Catch-22: Coming Soon, to a Pharmacy Near You

Omniscience is no longer limited to God and third-person-narration. Earlier this month, the FDA gave a Gatsby-esque green light to the release of the first drug in the United States with an embedded digital digestive tracking system: Abilify MyCite. The pill contains a sensor that tracks and maintains the record of medication ingestion by patients. Reaching the stomach after consumption, the sensor in the pill works to send a signal to a wearable patch on the patient’s body, which then transmits the confirmation of consumption to a smartphone compatible app. From there, the patient’s doctor will be alerted and up to four other people can be added to receive information about the date and time that pills are ingested. According to the FDA website, Abilify MyCite is approved now only in the treatment of schizophrenia, some episodes associated with bipolar I disorder, and as an “add-on treatment” for depression in adult users. Currently, opting-in to this new digital form of the already-existing drug Abilify is voluntary. There is, however, rightful concern about ethics and potentially nefarious or coercive future uses of such traceable medical technology.

This article primarily covers the practical value of the digital drug Abilify MyCite. Parts two and three in this series will explain and address the well-founded concerns about privacy and the ethics of such a drug.

Proponents of Abilify MyCite claim that its defined scope is sufficiently narrow to prevent the abuse of privacy rights, while being still a significant tool in increasing the likelihood that at-risk patients will maintain a consistent medication regimen. Many patients with schizophrenia, bipolar disorder, and manic depression do not take their prescribed medication regularly, and it is for these individuals alone that the drug is presently intended. Non-adherence to medication leads to what some approximate as $100 Billion a year in costs associated with the destruction of property, required treatment of more serious illnesses, or re-hospitalization.

This screen-cap from an old Abilify commercial says it all…

The aim of the Abilify MyCite is to combat the longstanding battle against the adverse consequences for the individual and for the society that is patients who do not comply with treatment as prescribed. The so-called solution presented with the digital tracking technology of Abilify MyCite is not, however, adequate to achieve the outlined aims of the new pill. For the time being, the digital form of the drug is entirely voluntary and exclusive to patients for whom the implications of the decision are clear. Individuals whose non-compliance status stems from forgetfulness— “have I taken my medicine today?”—likely will benefit from the tracking features that confirm or deny consumption.

Non-compliance is not only an affliction of the forgetful. A group whose reasons are as diverse as the individuals themselves, people who forget to take their prescribed pills are coupled with those who just-plain-refuse them for any variety of reasons, such as the experience of unpleasant side-effects or distrust of mood-altering substances. Those patients who do want to take their medicine but fail to remember are boosted by this new drug, whereas the status of those who hesitate based on concern stemming from another source is not addressed. Putting aside for the moment very-relevant questions of privacy and biomedical ethics that arise with this digital drug, on the level of aim alone, the pill likely will not impact the core issue that it seeks to address. One can assume rightly that forgetful patients are not the majority, but rather a minority of non-adherers. Following this, their noncompliance does not lead to a great number of the “severe consequences” which this drug seeks to curb. The greater aim then, of minimizing the monetary and social costs of non-adherence, is not to be achieved without greater implementation of the new technology. On a practical level alone, the new pill fails because it does not address the majority of would-be “offenders.” Yet, it cannot address these people without expanding well-beyond its current scope—beyond voluntary enrollment to potentially mandated medication of patients in order to reach the majority group of non-compliers. Such is the Catch-22: With expanded scope comes potentially more effective progress towards the articulated aim, albeit with outstanding costs imposed on the right to privacy, individual autonomy, and the future security of choice in medical decision-making.

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