Tuesday, March 8, 2011
WASHINGTON - Unaccustomed public criticism has dogged the Food and Drug Administration since last May, when the Agency began its controversial effort to regulate millions of laboratory tests -- including direct-to-consumer (DTC) genetic tests -- as medical devices.
Critics seemed to gain new momentum on Tuesday, when a YouTube video provided to this reporter showed senior FDA official Dr. Jeffrey Shuren apparently dissembling under oath in response to Energy and Commerce Committee chair Henry Waxman (D-CA). The video contains footage of an exchange from last July's Congressional hearing on genetic tests.
"Do these companies have researchers that are adding to the information, that will help us have these breakthroughs for learning more about propensity to disease, how to make medicine more personal? Do they have researchers, are they adding to the scientific knowledge?" asked Rep. Waxman. "Or are they charlatans, and if they're all closed down, then so be it? That they don't really serve a useful purpose?"
"From the information we know," responded Dr. Shuren, "they are not doing their own research on the genetic profiles... they are interpreting the studies that have been performed by others."
Rep. Waxman seemed convinced. So did Rep. Parker Griffith (D-AL), who remarked: "I don't think the companies here, if they disappeared tomorrow, would impact the scientific community...this is all bogus. This is nothing more than the snake-oil salesman revisited again in a high-tech way."
But just two days earlier, Dr. Shuren and other senior FDA officials sat ten feet from the podium as Anne Wojcicki, founder of personal genomics leader 23andMe, boomed into a microphone. "A unique and significant part of 23andMe's site is the research component," said Wojcicki. "In 2009, we launched our first disease community in Parkinson's disease. We enrolled over 2,000 individuals in the first three weeks alone. We have over 4,000 participants today... we are running hundreds of genome-wide association studies on a nightly basis. We have been able to replicate many of the major genetic findings and plan to publish more soon."
Ms. Wojcicki detailed one of the largest genome studies ever performed, published in the prestigious PLoS Genetics. After being featured on the cover of Wired, the 23andMe paper was viewed more than thirteen thousand times, and described by Ms. Wojcicki for approximately 15 minutes via 30 foot high slides as Dr. Shuren looked on. Less than 48 hours later, Dr. Shuren maintained to Representative Waxman that the companies were "not doing their own research on the genetic profiles."
While prosecutions for inaccurate Congressional testimony are rare, the apparent inaccuracy of Dr. Shuren's testimony feeds a growing uncertainty about the FDA's concern for the legal implications of potentially inaccurate public statements. Since FDA Commissioner Margaret Hamburg effectively ended prior legal review of warning letters last summer, "I have noticed what appears to be a diminution in the quality of warning letters - issues ranging from typographical errors to lack of legal support for assertions," said Skadden, Arps partner Jennifer Bragg.
Many scientists likewise single out the FDA's attempt to regulate access to the genome for particular concern, including Eric Topol of the Scripps Institute and David Hafler of Yale. "Give our patients the opportunity to make their own decisions," says Dr. Hafler, chairman of Yale's neurology department.
Influential proponents of increased FDA power include the American Medical Association (AMA), which last week filed a brief demanding that its members mediate all access to personal genomes. Joining the AMA in calling for increased regulation is drug manufacturer Genentech, which filed a citizen's petition urging the FDA to crack down on the smaller clinical labs which constitute some of its main competitors.
For now, Dr. Shuren appears to be most sympathetic to Genentech. There is a bright side to companies like 23andMe "going out of business", he said. "Traditional manufacturers," the CDRH director suggested, could then "get more involved in this area."