Abilify MyCite was approved by the FDA in November of 2017, but it isn’t being used much. At least one expert said that was because the antipsychotic pill contains a tracking chip the size of a grain of sand that confirms whether or not an individual actually takes the medication. A psychiatrist from Columbia University said people with psychotic disorders often struggle with some degree of paranoia, believing that outside forces are trying to monitor and control them. “The idea that we’re giving this group of patients a pill that, in fact, transmits info about them from inside their body to the people that are involved in their treatment almost seems like a confirmation of the worst paranoias of the worst patients.”

The Daily Mail reported medication nonadherence is a particular problem for doctors treating schizophrenic patients. Otsuka Pharmaceuticals replied that people who are afraid of their medicine, are not likely to be given Abilify MyCite. The medication is supposedly designed for people who ask for it as a way of improving their mental health. A spokesperson for Otsuka said, “It’s really about patients who want to improve their treatment goals. If they have any concerns, it’s probably not the right solution for them.”

Really? A medication that tracks when you have taken your medication is for motivated clients who want to improve their treatment goals, meaning to be more compliant with taking Abilify MyCite? What about patients who seek to minimize or eliminate the adverse side effects from the medication, including weight gain, agitation, unusual urges, akathisia (a feeling of inner restlessness), and more, including thoughts about suicide?

An individual who participated in the clinical trial for Abilify MyCite and who was compliant with his medication hasn’t had paranoid thoughts in a long time. He said that if he had an opportunity to take ‘digital Abilify,’ “I wouldn’t take it.” See, “Biomedical ‘Big Brother’” for more on the adverse side effects of Abilify and other antipsychotics.

The metallic tracking chip contains copper, magnesium and silicon sends a signal to a patch worn on the patient’s arm. It is activated when it becomes immersed in stomach juices, completes a circuit and generates a small electric charge. “The patch then synchronises with a mobile app on the patient’s smartphone or tablet, and sends data to their doctor over the internet to show whether the pill has been taken.” Ingestion is recorded between 30 and 120 minutes after the patient swallows the drug.

The BMJ Evidence-Based Medicine journal published research by Lisa Cosgrove and others that analyzed evidence submitted to the FDA for approval of digital arpiprazole (Abilify MyCite). This was the first such drug-device combination to receive FDA approval, and it “sets a precedent for how technology-enhanced products will be evaluated before marketing.” The authors also said it was important to examine how the clinical trial evidence supporting this approval was represented in news stories and reports. Recent research had documented the presence of ‘spin’ (distorted interpretation of trial evidence) when the results of clinical trials are reported in journals and news reports. This spin gives the impression of there being a greater benefit to the drug than is warranted by the data in both media reports and the scientific literature.

Their review of the clinical trial data submitted to the FDA for the approval of Abilify MyCite revealed the data were limited to trials that “simple assessed whether patients could use the product as intended.” There was no evidence of superiority or non-inferiority compared with non-digital versions of arpiprazole, other antipsychotics or placebo. In the FDA’s clinical review letter, one simulated trial (where the participants did not ingest the drug, but simply placed it in a container to simulate ingestion) provided no additional data about adherence or regarding transmission times. “Considering these limitations, the most accurate statement regarding Abilify Mycite’s capabilities is that ‘Abilify MyCite successfully tracks ingestion of aripiprazole with embedded sensor.’” The lack of even a single comparative trial was said to mean “there is no way to know whether digital aripiprazole improves treatment adherence, quality of life, psychiatric symptoms or remission.”

Patients with serious psychiatric illnesses often suffer from paranoia. An ingestible drug with a sensor brings surveillance to a new level, and the potential negative effects on this patient population merit careful consideration. The potential harm of the surveillance aspect of this technology to the therapeutic alliance and to patients has not been adequately assessed. Thus, it is reasonable to ask if there was a financial rather than a scientific impetus for choosing aripiprazole as the first-ever digital drug.

