first drug with a sensor embedded in a pill that alerts
doctors when patients have taken their medications was
approved by the Food and Drug Administration, raiding
issues involving privacy, cost, and whether patients
really want caregivers looking over their shoulders.
Otsuka Pharmaceutical Co. will insert a tiny chip ó
the size of a grain of sand ó inside the psychiatric
medication Abilify used to treat schizophrenia and other
serious mental illness.
technology is a breakthrough in allowing others to see
whether patients are taking their medicines as
prescribed, but also raises privacy concerns. Forty
percent to 45 percent of people with common
cardiovascular and other chronic diseases such as
diabetes do not take their medications as prescribed.
a big deal because medication non-adherence is a huge
public-health challenge in the United States," said
Kevin Volpp, a physician and director of the University
of Pennsylvaniaís Center for Health Incentives and
tablet, Abilify MyCite, contains a digital sensor that
is activated by stomach fluids, sending a signal to a
patch worn by the patient, which, in turn, notifies a
smartphone app that the medication has been taken. The
information can be shared with physicians and others
with the goal of keeping doctors more informed in making
the pill is not magic. People still have to take it, and
the skin patch has to be replaced every seven days.
technology is likely to be controversial. "Thereís
an open question of how paternalistic do we want our
health care providers to be," Volpp said.
"Many patients, for whatever reasons, may decide,
ĎI donít want to take the medicine.í Having their
provider, or health plan, monitor closely whether they
are taking the medicines on a daily basis may be
uncomfortable to some patients."
Choudhry, a physician at Brigham & Womenís
Hospital in Boston and a professor at Harvard Medical
School, said: "This is a technological feat. Thereís
a lot to be celebrated here from a purely technological
perspective. That said, there are a ton of
will the technological monitoring be reliable, and will
the data improve patientsí taking their medications?
"We really donít know anything about that
yet," Choudhry said.
patients feel better, be hospitalized less often, and
function better? "Those clinical outcomes, some of
which are very patient-centric, need to ultimately be
established," Choudhry said.
technology raises a medical ethics issue: What will the
information collected from the devices be used for?
problem of people not taking their medications is
"a normal human behavior, like not exercising, or
following a diet," Choudhry said. "For some
patients, this technology will almost certainly be
helpful and useful. But it may not be applicable for all
patients, nor for all conditions."
new pill will likely cost more than the existing Abilify,
or generic versions. "So thereís a trade-off
between the advantages that a new technology like this
one offers, and the cost that is added because we have
to pay for the technology," he said.
and partner Proteus Digital Health plan to introduce the
treatment to some health plans and providers, who will
identify a "limited" number of adults with
schizophrenia, bipolar disorder, or major depressive
disorder who may benefit. Patients can choose not to
share some information, or opt out at any time, the
Duckworth, medical director for the National Alliance on
Mental Illness, called the new pill "a tool that we
donít know how to use yet. But it has the potential,
if a person wants to communicate information to a family
member, or their doctor, that they are taking their
people with schizophrenia spend a lot of time convincing
people that they are actually taking the medicine. This
is one way to accomplish that," Duckworth said.
might also help doctors answer the question: ĎWas this
medicine successful?í One question with all
medications, not just medication for schizophrenia, is
did this person take the medicine?" he said.
"Itís important because if the person didnít
take the medicine, itís hard to conclude that it was a
failed treatment. But if he took the medicine, and
continued to have symptoms, then you can make a change
in the regimen."
the technology is commercially successful, Volpp said
"there will be a lot of other companies working on
think there are some clear clinical applications here.
It will be interesting to see how this unfolds and
whether this gets extended to other types of
medications," Volpp said.