industry funding of cme: how drug companies have taken over ...

1. Industry Funding of CME: How Drug Companies Have Taken Over Medical Education Daniel Carlat, M.D. Last fall, I attended an educational meeting sponsored by one of the APA�s competitors. Story of symposium on antipsychotics and the control of topic. Last fall, I attended an educational meeting sponsored by one of the APA�s competitors. Story of symposium on antipsychotics and the control of topic.

3. Background on CME Most state medical boards require evidence of CME for re-licensure Category One CME is regulated by the ACCME Physicians are a �captive audience�

4. CME Commercial Support Has Quadrupled 1998: $302 million (33%) 2007: $1.2 billion (48%) Depression is an increasingly important health problem, with an estimated lifetime prevalence of 17.1% in the United States.1 Lifetime prevalence is defined as the proportion of those sampled who have experienced a psychiatric disorder at least once in their lifetime1 Depression is almost twice as common in women (~21%) as in men (~13%)1 A recent cross-national survey of epidemiologic studies showed that major depression occurs more often in women in every country studied2 According to a worldwide epidemiologic survey, the mean age of onset of depression ranges from 25 to 35 years2 The current model of depression has shifted from one based on maladaptive psychological processes to one based on biologic processes. This shift has increased the recognition of depression as a medical illness and has increased the emphasis on pharmacotherapy in its treatment Sources: Kessler RC, et al. Arch Gen Psychiatry. 1994;51:8-19. Weissman MM, et al. JAMA. 1996;276:293-299.Depression is an increasingly important health problem, with an estimated lifetime prevalence of 17.1% in the United States.1 Lifetime prevalence is defined as the proportion of those sampled who have experienced a psychiatric disorder at least once in their lifetime1 Depression is almost twice as common in women (~21%) as in men (~13%)1 A recent cross-national survey of epidemiologic studies showed that major depression occurs more often in women in every country studied2 According to a worldwide epidemiologic survey, the mean age of onset of depression ranges from 25 to 35 years2 The current model of depression has shifted from one based on maladaptive psychological processes to one based on biologic processes. This shift has increased the recognition of depression as a medical illness and has increased the emphasis on pharmacotherapy in its treatment Sources: Kessler RC, et al. Arch Gen Psychiatry. 1994;51:8-19. Weissman MM, et al. JAMA. 1996;276:293-299.

5. Industry Funding Trends

6. Industry Support as Percentage of Total

7. CME versus Promotion:What�s the Difference? Drug Promotion Speakers paid directly by drug company Off-label discussion forbidden Regulated by FDA for accuracy and fair balance 40 FDA staffers assigned to monitoring Division of Drug Marketing, Advertising, and Communications (DDMAC) is part of Center for Drug Evaluation and Research (CDER). Staff of 40 in 2007. Responsible for reviewing promotional and DTC ads. Source: Janet Woodcock 2007 testimony http://www.hhs.gov/asl/testify/t030722b.htmlDivision of Drug Marketing, Advertising, and Communications (DDMAC) is part of Center for Drug Evaluation and Research (CDER). Staff of 40 in 2007. Responsible for reviewing promotional and DTC ads. Source: Janet Woodcock 2007 testimony http://www.hhs.gov/asl/testify/t030722b.html

8. CME versus Promotion:What�s the Difference? CME: Speakers paid indirectly by drug company Off-label discussion allowed Regulated by ACCME for accuracy and fair balance 4 ACCME staffers assigned to monitoring 89,462 CME activities in 2007

9. Drug Promotion Money Flow Pharmaceutical Company Experts Journals The flow of money is complicated and is often very difficult to trace. In the case of the APA symposia, there are innumerable different MECCs that are involved. The APA handles the money and claims that it is in control of all content. However, it doesn�t actually work that way. The flow of money is complicated and is often very difficult to trace. In the case of the APA symposia, there are innumerable different MECCs that are involved. The APA handles the money and claims that it is in control of all content. However, it doesn�t actually work that way.

