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

         

                     

• Nature, Use, and Claims of CAM

• Endocrinology & CAM

• Research and Ethical Issues in CAM

Presentation Overview

                        

      

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”

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

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

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/medwatch

– See FDA Consumer Health Page: “Bio-Identicals: Sorting Myths from Facts” http://www.fda.gov/consumer/updates/bioidenticals010908.html

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

The plural of anecdoteis not evidence