Is It Ethical to Do Research on Healthy People?

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Is It Ethical to Do Research on Healthy People?

Death of Johns Hopkins Volunteer Stirs Old Debate

By Jeff Levine

June 18, 2001

One of medicine's most time-honored principles is "Do no harm."

But when it comes to certain kinds of studies, healthy people could be put in harm's way. Such situations can occasionally lead to tragic consequences, for example the recent death of a young volunteer involved in an asthma study at the renowned Johns Hopkins Medical Institution in Baltimore.

Ellen Roche, a 24-year-old lab technician at Johns Hopkins University, died June 2, about a month after she began the experiment. The goal of the research was to find out more about how asthma can shut down a person's airways. Two drugs were used in the trial, initially planned for 10 people.

One medication triggered asthma symptoms. The other, hexamethonium, might hopefully tell scientists why some people are able to resist irritants that trigger an asthma attack while others can't.

The day after Roche started the experiment, she was hospitalized at the university's Bayview Medical Center with lung problems and never recovered. Her death, particularly at one of America's most prestigious medical centers, raises many questions. First, is it ethical to do research on healthy people? Many were ready to chime in with their opinions.

"It was intended to harm. The purpose of the study was to measure and analyze the nature of harm," attorney Alan Milstein tells WebMD. Milstein represented Jesse Gelsinger's family following the 1999 death of the 18-year-old, the first fatality caused by a gene therapy experiment.

Although Gelisinger had a genetic liver disorder, the disease was under control at the time of the treatment. The teen participated in the study for altruistic reasons.

"I think it's very close to what happened to Jesse Gelsinger," says Milstein of the Hopkins case. Milstein says too many institutions treat patients simply as a means to an end.

Roche got $365 to participate in the trial. Was she coerced?

"Of course not," Johns Hopkins spokeswoman Joann Rogers tells WebMD.

But many think that so-called "challenge" studies on healthy people are a crucial part of our medical system.

"These healthy volunteers are ... standing there as protectors of patients, and they willing to take these risks for a variety of reasons. Some for the income, some because they know someone who's ill with the particular disease, some just because they're good people," ethicist LeRoy Walters of the Kennedy Institute of Ethics at Georgetown University tells WebMD.

Though we often think of the hundreds of thousands of Americans participating in medical trials as people with life-threatening conditions like cancer or heart disease, that's not necessarily the case. Taking new drugs could be too dangerous for these people. And vaccine testing is another example -- a vaccine can be tested only on healthy people to see if it really can boost the immune system.

One key question is how well-informed patients are in these studies. Walters has questions about the Johns Hopkins asthma study. "The consent form did not mention a risk of serious illness or death. It talked more in terms of lowering blood pressure," says Walters.

Are there signs that a trial might have some inherent dangers?

"If you have a doctor standing by, that's probably because you think something could go wrong," ethicist Arthur Caplan, PhD, tells WebMD. The Johns Hopkins study did have a physician present throughout the administration of hexamethonium. "The consent then has to be ironclad, rock solid, perfect," says Caplan.

Walters says that these rare but tragic events point to the need for a federally sponsored insurance safety net for those injured in clinical trials. The U.S. Office for Human Research Protections has already launched an investigation into the asthma study and Johns Hopkins has promised full cooperation.