Kim’s public health blog

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
The products are:
–Zicam Cold Remedy Nasal Gel
–Zicam Cold Remedy Nasal Swabs
–Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”
Comment: One more OTC product found sufficiently harmful to withdraw from stores. It is one more example of a highly advertised product that not only does not perform as touted but is in fact dangerous.

The Chicago Tribune (6/18) reports, “Probiotics…have broken out of the dairy case and are colonizing other areas of the supermarket” because they are “thought to aid digestion and support the immune system.” But as more manufacturers fortify their foodstuffs, experts are beginning to “caution that the word ‘probiotic’ is widely misused by the industry and misunderstood by consumers.” Currently, “there is no standard definition of probiotics, according to the” FDA. “But scientists generally say the term refers to foods, beverages, or supplements containing live microorganisms that studies show promote health when people take enough of them. Without studies, products shouldn’t be called probiotic.” Comment: one more piece of false advertising, usually from Dannon for their Yogurt, who are currently being investigated by the European Union for false statements.. There are a number of beliefs among credible clinicians, for specific purposes but few if any clinical studies that support these beliefs.

FDA alerts consumers to the finding of new undeclared drug ingredients. The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The products listed in this announcement, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients. Comment – The Weight Loss Hucksters are probably taking as much out of the economy as Bernie Madoff or AIG.

Another in the series of “How often do we need to repeat the message to make a point. Multivitamins do not have any impact on postmenopausal women’s risk of dying, getting cancer or cardiovascular disease, said the most extensive study to date on the subject, released Monday. The research examined 161,808 women, age 50 to 79, who took part in clinical trials on hormone therapy, dietary modification and vitamin D supplements, as well as 93,676 women who were part of an observational study.”Analyses revealed no significant associations between multivitamin use and the likelihood of developing cancer or cardiovascular disease, or of dying,” said the findings, published in the Archives of Internal Medicine [Arch Intern Med. 2009;169(3):294-304.] The fad for complementary medicines and efforts by the hucksters of OTC drugs continues unabated.

Researchers at the Nordic Cochrane Centre in Copenhagen analysed evidence from thirteen acupuncture pain trials involving over 3,000 patients. The trials compared three arms of treatment (real acupuncture, placebo or ‘pretend’ acupuncture or no acupuncture) for a broad range of common conditions such as knee osteoarthritis, migraine, low back pain and post-operative pain.  They found a small analgesic effect of real acupuncture compared to placebo acupuncture. This corresponded to a reduction in pain levels of about 4mm on a 100mm pain scoring scale. A 10mm reduction on this scale is classed as ‘minimal’ or ‘little change’ so the apparent analgesic effect of acupuncture seems to be below a clinically relevant pain improvement, say the authors. Comment: I wonder how often we have to repeat research on complementary medicines before we stop wasting research dollars?

An article published in JAMA today identifies the dangers posed among many people, especially older ones, who use multiple medicines, mixed with over the counter (OTC) drugs and dietary supplements which often interact.  Most physicians do not ask about the use of OTC drugs or supplements. If they discourage them there is no assurance patients will follow  their advice.

According to a report titled, Complementary and Alternative Medicine use United States, 2007, issued by the NIH. The researchers found that use of yoga, ‘probiotics,’ fish oil, and other ‘complementary and alternative’ therapies held steady among adults since the last national survey five years earlier, and that such treatments have become part of healthcare for many youngsters. Critics warned that “some studies have found some dietary supplements might increase that risk of some serious health problems, including cancer.” Comment: Why are the health professionals so bad at explaining which preventive services work that so many members of the public seek out scams, often dangerous ones, for themselves and their children. The Magic Medicine Peddlers still run their carnival shows, but on TV and the internet instead of travelling side shows.

Diets and beauty products which claim to have anti-oxidant properties are unlikely to prevent aging, according to research funded by the Wellcome Trust. Researchers at the Institute of Healthy aging at UCL (University College London) say this is because a key fifty year old theory about the causes of aging is wrong. ‘Superoxide’ free radicals – oxygen molecules which have an imbalance of electrons to protons – are generated in the body through natural processes such as metabolism. These free radicals can cause oxidation in the body, analogous to rust when iron is exposed to oxygen. Biological systems, such as the human body, are usually able to restrict or repair this damage. Dr Gems believes the study suggests that anti-ageing products, that claim to have anti-oxidant properties, are unlikely to have any effect. “A healthy, balanced diet is very important for reducing the risk of developing many diseases associated with old age, such as cancer, diabetes and osteoporosis,” he says. “But there is no clear evidence that dietary antioxidants can slow or prevent ageing. There is even less evidence to support the claims of most anti-ageing products.”

ScienceDaily (Dec. 1, 2008) — Acupuncture works – but it works equally well with or without needle penetration. This conclusion can be drawn from a treatment study involving cancer patients suffering from nausea during radiotherapy. The acupuncture study of 215 patients who were undergoing radiation treatment in the abdomen or pelvic region chose by lot one of these two acupuncture types. 109 received traditional acupuncture, with needles penetrating the skin in particular points. According to ancient Chinese tradition, the needle is twisted until a certain ‘needle sensation’ arises. The other 106 patients received a simulated acupuncture instead, with a telescopic, blunt placebo needle that merely touches the skin. The effects therefore seem not be due to the traditional acupuncture method, as was previously thought, but rather a result of the increased care the treatment entails. COMMENT: Like most complementary medicine, well conceived studies rarely show the ‘treatment’ makes as much difference as the enhanced links between the therapist and patient

Initial, independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute (NCI) and other institutes that comprise the National Institutes of Health shows that selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer. The data also showed two concerning trends: a small but not statistically significant increase in the number of prostate cancer cases among the over 35,000 men age 50 and older in the trial taking only vitamin E and a small, but not statistically significant increase in the number of cases of adult onset diabetes in men taking only selenium. Because this is an early analysis of the data from the study, neither of these findings proves an increased risk from the supplements and both may be due to chance.