“S

mart 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.

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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.

Tia P. Powell, M.D., is director of the Montefiore Einstein Center for Bioethics and professor of epidemiology and psychiatry at the Albert Einstein College of Medicine.

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  • I couldn’t agree more with Dr. Tia Powell’s sensitive comments on the new Abilify MyCite Pill implanted with a tracking device. I would add a few more points and emphases to her concerns.

    First, I’d like to underscore the point that everyone in our society has the right to ingest what he or she chooses. Being coerced to put any substance in your body is tantamount to violence.

    Second, most psychotropic meds can take a significant physical toll on people who use them. Abilify is one of these. When we coerce someone to take this medication, we are pressuring them to ingest something that could seriously harm their body.

    Third, not only can MyCite pills lead to more coercive modes of treatment, they are clearly oriented towards a severe violation of a person’s right to privacy. They are a threatening, invisible form of surveillance.

    Fourth, coercion simply doesn’t work. Increasingly, we are finding that people get better in collaborative — not coercive – relationships. We see that people take their wellness into their own hands only when treated as partners in their care.

    Last, the notion that the brains of psychiatric patients remain permanently damaged without meds is more a hypothesis than a fully researched fact. That hypothesis can become a dangerous narrative, in which coercion is justified in the name of help.

    Over fifty years ago, French philosopher Michelle Foucault described how modern power is driven by surveillance. No longer do we punish bodies; rather, we discipline through our gaze. The ultimate example of this was the Panopticon, a tower in the middle of prisons in which guards, unseen by prisoners, watched everyone. Since that time, and in large part due to the effects of medicine (both positive and negative), we’ve seen a rapid emptying of our psychiatric hospitals, and a greater respect for the rights of psychiatric patients. The MyCite pill is a major step backwards in this process, and a giant step forward for the forces of coercion that remain. Each pill: a nano-Panopticon placed inside the body.

  • Unconscionable are the reasons this idea even came about. Why are people suffering from mental illness the ones who get to break new ground when it comes to something like prescription medication compliance. There are plenty of other diseases where the treatment drug side-effects are often worse than the ailment they treat: chemotherapy, MS, MD, COPD, asthma and diabetes. Why don’t we come up with a “fat pill” that will fill you up while having the tracking device in it so we can “involuntarily” mandate morbidly obese people stop overeating and being a drain on Medicare and Medicaid.

  • Professor Powell seems to be “looking a gift horse in the mouth”. Confirming compliance with a (presumably) patient-approved regimen, or identifying non-compliance with that regimen, are good things for patients and prescribing clinicians. I wonder if the good professor found ethical problems with the use of “Directly Observed Treatment” (DOT) of tuberculosis; a regimen instituted to decrease poor compliance, one of the causes of drug-resistant TB?

  • Interesting questions arise but coercion and compliance reporting are 2 very different things. Whether a device in a pill tells the treating physician there is non-compliance or the patient’s spouse tells the physician is unrelated to coercion and may help determine whether the treatment is efficacious or not desired by the patient, potentially avoiding additional, potentially harmful treatment. Where the medicolegal system draws the line between patient autonomy and self-determination and the loss of this autonomy for the protection of society and the patient… defining competency to decide ones fate in the context of psychosis… these are larger questions unrelated to a drug delivery device.

  • this article seems to overlook the fact that depot forms of antipsychotic medications have existed for many decades

  • There is absolutely no proof that episodes of psychosis damage the brain. The linked study doesn’t prove it and brain shrinkage, if it exists, is more likely due to the medications used to treat psychosis. Another point, not adequately addressed in this article is how anyone can justify forcing an individual to take a drug which has the extensive and serious side effects of the antipsychotics, including weight gain, tardive dyskinesia, akathisia, and reduced life span. In addition, there is doubt as to how effective the antipsychotics are and even if they help some people (most likely in the short term) does this mean everyone should take them? In my opinion this new drug is unconscionable.

  • I have the distinction of viewing this both from a clinical standpoint and a personal one, with an immediate neighbor who refused to take court ordered medication for schizophrenia prompted by a violent attack on his elderly mother and a hours long standoff with police. While I do support a patient’s right to chose, I also see the ramifications when they chose not to take medication and the court system is too overwhelmed to ensure compliance.

  • An unceasing regimen of medication does more harm than good.

    Only a punctuated (with rest) regimen can deliver the optimum good.

    (It is learning to punctuate (the response to) the disease that is the chief difficulty).

  • It seems like you either don’t need this medication or you don’t want this medication. How many people are willfully, but accidently taking the medication wrong?

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