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AN INVESTIGATION INTO ALTERNATIVE MEDICINE
Blind trust: Herbal `cures' It's a free-for-all of weak standards, few rules and unknown side effects
Toronto Star Staff Reporter Canada's herbal medicine industry bottles millions of ``natural'' pills and capsules each week but ultimately sells a single product - blind trust. For that, there's an open market as Canadians become increasingly herb-obsessed. Remedies once found only in health food stores, sold alongside organic peanut butter and incense, have moved into pharmacies. And popular herbs have percolated further down the food chain, with echinacea added to instant chicken soup; ``smart'' soft drinks spiked with ginkgo biloba, and granola bars enhanced with prostate-shrinking saw palmetto. Bowing to the trend, Ottawa is building a new herbal-friendly bureaucracy - the Office of Natural Health Products. But, despite their use by up to 10 million Canadians, there's scant evidence natural remedies actually work. No one knows which chemicals, among hundreds in a herb, produce a desired effect. And ``natural'' doesn't mean harmless:
That point is underscored in a series of Star-sponsored lab tests on ginseng, garlic and feverfew pills sold in Toronto. Results show buyers don't always get what they pay for from herbal remedies. And that mirrors several international studies showing industry-wide quality control problems.
``It's open season on the consumer,'' warns scientist Dennis Awang, formerly the federal government's leading expert on natural products and now a consultant. ``When you buy one of these products, it's an act of faith.'' And that faith is too often betrayed. People take garlic pills for lower cholesterol. But of three garlic supplements tested by The Star, all of which had labels boasting of ``allicin compounds,'' or specific allicin levels - none met their claim. (Allicin is an accepted indicator or ``marker'' for overall potency.) ``We don't want to mislead anyone,'' Trevor O'Neil, president of Holista Health Corp. said, after testing found his odourless garlic brand had no allicin at all. Yet green Holista bottles containing these pills, sold across Canada, carry a label stating: ``Rich in allicin compounds.'' That claim isn't entirely correct, O'Neil said. ``I don't expect allicin to be in our product.'' Garlic contains a great number of chemicals and it's not clear which create healthy effects. There's debate over the importance of allicin, which is responsible for garlic's distinctive odour. ``The correct word on that label should have been allicin-like compounds,'' O'Neil said. ``Maybe we should have been more vigilant.'' Allicin is used as a ``marketing word,'' he said. ``We're as guilty as anyone else.'' Another marketing word, just as prominent on drug store shelves, is ``ginsenoside'' - a family of chemicals believed to play a role in the benefits attributed to ginseng, such as reducing stress and boosting energy. Yet five out of six ginseng products promising specific amounts of ginsenoside failed to meet their label claims in University of Guelph testing commissioned by The Star. And when migraine-fighting feverfew brands were examined for parthenolide (a chemical showing their quality), two of six fell short. Big companies were found to fail as often as small ones. ``I'm a consumer myself, and when I see this it's scary,'' said Chung-Ja Jackson, project leader at the university's lab services division. ``We need regulations for this industry. We're not capable of policing ourselves,'' said O'Neil, the plain-speaking head of Holista, in Langley, B.C. His company is typical - certainly better than some. Star testing found his feverfew brand exactly on target for parthenolide. But there are no saints in the herbal sector. It's the pill-makers' version of the wild, wild west - where rules are few, and often broken, and even the most careful company can fall prey to fast-talking hustlers selling discount raw herbs of dubious quality. ``The public have been unwitting dupes all along,'' said O'Neil. ``So have companies. You've got brokers out there who (obtain) raw material, maybe from Europe or China, and they don't know a herb from a pork belly. But they've got a line on it, and they've got a price on it. We get letters and faxes and phone calls from them every day.''
