Carl Elliott is Professor in the Center for Bioethics and the Department of Pediatrics, and an affiliate faculty member in the Department of Philosophy and the School of Journalism and Mass Communications. He is the recipient of a 2018 Guggenheim Fellowship and a 2018 National Endowment for the Humanities Public Scholar Award. Elliott is the author or editor of seven books, including White Coat, Black Hat: Adventures on the Dark Side of Medicine (Beacon, 2010) and Better than Well: American Medicine Meets the American Dream (Norton, 2003.) His articles have appeared in publications such as The New Yorker, The Atlantic Monthly, The New York Review of Books, Mother Jones, The New York Times, The American Scholar and The New England Journal of Medicine. He is currently working on a book about whistleblowing in research on human subjects.
In 2019, Elliott was the Cary and Ann Maguire Chair in Ethics and American History at the Kluge Center.
I interviewed Elliott on how some current issues in medicine connect to his research.
Dan Turello: Carl, whenever I hear about clinical trials, I wonder what would make someone want to participate. If they are super sick, and they know they risk getting a placebo, what is the incentive?
Carl Elliott: Depends on the study. Some research subjects get a paycheck. That’s the main draw for healthy subjects who test the safety and toxicity of unapproved drugs. Those safety trials—Phase I trials—used to be done on prisoners. Now they are done mainly on poor people: undocumented immigrants, the unemployed, the homeless, contract workers and anyone else who’s desperate for money and has run out of options. The situation is similar for Phase I vaccine trials. The University of Maryland is running an advertisement for a COVID-19 vaccine safety study on Craigslist right now. The payment is $1,375.
It’s very different for research subjects who are sick. Some patients volunteer for humanitarian reasons, but the main draw is the possibility of a better treatment for their condition. Sometimes there’s no effective standard treatment, or maybe the standard treatment comes with painful or unpleasant side-effects. It makes sense that these patients might be looking for something else. Of course, that something else generally means treatment, not a placebo. Having an effective treatment stopped and getting assigned to a placebo instead could put some patients at serious risk.
DT: What safeguards are in place to ensure patients are fully aware of their rights?
Bad ones. After the Tuskegee syphilis study and other research scandals in the 60s and 70s there was political pressure to regulate medical research. But researchers pushed back, of course, and the compromise we wound up with is the bureaucratic oversight apparatus we have now—“Institutional Review Boards” or IRBs. It’s a deeply flawed system. IRBs are supposed to protect research subjects, but subjects themselves have no idea what an IRB is. Some IRBs are for-profit businesses paid by the companies whose research they’re supposed to oversee. Almost never does a member of an IRB set foot in the place where the research is being done; IRBs simply review studies on paper before they start. That’s why we get scandals like the SFBC fiasco in Miami in 2004, where researchers were paying undocumented immigrants to test experimental drugs in a dilapidated hotel with a history of fire and safety violations. At the time, it was the largest research facility in the country.
DT: Could you tell us something about investigational drugs, and the FDA’s “compassionate use” category?
“Investigational” is just a less scary way of saying “experimental.” The medical community has lots of weasel words like this. It turns out that when people hear the word “experiment” they think “Nazis” or “Tuskegee,” which can make them pretty reluctant to sign up. So in the 1990s researchers started saying “clinical trial” and “research study” instead. It’s similar for deaths and injuries in research. The research community calls those “adverse events,” which sounds much less terrifying.
An “investigational drug” is simply a drug that the FDA hasn’t approved yet for the condition in question. Usually the only way to get access to an investigational drug is in a research study. But some patients may not be eligible for a study and are willing to risk trying the drug anyway, before it has been shown to be safe and effective. Through a compassionate use policy, those patients and their doctors can apply for access to those drugs or devices outside the study.
DT: During the COVID-19 pandemic, many Americans are thinking about medical ethics in terms of what happens to them if they are hospitalized or incapacitated. What are the key questions every individual should consider before landing in a hospital, and how can advanced directives be used to help?
The most important thing for anyone in the hospital is to have someone to advocate for them. There are so many things that can go wrong in hospitals. You don’t want to be alone and vulnerable. That’s one of the most frightening things about the COVID-19 crisis—the fact that family members of afflicted patients are shut out of the hospital.
As for advanced directives: The first thing to decide on is who you want to be making decisions for you if you become unable to make them yourself. If there is likely to be disagreement in your family, you should make sure everyone knows who speaks for you. The next thing is to have a conversation with that person and everyone close to you about what you would want done in specific circumstances— whether you’d want to be given CPR if your heart stops, how aggressively you want to be treated, the circumstances under which you would agree to be put on a ventilator or given tube feeding.
DT: As the world races to develop a vaccine, what ethical issues are of concern to you?
This virus has been like a missile aimed at the most vulnerable people in America—poor people, ethnic minorities, the elderly, homeless people, disabled people living in group homes. Over 80% of COVID-19 deaths in Minnesota have been people in long-term care facilities. What makes it even worse is that the economic consequences of the virus have also hit hardest at the most vulnerable populations.
I worry that the urgency of developing a vaccine may lead researchers to cut corners. I’m also concerned that vaccine trials will draw on the same poor, vulnerable populations as Phase I drug trials. If any subjects are injured, chances are they’ll be responsible for their own medical bills. The United States is the only developed country in the world where research sponsors are not required to pay for the medical care of injured subjects. And if a vaccine is developed, I’ve still seen no guarantees that it will be made available to everyone regardless of their ability to pay.