Walgreen's announcement and subsequent retraction of its intent to sell genetic testing kits has proven to be a tipping point in the Direct To Consumer (DTC) Genetic Testing industry as shown most recently with the Congressional efforts to investigate three prominent DTC genetic companies. Notwithstanding the FDA's relatively weak jurisdictional arguments or the lack of any official FDA guidance regarding DTC tests, Walgreen's actions have forced Congress and the FDA to step-up in the face of a growing and unregulated industry. Our current understanding of risk and relationship between many of the tested diseases and their underlying genes is far from complete, and what we do know is complicated by caveats and qualifications. Even when genetic predispositions are relayed by a qualified professional, the disclosure of genetic information and statistical disease risk can be overwhelming. As long as society's vision of genetics is framed principally by movies --like Gattaca-- the release of genetic testing kits should be coupled with new ideas on how to better educate consumers to grapple with the information it grants them.
Dov Greenbaum, JD PhD
Mark Gerstein, PhD
Unpublished letter in response to:
"House launches investigation into genetic tests"
By Rob Stein
Published: May 19, 2010
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