01/16/18

Biomedical ‘Big Brother’

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The FDA approved a new pharmaceutical product that combines technology and medication: Abilify MyCite, “the first drug in the U.S. with a digital tracking system.” The pill contains a sensor that tracks whether or not a patient has taken their medication. The pill’s sensor sends a message to a wearable patch, which then transmits the information to a mobile app, enabling the patient to track their ingestion of the medication on their smart phone. Patients can also “consent” for others to access the information through a web-based portal. As more than one person observed, the old hide-the-pill-under-your-tongue trick doesn’t work with the new technology.

Science Alert said the sensor, called an Ingestible Event Marker (IEM) is about the size of a grain of sand. It’s made of safe levels of copper, magnesium and silicon.  When the pill and IEM are swallowed, stomach acid activates the sensor, which sends an electrical signal to the patch. “The patch records the date and time the pill was ingested, and relays this information to a smartphone app.”

A New York Times article on the approval, “First Digital Pill Approved to Worries About Biomedical ‘Big Brother,’ noted where experts estimate nonadherence or noncompliance with medications costs about $100 billion per year. Much of that cost is said to be due to patients getting sicker and needing additional treatment or hospitalization. Dr. William Shrank said: “When patients don’t adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly.”  Ameet Sarpatwari said while the pill has the potential to improve public health, “If used improperly, it could foster more mistrust instead of trust.”

The IEM could be used to monitor medication compliance with post-surgical patients or for individuals required to use a digital medication as a condition for release from psychiatric facilities. “Asked whether it might be used in circumstances like probation or involuntary hospitalization, Otsuka officials said that was not their intention or expectation, partly because Abilify MyCite only works if patients want to use the patch and app.”

Nevertheless, Abilify was said to be an unusual choice for the first sensor-embedded medication. As an antipsychotic or neuroleptic, Abilify is approved for treating schizophrenia, bipolar disorder and as an adjunct for major depression. Some of these individuals may have delusions or become paranoid about their doctor or what the doctor intends. How receptive will they be to using a system that monitors their behavior and then potentially signals their doctor?

Dr Paul Applebaum of Columbia University’s psychiatric department said: “You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.” Dr. Jeffrey Lieberman said many psychiatrists will likely want to try Abilify MyCite, but it has not yet been shown to improve medication adherence. “There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.”

Many patients aren’t compliant with neuroleptics because of the side effects. These side effects can include: weight gain, diabetes, pancreatitis, gynecomastia (abnormal breast tissue growth), hypotension, akathesia (a feeling of inner restlessness), cardiac arrhythmias, seizures, sexual dysfuntion, tardive dyskinesia, anticholinergic effects (constipation, dry mouth, blurred vision, urinary retention and at times cognitive impairment). For more on the adverse effects with Abilify and other antipsychotics, see (“Abilify in Denial,” “Broken Promises with Abilify,” “Antipsychotic Big Bang,” “Wolves in Sheep’s Clothing,” and “Downward Spiral of Antipsychotics”).

Otsuka, the pharmaceutical company with the patent rights to distribute Abilify MyCite, has not set a price for the drug yet. Although Abilify alone is now off patent, Otsuka will have a new patent time frame for Abilify MyCite. Here may be the reason that Otsuka invested so much capital into Proteus Digital Health, the California company that developed the IEM technology. Profits from Abilify will continue to be made by Otsuka with the newly patented formula.

The labeling information for Abilify MyCite notes the ability of the product to improve patient compliance hasn’t been demonstrated yet. Additionally, it should not be used to track drug ingestion in “real-time” as detection may be delayed or may not occur. Robert McQuade, an executive vice president for Otsuka, confirmed the company does not have current data to say it will improve adherence. But they will likely study that after sales begin.

How patients themselves view Abilify MyCite is mixed. One person who takes Abilify for schizoaffective disorder participated in the clinical trial for Abilify MyCite. Compliant with his medication, he doesn’t think he needs digital monitoring. He hasn’t had paranoid thoughts for a long time. If he had a chance to take ‘digital Abilify,’ “I wouldn’t take it.” Another person who sometimes will stop taking his medication thought the idea behind Abilify MyCite was “overbearing.”

