What's Really Behind Health Canada's New Proposals For NHPs?

 

Proposed New Health Canada Natural Health Product Regulation changes in 2017.jpgDespite Health Canada's claims that sound so reasonable, what is really behind their proposals to change how Natural Health Products (NHPs) are regulated?

These proposals contradict Health Canada's stated goals for NHPs in so many ways that the only seemingly logical conclusion is that their actual purpose is to grant an extra layer of exclusivity to pharmaceutical companies that come up with over-the counter NHP drugs, protected by otherwise weak use-patents.

You can't patent a naturally occurring botanical or substance. Yet, if you can isolate an individual active constituent from a plant, and find a unique use for it, you can get a use-patent. And the pharmaceutical industry has such use patents on every natural constituent you could possibly imagine, plus thousands more.

patent protected.jpgYou see, when the pharmaceutical industry decides to really enter a commercial sector, like the NHP sector, they have no intention of competing with the NHP industry. Instead they use regulation as a tool to control it, and this is their third attempt to push NHPs under the same regulatory umbrella as pharmaceuticals.

The pharmaceutical industry doesn't break the law...they make the law... using intense lobbying, pulling strings deep within the bureaucracy, and exerting financial influence on the media with advertising revenue, and academia by funding research, all of whom then come out with slanted explanations of the situation, quoting medical and academic professionals who know little to nothing about natural products, to justify the new regulatory order.

Our Police and Military Enforce our Laws...They Don't Create Them.

Our police and military enforce our laws, they don't create them. They are kept separate, because if a body were responsible for both, vested interests would quickly exert massive influence on policy creation... and enforcement. Yet, as pointed out by Dr. Michele Brill-Edwards, a former senior officer in charge of drug approval at Health Canada, the agency both creates and enforces policy, while regulating the trillion dollar pharmaceutical industry, with which it shares a revolving door of employees.

What do you think is going to happen? 

See no evil-1.jpgIn addition, despite pharmaceuticals being a well-established leading cause of death, and drug after drug being pulled from the market because of deaths or life-threatening side-effects, academics, medical professionals and the media still take the "Hear no evil, See no evil, Speak no evil" approach and claim that pharmaceuticals have been proven "safe and effective", and that Natural Health Products have not... even though NHPs have been studied intensely for decades, have had every imaginable constituent patented with the highest levels of science, and way over 100,000 NHPs have killed zero (0) Canadians in over 60 years.

Yet, as clarified by past MP Terence Young in his book "Death By Prescription", when it comes to pharmaceuticals "Safe" doesn't actually mean "safe." It's simply a euphamism indicating that according to Health Canada the potential benefits of a drug outweigh the risks.

Unfortunately, sometimes Health Canada gets it wrong, and people die! In fact, according to Young as many as 20,000 Canadians die from pharmaceuticals every year. So 20,000 deaths a year for 60 years... conservatively over 1,000,000 deaths, including many from OTC drugs... versus no deaths from NHPs. Yet Health Canada says they should be regulated together. Does this make sense? No!

It's ludicrous, yet what's behind it all? Health Canada looking the other way. Smart people saying absolutely ridiculous things. The media continually spouting rubbish, and politicians and a large segment of the public buying it lock stock and barrel. All the while the pile of literature and studies on natural substances, now the size of Mount Everest, continues to grow.

This outright denial of fact can be somewhat confusing, because you can search tens of thousands of natural substances and constituents on Pub Med and come up with more peer-reviewed evidence than you could ever possibly present. Yet, the mindset that there is no evidence for NHPs persists. Why?

It all has to do with institutional bias, and a sliver of truth that completely distorts the reality.

To explain,  consider a scenario. Say there are 150,000 studies on Curcumin, (the major constituent in turmeric), and Health Canada comes out with a monograph on it saying that, based on several human trials, at a certain dose, curcumin can be used to relieve joint pain, (HC has already produced such a monograph). So Company X sources a 95% curcumin extract that it tests for potency, and recommends the amount on the government monograph for joint pain.

