Steven E. Nissen MD

1. Industry Influence ProfoundlyAffects Professional Medical Societiesand Must be Strictly Controlled Steven E. Nissen MD Disclosure Consulting: AstraZeneca, Abbott, Atherogenics, Bayer, Lipid Sciences, Wyeth, Novartis, Pfizer, Sankyo, Haptogard, Hoffman-LaRoche, Kemia, Takeda, Kowa, Sanofi-Aventis, Protevia, Novo-Nordisk, Eli Lilly, Kos, GlaxoSmithKline, Forbes Medi-tech, Vasogenix,Vascular Biogenics, Isis Pharma, Viron Therapeutics, Roche, and Merck–Schering Plough Clinical Trials:AstraZeneca, Eli Lilly, Takeda, Novartis, Sankyo, Sanofi-Aventis, Roche, and Pfizer. Companies are directed to pay any honoraria directly to charity. No personal reimbursement is accepted for directing or participating in clinical trials.

2. A Perspective • Industry is vital to the development of new therapies for cardiovascular disease and pharmaceutical research efforts should be encouraged. • However, professional societies and physician leaders must independently assess both the effectiveness and safety of these therapies without undue industry influence. • This is particularly true in educating colleagues where excessive industry influence may distort the benefits and risks of treatments, raising healthcare costs and compromising quality of care.

3. Annual Spending on CME by Industry (US) Now exceeds 50% of all CME spending ACCME Annual Report

4. Why Does Industry Spend So Much on CME? A. Pharmaceutical and device companies are really just large philanthropic organizations. • Companies really care about physicians and don’t want them to have to pay for their CME. • Pharma and device companies have so much money, they just don’t know how to spend it. • CME helps companies to sell their products and provides a good return on investment.

5. Why Is Industry Willing to Spend So Much? What is the annualized return on CME spending? • A. 10% • B. 20% • C. 50% • D. 100% • E. 350% Source: Scott Neslin ROI Analysis of Pharmaceutical Promotion

6. Per Capita Spending (Drugs/Nondurables) United States 2006 data R2 = 0.22 $90 billionspending gap France Canada Germany Czech Republic Spain Iceland Portugal Switzerland SouthKorea Poland Source: Organization for Economic Cooperation and Development

7. The Problem with Industry-Sponsored CME • The topics are chosen by the sponsor and always designed to support their product(s). • The recipients of industry money know thatthey will receive future funding only if the CME program supports the company’s goals. • So, consciously or unconsciously, CME providers choose speakers and topics theyknow will please the sponsor. • Speakers know that if they do not promote the sponsor’s products, they will not be invited back.

8. Industry-Sponsored CME Topics You’ll Never See A. How to choose generic drugs to save your patient and the health care system from undue expense. B. Common serious adverse reactions to widely used pharmaceutical agents. • How to avoid using CRT in patients who will not benefit. • Which commonly used therapies are not cost effective.

9. Anatomy of an Industry Sponsored CME Program

11. Med IQ: A Medical Education and Communications Company (MECC) For educational activities during the period of 2008-2009, Med-IQ acknowledges commercial support from the following companies: Abbott Laboratories The Alliance for Better Bone Health BoehringerIngelheim Corporation Bristol-Myers Squibb Cordis Corporation CV Therapeutics Daiichi Sankyo-Lilly Eisai Inc. Eli Lilly and Company GlaxoSmithKline Merck & Co., Inc. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Procter & Gamble Pfizer Inc. Roche Pharmaceuticals sanofi-aventis Sepracor Inc. Schering-Plough Corporation Shire Pharmaceuticals St. Jude Medical Takeda Pharmaceuticals TAP Pharmaceuticals Teva Pharmaceuticals US The Medicines Company UCB Vertex Pharmaceuticals Watson Pharmaceuticals, Inc.

