Events surrounding the DeStefano et al (2004) MMR-Autism Study
Prepared by Dr. William E. Thompson
September 9, 2014
Statement delivered to Congressman Posey (excerpted)


13.  .... In the Excel File named “describe_results_2002_0702.xls”, Table 7 shows the RACE analyses that I had run using ONLY the BIRTH CERTIFICATE Sample --- the unadjusted RACE effect was statistically significant. (OR=1.51, [95%CI 1.02 - 2.24]). At the bottom of Table 7, it also shows that for the NON-BIRTH Certificate Sample, the adjusted RACE effect statistically significance was HUGE. (OR=2.94 [95%CI 1.48 - 5.81). That is the main reason why we decided to report the RACE effects for ONLY the BIRTH Certificates.
 
14. In the Excel File named “describe_results_2002_0801.xls”, I split Table 7 into three different Tables (Table 7a, Table 7b, and Table 7c) to further investigate the RACE subgroup analyses.

15. All the coauthors met and decided sometime between August 2002 and September 2002 not to report any RACE effects for the paper.

16. Sometime soon after the meeting where we decided to exclude reporting any RACE effects, also between August 2002 and September 2002, the coauthors scheduled a meeting to destroy documents related to the study. Dr. Coleen Boyle was not present at the meeting even though she was involved in scheduling that meeting. The remaining 4 coauthors all met and brought a big garbage can into the meeting room and reviewed and went through all our hard copy documents that we thought we should discard and put them in the large garbage can. However, because I assumed this was illegal and would violate both FOIA laws and DOJ requests, I kept hard copies of all my documents in my office and I retained all the associated computer files. This included all the Word files (agendas and manuscript drafts), Excel files with analysis and results, and SAS files that I used to generate the statistical findings. I also kept all my written notes from meetings. All the associated MMR-Autism Study computer files been retained on the Immunization Safety Office computer servers since the inception of the study and they continue to reside there today ....

Conclusion
I believe we intentionally withheld controversial findings from the final draft of the DeStefano et al (2004) Pediatrics paper. We failed to follow the final approved study protocol and we ran detailed in depth RACE analyses from October 2001 through August 2002 attempting to understand why we were finding large vaccine effects for blacks. The fact that we found a strong statistically significant finding among black males does not mean that there was a true association between the MMR vaccine and autism-like features in this subpopulation. This result would have probably have led to designing additional better studies if we had been willing to report the findings in the study and manuscript at the time that we found them. The significant effect of early vaccination with the MMR vaccine might have also been a proxy for the receipt of thimerosal vaccines early in life but we didn’t have the appropriate data to be able to code the level of thimerosal exposure from the MADDSP school records.
 
In addition to significant effects for black males, we also found significant effects for “isolated autism cases” and for the threshold of 24 months of age. If we had reported the 24 month effects, our justification for ignoring the 36 month significant effects would not have been supported. In the discussion section of the final published manuscript, we took the position that service seeking was the reason we found a statistically significant effect at 36 months. This was a post-hoc hypothesis regarding the findings after we confirmed one of our primary hypotheses. Because we knew that the threshold for 24 months was also statistically significant, reporting it would have undermined the hypothesis that service seeking was the reason we found an effect at 36 months. (See published paper).