Consulting Canadians on the Regulation of Self-Care Products in Canada Dilutes Ethnic Diversity and Freedom of Choice for NHPs
Our Prime Minister’s address to the UN General Assembly on Sept 21 2016 made Canadians proud. He said:
“In Canada, we got a very important thing right, not perfect, but right. In Canada we see diversity as a source of strength, not weakness.” 1
Prime Minister Justin Trudeau went on to say that our country has learnt from its mistakes . . .
This talk has gained 10’s of millions of favorable views from around the world.
This is one of the reasons that the new discussion of Consulting Canadians on the Regulation of Self-Care Products in Canada is rather confusing. It seems to be devised to reduce ethnic diversity at its very core. If implemented, these new regulations will block our access to Traditional Medicines and Herbal Remedies in the context they have been used safely for thousands of years. At first glance Traditional Medicine might not seem important to many Canadians, but it is the heart of many cultural identities. A brief look through various ethnic neighborhoods can confirm that Traditional Medicine is one of the first places of commerce that is embraced by various cultures. These places have stood the test of time in the Canadian landscape, with some stores in Vancouver and Toronto being well over 100 years old. These now have become part of the traditions of Canada. Even though some ethnic groups’ Traditional Medicine might not be highly visible, they still have great value to these groups and Canadians as a whole. With new cultural diversity, we have seen many of these remedies from around the world entering into the Health Food Market and specialty stores across Canada.
The basis of these new regulations proposes that if a self-care product makes a health claim describing how and when to use the product, that health claim must only be backed by scientific evidence based on the current drug model, ie double blind placebo controlled studies.
“Health Canada, as a science-based regulator, wants to make sure that Canadians can trust that a standard has been met when we authorize a claim.”
Claiming that a randomized double blind placebo controlled study is the only way to prove a NHP is effective and safe is an extremely bigoted point of view and insultingly negates a worldwide view of Traditional Medicine.
There are many ethnically based traditional health systems that are logically consistent, and have stood the test of time for safety and efficacy. Some of the top minds throughout history to present day have focused their research on Traditional Medicines. The World Health Organization states that between 65 – 85% of the population on the planet use Traditional Medicine as their major form of health care.8 This is not because they are too poor, or too stupid to use scientifically proven medicines, this is because their traditional medicines have safely and effectively worked for them for millennia. Traditional Medicine is one of the central icon of a culture.9 These traditions are still quite robust in the cultures of origin and have been shown to immigrate with the people.10 While Traditional Medicine is still a strong part of the backdrop of healthcare in the country of origin, the tools (NHPs) are getting increasing less available.11
While First Nation and Indigenous peoples of Canada are emerging as a stronger cultural presence, they too want to used their traditional medicines. 12-15
By adopting a scientific only model, access to these materials in Canada will be substantially lowered. Canadians want to used Traditional Medicine.
This is not new information to Health Canada as it clearly states on its website:
“More than 70% of Canadians regularly use complementary and alternative health care therapies such as vitamins and minerals, herbal products, homeopathic medicines and other natural health products to stay healthy and improve their quality of life.”16
Again, 70% of Canadians don’t do this based on a lack of a knowledge of the scientific model or the need to have randomized clinical trials (RCT) to prove that it works. It is because we live in a free, open society, that is based on freedom of choice and ethnic diversity. We strongly feel that by turning NHPs into drugs, these freedoms of choice and access to our diverse ethnic backgrounds will be severely reduced.
Health Canada suggests public safety is at stake because the present system is too confusing.
Confusing for who?
Is Health Canada implying that the 70% of Canadians that use these products are easily confused? It seems to me that Canadians are more than capable of discerning the difference between scientific drugs and Traditional Medicines. A person shopping in a Health Food store is not shopping for drugs. In fact, the person shopping in a Health Food store is likely looking for an alternative to drugs. They are not confused. They are exercising their right to choice.
So Health Canada, how about you treating us like the free thinking, intelligent adults that we are?
The safety record for many of these traditional remedies goes back over 5,000 years and has been thoroughly vetted by over 20 years of government scrutiny and tens of thousands of hours of academic consultants and industry input. In fact, four previous Health Ministers have signed off on this evidence.
