July 13, 2000 Vol . 18, No. 6
Because herbalists make medical claims their
products should meet the same standards as prescription drugs.
By Barry Beyerstein
If it is true that those who ignore history are condemned to relive it, recent trends in the marketing of herbal medicines and supplements should scare us all. Canadians forget that it was harms and abuses by unregulated patent medicine peddlers in the early 1900s that prompted laws to protect us from dangerous nostrums and unsubstantiated medical claims.
In a nostalgic wave of ill-informed naturalism, they are permitting these safeguards to be eroded by politically driven changes in government policies. If so-called natural health products are potent enough to benefit one's physiology, as promoters claim, they are potent enough to cause serious adverse effects as well. Show me a product that has no side effects and I will show you a biologically inert panacea; in which case, vendors will merely be scamming trusting consumers with inactive placebos.
Either way, we cannot afford to leave regulation to those with inadequate education and a financial stake in the sale. Because herbalists make medical claims, their products should meet the same standards as prescription drugs.
The first laws regulating prescription drugs stemmed from the public response to Samuel Hopkins Adams' journalistic exposures of abuses by the patent medicine industry in the early 1900s. Those laws were stiffened in 1938 when 106 American children died from contaminated sulfanilamide elixirs. In 1962, the tragedies from insufficient testing of thalidomide led to the Kefauver-Harris Act that set modern U.S., and essentially world, standards for scientific vetting of pharmaceuticals. Before receiving a licence, manufacturers must establish safety and efficacy with basic laboratory research, animal screening, and controlled clinical trials.
Health Canada's regulations used to be broad enough to prevent sellers of herbal concoctions and so-called health food supplements from making specific medical claims, unless they were backed up by such evidence. Herbalists and health food merchants have long resented these impediments to their wealth. Now they are on the verge of being able to set their own rules, as is already the case in the U.S. where the government must now prove a herb or supplement is dangerous before sellers must take it off the market. Instead of making dealers prove safety and efficacy beforehand, people must now get sick or die before the government can act. Even if they are not dangerous, selling useless products is still an assault on the pocketbook.
The slackening of rules that I see as a recipe for disaster began before our most recent federal election. The then minister of health merely suggested that herbs and supplements should be required to have labels that accurately depict their contents and details of manufacture. The health food industry vigorously attacked these sensible proposals. Fearing loss of votes in key ridings with large ethnic and new ager populations, the government retreated and referred the matter to a study panel. I immediately wrote asking to testify before this advisory group, as I had done with similar bodies before. Such was their interest in scientific input that I didn't even receive an acknowledgment of my letter. It soon became apparent why. The advisory committee had been stacked with business people with little scientific background and financial reasons to fear scientific oversight of their industry.
Its report propounded the self-serving nonsense that there are "other ways of knowing" that their concoctions are safe and effective, making proper scientific tests of natural products unnecessary. They accepted historical anecdotes and folklore as evidence and asserted that since scientists and medical doctors knew nothing about herbs and supplements, they should be excluded from the entirely separate regulatory agency the panel proposed (to be under their own thumbs, of course).
The report was so antiscientific and self-serving that one member of the panel who has high scientific and personal integrity, Meera Thadani, a pharmacy instructor at the University of Manitoba, denounced it as "scientific gobbledygook." She refused, despite extreme political pressure, to sign it. Health minister Alan Rock ignored strong scientific opposition and set up a transition team to implement the recommendations anyway.
A group I helped found, Canadians for Rational Health Policy (http://www.crhp.net) met with the minister's assistant and warned him of the dangers it entailed. We recommended several Canadian scientists with world-class reputations in pharmacognosy (the legitimate science of plant-derived drugs) to serve on the regulatory board if he insisted on going ahead with the ill-advised plan.
None was picked and the team was again dominated by non-scientist, natural product merchants. Would the media and ordinary Canadians stand for an official body advising Health Canada on prescription drugs that was comprised overwhelmingly of representatives of the pharmaceutical industry? This is how I view the makeup of the new office of natural health products. The minister has made the goat the gardener.
Herbal defenders have denounced our criticisms. "Natural is safe," they say. This benevolent view of nature is belied by noting that tobacco is a natural product, as are plants that produce strychnine, belladonna, deadly mushroom poisons, and shellfish toxins.
"We are entitled to a choice," they say. True, but only a fool would make a potentially dangerous choice without first obtaining all the relevant facts. Whose facts are more likely to be unbiased -- impartial scientists and government regulators or someone who stands to gain from the sale? If we are going to open access to unscientific remedies, all the more need for a nonpartisan watchdog.
"I took it and I got better," they say. But how do they know they wouldn't have recovered just as well if they hadn't taken the potion? Because of natural recovery and the powerful placebo effect, testimonials prove nothing. The history of medicine is strewn with crackpot remedies that both doctors and patients once swore by. For example, throngs of intelligent people attested to cures from the most expensive panacea of its day: scum scraped off the decaying head of an executed criminal. Without the controlled clinical trials, we can never know what works and what only seems to.
How knowledgeable are the herbalists who want to regulate themselves? I have been debating them publicly for years and visiting their establishments to "chat them up." As a group, I am appalled by their lack of basic pharmacological knowledge. They have deluged me with pseudoscientific misinformation, and not infrequently, with advice that could be dangerous. In my courses, I review the poor scientific support for most herbal products. A new journal I am associated with, Scientific Review of Alternative Medicine, does so as well, as does the excellent website, (http://www.quackwatch.com).
As I write, there are 110 women in Europe awaiting kidney transplants; many have also developed urinary tract malignancies. This from a natural slimming agent that contained the toxic herb aristolochia, sold by expert herbalists.
My files contain numerous reports of allergic and toxic reactions and deaths due to herbal medications. Evidence is also growing that many herbal concoctions interact badly with doctors' prescriptions. In other studies, chemists have bought herbal preparations, off the shelf, and analyzed them. A high proportion were found to be mislabeled, to contain unlisted prescription drugs, or to be contaminated by toxic metals, addictive agents, or other dangerous substances.
Although several modern medicines were derived from ancient herbal concoctions, many more are useless, some actively dangerous. The ones scientific biomedicine accepts have passed rigorous tests for safety and effectiveness. Most herbs on the market today have not met the minimum standards I think the government should demand. It will give me little pleasure to say "I told you so," when the final costs are tallied from this nostalgic attempt to turn the clock back to the "good old days" of the snake-oil salesman and his traveling medicine show.
Barry Beyerstein is an associate professor of psychology
who specializes in the effects of drugs on the brain and behaviour.
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