For the first time, the Food and Drug Administration has
approved a digital pill — a medication embedded with a sensor that can tell
doctors whether, and when, patients take their medicine.
The approval, announced late on Monday, marks a significant
advance in the growing field of digital devices designed to monitor
medicine-taking and to address the expensive, longstanding problem that
millions of patients do not take drugs as prescribed.
Experts estimate that so-called nonadherence or
noncompliance to medication costs about $100 billion a year, much of it because
patients get sicker and need additional treatment or hospitalization.
“When patients don’t adhere to lifestyle or medications that
are prescribed for them, there are really substantive consequences that are bad
for the patient and very costly,” said Dr. William Shrank, chief medical
officer of the health plan division at the University of Pittsburgh Medical
Center.
Ameet Sarpatwari, an instructor in medicine at Harvard
Medical School, said the digital pill “has the potential to improve public
health,” especially for patients who want to take their medication but forget.
But, he added, “if used improperly, it could foster more
mistrust instead of trust.”
Patients who agree to take the digital medication, a version
of the antipsychotic Abilify, can sign consent forms allowing their doctors and
up to four other people, including family members, to receive electronic data
showing the date and time pills are ingested.
A smartphone app will let them block recipients anytime they
change their mind. Although voluntary, the technology is still likely to prompt
questions about privacy and whether patients might feel pressure to take
medication in a form their doctors can monitor.
Dr. Peter Kramer, a psychiatrist and the author of
“Listening to Prozac,” raised concerns about “packaging a medication with a
tattletale.”
While ethical for “a fully competent patient who wants to
lash him or herself to the mast,” he said, “‘digital drug’ sounds like a
potentially coercive tool.”
Other companies are developing digital medication technologies,
including another ingestible sensor and visual recognition technology capable
of confirming whether a patient has placed a pill on the tongue and has
swallowed it…
Insurers might eventually give patients incentives to use
them, like discounts on copayments, said Dr. Eric Topol, director of Scripps
Translational Science Institute, adding that ethical issues could arise if the
technology was “so much incentivized that it almost is like coercion.”
Another controversial use might be requiring digital
medicine as a condition for parole or releasing patients committed to
psychiatric facilities.
Abilify is an arguably unusual choice for the first
sensor-embedded medicine. It is prescribed to people with schizophrenia,
bipolar disorder and, in conjunction with an antidepressant, major depressive
disorder.
Many patients with these conditions do not take medication
regularly, often with severe consequences. But symptoms of schizophrenia and
related disorders can include paranoia and delusions, so some doctors and
patients wonder how widely digital Abilify will be accepted…
The newly approved pill, called Abilify MyCite, is a
collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital
Health, a California company that created the sensor.
The sensor, containing copper, magnesium and silicon (safe
ingredients found in foods), generates an electrical signal when splashed by
stomach fluid, like a potato battery, said Andrew Thompson, Proteus’s president
and chief executive.
After several minutes, the signal is detected by a
Band-Aid-like patch that must be worn on the left rib cage and replaced after
seven days, said Andrew Wright, Otsuka America’s vice president for digital
medicine…
Abilify, a widely used drug, went off patent recently, and
while other companies can sell the generic form, aripiprazole, Otsuka, has
exclusive rights to embed it with Proteus’s sensor, said Robert McQuade,
Otsuka’s executive vice president and chief strategic officer.[n.b.]…
How patients will view Abilify MyCite is unclear. Tommy, 50,
of Queens, N.Y., who takes Abilify for schizoaffective disorder, participated
in a clinical trial for digital Abilify.
Tommy, who withheld his last name to protect his privacy,
encountered minor issues, saying the patch was “a little bit uncomfortable” and
once gave him a rash.
A compliant patient, Tommy said he does not need monitoring.
“I haven’t had paranoid thoughts for a long time — it’s not like I believe
they’re beaming space aliens,” he said. If offered digital Abilify, he said, “I
wouldn’t do it again.”
But the method might appeal to patients who want to prove
their compliance, build trust with their psychiatrist, or who feel “paranoid
about getting accused of not taking their medicine.”
https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html
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