Traditional medicines (NHPs) have repeatedly been shown in thousands of studies and many meta-studies, to be as effective, if not more effective and more cost efficient both in Canada and worldwide.17-20 Studies include reviews of traditional herbal formulas compared allopathic pharmaceutical, focusing on specific disease issues,21 to larger treatment meta-studies.22-25
These and other studies have concluded that the patients and the public find the clinical outcomes to be quite beneficial.26,27
Health Canada has asked for our input into this proposed policy change:
“As committed to in the Regulatory Transparency and Openness Framework, Health Canada continues to make more information available to Canadians than ever before. Canadians are also being offered more opportunities to participate in discussions on government policies and priorities. This consultation document is one such opportunity for Canadians to provide feedback at an early stage on some policy proposals under development.”28
Well Health Canada, here is my input:
“NHPs are not drugs, so don’t treat them like drugs!”
ICMRA (International Coalition of Medicines Regulatory Authorities)
It is always important to look behind the scene and see what is really driving this initiative. It seems that these new proposals are made not to advance our ethnic diversity, but to harmonize with proposed ICMRA concepts29 even though this proposed regulatory authority has no official government sanction in Canada or any other country for that matter.
So why is Health Canada taking a prominent role in the ICMRA by holding both the interim Chair and interim Secretariat positions?
It appears that ICMRA has a close relationship with the global pharmaceutical industry.
Could the ICMRA simply be a way to restrict access to ethnic traditional products around the world, thus opening the door for global corporate interests to monopolize our health care?
The current system Health Canada uses for regulating natural health products is working. It has behind it 25 years of research by the Canadian Government and has been signed off by 4 previous Health ministers. I guess this is understandable as traditional medicines have co-evolved over several millennia with DNA that has adapted to work with us.
The EU studies on NHPs prove that they are 45,000 times safer than prescription drugs and 75 time safer than eating a meal.30,31
But the ICMRA concepts will reduce our freedom of choice to access to these plant based natural health remedies at a time when our population is aging and the use of drugs in the treatment of chronic and drug resistant diseases is failing.
It seems to me that the ICMRA model will violate some of our basic human rights, as has been shown in a few court cases in the EU.
In the USA, the new guidelines put forward by the FDA on Aug 11th 2016 32 could result in natural health product manufacturers requiring costly and lengthy pharmaceutical-style random clinical trials (RCT). If implemented in Canada, this will cripple NHP manufacturers in Canada and result in the hundreds of effective and safe products being removed from store shelves.
This ICMRA global harmonization of health product regulations seems to be the springboard of rapid globalization of NHPs driven by Big Pharma for the sole benefit of Big Pharma.
It produces the following concerns:
- Assessing Herbs, NHPs and Traditional Medicine as pharmaceutical (with science only models) seems to be behind mandating standardized dosages of ‘active’ ingredients. Those of us who have studied the correct use of natural medicines know that ‘active’ ingredients in plants is akin to finding the active ingredient in a food.
- ‘Rule of Doubt’ clause says that the absence of modern scientific information is sufficient to implement a ban, ie. restricting the sale of certain natural health products that have been used for safely for centuries.
- Once a Herb, NHP, traditional medicine, or vitamin is proven to be effective by drug standards, that product will only available if prescribed by a registered medical doctor who might not have sufficient knowledge on the product’s use. These should be left in the hands of professional Herbalist, Naturopaths and traditional Healers who have specifically studied the correct use of natural medicines. Much of their education is as rigorous as allopathic practitioners.
This will open the door to ‘back door patents’ on indigenous plants, which is currently forbidden by international law. 33
- If adopted, this leave the door open for synthetic copies of herbal ‘active ingredients’ by using a discredited principal of ‘substantial equivalent’. Of course then manufacturers can adulterate traditional remedies to produce cheap copies of a traditional remedy without labeling it so.
- In some countries the implementation of ICMRA type concepts has made the minimum proven therapeutic dose the new maximum daily dose on manufactured products. This means the product cannot treat deficiencies, but will only provide enough to maintain minimum health. To access a product that treats deficiencies the consumer will require a prescription from a medical doctor using prescribed effective doses controlled by big Pharma.
- ICMRA takes the regulation of NHP out of the hands of our government (or any other national government) and puts it in the hand of international bureaucrats subverting national sovereignty and undermining indigenous knowledge, Traditional knowledge and the freedom to choose NHPs away from the people. This effectively will give our world class Canadian Health Care system over to corporate interests.
