The decision marks a milestone in the convergence of technology and health care that also raises privacy concerns.
The so-called digital pill is a version of Otsuka Pharmaceutical’s Abilify, which treats depression, bipolar disorder and schizophrenia. The sensor, developed by Proteus Digital Health, is activated by stomach fluids, sending a signal to a patch worn on the patient’s torso and transmitting the information to a smartphone app.
“This is the first time we’ll have an objective measurement of adherence,” said Kabir Nath, chief executive officer for North America at Otsuka Pharmaceutical. By allowing physicians to track a patient’s use, Nath said he hoped to avert “dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER”.
The Food and Drug Administration’s approval this week comes as the technology sector increasingly turns to health care to test advances such as machine learning, artificial intelligence and micro-electronics for everything from drug development to insurance.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Centre for Drug Evaluation and Research.
Through an app, patients can also opt to report activity, rest and mood information to share with their caregiver, the companies said.
While many in the health industry are embracing new technology, others worry about protecting patient privacy as more data is generated and shared.
Patients who are prescribed the product, called Abilify MyCite, have to agree that their physicians can see the data. They can also choose whether to share information with caregivers, such as family members. Otsuka Pharmaceutical and certain insurers also plan to gather anonymous, aggregated data from patients who consent.
“We know some people don’t have relief of symptoms and we don’t know if that’s just because they’re not taking their medication,” Nath said.
Otsuka Pharmaceutical, which is a unit of Tokyo-based Otsuka Holdings, planned to start the programme with just a handful of health systems and gather evidence on the drug’s effects on adherence, he said.
Not all patients would appreciate such monitoring, said Lucia Savage, chief privacy and regulatory officer at Omada Health, a start-up focused on digital counselling programmes for chronic conditions like diabetes.
“It creates a looking-over-your-shoulder effect."
Information about mental illness was particularly sensitive, said Savage, who previously was a privacy officer at the Department of Human and Health Services.
She suggested patients and their physicians asked questions like: “How is the data flowing? Where does the signal go? If it goes to somebody’s server, whose server is that? What are the business arrangements?”
Bob McQuade, Otsuka Pharmaceutical’s chief strategic officer, said patients would have a choice. The company would continue to sell regular Abilify, he said, and generic versions of the drug were available as well.
Proteus is based in Redwood City, California. - Bloomberg