12. Optimizing Patient Outcomes in Acute Heart Failure Syndromes: Strategies to Preserve Cardiorenal Function • If you watch this CME Program on Cardiosource, you can learn about the wonders of a drug known as rolofylline, a selective adenosine A1 antagonist that: • Functions as a vasodilator, improving heart failure symptoms • Preserves renal blood flow • Promising agent for treatment of acute congestive heart failure

13. Merck & Co., Inc. to Acquire NovaCardia, Inc., to Boost Clinical Pipeline of Cardiovascular Drug Candidates Acquisition Gives Merck Access to KW-3902, an Investigational Phase 3 Compound for Acute Congestive Heart Failure WHITEHOUSE STATION, N.J. and SAN DIEGO, July 25, 2007 - Merck & Co., Inc., one of the world's leading research-based pharmaceutical companies, and NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular diseases, today announced that they have entered into a definitive agreement under which Merck will acquire NovaCardia. Under the agreement, Merck will acquire all of the outstanding equity of NovaCardia for $350 million… NovaCardia's lead product candidate KW-3902, an adenosine A1 receptor antagonist, is being studied in Phase 3 clinical trials in patients with acute congestive heart failure (CHF). KW-3902 is believed to block adenosine-mediated constriction of blood flow to the kidneys and inhibit reabsorption of salt and water by the kidney, thereby increasing urine volume and maintaining renal function in patients with CHF. To date, no other vasodilator has demonstrated the selective renal vasodilation attribute of KW-3902 that helps preserve renal function.

14. This CME program is known a “market preparation” business activitydesigned to hype a yet unapproved product in anticipation of successfulnear-term launch of a new drug

15. Rolofylline fails to PROTECT in acute heart failure SEPTEMBER 1, 2009 Sue Hughes Barcelona, Spain - The selective A1 adenosine receptor antagonist rolofylline (Merck), showed no difference from placebo in the main efficacy end points in the PROTECT trial in acute heart-failure patients. The drug was also associated with an increased rate of seizures and strokes compared with placebo. These results are particularly disappointing given that an earlier pilot trial with rolofylline in this indication showed much promise. The drug, previously known as KW-3902, has now been dropped from development.

16. The American College of Cardiologyand Heart Rhythm SocietyGet Caught in an Industry Scam

17. Afibprofessional.org

18. Facts about ‘afibprofessional.org’ • A joint project of the ACC and HRS, sponsored by a single company, Sanofi-Aventis. • Both organizations receive presumably huge, but completely undisclosed financial compensation. • The site is purely promotional without even the guise of CME! • The Editor of the site and major new lecturer are both Sanofi-Aventis paid consultants and advisors. • Neither physician discloses their conflicts on the website until the media expose this outrage.

20. The goal of the site is the shameless promotion of dronedarone

21. Complete with a new “guideline” algorithm that prominently features dronedarone

22. The ACC and HRS sold their imprimatur for hard cold cash

23. Does the AHA any better at seeking independence from industry?

26. What is the price tag for inclusion in the AHA Pharmaceutical Roundtable? $1 million per year What do pharmaceutical companiesreceive in exchange for this “philanthropy”?

31. The price for accepting industry funding

33. Heart Group Backs Drug Made by Ally By STEPHANIE SAUL Published: January 24, 2008 After a study last week showed Vytorin, an expensive combination of two drugs for cholesterol, worked no better than cheapZocor alone in reducing artery plaque that can lead to heart attacks, the American Heart Association came to the drug’s defense. In a statement issued on Jan. 15, the day after the report’s release, the heart association said the study was too limited to draw conclusions about Vytorin’s ability to reduce heart attacks or deaths compared to Zocor alone. The group advised patients not to abruptly stop taking it without consulting their doctors. What the association did not note in its statement, however, was that the group receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals, the joint venture that markets Vytorin.

35. CMSS: Bold New Guidelines? • Societies will only accept Corporate Sponsorship of an item or program if the item or program is aligned with the Society’s strategic plan and mission. • Societies will require Satellite CME Symposia to undergo an application and selection process. • Societies will adopt written policies that govern the nature of exhibits and the conduct of exhibitors, including by requiring exhibitors to comply with applicable laws, regulations, and guidance. • Societies will base Clinical Practice Guidelines on scientific evidence.

36. Cleaning Up Medical Advice Editorial in the New York Times, April 30th, 2010 “The code’s main weakness is the lack of any effort to wean the societies from their dependence on money from the makers of drugs, biological medicines and medical devices. There have been complaints in recent years that some societies conduct educational programs that feel more like marketing sessions for products or issue practice guidelines that push their members to use treatments favored by their industrial benefactors.”

37. Summary • We need industry to develop vital new therapies. • However, physician education (CME) must be objective and independent of industry influence. • If industry is paying the bills, they expect a substantial return on their investment. • Professional societies must avoid accepting industry funding to maintain the necessary independence: • To write objective guidelines. • Speak out on public health issues. • Encourage cost-effective medical practice.