Privacy fears over the first FDA-approved drug with a sensor that records it’s been ingested may be easier to swallow in an age people have embraced the concept of “the quantified self.”
With widespread adoption of fitness trackers like Fitbit and genetic testing providers like 23andMe, the public may be comfortable with “digital drugs” such as Abilify MyCite, Pepper Hamilton LLP’s Sharon Klein told Bloomberg Law for a story on the newly approved product.
“I think it’s trending that way,” she said. “People are wanting more information.”
The drug, to be sold by Otsuka America Pharmaceutical Inc., contains a sensor made by Proteus Digital Health Inc. that’s activated by stomach fluids. It transmits data, such when the drug was taken and the patient’s activity level at the time, to a patch attached to the patient’s body. The patch then sends the data to a smartphone application, which the patient can share with health-care providers and family members.
“This is just a natural extension of precision medicine,” Klein said, referring to the use of person-specific data (such a patient’s genetic makeup and lifestyle) to prevent and treat disease. “You’re trying to get to the person, and what better way to get to the person than having something ingested, whether it’s a sensor or an embedded microchip?”
Abilify is used to treat schizophrenia and bipolar disorder, and it can serve as an adjunct treatment for depression. A key benefit of Abilify MyCite is the ability to track patients’ compliance with their treatment regimen.
The sensitive data Abilify MyCite will generate poses privacy risks—such as theft or unauthorized use—but there’s no need to be alarmist, former FDA health information privacy official Deven McGraw told Bloomberg Law.
Although there a legal tools and restrictions can provide protection, earning and keeping patients’ trust is the key to making a drug like this successful, McGraw said.
As health privacy director at the Center for Democracy & Technology, she got her hands on Proteus’ grain-of-sand-sized sensor and kept some in a desk drawer. The company was adamant promoting the benefits of treatment compliance and mitigating the risks its product might pose.
“It’s about deciding you’re going to create partnerships with patients and consumers around tools like this,” she said, “and not create the power dynamic that results in mistrust of the tool.”
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