The Food and Drug Administration approved a drug with a “digital ingestion tracking system” Monday that allows doctors to monitor whether patients are taking their anti-depressant medication.
The approved medication, called Abilify MyCite, manufactured by Otsuka Pharmaceutical Co., is a pill for bipolar disorder, schizophrenia, and extreme depression that includes sensors that transmit signals outside the body as the pill is absorbed. The sensors, made by Proteus Digital Health, send information to a patch worn on the patients arm, and the patch pings the patient’s smart phone. The information can also be stored online with express patient approval for the physician to review.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Dr. Mitchell Mathis, director of psychiatric products for the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”
The drug will hit the market in 2018, and the company has not yet set a price point. This is the first time the FDA has allowed an ingestible digital tracking method to be sold in the U.S., and the approval quickly garnered concern from bioethicists.
It may be helpful for an honest patient “who wants to lash him or herself to the mast,” however, the idea of packaging a drug with a tattletale “sounds like a potentially coercive tool,” Dr. Peter Kramer, psychiatrist and author of “Listening to Prozac” told The New York Times.
Starting the approval of digitally tracked drugs with an anti-schizophrenia drug also raised some questions, as the patients who will take Abilify MyCite may be especially prone to paranoia, and knowing the medication they are taking is tracked would likely not help such thoughts.
“Many of those patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions,” Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University, told The NYT.
“A system that will monitor their behavior and send signals out of their body and notify their doctor?” Appelbaum said. “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.”
“There’s an irony in it being given to people with mental disorders than can include delusions,” Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University, told The NYT. “It’s like a biomedical Big Brother.”
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