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by Geoff Olson
Some years back, a friend was bemoaning the health claims made for herbal remedies:
echinacea in particular. "There's been no proper clinical trial," he said, as
we hiked up a North Shore trail in BC. He shook his head at what he considered
to be the gullibility of health consumers who buy into products with little or
no standard of proof, other than the soft-focus claims of folklore. For my friend,
such anecdotal "evidence" was about as trustworthy as the "pockets full of posies"
used for warding off the Black Death in the children's nursery rhyme.
I agreed with his concerns about inflated claims for some herbal remedies. But
I qualified it by saying that personally it came down to an issue of epistemology: a fifty-dollar word meaning what you know, and how you can know
it. I have no absolute way of knowing I am getting the straight goods on anything
I put into my body, no matter who the "informed source"
is: whether it's a beaded-and-bangled aromatherapist
fresh off the bus from Sedona, an overworked GP who has no time to assess the
claims made for glitzy new drugs by glad-handing drug reps, or a superannuated
hippie who's trying to sell me a bottle of blue-green algae along
with a multilevel marketing scheme.
Yet I told my friend if I had to choose between claims for a new drug rubberstamped
by Health Canada after its speedy approval by the FDA: an American
organization that is increasingly the lapdog, rather than the watchdog, of profit-hungry
pharmaceutical giants:and claims for a herbal remedy that has been
in use for hundreds, if not thousands of years by tribal peoples, I would probably
go with the latter. If science and government are asleep at the switch, "informed
choice" becomes tricky. With the gatekeepers shaking pom-poms and
doing the splits for the pharmacartels, we may be nearing a situation where all
we'll have left is guesswork at best, and leaps of faith at worst.
In many ways, the debate with my friend was a microcosm of the issues surrounding
herbal remedies and dietary supplements. When it comes to claims made for or against
such products, there is undoubtedly truth-stretching in both directions.
"Natural health product" (NHP) is the all-embracing term
we now give to organic supplements said to have medicinal benefits. This includes
herbs, vitamins, minerals, amino acids, extracts, fungus, algae, homeopathic medicines,
essential fatty acids, and animal materials. The trouble comes when we try to
define this mixed bag further. Do we define all NHPs legally as foods or drugs,
when some are not foods in the traditional sense, and some are not drugs in the
traditional sense? Or do we go for some other category entirely?
The debate is more than semantic. Canadians spend billions of dollars a year on
herbal remedies and other non-pharmaceutical means of managing their health. Several
years back, then health minister Allan Rock concluded there was a need to address
this issue. Health Canada, which has regulations for the safety and efficacy of
pharmaceutical products, had only loose guidelines for natural health products.
In the first round, thousands of Canadians rejected any future attempts to regulate
their favorite health products, and protested directly to Ottawa by petition,
letters and phone calls. "Canadians are speaking out across the country
against attempts by the Health Protection Branch to limit their access to safe
natural health products," wrote NDP health critic Svend Robinson,
"including Chinese herbs, and to charge exorbitant new fees which might
drive them out of business and to restrict access internationally through the
Codex forum."
Critics have long said "hands off" to any federal definition
and regulation of natural health products as drugs. They claimed this would sabotage
all but the biggest players in the health product industry, leaving such companies
and the giant pharmaceutical corporations to pick up the pieces. The advocates
for tighter restrictions claimed that allowing natural health products to be defined
as foods would allow shoddy products to go unchallenged, possibly risking the
health of consumers.
The definition of "natural" is itself suspect, say the
supporters of tighter regulation. "The anthrax spores that we worry
about are perfectly natural," writes a reporter from Functional
Foodnet, citing a story in The Montreal Gazette. "So are strychnine,
cocaine and arsenic. The efficacy and safety of a substance does not depend on
its origin, it depends on its molecular structure and the dose to which we are
exposed."
This is certainly true, although it probably makes more sense to focus discussions
about toxicity on the pharmaceutical industry and US-style healthcare, rather
than to natural health products in Canada. Prescription drugs are the fourth leading
cause of death in the industrialized world, according to a 1998 article in the
Journal of the American Medical Association. (The article didn't address
drug abuse or overdoses, but rather, adverse effects from appropriately administered,
FDA-approved drugs.) Physician-prescribed medicine kills more people annually
than illegal drugs.
