FDA Approves “Digital Pill” to Track Patients’ Compliance with Psych Meds

FDA Approves “Digital Pill” to Track Patients’ Compliance with Psych Meds

People commonly ignore doctor’s orders, and it’s not uncommon for people to accidentally miss a dose or two. It’s also common for people to lie about it to their doctor. Now imagine that every time you swallow a pill – or don’t swallow one – your doctor, and God knows who else, knows it. They just know. It sounds like the premise of an “X-Files” episode, but the creepy technology is real and it’s getting ready to be rolled out, soon. [1]

The first-ever digital pill was approved by the U.S. Food and Drug Administration (FDA) in November 2017 in the form of a newly-formulated psychotropic drug, Abilify. The techno-pill notifies your doctor every time you swallow one.

Dubbed AbilifyMyCite, the drug comes with an ingrained sensor that operates on the same principles as a potato battery. Now, if you don’t take Abilify, this isn’t something you even need to give a second thought to … at least not today. But in the not-so-distant future, you might.

Andrew Thompson, the co-founder and CEO of Proteus Digital Health, which makes the sensor, explains:

“I think it would be a bit of a stretch to say that this would be, in the next five years, in every medication. I don’t think that’s realistic. I think you could 20 to 30 years from now, that’s a possibility.”

Here’s how the sensor works. Stomach acids make the metals of the sensor exchange electrodes and create an electrical signal in a process known as oxidation-reduction reaction. A patch worn by the individual on his or her skin picks up the signal – a string of numbers that is specific to an individual tablet – and filters and decodes the signal, then transmits information about the dose and manufacturing batch of the medication to a smartphone via Bluetooth.

Patients who agree to take the digital pills can sign consent forms allowing their doctors and as many as 4 other friends or family members to receive electronic data showing both the time and date the pills are swallowed. If they decide they don’t want a certain person to be able to access the information, a smartphone app will allow them to block that individual. [2]

Hacking, Mistrust, and Coersion

The sensor used in AbilifyMyCite pills has been around for years – it won FDA approval back in 2012. All it needed was a drug to go in.

Three years after the sensor’s approval, noted bioethicist Arthur Caplan warned:

“The challenge to your privacy begins right now.” [1]

Caplan referred to the pills as “snitch pills,” adding:

“How secure is the technology? Are hackers going to threaten to exposure your medical secrets online if you don’t pay, as they are doing in the Ashley Madison adultery hack? Will children or incompetent people be forced to use tracking pills with no consent, or will a judge have to authorize their use?”

Kabir Nath, CEO of Otsuka Pharmaceutical in North America, the company that makes Abilify and AbilifyMyCite, says Otsuka has “done everything” it can to ensure the security of the digital pills, and claims that “This is a fundamental issue that we have addressed.”

Regardless of the safety of the technology, many individuals are likely to feel coerced into agreeing to take them. According to Dr. Eric Topol, director of Scripps Translational Science Institute, insurers might eventually offer patients discounts on co-payments and other incentives for taking the pills. [2]

An Odd Choice for a Test Run

But the controversy doesn’t end there. There could come a day when an inmate’s parole or a patient’s release from a psychiatric facility might be dependent on their willingness to take the so-called snitch pills. If you don’t know much about psychotropic drugs, this might not sound like a bad idea. It could prevent things like mass shootings, right?

It could…or it cause a violent event. I don’t say this to alarm you.

The uncomfortable truth is that many of these meds can cause violent behavior, including Abilify. Are we sure we want to force people with criminal histories and severe mental illness to take it? Most mentally ill people are not violent and are actually more likely to be the victims of violence. There is a terrifying possibility that forcing mentally ill patients to take AbilifyMyCite…could make them violent.

The odds are against it, but if it were not possible, there would not be warnings about it on the drug’s label.

The FDA states in the online Medication Guide for Abilify that the drug may increase suicidal thoughts and actions, particularly among children, teens, and young adults, and states that the patient or a patient’s family member should contact a healthcare provider if they experience the following symptoms:

  • thoughts about suicide or dying;
  • attempts to commit suicide;
  • new or worse depression;
  • new or worse anxiety;
  • feeling very agitated or restless;
  • panic attacks
  • trouble sleeping;
  • new or worse irritability;
  • acting aggressive, being angry, or violent;
  • acting on dangerous impulses;
  • an extreme increase in activity and talking (mania);
  • unusual changes in behavior or mood.

Why Abilify, in the first place? Of all the drugs on the market, Abilify is an odd choice for a technological test run.

Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department, finds it odd that the sensor would first reach the market in the form of a drug used to treat mental health conditions that are already associated with paranoia.

Appelbaum explains:

“Many of those patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions.

A system that will monitor their behavior and send signals out of their body and notify their doctor? 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.”

If people aren’t paranoid about taking pills that send compliance information to their doctor, they just might be about the fact that the first drug chosen to use the technology is a psychotropic one.

It might be smart to be a little bit paranoid.

Additional Sources:

[1] Newsweek

[2] The New York Times