A REVIEW OF MILES & TAKAHASHI STUDY AND RELATED LITERATURE
ON AUTISM RISK FROM ANTENATAL RHO-D IMMUNE GLOBULIN
Sallie Bernard, Mark Blaxill, Lyn Redwood http://www.safeminds.org/pressroom/pres_releases/Review_Miles_Takahashi_6-20-07.pdf
SafeMinds has released a review of the May 2007 study on thimerosal and
autism by Judith H. Miles and T. Nicole Takahashi appearing in the May
issue of the American Journal of Medical Genetics. The review challenges
the study conclusion that the mercury preservative thimerosal administered
to pregnant women through Rh immune globulin injections (RhIg) does not
increase the risk for autism.
The SafeMinds review, available here, , uncovered an earlier version of the
study data, presented by Drs. Miles and Takahashi at a conference in 2005.
Earlier data showed an increased rate of RhIg administration during
pregnancy of children later diagnosed with an autism spectrum disorder
(ASD) compared to their non-ASD siblings, as shown in the graph at right.
This positive finding of an increased risk of autism from RhIg is
consistent with other published studies reporting an association and is in
contradiction to the later journal version of Miles and Takahashi.
The SafeMinds review found multiple reasons for why the journal version may
have differed from the earlier 2005 version. The sample was altered so that
the majority of multiplex families and nearly half the minority families
were removed, representing approximately 1/3 of the original sample. The
final sample may reflect selection bias related to the exposure variable,
RhIg with thimerosal, as 59% of the eligible families were lost to follow
up or declined to participate, and those excluded are likely to have had
greater RhIg exposure. The authors failed to adequately identify the amount
of mercury in the RhIg given, invalidating exposure risk calculations. They
reported that all RhIg given was the Johnson & Johnson brand RhoGAM®, even
though this brand had only half the market share during the period of most
study pregnancies. The RhIg comparison control group in the journal version
consisted of just 27 families, too small for statistical power.
The study deficiencies may be linked to conflicts of interest. Johnson &
Johnson was a study sponsor, Dr. Miles has served as an expert witness in
RhIg/autism litigation, and the authors' clinic is oriented strictly to
genetic causality in autism, with no room for environmental contributions
like mercury. The SafeMinds review concludes that higher quality, unbiased
studies are needed to adequately address autism-mercury concerns.
http://www.safeminds.org/pressroom/pres_releases/Review_Miles_Takahashi_6-20-07.pdf
A REVIEW OF MILES & TAKAHASHI STUDY AND RELATED LITERATURE ON AUTISM RISK
FROM ANTENATAL RHO-D IMMUNE GLOBULIN
Sallie Bernard, Mark Blaxill, Lyn Redwood
June 20, 2007
Ó 2007 by Coalition for SafeMinds
Corresponding author telephone: (404) 934-0777 E-mail address:
sbernard@safeminds.
Executive Summary
Background
Rho(D) immune globulin routinely given during pregnancy formerly
contained mercury from thimerosal, raising concerns over a possible role in
autism causation. A May 2007 paper by Miles & Takahashi reported no
association. The conclusions contradict other studies on the subject. This
review evaluates the Miles & Takahashi research, related documents, and
other relevant literature and identifies alternate explanations for the
reported observations.
Conflicts of Interest - The Miles & Takahashi work reflects several
conflicts of interest, which appear to have affected study design and
interpretation.
The 2005 poster lists “Johnson & Johnson Pharmaceutical Research”
(J&J) as the supporter of the study, and the AJMG paper disclosed “Johnson
and Johnson Company” as a funding source. J&J is the largest manufacturer
of RhIg products. J&J has a direct financial interest in ongoing legal
proceedings regarding thimerosal in Rho D immune globulin therapies and
autism. 20 Analyses have shown that journal research funded by industry is
more likely to present results favorable to the manufacturer’
RhIg research sponsored by J&J therefore deserves special scrutiny for bias
and conflict of interest. Notably, the University of Missouri press release
omitted mention of industry sponsorship. In addition, the AJMG paper failed
to alert the reader that J&J was the manufacturer of the product under
study, saying only that “RhIg was first licensed by Ortho Clinical
Diagnostics under the brand name Rhogam [sic]”, and never offering that
Ortho is a J&J subsidiary.
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