Thursday, August 17, 2006

Conflicts of Interest in Clinical Research - Bold Thinking in the Journal of General Internal Medicine

The Joournal of General Internal Medicine has published a significant study and an important editorial on conflicts of interest affecting clinical research.

The article (Weinfurt KP, Friedman JY, Allsbrook JS et al. Views of Potential Research Participants on Financial Conflicts of Interest: Barriers and Opportunities for Effective Disclosure. J Gen Intern Med 2006; 21:901-906.) reported on research that used focus groups to question patients and prospective patients about their understanding of and preferences concerning disclosure of potential conflicts of interest (COI) affecting clinical research in which they might participate. Parenthetically, although the participants were given explanations of numerous species of COI, some significant ones were omitted, notably service by researchers on boards of directors of the companies sponsoring research, and conflicts affecting contract research organizations and for-profit institutional review boards (IRBs). The study produced some disturbing findings, particularly:

  • Some participants were initially unaware that such conflicts could even exist.
  • Participants found certain kinds of more complex financial relationships hard to understand even after considerable explanation.
  • Some participants did not want to hear about conflicts because they were afraid doing so would remove their illusions that the researchers were trustworthy.
  • Participants noted that extremely sick patients might be too desperate to care about COI.
The commentary (De Vries R, Elliott C. Why Disclosure? J Gen Intern Med 2006; 21: 1003-1004.) began with a discussion of some recent cases in which "financial interests have arguably placed subjects at risk." These included the TGN 1412 trial run by Parexel for the now bankrupt TeGenero (see our most recent post here), and trials run by SFBC International (see our most recent post here).

The editorial's summary of the effects of financial interests on clinical research was notable:

Medical research, once largely the province of academic researchers working in universities, has become a multinational corporate enterprise. Only about a quarter of clinical research now takes place in academic settings; academic researchers themselves have considerable financial ties to industry; and even the ethics review of clinical trials has become a major commercial enterprise.

How can a research subject be sure that the emphasis on 'return on investment' will not translate into a dangerous trial?

Summarizing the results of the study by Weinfurt et al, the editorial then suggested that "it is not irrational" for research subjects to "distrust disclosure as a remedy for conflicts of interest."

It then went on to summarize some recent research by cognitive psychologists. Cain and colleagues' experiments showed that disclosure of conflicts of interest did not lead those to whom the disclosure was made to be appropriately skeptical of advice provided by those with the conflicts. Even more important, after making disclosure, those with conflicts tended to say things that appeared even more biased by their own conflicts, as if "disclosure had given them moral license to exaggerate." The psychology researchers concluded "the solution to the bias created by conflict of interest is not simply to disclose the conflict, which makes bias even worse. Rather, the solution is to eliminate the financial conflicts."
So, "the important ethical question raised by conflicts of interest is not, as Weinfurt and his colleagues seem to assume, 'should researchers disclose?' but rather 'why has disclosure become such a popular way of managing financial conflicts of interest in medicine?'" Furthermore, "a more cynical explanation of the popularity of disclosure suggest that it is a 'remedy' for financial conflicts of interest that allows those conflicts to stay in place. Thus it does nothing to threaten the existing funding arrangements for clinical research."
Finally, "what is being overlooked here is the need to protect the welfare of potential research subjects. The real problem raised by industry-funded research is that the pursuit of financial gain might leader researchers to place subjects at risk in dangerous studies."

Bravo to the Journal of General Internal Medicine for publishing something so bold.

In my humble opinion, De Vries and Elliott are exactly right. Full disclosure, which is rarely practiced, might tell us about the extent of conflicts of interest affecting research, but it does nothing to manage these conflicts. The only real way to manage these conflicts is to eliminate them.

We need to drastically revise our system of funding clinical research. Clinical research should not be directly funded by, supervised, or implemented by organizations with a financial stake in the outcome. We need to develop a funding mechanism that funds clinical research as a resource that benefits all the people, and a cohort of researchers who will do their work well and honestly, devoid of financial arrangements with organizations that might benefit if their results turn out one way or the other.

1 comment:

Ken said...

You wrote that "Clinical research should not be directly funded by, supervised, or implemented by organizations with a financial stake in the outcome." I fully agree, but why not go the full mile? The same could be said with regards to health care... As long as organizations with a financial stake in the outcome - including individual physicians - are in charge, the same conflicts of interest are unavoidable...