Donna M. Jacobsen International AIDS Society–USA

1. 2007 Asilomar PAETC Faculty Development ConferencePharma Support, CMEs, and You: Ensuring Independence in Commercially Supported CME Donna M. Jacobsen International AIDS Society–USA The International AIDS Society–USA

2. Ensuring Independence in Commercially Supported CME • Learning Objectives: • Describe the Standards for accepting (and managing) support from pharmaceutical companies for AETC-sponsored CME programs • Identify strategies for soliciting pharmaceutical company support for AETC CME programs • Ensure that AETC training programs meet ACCME requirements (for commercial support)

3. Question • Are you familiar with the ACCME Standards for Commercial Support • Yes, very familiar with the Standards and apply them regularly • Somewhat familiar in that I know they exist but am not as familiar with each one • No, not really • No, not at all

4. International AIDS Society-USA • Not-for-profit professional educational organization founded in 1991 • Mission-based • Accredited with commendation by the ACCME to sponsor continuing medical education (CME) programs for physicians • Guided by a volunteer Board of Directors • Select activities are supported by industry funding; IAS-USA has developed a highly effective model for ensuring independence

5. Ideally, What Are the Companies Looking For in Supporting CME • Contributing to the improvement in clinical knowledge/skills and thus in patient care and well being • Recognition for contributing to worthy activities at the Corporate level • Charitable contribution benefits? • Building and maintaining relationships

6. What Are the Companies Also Looking For In Supporting CME • Dissemination of positive information about their products • New research • Off label uses • Positive “spin” • Negative information about their competitors’ products • Safe harbor from FDA oversight • Has CME become a “tactic”?

8. Committee on Finance concerned with drug payment increases under Medicaid • Became aware of use of CME to market more expensive drugs/those with less clinical experience • Contacted 23 Pharma companies and ACCME about CME grants • Concluded that industry does use CME to market; some efforts made to separate grants from marketing but grey area exists; numerous cases of influence; lack of real time or proactive oversight; ACCME is slow to address violations

9. CME: Definition and Purpose • Definition: Educational activities [that] serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. • Purpose: • Help physicians change and learn • Transmit current and accurate information • Provide an unbiased learning environment • B. Wilson, 2004

10. ACCME • Governing body for CME providers; 7 member organizations • Accredited CME providers are held to specific guidelines • Essentials • Standards for Commercial Support

11. ACCME Standards for Commercial Support of CME • It is the accredited provider’s responsibility to ensure that the purpose of the CME activity is to enhance physicians’ abilities to care for patients • The Standards describe appropriate behaviors of accredited providers in planning, designing, implementing, and evaluating certified CME activities that receive commercial support • Implementation of the Standards varies among Accredited providers, but the spirit of the Standards are consistent –it has to do with improving patient care, not product marketing

12. Question • SF Pharma Inc, the maker of a popular NNRTI, has developed a lecture on the signs and symptoms of HIV infection. They have 50 HIV experts (3 are medical directors within PAETC) who have been trained to give the talk and want to support a talk to your ETC. There is no mention of drug therapy at all, and no mention of their drug in particular. • Would having one of these lectures at your training be an independent educational activity or an SFP promotional event? • Independent activity • Promotional event

13. Pharmaceutical Promotion • Does not necessarily “promote” a product (FDA definition) • Any activity under the company’s control • advertising • brochures and detail materials • company trainings • speakers bureaus • Subject to regulation (eg, labeling and claims)

14. Standards for Commercial Support September 28, 2004 • Independence • Resolution of personal conflicts of interest • Appropriate use of commercial support • Appropriate management of associated commercial promotion • Content and format without commercial bias • Disclosures relevant to potential commercial bias

15. Standard 1. Independence • According to SCS Element 1.1: When planning a CME activity, the provider must make the following decisions free of the control of a commercial interest: • Identification of needs • Determination of education objectives • Selection and presentation of content • Selection of all persons and organizations that will be in a position to control the content • Selection of educational methods • Evaluation of the activity

