"Smart pills" – good or evil?

To date, enthusiasm for a new digital medical tool – the so–called "smart pill" - is very strong, but researchers at the University of Illinois at Chicago have published an article warning medical professionals and health officials about the need to slow down the process of introducing this technology into clinical practice.

Smart, or digital, pills are prescription drugs equipped with biodegradable electronic sensors that, after swallowing the pill, send messages to devices such as electronic patches, smartphones or tablets. The first drug of this class, approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2017, is used to treat patients with schizophrenia, bipolar disorder and major depressive disorder.

Some experts hope that the new technology will help patients and attending physicians monitor patients' compliance with the treatment protocol and improve its quality. According to preliminary estimates, this will allow saving from $100 to $300 billion annually in the United States alone. At the same time, some experts express concern about the security of personal information, obtaining informed consent of patients and the collective use of data.

One of the authors of the article, associate Professor Eric Swirsky, a specialist in legal and ethical issues related to healthcare technologies, notes that both sides make convincing arguments, but neither of them asks the right question.

According to Swirski, we need to make sure that smart pills will improve the quality of life of patients, which is a much more complex issue than protocol compliance and data security. It is naive to believe that this type of controlled therapy with medications recommended by a doctor will become a magic pill. With a greater degree of probability, he will simply challenge the ingenuity of patients.

Swirski also states that to date there is no evidence that smart pills benefit patients and that the use of technology outside of clinical trials "contradicts the results of the study, according to which patients benefit more when receiving medical care from specialists who are able to solve many issues related to compliance with the protocol of therapy."

"The use of smart pills will lead to a dangerous reduction in the interaction between the patient and the doctor. There is no short way to improve compliance with the treatment protocol that occurs in a wide coordinate system consisting of home, work and medical institutions, not even to mention the peculiarities of perception and emotion. This technology absurdly simplifies an often very complex problem in the hope of a quick solution to a very costly medical problem."

For example, the first FDA-approved smart pill is used to treat patients with schizophrenia, who often suffer from paranoia about surveillance, as well as distrust of medicines and medical personnel. Svirski notes that the desire to improve compliance with the treatment protocol for this particular category of patients is understandable, given that many of them have stable use of medications that provides very good results. However, given their vulnerability and the uniqueness of the symptoms of the disease, the ethics of this issue can be very controversial.

The researchers warn that the clinical effectiveness of smart pills should be evaluated by comparing the effectiveness of drugs that are the standard of therapy, that is, the same as the effectiveness of any other interventions, and not solely based on data on compliance with the treatment protocol or financial savings.

Associate Professor Andrew Boyd, co-author and colleague of Svirsky, believes that when it comes to medical information technologies, "we should count on the long term. It's not just about the return on investment, but about using technology and data in a way that will change our lives for the better. There is nothing more personal than our health and, despite the fact that the healthcare system strives to introduce high-tech innovations, we cannot introduce them at the cost of losing trust between the doctor and the patient."

Boyd believes that the use of technologies of this type should also not outpace public policy and legislative activities, which should properly regulate the mechanisms of access to data, as well as their use or acquisition by various companies.

In their article, the authors write that "medical information technologies optimally perform their functions in conditions of cooperation between doctors and patients. Without a magic pill that can cure all the problems of modern relationships between doctors and patients, it is better for the latter to receive help from specialists seeking a comprehensive understanding of the issue of compliance with the protocol of therapy than from specialists using technology that they do not understand."

The article by Eric Swirsky & Andrew Boyd Adhesion, Surveillance, and Technological Hubris is published in the American Journal of Bioethics.

Evgenia Ryabtseva, portal "Eternal Youth" http://vechnayamolodost.ru based on the materials of the University of Illinois at Chicago: Smart pills dumb down medical care, experts warn.