Friday, May 16, 2008

Bill C-51: A Rant

There's a whole lot of fear-mongering going on about Canadian Bill C-51, an amendment to the Food and Drugs Act. Facebook groups are popping up against the bill, protests are being organized and a website has been set up to organize the troops.

What C-51 is, quoting from the bill, is an attempt
to modernize the regulatory system for foods and therapeutic products, to strengthen the oversight of the benefits and risks of therapeutic products throughout their life cycle, to support effective compliance and enforcement actions and to enable a greater transparency and openness of the regulatory system.
In other words, it's an attempt to regulate therapeutic health products to ensure their safety and efficacy. Obviously, this has raised the ire of the natural products industry who has responded with 'news' pieces like this with alarming 'facts' such as "C-51 is outlawing herbs, supplements and vitamins", or "a mother giving an herb to her child, under the proposed new language, could be arrested for engaging in the sale of unregulated, unapproved 'therapeutic substances.'" (more on that one in a moment). This alarmism is stirred in with a nice painting of draconian enforcement and a dollop of Big Pharma conspiracy theory to make it an amusing, if typical, propaganda piece.

I'm obligated to point out that I am not a lawyer, but I've read the bill. It is NOT outlawing products, but rather bringing the natural health product industry up to a certain standard of testing. It's an attack on deceptive labeling, improper health claims and pseudoscience. No thug is going to kick down your door for serving dandelion greens at dinner. What is being outlawed is selling dandelion greens in a misleading way (eg. with untested health claims).

This brings us to the definition of 'sell', which is a major point for the alarmists. The amended act, if passed, will define sell as
offer for sale, expose for sale or have in possession for sale — or distribute to one or more persons, whether or not the distribution is made for consideration — and, in relation to a device, includes lease, offer for lease, expose for lease or have in possession for lease.
The phrase that the bill-opposers have latched onto is 'distribute to one or more persons'. They take that to mean that, to use the above example, serving dandelion greens for supper counts as 'selling'. While this interpretation of the new wording is technically true, one has to look at the contexts in which the word "sell" is used in the bill. Reading through it, it becomes clear that it's very specific things that run contrary to the proposed law. For example, 'selling' dandelion greens is only prohibited if they have a poisonous or harmful substance in or on it; if they are unfit for human consumption; are adulterated; are injurious to human health; or are processed, manufactured, stored, etc. in unsanitary conditions. That does NOT sound like draconian restrictions on what you can put on your table or give your family. It sounds like common sense. The bill goes further than that, prohibiting 'selling' "a food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit, safety or origin." For a therapeutic product, this is expanded to include "creat[ing] an erroneous impression regarding its benefits, risks, conditions of use." In other words, no false claims. So, to the people who oppose this language change, is it because you want to be free to distribute harmful goods, or because you're interested in making false or untested claims about your product?

Shawn Buckley, natural product lawyer, has weighed in with a 20 page review of C-51. (You may remember his name being thrown around by the pro-algae folks on the StemEnhance thread) He goes on to list a number of concerns. First on his list is that roughly 60% of of natural health product licenses are failing, meaning that with this amendment over 60% of the products on the market will become illegal and can be removed from the market by Health Canada. What is implied in this statement, is that 60% of the natural health products already on the market are not licensed. Nor does he state why these licenses are being denied. Is he seriously pushing for unlicensed health products - products that have failed to get government approval - to remain on shelves?

Buckley tries to portray the government as being bullies towards the natural health product industry. He points to language changes proposed by the act, such as replacing 'drug' with 'therapeutic product' and then asks "is the change of terminology directed at the Natural Health Product industry or are there other reasons?" My guess is that the answer is 'yes' and I would respond with the question 'So?' The changes in the act seem to have in mind the goal of bringing the natural product industry to a particular standard. The pharmaceutical industry is already regulated in terms of safety requirements, evidence-based results, etc. Obviously bringing drugs and natural products under the same 'therapeutic product' umbrella is designed to ensure that ALL of these products are safe, effective and work as advertised. As Buckley himself points out, the pharmaceutical industry already has a high compliance rate with Health Canada rulings, while 60% of natural products go to market having their licenses denied.

