If you find it hard to remember to take your medicine, you are not alone – and you are doing yourself no favours. Research in the United States has shown that half of all medication issued for chronic conditions isn't taken as prescribed, leading to about 125,000 deaths, 10 per cent of all hospitalisations and a bill for the US health system of as much as US$290 billion (Dh1.07 trillion) every year.
Small wonder, then, that healthcare firms are scrambling to bring high-tech solutions to market. But if you are still coming to terms with the world of "wearables" – healthcare apps and sensors designed to monitor exercise routines and vital signs, including heart rate, temperature and blood pressure – brace yourself for the next big thing: "swallowables".
Last month, the US Food and Drug Administration approved the first "digital pill", a tablet embedded with a tiny sensor that tracks when and if patients have ingested their medication. The technology also has the potential to measure activity, such as the number of steps a patient takes and their heart rate, in some future applications, which means that swallowables could actually replace wearables.
Proteus Discover, the technology at the heart of the Abilify MyCite system, has been developed by Californian company Proteus Digital Health. It comprises an ingestible sensor, a wearable sensor patch, a mobile-device app and an internet portal.
The sensor, a silicon circuit sandwiched between thin films of copper and magnesium (all elements found in food), is about the size of a grain of sand. Activated and powered up by contact with stomach fluid – "like a potato battery", the company says – it transmits a message to the smart patch, worn by the patient, which in turn forwards it via Bluetooth to a smartphone app. With the patient's permission, caregivers and doctors can also access the information online. Job done, the sensor is digested and passed from the body.
The Abilify MyCite system has so far been approved for use only with aripiprazole, an antipsychotic drug used to treat schizophrenia, bipolar I disorder and, as a secondary treatment to other drugs, major depressive disorders. Clearly, it is a breakthrough for such patients, for whom compliance with medication regimes is crucial, but can often be a struggle. The system, as Proteus says, “has been designed for the individual with serious mental illness to allow them to record their daily medication intake and have a more informed dialogue with their healthcare team”. But it won’t be long before patients with a wide range of chronic conditions will be swallowing high-tech pills.
Abilify MyCite is a joint venture between Proteus and Japanese pharmaceutical company Otsuka. Robert McQuade, Otsuka America Pharmaceutical's US executive vice president and chief strategic officer, says the company sees plenty of potential for the technology in other clinical fields.
“People ask us: ‘Why mental health first?’ And it’s because adherence is such a major issue in the treatment of serious mental illness,” he says. “But adherence to treatment is a problem around the world in many diseases. We do think it has potential with other products and we are looking at some that are still in the development stage.”
For years, research has found that significant numbers of patients with serious conditions, including cancer, diabetes, chronic obstructive pulmonary disease and heart disease, fail to take their medicine as prescribed, despite potentially fatal consequences. Proteus, which developed the digital-pill technology, is already targeting some of these clinical areas in trials. "Digital medicines, medications that communicate that you've taken them, have the potential to help people with many health issues," says David O'Reilly, Proteus's chief platform officer.
Trials with patients being treated for conditions including raised cholesterol levels and high blood pressure have already found that combining medication with Proteus Discover technology improves outcomes. Interim findings presented at the annual meeting of the American College of Cardiology last year showed that patients taking digital pills saw greater reductions in blood pressure and cholesterol. In a 12-week trial involving 96 patients, 85 per cent of those taking digital pills achieved a lowered blood pressure, against 33 per cent of those on normal medication.
In addition to hypertension and cholesterol, Proteus envisages a role for digital medicines in the treatment of diabetes, hepatitis C, HIV and more. “In the future, we see digital medicines becoming mainstream to help patients achieve their health goals who have many different health issues, such as cancer or opioid addiction,” O’Reilly says.
Some experts caution that simple forgetfulness is not the only reason patients fail to take their medicine, and that digital pills should not be seen as a golden-bullet solution to non-compliance. “For conditions where there’s a threat to public health that can be mitigated with high adherence – for example, easily transmissible diseases with a high burden of illness, but with an effective and safe drug – such technologies might be useful,” says Meera Viswanathan, director of the RTI-UNC Evidence-based Practice Centre, an independent non-profit research institute based in North Carolina. But, she says, “non-adherence arises from many issues [and] the nature and consequences of non-adherence can vary by clinical condition, so addressing the problem will require many types of solutions”.
In health systems that are not free at the point of delivery, cost is likely to be the main barrier, she says. “The premise for these technologies is that patients have affordable access to healthcare and to the drug. For a range of chronic conditions, that may not be the case. In those instances, reducing the costs of medications should serve as the starting point for improving adherence, although more interventions to address other constraints or behaviours might also be needed.”
In an age of widespread fears about digital security and privacy, concerns have also been voiced about connecting patients so intimately to the internet. When the New York Times reported the FDA decision last month, its headline focused on "worries about biomedical Big Brother", and it quoted experts who feared the potential for coercing vulnerable patients into being remotely monitored.
Otsuka says that it recognises such concerns as entirely valid, which is why it took the “extraordinary” step of assembling an independent team of bioethicists to monitor development of the technology.
"We wanted to make sure we fully understood the potential for any ethical concerns well in advance of even making it through the FDA process," says John Bardi, vice-president of digital medicines business development for Otsuka America Pharmaceutical. "They worked very closely with the team as they went through different elements of what this product system was going to be." Everything about the product, McQuade says, "is driven by the consent of the patient, so if the patient doesn't want it, they don't get it – they get a normal tablet without the sensor in it. This is all about establishing a therapeutic relationship between a caregiver and a patient, and they both have to want to participate in that partnership."
Digital pills are here to stay, and Proteus is not the only company in the field. The Veloce Corporation of Denver, Colorado, is developing an ingestible wireless capsule that can be activated by a remote trigger or a monitored condition to release drugs at specific times or sites inside the body. The SmartTab Drug Delivery and Monitoring System, Veloce says, will “optimise patient outcomes, significantly increase prescription drug adherence, and drastically reduce healthcare costs”.
Though novel, in a sense there is nothing new about the digital pill, which has its roots in space-age technology developed almost 30 years ago by Nasa, in partnership with Johns Hopkins University. The Ingestible Thermal Monitoring System was a small capsule, loaded with wireless signal transmission telemetry, micro-miniaturised circuitry, sensors and batteries, designed to monitor the body temperature of astronauts. The device came down to Earth and became commercially available in 1988; it has since been used to monitor core temperature and prevent heat stroke in people taking part in a range of specialised, heat-sensitive activities, including sport, firefighting and the military.
Abilify MyCite will be brought to market next year, at a price yet to be fixed and, at first, within a limited number of US health plans. But global roll-out will follow quickly and many patients, with many conditions, could soon find themselves faced with the choice of taking their medicine with a side order of wireless technology.
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