|December 1998||Bruce H. Woolley, Pharm.D., Editor||Vol. 5, No.12|
|Ken Hunt, Assistant Editor|
ALTERNATIVE MEDICINES RECEIVE WIDE ATTENTION
"There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking." That is how an article entitled Alternative Medicine Meets Science begins. The article is one of many in the November 11, 1998 issue of the Journal of the American Medical Association (JAMA) which is entirely devoted to alternative medicines. The publication covers subjects from Yoga therapy for carpal tunnel syndrome to Saw Palmetto for benign prostatic hypertrophy.
The issue contains an article on the trends in alternative medicine use in the United States between 1990 and 1997. According to the article, use of alternative therapies in 1997 was up 10% from the figures in 1990, as were visits to unconventional physicians. Use of alternative medicines in 1997 was not confined to any narrow segment of society. Rates of use ranged from 32% to 54% in the wide range of sociodemographic groups examined. Use was more common among women (48.9%) than men (37.8%) and less common among African Americans (33.1%) than members of other racial groups (44.5%). People aged 35 to 49 years reported higher rates of use (50.1%) than people either older (39.1%) or younger (41.8%). Use was higher among those who had some college education (50.6%) than with no college education (36.4%) and more common among people with annual incomes above $50,000 (48.1%) than with lower incomes (42.6%). Use was more common among those in the West (50.1%) than elsewhere in the United States (42.1%). With the exception of observed sex differences in 1997, these patterns are consistent with those identified in 1990.
The JAMA issue also contains an article on the legal and ethical issues relevant to use of alternative therapies. The authors review relevant legal principles and case law to understand how malpractice law is likely to develop in this area. They conclude the article by suggesting some questions for physicians to ask themselves before referring their patients to alternative medicine practitioners. This dedicated issue is worth reading in terms of its summary of many alternative practices.
It is notable that Time magazines November 23 issue is also largely devoted to herbal medications. The magazine discusses the industry as a whole as well providing insight into many popular herbal remedies. Both of these publications provide important and significant reading as health professionals continue in their quest for data in clinical decision-making as it relates to the current but ever-changing alternative medicine business.
JAMA. Nov 11, 1998. 280(18):1549-1640.
EXPANDED USES FOR ASPIRIN
The FDA has issued a final rule that expands the prescriptive uses for low-dose aspirin in patients with cerebrovascular and cardiovascular diseases. Aspirin in doses of 50 mg to 325 mg are now recommended for use in women for the treatment of transient ischemic attack (TIA), in both genders for the prevention of an second ischemic stroke, in patients who show evidence of coronary artery blockages such as in angina, for acute myocardial infarction (MI), and for prevention of recurrent MI. Additional expanded uses include specific revascularization procedures and rheumatologic diseases. The rule is published in the Federal Register.
In separate action, the FDA will require expanded warning labels within six months on all otc pain relievers and antipyretics. Labels will now contain organ-specific statements advising people who consume > 3 alcoholic drinks daily to consult with their physician before using these products. Acetaminophen will carry a warning concerning liver damage and NSAIDs (including aspirin) will carry a warning concerning stomach hemorrhage.
FDA PHARMACY COMPOUNDING WEB SITE
The FDA has established a new Web site devoted to pharmacy compounding. The site includes the agencys proposals regarding drugs withdrawn or removed for safety or efficacy reasons. It also lists drugs/substances that can be used in compounding. The address for the new site is: www.fda.gov/cder/pharmcomp/default.htm.
DRUG ABUSE URINE SCREEN FOR HOME USE
A qualitative urine immunoassay for rapid detection of five drugs of abuse has been approved by the FDA. Quickscreen®/Pharmatech strips will show if one or more of cocaine, marijuana, opiates, amphetamines, and either phencyclidine or methamphetamine is possibly present in urine. However, a conclusive positive for the specific drug can only be determined if the testing strip is sent to a clinical laboratory. Negative results will be determined immediately.
THE SKINNY ON CHROMIUM PICOLINATE
The chromium picolinate craze began ten years ago, when Gary Evans published two six week studies which showed that chromium picolinate supplements increase lean body mass and decrease body fat percentage. Since then, just over a dozen studies have been conducted to replicate Evans work. Of those studies, only one showed chromium picolinate supplements to have any effect on lean body mass or weight. That study, a 24 week trial by Bulbulain, et al., resulted in an increased lean body mass and decreased per cent body fat in young male and female swimmers supplementing with 400 micrograms per day of chromium picolinate.
Most of the other studies showed no significant increase in lean body mass or decrease in body fat percentage as Evans had shown. Those that did have similar results used skinfold thickness to measure body fat, a far less accurate method than hydrodensiometry. Only two of the studies lasted longer than 12 weeks and both of them showed no effects. Furthermore, the Bulbalain study was one of only two studies which supplemented with chromium at levels higher than 200 micrograms, the ceiling of the chromium ESADDI.