Remember, Health Canada, not Company X, came up with the claim. So isn't it reasonable for Company X to rely on the extensive pre-established body of scientific evidence, accompanied by the monograph? Or like pharmaceuticals, (so many of which carry the worst side-effect of death), should Company X have to perform double-blind trials, costing millions of dollars that it could never afford, to prove that it's specific ultra-low-risk curcumin product works?

This is the fork in the road, where NHPs are treated the same as pharmaceuticals, when they are not even close in risk. Yet when when Company X follows all Health Canada's rules,  and puts out a product claiming to relieve joint pain, then academics and medical professionals scream that there is no evidence for it, because the double-blind trials weren't done on that specific product, and they pound the table for tighter controls, ignoring the pre-established body of literature.

This is ridiculous, especially when curcumin has been part of our food supply in curry for millenia...not to mention how much more expensive such trials would make NHPs!?

It is distortions of truth like this that are being used to justify "pharmaceuticalizing" NHPs.

So, despite the fact that a Canadian NHP company may have followed all the rules, created and enforced by Health Canada themselves, this Globe & Mail article still flaunts the title:

"Health Canada rules ask for science behind natural health product's claims"

The article states that all the new rules are designed to do is make sure "NHPs are safe and do what they claim to do"

(see: http://www.theglobeandmail.com/life/health-and-fitness/health/health-canada-rules-ask-for-science-behind-natural-products-claims-health/article33287337/

Dissecting Health Canada's Double-Speak.

This Globe and Mail article is full of false and misleading information, foisted on the public and politicians, who are likely completely ignorant about the current regulatory status of NHPs. 

For example, in the second paragraph the article states that:

"Under the new rules, companies that want to put health claims on their labels would need to provide scientific evidence and Health Canada will determine whether there is sufficient proof to warrant the claim. It’s a substantial change from the current system, under which Health Canada grants licences to all approved natural health products licenses and allows them to make a variety of health claims, which serve as important marketing tools."

Besides the fact that the last sentence makes no sense as written, (i.e. how do you "grant a license to a natural health products license"..?), these statements are utterly untrue.

Fact: NHPs have had to prove their claims since 2004.

Since 2004, when Health Canada defied Parliament and classed NHPs as a subset of DRUGS, (instead of placing them as a distinct category), NHPs have been forced to make a claim as to a product's use/purpose.  A company submitting the application then has to support that claim with either evidence of traditional use for 50 years, or two human clinical trials, as well as evidence of safety. If it cannot do this, the license application fails.

As of August 2010, out of a total of 69,934 applications Health Canada had failed almost 30,000!! Yes, Health Canada grants licenses to all approved natural health products, but to get approved is no simple task.

In addition, when you receive your license, it is Health Canada themselves that specify the wording of the claim that can be used, as well as the dosage that can be listed.

Our current system of NHP Regulation is considered to be the best in the world. At a recent international meeting held in Switzerland this fall, 26 out of 27 countries said Canada's system for regulating NHPs was the best. The Natural Health Products Database of Monographs is one of the largest repositories of NHP  information and guidelines on the planet! Yet, Health Canada wants to scrap this system that you, the taxpayer, have spent well over a Billion dollars forming.

What Health Canada is Proposing.

Health Canada has for years stated that their goal is to ensure that Canadians have broad access to NHPs that are "safe, effective, and of high quality!"

The new proposals would see NHPs regulated according to three levels, determined by their level of risk. At the lowest level would be ultra-low risk products, presumably like multi-vitamins and minerals, and Health Canada is proposing NO REGULATION for many of these products. This directly contradicts their claim that they are trying to ensure that NHPs Canadians have available are of high quality. After the vast sums of money and resources that have been spent by taxpayers and industry on our regulations, all of a sudden, Health Canada wants to reduce quality control???? (Does this make sense to you?)

If this happened our market would be flooded immediately by sub-standard garbage products from the US, potentially containing impurities like heavy metals or adulterants, for which current Canadian standards mandate testing. This contradicts HC's claim that they want safe products! (Does this make sense???)

At the other end of the spectrum, would be the "highest risk" ingredients and products, which would require the highest level of evidence to make a claim. This contradicts Health Canada's stated goal of maintaining broad access as certainly only a few products would be available from this "most dangerous" class.

