Oversight Agencies Crash the Spit Party
A July 22nd Congressional hearing on direct-to-consumer gene tests took a startling turn when a report compiled by the Government Accountability Office (GAO) was unveiled. The report, along with a damning video of clandestine phone calls made by GAO staff to DTC company representatives, were part of an undercover operation investigating the validity and reliability of DTC services. Three of the major DTC companies -- 23andMe, Navigenics, and Pathway Genomics -- were present at the session, which was titled Direct-To-Consumer Genetic Testing and the Consequences to Public Health and held by the House Committee on Energy and the Commerce Subcommittee on Oversight and Investigations.
The report and testimony revealed several unsavory practices by DTC companies, including misleading test results and deceptive marketing. For example, one company told an undercover GAO customer that he was at average risk for developing prostate cancer, another said he was at above-average risk, and a third reported that he was at below-average risk.
Even more disturbing were some of the claims made by DTC company representatives in conversations with the GAO staff posing as customers. In one such phone call, a representative stated that above-average risk for breast cancer meant that the person who had been tested would be "high risk of pretty much getting" the disease. Consulted experts deemed such an assertion incorrect; genetic risk does not translate to someone definitively getting a disease.
In another call, a company representative gave a woman permission to surreptitiously send DNA from her fiancé, a dangerous violation of privacy. Yet others tried to sell supplements to repair DNA and to replace medications for high blood pressure and high cholesterol - all offers with no basis in scientific findings, according to experts.
The report also pointed out that while none of the DTC companies could provide complete test results for (fictitious) customers of non-European ancestry, they did not explicitly disclose this prior to purchase of the test kits.
The Congressional hearing came the day after the Food and Drug Administration (FDA) held a two-day public meeting at which various stakeholders, including DTC companies, presented their case for regulating (or not regulating) DTC genetic testing. In addition, the FDA sent letters dated July 19 to fourteen genetic testing providers, stating that they were providing consumers with a "device" that should have FDA clearance or approval, but did not.
The Centers for Disease Control (CDC) has also weighed in on DTC, saying late last month that it is "not ready for prime time."
This accumulation of attention from federal regulators has persuaded even many DTC companies that regulation in the near future is probable. However, that hasn't prevented significant pushback against the GAO report, which we'll take a look at in an upcoming blog post.
The events of the last few weeks - the FDA meetings, the Congressional hearings, and the GAO report - have made a strong case for federal regulation of the DTC industry. We've long pointed to the problematic nature of direct-to-consumer genetic testing, the lack of protections for consumers, and the need for oversight. We look forward to watching this drama continue to unfold.