Consumer Health Digest #13-36

Your Weekly Update of News and Reviews
September 26, 2013

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

Bioidentical hormones don't measure up. More Magazine has published an article about the risks associated with lax regulation of compounding pharmacies. [Ramin CJ. The hormone hoax thousands fall for. More, Oct 13, 2013] As part of its investigation, the magazine's staff sent identical prescriptions for Tri-Est, a bioidentical hormone drug, to 12 compounding pharmacies, 10 of them online and two in brick-and-mortar stores. Tri-Est is a combination of progesterone and three estrogens: estradiol, estrone, and estrol. Estrol has never received FDA approval for use in any drug product. The testing laboratory reported that the estrol content varied from 67.5% to 89.5% of the labeled amount, which meant it was subpotent. The two other estrogens were mostly superpotent, ranging from 58.4% to 272.5% of the estrone prescribed and 95.9% to 259% of the estradiol (the most potent form of estrogen). The progesterone data showed that most samples delivered about 80% of the prescribed amount, although one contained less than 60% of the amount prescribed. The article noted: "Had the compounded products we tested been commercially manufactured pharmaceuticals, none would have passed the FDA's requirements for finished drugs, which mandate that the contents be between 90% and 110% of the prescription as the physician has written it." The investigation was subsidized by the Fund for Investigative Journalism.

"Bioidentical hormones" are plant-derived hormones that are claimed to be biochemically similar or identical to those produced by the human body. They are also claimed to be safer and to have fewer side effects than than standard FDA-approved synthetic hormones. However, the relevant chemicals (steroids) in plants are not identical to those in humans. To make products that work in humans, raw materials from the plants must be converted to human hormones synthetically. Thus, to the extent that they are potent, the "bioidentical" products would pose the same risks as those of standard hormones—plus whatever problems might be introduced during compounding. [Barrett S. Steer clear of bioidentical hormones. Sept 28, 2013] The American College of Obstetricians & Gynecologists has cautioned against their use.

Toxicologists blast homeopathy and unwarranted chelation. The American College of Medical Toxicology (ACMT) and American Academy of Clinical Toxicology (AACT) have jointly released a list of specific treatments, tests, and procedures that are commonly used, rarely necessary, and potentially harmful as part of the Choosing Wisely® campaign, an initiative of the American Board of Internal Medicine (ABIM) Foundation. The list contained five recommendations:

The Choosing Wisely campaign is intended to educate physicians and the general public about unnecessary medical tests. Consumer Reports, several voluntary health groups, and more than 50 major professional organizations have joined so far. Each group has listed "Five things patients and physicians should question." The full text of the ACMT-AACT recommendations is posted on the campaign's site and is downloadable as a 2-page flyer.

Index of disciplined chelationists posted. Dr. Stephen Barrett is compiling a database of disciplinary actions that state licensing boards have taken against practitioners who have administered chelation therapy for inappropriate reasons. In some cases, the action was based on misuse of chelation itself. In other cases, the complaint against the physician had other grounds or was based on conduct that would be regarded as improper regardless of whether chelation was involved. The database currently includes more than 90 medical and osteopathic physicians. More will be added as time permits.

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This page was posted on September 28, 2013.