Abilify With New Sensor: Useful Tool or Big Brother?
Whether Abilify MyCite can improve treatment adherence remains to be seen, but in the meantime the new technology is eliciting strong opinions from advocates and skeptics alike.
Psychiatrists who spoke with Psychiatric News are greeting the approval by the Food and Drug Administration of Abilify MyCite, an oral form of treatment for psychosis that has an embedded digital sensor that can monitor ingestion of the pill, with a range of opinions—from enthusiasm to stark skepticism.
“I think it’s a really positive development,” said John Torous, M.D., a member of APA’s Committee on Mental Health Information and Technology. “Developments in health care technology often bypass the most seriously mentally ill, but here we see a new technology that is being developed with patients who have the most severe forms of mental illness in mind.”
Abilify MyCite is approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults. A digital sensor embedded in the pill sends a message to a wearable patch when it is ingested; the patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone.
Patients can also permit their caregivers and physician to access the information through a web-based portal.
In an FDA press release, the agency acknowledged that the medication has not been proven to improve adherence, but advocates of the technology believe it can help promote communication between patients and physicians about their treatment.
“It’s a wonderful opportunity for the field of psychiatry to take a leadership role in a new and innovative treatment,” Torous said. “We’ve been handed this tool that may help improve medication adherence in a population with serious mental illness, so it’s up to us as a field to make the best use of it.”
For others, the approval of Abilify MyCite raises a host of questions about patient consent, privacy, autonomy, and control of personal information.
“It is important to start by noting that [Abilify MyCite’s] efficacy in improving rates of adherence, which is the purpose of embedding a sensor in a pill, is unproven,” past APA President Paul Appelbaum, M.D., told Psychiatric News. “Although in medicine we generally demand evidence of efficacy before adopting a new intervention, in this case such evidence is lacking. That might be of less concern if the potential downsides of pills with sensors were not so substantial.”
Although rates of nonadherence in patients with schizophrenia and bipolar disorder are known to be high, Appelbaum said this is most commonly caused by the fact patients deny the need for treatment or have concerns about side effects.
“Given that we don’t know whether the technology will actually improve adherence or what the negative consequences in general might be, piloting its use with a medication used for psychotic disorders seems very odd,” he said. “With paranoid patients often worried about being monitored or tracked, giving them a pill that does exactly that is an odd approach to treatment.”
Appelbaum, who is director of the Division of Law, Ethics, and Psychiatry at Columbia University, wondered whether a doctor who prescribes Abilify MyCite is communicating the message: I don’t trust you.
“We simply don’t know what the effect of that message will be,” he said. “I am concerned that asking many patients to let us track what they take and don’t take is not an innocuous intervention.”
Finally, Appelbaum raised the possibility of unforeseen uses that could be made of digital information. “In an era in which even the National Security Agency gets hacked, there are obvious concerns about patient privacy with a technology that communicates personal medical information,” he said. “The potential for this technology to be misused by judges and probation officers who may require offenders to use pills with sensors, and then respond punitively to the most trivial failure to adhere to the treatment regimen, is real.”
It’s About Promoting Dialogue
John Kane, M.D., who partnered with Proteus Digital Health (the maker of the digital sensor technology) in doing preliminary proof-of-concept research on the technology, emphasized the enormous role that treatment adherence plays in recovery from schizophrenia.
Kane, who is chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, said sharing of information gathered by the digital sensor is entirely voluntary, and added that the sensor technology could be especially useful in first-episode patients, for whom treatment adherence after initial recovery can be vital to their long-term trajectory.
In a paper published in June 2013 in the Journal of Clinical Psychiatry, Kane and colleagues reported the results of using the digital sensor technology in 12 patients with bipolar disorder and 16 patients with schizophrenia. (For the purposes of the study, the pill with the embedded sensor was not pharmacologically active.) A principle concern at the outset was whether patients who may have paranoid or persecutory delusions would be amenable to using a device allowing others to monitor their behavior.
Bioethics Panel Raises Patient Consent, Control of Data as Top Concerns
Craig Klugman, Ph.D., a professor who teaches ethics in the department of health sciences at DePaul University, was one of four bioethicists who served on an advisory panel to Otsuka, the manufacturer of Abilify MyCite. “We had a series of phone conversations and meetings with the company where we were presented with the product and given an opportunity to provide our concerns as bioethicists about what they were proposing,” he told Psychiatric News.
Klugman said members of the bioethics advisory group were paid hourly by Otsuka “for our time speaking with them and only with them.”
He added, “The bioethics advisory group was independent in thought and action. Each of us was ready to walk away if we felt that our concerns were not being addressed.”
A critical issue for the advisory panel was the language contained in the patient consent form. “We were very concerned that patients using this product were giving informed consent—that they were aware of the use that could be made of the data and aware of where data could go,” Klugman said. “We reviewed several different versions of the informed consent form and they changed the form on the basis of the concerns we raised.”
Patient control over use of information tracked by the digital sensor was also critical. “If patients just want to track their own ingestion of the medication, they can do that,” Klugman said. “If they are sharing the information with a third party and decide that they no longer want that information shared, they can stop. Every time a patient uses the medication he or she can opt in or out. At any time, the patient can get a non-MyCite prescription of Abilify or he or she can turn the app off on their phone.”
Klugman said that to his knowledge Otsuka has no current plans to expand the use of digital sensors beyond use in psychiatric conditions. But he said he sees promise in use of the technology by some populations, including seniors and patients with certain communicable diseases, which traditionally require direct supervision of antibiotic or other medications. “I think there are populations for whom this new technology could provide a new freedom,” he said.
Study results were positive. No subjects experienced worsening of psychosis due to use of the digital health feedback system (DHFS). Of the 27 patients who completed the study, 19 found the DHFS concept easy to understand, and 24 said they believed it would be useful.
“It’s not about Big Brother monitoring patients, but about a technology that can help facilitate discussion between a patient and psychiatrist,” Kane told Psychiatric News.
Past APA President Jeffrey Lieberman, M.D., was more cautious. “It’s hard to know how useful or innovative it is going to be,” he said. “No study has shown improvement in adherence or real cost benefit in terms of preventing relapse or rehospitalization. The hoped-for return on investment has yet to be demonstrated.”
Would he offer it to his own patients? “I would offer it, but I don’t know how well it is going to work,” Lieberman said. “Certainly, it is something that a clinician can make available, unless it is prohibitively expensive.”
Torous told Psychiatric News that amidst the tidal wave of new smartphone applications with little or no evidence to back their claims, the process of bringing Abilify MyCite to market—which included consultation with a bioethics advisory board—is an encouraging sign (see left). “Certainly, the process and the way [Otsuka, the manufacturer of the medication] went about this is so much different from what we are seeing in the mobile mental health space,” Torous said. “Some people may be jumping to negative conclusions because it is easy to confuse this with applications that aren’t proven, that don’t ensure privacy, and that don’t require a physician. This is a case where the FDA, researchers, and ethicists are trying to bring stability in the wild, wild west.” ■