July 13, 2000
Vol . 18, No. 6
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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