Background In November 2017, the Food and Drug Administration (FDA) approved a version of a second-generation antipsychotic, aripiprazole, embedded with a sensor (Abilify MyCite).
Objective To systematically review the evidence supporting the FDA’s approval of digital aripiprazole and how that evidence was disseminated in the scientific literature and news reports.
Study selection Prospective, double-blind, randomised controlled trials (RCTs), non-randomised and non-comparative studies were included if they focused on the use of digital aripiprazole. All scientific publications citing the trials were included if written in English. For the news reports, all languages were included if an English translation was available, and all records that were published after FDA approval were included.
Findings In the primary evidence search, no RCT comparing digital aripiprazole with a non-digital formulation, other active comparators or placebo was found. Only three non-comparative uncontrolled cohorts were found. No study provided data on remission, quality of life or any efficacy outcome. Fourteen scientific papers were identified that cited the trials and 70 news stories met the inclusion criteria. Almost 80% (11/14) of the scientific papers and three-fourths (52/70) of the news stories conveyed an unsupported impression of benefit.
Conclusions Regulatory approval for this first-ever digital drug was based on weak evidence, and there was no evidence of better adherence with the digital version of aripiprazole compared with the non-digital version. The possibilities afforded by this technology make room for a new type of evergreening (ie, patenting of older drugs with a sensor as a ‘new invention’). Both the scientific literature and news reports conveyed an unsupported impression of benefit.
Trial registration number CRD42018089515.
- public health
- mental health
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Contributors LC conceived of the study. LC and FN developed the design. LC, FN, IAC, BM and AFS contributed to data analysis and interpretation and review of the results. All authors discussed the results and contributed to writing the manuscript. LC took the lead in writing the initial draft, and FN wrote the draft of the primary evidence search and results. All authors contributed to writing subsequent revisions of the manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data are shared on the Open Science Framework (https://osf.io/auc9e/).
Correction notice This article has been corrected since it was published Online First. Second affiliation for Ioana Alina Cristea has been corrected.
Patient consent for publication Not required.
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