by Greg Knittl Scarborough Guildwood
some examples from
http://www.healthycanadians.ca/pr-rp/billC-51_e.html as of
2008-07-31
2. Why is it necessary to regulate natural health products?
"to ensure that ... health claims are supported by evidence"
23. What is the future under Bill C-51 for supplements and will
there be
regulated doses? Will 100mg tablets of vitamin C be available
and allowed without prescription?
"Allowable dosage levels for all natural health products will
continue to be determined by the evidence provided to support
their safety and efficacy."
In ideal world where Health Canada actually encouraged
Natural Health Products (NHPs) and sponsored research,
efficacy would cause less concern. In the current situation
where Health Canada derives considerable funding from
Pharmaceutical companies the regulatory mindset for drugs
spills over to NHPs.
http://www.naturalnews.com/011401.html explains how the US
FDA regulates drugs and I think also helps to explain what
Health Canada is saying and doing:
"there are two things that the FDA determines when it looks
at a drug: it determines whether or not a drug is safe and
it determines whether or not it's effective. Regarding the
determination of drug effectiveness, I think the FDA does a
pretty good job. If the FDA says that the drug will
have a particular effect, probably for many of the patients
who take the drug it will actually have that effect. If the
FDA says a given drug
will lower blood pressure and you're somebody who has
high blood pressure, there's a good chance that the drug
will have an effect that lowers your blood pressure. That
has to do with the rigor with which they force the drug
companies to establish that the drug actually has an effect."
Efficacy can be used to impose significant barriers on natural
products because:
1/ Natural Products can have complex mechanisms of action.
Sunshine has been around for ever, but Vitamin D was only
discovered in 1918, and it
was only 1998 that Dr. Michael Holick demonstrated that
cells throughout
the body can activate Vitamin D, not just the kidneys, which
indicated why the body might need more Vitamin D than previously
understood.
2/ NHPs are typically not patentable and not paid for by
hospitals and drug plans so there is little money for research.
In 2007 Health Canada was still recommending 400IU of Vitamin D
per day, when the Canadian Cancer Society moved to 1000 IU.
Much evidence suggests the real daily requirement is even higher.
Health Canada states
http://www.healthycanadians.ca/pr-rp/billC-51_e.html point 1:
"the standards that are used to assess the risks and benefits
of natural health products will continue to incorporate history
of use, traditional uses and cultural practices." If Health
Canada can take such a narrow view of Vitamin D, traditionally
used for ever in the form of sunshine,
where significant research had been done, you can imagine
the position they might take on any more novel NHP. In fact
Health Canada is rejecting a high percentage of licence requests
for NHPs.http://www.stopc51.com/c51/worse_than_we_thought.asp
NHPs are the opposite of drugs: generally safe with few side
effects but whose primary effects may be diffuse or long term
and known only through experience and observation not double
blind experiments. For NHPs Health
Canada should stick to regulating safety. It would be great
if Health Canada would sponsor original research into efficacy
and make it available as non-binding education. We and our
practitioners should be able to use NHPs and decide if they
are effective, not Health Canada.
Further information and action:
Green party C-51 press release:
http://www.greenparty.ca/en/releases/12.05.2008
http://www.commonground.ca/iss/205/cg205_tcm.shtml efficacy in the
context of Traditional Chinese Medicine
Some of the many national websites dedicated to stopping C-51:
www.cnhc.ca
www.stopc51.com
www.nhppa.org
Some Magazines that cover C-51:
http://www.vitalitymagazine.com/ where Helke Ferrie and others have
written on C-51
http://commonground.ca/iss/204/cg204_C51_readers.shtml (Helke Ferrie has
a comment here too)
Greg Knittl maintains an email list by riding to connect those
interested in working together to stop C-51 in their riding. To join
email gknittl@sympatico.ca and give your riding, postal code or MP
This work is licensed under the Creative Commons Attribution-Share Alike
2.5 Canada License. To view a copy of this license, visit
http://creativecommons.org/licenses/by-sa/2.5/ca/ or send a letter to
Creative Commons, 171 Second Street, Suite 300, San Francisco,
California, 94105, USA.
Monday, August 4, 2008
Bill C-51: What does Health Canada mean by Efficiency and why is it important
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1 comment:
Hi, Barry. Just a note from a namesake.
NHPs have been regulated since 2004 for safety, quality and efficacy.
For safety, it is up to the manufacturer to decide on the manner in which the NHP is going to be made available and used, and it is up to the manufacturer to prove any claims that are made. Health Canada does not impose the claims, just judges them based on the evidence provided. So the manufacturer can choose any dosage desired but has to prove that that dosage is safe.
Quality ensures that the white powder that is in that capsule is the untainted NHP listed on the label and not something else.
Efficacy is based on proving the health claim that the manufacturer chooses to make, which is either a Traditional Use claim OR a Non-traditional Use claim (i.e., a scientific claim). Traditional Use claims must prove only that an NHP was used for a specific purpose within a medical tradition (e.g., TCM, Ayurvedic or aboriginal) for over 50 consecutive years (i.e., two generations), not that that specific purpose actually worked. A Non-traditional Use claim must prove that the health claim actually works, typically by citing peer-reviewed articles in reputable medical or scientific journals, as opposed to doing novel clinical trials as required for pharmaceuticals. Accepted claims are then entered into the Health Canada NHP Compendium, and other manufacturers can cite the Compendium entry if they wish to make the same health claim for the same type of NHP.
Health Canada is not rejecting NHP license applications out of hand. Health Canada and NHP manufacturers are both responsible for facilitating NHP licensing. Health Canada may be imposing bureaucratic hurdles that can be streamlined, but NHP manufacturers are probably not submitting error-free applications. They must both work together to improve the success rate. Lowering the standard of application is not necessary when Compendial applications and Traditional Use applications are already relatively easy to submit.
Before you trust StopC51 (aka NHPPA, aka Truehope, aka many other websites) to give you honest, sage guidance on Bill C-51 and NHPs, consider that they may have alternative corporate motives. See for example:
A Triumph of Astroturf?
NHP consumers deserve to have the safety and quality of their NHPs protected, which is what Bill C-51 does.
Barry Green
Ottawa Skeptics
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