The House Energy and Commerce Subcommittee on Oversight and Investigations grilled representatives from 23andMe, Navigenics, and Pathway Genomics over the GAO investigation and other findings during a Wednesday hearing held to discuss the public health effects of direct-to-consumer genetic tests. Representative Parker Griffith, striking an alarmist tone, compared the information supplied by DTC genetic testing companies to his throwing a snake into the middle of the Congressional hearing. According to Griffith, when presented with genetic risk information for serious diseases such as Alzheimer’s or cancer, consumers are likely to panic first and ask questions only later, if at all. Representative Phil Gingrey (GA) was on the same page, expressing his concern that DTC genetic testing might lead patients to jump to the wrong conclusions “or, indeed, jump off of a building” without appropriate guidance.
The companies defended their products and said that consumers have the right to know their genome in order to make informed health decisions. "People have the right to access their genetic information if they want to do that," said Ashley Gould, general counsel for 23andMe. Dr. Vance Vanier, president and CEO of Navigenics, said, "This sort of testing is safe and does not cause long term undue psychologic harm." Gould said she was "concerned by the percentage of discordance" in the GAO report, but added that 23andMe is "extremely confident in the analytical work we do."
Rep. Bart Stupak (D-Mich.), chairman of the subcommittee, shot back: "Then why wouldn't you get the same results as the other companies?"
One witness, Dr. James Evans, a professor of genetics at the University of North Carolina at Chapel Hill, agreed that people should have the choice to access a profile of their genes, but he said the current tests don't actually deliver the medical value that they promise. "The value of the bulk of this information is extremely low," Evans told the panel. He used an example of a person discovering through a home genetic test that he has an increased risk to develop Crohn's disease. In his testimony today, Gregory Kutz (author of the GAO report) concluded that while genetic testing is a promising area of science, "consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science." Congressional members echoed this concern, saying that these results are being marketed as extremely significant information, and that is a problem. "Part of the problem for consumers is that when you hear genetic risk, it sounds formal and official, but the complexity is mind boggling even to the experts," agrees Susanne Haga, senior policy analyst at the Duke Institute of Genome Sciences & Policy. As it is now, these tests will wrongly reassure and wrongly alarm consumers, as even with the best possible interpretation, there is so much room for error, King adds.
As the panel wound down, Representative Stupak pressed the DTC companies to consider withdrawing their products from the marketplace pending development of an adequate system of regulatory oversight. The FDA is planning to ramp up its regulation of genetic testing companies, said Dr. Jeffery Shuren, director of the FDA's Center for Devices and Radiological Health. "When regulations over medical devices were first developed, FDA exercised discretion and did not regulate tests that were just being done in one lab. Now the situation has changed," Shuren said. None of the genetic tests currently offered to consumers have undergone FDA premarket review. The agency recently sent letters to a number of companies informing them that their products appear to meet the definition of a medical device. Shuren said the FDA is meeting with six genetic testing companies in the upcoming weeks to discuss the regulatory status of their products. The agency may take additional action after the meetings, Shuren said.
Abbreviated from Genomics Law Report by Dan Vorhaus