16. Opinion Question • It is appropriate for an academic or community physician to be serve on a company speakers bureau. 1 strongly agree 2 somewhat agree 3 no opinion 4 somewhat disagree 5 strongly disagree

17. Opinion • It is appropriate for an academic or community physician to be a paid product spokesperson. 1 strongly agree 2 somewhat agree 3 no opinion 4 somewhat disagree 5 strongly disagree

18. COI Disclosure • You received signed disclosure forms for each speaker at your annual conference and printed the information (with a list of the corporate supporters) in the syllabus handed to attendees at check-in. • Is showing speaker disclosure slides/verbalizing before each talk now needed to satisfy the new requirements for conflict of interest? • Yes • No

19. Standard 2: Resolution of Personal Conflicts of Interest • Everyone who is in a position to control content* of an education activity has disclosed all relevant* financial relationships with any commercial interest* • One who refuses to disclose will be disqualified from being a planning committee member, teacher, or an author, and cannot have control of, or responsibility for, the development, management, presentation or evaluation • The provider must implement a mechanism to identify and resolve all conflicts of interest prior to the activity

20. Resolving Conflicts • Attest that the PCCs will not influence content • Use non-conflicted PCCs • Divest oneselves of the relationship(s) • Replace the conflicted PCC • Modify the role of the conflicted PCC • Have another speaker discuss clinical implications or results • Alter or modify content • Change the focus of the activity • Peer review of content with independent certification • Disqualify the speaker • From UUHCC CME Booklet (www.uuhsc.utah.edu)

21. Standard 3: Appropriate Use of Commercial Support (cont’d) • Provider, joint sponsor, or partner must pay honoraria and out-of-pocket expenses • No other payment to director, planning committee, teacher, author, or joint sponsor from funder • Social events or meals cannot compete with educational events. Limits on costs? • Commercial support cannot be used for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants (except those in training)

22. Standard 4: Appropriate Management of Associated Commercial Promotion • Commercial exhibits or advertisements cannot influence planning or presentation, and cannot be a condition of support • Product-promotion or advertisement of any type is prohibited in CME activities • Educational materials cannot contain any advertising, trade names, or product-group messages

23. Question • Dr Reyes is an attendee at your CME conference. He walks into the session with a giant robin’s-egg blue SELZENTRY bag over his kaftan. Does ACCME prohibit this as “product promotion” in the CME activity? • Yes • No • It depends

24. Standard 5: Content and Format Without Commercial Bias • The content or format must promote improvements or quality in healthcare and not a specific propriety business interest of a commercial entity • Presentations must give a balanced view of the issue; use of generic names contributes to this impartiality

25. Question • VeryBig Pharma offers to donate the use of their ARS system to your next lecture, whatever the HIV topic is. They will leave the agenda and speaker absolutely up to you, and will not collect the data from the questions used. The only thing the rep asks is that you not print that the lecture is supported by VeryBig because there was no grant given and it might “look bad”. Is it OK to leave disclosure of this gift off the materials? • 1. Yes • 2. No

26. Question • Dr Bernstein very much wants to speak at your AETC training in July 2008, but you are concerned that she is on the speaker’s bureaus for Melck and Prizar companies and her husband holds stock in Turbotime Pharma. She resigns from the SBs and her husband sells the stock to his cousin. What should be disclosed at the July activity? • No relationships • Her SBs • Her SBs and her husband’s stock • Her SBs, his cousin’s stock • Her SBs, her husband’s stock, and his cousin’s stock

27. Standard 6: Disclosure Relevant to Potential Commercial Bias • Individual: Name, type of interest of any $$ amount, name of institutions (disclose if no relationship), back 1 year. Spouse or partner disclosure. • Commercial Support: Must be made (even in kind support). Never include trade names or product names or messages • Disclosure to be made to the learners prior to the activity start

28. Changes in Pharma Grant Applications • On-line submissions and independent grant committee review (centralizing) • Elimination of the term “unrestricted” to describe the grants (these grants are usually restricted—to use in education) • Outcomes assessment data

