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A new clinical study is underway at 16 health centers around the country to see if a pill with an ingestible sensor can improve medication adherence rates for hepatitis C drugs. Photo by Proteus Digital Health

This digital pill wants to make following your prescription easier

Doctors estimate about half of all medications for chronic conditions are not taken as prescribed, resulting in $100 billion to $289 billion in preventable health care costs and more than 100,000 deaths every year in the U.S. A majority of adults say they struggle with remembering to take their prescriptions.

Now, as with many other seemingly intractable challenges, technology has been enlisted to help. A new clinical study is underway at 16 health centers around the country to see if a pill with an ingestible sensor can improve medication adherence rates for Hepatitis C drugs.

Proteus Digital Health, the inventor of this so-called digital pill, is part of an emerging field of medicine and one of a handful of companies designing these high-tech pills.

While medication adherence is an issue for everyone, it can be especially difficult for patients with mental health and substance abuse conditions to rigorously follow their prescriptions.

And the latter is a significant factor in the spread of Hepatitis C. Intravenous drug use, particularly opioids, has fueled a spike in Hepatitis C infections in recent years.

On Wednesday’s PBS NewsHour, I explore how a new wave of Hepatitis C drugs, known as direct-acting antivirals, can cure the disease 95 percent of time when used as prescribed. But insurance providers have limited their payouts and the access for direct-acting antivirals, due to the drugs’ expensive price tag.

David Wyles, head of infectious diseases at Denver Health where the digital pill is being trialed, said the information gathered from the study may help convince insurers to expand access to the new but more expensive Hepatitis C drugs. Denver Health has 18 voluntary patients enrolled in the trial and is one of the largest study sites. The Colorado Department of Health estimates about 70,000 people in the state carry Hepatitis C, and Denver Health cares for many of them.

“Insurance payers have imposed restrictions, not necessarily based on medical or scientific facts,” Wyles said. “This is a population that some will look at and say, ‘They won’t take their medications, why would we want to treat them?’ Potentially this study is something to refute that if we can show adherence rates are good.”

Proteus’ digital pill consists of the prescription medication with a tiny, FDA-approved ingestible sensor, packed inside a gel capsule. Once swallowed, minerals in the sensor react when they hit the acids in the stomach and create a tiny electronic signal. A band-aid-like patch, worn on the skin of the torso, captures this signal and relays it to an app on a smartphone or tablet.

Patients share the data with their doctors but also control who else has access. Their doctors can then monitor when and how many pills have been taken.

“If the patient misses a dose or a couple of doses, you can set up an alert in the program to send you an email. You can contact them and hopefully intervene right away,” David Wyles said. “Without the technology, you may not know anything until your next visit, which could be a month later, and then it’s too late to do anything.”

Yet the new technology raises questions about patient privacy. Some doctors in the mental health community expressed concerns last year about patient trust and misuse of data when the FDA approved Proteus Digital Health’s sensors to be embedded in the antipsychotic drug Abilify.

“In an era in which even the National Security Agency gets hacked, there are obvious concerns about patient privacy with a technology that communicates personal medical information,” Paul Appelbaum, director of the division of Law, Ethics, and Psychiatry at Columbia University, told Psychiatric News. “The potential for this technology to be misused by judges and probation officers who may require offenders to use pills with sensors, and then respond punitively to the most trivial failure to adhere to the treatment regimen, is real.”

Dr. George Savage, chief medical officer for Proteus Digital Health, said his company is adamant about patients controlling their own data: “The patient owns their own data and decides who to share it with beyond their medical team. We don’t sell data and never will.”

Nine health systems across the U.S. have used the technology so far for conditions like diabetes, heart failure, and hypertension. Proteus Digital Health is also testing the digital pills with oncology and HIV drugs, and on patients using opioids for pain relief. Dr. Savage said adherence rates with the digital pills have been shown to be high.

‘When we provide feedback to the patient, adherence is about 87 percent,” Savage said. “When we add in someone following up with a patient, like a doctor, adherence is 96 percent. Near perfection.”

Editor’s note: This post has been updated to clarify that the signal is only sent once when the pill reaches the stomach acid and that the related patch is worn on the torso.

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