In the spring of 2016, two companies pitched their idea to the Food and Drug Administration: “a drug/device combination product” that makes technology part of patients’ medication schedules. They developed a tiny edible sensor inside a pill that could tell your doc exactly when and if you took your medication. The FDA said “not so fast,” and asked the companies for more information on the safety, efficacy, and risks associated with the digital pill.
And the two companies followed through. On Monday, the FDA approved Abilify MyCite, an upgraded version of the antipsychotic medicine used to treat bipolar disorder and schizophrenia, and major depressive disorder when taken in combination with an antidepressant. It’s a collaboration between Otsuka Pharmaceuticals and Proteus Digital Health, a Silicon Valley-based company that incorporates technology into medical treatments. Although the sensor will give docs important information about how and if their patients are taking their meds, people are concerned about privacy and how it will change the doctor-patient relationship.
At first glance, Abilify MyCite looks like a regular pill. But inside, there’s an ingestible sensor the size of a grain of sand that’s made out of copper, magnesium, and silicon. Here’s how it works: The patient swallows the pill, and when it gets drenched with the juices in their stomach, it sends an electric signal to a patch worn on the patient’s arm. Then, information on when the patient took the medication loads onto a mobile app where they can track it. The app tells them when they took their last dose, when their next dose is due, and collects other physiologic data like activity levels. People can opt in to notifications. The patient can choose to give access to their doctors and up to four other individuals.
The FDA approved the pill as a way to track doses, but there’s no evidence that it makes people take their medication as directed. In theory, it could help people take their meds, and the companies plan to study this when MyCite hits the market, Robert McQuade, Otsuka’s executive vice president and chief strategic officer, told the Times. The tracking system could be great for patients with schizophrenia and bipolar disorder, whose thoughts often become clouded and who may forget to take their medication.
“Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug,” John Kane, the chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, said in a statement. Kane conducted the pilot study funded by Proteus. “This information allows the opportunity for an open dialogue with the patient,” he added.
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People with schizophrenia and bipolar disorder often don’t follow prescribed medication regimens. Researchers estimate that about 41 percent of people with schizophrenia and 40 percent of people with bipolar disorders don’t take their prescriptions as directed, or at all. They may opt out of taking their meds because they don’t accept their diagnosis, they don’t like the side effects, or they simply don’t want to be on medication.
If we’re going to venture into the world of digital medicine and break down the barriers blocking physicians from knowing exactly how their patients take their meds, it seems odd to start with a group of people who often experience paranoia. “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,” Paul Appelbaum, director of law, ethics, and psychiatry at Columbia University’s psychiatry department, told the New York Times.
But the pill might be a good option for people who’ve just had their first psychotic episode and are at risk of stopping medication once they feel better, Jeffrey Lieberman, chair of psychiatry at Columbia University and NewYork-Presbyterian Hospital, told the Times. Still, he said, “There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.”
Otsuka may have sought approval for the sensor in Abilify because they lost their monopoly over the drug in May 2015, when the FDA started allowing other companies to sell aripiprazole, the generic version of Abilify. But the ingestible sensor will only be implanted in branded Abilify pills, not the cheaper, generic equivalents. The pharma company expects to roll out the new drug next year. We don’t know which patients will have access to it or how much it will cost, but STAT News reports it’ll be pricier than branded Abilify.
Just like with any new tech, this pill comes with a bag of questions about ethics and privacy. “It could set up a more hostile environment between doctors and patients,” Arthur Caplan, a bioethicist at New York University, told NBC News. “It is one thing to be able to lie to your doctor. It is another thing to be called a liar or be yelled at.”
And the transparency may change the doctor-patient relationship in big ways. “It sounds amusing, but doctors are going to have to learn how to manage non-compliant behavior in a way they haven’t had to before,” he says.
It’s not the first foray into digital medicine. A similar sensor called the ID-Cap is being tested with opioids and HIV medication by Florida-based company etectRx. That sensor works kind of like Abilify MyCite: It’s made of magnesium and silver chloride and produces a “low-power radio signal that can be picked up by a little antenna that’s somewhere near you,” the company’s president, Harry Travis, told the Times.
Pharmacies can insert the sensor into capsules with other medications—that technique has been used in six states in combination with medication for high blood pressure and hepatitis C. But Abilify MyCite is the first drug to have a sensor embedded inside.
Is it ethically sound to track people’s personal habits, even if the behavior is closely tied to their health? The patients can decide for themselves, since the tracking relies on the patient wearing the patch. Still, privacy is at the core of the debate. “Frankly, there is a creepiness factor of this whole idea of medicine tracking,” a senior vice president at etectRx, Eric Buffkin, told the Times. “If you are fundamentally opposed to this idea of sharing the information, then say, ‘No thank you.’”