TCM Community Sucked In by StopC51 Propaganda

StopC51 continues to play on the fears of natural health product (NHP) users.  This time, the people who have been duped appear to be the Traditional Chinese Medicine (TCM) community, according to articles in the Vancouver-based The Province (“Feds want to restrict traditional cures“) and CBC news online (“Traditional Chinese doctors fight federal regulation under Bill C-51“).  It’s too bad that, with just a little fact-checking by the journalists, the stories could have been balanced and factual instead of just outlets for StopC51’s unchallenged propaganda.

 
According to The Province in the following uncritical statement :
 

“If passed, Bill C-51 would require all natural medicine and herbs to pass Western-style scientific testing before being approved for sale in Canada.”
 

The implication of this statement is that health claims for TCM products will have to be proven scientifically valid, such as through clinical trials, in order for the products to be licensed as NHPs, but this is simply not true.  In reality, TCM products will be licensed based on what they have been traditionally used for and not on what they actually can be proven to do scientifically.
 
Traditional Use Claims
 
TCM products are currently licensed under the provisions of existing NHP Regulations (SOR/2003-196, SOR/2007-288 and SOR/2007-289), which allow for traditional use claims (see Health Canada guidance document Evidence for Safety and Efficacy of Finished Natural Health Products).
 
Health Canada defines “traditional medicine” as:
 

“the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.”
 

Traditional use claims are made in the context of the traditions of a particular culture or system of medicine.  For TCM, claims would be made in the format “Traditionally used in Chinese Medicine to …” and must conform to the dosage and method of preparation used traditionally and cited as evidence.

For example, here are some TCM-based traditional use claims that have been approved by Health Canada for the ingredient Astragalus: 

  • Used in Traditional Chinese Medicine (TCM) to tonify the spleen and augment the Qi (vital energy): for spleen deficiency presenting with a lack of appetite, fatigue, and diarrhoea (PPRC 2000; Benksy and Gamble 1986).
  • Used in TCM to tonify the lungs and for frequent colds (PRC 1998; Benksy and Gamble 1986).
  • Used in TCM to augment the protective Qi and stabilize the exterior: for deficiency with spontaneous sweating (PPRC 2000; Benksy and Gamble 1986)

Evidence for traditional use claims must indicate “a history of at least 50 consecutive years of traditional use of a medicinal ingredient within a cultural belief system or healing paradigm,” which is intended to represent at least two generations of use.  For evidence, reference must be made to at least one accepted pharmacopoeia (e.g., Pharmacopoeia of the People’s Republic of China) or, failing that, an accepted combination of reputable written references and expert opinion (e.g., ethnographic authority, indigenous elders) sufficient to prove the use of the treatment within the specified cultural context for at least 50 consecutive years.
 
None of these stated requirements indicates a need for scientific testing.
 
Reinforcing Amendments to the Bill
 
Under Bill C-51, the NHP Regulations will continue in force, so TCM products will continue to be licensed as traditional-use-based NHPs.  In fact, because NHP stakeholders have expressed concern about the licensing of traditional medicines, Health Canada is proposing, as one of many amendments to the bill, language that reinforces their commitment to these regulations:
 

“Obligation in respect of information in applications relating to natural health products
 
(1.3)  In making regulations under paragraph (1)(y) relating to the information that is required in an application for a market authorization for natural health products, the Governor in Council shall specify that the information to be provided may include information based on
(a)  traditional knowledge relating to the product; or
(b)  the history of use of the product or any of its ingredients.”
 
This amendment embeds the concept of traditional use claims in the legislation, instead of just the regulations, as desired by the TCM community.
 

NHPs are not Prescription Drugs
 
CBC reiterates another groundless StopC51 accusation:
 

“the government could designate any natural health product a prescription drug, making it available by prescription only, forcing smaller companies out of the market.”
 

Again, this is not true.  Under Bill C-51’s legislative framework, therapeutic products will be risk managed using a progressive licensing approach.  Since NHPs are generally safe when produced in accordance with their particular quality standards, licensed NHPs pose relatively little risk to consumers, which is why they will continue to be marketed over-the-counter and not under prescriptions.  As stated repeatedly on Health Canada’s FAQ site, Bill C-51 and Natural Health Products – The Facts:
 

“There is nothing in Bill C-51 that changes the regulatory status of natural health products from over-the-counter, as they are now, to prescription.  …  Since the Natural Health Products Regulations came into force in 2004, there have been no amendments to convert a product from a natural health product to a prescription drug.”
 

StopC51’s Self-serving Viral Campaign
 
Of all the facts that the journalists should check, the one that cries out for investigation is the one underlying CBC’s observation that:
 

“Websites and online groups have sprung up across the country imploring people to lobby their MPs to halt progress of the bill.”
 

Our question to the media is, “How many of these websites and online groups are run by Truehope, and what do they stand to gain corporately by fomenting this viral campaign against Bill C-51?”

20. July 2008 by barry
Categories: Alt. Med, Topics | Leave a comment

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