Uninsured People and Clinical Trials

Both ethical and practical issues raise concerns

 How does an uninsured person’s participation in a clinical trial affect the outcome? Does the lack of affordability of healthcare give rise to untenable situations in choosing participants for clinical trials?

 These were some of the issues addressed by George Marzouka, MD, who wrote an article called “Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets” in Medical Bag recently.

Dr. Marzouka cited a hypothetical example of a middle-aged American couple barely getting by, deciding to forego health insurance coverage and learning that the man of the house has a malignancy. Faced with the inability to pay for the treatment without health insurance, the man is eager to participate in a clinical trial in which the pharmaceutical company involved will cover all of the costs.

 According to the article, 38.7 million people in the United States faced this exact scenario in 2000. When the Affordable Care Act (ACA) was passed, the number of uninsured Americans dropped to 28.2 million in 2016. That accounted for 8.8% of the American population. Because of the recent political turmoil involving the ACA and the repeal of the healthcare-for-all insurance mandate, the number of Americans lacking health insurance is back up again. To complicate the situation, insurance companies are offering “skeleton plans” that many consumers do not completely understand. The patients think that they are insured, only to learn that they are underinsured or not insured for certain illnesses or conditions.

 Marzouka said, “The number of underinsured individuals is also on the rise as these second-rate plans become more popular due to their lower cost. So it is no wonder that uninsured patients are often enthusiastically willing to participate in research trials as a means to gain access to the healthcare or treatments they so desperately need.”

 Dr. Marzouka raised concerns about the ethics of underinsuring people and making them feel if their only option is to be part of clinical trials. Additionally, he expressed concerns about the practicality of having low-income earners as key players in clinical trials. As he explained, “Many face increased barriers to enrollment and retention in clinical trials. For example, many of these patients may not be able to get time off from work to attend follow-up sessions; may not have transportation to and from clinical centers; and if they have children, may not be able to afford daycare services. Socioeconomic issues can lead to problems with retention in clinical trials despite the willingness of uninsured patients to participate in these trials.”

 Until there is some kind of affordable healthcare system that works, this issue will arise. Apparently, some people are faced with using clinical trials as their primary means of healthcare access, and that creates issues on the part of everyone involved.