They are the ultimate in invasive surveillance: capsules containing digital sensors.
Dubbed ‘smart pills’ or ‘digital therapeutics’, they can track whether you’ve taken your medication, photograph your digestive tract and even measure the gas mix in your intestines.
Market researchers have tipped smart pill technology will spawn a global industry worth USD $7.5 billion by 2030.
That’s a brave prediction, particularly after lead player Proteus Digital, which investors valued at $1.5 billion in 2019 after nearly 20 years developing smart pill technology, was subject to a last-minute $15 million fire-sale to Otsuka Pharmaceuticals in 2020 after filing for bankruptcy.
Research and patent-filing around smart pills continues, however; a European study published in August assessing the global patent landscape for “digital pills with ingestible sensors” named Australia in the top five smart-pill patent holders worldwide, along with US, Canada, China and the European Patent Office.
The same study uncovered patents for 137 digital therapeutics (drug delivery) and 122 digital care products (typically mobile clinical monitoring and endoscopy diagnostics), with 25 of these already having regulatory and/or market authorisation in the US, Japan and Europe.
Digital therapeutic patents include smart pills to treat mental illness, HIV/AIDS, cardiovascular disease, diabetes, gastroenterology, oncology and tuberculosis and to control pain.
The appeal of smart pills is obvious: medication non-adherence is a global problem, with over 40 per cent of all patients with chronic conditions not taking medications as prescribed, causing a significant disease burden and economic impact.
Non-adherence is the main cause of relapse and hospitalisation among mentally ill patients, and one of the leading smart-pill applications Abilify MyCite combines the antipsychotic aripiprazole with a small, edible sensor that transmits information about the dose taken to a patch worn by the patient. The data is then sent via smartphone to clinicians or carers.
Genius or creepy? Or maybe both?
NYU bioethics professor Arthur Caplan weighs in on the ‘creepy’ side, warning that digital pills pose a medical privacy risk to vulnerable patients.
He says the Abilify MyCite ‘snitch pill’ will let third parties, including doctor, pharmacist, nurse, probation officer or all of the above, ‘snoop on you and nag you’ if you aren’t taking your psychiatric medicine pill as intended.
Despite the hype, smart pills are way less popular in the real world than in patent market research reports.
Smart pills have been around, and FDA-approved, for over five years – but they haven’t quite reached the dizzy heights that marketers predicted, and a French survey of 2250 respondents published earlier this year found that only 35 per cent of patients, and 16 per cent of health care professionals, would be willing to take digital pills.
Medical ethics professionals have questions. (Actually, we all do.)
A detailed stakeholder review of digital pills published by European academics just last week argues that current pill tracking systems are all about monitoring ‘compliance’ rather than ‘adherence’, and are incompatible with the best-practice Shared Decision-Making model.
Spanish writers de Miguel Beriain and Gonzalez point out that digital pills “might also diminish patient autonomy, reduce privacy, or promote inadequate use of pharmaceutical resources.” Sounds like it’s all a bit hard to swallow.
It’s a gas
But there’s one area where smart pills are making real headway; Australian research into ingestible electronic capsules that can sense different gases in the gut, could provide extraordinarily useful, early-stage information on chronic conditions like IBS.
Current methods for measuring digestive gas biomarkers involves breath tests, but gut gas concentrations are up to 10,000 times higher than those in the breath, and give far more direct and accurate information.
That’s where smart gut pills come in.
In 2017, a team from RMIT, Monash and CSIRO ran human trials of digestive gas measuring capsules powered by tiny batteries, containing with sensors for temperature, carbon dioxide, oxygen and hydrogen, along with a microcontroller and wireless transmission system to deliver results to a linked smartphone.
Fortunately, the gas trials were exciting enough to see investor follow-through.
Just last month, the ATMO Biosciences gas-sensing capsule (which has licensed the IP from RMIT) gained a US patent for technology which promises “tools to diagnose and manage functional gastrointestinal disorders (FGIDs) using its unique gas-sensing capsule platform, which provides insight into microbiome function.”
This is one smart-pill application where patients might be willing to trust their gut.