If you were to do a reading of 23andMe’s personal genome, things aren’t looking good.
The FDA in a letter late last week ordered the company to stop marketing its self-testing kits, which analyzes genetic information from a person’s saliva for clues about disease risk and ancestry, concerned that it didn’t have authorization from the government to market its product. What’s more, the agency was concerned that inaccurate test results could induce consumers to undergo health procedures they don’t need, such as breast-cancer surgery. The FDA seems particularly miffed that 23andMe had ignored several requests from the agency for more detailed information just as 23andme was rolling out a national TV advertising campaign.
23andMe CEO, Anne Wojcicki responded in a blog post, standing by the accuracy of the genetic testing results her company peddles, but acknowledging that “the FDA needs to be convinced of the quality of our data as well” and that 23andMe is behind in its responses to the agency’s queries.
This is complicated matter, naturally, with several “PBS Mystery Theater”-worthy sub-plots. There’s the data collection angle, a conspiracy theorist’s dream, with Wojcicki married (although separated) from Google founder Sergey Brin, a mammoth company renowned for sniffing up and all data to better personalize marketing messages. There’s also the fear that the testing may not be completely accurate — the analysis hasn’t gone through rigorous FDA testing. What happens if the information the company shares with a customer is either inaccurate or misleading, causing her to undergo dangerous surgeries that are unnecessary, or to forgo having children out of the fear of passing on bad genes?
As well, there is another message the FDA may be sending, and it is less targeted at genetic startups and more toward general health businesses.
Owen Tripp, CEO and co-founder of Grand Rounds believes 23andMe represents a certain facet of health tech, one that gives answers automatically without allowing for context. He emphasized that the FDA halted the marketing of 23andMe’s products but hasn’t banned the company from selling its product.
“What the FDA is saying is that it doesn’t want you making claims on television,” he said. “If you get people to believe that they can with a kit and a full Internet connection diagnose and treat themselves, then that sets a dangerous precedent.”
It’s precisely these instant diagnosis companies that may be receiving the brunt of the FDA’s wrath. Tripp wouldn’t comment about precisely which ones, but a few do seem to stand out among the rest. Home pregnancy tests and personal HIV testing kits like OraQuick come to mind instantly. But there are other, bigger health-tech companies like HealthTap and Counsyl that could be at play.
He, of course, sees his company as the antidote. Grand Rounds is a subscription-based provider that lets customers seek out second opinions from top physicians. Instead of waiting months to get an appointment, Grand Rounds sets up online appointments with them, forwards all their clients’ records, so that these doctors have all the necessary information and are able to provide quicker second opinions in dire circumstances. Tripp sees it as a way to use health technology in a way that isn’t just an instant diagnosis without any context. It lets experts see all the charts and get a real sense for the patient.
Programs like 23andMe are vastly different, others, too.
HealthTap, for example, lets users ask questions and receive answers from physicians. While the information HealthTap provides is coming from real doctor, they are not getting the full story. Someone can write “my back hurts” without providing other information yet receive an instant diagnosis of a slipped disk.
“We’d like to believe that mobile q&a products can take the place of a physician,” Tripp said. “But they can’t.” While the information may be useful to help understand what’s going on, in some ways it could also be hurtful. “[The FDA] does not want a group of people self-diagnosing themselves with breast cancer,” he added.
Perhaps more akin to 23andMe’s business is Counsyl. It enables couples to check their DNA for potential genetic diseases that could affect their future children. Like 23andMe, Counsyl lets parents submit their saliva and receive a “formal” dossier saying the kinds of illnesses their children will have.
Of course, without a child actually being born, or without any further knowledge beyond the DNA presented, the information Counsyl is offering is anything but exhaustive. It’s simply a list of possibilities — very scary possibilities.
What these three companies have in common is their reliance on one facet of person’s personal background to diagnose an entire disease, whose materialization is certainly riddled with numerous environmental contingencies. HealthTap, of course, is more benign than the other two. At the same time, it trumpets a doctor’s word to give itself credence.
Instant answers may not be the only things these companies have in common. There’s a data side to this as well. While companies like 23andMe and HealthTap gain popularity as go-to health tech ventures, they are also accruing masses information about their users. While 23andMe and Counsyl’s data is especially chilling — being that it’s the actual genetic makeup of its users — HealthTap, too, sits on a genetic data goldmine.
The company claims to have many million unique visitors each month, all of whom have accounts that track their personal symptoms. On the app it allows users to ask specific health questions, as well as fill out their entire medical history. While all of this information is protected and secured as per the company’s terms of service, the public questions on the app are stored in the company’s repository. To date the app has answered more than 1 billion questions, all of which are tied to specific users, which refer to their ailments. So even if HealthTap isn’t touching the actually identifiable information it houses, it has billions of personal questions tied to millions of customers.
In essence, the data these three companies can have may be (and perhaps should be) of concern to the FDA.
Tripp’s point, however, is not to point fingers but to shed light on other health tech options available. He doesn’t want people to think of sites like WebMD, which offer instant offerings that are never quite what a user is looking for.
With the FDA’s move against 23andMe, all of these companies are looking for instant answers — but, at least for now, none may be forthcoming.
[Illustration for Pando by Hallie Bateman]