Yet, given that since the total number of deaths attributed to any NHP in Canada is zero (0), on what basis are the risk levels of the three categories being determined? In fact, how can the risk level of any NHP be determined when there are no actual adverse events for that product, and if there are adverse events, why doesn't Health Canada tell us about them? Hence, which products or ingredients would fall into which class we have no idea because as usual HC has provided absolutely no specifics. They have committed to nothing, which allows them to move products between the levels at will.

For example, take Black Pepper...yes the same black pepper you sprinkle on your eggs. Commercially it is known as Piperine, and it is added to products to enhance absorption. Health Canada very recently upgraded its "risk" level from level one to level two. (Yes they already have levels in place based on supposed risk.) What prompted this move is a mystery, because Health Canada gave no official rationale for it...Why? Because they don't have to.  The agency has absolutely no oversight. There is no governmental instrument in place to hold them accountable...nothing. They answer to no one.

A former Director General of the Natural Health Products Directorate, (of which there has been at least 5 since 2004), was recently asked: "What is to stop Health Canada from simply making things up, or moving products between levels at will?" The response was: "Absolutely nothing."

So if the new proposals are enacted, piperine can be easily moved up to the new Level 3, where the highest level of proof is required. The agency may give this reason or that, but remember this is black pepper we are talking about, and Health Canada has given no specifics whatsoever on exactly what evidence they will be required for which products.

Now consider the following use-patents on Piperine:

http://www.google.co.in/patents/WO2002057260A1?cl=en   

https://www.google.ch/patents/US6455077   

http://www.google.ca/patents/US8007839   

https://www.google.com/patents/US20050074533

https://www.google.com/patents/WO2015050705A1?cl=en

So when a pharmaceutical compant exerts a patent there's nothing to stop Health Canada from simply moving whatever substance it is up to level three, where only a very few applications will be able to provide the necessary evidence....and you can imagine which companies they will be....even though their products will be NO more safe or effective than current products. In fact, they will likely 3X as expensive, and 1/3 as effective!

And what is Health Canada proposing as a penalty for not complying.... a $5,000,000 fine! So if one of the above patents gets applied and protected,  if someone sells an NHP with black pepper that isn't approved they will liable for a 5 million dollar fine... for selling black pepper. Does this make sense????

The real issue is not safety. It's the sale! Yet Health Canada is no stranger to protecting patents...they apparently did it for exactly 20 years with L-Carnitine. From 1991 till 2011 they disallowed L-Carnitine for sale in Canada without a prescription, despite it being recommended for pregnant women, and being an ingredient in baby formula. Here are two patents by Sigma Tau Pharmaceuticals on L-Carnitine and its salts, (note the publication date on the second one...1991!)

https://www.google.com/patents/US6696492 

https://www.google.com/patents/US5037851

So when patents like this one entitled: "Pharmaceutical grade botanical drugs"   https://www.google.com/patents/WO1997039355A1?cl=en are exerted on active constituents from herbs such as echinacea ... a plant that there has been such "controversy" about, and has been called useless and a waste of money by so many doctor's and scientists... don't be surprised when every one of these professionals does an about-face the moment echinacea's or any other herb's properties are "discovered" by a pharmaceutical company, and they come out with a product! Then it will be "proven".

Interestingly this patent on botanical drugs was filed in the 1997...the same year that Health Canada tried to push NHPs and pharmaceuticals together into the same regulatory class the first time with the Establishment Licensing Act! 

Such high-level evidence has existed for decades, and these regulatory changes have long been the plan. Health Canada just had to wait until the right time. Now, with the new government, so many completely inexperienced MPs and a new Minister of Health they can set about undoing the current regulations, which were specifically endorsed by the past four Ministers of Health. 

So Don't Stand For It! Call your MP and let them know what's going on!

  1. Find your MP 
  2. Sign the Canadian Health Food Association (CHFA) online petition
  3. Visit Citizens for Choice in Health care for more information.  

Citizens For Choice In Health Care

www.citizensforchoice.com

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