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UnInformed Consent

CDC Coauthors Defend Peer Reviewed Autism Study Amid Allegations of Misleading Public
April 7, 2004

  For Complete In-Depth Coverage and Stats of US National Academy of Sciences Continuing Investigation…

UNINFORMED CONSENT, SEATTLE. WA – The current version of the “Verstraeten Study”, a study that the CDC claims says has no link between autism and mercury in vaccines, has been embroiled in a continual flow of criticism since its publication in November 2003 issue of peer reviewed Pediatrics. See press release.

By December 17, 2003, Neil Halsey, MD, John Hopkins Bloomberg School of Public Health, Institute for Vaccine Safety stated, “The authors discount the positive association in HMO B between thimerosal exposure and language delays because no association was found in HMO C. The power to detect outcomes in HMO B was much greater than for HMOs A and C as the HMO B population was 8.3 and 6.6 times larger than HMOs A and C respectively. Also, HMO B had more variability in exposures to thimerosal, based on the information provided to the IOM, (Institute of Medicine).

Halsey also suggested there be “an independent organization, (sic), should convene a panel with expertise in neurodevelopment delay, effects of methylmercury exposure, and statistical methods to review the data and conduct additional analyses if indicated.” See document.

In January 9 2004, co-author, Frank DeStefano, MD of the CDC defended the study in a letter to the magazine stating that, “they were not more lax for the published report than for the IOM, (Institute of Medicine) presentation.” “We did not mean to discount the positive association at HMO B between thimerosal exposure and language delays because no association was found at HMO C. We do not feel, however, that this result by itself could be considered sufficient to establish a causal association.”

February 23, 2004 the magazine saw a lengthy and scathing letter from Mark and David Geier demanding withdrawal of the entire study from the magazine due to, among numerous other complaints, Verstraeten’s nondisclosure of his employment with GlaxoSmithKline, one of the largest vaccine manufacturers during phase II of the study.

Dr. Mark Geier and David Geier, Geneticist and Vaccinologist have been commissioned by Congress to investigate the CDC VSD data. Their recent and uncomplimentary testimony to the US National Academies of Science’s Immunization Review Safety Committee seemed to trigger the CDC’s barring of their VSD access within three days of their report to the committee.

DeSefano replied by March 2, 2004 that, “ The Centers for Disease Control and Prevention, (CDC) and all the co-authors stand behind the science and findings of the study.” “Although Geier and Geier try to discredit the study by impugning the integrity of the investigators, they have identified no substantive deficiencies with the study’s methods, analysis, or results.”

DeStefano goes on to defend the Geier allegations in some detail stating the CDC held deliberations outside of the Simpsonwood retreat center review internally at the CDC, by external organizations including representatives of SafeMinds, by an Institutes of Medicine, (IOM) committee and by peer reviewer for Pediatrics.”

1 of 2 Con’t

By March 24, 2004, Brian S Hooker, Research Scientist, Autism Healing Network states, “At no time were the SafeMinds individuals involved in review of the this document, neither were any presumed recommendations by SafeMinds ever enacted. This is based on a conversation I had with Lyn Redwood, President of the SafeMinds organization (3/23/04).”

Hooker goes on to include a scathing review of Redwood’s assessment quoted in the Insight on the News National Issue of the CDC, “On a scale of one to 10, I give the CDC study a big fat zero.” says Redwood in the quote.

DeStefano immediately responded March 26, 2004 by stating, “Ms. Redwood is the President of SafeMinds. She spent the better part of a day at CDC reviewing preliminary analyses and results with CDC researchers working on the study. The analyses of cumulative exposure by 7 months of age in the published manuscript were included at her request.

March 30, 2004 found Hooker retracting his previous submittal.

However March 31, 2004 Lyn Redwood, RN, MSN CRNP and President of SafeMinds spoke for herself in response to DeStefano.

“The suggestion here that the authors made good faith efforts to seek reviews from and respond to concerns by “external organizations” such as Safe Minds could not be further from the truth. Although Safe Minds addressed selected question to the CDC regarding the VSD analysis when it was under review by the Institute of Medicine in 2001 and later conducted our own independent investigations of the CDC’s research methods, we were in no respect invited reviewers. Our comments were never solicited, the authors’ responses to our questions were perfunctory and our most salient concerns have never been addressed. The suggestion to the contrary is misleading in the extreme.

Undaunted DeStefano responds April 5, 2004.

“We regret that Ms. Redwood feels that we did not adequately address her and SafeMind’s concerns. We spent considerable time with her individually reviewing the preliminary analyses. The fact that we incorporated an entire set of additional analysis (i.e., associations according to cumulative exposure by 7 months of age) at her request indicates that we gave her suggestions more than perfunctory consideration.

DeStefano continues that, “we would welcome any additional review or re-analysis of our study, but we are uncertain about the value of such a review at this time. Although other reviewers may be able to suggest improvements to the analysis, we do not think that any analysis would be able to fully overcome the inherent limitations of computerized health services data for evaluating causal associations with complex neurodevelopmental conditions.”

Despite DeStefano’s, who is a CDC representative, claim welcoming any additional review of their study, access to the CDC VSD database for congressional investigators Geier and Geier remains barred by CDC officials.


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