Steep competition creates pressure to cut costs, and some firms blindly accept test results provided by a seller - no questions asked. ``There's no standardization,'' says a Toronto pill company executive. ``You have to be careful who you're dealing with,'' warns another. ``A lot of companies don't play by the rules,'' agrees a third. The herbal market is a place where the local sheriff, in the form of Health Canada, sticks to the outskirts of town. And consumers can do little more than cross their fingers and hope the label in their hand might actually deliver what's promised. ``We're back to the snake-oil medicine show,'' said Dr. Morley Sutter, a University of British Columbia pharmacologist. Perhaps 1 per cent of herbal remedies are of real medical value, according to Dr. James Wright, managing director of Therapeutics Initiative, an independent agency funded by British Columbia to provide evidence-based data on drugs. ``We don't know for sure. The evidence isn't there.'' Despite those problems, between 20 and 30 per cent of Canadians use natural health products, according to statistics gathered by the Nonprescription Drug Manufacturers Association of Canada. That's up from 15 per cent in 1996. And, once started on herbal medicine, people tend to buy more brands as time goes on. Spending on natural health products in 1999 was expected to hit half-a-billion dollars - up 10 per cent over the previous year, according to the nonprescription drug makers. But heavy sales don't mean a product actually works, or that it's risk free. ``I thought I was taking some harmless herb,'' said Renate Herberger, a Vancouver Island woman who treated her insomnia with a remedy called Sleeping Buddha, from China. She developed a dependency on the pills after one month of use, and experienced withdrawal symptoms when she couldn't get more. ``I had panic attacks,'' she said, illustrating the feeling by raising her hands, claw-like and trembling. ``I felt I would lose my marbles. I had to have this stuff. I was ready to scream.'' Herberger pauses to sip raspberry tea from an earthenware mug. The dense smell of geranium-scented incense fills her chalet-style home, nestled among red cedars in a North Saanich forest. An empty bottle of Sleeping Buddha rests in her lap. Yellow day lily and Buddha fruit are the only contents listed. Under the heading ``precautions,'' the label states: ``None.'' Tests run by the federal health protection branch found two powerful prescription sedatives in this product - flurazepam and estazolam - pharmaceuticals in the same chemical family as Valium. The tainted pills were pulled from the market in 1997 and Herberger's withdrawal symptoms gradually eased over five or six days. She still favours some alternative medicine. ``But you have to be cautious,'' she warned. ``Betrayal can happen on any front.'' More recently, several Canadians were stricken by vomiting and diarrhea after swallowing dandelion root pills tainted with buckthorn bark. ``We did ourselves some pretty bad P.R.,'' lamented Ron Billings, president of Herbal Select, in Guelph. About 980 bottles of the company's Potent-Max Dandelion Root were pulled from the market on Nov. 10. Herbals imported from the Far East seem particularly prone to problems:
There have been no reports of Canadian injuries so far but ``taking this is as dangerous as walking near the centre of a nuclear power plant,'' warns Dr. Willem Betz, professor of medicine at Brussels University. He's studying almost 100 women suffering kidney damage after using Chinese herbs containing aristolochic acid at a Belgian slimming clinic in 1991. Several are in dire need of kidney transplants. ``Now - even worse - many of these ladies are developing cancers in the kidney and bladder, years after taking the drug,'' Betz said. Defenders of alternative medicine argue that prescription drugs deliver far more side effects than herbal remedies, and inadvertently kill far more people. ``The risk of conventional medicine is very high,'' University of Toronto professor Bruce Pomeranz told a conference last spring.
