Muiris Houston: Why smart pills are a stupid idea

As we become more aware of some borderline ethical practices by Facebook and other mega social media enterprises, it’s up to each of us to be alert about who may be doing what with our personal online information, including our health records.

While not yet at an Orwellian peak, the quiet accumulation and monetisation of our personal likes, dislikes and disabilities, is too covert for my liking.

The US Food and Drug Administration has just approved a digital pill – a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. This is right out of the Big Brother playbook, and – were similar approval to be given by the European Medicines Agency – something to be resisted strongly.

There is no doubt that huge amounts of money are wasted when patients, for whatever reason, do not take drugs as prescribed. In the US, experts estimate that noncompliance with medication costs about $100 billion (€85bn) a year.

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While smart pills may have a role for patients who want to take their medication, but genuinely have difficulty remembering their daily regimen, for others such pills risk sundering the trust that is an essential element in any doctor-patient relationship.

It’s particularly unfortunate that the first drug to be digitally enhanced is the antipsychotic aripiprazole, marketed under the trade name Abilify. A key medication in the management of schizophrenia and other illnesses where psychosis is a feature, the enhanced version of the drug requires patients to sign consent forms allowing their doctors to receive electronic data showing the date and time pills are ingested.

How does it do this? Abilify MyCite contains a sensor, containing copper, magnesium and silicon that generates an electrical signal when exposed to stomach fluid. The signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced every seven days.

For the FDA, to approve a medication for serious psychological illness as their first venture into digital pills is bizarre

The patch sends the date and time of pill ingestion via Bluetooth to a smartphone app. The app allows patients to add details about their mood then transmits the information to a database that doctors and others can access.

For the FDA, to approve a medication for serious psychological illness as their first venture into digital pills is bizarre. People with schizophrenia, bipolar disease and severe depression suffer from paranoia. They frequently have delusions about the behaviours of those around them, including doctors and family members.

As Dr Paul Appelbaum, director of law, ethics and psychiatry at Columbia University, noted, “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”.

When they are acutely unwell, patients with psychosis will often tell you that a particular person on the television or a voice on the radio is instructing them what to do. And sometimes, these messages exhort the patient to commit crime or to harm somebody. I’ll leave readers to imagine how having a sensor inside you, actively broadcasting information about your body, to the outside world, might play out inside the head of someone in the vulnerable psychotic phase of an illness.

Why did the FDA not fast-track approval for a sensor pill for tuberculosis medications? These must be taken for up to nine months, and where the patient has a drug-resistant strain of the disease, they must be directly observed swallowing the medication by a nurse.

Remarkably, Abilify MyCite has been approved without evidence that having the sensor actually improves compliance with the drug. And who is to say it will not be used in the future as a condition of discharge from a psychiatric hospital or prison?

With so many caveats and no guarantee of online security for the information accumulated by the app, it’s an idea I would have expected to read about in a novel rather than from a regulatory body.