Controversy grows around FDA's Shuren

Wednesday, March 9, 2011

WASHINGTON - Controversy around senior FDA official Dr. Jeffrey Shuren intensified Wednesday, as a new YouTube video which seems to show Shuren misleading Congress about Google-backed genomics startup 23andMe drew sharp reactions from prominent scientists and bloggers.

"The statement, for 23andMe in particular, that 'they are not doing their own research on the genetic profiles,'" said Stanford's Serafim Batzoglou, "is patently false." "Clearly this is false," said Russ Altman, also at Stanford. "I am reviewing [23andMe's paper] in my annual review of translational bioinformatics." And asked whether he thought Shuren prevaricated, Harvard's George Church was blunt. "The question is not whether, but why?" said Church. "And did he think that no one would notice?"

Scientist and blogger Misha Angrist, of Duke's Institute for Genome Sciences and Policy, hit back angrily. "If last year's hearings were predicated on testimony that turns out to have been anything less than cricket," said Angrist, "it calls into question whether the self-righteousness of those who were doing the finger-pointing ought to be taken at face value." And geneticist Daniel MacArthur, at Wired Science, wrote:

"That would appear to suggest that Shuren either forgot about 23andMe’s research efforts over a two-day period – despite having sat and faced Wojcicki for the whole of her talk – or that it simply seemed more convenient to pander to the committee’s witch-hunt by ignoring any positive contribution made by these companies. Either way, his slip is yet another embarrassment for the FDA."

Discover's Razib Khan was even more impassioned. "This is a power grab, this is not about safety or ethics," wrote Khan. "If you have a blog, post the video. Raise awareness. If they take away our rights because we're silent, we have only ourselves to blame."

FDA officials have not yet commented on the video, which may draw attention from the House's new Republican majority. "Obscure subcommittees of obscure congressional committees don’t get much media coverage," said John Derbyshire of the right-wing National Review. "This one should have, if only for the brazen Nanny State arrogance on display."

The House recently moved to demote and discipline Gregory Kutz of the GAO for providing systematically misleading information to Congress. Mr. Kutz and Dr. Shuren testified together in the July 22, 2010 hearing, and the FDA is currently slated to have hundreds of millions cut from its budget by a Republican Congress.

But Dr. Shuren's apparent preference for "traditional manufacturers" may also raise hackles among progressives. The FDA's attack on 23andMe and other consumer-genomics startups seems at odds with President Obama's recent editorial on 21st-century regulation.

"It means using disclosure as a tool to inform consumers of their choices, rather than restricting those choices," wrote the President in January. "Today I am directing federal agencies to do more to account for -- and reduce -- the burdens regulations may place on small businesses. Small firms drive growth and create most new jobs in this country. We need to make sure nothing stands in their way."

Other stories and reactions around the Web: Mass Device, MIT Technology Review, Reason, John Hawks, Genomes Unzipped, Harappa Ancestry Project.

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