Have you taken your medication? Abilify MyCite could help doctors track patients' medication – or scare them.

When the Food and Drug Administration approved a schizophrenia pill at the end of 2017 that sends a signal to the patient's doctor when it is ingested, it was considered not only a major step forward for the disease, but also a new frontier for medicine connected to the Internet.

Patients with schizophrenia often stop taking their medication, which triggers psychotic episodes that can have serious consequences. Thus, the pill, a 16-year-old drug associated with a microchip, would help doctors intervene before a patient moves dangerously away from his or her path.

Seventeen months later, few patients use this drug called Abilify MyCite. Doctors and insurance companies say this is a case in which real-world limitations, as well as costs, outweigh the innovations that the medical industry can produce.

[Forget to take your medication? A new digital pill will alert you — and your doctor.]

In the case of schizophrenics, some doctors warn that "Abilify MyCite" could exacerbate the delusions that the drug is designed to prevent.

"Patients who have a lot of paranoia could be uncomfortable with the idea of ​​a drug that transmits signals. The patient may be afraid to take it, "said Richmond psychiatrist James Levenson. "The science of it is a little ahead of the data."

The debate on Abilify MyCite highlights a dilemma in the health sector in the United States as the medical industry and Silicon Valley attempt to promote innovation. For decades, medicine has been administered effectively by a few simple mechanisms: a pill, a cream, a nasal spray, a needle.

But in the hope of further improving the results, the industry is addressing a range of new technologies to combat one of the biggest and most humane challenges of treating diseases: getting people to take their medications coherently.

Companies quickly produce applications for addiction treatment, diabetes management, and blood pressure and heart monitoring. Studies are underway to increase the number of digital pills for the treatment of cancer, cardiovascular disease and infectious diseases.

And even though many of them can pass regulatory hurdles that show they are safe, especially at a time when the Trump administration is relying on medical innovation to oppose excessive regulation, Doctors and insurers are not convinced that the technologies will make so easily the difference that the pharmaceutical industry is betting billions.

"I think these technologies have a lot of potential benefits, but it will be a matter of evidence – that they can demonstrate value to patients and payers," said Scott Gottlieb, who resigned this month as FDA Commissioner, a position in which he made advanced technology an endorsement.

[With fitness trackers in the workplace, bosses can monitor your every step — and possibly more]

The first digital therapy to gain market approval by the FDA, Abilify MyCite's built-in sensor pill is no longer on the market because of the reservations made by doctors and insurance companies.

Today, Otsuka Pharmaceutical, of Maryland, which manufactures the drug, may be able to revive its acceptance by offering it to people with mental illness eligible for low-income public health insurance. Otsuka got approval from Virginia Medicaid authorities last month to start coverage. The company is also launching a pilot program in Florida and plans to launch another in Oklahoma.

Otsuka considers himself a pioneer. Abilify is an old branded drug marketed by the company to treat schizophrenia and other serious mental illnesses. Abilify MyCite adds the electronic tracking component and, at $ 1,650 per month, costs almost 30 times more than 30 days of generic Abilify supply 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 swallowing the daily antipsychotic pill, a digital sensor of the size of a grain of sand (composed of copper, magnesium and silicon, which according to Proteus, are all present in food) transmits a signal when & # 39; 39 he comes into contact with stomach acid. The signal is picked up by a patch worn on the patient's torso. The patch sends a signal to an application of the patient's smartphone. The application downloads the data to a secure website for viewing by physicians. Otsuka has received special approval from the federal government to provide smartphones "with very limited functionality" to people who can not afford to buy them.

[Apple now says its smartwatch app to detect atrial fibrillation is not for those with atrial fibrillation]

The goal is to solve a thorny problem: patients with schizophrenia often stop taking their medication, which triggers psychotic episodes that can have serious consequences. Abilify MyCite is supposed to help doctors determine the number of patients under treatment. The application also allows patients to enter information about their mood.

This approval sparked a debate among psychiatrists about the ethics of invasive surveillance in patients whose mental competence could sometimes be marginal. They asked questions about patient autonomy, data privacy, and their ability to handle technical problems with the system.

