The FDA is standing behind comments made by the chief of its medical device arm, Dr. Jeffrey Shuren, during testimony before a U.S. House committee last summer on direct-to-consumer genetic tests.
The remarks, made during a House Energy & Commerce Committee hearing on whether DTC genetic tests should be regulated by the Food & Drug Administration, passed un-noticed for the better part of a year until a video posted on FDAblog.org drew the attention of genetics researchers and bloggers this month.
During the hearing, Shuren told Rep. Henry Waxman (D-Calif.) that companies that make the tests do not conduct their own research.
"From the information we know, they’re not adding — they’re not doing their own research on the genetic profiles, but they’re interpreting the studies that have been performed by others," Shuren said during his July 22, 2010 testimony.
But just two days earlier, according to a video posted on FDAblog.org, Shuren attended a presentation by 23andme founder Anne Wojcicki detailing her company’s studies of its database of human genetic information.
It’s an especially sensitive issue given an FDA panel’s vote yesterday to recommend that the federal watchdog agency require a doctor to dispense DTC genetic tests. Genomics researchers and science bloggers hate that idea, arguing that the benefits for patients who delve into their genomes far outweigh any potential risks.
"We stand behind comments made by Dr. Shuren" during the hearing, spokeswoman Erica Jefferson wrote in a statement emailed to MassDevice. "At that time we were not aware of any of the more than a dozen DTC genetic tests making medical claims that were based on results of a company’s own research. Instead, the companies relied on published research in the literature.
"At a separate two-day public meeting on laboratory-developed tests held by the FDA in 2010, a panel of experts and agency officials, including Dr. Shuren, listened to a brief presentation from 23andMe CEO Ann Wojcicki about her company’s early research efforts. However, most of the described activities, including the one paper they had published, pertained to non-medical claims, such as eye or hair color."
Any diagnostic tests that make medical claims fall under the purview of the FDA, but tests for hair or eye color do not.
"The FDA is responsible for reviewing clinical genetic tests. To date, direct-to-consumer genetic tests have not been reviewed by the FDA and as a result, we cannot verify that they provide safe and accurate results," Jefferson wrote. "The FDA just concluded an advisory panel with experts representing various aspects of the testing community, which provided us with a set of opinions on several scientific issues in DTC testing. We will review these and other public comments in the weeks ahead to determine what we think is the best path forward for addressing the complex issues related to direct-to-consumer testing products."
The FDAblog video caused a stir among science bloggers and researchers, with Wired magazine’s Daniel MacArthur asking, "Did the FDA’s Jeffrey Shuren mislead a Congressional hearing?"
"If last year’s
monkey trial hearings were predicated on testimony that turns out to have been anything less than cricket, then — in my mind, at least — it calls into question whether the self-righteousness of those who were doing the finger-pointing ought to be taken at face value,” added Misha Angrist on his GenomeBoy blog.
"This is a power grab, this is not about safety or ethics," fulminated Razib Khan on his Gene Expression blog at Discover. "Let’s make our voices heard. If they take away our rights because we’re silent, we have only ourselves to blame. If they take aware our rights despite our efforts, we’ll set up the infrastructure for the day when we can take back what is ours" [emphasis his].
Here’s a look at the FDAblog video that kicked up the fuss: