Consumer Health Digest #08-44

Your Weekly Update of News and Reviews
October 28, 2008


Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. 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.


Selenium and vitamin E fail to prevent prostate cancer. Recently published data from the NIH-funded Selenium and Vitamin E Cancer Prevention Trial (SELECT) show that selenium and vitamin E supplements, taken either alone or together for an average of five years, did not prevent prostate cancer. The study participants will continue to be monitored but are being advised to stop taking the products. The data are being prepared for submission to a peer-reviewed medical journal. SELECT was undertaken to explore incidental findings from other studies in which prostate cancer was not the primary outcome measured. One study tested whether vitamin E would prevent lung cancer in smokers and found 32% fewer prostate cancers among those who took the supplement. Another much-publicized study examined whether selenium could prevent skin cancer but found that the supplement-takers developed 52% fewer prostate cancers. SELECT enrolled with more than 8,000 men in each of four groups: one group took both selenium and vitamin E; one took selenium and a vitamin E placebo; one took vitamin E and a selenium placebo; and the fourth group received placebos of both supplements. [Review of prostate cancer prevention study shows no benefit for use of selenium and vitamin E supplements. NCI news release, Oct 27, 2008]


Bayer ordered to stop marketing two aspirin products. The FDA has sent warning letters ordering Bayer HealthCare to stop marketing two over-the-counter (OTC) products that combine aspirin with a dietary supplement ingredient: "Bayer Women's Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage" (which contains phytosterols). In addition to being labeled for use as a pain reliever, both products were labeled for reducing heart disease risk and the Women's product was also labeled for "fighting" osteoporosis. Although certain calcium-containing dietary supplements may legally bear claims to reduce the risk of osteoporosis, products labeled to "fight" or otherwise treat osteoporosis require FDA approval as drugs. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol or prevent coronary heart disease are considered drug claims that require FDA approval. In addition. nonprescription products cannot be marketed for uses that require professional supervision. The warnings reaffirm the FDA's position that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketable in the United States. [FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs. FDA news release, Oct 28, 2008]


Dentist approval of amalgam has increased. Despite campaigning by dental mavericks, the 2007 American Dental Association Survey of Current Issues in Dentistry has found that dentists' satisfaction with amalgam increased between 2000 and 2007. During this period, the percentage "very satisfied" or somewhat satisfied" increased from 83.4% to 94.1% and the percentage who were "very dissatisfied" dropped from 9.1% to 0.8%.


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This page was posted on October 31, 2008.