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UNINFORMED CONSENT, SEATTLE. WA – The lead author, Thomas Verstraeten, MD, of the hotly debated CDC study known as the Verstraeten Study published in the November issue of Pediatrics, adamantly defends himself saying, “the article does not state that we found evidence against an association.” (Between mercury in vaccines and autism).
“Because of the findings of the first phase were not replicated in the second phase, the perception of the study changed from a positive to a neutral study.” Verstraeten says. “It may make it less attractive to publishers and certainly to the press, but it in no way diminishes its scientific and public health merit.”
The November peer-reviewed article states in part, “Conclusions. No consistent significant associations were found between TCVs, (Thimerosal Containing Vaccines), and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes.”
Verstraeten goes on to say, “The CDC screening study of thimerosal-containing vaccines was perceived at first as a positive study that found an association between thimerosal and some neurodevelopmental outcomes.” “It was foreseen from the very start that any positive outcome would lead to a second phase.”
The first phase was done from data collected by the CDC’s Vaccine Safety Data-link, (VSD) from the super bills of two large HMOs, (HMO A & HMO B), (Health Maintenance Organizations), Group Health Cooperative in Seattle and Northern California Kaiser with a combined enrolled population over 6 million people. They included 124,170 children that were born between 1992 and 1997 of families continuously enrolled and had records of all vaccines received during the child’s first year of life. They excluded some children from the study, notably, those who had been vaccinated with the Hepatitis B immunoglobulins, containing an additional 12.5ug of thimerosal/mercury, in the first six hours of life as they, “would have a higher likelihood of the outcomes” such as autism.
In the November 2003 version of the CDC sponsored study, “Phase II” – “HMO C”, (Harvard Pilgrim), was added to the study.
Results in “phase I at HMO A & B resulted in a significant positive association with tics and increase risk of language delay at 3 months.” Verstraeten says in the study. “In phase II at HMO C, no significant associations were found.”
Verstraeten’s original version of the study dated February 9, 2000, shows the risk of autism was sharply higher than even the next presentation presented to 52 doctors, scientists and researchers affiliated with various public protection government agencies, including the CDC, at the infamous Simpsonwood meeting four months later in June 2000.
1 of 2 Con’t
Critics claim, in the last three years, the study has apparently undergone numerous evolutions, face-lifts and additions - one in particular, by adding children in “phase II in HMO C” to mathematically “water down” the alarming results of the original findings.
HMO C data was collected from Harvard Pilgrim who filed for bankruptcy in 1999 and was taken over by the state in 2000. According the Journal of Law, Medicine and Ethics, (Sept 2000), they, (Harvard Pilgrim), used computers that had “little compatibility to communicate effectively with one another” and are “incapable of consolidating the data accurately.”
Critics claim the HMO is so riddled with bookkeeping and tracking failures that it would be impossible to know if there were any statistical correlations since the bankruptcy was precipitated by its inability to keep its own accounting.
Verstraeten claims that Harvard Pilgrim “was the only site known to myself, (Verstraeten), and my coauthors, (Frank DeStefano and Robert Davis on the original study), that could rapidly provide sufficient data that would enable a check of the major findings of the first phase in a timely manner.” (The study seems to have picked up several more coauthors with phase II, Robert Chen, Tracy Lieu, Phillip Rhodes, Steven Black, and Henry Shinefield now called the Vaccine Safety Datalink Team.)
Critics claim Harvard Pilgrim was an HMO outside the VSD coding system making Harvard Pilgrim one of the most difficult to include in the VSD data for the study seeming to directly contradict Verstraeten’s claims. Harvard required human data entry since the internal coding system does not match the VSD coding. Investigators say there were three other HMOs available in the CDC VSD bought, ready to use and paid for by the CDC, Kaiser Southern CA, (bigger cohort than Northern Kaiser therefore more reliable results), Kaiser Northwest, and Kaiser CO that would have been better choices.
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