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Convenient, yet controversial: First FDA-approved digital pill raises public concerns


First FDA-approved digital pill raises public concerns

A handout photo showing a “digital” version of the antipsychotic medication Abilify. The pill has a sensor the size of a grain of sand embedded in it, which can send a signal to a device and, if the patient allows it, to a doctor. Photo credit: Proteus Digital Health

According to studies, many patients skip on medications – not taking them as prescribed – making it hard for doctors to know the efficacy of the given drugs, which may endanger the treatment. As echoed by Dr William Shrank, chief medical officer of the health plan division at the University of Pittsburg Medical Centre, “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.”

Now, technology has come into place to address the problem. Enters the “digital pill” which allows doctors to know whether their patients have taken their medication. It is the first oral tablets with self-tracking sensors embedded – not forgetting, also the first of its kind to secure an FDA approval


Digital pill: how it works to benefit medicinal field?

The oral tablet, Abilify MyCite, is a self-tracking sensor-embedded pill which acts as an antipsychotic medication for schizophrenia, bipolar disorder, depression and Tourette’s.

After ingested, the sensor containing copper, magnesium and silicon would activate when it hits the stomach fluid. Then, it creates an electric signal, and send it to a patch worn by the patients on their left rib cage, before it disintegrates. The signal will then be sent to a smartphone app. 

New technology used in Abilify’s digital pill can collect data on whether patients have taken their medicine, as well as patients’ own reports on their mood. Photo credit: The New York Times
Through the app, the doctors and patients can keep an eye on the date and time of pill ingestion as well as the patient’s activity level. The app also allows patients to add in their mood and their resting hours to a database which physicians and others who have the patients’ permission can access. 

Patients who agree to take the digital medication, can sign consent forms to allow their doctors – up to four other people, including family members – to receive the data. Relatively, patients can also block anyone from receiving the alerts anytime through the smartphone app. 

This digital medication hopes to inspire patients to take their medications as prescribed, as well as helping doctors to know whether a prescription is working or proper dosages are set. “Once a patient is using our solution, they can see how they’re using their drugs, they can see how it affects their body, and we can create all kinds of behavioural tools that enable them to keep doing that,” asserts Andy Thompson, CEO of Proteus Digital Health, maker of the sensor technology and patch incorporated in Abilify MyCite.



Digital pill raises public concerns

Though the digital comes with a number of benefits, it has raised concerns among doctors and patients. Doctors and patients are wondering how widely the digital pill – that is targeted at those with mental health issues – will be accepted; considering those patients who do not take medication regularly are usually the ones with severe consequences, or those suffering from paranoia and delusions. 

“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,” explains Dr Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department. 

Besides, Dr Jeffrey Lieberman, the chairman of psychiatry at Columbia University and NewYork-Presbyterian Hospital also notice that the digital pill has only been approved to track doses, but has yet to show an improvement in adherence – making the uses of the pill controversial. 

“Is it going to lead to people having fewer relapses, not having unnecessary hospital readmissions, being able to improve their vocational and social life? There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother,” he expresses.

Besides that, the technology also prompted questions about privacy and whether patients would be under-stressed to take medication in a form that their doctors can monitor. “I would not want an electrical signal coming out of my body strong enough so my doctor can read it,” expresses Mr Jiang, a schizophrenia patient who took Abilify steadfastly for 16 years to prevent episodes of paranoia. Another patient with Schizoaffective Disorder also considers digital pills as overbearing – “it stymies someone and halts progress in therapy.”

A participant in the clinical trial for the digital Abilify, Tommy also encountered minor issues during the trial, as he said that the patch is making him uncomfortable and gave him a rash. According to him, he does not need monitoring, “I haven’t had paranoid thoughts for a long time – it’s not like I believe they’re beaming space aliens.”

In view of the publics concerns raised by several groups, the power of the technology outweighs the risks, according to The Verge. “There are challenges with bringing digital into any sector. The reason to embrace the challenge in healthcare is because the need is so great,” remarks a company representative from Proteus. MIMS

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