Home » The Daily Scan

GAO 'Sting' 'Doesn't Bode Well' for DTC Industry

July 23, 2010

This post has been corrected to reflect that 23andMe's General Counsel is Ashley Gould.

The United States Government Accountability Office dealt a blow to several direct-to-consumer genetic testing firms yesterday during testimony delivered to the House of Representatives Committee on Energy and Commerce's Subcommittee on Oversight and Investigations. Gregory Kutz, managing director of Forensic Audits and Special Investigations, issued a 33-page report outlining his group's investigation — which some have dubbed a "sting" operation — of the "deceptive" marketing claims made by four DTC firms. Kutz's team sent 10 saliva samples to each of the four companies — not named in the report — from volunteer donors, and submitted along with them both accurate and fictitious health information. The GAO team received "test results that are misleading and of little or no practical use," and found "10 egregious examples of deceptive marketing, including claims made by four companies that a consumer’s DNA could be used to create personalized supplement to cure diseases," according to the report. A customer service representative at one of the companies told a GAO volunteer that "an above average risk prediction for breast cancer meant she was 'in the high risk of pretty much getting' the disease."

Our sister publication GenomeWeb Daily News has coverage of yesterday's meeting here. The GAO has also posted a video containing taped responses to its undercover customer inquires and a summary of its findings here.

According to the Wall Street Journal's health blog, DTC firm executives "said they believed the field needed some common standards." Pathway Genomics CSO David Becker said that "the company is requiring the test to be sold through a doctor until the firm works out all the regulatory issues with FDA," the WSJ reports. Ashley Gould, director of 23andMe's legal affairs, stressed the distinction between "risk-prediction models" and diagnostic tests.

Maureen Martino at Fierce Medical Devices says that "the GAO's finding doesn't bode well for consumer genetic testing industry." Genetic Future's Daniel MacArthur says the testimony represents a "sad day for personal genomics," and suggests that "this is far, far bigger than personal genomics. …The suffocating effects of this power-grab will be felt well beyond our little circle of personal genomics aficionados." Dan Vorhaus at Genomics Law Report provides an in-depth look at the meeting proceedings, and says that "obviously, much depends on where the regulatory and legal landscape moves from here. …No matter what comes next, over the long term I continue to believe … that there is considerable demand for direct consumer access to personalized genetic information."

Just to address an error and

Submitted by mikki (not verified) on Fri, 07/23/2010 - 12:19.

Just to address an error and a misleading piece of information:
(1) The attorney for 23andMe is Ashley Gould, not Anne.
(2) The claims about creating personalized supplements did not come from the 4 companies to which the GAO supplied DNA. The GAO also investigated several other companies, and those claims came from that group.

Mikki, thanks for pointing

Submitted by GT_editor on Fri, 07/23/2010 - 13:16.

Mikki, thanks for pointing that out. We've corrected our error with Ashley Gould's name. On point (2), yes, those claims did not necessarily come from the four companies that GAO sent samples to. The GAO also investigated 11 other companies, though did not send them samples, and, from that group of 15, it "found 10 egregious examples of deceptive marketing, including claims made by four companies that a consumer's DNA could be used to create personalized supplement to cure diseases." We apologize for the confusion.

Dear GT_editor, The confusion

Submitted by andras on Fri, 07/23/2010 - 15:12.

Dear GT_editor,

The confusion is not your fault. As I elaborate in my column, the GAO “sting” IMHO would be “inadmissible evidence” in any US court since its 2006 conclusions on one group of companies are mixed up with under cover investigations in 2010 of another (large) group, yet the admittedly “not scientific” analysis was picking on human imperfection at just 1-2 unnamed companies. Attempting to establish “collective guilt” – and not even inviting e.g. Kari Stefansson, M.D., Ph.D. whose company was also targeted by the investigation seems grossly biased. From a science viewpoint (though GAO voluntarily excused itself from science standards!) it seems pathetically amateurish if some deliberately submit false consumer profiles and expect impeccable interpretation.

A further confusion is to equate “SNP-DTC” with the global business devoted to satisfy considerable demand for direct consumer access to personalized information for “P4 Health Care”. As HolGenTech demonstrated, the interoperability of SNP-data with full DNA analytics and with digitalized health-records is the future, clearly overridden by personal preferences.

Problems of sustainability of SNP-DTC because of what Dr. Venter characterizes in Nature “We're at a frighteningly unsophisticated level of genome interpretation” may foreshadow similar questionable sustainability of Full DNA Interpretation (without which full human DNA sequences will might become “affordable but worthless”) – and may even jeopardize Synthetic Genomics, where “designer gene-sets” would have to be endowed by an also modified genome regulation, should we advance from the present level of sophistication.

Thus is the importance of answering Dr. Collins’ call “to re-think long-held beliefs” and to focus on solid theoretical principles of “recusive genome function”. Perhaps for this reason the quoted string regularly yields well over 100,000 hits in Google, in recent days with a surge of close to a million returns!

Pellionisz_at_JunkDNA.com