Genetics Journal Thimerosal/Autism Study the 'Best Science DrugCompany Money Can Buy'Critique of Industry-Funded Immune Globulin Study Uncovers Sample Manipulation, Design Flaws
NIXA, Mo., June 26, 2007 /PRNewswire-USNewswire/ -- An analysis released today critically examined a recent industry-sponsored study ruling out a link between autism and Rh immune globulin (RhIg) injections, some of which contained the mercury-based preservative thimerosal. Besides extensive design flaws, the analysis uncovered manipulation of the study sample, so that earlier data revealing a positive autism-RhIg association was concealed.
"This study is just another example of the pharmaceutical industry's corruption of research to suit its own purposes," according to National Autism Association president and parent Wendy Fournier. "They back the study designs that give the desired results of no harm."
Johnson & Johnson, parent company of Ortho Clinical Diagnostics, which manufactures the once mercury-sterilized RhIg shot RhoGAM, funded the study. It was published in the May 2007 American Journal of Medical Genetics (AJMG) by Judith H. Miles and T. Nicole Takahashi of the University of Missouri.
A University press release entitled, "Study Finds No Link Between Autism and Thimerosal in Vaccines" suggested deliberate deception as immune globulins are not vaccines. J & J's involvement in the study was not disclosed in the press release, and J&J's role as the parent of Ortho and the largest manufacturer of mercury-containing RhIg were not communicated in the published paper. Dr. Miles has served as a paid consultant in autism-related litigation involving RhIg, which was also not divulged.
The critical analysis, conducted by the nonprofit research organization SafeMinds, examined earlier data from a 2005 poster presentation of the Miles and Takahashi research. They found that between the 2005 and 2007 versions, the control groups changed and major portions of the original autism sample were removed. Calculations based on the original data indicate that children with autism "were 71% more likely to have been exposed to RhIg in utero than their non-ASD siblings," according to the SafeMinds analysis.
NAA's Fournier points out that the RhIg study fits a recurring pattern for thimerosal research with drug company/researcher ties. Manipulation of data to reach a desired conclusion was seen in CDC studies conducted in 2000 showing a relationship between thimerosal-containing vaccines and a range of adverse neurological effects including autism. The data was manipulated to lower the relative risk factor before publication in the journal Pediatrics in 2004. Lead investigator Dr. Thomas Verstraeten left the CDC to work for vaccine maker Glaxo-Smith-Kline in 2001 while the data alterations were ongoing, but his employment was not disclosed by the journal. Likewise, Dr. Michael Pichichero, an Eli Lilly-funded researcher and holder of numerous vaccine patents, tried to clear thimerosal as harmful by conducting a blood mercury evaluation after infant vaccination which missed peak blood levels, had a sample size too small to detect susceptible subgroups, and failed to address implications of the findings for long term mercury deposition in the brain. His industry ties were not disclosed by the journal, The Lancet.
"While this latest RhIg effort is the best science drug money can buy," points out Ms. Fournier, "NAA feels that the public and families with autism deserve better quality studies. This is a critical product safety issue." RhIg is given to approximately 15% of all pregnant women.
Rita Shreffler (Nixa, MO) 401-632-6452
Wendy Fournier (Portsmouth, RI) 401-632-7523
CONTACT: Rita Shreffler, Nixa, MO, +1-401-632-6452, or Wendy Fournier,Portsmouth, RI, +1-401-632-7523, both of National Autism Association
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Posted: June 2007