The first medical pills date from the ancient Egyptians and, apart from the ingredients, not much has changed ever since: you just swallow them and hopefully they're good for what ails you. But now revolutionary tech-enabled pills are helping doctors and patients in new ways.
One of the biggest problems for traditional pills is something call adherence: that is, how often patients actually take the medication in the way the doctor advised. It's thought that levels of adherence may be around 50%: in other words, around half of patients take the medication at the wrong time, or wrong dose, or don't take it all.
A new generation of tech-enabled pills is aiming to help measure adherence in people taking medicines regularly. When the patient swallows the pill and it hits their stomach, the acid environment activates the pill's onboard sensor. The pill then signals to a wearable patch or lanyard that the medication has been taken.
The first sensor-packing pill to be approved was Ablify Mycite, which contains aripiprazole, a medicine for psychiatric conditions like bipolar disorder and schizophrenia. Mental health conditions like these can make it difficult to keep on top of taking medications regularly and the consequences of missing doses can be serious. When Ablify Mycite is swallowed, the pill's sensor communicates that status via Bluetooth to a chest-worn patch, which then lets a smartphone app know the pill was taken. The system can also be used to record other factors, such as the user's activity and rest times. Data gathered by the system can be for the user's own information, or shared with their doctor or caregivers such as family or friends. While Ablify Mycite is the best known use of digital pills for tracking medication adherence, other companies are experimenting with their use in other patient populations.
There are challenges to digital pills, however: they cost far more than their non-tech-enabled counterparts, and there are questions over whether they actually improve adherence rather than just monitoring.
Privacy and security issues remain, too: people may feel uncomfortable sharing their levels of adherence with caregivers or with authorities.
With digital pills, "there's actually digital data that exists about whether you've taken the medication or not, and so there are questions about who might gain access to that data besides your healthcare provider," says Mary Lee, author of policy thinktank RAND Corporation's recent report on the Internet of Bodies.
This in turn can potentially lead to further tricky questions. "If your insurance company is paying for this expensive pill will they stop paying for it if you're not compliant?" Lee asks.
Some of these challenges, at least, can be addressed with standard good medical and technological practice.
Doctors will need to make sure patients can provide informed consent to the use of digital pills in the same way as they would to other medical interventions, according to Professor Theodoros Arvanitis, director of the University of Warwick's Institute of Digital Healthcare. "If patients take these, they understand they need to communicate their information to the healthcare professionals," he says.
"I don't see it as an issue of privacy, so much as a matter of communication between the clinician and the patient. In terms of making sure that the technology, the telecommunications, and the way the information is transmitted, is secure, it's the same as in any digital health intervention. Appropriate security and privacy assurances should be made for [digital pills], I don't see it as a different exercise."
Smart pills aren't only being used for drug adherence: they're also being used as a way of tracking health or disease, too.
Pills containing onboard sensors have a relatively long history: a swallowable sensor in pill format, created by NASA, has been used to help athletes track their core temperature for almost 15 years.
Experimental sensors are also being developed to detect disease – from the inside. MIT researchers have created a pill containing a sensor that can pick up intestinal bleeding, for example. The sensor contains bacteria that respond to a compound called haem, found when there's blood in the gut, by emitting light. That light then triggers a wireless signal that can be picked up by phone or computer. MIT researchers also more recently created sensor-containing pills that, when swallowed, are made of hydrogels that swell to the size of a ping pong ball in the gut. That way, rather than passing straight out of the stomach, the ball-sized ingestible sensors can remain in situ for longer and keep tabs on the gut for a greater time. (The pill can be shrunk back down to the right size to pass out of the body when the user swallows a solution of calcium).
Perhaps the smartest of smart pills is the PillCam: a swallowable camera that can film the inside of the gut all the way from top to bottom. The PillCam is a pill-sized camera that, once swallowed, takes photos of the patient's bowels as it travels through the gut. A data recorder worn on the patient's body picks up the feed from the pill wirelessly.
And it's not just the doctor that reviews the images that PillCam takes: there's an AI keeping an eye on them, too. As the PillCam journeys through the bowels, the AI spots when it's at rest and slows down the frame rate and speeds it up when it's in motion, to make sure nothing is missed and extraneous data isn't being gathered. And, having taken thousands of images, the AI picks out the most important ones that the doctor needs to review to come up with a diagnosis.
PillCam not only allows doctors to visualize parts of the bowel they can't with traditional endoscopies and colonoscopies, it's also easier on the patient: the swallowable camera doesn't need the same sedation as endoscopies, they're not painful or uncomfortable, and patients don't need to spend the same amount of time in the doctor's office or hospital.
With that in mind and against a background of increased telehealth use due to the COVID-19 pandemic, Medtronic recently got emergency FDA approval to offer PillCams for use remotely. Instead of coming into the hospital to take the pill, the patient can ingest the jellybean-sized capsule at home. Once the decision to have a capsule endoscopy is taken, the doctor can order one from Amazon (yes, really), have it dispatched to the patient's home, and then arrange a remote consultation for the gastroenterologist to talk the patient through the process. So far, 20 patients in the US have done their capsule test at home.
"The patient is able to get the diagnosis without any visit [to the hospital] or any move from home, which is pretty amazing. That's actually where I think our team needs to focus in the future and where we believe that we should be able to bring this technology eventually… We'd like to collect a little bit more data and ask for a 510k [premarket clearance given by the FDA to use the product in new ways] in the USA, so we can also use this technology as an option at home," Giovanni di Napoli, president of Medtronic's gastrointestinal (GI) business, said.
At the moment, the PillCam is typically only offered once someone's already had an upper and lower endoscopy – procedures that are pretty unpleasant for the person that has to undergo them – that haven't thrown up the cause of their symptoms such as suspected intestinal bleeding. Medtronic is hoping that eventually the PillCam endoscopy will become the first-line way for medics to investigate such symptoms and the tests will increasingly be offered remotely.
"It is really the way that we see the future... imagine if you can get this technology at home as well. You swallow the capsule, go about your day and it screens your esophagus, your stomach, and you don't need to be in an endoscopy suite with any anesthesia. I think that's where we have to aspire to be as a company and also for our patients. Now, having said that, it is going to take some time, I'm sure because there are many different issues that we need to solve before that. But that's the goal for all of us," di Napoli said.