When the Food and Drug Administration approved in late 2017 a schizophrenia pill that sends a signal to a patient’s doctor when ingested, it was seen not only as a major step forward for the disease but as a new frontier of Internet-connected medicine.
Patients who have schizophrenia often stop taking their medicine, triggering psychotic episodes that can have severe consequences. So the pill, a 16-year-old medication combined with a tiny microchip, would help doctors intervene before a patient went dangerously off course.
Seventeen months later, few patients use the medication, known as Abilify MyCite. Doctors and insurance companies say it is a case in which real-world limitations, as well as costs, outweigh the innovations that the medical industry can produce.
In the case of schizophrenia patients, some doctors warn that Abilify MyCite could exacerbate the very delusions that the medication is designed to prevent.
“Patients who have a lot of paranoia might be uncomfortable with the idea of a medicine that is transmitting signals. The patient may be afraid to take it,’’ said Richmond psychiatrist James Levenson. “The science of this one is kind of ahead of the data.’’
The debate over Abilify MyCite underscores a dilemma American health care will increasingly face as the medical industry and Silicon Valley try to promote innovation. For decades, medicine has been effectively delivered through a few simple mechanisms: a pill, a cream, a nose spray, a needle.
But in the hopes of improving outcomes further, the industry is turning to an array of new technologies against one of the biggest, and most human, challenges in treating disease: getting people to take their medicine in a consistent way.
Companies are producing apps for substance abuse treatment, diabetes management, and heart and blood pressure monitoring at a rapid clip. Studies are underway for more digital pills to treat cancer, cardiovascular conditions and infectious disease.
And while many of these may pass regulatory hurdles that show they’re safe — especially at a time when the Trump administration has been leaning into medical innovation and pushing back against excessive regulation — doctors and insurers are not convinced that the technologies will so easily make the difference that the pharmaceutical industry is betting billions on.
“I think that these technologies have a lot of potential benefits, but it’s going to be a question of evidence — that they can demonstrate value to patients and payers,’’ said Scott Gottlieb, who stepped down this month as FDA commissioner, a job in which he made approval of leading technology a hallmark.
The first digital therapy to win FDA market clearance, Abilify MyCite’s sensor-embedded pill remains off the market because of physician and insurance industry reservations.
Now Maryland-based Otsuka Pharmaceutical, which makes the medication, may be able to jump-start its acceptance by offering it to mentally ill people who qualify for low-income government health insurance. Otsuka won approval from Virginia Medicaid authorities last month to begin coverage. The company also is starting a pilot program in Florida and is considering another in Oklahoma.
Otsuka considers itself a pioneer. Abilify is an older brand-name drug marketed by the company to treat schizophrenia and other serious mental illnesses. Abilify MyCite adds the electronic tracking component and, at $1,650 a month, costs almost 30 times as much as a 30-day supply of generic Abilify at a Costco pharmacy.
Otsuka developed the treatment with Proteus Digital Health, a Silicon Valley company that markets the digital component. Proteus is pioneering its use in other therapies including cancer patients taking chemotherapy drugs.
After the daily antipsychotic pill is swallowed, a digital sensor the size of a grain of sand (and made of copper, magnesium and silicon, which Proteus says are all found in food) transmits a signal when it comes into contact with stomach acid. The signal is captured by a patch worn on the patient’s torso. The patch sends a signal to an app on the patient’s smartphone. The app uploads data to a secure website for viewing by doctors. Otsuka has won special federal approval to provide smartphones “with highly limited functionality’’ to people who can’t afford them.
The goal is to solve a vexing problem: Schizophrenia patients often stop taking their medicine, triggering psychotic episodes that can have severe consequences. Abilify MyCite is supposed to help doctors keep track of which patients are staying on their medication. The app also allows patients to enter information about their mood.
The approval led to debate among psychiatrists about the ethics of invasive monitoring for patients whose mental competency at times may be borderline. They raised questions about patients’ autonomy, data privacy and ability to navigate the technical challenges of the system.
But proponents say the medical need is so great that Abilify MyCite deserves a close look.
