Docs: Deluge of genetic data calls for international regulatory framework

Your genetic data could be analyzed in another country, sparking debate over the need for an international, harmonized approach toward management of genomic data. And meanwhile, one American company is already analyzing blood samples of Japanese women obtained from a prenatal test.

Given such complexities and the rise of more powerful tests and sequencing technologies, the controversy in the U.S. over questionable genetic testing company 23andMe risks missing the larger point, according to a letter to the editor in the New England Journal of Medicine by three doctors at the University of Tokyo.

"Any regulatory framework for the genome business should be based not solely on domestic laws but on an international harmonization," they write in response to an NEJM article about 23andMe, which they say is "limited to a domestic U.S. perspective."

The authors of the NEJM article, from the Boston University School of Public Health and Northwestern University Feinberg School of Medicine, say than an international perspective is needed. They respond that while "it is always tempting to adopt a lowest-common-denominator approach," there is to date no global initiative that has been successful.

NIH Director Francis Collins

The current deluge of genetic data raises many ethical challenges. National Institutes of Health Director Francis Collins is concerned about what doctors should do when next-generation sequencing reveals that patients have disorders that are unrelated to the problem for which they sought treatment.

Guidelines are, however, beginning to emerge. The American College of Medical Genetics is developing guidelines for reporting "incidental findings." As more and more genetic databases include information from citizens in various countries, intergovernmental bodies like the Asia-Pacific Economic Cooperation forum are developing guidelines on issues such as data privacy.

The question facing these myriad recommendations and guidelines is whether they can cohere to form a cogent framework governing genetic data. The fight over 23andMe is already outdated.

- read the letter to the editor and authors' response

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