Vlog 19: Will This Pill Work? Health Canada Shrugs | The Body of Evidence

Vlog 19: Will This Pill Work? Health Canada Shrugs

Would you like natural health products to be approved on the basis of whether or not they work? Instead, Health Canada is considering revising its approval process and basing it on risk.



Hey, this is Jonathan from The Body of Evidence.

Today, we need to talk about Health Canada and natural health products. As you probably know, herbal supplements, homeopathy, and these types of products are currently approved for sale by Health Canada with very little oversight. Health Canada has begun a process of consultations with the public and with interest groups because they want to modernize this regulatory pathway. I participated in the first wave of online consultations and I recently attended a public consultation in Montreal with a few familiar faces.

I first want to explain what is the current situation; how Health Canada is proposing to change things; and what arguments I've heard on either side, before sharing my own opinion on the topic. And, as always, I'd love to see your input in the comments below.

Right now, natural health products, like these green coffee beans here, pretty much get a free pass. They don't need to prove that they work for Health Canada to approve them and give them an "NPN" number, as long as the claim is vague like "Weight Management". In fact, if you read the fine print on the back, under "Recommended use or purpose", it says, "Helps with weight management when used in conjunction with a reduced calorie-diet and exercise program". Skeptics rightfully say that, if you lose weight using this product, it's because you're eating fewer calories and exercising.

Health Canada now wants to change the way in which three types of products are being approved. These products, known overall as "self-care products", are natural health products (like these coffee beans); cosmetics (like makeup); and non-prescription drugs (like over-the-counter allergy medication and cough syrups).

The main change they are proposing-and this is, at this point, being communicated as a "proposal"-is to use *risk* to determine whether to approve a product or not. They define risk as an equation made up of two variables: how safe is the product itself plus what is the risk of harm if the product is not as effective as the manufacturer says it's supposed to be. This would create two classes of self-care products. Class I products would be low overall risk and they would only be registered with Health Canada. Class II products would be higher risk products and would need to be actively reviewed by Health Canada. Natural health products, like green coffee beans and homeopathy, would belong to either class I or class II depending on their risk profile.

So, to summarize, so far, Health Canada wants the approval process of all self-care products to be based on risk and wants to split products into two risk classes. Class I gets a pass and only requires registration, whereas class II requires an actual review process.

With me so far? Because that next bit gets confusing and contradictory.

You can't make any kind of health claim for a class I product. On one of their slides, Health Canada listed that class I products are intended for one of three purposes:

1) To cleanse, protect, alter the complexion/skin/hair/teeth, beautify... basically, cosmetics.

2) For general wellness, to maintain, support, manage, provide a source of, or a mechanism of action having a physiological effect... these are structure/function claims and we'll come back to those.

And 3) To treat, prevent, mitigate certain conditions including symptoms.

But then, under class II, products are intended to likewise treat, prevent, mitigate certain conditions including symptoms. The difference? Class II must be supported by modern evidence to be reviewed by Health Canada, whereas class I can be supported by traditional use and this evidence is only needed if Health Canada requests it.

I'm going to read examples they provided of health claims that class I products could make under this new system. Keep in mind, these are products that will not be reviewed but will simply be rubber-stamped by Health Canada if they don't think they are particularly risky.

"Relieves nervousness; soothes sore throat; traditional Chinese medicine used to replenish Qi; traditionally used in Ayurvedic medicine to improve agni (digestive fire)".

Moving on from health claims, all self-care products, under this new proposal, would sport a unique identifier, which could be used to report adverse events and quality control issues.

Products could also boast a statement on the label, and Health Canada is moving away from disclaimers (which are negative), statements like "This product has not been shown to be efficacious using scientific evidence", and moving toward proclaimers, statements like "This product is based on traditional Chinese medicine". Finally, in terms of compliance and enforcement, class I products would not necessarily be inspected before entering the market, whereas class II would.

Following the online consultation last fall, we know that some people are for this change whereas some are against. The people for it cite increased clarity, consistency, and reliability, whereas the people against it claim this new system may reduce the range of natural health products available to the public, either by prohibiting the sale of some of them or by discouraging their use. As to whether or not these products should carry unique identifiers, Canadians were split 50/50.

There was a number of homeopaths and pro-homeopathy citizens in the room who went to the microphone and voiced concerns during the recent in-person consultation. They stated they would have liked to have been consulted by Health Canada to help them develop this new system and felt slighted that they hadn't; they expressed concern that their remedies would end up in class I despite the fact that homeopaths treat people with major health issues and they want their products to be safe and effective and to appear as such to consumers; they said that consumers' freedom of choice would be curbed by this system, that the current system is pretty good, and that double-blind studies don't necessarily apply to every treatment. A homeopath also stated that Health Canada should not act as a consumer protection agency. And, finally, the mother of a child with epilepsy said anti-convulsants didn't work for her child, but homeopathy did, so we need to keep an open mind. Since 76% of Canadians use natural health products, she could not believe 76% of Canadians could be wrong.

