Natalie Salmanowitz, SPINS fellow

In discussing the balance of power in doctor-patient relationships, we usually view doctors as having the upper hand. After all, they serve as gatekeepers to many medical treatments and record meticulous details of our personal lives. In a single appointment, doctors gather information ranging from our daily eating habits to our current stressors. Despite this skewed dynamic, the scale is not solely in the doctor’s favor. For instance, patients control the quantity and truth of their answers, and in most cases can choose whether to follow or reject a doctor’s prescribed course of treatment.

This last fact is often overlooked, but carries serious consequences for both individual patients and the healthcare system. Noncompliance can worsen a person’s existing condition while provoking additional illnesses. It can also lead doctors down rabbit holes in seeking solutions to ostensibly treatment-resistant problems. As far as the broader healthcare system is concerned, the waste of pills alone costs the United States up to $300 billion a year. 

A new invention might break this trend. “Digital pills” track ingestion through small sensors, which transmit information to a patch on the patient’s skin. This patch in turn sends confirmation of compliance to the patient’s smartphone, in addition to other metrics such as heart rate and the number of steps walked that day. Patients can then grant their doctor or caretaker access to this data. Although not yet clinically available, digital pills could soon become a reality. In a joint effort, Proteus Digital Health and Otsuka Pharmaceutical Company created a digital antipsychotic drug, which the FDA just recently agreed to review.

The advantages of digital pills are extensive, and have unsurprisingly garnered excitement among clinicians, members of the healthcare industry, and pharmaceutical researchers alike. Positive outcomes include decreased expenses from wasted medications, faster recovery times from greater adherence to treatment regimens, and higher-quality clinical trials for studies involving prolonged medication use. Beyond the healthcare setting, objective tracking tools could enable court-mandated treatment programs to more effectively meet their goals: the more transparent compliance becomes, the more accountable offenders are held for their behavior.

But for all the potential advantages hailed in the media, we should consider the less appealing consequences as well. Start with consent. In its public statement, Otsuka preemptively claims, “[The] information is recorded and relayed to patients on a mobile phone […], and only with their consent [emphasis added], to their physician and/or their caregivers.” See here In theory, this setup circumvents a major ethical issue. In practice, it assumes patients using this technology will have the capacity to provide valid consent. Here is the catch: digital pills are explicitly envisioned for use in vulnerable patient groups.

Otsuka’s antipsychotic drug, Abilify, is primarily intended for patients with schizophrenia. The hallmark symptoms of the disorder include: fluxes in and out of psychotic states, hallucinations and delusions, and declines in basic cognitive capabilities. So what happens when a patient with schizophrenia grants a doctor access to her data, but changes her mind during a psychotic episode? Is the withdrawal of consent valid in this second instance and if not, do doctors have a right to ignore it? And if granting consent is as easy as clicking a button, how can competence be assessed?

Digital pills have also been suggested for patients with Alzheimer’s disease, a condition marked by intense dementia and personality changes. How do we handle consent when an Alzheimer’s patient forgets having granted access to a caretaker? Unless careful steps are taken, tracking behavior without valid consent risks violating cardinal principles of medical ethics.

Consent is not the only issue, however. Even among fully competent patients, questions of privacy and autonomy rise to the forefront. Consider external pressures. What if insurance companies create financial incentives to share information with doctors? Could this added enticement sway patients’ decisions enough to elicit consent? While hypothetical, this scenario is not very different from existing wellness programs.

One can also imagine subtler pressures to share data, such as familial obligations. An elderly patient might grant access to his children, showing he is capable of independently managing his medications. Similarly, parents with older children who have daily medication requirements might demand access once their children leave for college. Although the choice to share information is technically within a patient’s control, the pressure to assuage one’s relatives or caretakers could significantly impact decisions.

Admittedly, confirming treatment adherence might be relatively harmless. Yet, digital pills track many additional metrics—the time of day the patient takes the pill, how much the patient is moving, how frequently he is resting, and so forth. While patients could withhold the extra information, this choice might strike their caretakers as suspicious. Sharing information is not inherently problematic, but patients should be aware of how much autonomy and privacy they are relinquishing.

Lastly, consider the altered dynamic between patients and doctors. Once doctors can confirm compliance, the flow of information is no longer the patient’s sole prerogative. Granted, doctors can already gauge compliance using basic tactics such as refill orders. But tracking ingestion goes substantially further, challenging expectations for doctor-patient relationships. Is it reasonable to add this burden to doctors’ professional obligations, especially given their notoriously packed schedules? Is it appropriate to make patients so accountable to their doctors? Digital pills will not just increase compliance; they might also fundamentally change how we view the duties and privileges of those in the healthcare setting.

Since the FDA has only agreed to review the application, digital pills are still a distant matter. Nevertheless, this prospect has generated excitement for laudable reasons. The arguments raised in this post are not meant to condemn the use of digital pills. But if the FDA grants its approval, we must question whether this technology, and its associated implications, is something society should readily embrace.

Natalie Salmanowitz is currently a fellow in the Stanford Program in Neuroscience and Society