Will New Pills Be Used Ethically?

The first drug with a sensor that can track whether patients have taken their medicine has been approved by regulators.

“The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012. The FDA said Monday that the digitally enhanced medication ‘works by sending a message from the pill's sensor to a wearable patch.’”

So far so good.

“Being able to track ingestion of medications prescribed for illness may be useful for some patients,” Dr. Mitchell Mathis of the FDA said in statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how this technology might benefit patients and prescribers.”

The Abilify MyCite was developed by Otsuka Pharmaceutical Co., based in Japan, and the sensor was created by Proteus Digital Health, based in Redwood City, Calif.

But the notion of tracking pills has raised some ethical concerns.

While the approval, announced late on Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the longstanding problem that millions of patients do not take drugs as prescribed and adherence.

Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization.  The digital pills will help, but others see potential for abuse.

“If used improperly, it could foster more mistrust instead of trust.” says Ameet Sarpatwari, an instructor in medicine at Harvard Medical School.

A smartphone app will let them block recipients anytime they change their mind. 

Dr. Peter Kramer, a psychiatrist and the author of “Listening to Prozac,” says, “While ethical for “a fully competent patient who wants to lash him or herself to the mast,” he said, “‘digital drug’ sounds like a potentially coercive tool.” Other companies are developing digital medication technologies, including another ingestible sensor and visual recognition technology capable of confirming whether a patient has placed a pill on the tongue and has swallowed it.

Not all will need regulatory clearance, and some are already being used or tested in patients with heart problems, stroke, H.I.V., diabetes and other conditions.

Might requiring digital medicine be used as a condition for parole or releasing patients committed to psychiatric facilities?

Abilify is an arguably unusual choice for the first sensor-embedded medicine. It is prescribed to people with schizophrenia, bipolar disorder and, in conjunction with an antidepressant, major depressive disorder.

But symptoms of schizophrenia and related disorders can include paranoia and delusions, so some doctors and patients wonder how widely digital Abilify will be accepted.