23andMe to Offer Discounts to Docs, But at What Cost?
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.
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[...] between direct-to-consumer genetic testing and the clinical practice of medicine (also see here, here, here and here). One potential effect of confusing the clinical/non-clinical divide in the DTC [...]
Daniel,
I am curious. Do you think what they are doing is clinical medical testing? If not, why not? If yes, why so? I think they meet CLIA’s criteria for clinical laboratory testing. I also think by interpreting that testing, they are in essence performing medicine. I am super interested in your “legal” take.
-Steve
http://www.thegenesherpa.blogspot.com
Hi:
Are there differences with the UK legal system and laws compared to the USA, related to genetic testing that would bias the selection of doctors, doctors who will be offered a discounted test? I am curious about why go the GBs in the UK with a discount as opposed to offering a discount to the USA primary care doctors? Are there legal advantages/differences that might influence location of companies performing genetic tests (Iceland/USA/UK)?
Clarification, GP in the UK, not GB.
Steve:
It’s a great question and I apologize for my tardy response. The high-level answer is that the precise line that separates clinical from non-clinical activity with respect to the conduct and interpretation of genetic testing or genomic sequencing is difficult if not impossible to define.
On the clinical side of the line exist more extensive duties, greater liabilities and (typically) a higher price tag. The converse is generally true of non-clinical activity. But not only is the line fuzzy generally – due to a complex mix of competing principles, risks and benefits that attend any effort to define the line more precisely – where the line is drawn in any particular instance depends substantially on the specific set of facts. Where 23andMe or any other DTC provider falls with respect to the clinical/non-clinical line in any given instance is almost certainly too fact-specific (including facts that may not be public knowledge) and subjective to render anything more than an educated guess as to how a legislative, regulatory or judicial authority might conceivably rule.
I know that is in some ways an unsatisfactory answer to what is, indeed, a tremendously important question, but it does reflect the considerable uncertainty surrounding this portion of the law. I will consider whether or not this issue can be expanded into a complete post and provided with a more thorough treatment.
Thanks.
- Dan
David -
There are certainly differences in the applicable law of different countries, including the US and UK. For example, the recent legislation enacted in Germany (see: http://www.genomicslawreport.com/index.php/2009/09/02/genetic-exceptionalism-and-paternalism-themes-in-new-german-legislation/) which appears to outlaw DTC genetic testing might suggest that 23andMe’s strategy of targeting doctors with discounted products might be one of its only viable options for actively growing its customer base in that country. With respect to the US/UK, there are substantial differences in the reimbursement of medical testing in general that I would imagine 23andMe is cognizant of in determining which doctors should be targeted with discounted products. However, I’m not familiar enough with those differences off the top of my head to analyze whether or why 23andMe would prefer primary care doctors in one country over the other.