Conflicts of Interest: The Hidden Side of Science

New evidence indicates that conflicts of interest permeate much of what passes as unbiased scientific judgment, and that three gatekeepers of medical knowledge — the National Institutes of Health (NIH), institutional review boards, and major medical journals — are part of the problem.

The situation at NIH surfaced more than three years ago and has not been adequately addressed. Conflicts of interest gained prevalence after 1995 when NIH relaxed its restrictions on the outside activities in which its staff members could engage. The new policy struck down a ban on the acceptance of honoraria, lifted the cap on the amount of money employees could earn from outside activities, and allowed payment in stocks and stock options, thereby cementing long-term links between NIH scientists and the pharmaceutical and medical equipment industries.

In 2003, when the press revealed that some ranking NIH officials were getting tens of thousands of dollars in honoraria from industry, the issue became a political problem. Committed to eliminating all “real and apparent conflicts of interest” within the agency, the director of NIH appointed a Blue Ribbon Committee and adopted  new rules and regulations banning  NIH staff members from engaging in paid consulting with the pharmaceutical and biotechnology industries.

Despite assurances of accountability and transparency, however, NIH has been slow in putting its house in order. Last September, agency officials revealed that 34 scientists had been disciplined for violating the ethics rules by failing to seek approval for, or report, consulting relationships with industry; failing to take annual leave while consulting; or by consulting in areas that overlapped with their official duties. But most of these (21/34) received only a letter of caution, and six others received an oral admonishment, punitive actions that can best be described as “slaps on the wrist.” As a result, NIH’s reputation has lost credibility as a promoter of scientific knowledge and bastion of unbiased research.

The case of institutional review boards (IRBs) is more subtle, but no less important. IRBs are charged with monitoring patient studies at hospitals and research facilities. Primarily concerned with the protection of research participants, IRBs ensure that there is informed consent, that all risks and benefits are made explicit to participants, and that no one is subjected to harm. IRBs should therefore be free of undue influence by financial interests or by the appearance of such interests. Yet this is not always the case.

A recent study published in the New England Journal of Medicine reported findings from a survey of 893 IRB members at 100 academic institutions, asking them about their financial relationships with industry. The latter included employment, membership on boards, consulting, receipt of royalties, and paid speaking. The researchers found that 36.2 percent of the responders had had at least one relationship with industry in the past year. Seventy-eight respondents (15.1 percent) reported that at least one research protocol had come before their IRB during the previous year either by the company with which they had a relationship or by a competitor of that company, both of which could be considered conflicts of interest. Even more worrisome, more than half of those answering the survey reported that their IRB did not have a formal process for disclosure of relationships with industry or that they did not know of one.

Another recent survey by researchers at UCLA queried editors of 135 peer-reviewed publications on specific conflict-of-interest (COI) policies, restrictions based on conflicts of interest, and the public availability of these disclosures. While 93 percent of the 91 respondents had a conflict-of-interest policy for authors, 77 percent reported collecting COI data on all author submissions and only 57 percent published all author disclosures. Interestingly, the absence of disclosure was more common for narrative reviews, editorials, policy statements and guidelines — precisely the types of articles that reflect the opinions of the authors and may well have the greatest influence on readers.

These three examples show the extent to which medical institutions involved in the discovery and dissemination of knowledge have failed to protect the public. Because NIH, IRBs, and professional journals all concern “behind the scenes” aspects of medical research and practice, their conflicts of interest are less exposed to the public and therefore more difficult to combat. But cozy relationships between the arbiters of good science and industry are unacceptable, and researchers, academic reviewers and publishers should be held to the highest and most stringent standards concerning conflicts of interest. Scientists and those who vet their research should never be placed in the position of juggling their financial self-interest against their stewardship of the public’s trust.