Download MBlackman_AACE_press_conf_051708

Alternative Medicine and Endocrinology
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
Presentation Overview
• Nature, Use, and
Claims of CAM
• Endocrinology &
CAM
• Research and Ethical
Issues in CAM
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:
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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
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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
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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 anecdote
is not evidence