A “digital pill” approved by the Food and Drug Administration could be the start of a new wave of ingestible technology.
The recently approved medication is a version of Otsuka Pharmaceutical’s Abilify–used to treat schizophrenia, bipolar disorder, and depression–with a safe-for-consumption electronic sensor inside the pill. When someone takes the pill and it reaches the stomach, the sensor sends an electrical signal through the body to a wearable, bandage-like patch. That patch then sends a wireless message to an app on the patient’s phone, recording that the dose was taken.
“What we’ve done is combined silicon and software and analytics on the backend with a pharmaceutical product,” says George Savage, cofounder and chief medical officer of Proteus Digital Health, the Redwood City, California, company that developed the sensor technology for Otsuka.
The goal is to let patients track their own doses and voluntarily share those records with their doctors–and, if they wish, with their relatives and caretakers. Only about 50% of patients actually take prescriptions as directed, even in developed countries, according to a widely cited estimate. That makes it difficult for doctors to know if patients who aren’t improving need different prescriptions or simply aren’t taking the intended dose.
“For the first time, physicians are going to know objectively whether their patients are taking their medications or not, and it really has the potential to make their care significantly better,” says Robert McQuade, chief strategy officer at Otsuka.
Your Digestible-Tech Future
In the future, as more sensor-enabled pills are approved, they could be used by patients taking medication for chronic conditions like diabetes and high blood pressure, who can see less-than-ideal gains if they get off their medication schedules. Proteus has also worked with researchers on early testing with infectious diseases, including the technology in pills to prevent HIV in high-risk patients and in the expensive medicines used to cure hepatitis C, which insurers are sometimes reluctant to approve for patients who they identify as not being likely not to adhere to treatment schedules.
Further down the line, patients might even routinely swallow pills embedded with different sorts of sensors to automatically track temperature and acidity levels inside the body, delivering real-time data to the patient or a doctor without the need for more invasive procedures or even a physician visit.
“The pill follows a certain trajectory within the body, and it could monitor anything from reactions to food you’re taking, monitor your diet, [even] help with losing weight,” says Asimina Kiourti, an assistant professor at the Ohio State University ElectroScience Lab who has written about the subject.
For now, the first smart pill, called Abilify MyCite, isn’t yet available. Otsuka is planning a small-scale rollout early next year with a limited group of doctors and insurers to track how patients respond to the sensor and app.
“The goal of this is to learn as much as possible in the real world as opposed to in the clinical setting or in sort of usability work,” says Andrew Wright, Otsuka’s vice president for digital medicines.
But the drug has already sparked controversy, with critics warning that patients could feel pressure from doctors, insurers, or others to take unwanted medication if the technology goes mainstream.
Peter D. Kramer, a psychiatrist and the author of Listening to Prozac, wrote in an opinion piece for Fortune that there’s “something creepy” about the pill, warning of a potential future where relatives, judges, or even employers can check whether patients take their medication.
Proteus CEO Andrew Thompson argues those fears are overblown. He emphasizes that the company has declined to work with institutions like prisons and mental hospitals where people could be compelled to wear the tracking patches without their consent.
“We have rejected the opportunity to work with those kinds of institutions because we don’t think that’s where these solutions should find their home,” he says. “All of this speculation about, ‘Let’s imagine all the bad things that could happen’ in my view is deeply displaced.”
Proteus has done promising studies of the technology by tracking other types of medication: kidney transplant patients taking antirejection drugs, tuberculosis patients who often have trouble keeping with medication, and hepatitis C patients with risk factors that make them more likely to not stick with the pricey medication that can cure their potentially deadly infection. One study of eight patients with high blood pressure found each had reduced blood pressure after two weeks of using the sensor with their regular medication.
In some cases, if patients miss a dose of medication, medical workers can even get in touch with them that same day to urge them to take their drugs. But even if patients don’t have constant access to a charged cell phone when they take their medication, the patch can report doses to a synched phone when it has a Bluetooth Low Energy signal or store dose records until the next time the patient goes to see their doctor.
Proteus has worked with other drug companies besides Otsuka, including Novartis, on some applications. And other companies have announced their own trial of smart pill technology.
“We certainly view this as a platform that eventually can apply across medicine,” Savage says. “The trick, of course, is which applications do you focus on first and what order.”
Getting approval to add Proteus’s sensors and patches, which are themselves FDA approved, to existing FDA-approved drugs should generally be a much simpler process than getting entirely new drug formulas approved, Thompson says. Otsuka first sought approval of Abilify MyCite in June 2015, and the FDA requested additional information last year before approving the drug on November 13.
Researchers at Proteus and its partner drug companies aren’t the only ones working on ingestible technology. An article set to be published in the December issue of the journal Anesthesia & Analgesia looked at using a similar pill-and-patch system from Gainesville, Florida-based etectRx to track opioid use in fracture patients. That company also announced in September its technology would be used in a study of adherence to HIV prevention medication.
And ingestible sensors may have uses beyond tracking whether people are taking their pills.
“Ingestible sensors have been out there for a while,” says Kiourti. “The first ones were about capturing pictures or video from the gastrointestinal tract.”
Those devices, called capsule endoscopy cameras, can be used in place of more invasive procedures like colonoscopies. And with increased coordination with wearable tech and commonplace devices like smartphones, there will be more opportunity for pill-based sensors that can be taken at home rather than in a doctor’s office. Recent studies have looked at how swallowable devices can best harness the body’s own chemistry to generate power as they pass through the digestive tract.
To Thompson, the technology opens up new possibilities for the pharmaceutical industry to take advantage of modern digital technology.
“There are obviously many different avenues in which this could now unfold,” he says. “What people should be confident about is that this is a new era in healthcare, where there is an opportunity for the pharmaceutical industry to integrate silicon and software into their toolkit.”