Disclosure Slide. Example 1:

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1 Resolving Conflicts in CME George C. Mejicano, MD, MS Professor of Medicine Senior Associate Dean for Education Disclosure Slide Dr. Mejicano has no personal financial relationships with commercial interests Dr. Mejicano is a CME consultant to the American Board of Medical Specialties Example 1: Doctors speaking at events approved by independent body for CME credit, to which industry has contributed unrestricted funds in exchange for acknowledgement in program materials 1

2 Example 2: Doctors speaking at industry-sponsored promotional event (non CME), link between industry and company/product is made clear to all involved Example 3: Doctors using promotional materials in office settings Pens Pencils Note pads Desk Trinkets Calendars Example 4: Doctors providing free samples to patients (samples provided free to doctor by industry) 2

3 Example 5: Dinner Lectures Industry pays speaker, audience treated to dinner by industry during lecture Example 6: Medical Meeting Freebies Nametag lanyards Bags Personalized Pens Videos etc Example 7: Doctors belonging to industry scientific advisory boards 3

4 Example 8: Doctors acting as consultant to industry to develop medications, devices, etc Example 9: Interactions of industry with residents and fellows to provide Textbooks Educational opportunities Lecturers Off campus visits Meals/Journal Clubs Example 10: Industry-sponsored Satellite Symposia at major medical meetings 4

5 Example 11: Doctors serving as review-article authors regarding topics in which they have financial interests as speakers, consultants, or advisors Example 12: Doctors serving as generators of data, quotes, or authors of industry bulletins Pamphlets given or mailed to patients or other physicians Throw-away journals Example 13: Journal articles ghostwritten by industry employees 5

6 Example 14: Physician works with industry to develop new drug/device Physician receives financial gain from success of drug/device Physician benefits academically from industry-sponsored research Physician is integral part of study of clinical applicability of drug/device Example 15: Physician holds common stock in company with significant product in area of specialty of physician Example 16: Physician develops good idea into drug/device ready for clinical use Physician creates company as conduit for finances to support maturation into clinical treatment Physician retains ownership of company, is integral part of study team 6

7 Example 17: Academic institution creates partnership with industry in particular clinical area Institution benefits academically and financially from relationship ACCME Criteria creditation-requirements-cmeproviders/accreditation-criteria 7

8 ACCME: SCS 2.1 Provider must show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider Financial relationships in any amount Financial relationships over past 12 months ACCME, 2004 ACCME: SCS 2.2 An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation or evaluation of the CME activity. ACCME: SCS 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. 8

9 JAMA 2005; 294:2287 ACCME Annual Report Data available at: ACCME Accredited Providers 2012 Circle Size Proportional to Hours ACCME Annual Report Data available at: 9

10 Conflict of Interest in CME Some CME providers receive large amounts of funding from companies that manufacture drugs or devices Many content experts receive funds for serving on advisory boards, consulting, doing research, and speaking on behalf of these same companies As a result, numerous stakeholders have expressed concern about bias and COI ACCME and COI Paradigm shift with regards to the issues of bias and conflict of interest Old paradigm: learners can figure out when there is bias so providers simply have to ensure that learners are aware of financial relationships between the speakers/authors and a commercial supporter New paradigm: CME provider must determine if there is a conflict of interest and find a way to resolve it before the activity takes place Commercial Supporter Scientific Advisory Board Planning committee members Distinguished researchers/clinicians Medical writers/authors Speakers Any person choosing speakers Medical Education Company Medical writers Any person choosing speakers/authors CME Speaker/Author Learners Academic Medical Center Basic science and clinical faculty CME office staff Any person choosing speakers/authors 10

11 Commercial Supporter Scientific Advisory Board Planning committee members Distinguished researchers/clinicians Medical writers/authors Speakers Any person choosing speakers Medical Education Company Medical writers Any person choosing speakers/authors CME Speaker/Author Learners Academic Medical Center Basic science and clinical faculty CME office staff Any person choosing speakers/authors Commercial Supporter Scientific Advisory Board Planning committee members Distinguished researchers/clinicians Medical writers/authors Speakers Any person choosing speakers Medical Education Company Medical writers Any person choosing speakers/authors CME Speaker/Author Learners Academic Medical Center Basic science and clinical faculty CME office staff Any person choosing speakers/authors Commercial Supporter Scientific Advisory Board Planning committee members Distinguished researchers/clinicians Medical writers/authors Speakers Any person choosing speakers Medical Education Company Medical writers Any person choosing speakers/authors CME Speaker/Author Learners Academic Medical Center Basic science and clinical faculty CME office staff Any person choosing speakers/authors 11

12 Implications of Current Standards Many more persons must disclose CME office staff Planning committee members Advisory board members Content reviewers Medical writers Speakers Authors Anyone who controls/influences content! ACCME, 2004 Commercial Supporter Scientific Advisory Board Planning committee members Distinguished researchers/clinicians Medical writers/authors Speakers Any person choosing speakers Medical Education Company Medical writers Any person choosing speakers/authors CME Speaker/Author Learners Academic Medical Center Basic science and clinical faculty OCME office staff Any person choosing speakers/authors Implications of the New Standards Once disclosure obtained Provider reviews the disclosed information Provider decides if there is a conflict If conflict of interest identified, provider must resolve conflict ACCME,

