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The era of digital medicine just got one step closer to reality. The U.S. Food and Drug Administration (FDA) has for the first time approved a digestible device – a sand-particle sized microchip that can be embedded in drugs to monitor patients’ response to treatment, according to a new report in Nature.

The device is currently only approved for use with placebos but Proteus Digital Health, which is developing the technology, hopes approval with other drugs will be forthcoming in the near future. Co-founder and chief medical officer for Proteus George Savage tells Nature the enhanced pills could be used to treat everything from drug-resistant tuberculosis to diabetes.

“The point is not for doctors to castigate people, but to understand how people are responding to treatments,” Savage tells Nature. “This way doctors can prescribe a different dose or a different medicine if they learn that it’s not being taken appropriately.”

So how does this digital pill work? The sensor itself is made of a tiny silicon chip containing trace amounts of magnesium and copper. When a patient swallows it, the pill generates slight voltage which responds to digestive juices. The voltage sends a signal to a patch worn by the patient, which transmits relevant information to a healthcare provider’s mobile device.

If that sounds like something out of a science fiction movie, get ready for a whole new world of healthcare. Nature reports similar technologies in the works include implantable devices that wirelessly inject drugs at pre-specified times and sensors that would deliver a patient’s electrocardiogram to their smartphone.

Would you feel comfortable ingesting a digital pill? Tell us what you thing of this medical breakthrough in the comments below.

Earlier this week, Proteus announced that they have been approved by the FDA to market their ingestible microchips for pills.

Generally, the FDA approval process for devices that are totally new like this is a painful one, with much suffering. So it is a big deal for anyone to get approved for anything.

But this is a far more important accomplishment than a mere incremental improvement. It is an entirely new kind of medical device and, most importantly, a whole new potential data stream on one of the most critical issues in the delivery of health care.

Modern drugs work wonders, but it does not help a patient if the patient does not take them. Historically, and I do mean the stone age here, the ability to consistently take pills correctly has been called “compliance.” But please do not call it that. Most participants in the movement for patient rights regard that term as paternalistic.

“Adherence” is a much more respectful term (although I have certainly heard it used in a paternalistic manner). In fact, as we progress, I should define that when I say “adherence,” what I mean is “adherence to a plan that belongs to the patient.” If a pill that I am taking makes me so sick to my stomach that I cannot take it any more, then when I decide to stop taking it, I am not being “non-compliant” or “non-adherent” to a medication plan; I have changed my medication plan, and I have yet to discuss the issue with my doctor.

Still, even for patients who want to consistently take their pills according to a plan, it can be extraordinarily difficult. It is hard to remember when a pill has been taken. It is hard to remember to pick up a new supply or to call for a renewal. It is easy to forget pills on trips and run out unexpectedly far from home. Pills frequently must be taken with food, or without food, or with or without specific foods. They must be taken before bed or before breakfast. Personally, I have trouble remembering to take even a single pill consistently. But many people need to manage a tremendous number of pills, and they frequently go off one set of pills and onto another. In short, pill management is a huge mess, and it is difficult to organize anything.

The Proteus technology allows a person to wear a patch that can detect when any pill carrying a proteus microchip is swallowed. Using that patch and a wireless connection of some kind, it is pretty simple to enable all kinds of clever “take your pill UX.” With this technology, it will finally be possibly to reliably perform “quantified self” on pill regimes.

It is hard to imagine just how large of an impact this will have on the problem of pills, but “huge” is a conservative estimate. New systems will be able to have digital pharmacy dispensers in the home, which will enable schedules like “take one of these every 56 hours until you have taken 10, and then take one after that in a Fibonacci retracement.” Or complex sequences like “take A and B every two hours, take C every three hours, take D every other day and take E as needed but not more than once a day.”

This should not be taken to mean that this technology will be taking the thought out of taking pills. Instead, think of this as a mechanism to enable greater self-knowledge through numbers. Already, Proteus engineer Nancy Dougherty has demonstrated that the technology could revolutionize placebo research. Dougherty’s work is and should be utterly surprising and delightful, and it should also demonstrate that the potential uses for this technology are unlimited.

As with any game-changing tech, Proteus will have to make sure it uses its new super power for good.

 

This article was previously published at: squidoo.com

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