I didn’t want to attend this conference because I knew that it would be difficult and painful. Like having your wisdom teeth pulled without anesthesia.
As my colleague, bioethicist Carl Elliot, put it: “Only 16 percent of academic health centers in this country will pay the medical bills for research subjects who are injured in clinical trials. None will pay for lost wages and suffering. And an ethicist is arguing that we all have a duty to sign up for these trials? Give me a break.”
But Carl was not able to attend this conference and I knew that Mary Weiss, the mother of Dan Markingson, would be there. Her son died in connection with a clinical trial at the University of Minnesota that has become notorious. I wanted to offer moral support. I met her - for the first time - before the start of the conference. She seemed in control, and we had a pleasant conversation, but I was concerned. After the first talk, on the pro side, she had to leave. I could understand why.
My original intention was to try to present a dispassionate description here of the pros/cons of the question outlining the case made by each side. But I can’t. At first I was offended that my university would put on such a conference given our terrible record with clinical trials in the past. It seemed hypocritical. But in retrospect, I thank the Center for Bioethics for broaching the subject. During the conference most of the points that needed to be made came out. Professor Joan Liashenko did the heavy lifting of organizing and running the conference.
I was particularly impressed by two African-American women who persistently questioned the claim that treating research participation as a moral obligation would actually help the minority community. Henrietta Lacks came up during the discussion. I later learned that one of these women is a bioethicist and the other the president of the Minnesota Black Nurse’s Association.
Which brings me to the first problem I have with the title proposition. Cui bono? And I maintain that the answer is overwhelmingly the pharmaceutical industry. This proposition finds support in the Lysaught presentation cited below.
But what really frosted me was the “moral obligation” business. Thou shalt not steal, thou shalt not kill, thou shalt not covet thy neighbor’s wife, thou shalt participate in clinical research?
The argument that it’s just like paying taxes or giving to charity seems absurd to me. As one of the participants put it, the consequences of paying taxes are not nearly as great as losing one’s life, or being blinded. And for what? Mostly to justify supposedly new clinical therapies for pharma?
And as for charity... Most of us believe, even if we don’t believe in a God, that we are our brother’s and sister’s keepers. When we give to charity, if we are so inclined, we can do a little investigation. We can find, if we wish, something about the percent of money that actually goes to use in a charity and how much goes to administration.
Most patients are not capable of making scientific judgments about whether a clinical trial is worthwhile. Many doctors and people who sit on institutional review boards are not. To claim that people should risk themselves, out of beneficence, to participate in a clinical trial is unreasonable. Certainly to declare it to be a moral obligation is wrong.
I was upset by the use of the term “moral obligation” because I think this means something far beyond “this would be a good idea.” I don’t think there is support for the proposition in the works of, for example, Kant or John Stuart Mill. But these arguments are dense and not easily capsulized for this forum.
I did find a wonderful talk by Professor Susan Wolf of the University of North Carolina, who gave the Frumke lecture at NYU entitled: “Moral Obligations and Social Commands.” This talk examines the concept of what a moral obligation is and gives examples. To claim that participation in research is a moral obligation does not seem to pass the Wolf Test. This outstanding lecture is available in hard copy here and even, mirabile dictu, on YouTube.
It was an exhausting day. Certainly caused a Brainstorm. I drove one of the speakers to the airport and came home. Took three beers to return to earth.
I feel a little guilty in taking what may be a polemical stand on this question. So, in fairness, I put some links below to the slide presentations of the speakers. They very generously allowed them to be posted publicly on the Bioethics Web site at Minnesota.
Speakers with links to slides:
M. THERESE LYSAUGHT, PhD - Theology, Marquette University
Corporeality and the Corporation: Biopolitics and the Moral Obligation to Participate in Biomedical Research
DAVID ORENTLICHER, MD, JD - Medicine and Law, Indiana University
Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research
ROSAMOND RHODES, PhD - Bioethics, Mt. Sinai School of Medicine
Why We Are All Obliged to Participate in Biomedical Research
RICHARD SHARP, PhD - Bioethics, the Cleveland Clinic
MARK YARBOROUGH, PhD - Bioethics, UC Davis Medical School
Strong vs. Weak Obligations to Participate in Research: The Importance of Trust and Community
References to two papers - one pro and one con - that may help frame a beginning inquiry:
Rosamond Rhodes, Rethinking Research Ethics, American Journal of Bioethics, 5, 7-28 (2005).
M. Therese Lysaught, Docile Bodies, Transnational Research Ethics as Biopolitics, Journal of Medicine and Philosophy, 34, 384-408 (2009).