There’s a video that’s become popular among conspiracy theorists pushing the false idea that COVID vaccines could be used to track people. In the footage, which comes from 2018, Pfizer CEO Albert Bourla talks about a new digital pill on the market. “Imagine the implications of that compliance,” Bourla says—that is, with this new technology, we’ll be able to know whether people take their meds. Some conspiracy theorists are treating Bourla’s words as evidence that “microchip” tracking exists in medicine. In reality, digital pills can’t track patients the way conspiracy theorists posit—but they do bring up a host of ethics questions worth examining in their own right.
The medication Bourla is discussing in the video is Abilify MyCite, an updated version of the blockbuster antipsychotic drug Abilify (aripiprazole), which is often prescribed for depression, bipolar disorder, and schizophrenia. (For a period, it was also commonly prescribed as a potential treatment for autism before data suggested it was not effective.) The U.S. Food and Drug Administration approved Abilify MyCite back in 2017 as the first-ever medication with an embedded chip; the medication’s parent company, pharmaceutical giant Otsuka, calls that chip an “ingestible event marker,” or IEM, which sends a signal when it reacts with stomach acid.* That signal is picked up by a patch users wear, which connects via Bluetooth to a smartphone app that can also measure users’ steps and rest, and allows users to record their self-reported moods or reasons for not taking medication.
Abilify MyCite is marketed as a way to “stay on top of how your treatment is going” by recording when patients take their medication and sending their MyCite app data to their health care team or designated family and friends. If you’ve embraced social health tech—like sharing your workouts with friends via a smartwatch or app—this might sound innocuous. But this sharing, perhaps under pressure from health care providers or loved ones, collides with a long history of paternalistic attitudes toward people with mental health issues. For much of the 20th century, people diagnosed with mental illness were kept in asylums and forced to take powerful drugs. Patients often resisted their medications, which caused serious side effects like extreme sedation and tardive dyskinesia.* Though the U.S. has moved on from widespread institutionalization of people with mental illness, stereotypes remain that people with mental health issues refuse to take medication, or that they are unable to manage their own illness. While it’s true that some people with mental illness may not take antipsychotic medication as prescribed, so do plenty of people who are taking medication for other reasons; a 2018 paper published in the prestigious medical journal JAMA estimated that 30 to 50 percent of people with a chronic illness like hypertension or diabetes don’t take their medication as prescribed, a range similar to that of people with bipolar disorder or schizophrenia.
Given that baggage, making Abilify MyCite the first-ever medicine to contain a digital tracker was a revealing choice. “Of all medications they could pick, it’s curious they’d pick a medication that’s given to people who often struggle with paranoid feelings, who worry they’re being surveilled and watched,” says Lisa Cosgrove, a clinical psychology professor and an Applied Ethics Center fellow at the University of Massachusetts Boston. (One person posting in a subreddit for people diagnosed with bipolar disorder said the whole situation seemed reminiscent of an SNL skit.) Perhaps this technology could have instead been rolled out to help people with memory or cognitive issues, who might benefit more from reminders to take their meds, Cosgrove says.
There’s also another big issue at hand: The app may not accurately track whether you’ve taken your pill; according to the MyCite FAQ page, around 94 percent of pills actually get tracked in the app. Six percent of pills not getting tracked could cause issues if users and their health care team really are relying on the pill and associated app as a true record of users’ medication ingestion. Taking a double dose of aripiprazole is unlikely to be fatal, but could result in some uncomfortable side effects. And it could pit users’ word against the app’s—if a doctor notices a user hasn’t taken their meds, but it’s a glitch in the tech, whom will they believe?
And though Abilify MyCite is marketed as a way to improve patients’ ability to remember their meds, there’s not actually any evidence it does that. (I reached out to Otsuka for comment twice in the course of my reporting to ask them about this and other concerns experts raised in this piece, but never received a response.) If people have a hard time remembering to take a pill daily, it seems like a big ask to require them to change their patch every week, make sure their phone is connected to that patch via Bluetooth, and track their other symptoms in-app. I asked psychiatrist Rajan Grewal about how she works with patients to determine care plans and if she’s considered prescribing MyCite to help patients take their meds. “I can’t think of any circumstance where I’d ever consider prescribing this,” she said.
Her approach, she told me, is to carefully weigh whether a medication might be effective for a given patient—would it fit into their lifestyle on a practical level? Given the steps Abilify MyCite requires to work, and the lack of data on its efficacy in helping people take their medication, Grewal says she’d instead advise patients to try low-cost, surveillance-free options, like marking when they take pills on a calendar, setting up a pillbox, or setting recurring alarms on their smartphones. And if people really have issues taking their meds, Grewal points out, there are injectable, long-acting forms of aripiprazole that require people to see a doctor once every month or two. Overall, Grewal says she’s baffled by the creation of Abilify MyCite; as a psychiatrist, she’s never wanted the ability to track her patients’ data. “It’s not for patients, and it’s not for psychiatrists,” Grewal says. “It makes me wonder why they made it—for profit, or to offer something new?”
Cosgrove’s theory? Otsuka wanted a new way to patent a version of Abilify. The drug generated billions of dollars a year in the mid-2010s, but sales dropped off in 2015, when Abilify’s patent protections ended. That year, Otsuka submitted an application for FDA approval of Abilify MyCite. “It’s no coincidence that the development of Abilify MyCite occurred shortly after it went off patent,” says Cosgrove. In a 2019 paper she and her colleagues published in BMJ Evidence-Based Medicine, they write that while general aripiprazole costs about $20 for a month’s supply, Abilify MyCite costs around $1,700. (According to GoodRx.com, those prices are nearly identical in 2022.)
Unfortunately for drug developers, it seems like the digital pill business might not be a cash cow—at least not yet. Proteus, the company that created the IEMs used in Abilify MyCite, generated excitement in the mid-2010s, when MyCite was first introduced. It seemed IEMs might be the future of medicine, and at its height, Proteus was worth $1.5 billion. But in 2020, the company filed for bankruptcy, and Otsuka purchased its remaining assets. Still, there are other companies developing “digital pills,” like HIV meds with digital trackers. Previous studies have also looked into using IEMs in medication for tuberculosis and hypertension and opioids prescribed to treat pain from broken bones, but it’s unclear whether any of those are still actively in development.
As technology progresses, it’s tempting to think that our new inventions will fix our problems. Surely we’ll invent some way to burn coal but also avoid climate collapse; we’ll deploy robots to clean the Great Garbage Patch; we’ll create digital pills to optimize our health. But not everything can be fixed by technology, and even in cases where technology can help, analog approaches might be easier and more effective. If a patient isn’t taking their pills, perhaps they need a different kind of support than Abilify MyCite can offer. “To simply focus only on people not taking meds as prescribed deflects attention from why people won’t take them,” says Cosgrove. While users might track their symptoms on an app like MyCite’s, a conversation with a caring medical professional will likely reveal the underlying issues more quickly: For instance, aripiprazole and other antipsychotics commonly cause difficult side effects, like cognitive fog, weight gain, and high blood sugar. Few things can replace the care and attention of an actual human, but it would be much harder, more expensive, and less sexy to revamp our medical system to ensure patients receive the support they need.
Correction, April 20, 2022: This piece originally misidentified the Food and Drug Administration as the Federal Drug Administration and tardive dyskinesia as tardive kinesthesia.