What is more concerning is the National Health Products Protection Association (NHPPA, of which Buckley is president) position. In the legal review of C-51, their goals are listed as a regulatory environment where, among other things, "NHPs [natural health products] are presumed to be safe. A NHP cannot be taken off of the market unless the Government can prove that it is unsafe." This is just a ridiculous attitude. If the default position for a natural product is 'safe', that means people have to start getting ill or dying before somebody steps in. The reality is that health products should be deemed safe before they go to market. Just because it's labeled natural doesn't make it safe. As I've pointed out before, several potent cancer drugs are natural products. Would the NHPPA have these, or any future similar discoveries given a blanket 'safe' label and start selling to people?

Therein is the lunacy of the natural product position: The want their products to be at once efficacious and totally harmless. For any product to be useful in some therapeutic way, it has to have a biological effect. If it has a biological effect, then you have to start thinking about how it works, safe doses, potential side-effects, etc. Now don't get me wrong, I don't think the bottle of vitamin C in the medicine cabinet is particularly dangerous (of course, anything is at a high enough dose), but natural health products include more than standard vitamin supplements with known tolerances. They include products that claim to mobilize stem cells, alter gut flora composition, and stimulate the immune system as well as non-standard megadoses of of common vitamins. All of these effects have the potential to cause adverse events. The default position is not 'totally harmless'.

Mr. Buckley does raise some interesting points about the use of the word 'government' in the bill, and how it may affect adoption of future regulations. In C-51, the definition of government includes international bodies and foreign governments and states that "A regulation may incorporate by reference documents produced by a person or body other than the Minister of the Canadian Food Inspection Agency including ... (c) a government." This sounds like the amended bill makes it easier to incorporate foreign policies into Canadian law. However, given Buckely's position with the NHPPA, I doubt the sovereignty of Canadian law is his primary concern.

Of course there will be people arguing that the government has no right to tell us what to put in our bodies. That's not what these changes are doing. It doesn't say you can't eat your dandelion greens, take your garlic supplement or multivitamin. It says that the products must be safe and that their sales and marketing can't be false, misleading or deceptive. You can eat your greens, but they can't be sold as age-reversing. You can take your garlic pills, but they can't be sold as cancer-curing. Unless, of course, there's evidence.


13 comments:

Anonymous Coward said...

On the website there are suggestions that herbal remedy users would commit suicide if their herbs are removed from market... That sounds like a threat from a cult leader.

"A 2006 court trial exposed the clear and unchallenged evidence of warnings and pleadings by Ron LaJeunesse, Alberta Director of the Canadian Mental Health Association (click here for transcript). He bore witness of suicides that were the result of desperation when Canadians were advised they would no longer have access to their natural health product. "

Anonymous Coward said...

Perhaps we should introduce bill C-52 to regulate lawyers who misrepresent the facts to get business.

To suggest the feds would send a SWAT team to stop a family from eating a dandelion salad is just asinine.

henchminion said...

I really wonder what the alternative medicine industry is going to tell their supporters when the bill passes and the black helicopters fail to materialize, and no one kicks down anyone's door. Will they lose credibility, or are their supporters already used to hearing statements contrary to fact?

Anonymous said...

sorry to tell you the black helicopters are already here....No government is a good government. when will you people realize this?

kamel said...

henchminion, I guess you have your answer.

Anonymous said...

Finally a resonable voice on this subject!!!

I have worked in the natural health industry for 20 years here in Canada. Currently I work for the largest manufacturer/distributor of natural supplements in Canada. We completely agree with everything you have said above and believe that a lot of this fearmongering has been started by companies that are non compliant to the newer NHPD regulations.

Angelo G. said...

Listen, this bill has to be better explained, or written in a way in which all parts of the bill make sense upon reading it.

There is some fear monguring with some groups, but don't paint the whole industry as all conspiracy theroists.

If all the health food stores and clinics had individuals that knew about natural health products because they were well educated, there would not be a problem. there are more problems with NHP's and side effects because the person helping the customer failed to ask the right questions and selected the wrong supplement because he/she thought they knew what they were giving the individual. I have worked in the industry for over 10 years, let me tell you, 90% of the products on the shelves today are safe. If one is educated, there are no problems.

Kurt said...

I found your article somewhat narrow. You have not thoroughly presented the facts. I’ll get into some of the core things you didn’t include which didn’t serve your thesis, but first I’ll raise a question about your thesis: since you were selective about what you discussed, why do you want to sway public opinion? You’ve presented the whole anti C-51 movement as manipulative… why do you choose to manipulate?