29. Changes in Pharma Grant Applications (cont’d) • Additional requirements for reporting at completion of activity • Staggering of grant payments • Return of unused funds

30. Web-based Grant Applications • Not uniform (budget formats, agenda requirements, etc) • Templates are often geared toward MCCs • Usually focus on single activities, largely live • Reviewed by a committee that may have no background in your disease or health focus

31. Submitting Pharma Grants • Base the program on the needs of your audience • Read the grant criteria • Incorporate compliance with/understanding of the Standards where possible • Find out key areas of interest or off-limit issues • Focus on your experience, reach, expertise • Promote your relationships with respected individuals

32. CME Tips • Be wary of MCCs (or other agents for industry) with packages • Terminology: “Sponsor” • Disclosure • Providers are accredited, activities are not • Paragraphing of the Accreditation Statement (2 separate paragraphs) • Inclusion of the Accreditation Statement • No “CME credits have been applied for”

33. IAS-USA Additional Measures to Ensure Independence • For efforts that do allow commercial support, funds must be received from several companies, including those with competing products (BMS+Gilead or Pfizer+Monogram—doesn’t count!) • Firewall between funders and content • For some activities, commercial support is not appropriate (guidelines) • All aspects are handled internally; no collaborations with agents of industry

34. IAS-USA Additional Measures to Ensure Independence (cont’d) • Potential contributors are pre-screened for ability to present balanced perspectives • Conflicts of interest collected prior to confirmation • Contributors with financial relationships to only 1 company generally—but not always—avoided • Chair peer review of overall materials • Group peer review of near-final materials

35. Thank You! • And many thanks to • Mona, E. Michael, Michelle • Michelle Tayag

36. Additional Discussion Items

37. What’s Wrong with This Picture? “The funds should be in the form of an educational grant. Note that a recent (1999) amendment to ACCME policy allows grants to be paid to a third party, such as a communications company, and the communications company then pays the CME provider — "Joint Sponsorship". You are still required to have a Letter of Agreement with the CME provider and the CME provider is still ultimately in control of everything. Some CME providers are sticking to the grant being paid to them directly. If they have the resources to handle timely distribution to vendors, then it is no big deal. Something to watch out for here is to make sure that the CME provider is aware that there is a third party up front. As in this example, the communications company you are working with usually selects the CME provider. Make certain you have direct conversation with the CME provider to ensure that they are on the up-and-up and can handle the job.” Excerpted for FCG Institute website, guide to CME for Product Managers

38. ACCME FAQs • 3) Is the following scenario allowed?...A CME provider is hired by a drug company to run an event where a doctor (hired by the same drug company) would present a CME seminar, talk, or author a CME paper. (SCS 1.1) • This should not occur as described under either the 1992 the Updated SCS. There is a requirement that the provider ensure that critical elements of activity planning be done independently of a commercial interest (SCS1.1). The accredited provider is not ‘hired’ but rather receives commercial support and is required to fulfill SCS Standard 3, in this regard. The teacher or author must be selected and paid by the accredited provider (SCS 1.1, SCS 3.8). No funds can go directly from the commercial supporter to the teacher/author (SCS 3.9). • Complaints: http://www.accme.org/dir_docs/doc_upload/5425eedc-f494-4859-9451-e3b1cfabbeb8_uploaddocument.doc • From www.ACCME.org

39. Under what circumstance(s) do you think being listed as an author on a manuscript that has been ghostwritten by a medical writer is appropriate? (check all that apply) • Never • If the author wrote the outline and carefully edited the manuscript and reviewed it for/ensured balance • if the author has carefully edited the manuscript and reviewed it for balance • If the medical writer is independent from a commercial company and is not being paid by a company (eg, hired by a journal) • If the manuscript discloses that the manuscript was drafted by a medical writer • If it is the report of a company study in which one (or more) of the authors is a company employee, and the medical writer is employed by or hired by the company