US, EU Move to Regulate Direct-to-Consumer Genetic Testing

Discussion is accelerating in the United States and European Union to regulate private genomic testing that provides consumers medical information, according to Science magazine and the European Journal of Human Genetics. No mention is made in the reams of white papers about ancestry testing, but some of the pitfalls and bureaucratic morasses in the thinking about true genetic/medical testing are fairly ominous, if not silly.

“Although there has been speculation about the potential psychosocial harms of testing [that is, genomic medical testing], such as an increase in anxiety or encouragement of fatalistic behavior, there are, to date, few studies addressing these concerns,” writes the reporters for Policy Forum in the Oct. 8 issue of Science. “The limited evidence tends to be reassuring, even for risk information associated with relatively serious ailments…however, the scope for potential harm from unnecessary or unproven treatment after genetic risk assessment is an important unstudied question” (pp. 181f.).

We commend scientists and physicians for finding a new field of study divorced from reality but have to wonder what they will do about ancestry testing once they have conquered and tamed Frankenstein’s elder monster. We suggest the following guidelines:

  • Labeling on Internet sites and Zen Shopping Carts that explicitly states, “The claims for this ancestry product have not been evaluated by the U.S. Government Accountability Office (GAO), U.S. Federal Trade Commission (FTC), House Energy and Commerce Committee, Food and Drug Administration, National Institutes for Health or Department of Bioethics and Humanities, University of Washington School of Medicine, Seattle, WA 98195 USA.”
  • Predictive ancestry information may be hazardous to your progeny.
  • No animal has been harmed in the production or clinical evaluation of this ancestry test.
  • If you discover you have ancestry you did not expect, take a deep breath. Then take a healthy dose of skepticism, followed by two aspirins and a glass of water.

We’re waiting for the next gambit from the genius bar in Washington!

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