Main Objections to Business Partnerships between Sponsors and Clinical Trial Participants

June 29, 2021 by Pierre Etienne in Actu-Real Blog

I have received a number of comments to my previous (Blog 4), including one by Dr. Indersen Gandhi, a medical consultant in pharmaceutical medicine from Hyderabad that offers the following idea: Instead of making clinical trial participants pharma business partners at the outset i.e. when they are asked to sign the ICF, as it would be rejected by many IRBs, why not encourage pharma sponsors to consider sharing some their profits with clinical trial participants AFTER the drug is successfully launched. This would avoid the risk of undue influence. “Consent should be given without this conditionality and sponsor should be encouraged to offer equity after successful approval. Precedents will be motivational (enough) without exercising undue influence. Such modified, consent will become an “experience-based decision.”

I had not thought of such a solution, and I would like to thank Dr. Gandhi for it.

I remain surprised however that so many critics of the business partnership proposal (attached to the ICF) anticipate that IRBs will universally see this arrangement as undue influence. Of course, those critics may be right; I have no data to the contrary, but the payment guidance document from the Harvard Clinical and Translational Science Center (HCTSC) (1) does suggest such a generalized reaction. This document simply says that:

being motivated by payment to participate in research, even when someone would not otherwise have made the choice to participate, is not by itself concerning; payment only raises concerns when it threatens to distort decision-making, and that IRBs concerned about undue influence should consider placing increased safeguards around informed consent (such as methods to ensure comprehension) as payment amounts increase.

At any rate, comments from Dr. Gandhi and others have prompted me to revisit the objection of undue influence and a second objection, the risk of commoditization of the human body that remains, even if one succeeds in resolving the first one. There were a number of objections of a technical / financial nature that are only relevant if these ethical objections are resolved.

As with cash compensation at entry, IRBs concerned about undue influence should consider placing increased safeguards around informed consent (such as methods to ensure comprehension). Intuitively, the fact that this compensation is deferred should reduce the risk of undue influence at trial entry. As to the risk of undue influence on the continued participation in a trial (despite adverse events, for instance), it is eliminated by making the deferred compensation independent of the duration of trial participation until trial exit. [As long as the main participation incentive remains the benefit of treatment, the risk of participation pretense, for financial benefits, should remain small.]

The other main ethical objection, the issue of commoditization of the human body is complex. Here, I do not want to engage over whether the organ trade (and its derivatives, biopsies, biological samples) should be legalized. Instead, I agnostically report that the beliefs and opinions regarding this question are distributed over a broad spectrum. At one extreme, objection to organ trade is eloquently expressed by one of the justices in the 1984 landmark case: Moore v. Regents of the University of California, who rationalized his decision to rule against Moore (who had sued the University of California for ownership of the cell line immortalized with his own spleen cells) as follows: “Plaintiff has asked to recognize and enforce a right to sell one’s own body tissue for profit. He entreats us to regard the human vessel – the single most venerated and protected subject in any civilized society – as equal with the basest commercial commodity. He urges us to commingle the sacred with the profane. He asks much.” (cited in (2, page 210)). At the other end of the spectrum, there are those who claim that the bottom line is that the body belongs to the individual, and, like any commodity owner, the individual is free to dispose of her possession as she pleases: it is her inalienable right to sell her body parts if she so wishes. (cited in (3, page 28)). More nuanced is an argument from a supporter of organs markets (cited in (4, page 42)): “I am advocating not that people be treated by others as property, but only that they have the autonomy to treat their own parts as property, particularly their regenerative parts”.

Opinions on the moral aspects of organ transplantation can be expected to remain distributed over a broad spectrum but we do not see them as germane to the question of whether deferred payments (that we equate with investments in this proposal) in exchange for participation in a clinical trial is a violation of the “sacred vessel”. In most instances, there is no body part being extracted from clinical trial volunteers except for regenerative parts such as blood, urine or other samples including biopsy material. More importantly, the value of participating in a clinical trial, in the eyes of a sponsor, is not the human body (the “sacred vessel”) or its parts, but representations (data) of the structure and/or function of the body, or the body part under study and its response to an external agent (the drug or biologic under examination). Those representations are immaterial and only have knowledge-value. Finally, those representations whether they are obtained outside clinical trials (as part of routine health care) or inside clinical trials (as part of health care research), are already systematically de-identified and sold on the health data market which is continually growing in breadth and sophistication. These health care data transactions do not directly benefit the individuals whose data contributed to the aggregated value of that market. The issue of commoditization of bodies or body parts in clinical trials appears minuscule in comparison with the issue of commoditization of data i.e., immaterial representations on the body’s responses to natural events (such as ageing) or exposure to standard of care, that is already being practiced on a large scale, beyond the explicit and specific authorization of their previous owners, before de-identification.

In the next blog, I plan to address practical aspects of establishing a financial partnership between clinical trial participants and pharma sponsors.

References

1. Harvard Catalyst. (Harvard Clinical and Translational Science Center) Payment Guidance. Version March 26, 2018

2. Wald, Priscilla. “What’s in a Cell? John Moore’s Spleen and the Language of Bioslavery.” New Literary History: A Journal of Theory and Interpretation 36.2 (2005): 205-25.

3. Fox, Renée and Judith Swazey. The Courage to Fail : A Social View of Organ Transplants and Dialysis. New Brunswick, NJ: Transaction Publishers, 2002.

4. Shital Pravinchandra Laxmidas. Inhuman transactions? Representing the commodification of human body parts. Ph.D. dissertation presented to the faculty of the graduate school of Cornell University, August 2009

Appendix

Pierre Etienne

Chief Medical Officer and Co-founder

Pharma industry veteran with 30+ years in large Pharma & in leading small biotechs, spearheading large initiatives and securing funding, psychiatry practice and research for 10+ years.