A Hard Pill to Swallow: Medication with built-in adherence monitor

On November 13th the FDA approved Abilify MyCite, the first pill that contains a sensor to monitor whether or not the patient is taking her medication. This event ticks several boxes, cutting edge science and technology, a boon to the forgetful, a giant step forward for obtaining data and a giant step backward for what remains of privacy.

Ironically (Kafka couldn’t make this up) Abilify is a drug used to treat paranoia. One can only imagine the psychiatrist’s conversation with a paranoid patient. “So this new pill has a device in it that tells us whether you’re taking your medication or not. It will help us help you.” No problem.

The pill combines the antipsychotic, aripiprazole, with Proteus’s ingestible event marker (IEM). The IEM is activated in the stomach. There it sends a message to a wearable patch that transmits to a mobile application on the patient’s smart phone and is accessible to caregivers through a web-based portal. This last bit requires patient permission.

Abilify is commonly used in schizophrenia. About 1 percent of Americans, more than 32 million people, have schizophrenia. In fact, 1% of any population anywhere in the world is schizophrenic.

Historically, new medical interventions gain initial acceptance for the treatment of serious disorders found in specific populations. With time, the culture mainstreams many of these advances for other purposes.

For instance the original task of plastic surgery was to restore the appearance and function of parts of the body deformed by disease or injury. World War II provided a testing ground for the development of many contemporary plastic surgery techniques. In 2015, 16 million Americans had cosmetic procedures. The statistics are reason for concern. A recent survey of more than 10,500 women and girls found that females’ confidence in their body is on a steady decline. 92% of the cosmetic procedure patients are female. 85% of the surgeons are male. The most popular procedures change from one decade to the next as the culture redefines feminine beauty.

How ingestible event markers might be mainstreamed in the future is unknown. They are already being studied in diabetics and people with high blood pressure. Like any technology, it could be used in a helpful or harmful way.

Patient compliance with medication is notoriously poor. About 50% of medications are not taken as prescribed. This non-adherence causes 30–50% of treatment failures and contributes $105 billion to the $213 billion annual avoidable healthcare costs.

It is interesting to note that unlike the usual FDA approval process, Abilify MyCite passed without having been shown to improve patients’ compliance with their treatment regimen.

There are many reasons why patients don’t take their medications. Some forget. But often people don’t like the way they feel on a medication or they don’t understand their disease and why they need to take a drug, or they simply can’t afford it.

These issues will not be solved with technology. They are symptoms of a communication problem. Understanding patients’ experience of having an illness and taking a medication is essential to helping them comply with a treatment. This can’t occur in a 15 minute visit.

However lengthening the visit is an inadequate solution. Our model of healthcare as an interaction between a doctor or nurse and a patient does not work for the chronic diseases that plague our society.

The concept of a technology that allows an expansion of this traditional doctor-patient dyad is a good one. Recent work by behavioral economists highlights the value of harnessing social interactions with friends and relatives who are embedded in patients’ lives. Research indicates that behavior (good and bad) is contagious. You’re more likely to smoke if your social circle smokes, and more likely to quit if they quit. A doctor’s recommendation to stop smoking has had little effect.

The explosion of new biomedical techniques raises new issues. The first generation of gene therapies has arrived. Genetic manipulation to treat disease is an obvious good. What are the boundaries of the genetic modification of people? Will gene therapy be the new plastic surgery?

There is no question that ingestible event markers will soon be used in a variety of settings. Who will determine when data gathering technology becomes harmful?

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Originally published at www.huffingtonpost.com on January 3, 2018.

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