Healthy Skepticism Library item: 7007

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Weiss R.
Most Cancer Patients Unconcerned About Doctors' Ties to Drug Firms: Research Reviewers Also May Often Have Links to Industry
The Washington Post 2006 Nov 30
http://www.washingtonpost.com/wp-dyn/content/article/2006/11/29/AR2006112901387_pf.html

Abstract:

The vast majority of cancer patients participating in studies of experimental drugs do not care if the doctor running the study has financial ties to the drug’s maker, according to a new survey that undermines “full disclosure” as a central tenet of clinical research.

Medical and professional societies have increasingly urged doctors to reveal all such conflicts of interest so patients can judge whether their doctor may have more than their health at heart. But perhaps because they are already overwhelmed by the challenges of their disease, most patients said they did not need to know those details and trusted that rules were in place to protect them.

That trust, however, may be misplaced, according to a second survey, published alongside the first in today’s issue of the New England Journal of Medicine.

In that survey of “institutional review board” members — who decide whether proposed clinical studies are ethical and reasonably safe — about one-third of those who were asked to judge a proposal in which they had a financial stake had not disclosed that conflict to the board’s chairman and did not consistently recuse themselves, in apparent violation of federal rules.

In addition, more than 40 percent of review board members did not know if the board they served on had a formal definition of what constituted a conflict of interest.

“You’d think they’d be asking, ‘How do I know when to do things and when not to?’ “ said Eric G. Campbell, of the Institute for Health Policy at Massachusetts General Hospital and Harvard Medical School, who led the survey of review board members with co-worker Edward Greg Koski.

“My sense is that relationships with industry are a fundamental part of the modern life-science enterprise,” Campbell said. “They are not universally bad and not universally good. But you can’t manage what you don’t know about.”

The surveys highlight issues arising from the growing presence of for-profit medicine in the academic and clinical research arena, which in decades past was largely free of corporate ties.

Virtually all major medical centers and research universities now have collaborations with pharmaceutical or biotechnology companies. The research centers provide expertise, academic cachet and willing patients for companies developing drugs, while the companies provide income for the institutions and, in many cases, for doctors and faculty members serving as consultants, officers or board members.

That poses a conflict of interest for doctors and review board members, whose first responsibility is to protect patient health and safety. That is why the American Medical Association, the World Medical Association and other prestigious institutions have called for full disclosure to patients of such relationships.

To find out whether patients cared, a team led by Ezekiel J. Emanuel and Lindsay A. Hampson of the Department of Clinical Ethics at the National Institutes of Health in Bethesda surveyed 253 cancer patients enrolled in clinical trials at five U.S. medical centers.

Eighty percent said they were “not worried at all” that the doctor leading the study may have a stake in the company that could profit from the tested drug. About 70 percent were similarly unworried about links between the cancer center and the drug company.

More than 60 percent of patients said it was acceptable for researchers to own stock in the company whose drug they were testing; 70 percent said they did not mind if doctors received royalty payments; and 80 percent said the same about consulting fees.

Most patients said they opposed bans on such relationships and some said they would be more likely to participate if a company were involved.

Patients with the highest education levels tended to be more concerned about conflicts of interest. But even though most of those surveyed were well educated and economically privileged, less than one-third said they wanted to know about potential conflicts.

“They said they don’t want this information and it’s not going to affect their decisions,” Emanuel said. In many cases, when the information is there, it is buried in dense consent documents, he added.

What patients do want, however — and what 62 percent of them said they presumed is in place — is an oversight system for those issues. And in that regard, said Campbell of Harvard, some may be disappointed to learn the truth.

In his survey of 574 institutional review board members, 15 percent had in the past year been called upon to judge a proposal in which they had a financial stake. Of those, about a third said they “never” or “rarely” disclosed such conflicts, and a similar proportion said they “always” or “sometimes” vote on such proposals, a breach of federal research rules.

David Korn, a senior vice president at the Association of American Medical Colleges, said the finding that concerns him most is board members’ apparent lack of understanding of the rules.

“If it were my institution, I’d want to make sure my IRB members damn well knew what a conflict was and how to deal with them,” Korn said, adding that review boards need to be sensitive not only to financial conflicts but also to professional and academic rivalries that could affect decisions.

But he said it would be wrong to conclude from the patient survey that patients should not be informed of potential conflicts.

“They may decide it doesn’t matter to them, but I think they have a right to know,” Korn said. “What if they find out later? Then it becomes a worm of mistrust.”