NEWS

Studies Prompt Closer Scrutiny of Conflict of Interest Policies

Karen Young Kreeger

A new study has once again focused the spotlight on the ever-increasing connections between academic research and private enterprise, raising questions about scientific objectivity.

The report, published in the April issue of Science and Engineering Ethics, found that of the 61,134 original research articles published in 1997 in 181 peer-reviewed journals that have conflict of interest policies, 327, or 0.5%, revealed author personal financial interests related to the research.

These interests included honoraria and equity in companies—the most common types of interests—as well as consulting fees, patents, and expert witness fees. Additionally, those disclosures occurred in one-third of the 181 journals reviewed, with the remaining journals showing no published disclosures.

The report was written by Sheldon Krimsky, Ph.D., a professor of urban and environmental policy and planning at Tufts University in Medford, Mass., and L.S. Rothenberg, J.D., of the Department of Medicine at the University of California at Los Angeles.



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Dr. Sheldon Krimsky

 
Because nearly three-quarters of the journal editors surveyed for this study usually publish author disclosure statements, the authors suggested that the seemingly low proportion of disclosure came as a result of low rates of author financial interest in the research discussed or poor compliance by authors to journals’ policies, perhaps because of misinterpretation or vagueness of the policies themselves.

Mildred Cho, Ph.D., senior research scholar at the Stanford Center for Biomedical Ethics at Stanford University, said that these are likely explanations, but that in her experience, authors may simply not understand what a potential conflict is.

"I run across that a lot. When authors see ‘conflict of interest’ they think that it automatically means misconduct, and so feeling that the financial interest hasn’t affected their judgment, they don’t report it." She added that another explanation might be that journal editors decide that a disclosed author conflict is too insignificant to pass on to the reader.

David Blumenthal, M.D., director of the Institute for Health Policy at Massachusetts General Hospital in Boston cites a few other reasons for authors not readily disclosing financial conflicts with published research: privacy; wanting to avoid the suspicion that their work is in any way affected; and outright denial that it matters. "I think that unless [authors] are required and monitored in their disclosure that investigators will tend to minimize it, and even to avoid it," he said.

"I can see why authors don’t want to disclose because there’s an implication that they’re not honest if they do, but if the requirements are that you need to disclose, then let somebody else make that judgment," said Krimsky.

It is this type of focus that concerns Kenneth J. Rothman, Dr.P.H., professor of epidemiology at Boston University, and editor emeritus of the journal Epidemiology. Although Rothman is very much in favor of disclosure policies and Epidemiology has a conflict of interest policy for authors, he said, "the way this discussion goes is that the funding source becomes the focus of discussion and the work gets to be of secondary interest. The dialogue of the science moves away from what you did to who you’re working for. That’s not science, that’s politics."

The fact that an author has financial ties to the research discussed in a publication does not necessarily mean that the study is inherently biased, agree most researchers. "If we assume that disclosing somehow taints their results, is that correct?" asked Stephanie Bird, Ph.D., editor of Science and Engineering Ethics and special assistant to the provost at the Massachusetts Institute of Technology. "That seems quite questionable. I’m concerned that disclosure gives us a false sense of security." But Bird was quick to add that the scientific community has to be attentive to inappropriate bias in data analysis and research findings.

Subtle Trends

Over the last 2 decades an increasing number of academic researchers have become associated with industry funds in some way, but little is known about the extent, except for results from a few regional studies.

For example, in an earlier study, Krimsky and colleagues examined nearly 800 articles from 14 journals published in 1992 by biomedical scientists from nonprofit research facilities in Massachusetts and found that 34% had a first or last author with a financial interest in the paper’s research. Disclosure of that relationship appeared in almost none of the papers.

The results of this study lead Cho to think that low rates of authors’ financial interest is the least likely explanation for results of the current Krimsky and Rothenberg study.

More recently, Elizabeth A. Boyd, Ph.D., and Lisa A. Bero, Ph.D., found that, in 1999, 7.6% of faculty at the University of California at San Francisco reported personal financial ties with industrial sponsors of their research in documents maintained by the UCSF Office of Research Administration.

Despite the low rate of compliance found by Krimsky and Rothenberg, Krimsky cited a few compelling reasons for disclosure. First, he said that even the appearance of conflicts of interests should be noted to the public by editors and reviewers as a matter of principle.

Second, Krimsky and others point to a small, but growing body of evidence that shows financial interests can affect the outcome of research. One New England Journal of Medicine study comparing the source of authors’ funding versus the authors’ opinion on the safety of calcium channel antagonists found that 96% of authors who were supportive of the antagonists had financial relationships with their makers, compared with 60% who were neutral and 37% who were critical.

This kind of evidence, said Blumenthal, "supports what one expects of human nature—that personal connection, financial or other, [tends] to create a favorable inclination for the group or individuals to which you have a connection."

And third, said Krimsky, a manuscript’s reviewer needs as much information as possible to enable him or her to provide a critical review. In fact, 19% of the journal editors surveyed in the current Krimsky and Rothenberg study reported that they rejected a submitted manuscript primarily based on conflict of interest grounds. "Now that was surprising," said Krimsky. "I never realized that that many journals were that highly sensitive to the issue."

To explain this finding, Krimsky pointed to reports in the past 5 years that have exposed conflicts of interest in journals with well-known policies. One recent example is a letter of apology that editors of the New England Journal of Medicine issued to its readers for failing to mention potential author conflicts in several published papers in the late 1990s.

"One hypothesis is that [journals] don’t want [conflicts] to lead to an embarrassment," said Krimsky. "Secondly, they might have had some suspicions about an article and therefore this was just another strike against it."

Disclosure and Objectivity

Krimsky and Rothenberg found that of the 1,400 high-impact science and medical journals they examined, 15% had disclosure policies. More medical journals had policies than other types of journals. Blumenthal said that simply having disclosure policies at journals and enforcing them will not eliminate all bias. Compliance to disclosure policies "simply will alert the reader that there may be an effect of the funding relationship," he said.

But does that mean that journal editors should be disclosure police? "We’ve had evidence that even though [journal editors] knew [authors] had a conflict of interest they allowed the article to go in without a statement because they don’t want to be police," said Krimsky. What’s more, there is great variation in policies from journal to journal and some requirements are not very explicit. Many journals simply ask authors to report anything they believe will be a conflict of interest, amounting to self-policing by authors.

Although Rothman does not think that journals should take on the role of enforcer, he says that his position is the same as editors have taken at Nature and the Lancet, which is to encourage disclosure of anything that should it be disclosed later would be embarrassing to the author and to the journal.

"I think the authors’ role is similar to the institutions’ in that it’s their responsibility to see that a disclosure is necessary and that it sees the light of day," said Cho. "It’s the first line of defense, so if disclosure isn’t happening it means that the mechanism for trying to mitigate conflicts [is] failing."

Cho said that institutions depend on authors to make disclosures to journals and on the journals to actually publish the disclosures. But she added, "I think a lot of people think too much fuss is being made about disclosing conflicts of interest. Given that they are so frequent, it might be something that people pay less attention to."

No matter what scientists may think, there’s no question in Krimsky’s mind that conflicts of interest are a problem in health care. "There’s enough evidence now that health care research is biased in many areas because of this, and the more research we do, the more we see this."



             
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