When the Food and Drug Administration approved in late 2017 a schizophrenia pill that sends a signal to a patient's doctor when ingested, it was seen not only as a major step forward for the disease but as a new frontier of internet-connected medicine.

Patients who have schizophrenia often stop taking their medicine, triggering psychotic episodes that can have severe consequences. So the pill, a 16-year-old medication combined with a tiny microchip, would help doctors intervene before a patient went dangerously off course.

Pill that pings doctors shows promise, pitfalls

Christopher Rowland, The Washington Post

Published 7:38 pm EDT, Sunday, April 28, 2019

When the Food and Drug Administration approved in late 2017 a schizophrenia pill that sends a signal to a patient's doctor when ingested, it was seen not only as a major step forward for the disease but as a new frontier of internet-connected medicine.

Patients who have schizophrenia often stop taking their medicine, triggering psychotic episodes that can have severe consequences. So the pill, a 16-year-old medication combined with a tiny microchip, would help doctors intervene before a patient went dangerously off course.

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Seventeen months later, few patients use the medication, known as Abilify MyCite. Doctors and insurance companies say it is a case in which real-world limitations, as well as costs, outweigh the innovations that the medical industry can produce.

In the case of schizophrenics, some doctors warn that Abilify MyCite could exacerbate the very delusions that the medication is designed to prevent.

"Patients who have a lot of paranoia might be uncomfortable with the idea of a medicine that is transmitting signals. The patient may be afraid to take it," said Richmond psychiatrist James Levenson. "The science of this one is kind of ahead of the data."

The debate over Abilify MyCite underscores a dilemma American health care will increasingly face as the medical industry and Silicon Valley try to promote innovation. For decades, medicine has been effectively delivered through a few simple mechanisms: a pill, a cream, a nose spray, a needle.

But in the hopes of improving outcomes further, the industry is turning to an array of new technologies against one of the biggest, and most human, challenges in treating disease: getting people to take their medicine in a consistent way.

Companies are producing apps for substance abuse treatment, diabetes management, and heart and blood pressure monitoring at a rapid clip. Studies are underway for more digital pills to treat cancer, cardiovascular conditions and infectious disease.

And while many of these may pass regulatory hurdles that show they're safe - especially at a time when the Trump administration has been leaning into medical innovation and pushing back against regulation - doctors and insurers are not convinced that the technologies will so easily make the difference that the pharmaceutical industry is betting billions on.

"I think that these technologies have a lot of potential benefits, but it's going to be a question of evidence - that they can demonstrate value to patients and payers," said Scott Gottlieb, who stepped down this month as FDA commissioner, a job in which he made approval of leading technology a hallmark.

The first digital therapy to win FDA market clearance, Abilify MyCite's sensor-embedded pill remains off the market because of physician and insurance industry reservations.

Now Maryland-based Otsuka Pharmaceutical, which makes the medication, may be able to jump-start its acceptance by offering it to mentally ill people who qualify for low-income government health insurance. Otsuka won approval from Virginia Medicaid authorities last month to begin coverage. The company also is starting a pilot program in Florida and is considering another in Oklahoma.