Schizophrenia: The Pill Of Truth

6. February 2018

Many patients with schizophrenia or depression take their medication irregularly. The 'smart' pill informs us whether it has been swallowed. This is therefore supposed to improve compliance. Is this a big step forward, or a step in the process of patients being progressively disenfranchised?

The neuroleptic Abilify containing the active ingredient aripiprazole has been prescribed for schizophrenia, depressions and manic phases of bipolar disorder since 2002 in the US and in Europe since 2004. Now the tablet comes with a digital upgrade in the form of tiny swallowable sensors. These are called ingestible event-marker sensors (IEM). They are supposed to make it ascertainable as to whether patients are taking their medication according to instructions or not. Already in 2012, the US Food and Drug Administration (FDA) granted approval for research on the digital pill. The medication is targeted to come onto the market in 2018 under the name Abilify MyCite.

Billions in damages

The entire system, in addition to the tablet, comprises the MyCite patch and the MyCite app. And it works as such: copper, magnesium and silicon generate an electrical impulse when in contact with gastric fluid. This impulse is detected by the skin patch – located on the left sternum – and a signal is transmitted via Bluetooth to the app. The data is transmitted to the Abilify-MyCite internet portal. From there, doctors, nurses or family members get an overview of whether the patients are complying with intake as prescribed. However, the patient must consent to the perusal of the data by other people; this decision can be reversed at any time.

The New York Times explains why the digital pill makes sense from a financial perspective. In the US, millions of patients do not take their medication as prescribed. On account of this annual costs of around 100 billion US dollars result. Ameet Sarpatwari, a medical lecturer at Harvard Medical School, is a proponent of the technology. He believes that the technology will significantly contribute to improving public health. In his opinion older patient groups in particular would benefit from this because they do wish to take their medication, but often forget to do this.

 

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A digital patch is used to detect the signal from the pill from within the body. © Proteus Digital Health

Better compliance: not proven

Critics in contrast do not understand why Abilify MyCite should now come into use for the first time by treating people with schizophrenia. The Times’ article further mentions that people in this specific patient group frequently discontinue taking their medication, often with severe consequences. One would like to be able to better intervene here. Many psychiatrists are therefore interested in testing the system. For example, on patients who have experienced their first psychotic episode. There is a danger here that medication will cease being taken as soon as the person feels better, mental disorder specialist Jeffrey Lieberman says.

Yet how does one convince these patients that equipping their bodies internally with a transmitter is only being done for their very best interest? Does that not that increase distrust? The FDA and the manufacturer point out that it has not yet been investigated as to whether adherence to taking medication actually improves through the use of the digital pill. The system should not be used in an emergency, because detection can take up to two hours, or even fail completely. Of course, should the signal not be transmitted despite a tablet being ingested, it is important that the patient does not take a second dose. Critical voices give food for thought by indicating that the tablet is also too easy to manipulate by simply dissolving it in a little acid. To what extent the system will be accepted and used in the future will be shown in the coming years.

Smart patches

Patches thus play an important role in modern medical technology by relaying signals from the body to processing programs. Much hope is also being placed in a new generation of them which should revolutionise wound care. A patch that can indicate the presence of infections is currently being developed by bioengineer Ali Khademhosseini from the University of California, Los Angeles.

With the help of electrical sensors, the patch measures parameters such as temperature, moisture content, pH value and oxygen saturation. If the measurements point to an infection, the patch may even release antibiotics and treat the lesion as quickly as possible. The developers foresee that the data would be available for access on a smartphone so that doctors can follow the healing process most closely. This could, especially with chronic skin infections, be an advance.

Wound dressings however often lie in the closet for a long time before they are used. Some engineers doubt the everyday practicability of the smart patch with its sensitive sensor technology. The research group led by biochemist Toby Jenkins from the University of Bath (UK) has therefore come up with a completely different principle. Their wound dressing contains nanovesicles with fluorescent dyes in a matrix of agarose. Only the presence of bacterial exotoxine-typical skin germs such as Staphylococcus aureus, Pseudomonas aeruginosa and Enterococcus faecalis leads to lysis of the vesicle. The dye is released and the infection becomes visible early.

 

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Exotoxine from skin pathogens serve as a trigger with this colour indication patch © University of Bath

 

Using artificial “cardiac muscle patches”, functionless infarct tissue could in the future be repaired. American bioengineers from Duke University (USA) for this purpose bred pluripotent stem cells to become cardiomyocytes, fibroblasts and endothelial cells. After the scientists had found the right composition of cells, support structures and growth factors, the substances self-assembled into functional myocardial tissue.

The contraction force of the patches and their electrical conductivity are the same as those of healthy heart tissue. If one applies them over scarred infarct tissue, they support the injured muscle and also release enzymes and growth factors, which promotes the regeneration of injured cells. Scarred infarct tissue would otherwise lead to heart failure, because it is neither contractile nor conductive. Given that until now the world’s more than 12 million sufferers have only been treated symptomatically, replacement of the damaged muscle would be a great step forward. Before it can be employed, however, a way must still be found to induce the patches to grow significantly thicker.

Biomedical BigBrother

When working with the MyCite-app for the digital pill, the patient can also enter data about how he or she feels, daily activities and sleep patterns. The FDA states that it supports the development of such new applications in order to find out how patients and therapists could be helped. For critics this goes too far in terms of details, they see ethical problems here.

What would happen if health insurance companies were to employ detectable tablets nationwide in prescription medicines in the future? For example, so as to refuse services or to charge fees to those who forget to take their tablet. Will there be a push notification on our smartphone stating that additional costs will be incurred if the medication is not taken within the next hour?

The drug Abilify with its therein contained active substance aripiprazole was already been approved for use in the whole EU in 2004. Recent FDA approval for the digital pill applies initially to the US market.

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