martes, 12 de diciembre de 2017

Abilify MyCite, ethical questions...

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  • ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (wearable sensor); the MYCITE APP (a smartphone application); and web-based portals for healthcare providers and caregivers
  • The system records medication ingestion and communicates it to the patient and healthcare provider. In addition, it can collect data on activity level, as well as self-reported rest and mood which, with patient consent, can be shared with the healthcare provider and selected members of the family and care team
  • The system provides an objective summary of drug ingestion over time, to help enhance collaboration with healthcare providers who treat patients with certain serious mental illnesses (Más)

The ‘smart pill’ for schizophrenia and bipolar disorder raises tricky ethical questions

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.
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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. (Más)

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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