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Pills with a mind of their own

"Did you take your medicine today?" Soon, patients won't have to rely on their memories for the answer. Scientists are developing tablets and capsules that track when they've been popped, turning the humble pill into a high-tech monitoring machine.

The goal: new devices to help people take their meds on time and improve the results coming out of clinical trials for new drugs.

Doctors can already prescribe pills that release drugs slowly or at a specific time. They even have camera pills that take snaps of their 20- to 40-foot journey through the gastrointestinal tract. The new pills tote microchips that make them even cleverer: They will report back to a recorder or smart phone exactly what kind and how much medicine has gone down the hatch and landed in the stomach. Someday they may also report on heart rate and other bodily data.

This next generation of pills is all about compliance, as it's termed in doctor-speak the tendency of patients to follow their doctors' instructions (or not). According to the World Health Organization, half of patients don't take their pills properly. We skip doses, take the wrong amount at the wrong time or simply ignore prescriptions altogether. In a 2006 survey of 1,000 people by two pharmacist associations, three-quarters of those queried admitted to occasional noncompliance.

Medication misuse can lead to hospitalizations and deaths. Those preventable events cost the healthcare system $100 billion to $300 billion annually, according to a 2009 report by the Pharmaceutical Research and Manufacturers of America.

The most common reason for medication mistakes is forgetfulness, particularly among the elderly just the age group, of course, that has to manage multiple medications. "The number of doctors that they have and the number of prescriptions that they get is mind-boggling," says Jill Winters, dean of the Columbia College of Nursing in Milwaukee, Wis., who says she often sees older people come to the ER toting a bag of prescription bottles. According to a 2004 report by the Centers for Disease Control and Prevention and the Merck Institute of Aging and Health, the average 75-year-old takes five different drugs.

Often, occasional lapses don't matter. Smart pills like these are "not for your aspirin or even simple antibiotics," says Maysam Ghovanloo, an electrical engineer at the Georgia Institute of Technology in Atlanta. The new technology is aimed at time-sensitive or costly medications.
For certain medications, not taking every pill can have serious consequences. For example, people who are mentally ill may require regular treatment to stay stable. Chemotherapy drugs and antibiotics for treating tuberculosis are time-sensitive as well.

Blood pressure medication works only when taken on a regular basis, and suddenly stopping it can cause blood pressure to skyrocket, says Daniel Touchette, a pharmacist and researcher at the University of Illinois in Chicago.

With drugs for transplant patients, a person who misses a dose risks rejection of the new organ. Novartis International AG, based in Basel, Switzerland, is developing pills for transplant recipients; the pills communicate with a patch on the skin when they reach the stomach.

And in the case of tuberculosis, which is common in many countries, treatment requires a six-month course of antibiotics that come with side effects such as nausea and heartburn. Many people don't understand why they have to keep taking the unpleasant drugs once they feel better but going off the medication can make patients contagious again and allow drug-resistant tuberculosis to develop. Currently, the World Health Organization recommends that healthcare personnel observe patients as they take every dose an inconvenience for patients and a burden on healthcare workers.

Yet another arena where compliance is crucial is in clinical drug trials. Drugmakers can only be sure their medicine works if they're sure subjects are actually taking it as directed. For now, experimenters rely on diaries where participants record their medication use. But people may fudge the data, not wanting to admit they dropped a pill down the drain or forgot to take it for a few days. To account for people who miss their meds, drug companies have to spend extra money trials cost hundreds of millions of dollars for larger trials just so enough people will actually take the drug.

Necklace tracer

Technology already offers some solutions, with cellphone reminders and pill bottles that record when they're opened. But none of these actually confirm that the medicine has been swallowed.

"You don't know who opened it," Ghovanloo says. "You don't know what is done with the pill."

Ghovanloo hopes to improve compliance with a necklace that records every time a special pill slides down the esophagus. He calls the system MagneTrace. By sounding an alarm or sending a cellphone message, the necklace also would inform the wearer when it's time for another dose. Caretakers or doctors could monitor the signals too.

The system works by radio-frequency identification, or RFID. You experience RFID every time you exit a large store: The pair of pillars you pass through on the way out converse with RFID chips on the products you're carrying to confirm you did indeed pay for them.

In the case of MagneTrace, three magnets on a choker-type necklace act like those pillars, continually surveying the neck. The pill contains an RFID chip to communicate with the magnets. When Ghovanloo tested the system in an artificial neck made of PVC pipe, the necklace detected 94% of pills passing through it. He hopes to get that number up to 99% and is adding a microchip that will also transmit information about the specific drug taken and its dose.

Ghovanloo coats the chips with a non-reactive material so that after the medicine dissolves, the hardware simply passes through and out of the digestive tract. He has tested the tracer chips in a hound dog, and they were harmless.

However, before trying the system in people, Ghovanloo says he needs make the design more fashionable. "Right now, it's not something that a lady would be willing to wear," he says. For men, he might embed the device in a shirt collar.

Rizwan Bashirullah, an electrical engineer at the University of Florida in Gainesville, is another scientist working on pills that will confirm they've been taken. "They're essentially little stickers," he says of his technology, called the ID-Cap. Gainesville-based eTect is developing the product.

Each sticker contains three components: a microchip, an antenna and an acid sensor. Altogether it's approximately half the size of a postage stamp, says eTect President Eric Buffkin. The sensor activates the device when it lands in the acid environment of the stomach, and the chip uses the antenna to send electronic signals directly through the body's tissues to a receiver, worn on a wristband. The silver antenna and sensor dissolve into safe components; these and the microchip, about as big as a grain of sand,are flushed out of the gut.

Over the next year, the company plans to test the capsule for safety in animals and people, Buffkin says.

The ultimate cost of these fancy pills is uncertain. If there is enough demand for the devices, Bashirullah estimates they'd cost less than a dollar each. And beyond just delivering medicine, the smart pills could someday also report on heart rate, temperature or other medical data.

But in order to do any good, people have to want to take the pills. Many people don't just forget, they actively avoid medication because they don't like the side effects or don't think it's worthwhile.

"These new pill technologies, they don't address these other issues," Touchette says.

Based on the results of other compliance strategies, Touchette estimates the reporter pills would raise compliance by 5% to 15%. They would work better, he says, in a multi-pronged approach that included patient education.

But for people with conditions such as tuberculosis and mental illness, who simply must take their meds, Touchette is confident that trackable pills will be worthwhile.

Pill monitoring also raises some concerns about privacy, although researchers say those are unfounded. "The important thing is that it's under the patient's control," Ghovanloo says. "I would compare it with the information you put on your Facebook you can limit it to just your friends, or you can have it for the world to see."

Bashirullah notes that the pills aren't so different from well-accepted electronic implants such as pacemakers and other stimulators that transmit data such as heart rate.

So open wide and swallow your meds. The smart pills of the future will know if you don't.

Source: By Amber Dance, Special to the Los Angeles Times

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