But proponents say the medical need is so great that Ableify MyCite deserves careful consideration.

Senator R. Creigh Deeds (D-Bath), of the state of Virginia, who chairs a special committee on mental health in the legislature, said that he had not not heard of the therapy before being 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 cut his face in 2013 before suicide. Deeds said his son stopped taking his medication almost a year ago.

"Caregivers need to make sure the person takes the medicine," Deeds said. "The other side is the question of the civil liberty of the sick person."

Gus Deeds thought his medication "made him less than what he was. It's his personality that has been botched, said Deed. But, he added, "a person does not have the right to destroy his life or that of others".

He added that he did not know if Virginia Medicaid should add Abilify MyCite to its list of approved prescription drugs.

Otsuka points out that no patient will be invited to use Abilify MyCite without clearly wanting it. Patients with schizophrenia who have paranoid feelings about the ingestion of a digital pill are unlikely candidates for the drug, the company said.

"It's different from a pharmaceutical launch in which we proactively blitz all states. We will not do it, "said John Bardi, Otsuka's vice president of public affairs and digital business development." It's really about patients who want to improve their treatment goals. " have concerns, it's probably not the right solution for them. "

Otsuka officials recently introduced the drug to the Virginia Chapter of the National Alliance for Mental Illness, a patient advocacy group, said Rhonda Thissen, executive director of the section. She praised her goal of keeping patients on medication, but added that this raised many troubling questions.

"There is the Big Brother factor in all of this," she said. "What worries me as an advocate is that many people with schizophrenia have low income and are under Medicaid. Is there a cost-benefit analysis that would indicate it? . . the increased cost would be worth it? & # 39; & # 39;

[Investigation of generic ‘cartel’ expands to 300 drugs]

The wave of digital medicine raises similar issues of value across the spectrum. With FDA approvals on hand, medical technology companies are looking for doctors and healthcare 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 for each use. The FDA has also approved a program that uses artificial intelligence to help doctors detect strokes at an increased rate.

Leaders and analysts believe the digital health market is a disconcerting Wild West for most consumers and doctors. In 2017, 318,000 mobile health apps were available worldwide, according to a government report. the majority has not been subject to rigorous review by the FDA.

In cases where the software is associated with drugs and devices or that it guides medical decision-making, the FDA intervened. It has erased functions requiring a prescription, such as Abilify MyCite, and those that are not, like the latest Apple Watch cardiac monitoring features.

However, even the approval of the FDA does not confer profitability. Insurance companies are reluctant to offer coverage at this early stage, experts said, especially when the trials behind the FDA approval involved relatively few patients.

"There could be a series of unexpected consequences. You have to be careful with something so new that is put forward, "said a health insurance official who spoke on condition of anonymity to discuss internal deliberations on the cover.

In addition to the many ethical issues, FDA approval has failed to prove that Alyfify MyCite is meeting its clinical goal. The only thing that the agency has approved, is that the digital pill has transmitted its signal and that most patients can manage the smartphone application. The product label explicitly states that the FDA has not established whether it will help patients continue to take their medications.

The South Florida Behavioral Health Network, which coordinates state payments to mental health treatment centers, has agreed to start paying for treatment.

Often, patients do not report reliably when they take their medications. Abilify MyCite will provide physicians with data that will help them make important decisions about care, "said John Newcomer, President and CEO of the network.

"If this is presented as another useful tool in the toolkit, to help you regain control of your life, it will end up empowering patients," said Newcomer. "This is another way to put them on the road to recovery."

Experts who are closely following these advances claim that consumers and physicians are ready to deal with a wave of such digital therapies and will inevitably be confusing.

"I think you see growth problems," said Steven Chan, a physician at the US Department of Veterans Affairs in Palo Alto, California, who has expertise in telemedicine and health technologies. "The FDA is trying to find ways to create a legitimate space, but also a space in which pharmaceutical manufacturers can innovate and find new ways to provide care."