13 It is not the intent of the ACCME to block participation in CME events by all physicians who receive any remuneration from a pharmaceutical or medical device company; and It is not the intent of the ACCME to adopt a policy whereby conflicts of interest can only be addressed by excluding physicians from participating as planners or teachers in CME activities that might be related to their conflicts of interest. Murray Kopelow MD CEO ACCME Alliance for CME Annual Meeting January 2004 The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both A financial relationship with a commercial interest and The opportunity to affect the content of CME about the products or services of that commercial interest. Process STANDARD 2:Resolution of Personal Conflicts of interest The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. How do these circumstances create a conflict of interest? The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME an incentive to insert commercial bias. The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both A financial relationship with a commercial interest and The opportunity to affect the content of CME about the products or services of that commercial interest. Process STANDARD 2:Resolution of Personal Conflicts of interest The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. Any amount within the past 12 months Salary Royalty Intellectual property rights Consulting fee Honoraria Ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds) Other financial benefit Of person, spouse or partner. 13

14 Roles That Might Result in Financial Benefits Employment Management position Independent contractor (including contracted research) Consulting Speaking and teaching Advisory committees or review panels Board membership Other activities from which remuneration is received or expected Mechanisms to Resolve Conflicts of Interest Sometimes the mechanism involves specifying, Who does what? within an activity Sometimes the mechanism involves content validation Time to Brainstorm! 14

15 Some Examples of How to Resolve Conflicts of Interest Do not offer credit for event Exclude person from event Give clear instructions to speaker Monitor for commercial bias Peer review of educational content Alter or limit role of speaker/planner Ensure content reflects the best available evidence Now a Digression 15

16 Chlamydia Rates by Gender: United States, Chlamydia Rates by State: United States and Outlying Areas, 2002 Note: The total rate of chlamydia for the United States and outlying areas was per 100,000 population. Chlamydia Prevention Primary Prevention Secondary Prevention Tertiary Prevention Screening and Monitoring 16

17 Chlamydia Prevention Example of Primary Prevention Educate teenagers about chlamydia and other sexually transmitted infections (STIs) so that they minimize their risk of acquiring STIs by making well informed decisions regarding sexual encounters Example of Secondary Prevention Counsel teenagers who present to a clinic because they are concerned that they may have acquired chlamydia or another STI Chlamydia Prevention Example of Tertiary Prevention Treat young women with proven chlamydia infections so that they do not progress to pelvic inflammatory disease (PID) Example of Screening and Monitoring Annually screen all sexually active women who are < 25 years of age, even if they are asymptomatic, in order to diagnose and treat chlamydia as well prevent its complications COI Prevention Examples of Primary Prevention Educate faculty and CME planners regarding potential COI and commercial bias in CME Choose faculty that are trusted by your organization and who you know have no financial relationships with commercial supporters Example of Secondary Prevention Convey expectations to instructors, authors, and planners that CME content must be evidence-based and free of commercial bias 17

18 COI Prevention Examples of Tertiary Prevention Peer review of educational content by experts Examples of Screening and Monitoring Ask learners to report any perception of bias in the CME activity on an evaluation form Ask knowledgeable peers to closely monitor CME activities in their area of expertise and report any perceived bias to CME planners COI Prevention Primary Prevention Secondary Prevention Tertiary Prevention Screening and Monitoring 18

19 Problems with COI Prevention Primary Prevention Ultimately relies on faculty and planners to learn about COI and commercial bias when there may be little personal incentive to do so Secondary Prevention Assumes that faculty and planners actually read instructions that are conveyed to them Screening and Monitoring Occurs after the fact Screening is finding proof that you failed... George Mejicano, MD, MS 2004 Board of Scientific Counselors Meeting National Center for Infectious Diseases Centers for Disease Control and Prevention COI Prevention Primary Prevention Secondary Prevention Tertiary Prevention Screening and Monitoring 19

20 Content Validation at Wisconsin Contracted panel of specialists from the academic faculty Led by Dr. Andrew Urban, a physician on the CME staff Peer reviewers provide written documentation Issues in Peer Review What are the pros and cons of blinding reviewers? Is there an optimal number of reviewers? How do we ensure reviewers have no commercial bias or conflict of interest? Are there optimal credentials for a reviewer? What is the optimal training for a reviewer (and how steep is the learning curve)? Issues in Peer Review What is the optimal lifespan of a reviewer? How skeptical should a reviewer be (i.e. should a peer reviewer simply assume there is bias)? What is the optimal documentation? Who decides which faculty expert to use for a given project (i.e. should there be a firewall between reviewers and leaders)? 20

21 Current Health Priorities General protection Targeted protection Primary prevention Secondary prevention Tertiary prevention Safer Healthier People X Vulnerable People X Affected People Without Complications X Affected People with Complications X Death from complications Future Health Priorities General protection Targeted protection Primary prevention Secondary prevention Tertiary prevention Safer Healthier People Affected X Vulnerable People X People Without Complications X Affected People with Complications X Death from complications Wisconsin s COI Management System 21

22 COI Risk Stratification Instructor with Large Financial Relationship? Yes No Activity with Lots of Commercial Support? Yes Highest Risk Low Risk No High Risk Lowest Risk Extent of Conflict of Interest Depends on Many Variables Is the relationship exclusive? Is the relationship transient? How much is the relationship worth? Percent of income versus a set maximum amount? What is the potential patient impact? Therapeutics >> diagnostics >> basic science? Is the person an agent of the supporter? Is there a firewall in place? Is there a peer review process? The Future Focus shifts to disclosure in clinical practice (i.e., not to the learners but rather to the patients being seen) Focus shifts to non-financial conflicts (i.e., not about an easily quantified issue but rather to more subjective variables) 22

23 Non-Financial COI Type of Relationship Academic commitments Personal relationships Institutional affiliations Professional conflicts Recognition for professional achievement Professional affiliations Rationale Intellectual passion Political or other ideological beliefs Religious beliefs Professional relationships Favors to students, friends, or family Published opinions or advocacy positions Thank you!! 23