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FDA efforts to improve compounded drug safety upsets naturopaths

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Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances.

According to the American Association of Naturopathic Physicians (AANP)

these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.

Not to mention the fact that it is highly doubtful these questionable remedies could make it through the FDA drug approval process, which requires proven safety and efficacy.

The FDA’s recent steps to improve drug compounding safety is a welcome curb on these practices. Draft Guidance issued in April addresses both compounding for office use and by prescription. (“Office use” refers to creating a supply of a compounded drug to be used by a health care practitioner as needed, as opposed to compounding a drug per a specific prescription for an individual patient.) In June, the FDA also issued an Interim Policy on substances that can be used in compounding a drug. We’ll discuss how these affect naturopathic practice in a moment. (more…)

Posted in: Guidelines, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Bioidentical Hormones

The Medical Letter recently evaluated “bioidentical” hormones and concluded

There is no acceptable evidence that “bioidentical” hormones are safe or effective. Patients should be discouraged from taking them.

“Bioidenticals” include progesterone, estrogens (estriol, estradiol, and estrone), and testosterone. They have mainly been promoted as a safer, more natural alternative to menopausal hormone replacement therapy (HRT), but they are also claimed to increase energy, well-being, and quality of life, and to have an anti-aging effect. Suzanne Somers recommends them for all age groups and both sexes. There is no evidence to support any of those claims.

The whole “bioidentical” thing is a pseudoscientific concept: it is a marketing term rather than a scientifically meaningful one. Bioidenticals are promoted by celebrities like Suzanne Somers, a few maverick medical doctors like Kent Holtorf, proponents of “natural” medicine, patients who were frightened by the Women’s Health Initiative study of hormone replacement therapy, and critics of Big Pharma. The mainstream scientific community is in consensus: a number of medical organizations, from the American Cancer Society to the Mayo Clinic, have issued statements similar to that of The Medical Letter.
(more…)

Posted in: Pharmaceuticals

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