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A sensitive question

Scientific publications look for ways of dealing with conflicts of interest

NegreirosThe problem of conflicts of interest in scientific research, particularly in the field of biomedicine, is beginning to stir prestigious scientific publications. It is, undoubtedly, a complex question, since currently a great deal of research is paid for by companies and development agencies and it is undertaken by scientists they have hired or supported. The potential ability of certain financial interests to impose their wishes over ethical considerations led some prestigious magazines to adopt more rigid criteria in the choice of articles for publication. Since October 1, Nature has taken a series of measures to make any conflicting situations public. Before this, editors of 11 of the most prominent publications in the world had announced a similar decision. FAPESP, since March, has been employing the principle of full disclosure of information to get round potential ethical problems.

Nature’s rules
Researchers interested in publishing their papers in Nature must declare in writing their funding sources and any conflict of interest there may be in publishing the research. A summary of this declaration will be published as part of the paper and the full version will be available to those interested on the magazine’s website. If the researcher prefers, he can keep the information confidential, but readers will be told of this choice. For Nature, financing, employment, and personal financial interests relating to the research are competing interests.

Nature says that the new policy is not based on the assumption that commercial interests of researchers are likely to lead to any lack of integrity in the research. “It is based, above all, on recognition of the potential problems” points out the editor Philip Campbell, in an editorial published in issue no. 412, of August 23, 2001. The “potential problems” to which he refers are “suggestive” evidence in the literature that publishing habits in biomedical research may have been influenced by the commercial interests of their authors. A general concern among researchers is a possible undermining of the integrity of scientific research because of the increase in commercial ties and their resultant effects and the fact that many institutions are adopting this requirement in their publishing policy.

“Where we find that trust has been significantly impaired by the acts of an author, we will work to correct the problem through sanctions and communications to the employing readers” warns the editor. Charles Jennings, executive editor of the specialized monthly issues of the magazine, has says that there is great concern in the United States regarding the commercialization of research and cases are not uncommon where scientists make millions of dollars out of patents or contracts with companies. The precautionary measures taken by the magazine presuppose that the authors of research are telling the truth and, if proven otherwise, they will be judged by the scientific community.

Joint editorial
On September 10, the editors of 11 of the most prominent publications issued a joint editorial declaring a succession of measures taken to deal with this matter. They established, among other measures, that articles authors, and their revisers, must make known any relationship that might be considered a conflict of interest. Researchers have to sign a declaration stating that they have had full access to all the data concerning the study and that they hold themselves accountable for the completeness and accuracy of these data and their careful checking. Those in charge of the New England Journal of Medicine, the British Medical Journal, The Lancet, the Annals of Internal Medicine and the Journal of the American Medical Association sign the editorial.

At the time, Jeffrey M. Drazen, chief editor of the New England Journal of Medicine, said to Reuters Health that the idea behind the editorial was to make sure that researchers participated in defining and analyzing clinical trials. He relates that there are signs that some companies have attempted to suppress unfavorable data from the published results or have tried to interpret these data in a favorable light, thus limiting the participation of academic researchers. Given that companies finance most clinical trials, the new editorial policy, he predicts, will help identify the real sources of data, giving the public a better idea about how the information should be absorbed into their day-to-day routines.

Conflict and ethics
But there are those that believe that these measures will have little effect. Arnold Relman, emeritus professor of medicine at Harvard University, who was editor of The New England Journal of Medicine, from 1977 to 1991, published an article in the New Scientist, on September 22, 2001, criticizing the terms of the joint editorial. “The editors sustain that the best way of dealing with conflicts of interest is to make them apparent. Presumably, the implication is that we can live with this, provided that everyone knows what is going on” he wrote. The joint editorial, he observes, takes as its starting point that plain disclosure can solve the problem.

“It cannot” he guarantees. He believes that “the time will come” when editors will be obliged to say “No, we are not going to accept this conflict of interest and we are not going to publish research involving this type of conflict of interest.” He also disagrees with the use of the word potential to describe these conflicts. “If you accept a commercial incentive that leads you to hide things to the in favor of you benefactor, this is a conflict” he points out. Potential conflict exists when the reader is unable to establish that the researcher has been influenced. He recognizes that a declaration of ethics is better than nothing and concludes, “But they chose the easiest path”.

Complicated strategies
In March this year, FAPESP took a succession of measures to face up to potential conflicts of interest. They are guided by the principle of complete information and full verifiability. “Not only the scientific community, but society as a whole must be kept informed of all the circumstances surrounding a project that may involve potential conflicts of interest” argues José Fernando Perez, FAPESP’s scientific director, and Luiz Henrique dos Santos, scientific advisor, in an article published in Pesquisa FAPESP in March 2001. They recognize that the easiest way of removing the risk of conflicts of interest is to prevent them from happening in the first place.

But this could be a “too simplistic” solution, they observe and they give an example: The clinical trial of a medication may not be possible without the support of the company, which may result in the denial of access by people to a therapeutic tool. Furthermore, they go on, “it seems reasonable that much of the cost of preparing a commercial product should be borne by the company that will profit from selling it and not, for example, by government bodies or agencies financed by public money”. For this reason, they justify, “there is no other course left to us but to deal with potential conflicts of interest through more complex strategies, which, very often, can only be fully established case by case”.