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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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Comments on this entry are closed.

  • greta andries February 4, 2018, 12:55 AM

    in regards to yr article i concur that it is an extremely tricky ethical question however consider this real life case: a young man (17yrs old) had a schizophrenic episode. His mum took him to the Mental Health Department of the hospital. However the facility triage closed at 6pm so mum took him to the Emergency Department. He became more and more agitated as was certain other people in waiting room were out to get him so after an hr they left (was a busy night in ED). Consequently she took him home. A short while later he knifed his mum, his dad and his sister. Mum didn’t make it. Now said young boy (who when taking his meds was totally placid) spends the rest of his life in a mental health institute. His sister survived but will never ever forget and to this day still cannot manage to go and visit him. Dad will never see his wife again and will have to live with this nightmare forever, he does however visit his son. We are a small community so all the young ones have had to come to terms with this and even though i am a nurse i have found it incredibly difficult to offer real solitude to my daughter who was a regular visitor at their house. So many lives destroyed and this includes the life of the boy (as he could not do anything about being in a psychotic episode). So where lies the guilt or shall we simply ignore these facts as they end up in the too hard basket? Ideologically i so totally agree people to stand up for the rights of minority groups but if one has the inability to control a psychotic episode due to not taking their meds (i concur they do make them feel like they are not themselves) where are the rights of the innocent victims? And lets not forget that now the boy is in a psychiatric facility instead of enjoying his life.
    What does that actually mean true respect? Let be what is? and yes i do agree mental health illness is definitely not something you would want to wish on anyone and most definitely do not judge. However we also have to be realistic and realise that the daisy fairy attitude doesn’t get society anywhere either nor are you actually helping the person with the mental illness. It is a wonderful example of the lady that managed her schizophrenia but reality is that not many people are as strong as her nor do they have the ability of insight so what happens then? Each case is different and should be treated differently. So yes, in the case of the lady that did manage her schizophrenia by all means it would be a lack of respect to even ask her to consent to taking the pill. Maybe the solution would be that research and pharmacology companies should be working explicitly to try and minimise the side effects of the meds (which are numerous) which most definitely would see an increase in compliance by schizophrenic/bipolar pts.