Personalized medicine made some big strides in 2013, including the launch of many apps that allow consumers to track their own health and develop personalized health plans and interventions – Sonic Boom Wellness, MyFitnessPal, Moves, Fitocracy, Lose It, and WellnessFX to name a few.
Additionally, there were advances in the genomics front. Companies like Navigenics (acquired last year by Life Technologies Corp.) gained traction by marketing a $3,000 gene mapping service with the promise that the price would be slashed by a third (see $1,000 And A Gene Map all members). And the personal genetics company 23andMe received $58 million in new venture capital funding (see For Consolidation Among Health Care Tech, The Direction Is Up all members) for its service analyzing DNA for genetic markers of disease and providing customers with a wide range of genetic information—such as propensity for disease, data about their ancestry—for a fee.
But like so much in the health care field, the landscape shifts rapidly. In a warning letter to 23andMe, dated November 22, the FDA said products that are designed to diagnose, mitigate or prevent disease are medical devices that require regulatory clearance or approval, “as [the] FDA has explained to [23andMe] on numerous occasions” (see 23andMe, Inc. 11/22/13). On December 5, the company agreed to discontinue its service providing health-related data pending completion of an FDA review.
What is the issue? I think it is about consumer control outside of the traditional health care system. The question – should consumers have access to their own genetic information and, if so, how and from whom?
Remember, knowledge is power. And in this case, genetic information distributed in a direct-to-consumer model by a non-health care organization upsets the current order in our health care delivery and financing systems. To borrow a quote from Dr. Dennis Morrison’s presentation, At The Speed Of Thought: The Role Of Disruptive Innovation In Behavioral Health – One Year Later , at the 2013 OPEN MINDS Technology & Informatics Institute, “The incumbents are threatened.”
Who is concerned about direct-to-consumer genetic information? Physicians for one. Control of the distribution of medical information by calling the act of education the “practice of medicine” is one issue. There is certainly a contingent of health care professionals who do not embrace direct-to-consumer information – everything from personal genetic information to transparency in the quality and cost of specific professionals and provider organizations.
Then there is the health insurance industry. Writing for FastComany, author Rebecca Greenfield notes that insurance companies are already worried that these kinds of widely available and cheap diagnostic tools could change consumer behaviors, and “lead to an increase in care – necessary or not – which insurers could end up covering” (see Why 23andMe Terrifies Health Insurance Companies).
What are the big picture lesson from the 23andme situation? Innovators get pushback (and sometimes, worse). The role of the FDA is unclear in terms of approval of future technology. Health insuring organizations will face challenges in the new world of empowered and engaged consumers, when consumer demand does not conform to financial underwriting assumptions. And, clinical professionals (physicians and others) will continue to grapple with the challenges of an information-rich health care environment.
This role change was best captured by Eric Topol, M.D., author of The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care, when he said the “…[the doctor’s] role will be progressively morphed into providing guidance, wisdom, experience on how to transform data and information to knowledge and judgment.” That is a new definition of the “practice of medicine.”
For another free resource, see: Personalized Medicine – Ready Or Not? all members