Enthusiasm for an emerging digital health tool, the smart pill, is on the rise but researchers at the University of Illinois at Chicago caution health care providers and policymakers to slow down when it comes to allowing this technology in patient care settings.
Smart pills, or digital pills, are prescription medications equipped with edible electronic sensors that send wireless messages to devices, like patches and smartphones or tablets, outside the body when they are ingested. The first of its kind, which is used to treat patients with schizophrenia, bipolar disorder and major depressive disorder, was approved for use in humans by the US Food and Drug Administration in 2017.
Some hope the technology will help patients and doctors track drug regimen compliance and increase patient adherence, which estimates show may save between $100 and $300bn annually in the US. Others have concerns about patient privacy, consent and data sharing.
Eric Swirsky, an expert in the legal and ethical issues related to health care technology, says that both groups have valid arguments but that neither is asking the right question. "We need to know if smart pills are going to actually improve patients' lives, which is much more complicated than compliance or privacy," said Swirsky, clinical associate professor of biomedical and health information sciences in the UIC College of Applied Health Sciences. "It is naive to think that this type of under surveillance compliance with provider-recommended drug treatments will function like a magic pill. More likely, it will just challenge the ingenuity of patients."
Swirsky said there is simply no evidence yet to suggest smart pills benefit patients and that using the technology outside of clinical trials "flies in the face of the research we do currently have, which shows that patients benefit by receiving care from providers who can manage the many issues around adherence."
"Smart pills are a dangerous reduction of the provider-patient relationship and there is no shortcut to improving patient adherence, which happens in a larger framework of home, work and clinical environments, not to mention perceptions and emotions," Swirsky said. "This technology dumbs down an issue that is often very complex in the hopes of quickly solving an expensive medical challenge."
For example, the first FDA-approved smart pill is being used in patients with schizophrenia, who often suffer from paranoia about being under surveillance and distrust of medication or care providers. Swirsky said the intent to improve medication adherence in this group of patients is understandable, given that many patients see remarkable benefits from consistent medication use, but it is arguably unethical considering their unique symptoms and vulnerabilities.
The researchers warn that smart pills should be evaluated based on their clinical efficacy against the standard of care drugs, like any other intervention, not based only on compliance or cost savings.
Swirsky co-authored the paper with his UIC colleague Andrew Boyd, who says that when it comes to health information technology, "we need to think about the long game."
"It's not just about return on investment – it’s about using technology and data in a way that changes lives for the better," said Boyd, associate professor of biomedical and health information sciences in the UIC College of Applied Health Sciences. "There is nothing more personal than our health, and as health care strives for high-tech innovation, we cannot do it at the expense of trust between provider and patient."
Use of this type of data-based technology, Boyd said, should also not outpace public policy and legislation in properly regulating how this data is shared, used or purchased by companies.
"Health information technology functions best when implemented in conjunction with doctors and patients in a collaborative manner," the researchers write. "With no magic pill to cure the ills of the modern doctor-patient relationship, patients would be better served by providers who seek a comprehensive understanding of adherence than those who employ technology they do not understand."
Eric S Swirsky, Andrew D Body
Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.
Craig M Klugman, Laura B Dunn, Jack Schwartz, I Glenn Cohen
[link url="https://today.uic.edu/smart-pills-dumb-down-medical-care-experts-warn"]University of Illinois at Chicago material[/link]
[link url="https://www.tandfonline.com/doi/abs/10.1080/15265161.2018.1498953?journalCode=uajb20"]American Journal of Bioethics abstract 1[/link]
[link url="https://www.tandfonline.com/doi/full/10.1080/15265161.2018.1498933"]American Journal of Bioethics abstract 2[/link]