An anti-psychotic pill which contains a tracker so doctors can check if it’s been taken isn’t being used because it could add to patients’ paranoia, an expert has warned.
The Abilify MyCite has a metallic chip the size of a grain of sand. It was approved to treat schizophrenia by the US’s Food and Drug Administration (FDA) in 2017.
But few patients are taking the pioneering new treatment because of concerns and the fact it costs so much more than usual medication.
The idea of swallowing a tracking chip which transmits signals may be too much for patients battling the disorder to handle, according to a psychiatrist.
The FDA approved Abilify MyCite (pictured), the first medication with a tracking device in it, in 2017. The drug contains a transmitter that sends information to a patch worn on the patient’s arm, which is then logged on a mobile app
Schizophrenic patients are already at risk of paranoia, delusions and hallucinations.
And Dr James Levenson, from Virginia Commonwealth University, said the pill, which still isn’t on the market in the US, could contribute to those.
Abilify is already used to treat schizophrenia but a pharmaceutical can add the tracking sensor – made of copper, magnesium and silicon – and put it into the pills.
When the patient swallows the pills it transmits a signal over the internet to let the doctor know it has been taken.
This process makes the medicine up to 30 times as expensive, however, hiking the price to $1,650 (£1,275) for a month’s supply.
As well as this, the extra component may be worsening the same symptoms it’s trying to control, according to Dr Levenson, who spoke to The Washington Post.
He said: ‘Patients who have a lot of paranoia might be uncomfortable with the idea of a medicine that is transmitting signals. The patient may be afraid to take it.
‘The science of this one is kind of ahead of the data.’
Dr Levenson’s comments mirror concerns which were raised when the drug was approved in 2017.
One expert said introducing the medicine in a schizophrenia medication wasn’t very considerate.
Dr Paul Appelbaum, a psychiatrist from Colombia University said at the time: ‘Psychotic disorders are often characterized by some degree of paranoia, often reaching delusional proportions, in which patients may believe that outside forces are trying to monitor and control them.
HOW DOES THE DIGITAL PILL WORK?
In 2017 Abilify MyCite became the first pill containing a tracking sensor to be approved by the US’s Food and Drug Administration.
It combined a tried and tested schizophrenia drug, Abilify, with a metallic chip the size of a grain of sand.
The chip, containing copper, magnesium and silicon, sends a signal to a patch worn on the patient’s arm when the pill is taken.
Ingestion can be recorded within between 30 minutes and two hours of the patient swallowing the drug.
The sensor has no battery or antenna but is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.
The patch then synchronises with a mobile app on the patient’s smartphone or tablet, and sends data to their doctor over the internet to show whether the pill has been taken.
In this way, doctors can collect accurate, reliable and real-time data about whether their patient is sticking to their prescription.
Past research has found around 50 per cent of patients given regular medication don’t take it properly, and this may be even higher for patients with schizophrenia.
‘The idea that we’re giving this group of patients a pill that, in fact, transmits info about them from inside their body to the people that are involved in their treatment almost seems like a confirmation of the worst paranoias of the worst patients.’
Past research has found that non-adherence – refusing to take medication properly or regularly – is a particular problem for doctors treating schizophrenic patients.
In 2014, the World Health Organization (WHO) reported that as many as 50 per cent of patients on prescription medications do not take their drugs as directed.
A study published in December 2018 by the Amsterdam University of Applied Sciences claimed 75 per cent of patients with schizophrenia quit their meds within 18 months.
Between 930,000 and 2.3million people in the US are thought to have schizophrenia or a similar disorder. Worldwide, around 21million people are affected.
Patients may be put off taking their medicine because they don’t believe it works, they don’t fully understand their illness, or they don’t trust their doctor, the study said.
And this is hard to measure because some patients may avoid taking their drugs but not tell their doctor about it.
Abilify MyCite is still not on the market in the US, potentially because of scepticism from prescribing doctors and medical insurance providers.
Scott Gottlieb, the former commissioner of the FDA, said: ‘I think that these technologies have a lot of potential benefits.
‘But it’s going to be a question of evidence – that they can demonstrate value to patients and payers.’
Otsuka Pharmaceutical, the Maryland-based company which makes Abilify MyCite, said people who were likely to be afraid of their medicine were not likely to be given it.
The pioneering pill, the firm said, is designed for patients who ask for it in a bid to improve their own mental health – rather than a replacement for existing medicines.
John Bardi, spokesperson for Otsuka, told the Washington Post: ‘It’s unlike a pharmaceutical launch where you proactively blitz all the states. We’re not doing that.
‘It’s really about patients who want to improve their treatment goals. If they have any concerns, it’s probably not the right solution for them.’