The JAMA article estimates that prescription drugs are responsible for 106,000
deaths a year in the US. That is the equivalent to four packed jumbo jets slamming
into the ground every day.
According to Helping Hand Consulting, the available figures from Statistics Canada
(1992) report 1,863 deaths due to complications from pharmaceutical drugs. Stats
Canada reported zero deaths from vitamins, minerals and herbs the same year.
Ironically, those who genuflect before the god of clinical studies can only cite
single-digit deaths from natural health products, usually from anecdotal reports.
Supporters of organic supplements say, quite rightly, "show us the
bodies!"
As for claims that most natural health products don't hew to the same
scientific standard used to assess the efficacy and safety of pharmaceuticals,
this is probably a case of the pot calling the kettle black. According to the
US Office of Technological Assessment, at least 65 percent of drugs and therapies
in use have never been subjected to controlled double-blind studies.
Given this pattern of hi-tech quackery, it's no surprise that talk
of a drug designation for natural health products was rejected out of hand by
the advocates of all things organic in the late nineties. The government seemed
to have backed down, but the issue has now returned in a new guise.
On June 18 of this year, Anne MacLellan, minister of health, announced the adoption
of the natural health products regulations. By January 2004, NHPs will no longer
be classified as drugs or foods, but as a "third category,"
with a two to six year phase-in period.
Said MacLellan: "Consumers have asked for labelling of all ingredients,
for any warnings to be clear and understandable, for assurances of quality and
safety, and for a system of product licensing. With the introduction of these
regulations, Canadians will now be in a much better position to make more informed
decisions about the natural health products they consume."
MacLellan added that The natural health products research program "has
been developed over the past two years through active dialogue with all relevant
stakeholder groups." The Canadian Health Food Association, a trade
organization representing NHP-related businesses across Canada, is stumping for
acceptance of this third category. The CHFA believes it will navigate NHPs through
the Scylla and Charbydis of the food/drug dualism.
In a letter to its constituents, the CHFA endorses The natural health product
regulations set to be published in Part II of the Canada Gazette. "The
Canadian Health Food Association (CHFA) and its members have worked closely with
the natural health products directorate of Health Canada and other industry stakeholders
to ensure that the new regulations are appropriate for the natural products industry.
Although the regulations are not perfect, the CHFA agrees that their implementation
will help to increase the credibility of the natural products industry and will
provide consumers with high quality, safe and effective natural health products.
"
The CHFA letter concedes that unanimity is missing among natural health product
providers on this matter. "There is a segment of the industry however,
that is not willing to accept the regulations as they are written and these people
are currently lobbying MPs and the health minister to delay the promulgation of
the regulations. Thus it is imperative that your MP and the health minister are
made aware of your support for these regulations."
The CHFA's vocal, and sometimes strident critics, claim the trade
organization is a rudderless ship, lost on a sea of wishful thinking. In their
view, the organization is signing many health product manufacturers onto a walk
off the plank.
Critics like NHP activist Truman Tuck claim that the new category will simply
become a means for the pharmacartels to deconstruct NHPs. If the new regulations
become law, they say, Health Canada could have the clout to remove whatever food
supplements they choose from the market place. (Tuck and his associates are currently
involved in attempting to get a private members bill passed through parliament
to address this matter, Bill C420.)
Donna Herringer, president of The Canadian Health Products Association, calls
such concerns over arbitrary use of federal powers "nonsense."
In an interview with Common Ground, she dismissed the notion that Health Canada
can and will pull product off the shelves unless there are legitimate health concerns.
"They have always had the power to do that, and Canadians want that.
Products are removed based on safety considerations alone."
Herringer cites a case from her personal experience, when she worked for an NHP
provider, when a product was found to have metal in it. "I can't
remember, I think it was a staple in bee pollen or royal jelly. There was a consumer
complaint, and Health Canada asked us to do a recall." Herringer
points out that health concerns are "not always about the ingredients"
on the label.
