1. Marc R. Blackman, M.D. Associate Chief of Staff, Research & Development Washington DC VA Medical Center Professor of Medicine Johns Hopkins University School of Medicine 17th Annual Meeting American Association for Clinical Endocrinology May 17, 2008 Alternative Medicine and Endocrinology

2. Nature, Use, and Claims of CAM Endocrinology & CAM Research and Ethical Issues in CAM Presentation Overview

3. The Appeal of CAM  Media reports of dramatic results  Belief that CAM treatments are natural  Patient empowerment  Focus on spiritual and emotional well-being  Therapist providing “touch, talk, time”

4. Dietary Supplements: DSHEA Definition Product intended to supplement the diet Contains one or more of the following: –Vitamin –Mineral –Herb or other botanical (not tobacco) –Amino acid –Any other dietary substance For oral intake as a concentrate, metabolite, extract, constituent, or combination

5. AACE Guidelines AACE Guidelines for the Clinical Use of Dietary Supplements and Nutriceuticals –AACE Nutritional Guidelines Task Force –Endocrine Practice vol 9 (no. 5) Sept/Oct 2003, pp 417-470

6. FDA Warning re Bioidentical Hormones-January 9, 2008 Warned 7 compounding pharmacies that claims re safety and effectiveness of BHRT products are unsupported by medical evidence, and are considered false and misleading to patients and health care professionals –Pharmacies claimed that their drugs, which contain estrogen, progesterone and estriol (not a component of an FDA-approved drug, and nor proven safe and effective for any use) are superior to FDA-approved menopausal HT’s and prevent or treat serious diseases, such as Alzheimer’s disease, stroke, and various forms of cancer –FDA’s actions do not target traditional pharmacy compounding (with MD prescription) where there is no false claim of benefits or safety –All patients using compounded hormones should discuss menopausal HT options with their health care providers to determine if BH’s are best Rx option. If problems are encountered with BH’s, patients and physicians should be encouraged to file a MedWatch report with the FDA at www.fda.gov/medwatchwww.fda.gov/medwatch –See FDA Consumer Health Page: “Bio-Identicals: Sorting Myths from Facts” http://www.fda.gov/consumer/updates/bioidenticals010908.html

7. Challenges of Natural Products Research Safety is assumed, not proven Products are not standardized Contamination and/or adulteration with drugs and heavy metals Allergic reactions Some are toxic Interactions with allopathic drugs Replacing proven therapies

8. The plural of anecdote is not evidence