Medical research can have big rewards—both in gratifying discoveries and in potentially turning them into profitable treatments. To achieve the former, researchers work hard. Very hard. To obtain the latter, they can start companies or sign commercial funding agreements—well before testing is over. So, do patients undergoing clinical trials for new treatments have a right to know about these monetary interests?
Legally, no. And no empirical data has tied researchers' financial interests in a study to negative outcomes for patients. In the past several years, however, more findings suggest that, ethically, patients should be informed prior to participating in a trial.
Various federal agencies, including the U.S. Food and Drug Administration and the Department of Healthe and Human Services, have made general recommendations that institutions review and consider conflict-of-interest notification policies. More pragmatic guidelines remain elusive.
A new letter, published yesterday in The New England Journal of Medicine, brings together data from the five-year Conflict of Interest Notification Study backed by the National Heart, Lung and Blood Institute, along with broader reports on conflict of interest in medicine released by the Institute of Medicine (IOM) and the Association of American Medical Colleges (AAMC) to examine the practical goals and challenges of presenting this information to possible trial participants. The paper's lead author is Kevin Weinfurt, an associate professor at Duke University in Durham, N.C. He asserts that making this information available to patients should help achieve the following: ensure patient welfare, promote informed decisions, respect assumed right to know, create trust, decrease legal liability, and ultimately discourage financial conflict of interest.
The impact of being informed
After finding out about a conflict of interest, who would trust a coach who was betting on the game?
Most patients, it turns out.
A 2003 survey, led by Scott Kim, an associate professor in the bioethics program at the University of Michigan at Ann Arbor, showed that if participants were told that a researcher or institution testing a treatment was being funded by the pharmaceutical company that made the drug, 40 percent would be more willing to participate—a finding Kim chalks up to an appreciation for up-front honesty. If the financial arrangement were switched, however, and a researcher had an equity investment in a company that owned the treatment method (and their share of earnings would increase if a treatment went to market and did well), more than a third of patients said they would be less willing to participate.
That sizable minority alone, says Kim, should indicate that investigators and institutions have an ethical obligation to disclose financial information to patients.
Making such a disclosure beneficial to all involved might be trickier than simply adding a line to the informed consent forms, the authors of the new paper point out. Some worry that bogging down already lengthy consent documents with details about financial arrangement could confuse patients. Weinfurt and others note that there's "a worry that patients already tune out and don't pay attention to what's there," he says. "Any decision to add length to the consent form is potentially going to make patients tune out even more." In focus groups, he found that many patients still weren't entirely clear on the implications of certain financial arrangements after hours of discussion, and he worries that even simple statements might not be understood or taken into account properly when patients are deciding whether or not to participate in a clinical trial.
"Informed consent is a huge problem," Kim also says. "The language is written by lawyers, [not] by psychologists. [And] rather than an opportunity to truly help people make difficult decisions, it mostly operates on institutional efforts to comply with federal regulations."