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Some patients might find this pill hard to swallow

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One psychiatrist compares the new product to a "biomedical Big Brother."

A revolutionary new pill will help schizophrenics stay on medication that could save their lives. It also could save people billions of dollars in otherwise unnecessary medical bills.

But in light of potential privacy issues surrounding the new pill, which lets doctors know electronically if a prescribed medication has been taken, some people are finding the arguments for the pill hard to swallow.

The U.S. Food and Drug Administration this week approved of “Abilify MyCite,” a modification of the anti-psychotic drug Abilify, which is prescribed to people with schizophrenia, bipolar disorder and, in conjunction with an antidepressant, major depressive disorder. The new product, which should be available next year, is a collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created a sensor attached to the medication. As the New York Times explained:

The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’s president and chief executive.

After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced after seven days, said Andrew Wright, Otsuka America’s vice president for digital medicine.

The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app. The app allows patients to add their mood and the hours they have rested, then transmits the information to a database that physicians and others who have patients’ permission can access.

Harvard ethicist I. Glenn Cohen, who was contracted by Otsuka to address privacy concerns, said that safeguards adopted include allowing patients to manipulate their cellphone app to stop physicians and others from seeing some or all of their data.

Some observers, however, questioned the wisdom of using digital technology in treating conditions that often are accompanied by paranoia.

“There’s an irony in it being given to people with mental disorders than can include delusions,” said Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and New York-Presbyterian Hospital. “It’s like a biomedical Big Brother.”

Many psychiatric patients don’t take their medications because they don’t like side effects, “or because they become paranoid about the doctor or the doctor’s intentions,” said Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department. “A system that will monitor their behavior and send signals out of their body and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.”

But Robert McQuade, Otsuka’s executive vice president and chief strategic officer, said the combination is “not intended for all patients with schizophrenia, major depressive disorder and bipolar. The physician has to be confident the patient can actually manage the system.”

“I get questions all the time, ‘Hey is the government going to use this, and can you track me?’” said Eric Buffkin, an senior vice president of etectRx, which has developed a similar product. “Frankly, there is a creepiness factor of this whole idea of medicine tracking. The thing I tell them first and foremost is there’s nothing to reach out of this technology to pry your mouth open and make you take a pill. If you are fundamentally opposed to this idea of sharing the information, then say, ‘No thank you.’”

Other possible uses of the digital pill include monitoring whether post-surgical patients took too much opioid medication, and requiring digital medicine as a condition for parole or releasing patients committed to psychiatric facilities.

Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, the Times said, much of it because patients get sicker and need additional treatment or hospitalization.

 

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