10. CME Money Flow Pharmaceutical Company Medical Education Companies, Medical Societies Experts Journals The flow of money is complicated and is often very difficult to trace. In the case of the APA symposia, there are innumerable different MECCs that are involved. The APA handles the money and claims that it is in control of all content. However, it doesn�t actually work that way. The flow of money is complicated and is often very difficult to trace. In the case of the APA symposia, there are innumerable different MECCs that are involved. The APA handles the money and claims that it is in control of all content. However, it doesn�t actually work that way.

11. Industry-funded CME: An Illustration

12. Meeting Agenda

13. $85,000 Buys 90 Minutes

14. �Repurposing:� $103,000 for an article

15. �Special Report�

16. Total income from the one day conference $85,000 + $103,000= $188,000 per symposium 4 symposia Total: 4 X $188,000 = $752,000

17. Industry-funded CME: Advertising in the Guise of Education? The flow of money is complicated and is often very difficult to trace. In the case of the APA symposia, there are innumerable different MECCs that are involved. The APA handles the money and claims that it is in control of all content. However, it doesn�t actually work that way. The flow of money is complicated and is often very difficult to trace. In the case of the APA symposia, there are innumerable different MECCs that are involved. The APA handles the money and claims that it is in control of all content. However, it doesn�t actually work that way.

18. How ACCME Tries to Prevent Commercial Bias Speakers cannot be paid directly by commercial sponsor Sponsor cannot have direct input into content of course Speakers must disclose conflicts of interest

19. Why Commercial Bias Continues Despite Firewalls Speakers still know who is �buttering their bread� Medical Ed companies don�t need sponsor�s input�they already know their marketing aims Disclosure of conflicts does not prevent bias�in fact, it may worsen it

20. Medical Education as Marketing: Implications Doctors prescribe the most expensive drugs Dangerous side effects get the brush-off Less lucrative treatments are ignored

21. Solutions Eliminate single-sponsor funding of CME Require pooling of funds Create a medical education tax, payable by companies seeking FDA approval for products Eliminate any industry funding of CME

22. Push-back from Medical Groups in 2008

23. Macy Foundation January 2008: Macy Foundation releases report on CME �Bias, either by appearance or reality, has become woven into the very fabric of continuing education.� Commercial support of CME must end

24. Sloan-Kettering Cancer Center February 2008: Bans commercial funding of CME throughout the institution. Adjusted by �defancifying� programs

25. American Psychiatric Association March 2008: APA President creates �Ad hoc Work Group on Adapting to Changes in Pharmaceutical Revenue� Will recommend a five year plan to reduce reliance on industry funds Focus on Industry Supported Symposia

26. American Medical Association May 2008: AMA�s Ethics Council releases report in industry CME Physicians and institutions �must not accept industry funding to support professional education activities." June 2008: AMA House of Delegates votes to delay action pending further review

27. AAMC Recommendations June 2008 Report Accept no Gifts from Industry Industry support of CME is permitted, BUT: All money goes through a central CME office Medical school faculty should not serve on company speaker�s bureaus

28. Pfizer Pharmaceuticals July 2008: Pfizer announces it will no longer directly fund MECCs for CME However, they will fund medical institutions which hire MECCs to create CME

29. Stanford University August 2008: Dean Philip Pizzo Announces new CME policy Companies cannot fund specific courses May contribute only to a schoolwide pool of money that can be used for any class, even ones that never mention a company�s products.

30. ACCME Policy Proposal: No �Double Dipping� September 2008: ACCME proposes new policy to improve commercial firewall Physicians on company speakers� bureaus would not be allowed to create CME content

31. Wisconsin Medical Society October 2008: Announced new ethics policy �Physicians shall accept no gifts from any provider of products that they prescribe to their patients such as personal items, office supplies, food, travel and time costs, or payment for participation in online CME.�

32. Institute of Medicine �Conflict of Interest in Medical Research, Education, and Practice� 24 month project funded by NIH, IOM, and major foundations Final report due by July 2009

33. Conclusion Commercial funding of CME is under siege Pooled funding arrangements becoming common Prediction: Industry funding will end within 5 years