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A ‘Smart Pill’ for Schizophrenia and Bipolar Disorder Raises Tricky Ethical Questions

Editors’ Note: This article originally appeared in STAT on Dec. 5, 2017.

blue capsule in woman's hand“Smart pills” that can track whether or when you’ve taken your medication might be helpful for some people. Unfortunately, the first smart pill approved by the Food and Drug Administration, Abilify MyCite, is a drug used to treat schizophrenia and bipolar disorder. That raises tricky ethical issues.

Decades of research and clinical experience support the fact that not taking medicines as prescribed is a significant problem across all domains of medicine. Smart pills might help people with memory problems, or those with diabetes, heart failure, or other medication-dependent conditions who want to do a better job of sticking with their prescribed regimens.

There’s no question that mental illness kills people and shortens lives, and that medications can be helpful. The World Health Organization identifies mental illness as a major contributor to the global burden of disease. Episodes of psychosis, which are common among individuals who do not take appropriate psychiatric medications, put them in additional danger by actually damaging the brain and increasing the risk of their harming themselves or others.

Sticking to a medication regimen is as important for people with mental illness as it is for those with physical illness. But what makes Abilify MyCite, a high-tech version of aripiprazole, problematic is that it could easily be incorporated into forced treatment, which ignores the values and preferences of people with mental illness. Involuntary treatment has a long and painful history in mental health. Without their consent, people with mental illness can be committed to inpatient or outpatient treatment, and sometimes forced to take medications. Only in the 1970s did the U.S. Supreme Court first address the lack of rights for people hospitalized against their will.

Though common, treatment in spite of objection may be appropriate to protect both the patient and the community. Clinicians and patients struggle to find the right balance of safety and autonomy.

One of my heroes, University of Southern California law professor Elyn Saks describes her personal struggle with schizophrenia and its treatment in her powerful memoir, “The Center Cannot Hold.” The book chronicles her efforts not only to find the right medication regimen but also to overcome her resistance to taking medication. She stresses that for any treatment to succeed, clinicians must engage and respect patients and collaborate with them. The best medicine in the world won’t work if the patient doesn’t take it.

The new pill falls right into this struggle. Manufacturers assure us that patients will consent to using it before taking the pill and its tracking device, a tiny bead embedded in the pill. But this smart pill has an obvious allure in the legal arena. For patients with court-ordered treatment or other involvement in the courts, “consent” takes on a different meaning if exchanged for freedom, child custody, or a lighter sentence.

I would bet that people will look for ways to outsmart the tracking mechanism. Perhaps the makers of this expensive new pill worked hard to foil tricks for disabling the tracker. An innovation I’d rather see would be one that builds trust and collaboration between people with serious mental illnesses and their capable clinicians.

We need to take a hard look at the risks and benefits of Abilify MyCite. It may help some people take their medications as prescribed, but it could also serve as a high-tech form of coercion in psychiatric care. If this new drug is to improve the treatment of people with schizophrenia and bipolar disorder, there needs to be a careful consideration of exactly who will benefit and who could suffer.

Abilify MyCite was approved without any directions for its ethical use. I believe that a panel of clinicians and consumers should be convened to create such ethical guidelines. That panel must include those for whom this drug might be appropriate — people diagnosed with schizophrenia and/or bipolar disorder.

True progress in psychiatric care includes real respect for those who struggle with mental illness, not just a new way to force treatment upon them.

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Tia Powell, M.D.

Tia Powell, M.D.

Dr. Powell is director, Montefiore Einstein Center for Bioethics and Master of Science in Bioethics. She holds the Dr. Shoshanah Trachtenberg Trackman Faculty Scholar Chair in bioethics, and is professor, epidemiology and psychiatry at Einstein.

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