It is felt that undermining ethnic diversity and freedom of choice is too high of a risk to adopt these rules. NHPs in Canada are presently regulated in a logically consistent way by ‘the best in the world’ process. Classifying NHPs as drugs, will not make them safer for the public and will not reduce confusion.
NHPs are not drugs!
I look forward to an open discussion on this so we can have a system in place that can help Canadians be safe and to reduce confusion. It appears we already have one! So my first question to you is what is wrong with it?
5. The use of Traditional Medicine by Ghanaians in Canada; Kofi B Barimah, Edwin R van Teijlingen
BMC Complementary and Alternative Medicine; The official journal of the International Society for Complementary Medicine Research (ISCMR)2008; http://bmccomplementalternmed.biomedcentral.com/articles/10.1186/1472-6882-8-30
9. New Horizons in Medical Anthropology: Essays in Honour of Charles Leslie; edited by Margaret Lock, Mark Nichter; Routledge; 2002; p 41
11. Results from Community Health-Seeking Behavior Vignettes and a Traditional Herbal Medicine Practitioner Survey; John Lambert, Kenneth Leonard, with Geoffrey Mungai, Elizabeth Ominde-Ogaja, Gladys Gatheru, Tabitha Mirangi, Jennifer Owara, Christopher H. Herbst, GNV Ramana, Christophe Lemiere; September 2011.
17. Evidence-Based Complementary and Alternative Medicine
Volume 2012 (2012), Article ID 953139, 61 pages; https://www.hindawi.com/journals/ecam/2012/953139/abs/
18. Complementary and Alternative Medicine Use in Australia: A National Population-Based Survey http://online.liebertpub.com/doi/abs/10.1089/acm.2006.6355
19. Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits to CAM Practitioners: United States, 2007 http://s3.amazonaws.com/academia.edu.documents/39806408/Costs_of_Complementary_and_Alternative_M20151108-5526-1uekbtk.pdf?AWSAccessKeyId=AKIAJ56TQJRTWSMTNPEA&Expires=1475696776&Signature=XdBA6yvf%2FE5Dxe705GyBIBazeEU%3D&response-content-disposition=inline%3B%20filename%3DCosts_of_Complementary_and_Alternative_M.pdf
20. Review of randomised controlled trials of traditional Chinese medicine
BMJ 1999; 319 doi: http://dx.doi.org/10.1136/bmj.319.7203.160 (Published 17 July 1999)
Cite this as: BMJ 1999;319:160: http://www.bmj.com/content/319/7203/160.short
21. Assessment of effectiveness of traditional herbal medicine in managing HIV/AIDS patients in South Africa: KC Tshibangu, ZB Worku, MA De Jongh, AE Van Wyk, SO Mokwena, V Peranovic
22. Review of randomised controlled trials of traditional Chinese medicine
23. Meta-analysis of the clinical effectiveness of traditional Chinese medicine formula Chaihu-Shugan-San in depression;Yang Wang1, Rong Fan1, Xi Huang, VALIDHTMLVALIDHTMLVALIDHTML; http://www.sciencedirect.com/science/article/pii/S0378874111006581
24. Patient Assessment of Effectiveness and Satisfaction With Traditional Medicine, Globalized Complementary and Alternative Medicines, and Allopathic Medicines for Cancer in Pakistan; Philip Tovey; Alex Broom; John Chatwin; Muhammad Hafeez, Salma Ahmad, http://ict.sagepub.com/content/4/3/242.short
25. The Journal of Alternative and Complementary Medicine; Evaluation of Impact on Health-Related Quality of Life and Cost Effectiveness of Traditional Chinese Medicine: A Systematic Review of Randomized Clinical Trials; Fang Zhang, Lin-lin Kong, Yi-ye Zhang, and Shu-Chuen Li. The Journal of Alternative and Complementary Medicine. November 2012, 18(12): 1108-1120. doi:10.1089/acm.2011.0315.
26. A Public Health Agenda for Traditional, Complementary, and Alternative Medicine
Gerard Bodeker, EdD, and Fredi Kronenberg; http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.92.10.1582
27. David Riley, Michael Fischer, Betsy Singh, Max Haidvogl, and Marianne Heger. The Journal of Alternative and Complementary Medicine. July 2004, 7(2): 149-159. doi:10.1089/107555301750164226.