At Truman Tuck's Friends of Freedom website, the scenario painted
by Canada's impending regulatory framework for NHPs is dark indeed.
"The natural health products directorate (NHPD), a body connected with
the Canadian Health Protection Branch, is drafting the second gazetting of a new
regulatory framework for natural health products," and "Canada's
natural health industry, as it currently exists, is on the verge of being shut
down."
"Contrary to the assurances of the NHPD, and (curiously) the Canadian
Health Food Association, these regulations are seriously flawed. By applying them
as written, the Health Protection Branch (HPB) will be able to legally block the
sale of any natural health product (NHP) while the prices of those remaining on
the market would increase dramatically. Because the regulations leave all of the
power to deny or allow products to be marketed in the hands of the HPB and contain
absolutely no conflict of interest guidelines, their acceptance by the natural
health industry stakeholders is simply an act of faith."
The Friends of Freedom argue that if you "have an herbal combination
of cayenne, ginseng and bee pollen," Health Canada could decide
that "it is too threatening to the sales of a particular pharmaceutical
drug." The HPB could find the individual ingredients well within
their safety guidelines, but insist they might pose a health problem when combined.
Under this nightmare scenario, the health product manufacturer is told to do a
clinical study, on their own dime, to determine the safety of this combination.
There is also the experience of natural health product advocates in other countries.
Dr. Anthony Rees, from South Africa, decries the path Canada is currently on,
having experienced a similar process in his own country. Once a "regulator
as a member of the complementary medicines committee of the South African medicines
control council," he has "witnessed the near death experience"
of his country's health food industry. He presents himself not as
a prophet of gloom and doom, but a humble person who has been where Canadians
now stand.
Initially, Rees was supportive of the new guidelines for natural health products
in South Africa, but his "convictions as a naturopath"
led him to question the wisdom of this new regulatory mindset, and after a three
year struggle with a number of other like-minded health care professionals, "we
eventually overturned the Medicines Control Council and bound the pharmaceutical
cartel."
The success against the MCC "sent shockwaves throughout the world,"
Rees writes in a PDF document available on the Internet. As soon as the pro-regulators
realized that this battle was not going to go their way, "they re-grouped
their vast collective international resources and began to assault the next vulnerable
country, which happens to be Canada."
"Many people are being fooled into believing that products such a tryptophan,
and melatonin can be brought back with a third category. The fact remains that
nowhere in the world where this promise has been made, have these products ever
been brought back."
When a nation's health product industry is attacked by what he regards
as an association of moneyed interests: Germany, New Zealand, and
Australia have also experienced this process: Rees says it risks
the "end of health freedom and the free availability of safe, affordable,
and healthy herbs." When this health freedom is deconstructed by
un-elected bureaucrats, in collaboration with large pharmaceutical manufacturers,
they have sometimes been joined by "sold-out health professional and
manufacturing associations."
Whatever the merits of Rees' arguments, no one can accuse the CHFA
of inattention on this issue. "We have been actively participating
in the process for five years," President Donna Herringer told Common
Ground, working with task forces and working groups, such as the HPB's
natural health product directorate, to "apply a minimum standard to
all players," with a two to six year transition period for NHP stakeholders.
As it stands now, Herringer says, a NHP supplier cannot legally make health claims
for their product on the label. With the new standards, they will have this opportunity: although certain health claims, such as any involving mental health,
will require clinical studies, with less dramatic claims requiring only a monograph
from the scientific literature.
"There is no doubt in my mind it's not over yet,"
she says of the CHFA's input in the government's "working
documents" on NHPs. She says the CHFA isn't yet getting
everything it wants, but defends the organization's role in getting
the best possible deal for NHP stakeholders and consumers alike. In her view,
nailing this matter down will serve both parties better than allowing the situation
to drift along as is. "Health Canada won't be arbitrary,"
she says, adding that Canadians want them "to have a say."
