Experts raise eyebrows at digital pill to monitor patients with schizophrenia

16 November, 2017, 02:00 | Author: Darrell Baldwin
  • FDA approves the first pill that can alert your doctor when you swallow it

When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor. At first techno-blush, concerns about Big Brother tapping one's body fall to the wayside; patients can voluntarily give access to the information gathered by the sensor to their doctor and designated family members or caretakers.

Mitchell Mathis, director of the Division of Psychiatry Products in the FDA'sCenter for Drug Evaluation and Research, said, "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients". But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.

Abilify was first approved by the FDA in 2002 to treat schizophrenia.

Abilify MyCite's tracking system is centred around a tiny ingestible sensor about the size of a grain of sand, called an Ingestible Event Marker (IEM), made from safe levels of copper, magnesium and silicon.

Beginning in 2018, the launch of Abilify MyCite "will be conducted in close collaboration with only a select number of health plans and providers", according to a joint press release from Proteus Health Systems, the makers of the pill's digital sensor, and Otsuka Pharmaceutical Co., the maker of Abilify.

It might sound creepy, but U.S. regulators have approved a drug that can digitally track whether patients have taken their medicine.




Ameet Sarpatwari, an instructor at Harvard Medical School, told the New York Times that while the pill "has the potential to improve public health, if used improperly, it could foster more mistrust instead of trust". Abilify MyCite is also not approved to treat older patients with dementia-related psychosis.

The idea behind Abilify MyCite is help doctors ensure that their patients are taking their medication when they should be, which is a problem for many people, especially mental health patients.

The technology carries risks for patient privacy too if there are breaches of medical data or unauthorized use as a surveillance tool, said James Giordano, a professor of neurology at Georgetown University Medical Center. It's also been approved as a supplemental treatment for adult depression.

The Japanese drugmaker has not said how it will price the digital pill.

"Technology will revolutionize behavioral healthcare and this advancement is simply the beginning of the digital transformation", said Birnbaum, who was not involved in the development or approval of the new medication system.

The landmark approval is the latest in an expansive rethinking of what constitutes a treatment.

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