Last year, Otsuka Pharmaceutical Company filed a New Drug Application with the FDA for a new form of Abilify, an anti-psychotic medication that is currently at the center of hundreds of lawsuits – and just happened to lose its patent protection in 2016. Known as Abilify MyCite, this “new and improved” product was given FDA approval in November 2017. The “new” Abilify contains the world's first ingestible sensor, manufactured by Proteus Digital Health. Among other things, this ingestible sensor monitors patient “adherence” so that a prescribing physician can be certain the patient is taking the medication as prescribed.
Is this a good idea? In a recent editorial published appearing in The Conversation, sociology professor Anthony Ryan Hatch raises some very troubling – and valid – concerns about the entire issue of digital medicine. Significantly, Professor Hatch's piece was republished in The Epoch Times, a right-leaning, highly conservative, pro-business website. Hatch writes:
“I am concerned about the formation of new pharmaceutical persons who are digitally enhanced to be compliant with the profit motives of corporations and the directives of health providers and drug companies...the fact that the drug is Abilify, which is prescribed to people who experience serious mental distress, should raise many ethical red flags.”
He describes the new form of Abilify as a “killer app” – which is essentially a new software application marketed as “indispensable” in order to lure consumers into purchasing the “latest and greatest” technological gadgets. Hatch fears that such an application means that the health care industry's primary motivation in using such technology will be to maximize profits, regardless of whether or not patients benefit, or are even harmed.
Given the history and behavior of the U.S. health care industry, Hatch's concerns are valid. In fact, on its corporate website, Proteus Digital Health features a statement from prominent mental health professionals, who call Ability MyCite “an innovative way” for physicians and patients and their families to communicate and insure that a course of treatment is being adhered to. A promotional video (which has since been taken down from the Web) also presents the new product as “revolutionary,” combining “both objective and self-reported data.”
Hatch points out that patient adherence, or compliance with a doctor's orders is “fundamentally a social and not a medical problem” – and one to which technology such as Abilify MyCite is not likely to provide a solution. In an increasingly de-humanized society and culture, where humans are increasingly being replaced by machines and “virtual assistants,” reducing the actual face-to-face interaction between physicians and their patients is unlikely to ensure compliance with instructions, nor will it help doctors understand why a patient is not adhering to his or her treatment. This is particularly true of mental health patients.
Hatch ends his editorial by warning that technology is not a substitute for those human caregivers who are responsible for a mental patient's treatment and well-being – and that we should be extremely wary of Big Pharma's takeover of what has traditionally been the role of physicians, nurses and other medical professionals.
The end result could be a nightmare out of dystopian science fiction.