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New 'Smart Pill' Raises Ethical Questions

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It happens to everyone. You’re prescribed a medication, and you forget to take it at the right time, in the right dose, or even to take it at all. This problem is amplified when it comes to mentally ill patients…leaving their families in the dark as to whether they’ve taken their medication, often with little ability to monitor compliance or really check in. To tackle this problem, a drug company developing the first "digital pill" has had its drug application approved by the FDA.

The FDA approved the New Drug Application (NDA) that embeds a sensor in the drug ABILIFY, a medication prescribed to adults with schizophrenia, bipolar disorder, or Major Depressive Disorder. Once it travels to the stomach, the "smart" pill communicates with a patch on the patient, programmed to notify the patient’s doctor if the medication wasn’t taken or isn’t working.  

Medical Ethicist Art Caplan joined Jim Braude and Margery Eagan for Boston Public Radio to discuss the ethical issues surrounding the digital pill. According to Caplan, about 20 percent of people who get prescriptions don’t fill them at all, and of the rest that do, about 50 percent don’t take the medicine the way it’s prescribed.  “It’s tough to get people to take their meds,” Caplan said. “This pill is kind of the first of its kind solution to yell at non-compliers.”

So what’s the issue?

According to Caplan, there are a laundry list of concerns:

1.     Are you really going to give it to people who are mentally ill? Are they competent? Did they consent to have it? Is it something that somebody else is going to consent to? And who might that be? Maybe you don’t want your relatives to know you have a mental illness.

2.     Is the thing hackable? I don’t know, but I bet it is. Signals flying around, all kinds of people can peer in…I can see Ashley Madison-type extortion happening.

3.     This pill is for mental illness, but I’m sure digital pills are going to start expanding to your syphilis treatment, your incontinence treatment, you take the stigmatized illness, and maybe again you don’t want people knowing you have a particular problem… but your boss is going to know. Your boss is going to say, ‘hey, we’re getting this message back from the doctors that we pay for, and if you want to keep your job here, you’d better be taking your medicine in a timely way.”

4.     You think you’re just sending it to your doctor, but you could send it to anybody. Is the court going to order that before you get paroled and you have to stay on your meds, that the judge should get a signal about whether or not you’re taking them?

“I’m not saying we shouldn’t have this pill, I’m just saying it would be nice to lay out the rules as part of the approval,” Caplan said.

To hear more from Art Caplan, click on the audio link above.

Medical Ethicist Art Caplan heads the Division of Medical Ethics at NYU’s Langone Medical Center, and co-hosts the Everyday Ethics podcast.

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