Thursday, January 03, 2008

Consumer Reports Wrong on Dietary Supplements

CR Wrong on Dietary Supplements By Neil E. Levin, CCN, DANLA Consumer Reports published an article on dietary supplements in January 2008, titled, “Risky Pills – Supplements to avoid”. Unfortunately, CR may have failed to live up to its reputation as an impartial arbiter of quality, apparently relying on its medical and research consultants’ opinions instead of actually testing products. How informed and impartial are these sources on this particular topic? Of course, there is no excuse for companies that blatantly break the law by illegally and knowingly adulterating dietary supplements with drugs or banned substances. The dietary supplement industry asks the FDA and FTC to throw the book at those bad apples pretending to be legitimate businesses. In fact, manufacturers overwhelmingly supported recent legislation – now the law of the land – to put teeth into FDA enforcement powers by banning steroid precursors, regulating manufacturing requirements (cGMPs, current good manufacturing practices) and instituting mandatory reporting of serious adverse events. The supposed burden on the FDA “to prove that a supplement creates “a significant or unreasonable risk” before it can demand its removal” is actually a very low bar, now that the US Supreme Court has allowed a ban on the herb Ephedra without requiring proof that the agency had followed the law, or even its own regulations, in the process. In the CR report, several dietary supplements are singled out for criticism, but with some startling omissions of fact. Androstenedione products (anabolic steroid precursors) have already been outlawed, with the explicit support of the dietary supplement industry. Only rogue manufacturers carry them because they are clearly illegal. Chaparral is mentioned as a present danger, but reputable manufacturers voluntarily withdrew the herb after an FDA warning – back in 1992. Organ and glandular tissues are singled out for risk of Mad Cow disease, but only certain ones are vulnerable and these have largely disappeared from the marketplace. Most glandular tissues are carefully obtained from range-fed animals in New Zealand or Argentina, from areas with no reported cases of this disease. The alkaloid synephrine from Bitter Orange (Citrus aurantium) often gets accused of causing “high blood pressure, heart arrhythmias, heart attack, stroke”. Yet the FDA Medwatch program’s web page does not list a single substantiated complaint of the herb causing these symptoms. Most Bitter Orange is used in formulations along with caffeine and other legal stimulants. In fact, there is evidence that Bitter Orange is not responsible for some of these products’ side effects: “Ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra. These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine … had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation.” (The American Journal of Medicine (2005) 118, 998-1003). In 2004, attorney Marc Ullman requested FDA records on Bitter Orange adverse events from the FDA under the Freedom of Information Act. Scrutinizing these files, he found that many so-called adverse events supposedly related to Bitter Orange were actually for unrelated products, combination formulas, pre-existing conditions etc; reporting that, “In its response to the April 14 FOIA, FDA disclosed it had conducted no research whatsoever concerning either the safety or efficacy of Citrus aurantium.” (Natural Products Insider) The American Herbal Products Association also reviewed every adverse event report on Bitter Orange disclosed under another FOIA request and, after eliminating products also containing ephedra and/or caffeine, found only one minor adverse event (weakness, leg swelling) remaining in the FDA archives, which involved a woman also being medicated for osteoarthritis, hypertension, and diabetes. (HerbalGram. 2006;69:52-55) Another study reported that, looking at formulations including Bitter Orange and caffeine with other herbs, “Laboratory testing (including vital signs, serum chemistries, CBC with differential, urinalysis, and electrocardiography) revealed no significant changes.” (Curr. Ther. Res., 60, 145 - 153.) And in another report, “Bitter orange dried-fruit extract did not significantly alter the [heart rate] or blood pressure after a single dose was administered.” (Pharmacotherapy, Dec. 2005) Yet another study reported that bitter orange had no significant effects on any of the cardiovascular variables measured. (Journal of Clinical Pharmacology, 2001;41:1059-63) Another small study reported small increases in these measures, but the point is that strong cautions are premature, at best. One expert has stated that synephrine works differently if synthesized or injected, rather than orally taking the natural herbal extract. (Experimental Biology and Medicine (vol. 229) and Washington Post 9/7/05). There is still reasonable doubt that Bitter Orange supplements have caused any serious adverse events. The herb kava is also the subject of a caution. I personally use this herb, and have looked at the few, unverified reports relating to liver problems and concluded that they are anecdotal and probably unrelated to use of the herb. Some toxicology experts note that the vast majority of such reports are unverified and that “kava extracts continue to demonstrate a far better risk-to-benefit ratio [than medical options].” (Toxicology Letters, Volume 150, Issue 1, 15 April 2004) My routine liver function tests remain optimal. I was surprised that CR touts the “USP Verified” mark, a certification that is not even as stringent and broad-based as the new federal cGMPs, which are mandatory. This explicit endorsement of a commercial testing program that does not yet meet the new national standard seems misplaced, and is also unfair to imply that GMP-certified manufacturers audited by competing certifying agencies have lesser quality controls. I believe that CR has missed the mark in portraying dietary supplements as dangerous and unregulated by using inconclusive, outdated and unrepresentative data. Why doesn’t the magazine to raise its coverage of these issues to the same high standard as its other reporting? Scaring consumers into using more dangerous medical treatments by such methods may sell magazines and gain media exposure, but at the cost of CR’s credibility, consumers’ wallets and real lives lost. Reactions to properly prescribed pharmaceutical drugs reportedly cause over 100,000 deaths per year and may be the fourth leading cause of death in the US; even ignoring medical errors and overdoses. (JAMA, Apr 1998; 279: 1200 - 1205.) Positioning herbs and other dietary supplements as dangerous, when they are rarely life-threatening, is irresponsible and completely disproportional to their relative safety.

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