A third person reported his use of Abilify for 16 years to prevent recurrence of episodes of paranoia. He thought some people might use the new drug to avoid the injections of Abilify if they were noncompliant with their pills. But he said he would not use the digital Abilify. He didn’t want an electrical signal, strong enough for his doctor to read, coming out of his body. “But right now, it’s either you take your pills when you’re unsupervised, or you get a shot in the butt. Who wants to get shot in the butt?”

The above are the milder responses to the FDA’s news about Abilify MyCite. What follows are the thoughts of Michael Cornwall. He is a Jungian/Langian psychotherapist who specializes in providing psychotherapy for people in psychotic states (which he refers to as ‘extreme states’) without the use of medication. He has his own website and commented there how digital Abilify “can now automatically send signals to your doctor, family members and the courts, to show them when you comply and swallow the pill.”  Not one to pull punches, his article on Mad in America was titled: “The Orwellian New Digital Abilify Will Subjugate Vulnerable People across the US.”

He predicted there will be tragic personal injury coming from the use of Abilify MyCite to control people’s dosing compliance, “something that I believe would even make dystopian visionaries George Orwell and Aldous Huxley shudder.” Singling out California as an example, he said the state was ripe for an even more oppressive mental health “best practice” service model and standard of care for people in “extreme states” who are receiving forced in-home treatment. Like California, most states now have some version of in-home compulsory court-ordered medication treatment. Research has shown that 74% of people prescribed antipsychotic medications who are in extreme state stop taking their medications by 18 months. Pro-medication people find this unacceptable.

Tremendous pressure, I believe, will also be exerted by mental health care providers for people to voluntarily accept taking the new digital Abilify. I see that pressure being put on people seeking discharge from in-patient units, and pressure will be put on people in extreme states or with such histories, who will be involved anywhere on the spectrum of community mental health services and in jails and prisons too. In both mental health and penal systems, medication compliance, not providing humanistic care, is clearly the highest priority.

Yet there is reliable evidence suggesting long-term use of antipsychotics like Abilify is not necessary. Robert Whitaker wrote a paper, “The Case Against Antipsychotics” where he critiqued the research cited by psychiatry as evidence for long-term use of antipsychotics. Additionally, he presented a history that tells how antipsychotics, on the whole have actually worsened long-term outcomes. Whitaker described a long-term study by Harrow that followed an original group of patients for 20 years (and counting) after their initial hospitalization for schizophrenia.

Harrow discovered that patients not taking medication regularly recovered from their psychotic symptoms over time. Once this occurred, “they had very low relapse rates.” Concurrently, patients who remained on medication, regularly remained psychotic—even those who did recover relapsed often. “Harrow’s results provide a clear picture of how antipsychotics worsen psychotic symptoms over the long term.” Medicated patients did worse on every domain that was measured. They were more likely to be anxious; they had worse cognitive functioning; they were less likely to be working; and they had worse global outcomes. Also see “Worse Results With Psych Meds” for more on the Harrow study.

Returning to the thoughts of Michael Cornwall, he said treatment with Abilify MyCite was “a morally bankrupt approach that ensures a soul-numbing, hi-tech compliance-monitoring device be in the digestive tract of every DSM-labeled person in an extreme state, in order to keep them in line.” It places the controlling impulse of psychiatric care “within our very guts.” To the uninitiated, Cornwall’s rhetoric may sound extreme. But I suspect that for individuals wanting to cope with their “extreme state” without medication or struggling to live with the side effects from antipsychotics, it is spot on. Clearly as the technology behind the IEM improves, it will be used to “convince” individuals that using a digital antipsychotic like Abilify MyCite is in their best interests, particularly if they want to be discharged from a psychiatric facility, or to continue living outside of one. The first Biomedical Big Brother has arrived.