One of the most common questions doctors ask of patients is “have you been taking your medication as directed?” It’s an important question that allows physicians to gauge the effectiveness of a drug and can have major ramifications on the patient’s treatment. But with digital drugs, doctors may not even have to ask; they will already have all of that data and more.
In late 2017, drugmakers Bristol-Myers Squibb and Otsuka America Pharmaceutical won FDA approval for Abilify MyCite, a first-of-its-kind tablet with an ingestible sensor embedded in the pill. Abilify MyCite’s sensor functions like a battery, and releases an electric signal once it reaches the body’s stomach acid. This signal then conveys information to an adhesive patch worn on the skin, including the time and date the pill was taken, the patient’s blood pressure, body temperature, and level of activity. The patch then sends this information to a smartphone app where the consented doctor and up to four additional caregivers can review the data.
For those unfamiliar with the original drug, Abilify is a powerful antipsychotic drug used to treat schizophrenia, bipolar disorder, and major depressive disorder. The drug came under fire (and legal trouble) for allegedly contributing to extreme compulsive behavior disorders like gambling, binge eating, and sex addiction. In 2016, the same year its patent expired, the FDA issued a black box warning on the drug.
Since the announcement of Abilify MyCite, ethics professionals have raised issues with the use of digital drugs, especially within the realm of mental health treatment. Sensor-equipped drugs would add a new layer of invasive monitoring to patients, risking non-compliance and distrust. Historically, patients with conditions like schizophrenia often suffer from extreme paranoia and are plagued by thoughts that they are being tracked or monitored. In most cases, these thoughts are symptomatic of the disease and not founded in reality. But how will these patients react to a digital drug like Abilify MyCite, and what effect could it have on their treatment and recovery?
Another concern is the necessity of face-to-face communication when treating mental health conditions. Speaking directly with doctors allows patients to express how a drug is affecting them, and psychologists have stressed the importance of human interaction as an essential element in staving off depression. Digital drugs may make it easier for doctors to monitor a patient’s adherence to medication, but that could lead to less face-to-face interaction.
Research has shown that non-adherence to a treatment plan often stems from the patient feeling a lack of control over their medical condition, and defying treatment is a way of regaining that control. Removing another layer of trust between doctor and patient could have catastrophic and unintended consequences.
Abilify MyCite is still in the initial rollout, but it’s likely that more digital drugs will soon be on the market. And while the ethical debate of these drugs has started in the classroom, it may end in the courthouse.
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