23andMe to Offer Discounts to Docs, But at What Cost?

fence (small)Mark Henderson of the Times of London recently sat down to talk with Anne Wojcicki, now the sole remaining co-founder of DTC genomics company 23andMe, to discuss the company’s future plans. As Mark wrote in yesterday’s paper, Wojcicki and 23andMe are undertaking what appears to be a new strategy for the company, encouraging “doctors to take [23andMe’s] tests themselves so they are better placed to help patients who take it and then approach them for advice.” The Times and Wojcicki continue:

We want to help [doctors] to make sense of this, we want them to help consumers,” she said. “If you come in with results that tell you your risk of type 2 diabetes is marginally higher than average, how much do you need to worry about that?

Over at Genetic Future, Daniel MacArthur has the first reaction to this new development. Although MacArthur focuses primarily on the difficulty of using DTC genomic services—even at cut rate prices—to improve genomic literacy among overworked clinicians, a valid point, he also notes in passing that the announcement by Wojcicki and 23andMe represents “a subtle shift in…tone from the ‘we’re not doing medicine’ tone that has long characterised 23andMe’s attitude.” Whatever the business justifications for encouraging medical professionals to familiarize themselves with 23andMe’s services, the “subtle shift in tone” that MacArthur correctly identifies is what I consider to be the truly significant piece of news in Wojcicki and 23andMe’s announcement.

In 2008, in battles with regulators in California, New York and elsewhere, 23andMe staunchly maintained that the genomics services they provided were educational, not medical. While 2009 has seen a gradual shift in tone from a number of DTC genomics companies, not just 23andMe, with an increased emphasis on genetic carrier screening and medical research, the official position taken before regulators and in legal documents is quite often a different story.

Take for example Section 3 of 23andMe’s Terms of Service, which in bold typeface states as follows:

3. Description of What the Services Are and Are Not: 23andMe Service Is For Research and Educational Use Only. We Do Not Provide Medical Advice, And The Services Cannot Be Used For Health Ascertainment or Disease Purposes

Section 3 goes on to add that 23andMe’s “testing service is not licensed by the relevant state and federal authorities for genetic testing conducted for health and disease-related purposes.” If Wojcicki and 23andMe intend, as it appears, to offer its products at a discount to medical professionals in order to encourage both patients and their doctors to utilize 23andMe’s services to reach clinical decisions, whether in whole or in part, then a change in 23andMe’s legal and regulatory posture may be in the offing as well.

Regardless, with this announcement 23andMe has taken another incremental step away from its former self-characterization as a provider of purely educational and informational content and toward the clinical practice of medicine. From increased FDA and state regulation to heightened duties to customers/patients to entirely novel regulatory and legal regimes, such as HIPAA and medical malpractice liability, the decision to cross over into the provision of clinical or medical care is one that is attended by substantially increased legal liability. Clearly aware of these risks, 23andMe nevertheless continues to push the envelope separating clinical and non-clinical services. Whether 23andMe and other DTC genomics companies can continue to inch ever closer to that line without crossing over—and without being dragged across by regulators or by the courts—will be a story that bears close monitoring in the coming months.