Senate Hearings on Direct to Consumer Genetic Testing
The Special Committee on Aging held
hearings on direct-to-consumer genetic testing services on July 27,
2006. Testimony was heard from representatives from the Federal
government, academia and the companies being investigated. The General
Accounting Office (GAO) conducted an undercover investigation where
samples of DNA from male and female test subjects were sent to four
labs for nutrigenetic testing. The DNA samples were accompanied by
varying profiles of age, physical activity, and diet information.
According to the testimony of the Managing Director, Forensic Audits
and Special Investigations (FSI), U.S. Government Accountability
Office, the results of the undercover investigations report
discrepancies in analysis of the DNA samples, health advice that is
more consistent with reported lifestyle and diet than with the DNA test
results, and the promise of personalized advice that actually was the
same for all tested samples and profiles. The entire GAO report can be
accessed
here.
The
results of this investigation are not surprising, though disappointing.
The promise of personalized diet and other lifestyle advice based on a
combination of genetic, demographic and lifestyle information is the
anticipated promise of nutrigenomics. However, we are not there yet,
not even close. With the negative publicity that is likely to be
generated by these results, I hope that we do not throw the baby out
with the bathwater. This type of testing, although clearly prematurely
and inappropriately being applied in these situations, needs to have
the type of regulatory structure that allows oversight without stifling
innovation. Ironically, these intrepid entrepreneurs who are pushing
the envelope by providing this technology to the public may actually
end up triggering a regulatory reaction that makes future innovation in
this area more difficult than it would have had to be.
Senator
Barack Obama has introduced legislation to regulate direct to consumer
testing. It will be interesting to see how this legislation is shaped
as it wends its way through the legislative process in the US Congress.
The legislation was introduced as
S.3822 on
August 3, 2006. So far, there are no co-sponsors. We will continue to
follow this and report any new developments regarding this legislation.
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