While many often disagree with Jeff Shuren, those of us who know him and have served with him know him as an honorable man and a dedicated public servant.
Using words like “perjury” to advance an agenda (even, in this case, one that I mostly support) is inappropriate. Intelligent people can (indeed must!) regularly disagree on many things. That's how progress is made.
As background, some reportage courtesy of the talented Matt Herper at Forbes.
FDA Says Official Did Not Lie Under Oath
Jeffrey Shuren, now the head of the FDA’s Center for Devices and Radiological Health, was asked at a Congressional hearing last July if direct-to-consumer genetics companies like 23andMe and DeCodeMe add to the medical literature by doing their own research. He said no.
“From the information we know,” Shuren said, “they are not doing their own research on the genetic profiles but they’re interpreting the studies that have been performed by others.”
FDA critics pointed out that Shuren had just days before those comments listened to a presentation by 23andMe founder and chief executive Anne Wojcicki during which she presented her company’s plans to do research in areas including Parkinson’s. On March 8, Michael Lee, whose FDABlog advocates less regulation for genetic tests, posted a video pairing Shuren’s comments with Wojcicki’s, and saying that Shuren was being “accused of misleading Congress.” That video is embedded below.
The charge was picked up by researcher-blogger Dan MacArthur at Wired and Duke professor and author Misha Angrist. John Derbyshire, writing for National Review, wrote that Shuren “went for Olympic Gold in bare-faced dishonesty.”Razib Khan at Discover viewed Shuren’s comments as a threat to people’s right to view their own DNA. “If they take our rights away because we’re silent, we have only ourselves to blame,” Khan wrote.
But the FDA says Shuren’s comments were accurate because the research 23andMe published was not medical, but instead related to physical traits like eye color and hair color. (23andMe’s paper is here.)
An FDA spokeswoman writes, “We stand behind the comments made by Dr. Shuren,” She adds: “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.” (The full FDA statement is below.)
This statement is true. 23andMe has said it is working on using its data, collected from patient volunteers and customers, to try and understand genetic variants that are linked to disease. One area of interest is Parkinson’s disease; Wojcicki’s husband, Google co-founder Sergey Brin, watched his mother suffer from Parkinson’s and carries a gene that may raise his risk of developing the disease.
In context, Shuren’s quote was clearly about medical research, but he should have made the statement in the past tense. The fact of the matter is the anger about his statement is driven by a larger conflict: the collision between a community of genetics researchers and consumers who see access to one’s own DNA as a fundamental right and the medical community, which sees the tests as medical interventions with risks and benefits.
The main fear of those involved with DNA research is that the FDA will create regulations that prevent people from getting DNA test results without a prescription. There are many arguments that this should not happen. Research shows that people can handle the results from these tests, and it’s not clear that doctors are any more ready to understand them than consumers. Right now, these tests provide only limited information, but the technology for understanding human genetics is advancing at a breakneck pace.
My take remains that we’re set up for a huge clash between traditional medicine and genetics as these two fields, which don’t know how to talk to each other, wind up having to work together more and more often. This spat is merely a prelude.
One piece of advice from those angered by Shuren’s comments is very good: it is past time for those who believe it is important for consumers to be able to access genetic data make their views known to Congress and to the FDA.
The full FDA statement:
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. 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.
We stand behind comments made by Dr. Shuren in a July 2010 Congressional hearing on a GAO investigation into DTC genetic tests made by several companies. 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 2-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.
