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Ephedra: Scientific Evidence Versus Money/Politics

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Ephedra: Scientific Evidence Versus Money/Politics PUBLIC CITIZEN HEALTH RESEARCH GROUP SIDNEY M. WOLFE, M.D., EDITOR May 2003 +VOL. 19, N0.5 Ephedra: Scientific Evidence Versus Money/Politics The folowing article by Health for safety or efficacy studies and is the death, these products are still market­ Letter editor Dr. Sidney Wolfe legal standard for FDA withdrawal. ed in the United States. appeared in the April 18 issue of In a review of 140 cases of adverse Notwithstanding FDA's reluctance to Science magazine. reactions to ephedra reported to the take action, Army and Air Force FDA by early 1999, hypertension was commissaries and post exchanges oes it make a difference, in the most frequently named, followed recently voluntarily removed all terms of FDA regulation, that by palpitations, tachycardia (rapid ephedra-containing dietary supple­ D a drug is natural, has been heart rate), stroke and seizures. The ments from their shelves. The FDA around for thousands of years and is adverse effects included 10 deaths and has received documentation of about dispensed as "servings" rather than 13 instances of permanent disability. 30 deaths in active duty personnel doses, if the drug has been known Even one standard "serving" of a typi­ who were using these supplements, for decades to cause increased blood cal ephedra alkaloid-containing although no direct cause-and-effect pressure, increased pulse rate, and dietary supplement can be dangerous: relation has been established. The an increased risk of cardiac arrhyth­ The average increase in systolic blood National Football League and the mias? For dietary supplements pressure was 14 mmHg, 90 minutes National Collegiate Athletic containing ephedra alkaloids, the after subjects took two capsules with a Association had previously banned answer is yes, it has made a differ­ total of 20 mg of ephedra and 200 mg ephedra. In June 2001, the Canadian ence. of caffeine. Three of the eight people government warned Canadians not to Because of dangers and abuse studied had evidence of "mild clinical use these products, and in January potential, in 1983 the FDA (Food and hypertension." 2002, it announced a recall of Drug Administration) banned all Despite convincing evidence of "ephedra/ephedrine products with over-the-counter (OTC) drugs that heart attacks, arrhythmias, strokes and labelled or implied claims for included both synthetic ephedrine more than 100 reports to the FDA of continued on page 2 and caffeine, the combination used most in dietary supplements contain­ ing ephedra alkaloids, and the CONTENTS agency is now finalizing the ban on OTC drugs that contain ephedrine alone. At a recent U.S. Senate Calcium By Any Other Name Is Still Calcium What you should know about calcium supplements .......................... 2 Hearing on ephedra alkaloids, acting FDA Commissioner Lester Crawford Bereavement conceded that if these products were The four stages of bereavement and where to go for help ...... .......... 4 drugs, not dietary supplements, they would be off the market. But he also Product Recalls stated that unreasonable risk of harm March 19, 2003 -April 16, 2003 at the recommended doses is suffi­ Blood glucose test strips, bicycle helmets and gas grills are on our list this month ........................................................................ .......... 6 cient for withdrawal under the 1994 Dietary Supplements Health and Outrage of the Month Education Act (DSHEA), which The Uncovering of an Undercoder: A story of medicine allows marketing of naturally occur­ triumphant. ..................................................................................... .. ... .. 12 ring products without requirements VISIT HEALTH RESEARCH GROUP'S WEB SITE AT WWW.CITIZEN.ORG/HRG/ Calcium By Any Other Name Is Still Calcium he jackals selling unregulated dolomite craze as the next wave. when indicated, drug treatment. dietary and herbal supple­ Oyster shell calcium supplements Postmenopausal women require an T ments have been hard at it contain calcium carbonate, the active average of 1,500 milligrams of bombarding the public with prepos­ ingredient in the antacid TUMS. One elemental calcium per day (see the terous, unsubstantiated claims about Web site maintains that it is used in explanation below of elemental calci­ the superiority of their particular traditional Chinese medicine to help um). Therefore, supplementation may miracle natural calcium products. with high blood pressure, heart be helpful for women who do not Some disreputable companies have palpitations, insomnia, dizziness, receive an adequate dietary intake of gone beyond just claiming a better blurry vision, cold sweats and calcium. The table at the end of this calcium product and are now declar­ swollen lymph glands, among vari­ article lists the elemental calcium ing that "coral calcium," for example ous other conditions. content of a number of foods. Vitamin if it is from Okinawa, is the secret to The better choice for consumers, D supplementation of 400-800 good health and a long life. however, is chemically pure calcium International Units (IU) per day may The Health Research Group has products, rather than these so-called also be required to ensure adequate been in existence since 1972, and we natural supplements. daily intake in postmenopausal view this latest surge in calcium One of the most important roles women. promotion as the "third wave" of of calcium supplementation, and Calcium is an element; it cannot natural calcium miracles. At one with the science to support it, is in be produced synthetically, and it time, it was calcium from the osteoporosis. The rest of this article can combine with a number of Dolomite Mountains in the Italian will focus on sources of calcium as other molecules to form what Alps as nature's perfect source of applied to the prevention and treat­ chemists call "salts." Each of these calcium and magnesium. Dolomite is ment of postmenopausal osteoporo­ other molecules weighs a different the very common mineral, calcium sis. amount, while the weight of calci­ magnesium carbonate. Some Internet The mainstays for decreasing the um stays the same. Thus, equal Web sites still advertise it as "perfect­ risk of postmenopausal osteoporosis amounts of these salts, by weight, ly balanced nutritionally." are weight-bearing exercise, adequate contain a different amount of calci- Oyster shell calcium followed the calcium and vitamin D intake, and continued on page 3 EPHEDRA, from page 1 California, Metabolife ranked fourth whether a proposed warning label appetite suppression, weight loss in the state for "soft money" contri­ makes sense. Much of this fluny of promotion, metabolic enhancement, butions, with $493,000 in 2000. "activity" is in the wake of the death increased exercise tolerance, body­ Additional federal and state influ­ of Baltimore Oriole pitcher, Steve building effects, euphoria, increased ence-peddling has taken the form of Bechler, whose death has been energy or wakefulness, or other stim­ soft money contributions to political partially attributed to the use of ulant effects." parties, whereby Metabolife gave ephedra dietary supplements. $1,718,000 during the 1999-2000 and "Regulation" is now coming from Political Influence 2001-2002 election cycles. the marketplace, operating in the According to the Washington Post, vacuum created by FDA inaction. Metabolife, the nation's leading seller Act Now Several companies have announced of ephedra products, spent more The recent Rand report reviewing that they will stop selling ephedra­ than $4 million between 1998 and published literature on ephedra and containing diet supplements. Even 2000 in Texas to lobby against state adverse reaction reports takes away Metabolife has announced that the regulations. There have also been the last excuse given by the govern­ company launched an ephedra-free accusations that Metabolife has ment for not yet acting on our 5 "alternative." attempted to exert influence in Texas September 2001 petition to ban all However, this alone is not an through political connections to dietary supplements containing acceptable way to safeguard public members of the Bush administration. ephedra alkaloids. However, the health, and product labeling is not According to Business Week, federal government is still equivocating and enough. We call on the FDA as an efforts to remove ephedra have been has announced, in a 7 March 2003 agency of the Public Health Service hampered "by deep-pocketed indus­ Federal Register Notice, that they to fulfill their legal responsibility and try lobbying. Metabolife, has want comments on any new infor­ to stop the occurrence of further contributed ... to national politicians mation on ephedra risks, public preventable deaths and injuries by since 1999, ... according to the opinion as to whether the legal stan­ banning ephedra products. Center for Responsive Politics." In dard for a ban can be met, and 2 +May2003 CALCIUM, from page 2 calcium-containing urn, actually elemental calcium. PERCENTAGE OF stones in their urinary Some of the most common calci­ CALCIUM SALTS ELEMENTAL CALCIUM tract are generally um salts include calcium carbonate, calcium carbonate 40 percent advised not to take calcium lactate and calcium calcium supplements. gluconate. The table on this page calcium phosphate 40 percent Calcium can interfere lists the common calcium salts sold calcium citrate 21 percent with absorption of for calcium supplementation and the calcium lactate 13 percent some other minerals percentage of elemental calcium and drugs. Some natu­ found in
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