Some Highlights of Institute of Medicine Report on Conflict of Interest in Medical Research, Education, and Practice As

1. Some Highlights of Institute of Medicine Report on Conflict of Interest in Medical Research, Education, and PracticeAs Related to Practice Guidelines Remarks by Robert Krughoff, President Consumers� CHECKBOOK/Center for the Study of Services for AHRQ 2009 Annual Conference

2. 2 The IOM Committee�s Charge Examine conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines Develop analyses and recommendations to inform policies to identify, limit, and manage conflicts of interest in these contexts without damaging constructive collaborations with industry .

3. 3 Scope Conflicts in academic medical centers, research institutions, professional societies, journals, etc. How conflicts might affect persons and organizations that rely on good research, education, care, and guidelines�and how these organizations might use their leverage to enforce conflict of interest policies Licensing boards, insurers, provider organizations, consumer organizations, patients, etc. Only considered financial conflicts related to drug, device, and biotechnology industries, not conflicts related to� Payment/reimbursement systems Professional training and preferences Ownership interests in provider organizations Intellectual biases

4. 4 Definition of Conflict of Interest Circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest Primary interests of medicine are to� Provide beneficial care to patients Conduct valid research Offer excellent medical education Interests of for-profit medical companies are to� Produce products that improve health Ensure a financial return to shareholders A conflict of interest is a risk--not necessarily the existence of biased judgment or action

5. 5 Tensions and Challenges There are benefits from interactions between clinicians/researchers and industry Translation of discoveries into products for clinical practice [But how big are these benefits, and what if the system had not evolved this way�not addressed by committee] And there are risks of interactions Bias in professional judgment Loss of public trust [Committee gave evidence of harm, but could not quantify harm] New policies on conflicts of interest might have unintended adverse consequences

6. 6 Committee�s Approach to Conflicts of Interest Disclosure an essential but limited first step Assess likelihood and seriousness of harm Determine whether conflict should be prohibited or managed, and if managed, how

7. 7 Recommendations on Disclosure/Management 3.1, 3.2 Institutions/organizations that conduct medical research, medical education, patient care, and practice guideline development should adopt and make public conflict of interest policies for individuals Create conflict of interest committee to review disclosures and determine response to conflicts (e.g., eliminate, manage) Make disclosures specific enough to identify and assess risks of relationships Avoid unnecessary administrative burdens

8. 8 Recommendations on Disclosure/Management(cont�d) 3.3 There should be a broad-based consensus process to develop standard categories and formats for disclosure of financial interests to institutions, with the expectation that this would lead to common software that individuals could use to report for multiple purposes-- Reduce burden on individuals who have to report Improve adequacy of information to assess relationships and risks 3.4 Congress should require pharmaceutical, medical device, and biotechnology companies to publicly report payments to physicians and other prescribers, researchers, health care institutions, professional societies, providers of continuing medical education, etc. Should be in a database searchable by name of recipient

9. 9 Broader-Disclosure Model Minority view All institutions that will get disclosures should require that the individual, using the new standardized reporting requirements and software, simply do �an extra click of the button� to send to a public database the same information that he/she is reporting to an institution Rationale� Would include information on patent and equity ownership not included in what industry has to report Would allow industry reporting to be cross-checked against reports of individuals to institutions Would reveal how aggressive institutions are in requiring reporting and managing and limiting conflicts Would not impose significant burden on individuals, since only individuals already required to report to institutions would be required to report the same information publicly, and many individuals will have nothing to report

10. 10 Recommendations on Continuing Medical Education 5.3 Consensus development process should be convened to develop a new system of funding accredited continuing medical education that is free of industry �influence� and provides high-quality education [Quotation marks here and later are mine to highlight ambiguities that trouble me.]

11. 11 Recommendations on Medical Practice 6.1 Physicians should Not accept items of material value, or consulting arrangements, except when a transaction involves payment at �fair market value� for a �legitimate service� Not meet with sales representatives except by documented appointment and at the physician�s express invitation Not accept ghostwriting Limit acceptance of drug samples�if at all, only give to patients who lack financial access to medications and only when generic alternatives are not available and the medication can be continued at little or no cost to the patient for as long as it is needed Professional societies and health care providers should amend policies to support these recommendations 6.2 Companies should have policies and practices consistent with these recommendations

12. 12 Recommendations on Practice Guidelines 7.1 Organizations that develop clinical practice guidelines should� Exclude as panel members individuals with conflicts of interest Not accept �direct� funding of guidelines from companies or company foundations Publicly disclose with each guideline their conflict of interest policies, procedures, and sources and amounts of �indirect� or direct funding for the guideline Report text: Some committee members also wanted groups that develop guidelines to report publicly all their sources, amounts, and purposes of funding because industry contributions to general revenues (e.g., from journal advertising) could also create undue influence. There was not consensus on this point.

13. 13 Recommendations on Practice Guidelines(cont�d) 7.1 cont�d--In the exceptional situation in which avoidance of participants with conflicts of interest is impossible because of the critical need for expertise, then organizations should-- Publicly document that they made a good faith effort to find expert panel members without conflicts of interest by issuing a public call for members and other recruitment measures Appoint a chair without a conflict of interest Limit members with conflicting interests to a distinct minority of the panel Exclude individuals who have a fiduciary or promotional relationship with a company that makes a product that may be affected by the guidelines Exclude panel members with conflicts from deliberating, drafting, or voting on recommendations Publicly disclose relevant conflicts of interest for panel members

14. 14 Recommendations on Practice Guidelines(cont�d) Note the exclusion of panel members with conflicts from deliberating, drafting, or voting on recommendations. Exclusion is not limited to portions of guidelines that relate to the member�s conflicts. Committee�s judgment was that if the guideline panel would be able to reach judgment without the conflicted member�s deliberation, drafting, or voting on a conflict-related issue, then the panel could do this on all issues�that the conflicted member�s role was merely to be a convenient source of information and understanding/education for other panel members, not one of the judges.

15. 15 Recommendations on Practice Guidelines(cont�d) Report text: Committee believed that an end to direct funding for guidelines is necessary to avoid the conflicts that come from industry financing. An expanded role for public-sector sponsorship of guidelines would be desirable, but that issue is beyond committee�s scope. Professional societies could collaborate and share costs. Pooling mechanisms might be created to support guideline development in broad categories. Committee endorsed a recent IOM report calling for Congress to require designation of a single entity with the responsibility to-- Establish priorities for and manage the development of systematic reviews of clinical effectiveness Develop standards for such reviews and for clinical guidelines Address conflicting guidelines.

16. 16 Recommendations on Practice Guidelines(cont�d) 7.2 Accrediting and certification bodies, health insurers, public agencies, and other similar organizations should encourage institutions that develop practice guidelines to adopt conflict of interest policies consistent with the recommendations in this report. Two desirable steps are for The National Guidelines Clearinghouse to require that all guidelines accepted for posting describe (or provide a link to) the developer�s conflict of interest policies, the sources and amounts of funding for the guideline, and the relevant financial interests of guideline panel members if any Accrediting and certification organizations, public and private health plans, and similar groups to avoid using practice guidelines for performance measures, coverage decisions, and similar purposes if the guideline developers do not follow the practices recommended in this report