Thursday, December 03, 2015 by: Julie Wilson staff writer
Tags: CDC scientists, autism study documents, MMR vaccine
My primary job duties while working in the immunization safety branch from 2000 to 2006, were to later co-lead three major vaccine safety studies. The MADDSP, MMR autism cases control study was being carried out in response to the Wakefield-Lancet study that suggested an association between the MMR vaccine and an autism-like health outcome.
There were several major concerns among scientists and consumer advocates outside the CDC in the fall of 2000, regarding the execution of the Verstraeten Study. One of the important goals that was determined up front, in the spring of 2001, before any of these studies started, was to have all three protocols vetted outside the CDC prior to the start of the analyses so consumer advocates could not claim that we were presenting analyses that suited our own goals and biases.
We hypothesized that if we found statistically significant effects at either 18 or 36 month thresholds, we would conclude that vaccinating children early with MMR vaccine could lead to autism-like characteristics or features. We all met and finalized the study protocol and analysis plan. The goal was to not deviate from the analysis plan to avoid the debacle that occurred with the Verstraeten thimerosal study published in Pediatrics in 2003.
At the Sept 5th meeting we discussed in detail how to code race for both the sample and the birth certificate sample. At the bottom of table 7, it also shows that for the non-birth certificate sample, the adjusted race effect statistical significance was huge.
All the authors and I met and decided sometime between August and September 2002, not to report any race effects from the paper. Sometime soon after the meeting, we decided to exclude reporting any race effects.
The co-authors scheduled a meeting to destroy documents related to the study.
The remaining four co-authors all met and brought a big garbage can into the meeting room, and reviewed and went through all the hardcopy documents that we had thought we should discard, and put them into a huge garbage can.
However, because I assumed it was illegal and would violate both FOIA and DOJ requests, I kept hardcopies of all documents in my office, and I retain all associated computer files. I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper.
So far, no hearings scheduled and no known inquiry of the alleged scientific misconduct.
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