The FDA Approves the First Digital Pill

Proteus Pill
Proteus Pill

In November, the FDA announced that it had approved the first digital pill, which had been developed in a partnership between Otsuka Pharmaceuticals and Proteus Digital Health.

What in the world is a digital pill, you might ask, and why is that something to get excited about? Or, is this just one more way for “them” — whoever “they” might be — to keep tabs on us in another intrusive, personal way?

Otsuka markets an antipsychotic medication called Abilify in many strengths and formulations. Abilify (generic name: aripiprazole) is prescribed for people who have been diagnosed with schizophrenia, bipolar disorder or depression. Antipsychotic medications treat the delusional thoughts that are often the most dangerous and frightening aspects of mental illness. These thoughts can range from thinking that a person has “superpowers” or other delusions of grandeur, to hallucinations such as hearing one or multiple audible (to the patient) voices, often telling them things like they have to perform certain tasks or risk bad luck or disaster, or that they need to do harm to themselves or to others in order to save themselves, loved ones, or even the world. Delusional thinking is devastating for the individual, and for caregivers.

Often, after other symptoms of depression, bipolar disorder or other maladies are well-controlled, the patient begins to understand that even if they are still having delusional thoughts, they can’t admit them to their counselor or psychiatrist, because then everyone starts to “freak out.” As a result, delusional thinking doesn’t become noticeable to others until it is creating acute problems that are endangering the life of the patient or others — up to and including things like violent and erratic behavior or substance abuse, which can result in arrests and incarceration, or, in the worst cases, suicide or overdose.

Nunzio Prenna © Nunzio Prenna © Capture0045-2
Proteus ingestible sensor to be embedded in medication. Not Final Packaging.

Anyone who cares for someone with these afflictions knows all too well the worry, fear, pain and destruction caused by those who cycle in and out of compliance with their medications that keep them between the guardrails of life. And one can understand why the idea of a digital pill (in this case, Abilify MyCite) that can be “traced” when it comes into contact with stomach fluid, could bring welcome and reliable answers to the question, “Are you taking your medicine as prescribed?”

The technology that allows this breakthrough is a tiny, digestible microchip that is encapsulated in the pill. Undetectable to the human eye, this chip transmits a signal to a patch that the patient applies to their torso (think of a nicotine patch as an example), and that patch in turn transmits a signal to a device or devices of the patient’s choosing. Not only can the patient check their smartphone application to answer the question, “Did I take my pill this morning?” with the simple touch of a finger, but doctors, trusted family members, friends or counselors can also get updates (with the patient’s permission, of course) as to whether or not the patient is taking the medication. Alerts can be configured to let them know when it appears that a dose or doses have been missed, which can in turn alert them to the potential for trouble and need for intervention before the full-blown panic of a crisis occurs.

This new formulation is expensive, and exponentially (at least for the time being) more expensive than the “analog” version of the medication. The case has been and will continue to be made, however, that the cost of noncompliance is much greater than just the cost of the prescription filled but never taken. Noncompliance creates massive expense to society at large when its impact results in loss of productivity, loss of income, loss of opportunity and increased cost of treatment. It can also involve massive taxpayer burden, as some of these patients end up in jail or as permanent fixtures on welfare rolls because they are unable to remain stable and keep themselves employed or in school, and safe from harming themselves or others.

It’s easy to understand why this development is so exciting, but it’s equally easy to understand why others who are already weary of tracking keystrokes and Facebook posts or mapping technology might be averse to it. This technology will be showing up in many other disease treatments in addition to mental illness. Cholesterol or blood pressure medication, diabetes medication, even birth control pills could soon include this traceable chip, potentially allowing any entity with an interest (which any government-funded healthcare system or private insurance company certainly has) to understand more about whether patients are maintaining their end of the healthcare bargain by taking their medications to prevent disease progression and reduce costs of hospitalization or other specialized care. Will there be penalties after sustained medication noncompliance leads to multiple hospitalizations or doctor visits? Will more expensive or advanced treatments be reserved for those who have demonstrated that they have reliably followed the doctor’s orders in the past and be denied to those who haven’t?

These concerns are valid, they will no doubt be debated endlessly as this new frontier continues to advance and evolve. But for now, those who understand all too well what a literal lifesaver this technology could be are excited and cautiously optimistic that the associated risks, in cases where compliance is critical, are far outweighed by the benefit of knowing that the patient is taking the medication as it has been prescribed.

In a future article, I’ll tackle the very real question of whether this technology and others like it will ever make it to the majority of patients most in need, given the severe shortage of and limited access most people have to mental health practitioners and the difficulty of navigating the mental healthcare system in our country (even when a patient thinks they have a generous insurance plan). That’s another critical concern as our nation begins to address the opioid abuse epidemic, and its impact on our healthcare system, our economy and our national security.


About the author: Kelly Warren Moore has sold clinical research and development software solutions to the pharmaceutical and biotech industry for the past several years. She previously spent 20 years in business development for the pharmaceutical research and development field, focusing on multi-study, global clinical programs. She has a Bachelor of Arts degree in economics from The University of Texas at Austin. Any opinions expressed in this article are strictly her own and are not meant to represent those of any employer, client or organization with whom she is affiliated.


Photos courtesy of Proteus Digital Health


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