In the United States alone, deaths from bad reactions to conventional medicine could claim between 137,000 and 76,000 lives yearly, Pomeranz estimated. Applying the same figures to Canada, about 10,000 people might die yearly due to drug allergies and other reactions to modern medicine. Pomeranz's figures were criticized as excessive after his findings were published in the Journal of the American Medical Association in 1998. More recent work by Kingston researchers, studying Ontario data, concluded that about 680 people die yearly in this province after developing bad reactions to conventional drugs. That translates into about 1,800 deaths Canada-wide - still a heavy toll. But it doesn't mean herbal remedies offer a better way, said Betz, in Belgium. Any medical treatment involves weighing benefits against risks, he said. And while modern drugs can be ``quite dangerous,'' and have serious side effects, these threats are generally known. So doctors, and patients, can balance the risks and proven benefits of such drugs in an informed choice. By contrast, most herbal remedies haven't been studied, so it's impossible to know what their real harm or benefit might be, Betz said. There's an element of risk involved even in popular herbs that are free of toxins, and which deliver everything they claim on their label. Hidden allergies are possible, and unexpected complications can happen, especially when herbal remedies mix with other drugs. A study published in the highly-respected Archives of Internal Medicine in 1998 found:
The American Society of Anesthesiologists advises patients to quit taking herbal medicines two or three weeks before surgery. And concern about herbs harming the unwary is evident even in the alternative medicine camp. ``I've seen people taking the herb ephedra (for weight loss and asthma) go to the emergency ward with palpitations - I've sent some there myself,'' said Paul Saunders, associate dean of medical affairs at The Canadian College of Naturopathic Medicine, in Toronto. (Naturopaths aren't MDs but rather alternative medicine general practitioners, offering a wide variety of treatments.) ``I'm pretty conservative,'' Saunders said, ``I don't like herbs at all in pregnancy. And I don't think you should take echinacea if you're HIV-positive or lactating.'' But few natural health products carry health cautions. Warnings, essential to protect consumers, have become lost in ``a vast gray area'' of conflicting rules and regulations. It's up to each producer to decide how to market a herbal remedy: either as a food item, a drug, or in a half-way category (requiring stricter standards than for food, but not as strict as rules for a full-fledged drug). Take feverfew. Under federal food rules, feverfew makers aren't allowed to put warnings on their product. A warning would mean the pills have a medicinal effect, automatically making them a drug. Under the half-way regulation, pill producers can write a feverfew warning - usually opting to caution pregnant and lactating women not to use this migraine remedy. Meanwhile, under drug rules, a label must carry - in full - the following notice: Feverfew shouldn't be used by anyone pregnant or breast-feeding; it should be discontinued if a sore mouth or mouth ulcers develop, and it shouldn't be used more than four months in a row, except on the advice of a health practitioner. Bizarrely, all three sets of rules are now in force. So, depending on the brand you buy, you could get a full and detailed warning; a partial warning, or no notice of risks at all. (Of 10 feverfew brands examined by The Star, five had a full caution, three had partials, and two had none).
Full warnings are sometimes avoided since these could scare people and hinder sales, said Randy Betts, brand manager at Herbal Select. ``It's a marketing perspective,'' he said. ``These are safe, natural remedies. As soon as you start putting warning statements on, people are frightened.'' The company's feverfew brand carries no warning since Herbal Select chooses to sell it as a food. But Star testing found these pills have a higher parthenolide level than most brands sold as drugs. Betts now says the firm might switch to a different set of marketing rules that would allow a pregnancy and lactation caution. Health food stores and major drug store chains - including Shoppers Drug Mart and Pharma Plus - stock feverfew brands lacking full warnings, sharing shelf-space with the same herb packaged with detailed cautions dictated by Health Canada. Whether or not you're fully warned depends on which brand you happen to choose. So, for a pregnant woman, buying feverfew becomes a game of Russian roulette with pills, and she doesn't even know she's playing. Reform has been promised. Ottawa's new Office of Natural Health Products is about to open. It's supposed to act as the herbal sector's long-awaited sheriff - imposing rules and order on a chaotic market. Regulations are expected governing how natural remedies will be made and tested. Solid quality standards have been pledged. Ingredients described on a label will have to be delivered. And consumers have been assured of protection through clear and consistent label warnings, sometime in the future. But real reform is far from certain, warn industry insiders. Such steps usually spend years oozing through thick layers of federal bureaucracy before making an impact on the marketplace. And herbs are so complex, so little understood - and so profitable - that there will be plenty of ways for special interests to jam up reform. ``I think there will be standards, but no enforcement,'' said Aubrey Dan, president of Wampole Canada Inc., a major herbal remedy producer. He predicted the industry will be too wild to tame, and doubted that the federal government would have the stomach to impose heavy financial penalties on companies breaking the rules. ``It's not going to make a damned bit of difference,'' Dan said. ``Nobody will enforce it. ``It's like building a brand new house complete with a brand new security system to catch burglars. If the police aren't dispatched, the robbers get away.''
Tomorrow: Quest for a miracle
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