New Supreme Court Rulings Reinforce Urgency of Radical Innovations in Healthcare

As if the healthcare crisis in this country were not bad enough, on Thursday of last week the U.S. Supreme Court issued two decisions that, in my opinion, made the crisis worse. Both further tipped the balance of power between individuals and healthcare institutions in favor of the latter – exactly the wrong direction in which we need to move.

The first ruling (PLIVA, INC., ET AL. v. MENSING) dealt with the question of whether generic drugs’ warning labels must be updated with new information of possible side effects as they arise, as is required by law for original makers of brand-name drugs. Gladys Mensing and Julie Demahy were prescribed Reglan (metoclopramide) in 2001 and 2002, respectively, to treat their digestive problems, e.g., acid reflux. However, both received a generic form of metoclopramide from their pharmacists, which were not labeled with the possible toxic side effects that had come to light. After taking the drug as prescribed for several years, both women developed tardive dyskinesia, a severe neurological disorder.

The court voted 5-4 in favor of the generic drug companies, absolving them of the requirement to update their warning labels. I believe that Justice Sonia Sotomayer was right on target when she declared, in her minority opinion: “As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.”

The second ruling (SORRELL, ATTORNEY GENERAL OF VERMONT, ET AL. v. IMS HEALTH INC ET AL.) deals with the constitutionality of a Vermont statute that prohibits a practice called “detailing.” Under this practice, pharmacies sell information about “prescriber (doctor) behavior,” collected when they process prescriptions, to data mining companies. The data mining companies in turn lease this information to drug companies so that they can better target their marketing messages to individual doctors.

The court voted 6-3 in favor of IMS Health and the other data miners, supporting their claim that the statute is unconstitutional. IMS argued that the data can be used to help monitor safety issues of new medications, to reduce costs, and to enable research such as studying research outcomes.

While I strongly support the concept that the innovative use of patient-related data (on an opt-in basis, by patients and doctors) can lead to huge benefits for patients, I think the opposite is true here. I agree with Justice Stephen Breyer who, in his dissenting opinion, said, “Shaping a detailing message based on an individual doctor’s prior prescription habits may help sell more of a particular manufacturer’s particular drugs. But it does so by diverting attention from scientific research about a drug’s safety and effectiveness, as well as its cost. This diversion comes at the expense of public health and the State’s fiscal interests.”

I am not qualified to comment on the constitutional validity of these decisions; nor do I think that they are in any sense monumental in the greater scheme of things. But when it comes to the skyrocketing cost of healthcare and the health challenges faced by individuals, these decisions are representative of the powerful forces in society that are wired to favor institutions over individuals.

If we are to repair our healthcare system, we must empower ordinary citizens, working in collaboration with the medical professionals who serve them, to seize control of their own health. This revolution can only be achieved through an equally powerful wave of radical innovations, such as those being explored in the New Media Medicine group at the MIT Media Lab and catalyzed by a new generation of health-focused venture accelerators such as Rock Health.

In the end, our only hope for curing our critically ill healthcare system is innovation – definitely not legislation or litigation.

 

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