Monday night’s groundbreaking announcement of approval from the U.S. Food and Drug Administration marked a jaw-dropping tandem victory for the Nanny State and Big Pharma, in the form of a new pill embedded with a sensor, which can detect whether or not a patient took their medicine as prescribed — thus, opening a veritable Pandora’s Box of compliance, quality of care, cost, and more.
To what should be our collective astonishment, the policing of pharmaceuticals — the ability to deny medicine to patients with habitual difficulty keeping a schedule, cognizance of medical staff to a patient’s refusal to comply, and a portentous degree of control relinquished to infallible human decision-making — is now an untenable but distinct possibility.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, stated in a press release late Monday. “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.”
Oddly, of all the conceivable medication types suitable for testing the technology, chosen was the antipsychotic prescription, Abilify — used in the treatment of schizophrenia, bipolar disorder, among other conditions — given to patients who frequently suffer delusions and paranoia which would drive them not to follow prescriptions all that reliably, nor be eager to swallow a sensor-laden pill.
“Abilify MyCite are aripiprazole tablets with sensors embedded in them. Once the pill goes down your hatch, the sensor can then send a message to a patch that you wear, essentially saying that ‘the pill has landed. Houston, we’ve reached the stomach.’ The wearable patch can then transmit this information to an app on your smart phone. From the smartphone, this information can go anywhere via the Interwebs, to, for instance, your family members or your doctors, granted that you give them permission to see this information. Otsuka Pharmaceutical Co., Ltd. makes the drug and Proteus Digital Health makes the sensor technology Abilify MyCite. …”
Before even touching on scanty possible benefits of a pill more befitting a conspiracy theorist’s worst nightmare, understand that — despite the digital pill’s initial rollout on a wholly voluntary and consensual arrangement between patients and physicians — an ingestible pill which can be tracked for beneficent reasons is an ingestible pill which can be tracked for less-than laudable, or even malevolent, reasons.
Unsurprisingly heralded by the Times as an advancement toward trimming astronomical pharmaceutical and healthcare costs, the outlet notes, “Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization.”
Explains Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department, to the New York Times, “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.”
Remarking on the peculiar choice in Abilify, he added, “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.”
Beyond the incongruent testing sample, some in the psychiatric community worry the ramifications of such tracking may extend to the impoverished or those released on parole or myriad other situations in which medication compliance dictates one’s ability to receive assistance, but for whom maintaining a regular pill schedule — of the strictness inherent to digital tracking — might not be feasible.
Further still, although the sensor-embedded pills have proven effective mechanically, for their stated purpose, whether it actually improves compliance has yet to be substantiated.
“Is it going to lead to people having fewer relapses, not having unnecessary hospital readmissions, being able to improve their vocational and social life?” queried Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and NewYork-Presbyterian Hospital, who affirms its general efficacy, particularly for patients evincing psychotic symptoms for the first time.
“There’s an irony in it being given to people with mental disorders than can include delusions,” he added. “It’s like a biomedical Big Brother.”
According to the Wall Street Journal, manufacturers of similar digital pills are expected to inundate the FDA, now that Abilify MyCite blazed a trail — with a concurrent rush to fit software to the nascent innovation.
How much time will pass, however, until a government agency, pharmaceutical company, or strained healthcare system develops a means to exploit the sensor-equipped pill into a punishment of some form remains the stuff of uncomfortable conjecture.