Health Committee on May 8th, 2008

[James D'Astolfo]

To touch on your point, Dr. Fry, that 60% of patients are not aware of the drug identification numbers, we feel that the government should put in place some sort of media campaign or education to make patients aware that these numbers exist on products such as vitamins or nutraceuticals.

I think you had another question.

[Hedy Fry, Liberal, Vancouver Centre, BC]

It was on mandatory reporting of adverse--

[James D'Astolfo]

Yes, it was on adverse reports for health professionals. We believe it's up to the patient to tell their provider that they are taking natural health products. But at the same time, we need to provide tools so that health professionals can talk with their patients effectively about natural health products and identify for them and work with them on reporting adverse reactions and on whether the product is safe enough and won't interfere with other treatments they're getting.

I think it's very important that health professionals are mandated to report to Health Canada, with support and education coming from Health Canada, to try to deal with adverse reaction reporting.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

[Trueman Tuck]

May I add to those last questions? I have an answer to them too.

[The Vice-Chair, Liberal, Lui Temelkovski]

You have 30 seconds.

[Trueman Tuck]

Okay. That's tough.

The consumer wants to have informed freedom of choice. The whole regulatory system is geared to the assumption that the drugs are safe, properly risk benefited, and everything.

I co-authored a book called Death by Modern Medicine with a naturopath and a medical doctor. You can look it up. We proved that in North America the most heavily regulated professions, nurses, doctors, and pharmacists, in the most heavily regulated facilities, hospitals and care homes, with the most heavily regulated products, prescription drugs, were killing the equivalent of seven jumbo jets full of people a day. I can provide scientific evidence to this committee. We've used it in court, and we commissioned a risk study that I'll provide to every member.

So the whole paradigm that there's some big bogeyman that consumers have to be protected from is not only outside of federal jurisdiction, it's a violator of our most basic human rights.

Thank you.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you, Mr. Tuck.

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

You can respond, Ms. Wilkie.

She wants to answer, so take it on my time.

[Anne Wilkie]

Merci. I have a couple of things to clarify.

There is mandatory reporting of adverse events for the industry within the natural health products regulations. So there is a requirement on industry to report adverse events.

We fully support the education of consumers, but based on the fact that there are currently only 7,000 licences in the marketplace out of 40,000 or 50,000 products, trying to educate the consumer at this time is going to cause more confusion than not.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, I would like to come back to something Mr. Tuck said.

If I understand correctly, the members of the public should be free to inform themselves and choose from all of the products on the market the ones best suited to their situation. The marketing of these products should not, therefore, be regulated.

Is that in fact what you said? If it is, I would like to get the reaction of the Canadian Health Food Association and the other panellists to your comment.

[Trueman Tuck]

When Dr. Carolyn Dean and I were here we met with a number of you--we gave you copies of our book, Death by Modern Medicine, and we'll provide copies to any member. We requested that there be a federal death registry created that would provide mandatory coroners' forms to ensure that the cause of death, regardless of whether it was from parachuting, or prescription drugs, or cosmetics...to provide not an opinion-based, but an evidence-based mandatory death registry with an input form that makes sure the data is as accurate as possible. So whether my daughter wants to go parachuting or skydiving, or whether someone wants to take a drug or not, or a mammogram, or fluoride, whatever it is.... There are so many issues that families are trying to make informed choices on now. Without having an evidence-based federal death registry, it's impossible. You have a bureaucrat with one viewpoint; you have a naturopath with another; you have a consumer. It's all opinion-based, which is very dangerous when you're making decisions that could be life-threatening to you or your loved ones.

So we strongly suggest that a federal death registry be set up. Obviously, the confidential information would be hidden, but it would be web-based so that everybody could go in and look at the risks.

We commissioned a study in 2004 that did the risk management across all activities in society, and our group would be pleased to provide a copy of that report to each of the members of this committee so they can see what we're talking about.

Then there have to be proportionate risk regulatory regimes. Take, for instance, peanuts. You probably don't realize that peanuts kill an average of 3.5 people in Canada a year. We suggest that we need to have a peanut standard so that anything that causes deaths equal to or greater than peanuts is in federal regulations and anything less is in provincial regulations--or not regulated at all if it's below a 0.5 threshold. It would sort out the jurisdictional issues between the provinces and the feds, and it would sort out the appropriate way to truly protect Canadians.

Thank you.

[Penelope Marrett]

Merci beaucoup, Monsieur Malo.

The Canadian Health Food Association was involved when the regulations came into force. Our members said, and continue to say, that with a separate category we believe the regulations could be seen and interpreted in an appropriate manner for low-risk products. From that vantage point, if I understand your question, our members have said that with a separate category we do support it. We believe that regulations are what consumers are asking for in order to ensure the products that are available are safe and effective.

Do you want to add any more on that?

[Peter Helgason]

The regulations themselves.... It's what's happening with natural products, and this is why the third category is probably necessary.

For example, you can go out and buy a Ferrari Testarossa or you can buy Le Car. They're both regulated products and they're both for transportation. And then you can get a two-wheeled scooter like my kids ride out on the street. They all serve a purpose, but clearly there's a significant difference in the potential risk between the scooter my son is on, on the street, and the Ferrari Testarossa. How do you balance that? The suggestion the committee arrived at 10 years ago was to have a third category.

