On July 22, 2010, Dr. Jeffrey Shuren, Director of FDA’s CDRH, testified under oath before Congress that 23andMe was not doing any original research. Yet two days earlier, Dr. Shuren sat before a podium in which Anne Wojcicki, CEO of personal genomics startup 23andMe, gave a speech detailing 23andMe’s peer-reviewed research, which made the cover of Wired and was published in PLoS Genetics.
Shuren’s testimony was important, because several members of Congress seized on his statements to conclude that there would be no impact on genomics research if 23andMe was shut down. However, several senior faculty at Stanford University have now gone on record to state that Dr. Shuren’s testimony was factually inaccurate.
Was Dr. Shuren intentionally misleading Congress to justify a regulatory crackdown on startups in favor of what he describes as “traditional manufacturers” like Genentech? Was he simply mistaken? Or is there another explanation?
UPDATE March 8, 2011:
Two tenured Stanford professors in computational biology have now gone on record to assert that Shuren’s statements before Congress were indeed false.