What you didn’t discuss is that Empowerplus does have radical results for thousands of bipolar patients. The world’s foremost psychiatric authority on bipolarity, Dr. Popper from the Harvard Medical Centre, a man who developed the lithium and other modern treatments for bipolarity, testified in court on behalf of Truehope that 1) his practice involved the worst cases in the Boston area, people who other psychiatrists had no success with and 2) Empowerplus destroyed his practice because patients whom he had to see weekly or more often for suicidal counselling and to manage the sideeffects of their medications were fully recovering under Empowerplus - they were becoming fully functioning members of society whereas in many cases they never were prior in their lives. This information is contained in the court transcripts.

Anthony Stephan, the owner of Truehope was motivated by personal interest in his family to develop Empowerplus. His wife’s family was severely effected by bipolarity. First his father-in-law, and then his wife committed suicide suffering from the disease. Both of his children had long been diagnosed with the severe form of bipolarity that had claimed the lives of his wife and her father. Here we have the motive of love for his children versus the claim that it is his personal greed that is motivating him. Two motives to choose from...

As the success of Empowerplus spread and caught the attention of psychiatrists and other mental health professionals in Alberta and abroad, research began at the university level, with the eager cooperation of Truehope. The Alberta goverment also set significant funds in place to conduct double blind tests on Empowerplus, again with the complete cooperation of Truehope which could not afford doing this research itself. It was at this time, as the promising results were being peer reviewed in publications by psychiatrists and others that Health Canada got wind of Empowerplus. They shut all the studies down, claiming that Empowerplus was not registered. What would be required to have Empowerplus registered? According to Health Canada in court, studies would have to be conducted to gain registration. Well why did Health Canada shut those studies down?

Truehope took Health Canada to court seeking an injunction against Health Canada’s attempt to stop Empowerplus and won. Part of the problem that you and I and many Canadians have is that we don’t really understand Health Canada. We think of it as sort of an advocacy agency of health in Canada. Sadly, that is not it’s legislated mandate. All health concerns are the constitutional responsibilities of the provincial governments, not the federal governements. An exception was made, through cooperative legislation, granting the federal governement to set up an agency to regulate food and drug safety - security - and that’s it, nothing more. In essence, Health Canada is a sort of police force when it comes to food and drugs. We need police agencies. Just think of what our cities and communities would be like without police departments. That being said, though, would you really want these same police departments running your school boards or your city hall. No. Their talents and mindsets are not best suited to those responsibilities.

As evidence of how narrow the corporate culture of Health Canada is, let’s also consider the impact of criminal law on companies supplying medecines or therapies to the Canadian public. In Canada, a company that irresponsibly withdraws a therapy without allowing patients using that therapy an appropriate transition to other therapies will be held criminally responsible for harm done to those patients. It’s known as the “do no harm” principle. This principle does not apply to Health Canada’s actions because currently HC does not have the jurisdiction to enforce it’s directions to recall product. But this principle does apply to the actions of Truehope and many other companies. That’s why the only companies that have ever dared defy HC’s directives have only been natural health companies, and they’ve proven in court time and again that following HC directives would do harm, and in some cases great harm, to the people using their products. That’s why Dr. Popper, and many other experts, came to the defense of Empowerplus in court. It’s also why HC lost in court and why it didn’t challenge the rulings.

But HC wasn’t finished. It went behind the courts back and ordered Customs Canada to seize Empowerplus at the border. Although headquartered in Alberta, Truehope manufactured the product in the US because of the well known corporate cultural biases of HC. People using Empowerplus knew HC would do something and most stocked up on their supplies, hoping to wait it out. Some supplies were not able to wait out this human injustice and when their last medecines were finished, they committed suicide rather than go back to the psychiatric institutions that many had been committed before Empowerplus, or rather than go back to some of the horrific side effects of the medications supplied by the pharmaceutical companies that were not effective for all patients. Those deaths were coroberrated by phsychiatrists and other professionals in court. HC’s statement about these deaths were that they were incidental and did not concern the policy of Health Canada: Health Canada’s mandate was to implement it’s policies and that’s where it’s concern lay. So you see, while extensive parliamentary studies have shown that not a single Canadian has died from a natural health product for all of Canada’s recorded history, several have died in just this one instance of Health Canada’s actions in implementing it’s own directives. Health Canada is not mandated to be concerned about the health of Canadians. It is only mandated to develop and implement policies and regulations towards its view of what constitutes a “safe” product, and then seek to have those regularions implemented. A big part of the problem with all of this is the culture within HC which is biased towards the pharmaceutical mindset. The lead lawyer behind Empowerplus, Shawn Buckley, knows this well because he used to be HC’s lawyer who successfully fought some of these little companies in court. I personally heard him talk about his change of mind and heart over this matter which caused him to leave HC. He also mentioned that the only companies to defy HC’s directives were the small natural health companies, and not because of self interest as you would think from greed, but because of the criminal liability that withdrawing their product could entail. He said that drug companies would never defy HC because their products typically have hazards, with the demonstrated studies showing that the benefits outweigh the damages that these products cause. If HC wants their products of the market, generally they would have a tough time demonstrating in court that it would be harmful to withdraw those protucts. Also, HC's culture is primarily interactive with, and highly attuned to, the pharmaceutical industry for better or worse.