In terms of the standards of evidence, etc., that are used to make therapeutic claims or what have you, the gold standard, as I hear it talked of all the time, is the double-blind placebo control clinical trial, which will give you a very good statistical predictor of how effective that product will be in any given situation. There's the old joke about the statistician; he has his head in the oven and his feet in ice water, and when you ask him how he feels, he says, “Well, on average I feel fine.” But the fact is, the statistics don't speak to the individual case.

I think even the more scientifically inclined here would look at genomics and begin to understand that there are dramatic differences between individuals, even out of the same cultures. For instance, a product that I can take that makes my symptoms go away, be it cancer or heart disease, may not work for somebody else. But the fact is it works for me, and I don't think I should justify my better health to anybody. It is my body, after all.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much. I get the message.

Madam Charlton.

[Chris Charlton, NDP, Hamilton Mountain, ON]

Thank you, Chair.

It's quite obvious that all of you who are here today are motivated by what's in the best interest of consumers, and obviously product safety is a concern for you all as well. Nonetheless, there's a pretty significant disagreement about what kind of regulatory framework gets us there.

I have knack for stating the obvious, so I just thought I'd do that.

I wonder, though, in light of that context—and you started to get at this answer a little bit—how important is it that we maintain that third category between food and drugs? Some of you have expressed some pretty significant concerns about that category as it exists and how regulations that apply within that category are applied and implemented.

I think I heard all of you say that the third category is important, yet you're raising concerns. So I wonder if you can comment about whether you want to maintain that separate category, and what kinds of changes in the regulations would you like to see to make that category work from each of your very different perspectives on this issue?

[Anne Wilkie]

Following on the previous comments, the industry has always been supportive of appropriate regulations. We're finding the challenge is the interpretation of the regulations and the implementation of them, and we find that it's biased by the very fact that we are a subset of drugs. We feel that once we're out from that category of drugs, there's a more balanced lens and a more balanced view of how these products are reviewed.

When you're talking about amendments to the regulations, there are some that we would like to see: the opportunity for post-market notification of some of the lower-risk products within that overall low-risk category, so going to market without a review, a post-market notification; removing some of the requirements for specifications right now, because whereas they're in product licensing right now, they belong with good manufacturing practices; and the ability for inspections versus attestations for site licences.

So there are some amendments we'd like to see in the regulations, but in general it's the interpretation and implementation of them.

[Penelope Marrett]

At the same time, I think we need to make it clear that in the legislation that exists today, there is no separate category for natural health products. There was a recommendation in the 1998 report, but in the current Food and Drugs Act, there is no separate category.

[Ian Stewart]

On behalf of Truehope, a third category is not only sought after, it's necessary. How can a vitamin-mineral supplement, which we typically would take just to maintain good health, fit into the categories that exist today, when a vitamin-mineral supplement has a profound therapeutic value to correct disorders that are typically treated with medications?

We don't fit in either category, and our struggle through this whole process is to maintain our purpose and to continue what we do to help people, especially those on the threshold of suicide, those who have tried all other treatments within the medical model and have failed. We do take those people and get them turned around. So how can we fit into the categories that exist today?

Aside from that, the big concern for us is not just the category but the abuse of process within the categories, and the means by which we can address those concerns and that evidence that comes forward during the process.

[Trueman Tuck]

It's very important to understand that the U.S. had this same issue in the early 1990s, and they resolved it by creating, in 1994, the Dietary Supplement Health and Education Act. They basically recognized exactly what Truehope has just said, that the vitamins had a powerful, necessary, and positive....

It was so powerful a movement, as it was in Canada, that in 1994 it was put through both the Congress and the Senate with 100% consensus. That's what we were hoping in 1997 when we invested the time and money, as over a million consumers and tens of thousands of small businesses. We were hoping that with the 1998 report—and they did start the legislative renewal, by the way, and I attended one of them—we would get a harmonization of this category with the U.S. third category, which was food and which was appropriate for what we had. That did not happen, and the regulations came out of the blue and sabotaged it.

On the second question, from a consumer point of view, we feel we need to be able to have informed freedom of choice, and the point has been made around the table that this doesn't mean having a federal bureaucrat telling me that I can or can't take a product, but it does mean that the federal government has a responsibility to provide me with the statistics so that I can make informed choices from evidence-based statistics of what's likely to harm me or what's likely to kill me or my family or loved ones.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Mr. Chairman. My first question is for the men in nursing. What types of comments are you hearing from members of your association in regard to regulations? Are they looking for stricter regulations? What exchanges have they had with patients about this? What sense do you get?

[James D'Astolfo]

I think stricter regulations are necessary to protect the best interests of patients throughout Canada. I think there were some comments made about identifying them in different categories versus a vitamin or herbal supplement. You have to take a look at history to see that herbs are very potent products and should be treated very carefully when patients are taking drugs along with those herbs.

I think to add a different category would be kind of disruptive. I think you should take a look at grouping them, herbs and vitamins, together in one category. I think that would be in the best interests of patients.

[Patrick Brown, Conservative, Barrie, ON]

This is a general question. When the regulations came into force, there were an estimated 42,000 natural health products and non-compliance was a big issue. They estimated 32,000 would be non-compliant. Do you view non-compliance as still being an issue today?

[James D'Astolfo]

Do you mean non-compliance in terms of mandatory reporting for health professionals?