The court of final appeal in matters of food and drug safety in Canada is Health
Canada and the Health Protection Branch. Yet the federal government is shutting
down major lab research in the food and drug divisions of the HPB. Critics claim
the government plans instead to rely on testing conducted by other countries,
and by universities, pharmaceutical companies and food "manufacturers."
If there is acquiescence to information from possibly suspect sources, critics
ask what merit to attach to federal expressions of concern over the safety or
efficacy of a given health-food product.
Dr. Michelle Brill-Edwards worked with HPB for 15 years as a prescription drug
expert. She resigned in 1996 because she wanted to speak out publicly about how
the HPB is "excessively lax in regulating high-risk products such as
blood and prescription drugs, but unjustifiably strict in cracking down on herbal
products and nutritional supplements."
Brill-Edwards witnessed snafus at the branch, but put them down to incompetence
or inattention. She later took a darker view, that "the branch is more
influenced by (pharmaceutical) industry forces than by consumer needs."
"The branch is quite open about the fact that it does not do any testing
on product," she later said. "It relies completely on
the manufacturer's commitment to the consumer that the product is
what it says it is."
Is the connection between the US pharmacartels and Ottawa turning into an organ-grinder/monkey
dynamic? Critics contend the Food and Drug Act already worked to effectively contain
the worst excesses of the natural health product industry. The mechanics of enforcement
are there, they insist: all that is needed is the political will
to enforce when needed. In this view, the idea that NHPs may present a clear and
present danger to Canadian health was part of a classic scenario of creating a
problem where there was none before.
By design or default, is Health Canada becoming a proxy of what Michelle Brill...Edwards
calls "big pharma", and does the "problem
creation" ultimately stem from moneyed concerns that act as both
arsonist and fire chief ?
And can we have any more faith in federal non-assessments of designer drugs from
the US than we can from the more enthusiastic claims made for herbal remedies
by organically-minded activists? And given this apparent abdication of its past
role as guardian of Canadian health care, what weight would we give any future
claims from the HPB that any given particular NHP represents a health threat?
Or is all this so much hand-wringing about worst-case scenarios?
"There is no question that there is much faddism and hype in the health
food industry," writes NHP supplier Croft Woodruff by email. "However,
the core business still relies on the tried and true standbys of vitamins, minerals,
herbals and whole foods. Herbal lore and the knowledge of the benefits of botanicals
has existed as long has humanity on the face of this earth."
Woodruff organically farms Echinacea in the Okanagan valley near Kelowna, and
is one of the NHP stakeholders who is very dubious about the proposed regulations.
"If herbs are in such disrepute, why are the pharmacartels currently
practicing the obscenity of bio-piracy in the jungles and forests homes of native
people who depend on these herbs for their health and well being? Why are they
patenting the essences of these herbs then restricting access to them through
their fraudulently acquired intellectual property rights? Who will most benefit?
It will not be the consumer."
Echoing Rees on the apparent international dimensions of this issue, Woodruff
adds that the UK and the European Union "have relegated potencies of
essential nutrients to levels that for all intents and purposes can be considered
inert if not barely effective."
Woodruff believes the natural health products directorate is a "Trojan
horse" designed to "eliminate the natural health products
industry within the next two to four years."
In the hall of mirrors created by the claims and counterclaims about natural health
products and their regulation, one can believe the best or the worst of either
side, or remain agnostic. But it may require an act of faith to believe that Canadians
will enjoy safe, affordable access to natural health products in the future as
they do today.
What do you think? Check out these web sites for further information on the
debate:
Alliance for Natural Health -
www.alliance-natural-health.org
BC Herb Growers Association - www.bcherbgrowers.com/
Canadian Health Food Association - www.chfa.ca/
Coalition for Natural Health -
www.naturalhealthcoalition.ca/
Friends of Freedom - friendsoffreedom.org
Health Action Network Society - www.hans.org
Health Canada - www.hc-sc.gc.ca/
The Herbal Collective - herbalcollective.ca/nhp.htm
Natural Health
Products Directorate - www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/links_e.html
Common Ground invites you to participate in part 2 of this debate. Write
us - contacts here.
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