So where should chromium fit into the supplement repertoire? The data show that a subjects response to chromium supplements depend on his or her own chromium status, dietary chromium, amount of chromium in the supplement, and duration of the study. A general rule for those with no chromium deficiency would be that chromium will have little if any effect on weight loss or muscle mass gain. Challenging this would require a study lasting longer than 24 weeks, supplementing with higher levels of chromium (400+ micrograms). Chromium is a very small piece in the weight-loss puzzle which includes exercise and restricted caloric intake as its staple. If chromium exerts any effect, it is likely long-term and is not, by any means, a quick fix.
Thanks to Richard A Anderson: Effects of Chromium on Body Composition and Weight Loss. Nutrition Reviews. September 1998. 56:266-270.
MORE REGULATIONS OF SUPPLEMENTS
The dietary supplement industrys recent explosion has flooded the market with products that often carry misleading claims and advertisements. Supplements currently on the market claim to help the consumer do everything from fighting depression to improving memory. The Food and Drug Administration has jurisdiction over dietary supplement labeling and stated health claims [see November Newsletter]. Advertising practices, however, are regulated by the Federal Trade Commission (FTC).
The FTC recently issued a warning to the dietary supplement industry to use more caution in their advertisements in outright claims about products as well as what they imply to consumers. The agency also issued a comprehensive guide to help companies that make vitamin, mineral and herbal supplements avoid making deceptive and dangerous advertising claims about their products. In the guide, the FTC indicates several examples of deceptive advertising. One weight-loss supplement advertisement shows a picture of a woman who claims she lost 20 pounds in eight weeks while taking the supplement. An asterisk next to the statement references a disclaimer in fine print at the bottom of the ad that reads, "results may vary." The FTC insists that the location and relative size of the disclaimer is of concern: It is insufficient to effectively qualify the claim.
The laws are in place and so the question becomes: Will the FTC enforce them? Many argue no as the FTC only brought seven cases against dietary supplement manufacturers last year, which is far fewer than the number with questionable advertising practices. The agencys power will potentially weaken even further if proposed legislation in Congress passes. The new bill would require the FTC to allow preliminary health claims, which include results of rat studies, in dietary supplement advertisements.
Adapted from Nutrition Week: "FTC says it will pay closer attention to the Dietary Supplement Industrys Ads," Vol XXVIII, No. 44: November 20, 1998.
Graeme Peterson, writing in the November 26 Press Association Newsfile, reported that a cure for asthma may become available if clinical trials for a recently developed vaccine are a success. He wrote that scientists are currently testing a preventative cure for the allergy at the University College Medical School in London. The investigators believe that as people are not exposed to the amount of germs they were in the past, bodies are no longer trained to protect them adequately. The vaccine is based on this theory and works by introducing a group of organisms to the body that act as "good bacteria" and restore the balance in the immune system.
DEMENTIA RISK DECREASED BY TREATING HIGH BLOOD PRESSURE
The October 24 issue of Lancet reported a study indicating that the risk of dementia in elderly people with high blood pressure can be cut in half by treating with a long-acting calcium channel blocker (nitrendipine). In the study, the type of dementia more commonly prevented was of the degenerative type (Alzheimers disease).
FDA DRUG MARKETING DECISIONS
Irinotecan injection (Camptosar®/Pharmacia & Upjohn) has been granted marketing approval for the treatment of metastatic colorectal cancer whose disease has recurred or spread following standard chemotherapy. Most common side effects included: diarrhea, alopecia, nausea, vomiting, cholinergic symptoms and neutropenia.
Recombinate Antihemophilic Factor/Baxter (Factor VIII) has been approved for increased manufacture by the FDA. This approval will allow the company to increase production by 40%. The product is a genetically engineered blood-clotting therapy for people with hemophilia A.
Telmisartan (Micardis®/Boehringer Ingelheim), an angiotensin II receptor blocker, has been approved for the treatment of hypertension. The drug is unique in this category due to its long 24-hour half-life. Most common adverse effects include: upper respiratory tract infection, back pain, sinusitis, diarrhea, and pharyngitis.
Etanercept (Enbrel®/Immunex) has received FDA approval for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients who have had inadequate response to more than one disease-modifying antirheumatic drug.
Thalidomide (Thalomid®/Celgene) has been granted orphan drug status for the treatment of multiple myeloma. It was previously approved as a treatment of erythema nodosum leprosum in leprosy.
The information and opinions expressed in the Therapeutics Letter do not necessarily reflect the official policy of the sponsoring organizations.