Are OTC Statins the Right Option for America?

1. Are OTC Statins the Right Option for America? James M. McKenney, Pharm.D. President and CEO National Clinical Research Professor Emeritus Virginia Commonwealth University NLA Secretary NLA Board of Directors Chairman, NLA Consumer Affairs Committee

2. Disclosure of Affiliations and Significant Relationships for James M. McKenney: Speaker honorarium: AstraZeneca LP, Kos Pharmaceuticals, Merck & Co. and Pfizer, Inc. Research Grants: AstraZeneca LP, GlaxoSmithKline, Kos Pharmaceuticals, LipoScience, Merck & Co., Pfizer, Inc., Schering-Plough, and Takeda. Consultant Services: AstraZeneca LP, Kos Pharmaceuticals, Merck & Co., Pfizer, Inc., and Sankyo Pharma, Inc. No speaker honorarium, research grants, or consultant fees from J&J Merck or Bristol Myers Squibb.

3. NATIONAL LIPI D ASSOCIATION Mission To enhance the practice of lipid management in clinical medicine. • Multidisciplinary membership based professional association • Education programs that focus on continuous growth and development  • Social responsibility with respect to review and analysis of pending consumer issues and national medical policy • Cooperation with key organizations to achieve common goals • Public service focus to advance practice standards that emphasize positive patient outcomes

4. Dietary Supplements for Cholesterol Lowering Creatine Walnuts Plant Stanols Pectin Tocotrienols Licorice Root Bilberry leaf Lycopene Lecithin He shou wu Soy Protein Carnitine L-carnitine Fiber Gugulipid Maitake Danshen Beeswax Genistein Arginine Copper Chondrotin -3 fatty acids Artichoke leaf Flaxseed oil Aortic glycosaminoglycans Silicon dioxide -carotene Hawthorn Aconite Red yeast rice Ginger Ashwagandha Spirulina Niacin Amla Chromium Gums Pantethine Indole-3-carbinol Fenugreek Selenium Garlic Saponin CoQ10 -sitosterol Fungal polysaccharides Ginger Acidophilus Basil Calcium

5. A LINE OF REASONING • How can consumers possibly do what health professionals do in managing lipids to reduce CHD risk? • We are not getting the job done. • We can try to overcome this by doing more. • We can also consider encouraging consumers to take more responsibility for their own health care. • For this to work, the treatments available to consumers must be effective and very safe and consumers must be able to implement the treatment effectively and safely. • Key questions: • Is the statin sufficiently safe and effective? • Can the consumer safely and effectively implement treatment?

6. THE NLA MONOGRAPH Should Consumers Be Given an OTC-Statin Option to Help Reduce Their CHD Risk?Exploring the Evidence The Current State of Cardiovascular W. Virgil Brown, MD Disease Risk Reduction in the US Considerations for Approval of Eric P. Brass, MD, PhD Prescription Drugs To OTC Sale A Survey of the Attitudes, Beliefs, and James M. McKenney, PharmD Perceptions of Consumers Regarding CHD And High Blood Cholesterol Overview of Consumer-Use Research Jerome D. Cohen, MD Value-Added Services Provided by Janet P. Engle, Pharm.D. Pharmacists in an Environment of OTC Statins

7. 74% of respondents said they “were likely to learn more” about an OTC statin if one became available 57% said they were “likely to purchase and use” an OTC statin, if approved Consumers with a high interest in the OTC statin option are demographically similar to those with less interest in terms of age, income, and ethnicity. But they are more concerned and more interested in learning more about cholesterol and more open to OTC medications. Many of those with interest in an OTC statin are also either regularly or occasionally already doing things to lower their cholesterol level 58% are taking supplements 64% are avoiding smoking 72% are exercising 80% are eating a low fat diet (80%) 82% are trying to lose weight (82%) Consumer Interest in an OTC Statin

8. 85% of consumers say that they would be very likely to consult with their physician or other healthcare professional before (80%) or just after purchasing an OTC statin (5%) 82% of consumers say that they would continue to consult with their physician after buying an OTC statin Consumer’s Interaction with Physicians

9. Characteristics of OTC Users

10. Potential Safety Concerns