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Pay to Play: Should patients have to pay to be part of experimental trials?

November 07, 2016
Linda Smith was diagnosed with osteoarthritis and was seeking a treatment that would serve as an alternative to traditional surgery. Linda turned to ClinicalTrials.gov, maintained by the National Institute of Health (NIH), the most comprehensive public database available to the U.S. and abroad that contains listings for more than 220,000 clinical studies. Linda came across a promising study being conducted by StemGenex Medical Group, but upon calling the company to ask questions, discovered she would have to pay $14,000 in “associated costs” [1].

By Danielle Martinez-McCormack

StemGenex claimed that it was doing an “observational study” and the actual treatment was not a part of its research protocol and would not be provided by StemGenex. Linda was understandably frustrated by the lack of transparency on ClinicalTrials.gov, as well as the prohibitory cost of the clinical trial, and ultimately found a free clinical trial that met her needs. Linda’s experience is not unique and begs the question of whether research subjects should have to “Pay to Play” and participate in experimental clinical studies [1].

Pay to Play

It is not uncommon for clinical studies to provide research subjects compensation for the risks and inconveniences they may incur as a result of a clinical study. However, a recent “Pay to Play” phenomenon is emerging that asks patients to pay to participate in clinical studies. The shrinking budgets of NIH and other research sponsors are creating a void that is forcing researchers to get creative with funding, and turn to patients to fill this void [1]. This strain on resources can be seen in other areas of healthcare, whether it be through higher deductibles or copayments, or patients bearing a larger fraction of their medical costs. While there are no legal or regulatory prohibitions that restrict researchers from charging subjects to participate in clinical studies, there are several ethical issues to take into consideration [2].

Proponents of Pay to Play

First, proponents of Pay to Play argue that participants’ payments allow unfunded research—that otherwise would not have been conducted due to limited resources—to occur. All properly conducted research studies enhance social value, even if they produce negative results. Studies either result in successful treatments or provide learning opportunities for future studies [2].

Second, advocates of Pay to Play state that it is a patient’s freedom to spend their money as they wish, as long as they are not harming others or “diminishing their own rights or opportunities.” If a sick patient participates in an experimental clinical study, there is a possibility that they will benefit from the treatment, and nobody else will be harmed by their participation. Pay to Play is very similar to “Right to Try” laws, which grant terminally ill patients the right to pay companies for access to experimental drugs not yet approved by the FDA; these laws have already been passed in 28 states [4].

Lastly, if a clinical study’s cost is prohibitive, as it was for Lisa, patients who lack the means to pay or are not interested have no obligation to participate. Since nobody has a right to unproven, experimental interventions, there is no need to guarantee equitable access [2].

Opponents of Pay to Play

That being said, Pay to Play studies can be seen as exploitative of terrorized patients or families of patients who have exhausted all other options and are desperate to try anything. Healthcare will never be a perfect market place as long as people are being asked to place a price on the life of a loved one. Terminally ill patients are placed under undue pressure and are willing to pay any cost to extend their lives, which puts into question the voluntariness of their participation. Patients in these dire conditions cannot be expected to act as rational consumers, are under heavy bias, and are unable to make informed decisions [4]. Research shows that subjects are overoptimistic about potential successful outcomes and believe that when they pay for medical care, they are guaranteed a benefit—this is more often than not the case. Studies with “promise” and supporting data are more likely to receive external funding, while unfunded studies are more likely to be early stage trials, which have the lowest success rates and are least likely to benefit individual participants [2].

Map of the United States highlighting which states have Right-to-Try

Pay to Play compromises the scientific validity of clinical studies and risks corrupting the entire scientific industry. Studies that place high price tags on participation will have a selection bias, and participants are more likely to be wealthy and from higher socio-economic backgrounds. This may incentivize research institutions to prioritize the research needs of the wealthy, since they will be the main providers of funding. Additionally, the Pay to Play model may encourage researchers to shift their attention away from major public health issues to lucrative areas of research that have less social value. By having patients pay for participation, they will be less willing to participate in randomization or placebo trials, which will compromise the validity and generalizability of the trial. This may also foster an unsafe research environment. Subjects may be less inclined to acknowledge symptoms or problems that would lead to their exclusion from the study and may be reluctant to accept that their investment failed [2].

Conclusion

When considering the societal harm that may result from the rise of Pay to Play clinical studies, one must consider if the possible benefits outweigh the risks. Researchers estimate that the individuals who would actually experience successful outcomes from their participation in these early stage trials are very few in comparison to the individuals who would be harmed by “compromising the integrity of the entire research enterprise.” The United States should strongly consider creating a policy to safeguard patients from being exploited by Pay to Play clinical studies and to protect the veracity of our clinical research industry [3].

References

  [1] E. Bazar, “Want to Enroll in a clinical trial? NIH database is huge-but lacks a few key details,” The Washington Post, Jul. 2016. 

  [2] E. J. Manuel and S. Joffe, “Should we charge patients for medical research?,” The New York Times, 31-Jul-2015. 

  [3] E. J. Emanuel, S. Joffe, C. Grady, D. Wendler, and G. Persad, “Clinical research: Should patients pay to play?,” Science Translational Medicine, vol. 7, no. 298, 2015.

  [4] R. Dresser, “The ‘Right to Try’ Investigational Drugs: Science and Stories in the Access Debate,” Washington University of St. Louis, Jul. 2015.

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  • The views expressed on the Student Blog are the author’s opinions and don’t necessarily represent the Penn Wharton Public Policy Initiative’s strategies, recommendations, or opinions.

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