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Experts suggest health care providers and policymakers proceed with caution when exposing patients to the digital pill.
Despite growing enthusiasm for the smart pill, research from the University of Illinois at Chicago (UIC) suggests that health care providers and policymakers should be cautious when allowing this technology into patient care settings.
Smart pills, or digital pills, are prescription medications equipped with edible electronic sensors that send wireless messages to devices, such as patches, smartphones, or tablets, outside the body when they are ingested.
In the paper, Adherence, Surveillance, and Technological Hubris, published on Sept. 20, 2018 in The American Journal of Bioethics, 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.
In November 2017, Otsuka Pharmaceutical’s Abilify MyCite became the first digital pill approved by FDA for human use the treatment of schizophrenia, bipolar disorder and major depressive disorder.
Some hope the technology will help patients and doctors track drug regimen compliance and increase patient adherence, but 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, in a Sept. 20, 2018 press release. “It is naive to think that this type of surveilled 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 in the press release. “This technology dumbs down an issue that is often very complex in the hopes of quickly solving an expensive medical challenge.”
For instance, the first FDA-approved smart pill is being used in patients with schizophrenia, who often suffer from paranoia about being surveilled 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 unethical considering their unique symptoms and vulnerabilities.
Swirsky coauthored the paper with his UIC colleague Andrew Boyd, who stated in the paper 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, in the release. “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.”
Boyd also states that use of this type of data-based technology 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 explained in the paper. “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.”