after holding the illegal secret Simpsonwood meeting when all of this was revealed - including to a representative of the AAP!

Now we have a generation of pediatricians, who face perhaps the greatest iatrogenic accident in the history of pediatrics, who actually need to be deprogrammed to understand what the true nature of all the neuro-behvioral problems are that they confront without any understanding of etiology or potential interventions.

The most serious message that affected children have sacrificed themselves for still goes unheeded. The message is that the level of industrial pollution we are exposing ourselves to is so great now, that just a little more toxic load will push us over the edge.

It pushed a generation of children over the edge and so while we ponder who is going to pay for the many who will go on full disability, we should ponder the fate of our species as well.

(Special thanks to the journalist David Kirby.)

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