“Imagine the implications of that, the compliance.” FDA has already approved pills with sensors, what’s next?

BY SIMONE J. SMITH

We cannot deny it, technology has pushed global societies forward in significant ways: some positive and some negative, depending on how you look at it. We may not be comfortable with the implications of new technology, particularly in a world where our data is constantly bought and sold, and not to mention monitored by governments. As much as some of us may be against some of the new technology that is being rolled out, Silicon Valley seems intent on trying, and what once seemed impossible may soon become routine.

In 2017, the U.S. Food and Drug Administration approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records when medication was taken. The product is approved for: the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

The digital sensor in each pill is tiny — about the size of a grain of sand. It’s made from elements found in common foods — copper, magnesium and silicon. Contact between the elements and stomach fluids trigger an electrical signal.

This is not the first time that digital medicine has been utilized. In June 2014, Proteus rang in a new era of what it called “digital medicine” in which your body’s vital signs and the medications entering your bloodstream can be tracked by computers. Software searches your body’s data for patterns in real time and reports that information to your doctors.

It sounds crazy, but the tiny computers exist. It sounds dangerous, but the company that makes them, Proteus, has tens of millions of dollars and relationships with some of the biggest drug companies in the world, including Novartis.

Reports also show that the FDA first approved Abilify in 2002 to treat schizophrenia. Since then, studies and lawsuits have blamed it for causing compulsive behaviour and other side effects in people taking it. The FDA approved the tracking system in 2012, but Abilify MyCite is its first approved use with a drug.

How does the tracker work?

A wearable patch on the patient’s body picks up the signal and relays the time and date via Bluetooth to a smartphone app. The patient can choose to automatically share this information with a doctor, family members or other caregivers.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

What are the positives of digital medicine?

Some medication can have harmful effects for the patient if pills are skipped or taken as a double dose, so if a physician or family member can be alerted immediately this would potentially be very helpful. Another thing to think about is that currently, physicians rely on self-report from the patient regarding their medication and this isn’t always accurate. Being able to properly track medication use could help physicians and family members determine what strategies actually work for aiding the person with dementia to remember to take their pills (ie. reminder phone calls, written reminders etc.).

What hazards and security issues exist with digital medicine?

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Also noted was skin irritation at the site of the MyCite patch placement may occur in some patients.

Abilify has been associated with serious side effects.

It even carries two black box warnings, which is the FDA’s most serious warning. One warns that Abilify is not approved for elderly patients with dementia-related psychosis. The other warns of an increased risk of suicidal thinking or behavior in children, teens and young adults.

Studies have also found associations between Abilify and neuroleptic malignant syndrome, a life-threatening reaction to antipsychotic drugs, and tardive dyskinesia, which causes involuntary muscle movements of the lower face, and compulsive behaviours. In addition, there were a combined 370 lawsuits over Abilify side effects presented to a Florida federal court in 2016. The people who filed the lawsuits claim the drug caused: compulsive gambling, spending or eating along with hyper sexuality and stealing or shoplifting.

What cannot be ignored are the ethical issues inherent in this type of tracking, especially issues around privacy. Information is sent to the “cloud” and although generally we are assured that this is secure, there is always a potential for this information to be hacked. There is also the fact that this information could be used in the future by third party companies who have a vested interest in understanding big data drug consumption or tracking individuals.

Who knows what is next for us? In a clip from the World Economic Forum held in January 2018, Albert Bourla stated, “Imagine the implications of that, the compliance.”

Yes, imagine the compliance indeed!