Researchers develop tattle-tale pills for medication compliance

Did Grandma remember to take her pills today? Is she playing hooky from her daily walk? Grandma’s doctor may soon get all that information and more simply by prescribing “smart” pills that track a patient’s every medical move.

Researchers have been working on digital pills for some time. Initially, drug manufacturers targeted the technology for the elderly, particularly for those suffering from Alzheimer’s disease.

In 2012, the Food and Drug Administration (FDA) approved an ingestible chip in a pill that works in conjunction with a patch worn on the torso. The patch contains sensors that track medication compliance and things like body temperature, heart rate, sleep, and whether the patient is standing, sitting, walking, or lying down. The sensors beam the information to a smartphone or tablet where it can be shared with family members and doctors,The Washington Post reported. A handful of physicians and hospitals are testing the pills while the company refines its software.

But applications for digital pills are spreading beyond the elderly. According to Newsmax Health, just last month the FDA approved the use of an ingestible sensor embedded in tablets of Abilify, a drug that treats schizophrenia, bipolar disorder, and clinical depression.

Now, researchers at the University of Massachusetts Medical School plan to conduct a pilot study with 30 post-surgery patients taking the opioid pain-killing drug, oxycodone.

The surgery patients will swallow the digital pill just like they would any other oxycodone pill, but a wireless sensor will be embedded in the gelatin capsule.

Stomach acid will activate a transmitter in the pill which will send information to an iPod-sized, hip-mounted device that will download the information to the web. Within minutes, the doctor will know the patient took the pill.

Proponents of smart pill technology point out the pills can give adult children peace of mind knowing aging parents remembered to take their medications and can enable doctors to provide better care and save healthcare dollars by improving patient compliance.

“As many as 20 percent of people who get prescriptions do not get them filled, and 50 percent of patients do not take them as prescribed by their physician,” said Edward Boyer, researcher and professor of emergency medicine at the University of Massachusetts.

But some medical ethicists fear the technology could compromise patient privacy and lead to a “Big Brother” scenario, where doctors and others could compel patients to take medications against their will and intervene if they refuse.

On a recent Boston Public Radio broadcast, medical ethicist Art Caplan outlined several potential ethical concerns. For one, there is always the possibility someone could hack into information on the web.

“I see Ashley Madison–type extortion happening,” Caplan said. Someone could say, “‘Hey, I just found out you’re mentally ill and you’re not taking your meds, and I think your boss would be interested, so why don’t you send me some money.’”

And that’s just the tip of the ethical iceberg. If a patient with mental illness or dementia is not capable of consenting to treatment with smart pills, will the person who provides consent have access to all of that personal information? Could an employer who pays for an employee’s medical insurance gain access to the information and make medication compliance a mandate for employment? Could an insurance company drop a non-compliant customer?

“I’m not saying we shouldn’t have this pill; I’m just saying it would be nice to lay out the rules as part of the approval,” Caplan said.

Gut check: Stomach acid powers edible diagnostic pills

The future of medical diagnostic technology likely will include edible sensors made of silicon-based circuitry and biodegradable materials, with batteries made of nutrients that use natural stomach juices as electrolytes.

Ingestible sensors, such as a pill containing a camera designed to examine the GI tract up close, already exist but carry a risk of getting stuck and requiring surgery to remove, according to a recent report in IEEE Spectrum.

Future edible sensors—which could check for early signs of bacterial infections or symptoms of gastrointestinal conditions like Crohn’s disease—might be encapsulated in a biodegradable hydrogel that can squeeze through tight openings.

To power the devices, researchers at Carnegie Mellon have built a tiny battery made of melanin—the pigment that colors hair and skin—and manganese oxide, a compound that plays a role in nerve function. According to the IEEE Spectrum, when it enters the stomach, gastrointestinal fluids complete the battery so it can transport current, “much the way the emergency lights of life vests light up.”

Since many of these compounds, including manganese, are considered essential nutrients, researchers think they will have no problem convincing the Food and Drug Administration of their safety.