Almost one year ago, the FDA gave the green light to a “digital pill” that helps physicians to monitor patient compliance.  The pill, developed by Proteus Digital Health, contains a small, ingestible transmitter that sends out an electronic signal via a sensor worn by the patient.  This sensor then sends a signal notifying the prescribing physician that the patient has taken his or her medication.

Abilify maker Otsuka and its U.S. partner Bristol-Meyers Squibb were among the first pharmaceutical companies to embrace this new technology, in a product known as “Abilify MyCite.”  Medical experts say that use of Proteus’ new technology could conceivably save billions of dollars in health care costs by helping to ensure that patients take their medication on time and in the correct amounts.  However, others have expressed serious misgivings over privacy concerns.

Dr. Aneet Sarpatwari, an expert on bioethics and public health policy, currently teaches at Harvard Medical School.  He has spoken out on both sides of the issue. On one hand, he believes that Proteus’ digital pill “has the potential to improve public health,” particularly in patients who need reminders to take their prescriptions as instructed.  However, he also warns that “if used improperly, it could foster more mistrust instead of trust.”

Dr. Sarpatwari’s concerns over trust are shared by University of Illinois researchers in Chicago. Recently, the research team published the findings of a study concluding that such digital pills do in fact threaten the relationship between physicians and their patients – and at the same time, provide no real benefit.

Dr. Eric Swirsky, an associate professor at the university’s College of Applied Health Sciences, calls the technology a “dangerous reduction of the provider-patient relationship.”  He adds, “There is no shortcut to improving patient adherence, which happens in a larger framework of home, work and clinical environments, not to mention perceptions and emotions.”  Swirsky believes that forcing patients to take medications in this manner would only lead them to devise newer, more ingenious ways to avoid compliance.

Additionally, Swirsky notes that there is “a lack of evidence regarding the clinical efficacy and benefit” of the Proteus digital sensor.  Drugmaker Otsuka acknowledges that “the impact of the Abilify MyCite system on treatment adherence has not been demonstrated.”

In response, Proteus’ medical director, Dr. Scooter Plowman, says it provides “transparency” between physician and patient.  “The patient is receiving regular and continual feedback on how they’re doing,” Plowman says.  “The provider is getting regular and continuous feedback on how they’re doing and how their medical decision making is going.”

To be sure, there are safeguards built into the process.  Patients must give their consent in writing before being prescribed Abilify MyCite or other digital medications.  They have control over who receives the data in addition to their primary care physician (typically, family members).  In addition, there is a smartphone app that will allow a patient to block a recipient from receiving data at any time.  Another argument in favor of the technology is the help it could provide for elderly patients who may forget to take their medication or have difficulty keeping track of their medication schedule.

One issue with Abilify MyCite that bears mentioning is the fact that patients who are prescribed Abilify in the first place suffer from mental disorders that include schizophrenia, bipolar disorder and clinical depression.  Such patients often forget to take their medications. Additionally, they may suffer from paranoia and related delusions, raising the question of how readily these patients would accept digital medications.

Shortly after Abilify MyCite was given FDA approval last year, Columbia University psychiatrist Dr. Paul Applebaum said, “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.”  He added, “There’s an irony in it being given to people with mental disorders that can include delusions.  It’s like a biomedical Big Brother.”

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.