FDA Approves New Smart Pill, Raises Concerns Of US Government Spying

Leigh Mccormick
November 16, 2017

Big news for the health industry: U.S. regulators have approved a pill that can be digitally tracked through the body using an ingestible sensor and a patch worn by patients. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. And digital systems could spare time and resources by replacing current practices of having doctors or nurses supervise certain patients taking their medications, which is a common practice for patients taking antibiotics for tuberculosis, for example.

Otsuka said that the pairing of the sensor with the antipsychotic Ability was created to allow patients with schizophrenia, bipolar I disorder or major depressive disorder to better track their daily medication intake and share that with their care team - which they can control through the linked app. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. Doctors and health care providers have to get your permission first to track the data.much like those opt-in auto insurance tracking devices customers can get discounts for if they install the device in their cars.

Ms Wells said advances that safely and economically supported patients in taking their medicine as prescribed had significant benefits to the patient and the health system in reducing the pain and costs of avoidable illness.

The system works by sending a message from the pill's sensor to a wearable patch.

The U.S. Food and Drug Administration (FDA) approves Otsuka Pharmaceutical Co., Ltd.'s Abilify MyCite, the world's first digital drug that tracks whether patients have swallowed the drug or not.

Abilify MyCite should not be used to track "real-time" medication ingestion because detection may be delayed or may not occur, the company warns.

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Patients wear a patch over their torso, which relays a signal between the drug pill and the mobile app.

Those concerns were shared by fellow Columbia University psychiatrist Jeffrey Lieberman, who likened Abilify MyCite to "a biomedical Big Brother", noting the "irony in it being given to people with mental disorders than can include delusions". The medication must also be dispensed with a patient Medication Guide with information about the drug's uses and risks.

Before a patient uses Abilify MyCite for the first time, clinicians must facilitate use of the medication, patch, and system to ensure the patient is able and willing to use it.

But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take-or forget if they've taken-their medication for the day. "The fact that someone might use this computer readout to decide if you are compliant-and that could affect your degree of freedom in society-is an issue that needs to be discussed and debated", she says.

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