Virginia state Sen. R. Creigh Deeds (D-Bath), who chairs a special mental health committee in the legislature, said he had not heard of the therapy until contacted by The Washington Post. But he said in an interview that he was intrigued by a technology that could help people like his mentally ill son, Austin “Gus’’ Deeds, 24, who slashed Deeds on the face in 2013 before taking his own life. Deeds said his son had stopped taking medication nearly a year beforehand.
“There is a need for people who are caregivers to make sure the person’s taking the medicine,’’ Deeds said. “The other side of it is the civil liberty issue for the person who is sick.’’
Gus Deeds thought his medications “made him less of who he was. It dumbed down his personality,’’ Deeds said. But, he added, “a person does not have the right to destroy their life, or the life of others.’’
He said he did not have an opinion on whether Virginia Medicaid should add Abilify MyCite to its list of approved prescription drugs.
Otsuka emphasizes that no patient will be asked to use Abilify MyCite without showing a clear desire to do so. Schizophrenia patients who have paranoid feelings about ingesting a digital pill are unlikely candidates for the drug, the company said.
“It’s unlike a pharmaceutical launch where you proactively blitz all the states. We’re not doing that,’’ said John Bardi, Otsuka’s vice president for public affairs and digital business development. “It’s really about patients who want to improve their treatment goals. If they have any concerns, it’s probably not the right solution for them.’’
Otsuka executives recently gave a presentation about the drug to the Virginia chapter of the National Alliance on Mental Illness, a patient advocacy group, said Rhonda Thissen, the chapter’s executive director. She praised its goal of keeping patients on their medication but said it raises many perplexing questions.
“There is the Big Brother factor in all of this,’’ she said. “My concern as an advocate is many people with schizophrenia are low income and on Medicaid. Is there a cost-benefit analysis that would indicate . . . the increased cost would be worth it?’’
The wave in digital medicine is raising similar value questions across the spectrum. With FDA approvals in hand, medical tech companies are looking for doctors and health-care networks to help them prove in the real world that their new products are worth the extra expense. These include manufacturers of smartphone apps for opioid addiction and diabetes, as well as an asthma inhaler that transmits data each time it is used. The FDA also has approved a program that uses artificial intelligence to help doctors spot strokes with increased speed.
Executives and analysts say the digital health marketplace is a bewildering Wild West to most consumers and physicians. In 2017, 318,000 mobile health apps were available worldwide, according to a government review; the majority have not been subject to rigorous FDA review.
In cases where software is paired with drugs and devices or it guides medical decision-making, the FDA has stepped in. It has cleared functions that require a prescription, such as Abilify MyCite, and those that don’t, such as Apple Watch’s latest heart monitoring functions.
Yet even FDA approval does not confer cost-effectiveness. Insurance companies are reluctant to offer coverage at this early stage, specialists said, particularly when trials that formed the basis of FDA clearance involved relatively few patients.
“There could be a series of unintended consequences. You have to be cautious with something that is so novel that is being brought out,’’ said a health insurance executive who spoke on the condition of anonymity to discuss internal coverage deliberations.
Aside from the fraught ethical questions, the FDA’s approval stopped far short of proving that Abilify MyCite meets its clinical goal. The only thing the agency approved was that the digital pill transmitted its signal and that most patients can manage the smartphone app. The product’s label explicitly states that the FDA did not establish whether it would help patients continue taking their medicine.
The South Florida Behavioral Health Network, which coordinates state payments to mental health treatment centers, has agreed to begin paying for the treatment.
Patients often do not reliably report whether they have been taking their medication; Abilify MyCite will give doctors data to help them make important decisions about care, said John Newcomer, president and chief executive of the network.
“If this is framed as yet another useful tool in the tool kit, to help you get back in control of your life, this ends up being an empowering thing for patients,’’ Newcomer said. “It’s another way to get them on the road to recovery.’’
Specialists who closely follow these advances say that consumers and doctors are in for a wave of such digital therapies and that it inevitably will be confusing.
“I think you’re seeing some growing pains,’’ said Steven Chan, a physician with the U.S. Department of Veterans Affairs in Palo Alto, Calif., who has expertise in telemedicine and health technology. “The FDA is trying to find ways to make a legitimate space but also a space where pharmaceutical manufacturers can innovate, to find new ways to deliver care.’’