Have you taken your medicine? Abilify MyCite can help doctors follow the patient's medication – or scare them.

When the Food and Drug Administration approved late in 2017 a schizophrenic pill that sends a signal to the patient's doctor when taken in, it was not only seen as an important step forward for the disease, but as a new boundary for Internet-connected medicine.

Patients who have schizophrenia often stop taking the medicine, trigger psychotic episodes that can have serious consequences. So the pill, a 16-year-old medicine combined with a small microchip, would help doctors intervene before a patient went dangerous, of course.

Sixteen months later, few patients use the medicine, known as Abilify MyCite. Doctors and insurance companies say it's a case where real constraints, as well as costs, outweigh the innovations that medical industry can produce.

In the case of schizophrenia, warn some doctors that Abilify MyCite may aggravate the actual delusions that the medicine is designed to prevent.

"Patients who have a lot of paranoia can be uncomfortable with the idea of ​​a medicine that transmits signals. The patient may be afraid to take it," said James psychologist James Levenson. "The science of this is A little ahead of the data. "

The debate on Abilify MyCite emphasizes a dilemma US healthcare is increasingly meeting the facial industry and Silicon Valley is trying to promote innovation. For decades, medicine has been delivered effectively through a few simple mechanisms: a pill, a cream , a nasal spray, a needle.

But in the hope of further improving the industry, the industry is facing a number of new technologies against one of the biggest and most human challenges in treating disease: Get people to take the medicine consistently

Businesses produce apps for the treatment of intoxicants, diabetes care and cardiac and blood pressure monitoring at a rapid rate. After all, cardiovascular conditions and infectious diseases.

And while many of these can pass regulatory hurdles that show they are safe – especially at a time when the Trump administration has embarked on medical innovation and pushing back against excessive regulation – doctors and insurance companies are not convinced that the technologies are It will easily make the difference that the pharmaceutical industry boasts billions.

"I think these technologies have many potential benefits, but it can be a matter of evidence – that they can show value to patients and payers," said Scott Gottlieb, who resigned this month as an FDA commissioner , a job in which he approved leading technology as a hallmark.

The first digital therapy to win the FDA market study, Abilify MyCite's sensor-built pill is still out of the market due to the medical and insurance reserve

Now, Otsuka Pharmaceutical, based in Maryland, has a medication that can start their acceptance by offering it to mentally ill people who qualify for low-income insurance. Otsuka won approval from the Virginia Medicaid government last month to begin coverage. The company also launches a pilot program in Florida and is considering another in Oklahoma.

Otsuka considers himself a pioneer. Abilify is an older brand name marketed by the company to treat schizophrenia and other serious mental disorders. Abilify MyCite adds the online tracking component and costs nearly $ 1,000 a month, nearly 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 groundbreaking for use in other therapies, including cancer patients taking chemotherapy.

After the daily antipsychotic pill is swallowed, a digital sensor is the size of a grain of sand (and made of copper, magnesium and silicon, as Proteus says is all that is in food) transmits a signal when in contact with gastric acid. . The signal is trapped 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 site for physician viewing. Otsuka has won special federal approval to provide smartphones with very limited functionality to people who cannot afford them.

The goal is to solve a worrying problem: Schizophrenia patients often stop taking the drug, trigger psychotic episodes that can have serious consequences. Abilify MyCite will help doctors keep track of which patients are on the 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 who often have mental competence. They raised questions about the patient's autonomy, data security and ability to navigate the technical challenges of the system.

But assumptions say that the medical need is so great that Abilify MyCite deserves a close look.

Virginia State Sen. R. Creigh Deeds (D-Bath), responsible for a special mental health committee in the law, said he had 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, Austin "Gus & # 39; Deeds, 24, who slashed Deeds in the face in 2013 before taking his own life Deeds said his son had stopped taking the medication almost a year beforehand. "" There is a need for people who are caregivers to make sure the person is taking the medicine, "said Deeds." The other side of it is civil liberty problem for those who are ill. "

Gus Deeds believed his medication" made him less of who he was. It dumbed down his personality, & # 39; & # 39; So then. But he added, "a person is not entitled to destroy his life or the life of others."

He said he had no opinion about Virginia Medicaid should add Abilify MyCite to his 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 taking a digital pill are unlikely candidates for the drug, the company said.

"It's different from a pharmaceutical launch where you proactively blitz all states. We don't," 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. If they have any concerns, it's probably not the right solution for them. & # 39; & # 39;

Otsuka leaders recently presented a presentation on the substance of the Virginia chapter of the National Alliance on Mental Illness, a patient-telling group, said Rhonda Thissen, chapter chief executive. She praised her goal of keeping the patients on medication, but said it claims many confusing questions.

"That's the Big Brother factor in all this," she said. "My concern as a lawyer is that many people with schizophrenia have low incomes and on Medicaid. Is there a cost-benefit analysis that will indicate … the increased cost would be worth it? & # 39; & # 39;

The wave of digital medicine raises equal issues across the spectrum, with FDA approvals in hand, medical tech companies are looking for doctors and health professionals to help them prove in the real world that their new products are worth the extra expense. Smartphone application manufacturers for opioid addiction and diabetes, as well as an asthma inhaler that transmits data every time it is used. The FDA has also approved a program that uses artificial intelligence to help doctors spot increased speed.

Managers and analysts say it Digital Health Market is a confusing Wild West for most consumers and doctors, and in 2017, 318,000 mobile health applications were available worldwide, according to a government Ngen's review: The majority have not been subject to strict FDA review.

In cases where software is mated with drugs and devices or it controls medical decision-making, the FDA has entered. It has cleared features that require prescription, such as Abilify MyCite, and those who don't, such as Apple Watch's latest heart monitoring features.

Although FDA approval does not provide cost-effectiveness. Insurance companies are reluctant to provide coverage in this early phase, said specialists, especially when trials that form the basis of FDA clearance involved relatively few patients.

"There may be a number of unintended consequences. You have to be careful of what is so novel that is being brought out," said a health insurance director who spoke on condition of anonymity to discuss internal coverage processes.

Apart from the full ethical issues, the FDA endorsed far from proving that Abilify MyCite fulfills its clinical goal. The only agency approved was that the digital pill sent its signal and that most patients can manage the smartphone app. says the FDA did not find out if it would help patients continue to take the medicine.

South Florida Behavioral Health Network, which coordinates state payments to psychiatric treatment centers, has agreed to start paying for the treatment.

Patients often do not report reliably if they have taken the medicine Abilify MyCite will provide army data to help them make important decisions org, says John Newcomer, president and CEO of the network.

"If this is framed as another useful tool in the toolkit, to help you get back in control of your life, this ends up being an empowering thing for patients," Newcomer said. "There is another way to get them on their way to recovery."

Specialists who follow these advances say that consumers and doctors are in the midst of a wave of such digital therapies, and that it will inevitably be confusing.

I think you see some growing pain, says Steven Chan, a US Department of Veterans Affairs doctor in Palo Alto, California, who has telemedicine and health technology expertise. "The FDA is trying to find ways to create a legitimate space, but also a space where pharmaceutical manufacturers can innovate to find new ways of providing care."

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