Consumer Health Digest #13-48
Your Weekly Update of News and Reviews
December 19, 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.
Multivitamin use blasted. The Annals of Internal Medicine has published the results of three studies which found no benefit from taking multivitamins:
- The U.S. Preventive Services Task Force updated its evaluation of vitamin supplements for primary prevention in community-dwelling adults with no nutritional deficiencies. After reviewing 3 trials of multivitamin supplements and 24 trials of single or paired vitamins that randomly assigned more than 400,000 participants, the authors concluded that there was no clear evidence of a beneficial effect on all-cause mortality, cardiovascular disease, or cancer. [Fortmann SF and others. Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer: An updated systematic evidence review for the U.S. Preventive Services Task Force. Annals of Internal Medicine 159:824-834, 2013]
- Another team evaluated the use of a daily multivitamin to prevent cognitive decline among 5947 men physicians aged 65 years or older participating in the Physicians' Health Study II. After 12 years of follow-up, there were no differences between the multivitamin and placebo groups in overall cognitive performance or verbal memory. [Grodstein F and others. Long-term multivitamin supplementation and cognitive function in men: A randomized trial. Annals of Internal Medicine 159:806-814, 2013] The full text is available online free-of-charge.
- Another team assessed the potential benefits of a high-dose, 28-component multivitamin supplement in 1708 men and women with a previous heart attack who participated in the Trial to Assess Chelation Therapy. After a median follow-up of 4.6 years, there was no significant difference in recurrent cardiovascular events with multivitamins compared with placebo, although, as the authors noted, the significance of this study was limited by high rates of nonadherence and dropouts. [Lamas GA and others. Oral high-dose multivitamins and minerals after myocardial infarction: A randomized trial. Annals of Internal Medicine 159:717-804, 2013]
An accompanying editorial, which considered the gamut of previously published studies drew a very harsh conclusion that generated headline news throughout the United States:
Beta-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful. Other antioxidants, folic acid and B vitamins, and multivitamin and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases. Although available evidence does not rule out small benefits or harms or large benefits or harms in a small subgroup of the population, we believe that the case is closed— supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough. [Gualler E and others. Enough Is enough: Stop wasting money on vitamin and mineral supplements. Annals of Internal Medicine 159:850-851, 2013]
Quackwatch has suggestions about the rational use of dietary supplements. Among other things, it recommends that people who wish to take multivitamins should do so only every 2 or 3 days and spend no more than $1 per month.
Cancer salve seller found in contempt for flouting drug laws. Toby Carl McAdam, doing business as Risingsun Health, of Livingston, Montana, has been found in civil contempt of court for violating a 2010 consent decree under which he was ordered to stop illegally marketing products and unapproved products for the treatment of cancer and other serious diseases. The prohibition included all topically-applied products derived from bloodroot or graviola plants. The FDA sought the contempt order because McAdam continued to "flout the law" despite repeated FDA inspections, warnings, and promises to stop. The judge's order requires McAdam to (a) immediately cease all manufacturing, processing, packaging, labeling, holding, selling, and/or distributing all products intended to be ingested by, or applied topically to, humans or animals, including any drugs and/or dietary supplements; (b) immediately shut down his website and the Risingsun Herbal Health Facebook page; (c) remove all products from Amazon.com, (d) remove any related telephone listings from phone books unless the FDA permits him to resume business, and (e) pay $80,000 in liquidated damages plus $4,936.48 for attorneys' fees.
R.J. Reynolds torpedoes proposed graphic warning labels. CNN has reported that the Department of Justice will not ask the U.S. Supreme Court to review a federal appeals court ruling that blocked nine proposed graphic warnings on cigarette packages. [Almasy S. FDA changes course on graphic warning labels for cigarettes. CNNHealth, March 20, 2013] Although the Tobacco Control Act gives FDA jurisdiction over cigarette labeling, the Federal district court judge who sided with R.J. Reynolds concluded:
- The FDA cannot require tobacco companies to place new warning images on cigarette packages, because this requirement would violate their free speech rights.
- The FDA's requirement that tobacco companies place one of nine images (including ones of a corpse, cancerous lungs, and a man blowing smoke through his tracheotomy hole) with new warnings on their cigarette packages unconstitutionally compelled speech because these nine images did not convey factual information to the public.
- The FDA had not shown that these images were accurate or their inclusion promoted a strong government interest.
- The agency's intent was not to educate or inform but to advocate behavior change.
- The FDA could use other tools to curb smoking, including raising cigarette taxes.
In contrast, in 2012, Australia's High Court upheld the world's toughest anti-cigarette law which requires 14 graphic warnings that are much more gruesome than those proposed by the FDA. In July, seven months after these labels were deployed, The New York Times reported that many smokers were complaining that their cigarettes tasted bad even though their ingredients had not changed. The Times also noted that taxes have raised the price of cigarettes to about US$14.70 per pack. [Siegel M. Law spoils tobacco's taste, Australians say. The New York Times, July 10, 2013] The Campaign for Tobacco-Free Kids reports that more than 60 countries require graphic warning labels. [Cigarette Package Health Warnings: International Status Report, October 2012]
This page was posted on December 20, 2013.