UMass Boston professor Lisa Cosgrove is lead author on BMJ evidence-based medicine article
UMass Boston Professor of Counseling and School Psychology Lisa Cosgrove is the lead author of a new study published last week in BMJ Evidence-Based Medicine that raises concerns about the FDA approval of a digitally enhanced antipsychotic medication.
Abilify Mycite, an antipsychotic (aripiprazole) medication embedded with a sensor, was approved by the FDA in November 2017, but the study found that the approval was based on very weak evidence and no evidence for improved medication adherence (the very purpose for a digital drug) or improved quality of life.
“Approval of this drug/device combination sets a precedent for how technology-enhanced products will be evaluated before marketing,” Cosgrove said. “Our study raises concerns that the FDA approved a ‘novel’ drug/device that may not be either as efficacious or as safe but will cost significantly more. While the generic oral version of aripiprazole costs approximately $20 per month, Abilify Mycite costs almost $1700 for a month’s supply.”
The study also raises questions about “digital evergreening.” Evergreening is a strategy used by industry to effectively extend patent protection by making small changes to existing products, changes that have almost no added benefit to the patient. This case example illustrates the ways in which sensor-based technology can facilitate a new type of evergreening (i.e., patenting of older, off-patent drugs with a sensor as a new invention to regain or maintain market exclusivity).
The study found that the evidence submitted to the FDA for approval of a digital version of aripiprazole was based on weak evidence, with no prospective, double blind, randomized, controlled trials comparing digital aripiprazole with non-digital formulations of aripiprazole or other active comparators or placebos.
In 2014 aripiprazole was the best-selling drug in the United States, costing on average over $800 for a month’s supply and generating over $7.5 billion in sales from October 2013 through September 2014. After the patent expired in the United States, however, sales revenues dropped to $600 million by 2015, which is when the first application was submitted for market approval for the digital version.
Authors in addition to Cosgrove included: Ioana Alina Cristea of Babes-Bolyai University, Romania, and University of Pisa, Italy; Allen F Shaughnessy of Tufts University School of Medicine, Malden, Mass.; Barbara Mintzes of University of Sidney, Australia; and Florian Naudet of INSERM, Paris.