The following letter was written by IOM President Harvey V. Fineberg in response to a letter written by Dr. Bernard J Carroll that appeared in the April 2005 issue of Nature Medicine.

Full citation: Carroll BJ. 2005. Can the Institute of Medicine review the FDA? Nature Medicine 11(4): 369.

Read more information on the Committee on the Assessment of the U. S. Drug Safety System

18 April 2005

The Editor
Nature Medicine
345 Park Avenue South
New York, NY 10010-1707

To the editor:

Dr. Bernard J. Carroll's letter in the April 2005 issue of Nature Medicine questions whether the US Institute of Medicine (IOM) can undertake a credible study of the Food and Drug Administration's postmarketing drug safety system because some IOM members serve as employees of pharmaceutical companies, serve on the boards of these companies or serve as deans in academic institutions that receive substantial funds from pharmaceutical firms. Dr. Carroll's reasoning is flawed because he does not take into account the actual procedures and policies followed by the IOM in conducting its studies.

The IOM is both an honorific membership body and an advisory organization.  Members of the IOM are elected in recognition of their achievements in the health sciences, professions and disciplines relevant to health. Although the stature of the membership as a whole lends authority to the advice offered by the IOM, the membership as a group neither conducts nor judges the individual studies and recommendations produced by the IOM.

Individuals invited to serve on an IOM study committee may come from within or outside the membership of the IOM, and they are selected because of their expertise and qualifications for a particular study task.  Of the 1,446 individuals who served on one or more IOM study committees in 2004, approximately one in five were members of the IOM.

Every individual who serves on an IOM study committee is appointed in accordance with National Academies' guidelines to avoid conflict of interest and bias. These guidelines (available at http://www.nationalacademies.org) require identification and disclosure of any personal, professional or financial interests that are relevant to the study.  When prospective members are identified for any study committee, the IOM posts their identities and pertinent background information on the web and invites public comment.  Only after the public comment period and review of individual information relevant to conflict of interest and bias is an individual's participation on a study committee confirmed.  All individuals who serve on a study committee do so as volunteers, without compensation.

Each IOM study committee operates independently to reach its findings, conclusions and recommendations.  Before a committee's report is final, it is subjected to an external review process that provides additional assurance of the integrity of the report's analysis.

Members of the Institute of Medicine understand that the value of our work depends both on the technical quality of our studies and on the policies that screen for conflicts of interest to ensure our studies are objective.

Harvey V. Fineberg, M.D., Ph.D.