IOM: Changes needed from individuals, institutions to reduce conflicts of interest

New voluntary and regulatory measures would strengthen protection against conflicts of interest without hindering patient care.

When dealing with conflicts of interest in medical research, education and practice, preventing bias and mistrust is more important than mending the damage caused by such conflicts, according to a recent report from the Institute of Medicine. To achieve this goal, the committee recommends various regulatory and voluntary measures be taken by individuals and institutions.

“It is important that the medical profession take the lead in making sure that policies on conflicts of interest are able to reassure the public; that there was no undue influence on research or clinical care,” Bernard Lo, MD, chair of the IOM Committee on Conflict of Interest in Medical Research, Education and Practice, and professor of medicine and director of the program in Medical Ethics at The University of California at San Francisco, told HemOnc Today.

The committee was established in 2007 in an effort to examine conflicts of interest and recommend steps to discover, reduce and manage such interests without negatively affecting beneficial collaborations. Their recent report offers recommendations for medical institutions, physicians, researchers and other organizations to improve the disclosure of financial relationships, limit company payments and gifts, and remove industry influence from medical education and practice guideline development.

Medical research

According to the committee, disclosing financial relationships is the first step in recognizing and responding to conflicts of interest. Financial disclosures should be followed by analyses of their risk to determine whether bias will occur or public trust in research will be damaged, according to the report. From there, institutions should determine if research should proceed or whether further disclosure, management of the relationship or prohibition should occur.

The committee suggests the following criteria be used to assess conflict of interest policies:

Proportionality: Is the policy effective, efficient and directed at the most important and most common conflicts?
Transparency: Is the policy comprehensible and accessible to the individuals and institutions that may be affected by it?
Accountability: Does the conflict of interest policy indicate who is responsible for monitoring, enforcing and revising it?
Fairness: Does the policy apply equally to all relevant groups within an institution and in different institutions?

To improve conflict of interest policies, both institutional and individual conflicts must be addressed, according to the committee. The report states that the Public Health Service requires institutions receiving grants to implement policies on individual conflicts of interest. The committee suggests the NIH continue to guide grantee institutions and publicize information about institutions with policies that do not comply with Public Health Service regulations. In addition, medical institution governing boards should create standing committees to oversee conflicts at the institutional level and the NIH should insist that its research grantees adopt such policies.

In the case of researchers holding patents on interventions tested in clinical trials, the committee recommends the researcher not participate in such trials. The NIH should also promote and organize discussions on nonclinical investigators with financial stake in the outcome of a research project, according to the report.

Conflicts in education and practice

Medical institutions such as academic centers, professional societies, patient advocacy groups or medical journals, should create conflict of interest policies requiring disclosure and management of individual and institutional relationships to industry, according to the report. Institutions should create committees to evaluate such relationships and board-level committees should deal with conflicts at the institutional level, when necessary.

“We call for a much clearer disclosure of these financial relationships and a much more specific disclosure,” Lo said. “Those disclosures need to provide enough information so that other people can judge what the risk for undue influence or bias might be.”

Payments made by pharmaceutical, medical device and biotechnology companies to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups and providers of continuing medical education should be required, by Congress, to be publicized through a national reporting program, according to the committee.

“We also went further and said there were some interactions where the risk of undue influence was so high that they really were unacceptable. We specifically mentioned gifts from drug companies to physicians, including meals,” Lo said.

According to the report, restrictions should be placed on industry visits and free drug samples should only be given to patients without financial access to medications.

To create a new system for funding continuing medical education that lacks industry influence, a consensus process should be established. The committee acknowledges that the system may increase costs and call for cost-cutting solutions from education providers.

Industry funding should not be accepted by societies and groups in connection to the development of clinical practice guidelines in an effort to increase transparency and accountability. Additionally, the Department of Health and Human Services should create a research agenda for stronger evidence base regarding future conflict of interest policies. The research should examine the affect of such policies in terms of desired outcomes and possible consequences.

“Doctors and the medical profession really need to take the lead in looking at what they do and developing policies that really reassure the public that they can trust that their doctors are making decisions on what’s best for them as patients, not on what might be profitable for a drug company or device company,” Lo said. – by Stacey L. Adams

Lo B. Conflict of Interest in Medical Research, Education and Practice. National Academies Press website.