June 26, 2007

Critique of JnJ's Rhogam Study

Earlier I had reported that Johnson and Johnson had cleared its own thimerosal containing product of any connection to autism. Now the critics are speaking:


The review found deficiencies in sample quality, including small and unmatched controls and inadequate methods for determining mercury exposure from RhIg brands. Poor sample recruitment design likely produced under-representation of mothers receiving RhIg, the key exposure variable. Alterations in sample composition during implementation, contravening accepted research standards, were detected, as were factual errors on vaccines, RhIg, and mercury. The lead author has many undisclosed conflicts of interest. These problems may underlie the negative finding on association between RhIg and autism. Additional calculations of the data, not done by Miles & Takahshi, show a 71% higher rate of Rh immune globulin exposure in children with autism relative to unaffected siblings, in contradiction to the original findings but consistent with other studies.


The Miles & Takahashi conclusions are questionable based on research quality issues. Recalculation of the data shows an increased risk of autism from Rh immune globulin. Definitive conclusions await higher quality studies.

Up until last month I have associated the name of Johnson & Johnson "A Family Company" with band-aids for boo-boos and gentile no tear shampoo for babies.

Now they are the big Pharma co that put mercury in my body while I was pregnant, and then paid for a deceitful study to say that injecting a neurotoxin into a pregnant women is not neurotoxic to her developing fetus.

Does the medical establishment and pharma understand that they are digging their own grave? Do they understand that people are paying attention to what they are doing?

Do they understand that people don't believe them any more?

The NAA/SafeMinds press release:

Genetics Journal Thimerosal/Autism Study the "Best Science Drug Company Money Can Buy": Critique of industry-funded immune globulin study uncovers sample manipulation, design flaws

Nixa, MO - 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.

To read the entire analysis, go to www.safeminds.org. For more about autism, visit www.nationalautism.org.

No comments: