A pill that can tell if it’s been taken?

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Rizwan Bashirullah holding a prototype pill. Image: Ray Carson/University of Florida

Imagine a pill that could tell your doctor whether you’ve actually taken it, or tell researchers conducted a clinical trial whether you’re using the medication as instructed. Rizwan Bashirullah, an assistant professor of electrical and computer engineering at the University of Florida, is working to develop exactly that. By applying miniscule microchips to pill capsules, he hopes to develop a technology that could electronically transmit information about when a pill has been consumed—not based on human reports, but based on chemical detection that the medicine is in fact inside a human stomach.

A major cost of developing new drugs is conducting the clinical trials to test their efficacy, Bashirullah explains, and a pricey piece of those trials is making sure that participants actually take the medication (or placebo). Noncompliance can make it difficult to interpret the data and seriously undermine the results of clinical trials. So, understandably, making sure that participants are actually taking the medication, and are doing so at the recommended time, is a central concern. Currently, the most effective way to do this is what’s known as “direct observation therapy,” or basically having someone actually eyeball the pill as it goes into a participant’s mouth. As Bashirullah explains, “a person has to go to a facility and is actually seen taking the pill.” Yet, while effective, that method can be quite costly. That’s where this self-reporting pill comes in.

Currently Bashirullah has a prototype pill that has been tested in what he calls “human phantoms”—or lab concoctions designed to have the same chemical make up as the human body. In the prototype, the tiny microchip with a tiny antenna is adhered to the outside of a pill with a biodegradable “sticker.” Once the pill hits the stomach, (or, in the lab, a solution with similar chemical make up), the microchip senses the change in surroundings. Drawing power from a small device—something like a watch or necklace—worn by the pill-taker, the microchip can then transmit information to an electronic device, such as a PDA or iPhone. “Once it’s energized it essentially replies back with a message that says, ‘Hey, I’m inside the stomach,'” Bashirullah says. And from there, the data could automatically be uploaded to a web database maintained by the researchers or physician’s office. “We’re developing an intelligent marker event technology. If you have that you can essentially exploit the internet and mobile infrastructure to really monitor whether people are taking their medication on time, or in the right dosage,” he says. After it had done it’s job, the microchip—which would be “much smaller than a grain of rice”—would simply leave the body through the digestive tract.

Bashirullah says that the technology currently used to print labels onto pills could be used to apply these microchip-containing stickers. And, based on the cost of producing RF (radio frequency) ID tags that are increasingly used on consumer products, he estimates that applying the microchips to medication would cost between 25¢ to $1.00 more per pill, a cost he says is “trivial” considering that pharmaceutical companies often spend some tens of millions on noncompliance.

The company formed in October of last year to take this technology beyond the lab is eTect, for whom Bashirullah is chief science officer. He estimates that a real-world product should be available within two years. If the product can improve compliance, he says, he’s hopeful that it could also save lives.

Yet, even as this technology is still being developed—and though it has yet to be tested in real humans—it already raises some serious ethical questions. Should it work, would a logical next step be to go beyond clinical trials and enable doctors to monitor whether their individual patients’ are taking medication as directed? Should children of the elderly be able to monitor whether mom and dad are taking their pills? “Some people are scared that it would be an invasion of privacy,” Bashirullah acknowledges. “We’re not there yet. We have to see what the potential benefits of the technology are. Once we see that, then we may see it move into the market,” he adds. And before it could come into widespread use, Bashirullah says ethical questions would have to be confronted. At the very least, “I’m sure it would require consent,” he says.

Yet, he’s quick to add, with a laugh, that while ethical considerations are important, it’s also worthwhile to acknowledge the limitations of technology. “You won’t have a satellite flying over you and checking whether you’ve taken your pills,” he says.