Before it went off patent in 2015, Abilify made over $7.5 billion. It was the best-selling drug in the US for 2014 with an average cost of $800 for a month’s supply. After the patent expired, sales of arpiprazole dropped to $600 million in 2015, which was when Otsuka and Proteus first submitted an application for market approval for digital arpiprazole. The cost for a month’s supply of the Abilify MyCite is $1,650. In comparison, the generic oral version of arpiprazole costs less than $20 per month. In order to avoid this dramatic loss in revenue, pharmaceutical companies have developed several different schemes.

Drug manufacturers have developed a number of strategies to extend market monopoly after a blockbuster drug (defined as over US $1 billion in yearly revenue) goes off-patent. These are known as ‘evergreening’ strategies, with highly questionable benefit to patients. Evergreening involves the patenting of a slight modification (eg, subtle changes to the medicine’s structure) of an existing drug as a new invention. For the manufacturer, the result is that their product is considered as a new chemical entity that qualifies for market exclusivity (ie, no generic version is available). The possibilities afforded by sensor-based technology make room for a new dimension of practice, an evergreening 2.0. That is, ‘digital evergreening’ may develop as a means whereby manufacturers can gain market exclusivity for a generically available medicine (such as aripiprazole) by combining it with a monitoring technology.

Cosgrove et al added to the growing body of literature documenting the extent and effects of spin in the scientific literature and in media reports by noting the affiliation of authors with the parent pharmaceutical company, Otsuka. Researchers searched the Web of Science to identify all publications in English citing the clinical trials for arpiprazole. Then they reviewed the database NexisUni for all news stories and press releases about the approval of Ability MyCite from January 1, 2015 to January 23, 2018. The researchers defined spin as ‘a specific way of reporting, intentional or not, to highlight that the beneficial effect of the experimental treatment [digital arpiprazole] in terms of efficacy or safety is greater than that shown by the results.’ They identified 70 articles and two press releases which met their inclusion criteria for their study.

Of these, 57% (40/70) did not acknowledge the lack of efficacy data from RCTs [randomly controlled trials], 93% (65/70) did not report on the scarcity of safety data, and no story reported on the absence of a non-digital comparator in clinical trials. Three-fourths (52/70) conveyed an impression of benefit without mentioning the lack of research to support that impression. Most of the news stories (77%, 54/70) cited an expert, and of those 39% (21/54) cited experts who had financial ties to either Otsuka or Proteus.

Not only were some authors of the published studies Otsuka employees, there was evidence of ghost writing in the dissemination of the trial data: “’Editorial assistance was provided by the medical communications company C4 MedSolutions LLC (Yardley, PA, USA), a CHC Group company’, with Otsuka funding.” Both of the positive clinical trial studies were published in the journal Neuropsychiatric Disease and Treatment, whose editor is described as an ‘independent pharma consultant [who] advises and consults worldwide to several pharmaceutical and venture capital organizations’.

Our case study reveals that the approval of this digital drug for marketing in the USA was granted on very limited data. Both the scientific literature and the popular news reports conveyed an unsupported impression of benefit. As a result, the general public and healthcare professionals may be making medical decisions based on industry-friendly, but not necessarily scientifically accurate, information about the efficacy and safety of this new product. Also, if patients are incentivised to take the digital version (eg, by being offered lower copayments or by being offered outpatient treatment—rather than forced inpatient treatment), the line between incentivising and coercion will be blurred. We recommend that other regulatory bodies (eg, the European Medicines Agency) take note of the findings in the current study as well as the medicolegal issues that emerge with the use of digital drugs.

The authors suggested the general public and healthcare professionals may be making medical decisions based on industry-friendly, but scientifically inaccurate, information about the safety and efficacy of Abilify MyCite.

Please do not let the allure of a new pharmaceutical technology seduce you. This doublespeak about how digital arpiprazole will improve your treatment goals, is simple marketing rhetoric. Also do the math, one month of Abilify My Cite is $1,650 and a generic pill will cost you less than $20 per month. The savings leaves you enough to hire a skilled mental health coach and have an even better chance of improving your treatment goals.