On the skeptics' side, Dr. Joe Schwarcz from McGill stated that Health Canada should approve products based on their efficacy first, then look at risk, not the other way around, and that giving homeopathy a Health Canada number of any sort misleads the public into thinking these pills are safe and effective. A few other skeptically-minded commenters mentioned the fact that Health Canada should be basing its decisions on science. And my favourite comment came from Chris (OK, I'm biased). He said that, if I go to the Apple Store and buy an iPhone, I have a guarantee that the phone will work. But if I go to a drugstore and buy one of these natural products approved by Health Canada, I have no such guarantee. To treat these situations differently, especially since the second one involves health, is ludicrous.

Now that the facts are out of the way, uh, my opinion on this proposal.

Overall, I think it's akin to rearranging the deck chairs on the Titanic.

First, what is Health Canada's goal? They are, according to their own website, responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances. To achieve this goal, Health Canada relies on high-quality scientific research as the basis for our work. They further mention, "We provide credible information, reliable advice and quality services."

So how is it that homeopathy would still be approved by Health Canada under this new system? Homeopathy flies in the face of science. It's the idea that a substance that triggers a symptom in a healthy person can cure it in someone who already has it and that, the more you dilute it, the more powerful it becomes. It is the low-hanging fruit of health-related skepticism because it is so inane and obviously ridiculous, yet some people still believe in its absurd principles and Health Canada wants to continue approving these products and slapping them with a number that will make people think these sugar pills are worth something.

Under the current system, homeopathic products and other herbal products that lack scientific backing are rapidly approved by Health Canada on the basis of historical evidence and are given a unique number. Under the new system, these same products would still be rapidly approved based on the same evidence (to be submitted only if specifically asked for) and would be given a unique number. The claims made would be the same sort of vague, structure/function claims that don't mean anything, like "helps with this" or "prevents that". The only potential difference is that there might be a text box on the packaging that would specify, in a positive tone, that this product is based on traditional medicine. It wouldn't even be a warning that this is NOT based on scientific evidence. It would essentially be redundant information that the product is based on some sort of ancient wisdom.

And the purveyors of natural products are anxious about this change, and I don't understand why, because basically nothing would change for them. They would have to slightly modify their packagings, but the availability of these pseudoscientific products would not change.

By using a risk-based approach, Health Canada is essentially saying they are not going to get involved in helping make Canadians enlightened decisions about which self-care product has been shown to work and which hasn't. They will simply inform us of the risk we're about to take. But this is little different from the current system, in which all of these products are available on store shelves and bear the stamp of Health Canada.

And, finally, to address some of the claims and concerns of the homeopaths who spoke out-and, let me tell you, they made up at least 3/4s of the room based on selective applause-,

If you manufacture fairy dust, a science-based organization like Health Canada should not involve you in drafting changes to the approval process.

If you see patients with major health problems and you think you can help with your sugar pills, you are acting against the interest of your patients. And touting a book about the use of homeopathy in acute and emergency care written by 18 doctors as proof that homeopathy means business is ridiculous. 18 authors? You need at most 2 authors on a homeopathy book before I'll start taking it seriously. 18 is not dilute enough.

If you claim that freedom of choice trumps consumer protection when it comes to physical health, you are in the wrong business.

If you believe that double-blind placebo-controlled randomized clinical trials are great to validate drugs but they're just not applicable to your brand of quackery, you are a hypocrite.

If you think 76% of Canadians take natural health products, you may not realize that over half are taking vitamin or mineral supplements and 11% are taking tea. The percentage of Canadians using homeopathy is 7%. Can 7% of Canadians be wrong? Yes. Yes, they can.

And, finally, to the mother of the child for whom anti-convulsants apparently didn't work, you have my sympathies, I can't imagine what it must be like to have a child who has 30 to 40 seizures a day, to go see doctor after doctor and go through different medication, and nothing seems to work. But sugar pills don't work. Anecdotes are not reliable. We don't know what else changed in the life of your child when he started to take those sugar pills. Was he on a new medication also? Did his diet change? Was this the natural course of the disease? We don't know, and you don't know, because an anecdote is just that. That's why we do clinical trials.

Health Canada wants to change the rules superficially, but the end result is going to be the safe: the Canadian market will be replete with health products making claims that are not backed up by science and consumers will be fooled into thinking these products work.

Classifying self-care products according to their risk is just not the way forward, in my opinion, but I'd love to hear yours. Let me know what you think of all this in the comments below. And if you want your voice heard, Health Canada will be back with more public consultations in major Canadian cities in June, to get your feedback on labelling, compliance, advertising, and market entry.