I hope this serves as a good base effort to get information out that you perhaps didn’t want, or couldn’t be bothered, to bring forward. It’s good that attention is being brought to Anthony Stephan and Truehope because their goal in this is not simply to get their product out. They want to shed a light on Health Canada and get Canadians aware of what’s really going on in that bureaucracy.

Importantly, because of these ongoing things, many points in C-51 pertaining to enforcement ARE PRIMARILY DIRECTED towards natural health products because these companies are the only ones who have, rarely but still in some instances, defied Health Canada. The big drug companies never have and probably never will. So Health Canada innocently pretending, and the Minister of Health sweetly pretending, that it’s the big drug companies that need these big penalties is bogus and dramatic enforcement methods is bogus. It’s clear that they’re lying. Again, why are they lying? The question is not if they are, but what is motivating them to lie. We need all products in Canada to be safe. But we need to establish methods and regulations that are true to the service of Canadians and go beyond the lies that are out there on the part of those who have the power to now make the rules. Many Canadians know this, if not in detail, at least in heart. And that’s why this IS a grassroots movement.

As you pursue the questions over C-51, I ask you to search in your heart for your own biases, and try to immunize yourself from them. This whole debate is good for soulsearching in all of us not just about natural health products, but principally about what type of organizations we want serving us as Canadians who not only supply those products but also regulate and make those products available, at all levels.

Anonymous said...

Steroids are illegal, DHEA is illegal, L freaking Carnatine is illegal, any remotely effective fat loss product (i.e. contains ephedrine) is illegal. Canadian NHP's are WAAAY too regulated as is. What's next? Creatine? Whey protein? If someone is aware of risks associated with a product what right is it of anyone to say that they can't have them?

Anonymous Coward said...

Well that's certainly one way to look at it. One obvious drawback to making unsafe products available (you mention steroids for example) is that once you get sick (and you inevitably will), taxpayers will have to support your treatment for your bad decision, whether or not you knew the risk associated. But that's not even the point.

What is at the heart of bill C-51 is not limiting access to products, it's making sure that the people who sell you those products don't make false claims on them (cures cancer, makes your penis grow) and provide with the information regarding toxicity. It's about protecting the consummer, not stopping them from buying creatine (even though that stuff is completely useless).

Anonymous said...

Everyone reading this article should read Kurt's comment. It's on the longer side but it sheds some truth on this incredibly biased piece of blogging.

Anonymous Coward said...

Anyone who read Kurt's incredibly biased piece of commenting should realize that anything sold for human consumption should undergo a minimum requirement of testing. You can't sell something and test for toxicity at the same time or later, that would be putting the lives of the consumers at risk. If the product isn't already recognized as safe, you have to make sure it is before you give it to people.

In this particular case, health canada stepped in for good reason : " Health Canada has received nine reports of serious adverse reactions in Empower Plus users. Patients saw a spike in symptoms of their psychiatric illness, possibly because they switched from regular drugs to the mixture of vitamins and minerals "
Lookup Shawn Buckley's history, the lawyer who represented them and you'll see he's a corporate Crony, trying to protect the multi-billion dollar "alternative" medicine industry by stopping attempts to ensure those products are safe and not sold under false pretense to consummers.

It boggles my mind that this industry is so poorly regulated. Toy companies are prevented from putting toxic plastic in baby toys, car companies have to put in air bags, it's time some rules are laid down for alternative medicine.

Anonymous said...

Well said Kurt