HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, March 12, 1998

• 0909

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): We call the meeting to order. This is the 26th meeting of the Standing Committee on Health.

We welcome the witnesses this morning. We have: coming here as an individual, not with a particular group, Dr. George Neville; from the Canadian Herb Society, Dr. Alison McCutcheon, Dr. Dennis Awang, and....

Somebody is missing from your group, right?

Dr. Alison McCutcheon (Chair, Canadian Herb Society): Conrad Richter.

The Chair: Is he coming in?

Dr. Alison McCutcheon: No.

• 0910

The Chair: And from the Gatekeepers of Health, we have Dr. Aileen Burford-Mason and Joan Farano.

We'll hear from you in that order. We hope you can keep your comments down to about five minutes and then all the MPs will have a chance to answer your questions. Also, please keep your answers down, because the MPs each get five minutes, which includes their questions and your answers, so if you go on, they're not going to get their other questions answered.

Again, thank you very much for coming. We'll start with Dr. Neville.

Dr. George A. Neville (Individual Presentation): Thank you, Madam Chair. First, I'd like to say that I'm going to wing it this morning, because I just looked in the newspaper to see where the meeting was taking place because I did want to hear my good friend and long-standing professional colleague, Dr. Dennis Awang, and Dr. McCutcheon present here this morning, only to find my name topping the list.

I have attended a couple of other sessions of the Standing Committee on Health, and I was struck by the fact that it would be perhaps useful to have a person such as myself make representation.

I had been employed for 31 years and four months as a research scientist within the bureau of drug research of the Health Protection Branch. I was head of the spectroscopy section and was well integrated with almost all facets of work going on in the department and had close association with the natural products work.

In fact, I think the committee should realize that natural products chemistry was a very integral part of the work of the bureau of drug research right from the beginning, right from the early sixties when I joined, the emphasis at that time being largely, and still continuing, on the drugs of abuse, like morphine and heavier narcotics, essential oils. Later on we got into quite a bit of work with herbals, particularly arising from China, southeast Asia, the subcontinent, and so on.

The other thing I want to emphasize is that throughout this roughly 30-year period there was a well-integrated resource of expertise and equipment. The chemistry section, the analytical chemistry section had respectively broad-ranging synthetic capability and analytical capability, the analytical involving resources to do such things as thin-layer chromatography and high-pressure liquid chromatography, and so on.

We in the spectroscopy section would be responsible for the characterization of substances, including the elucidation of new structures, the identity of substances, and so on. Very often this had to be done from first principles, because the substances we were working with couldn't be matched with reference spectra, and so on; we had to deduce their structures. We have many accomplishments in that regard. So this function is very important.

I'm sorry to say that today none of that exists. In fact, much of that capability was reduced as early as mid-February 1997. You may recall that the bureau of drug research was signalled to terminate by April 1, 1997, when Dann Michols, the director general, served notice in a surprise meeting on November 21, 1996. I, myself, was given notice of surplus on July 18, to be out on July 30.

The interesting thing that has come to light by way of access to information is that the official signing of that was not made by the deputy minister until July 2. In the meantime, much of the capability had already been devolved, scattered; people had been seconded off to other areas—the bureau of drug surveillance, environmental health, all kinds of things. The labs had been essentially reduced to inactivity. Many of the labs had been cleaned out, and equipment dispensed with. The chemicals were sent off for disposal, according to environmental restriction, at great expense, having to be packed in vermiculite and so on. So it takes a relatively short time, a few months to turn things down, but it takes years to re-establish that kind of capability and so on and so forth.

• 0915

I want to hurry on now to the last part, which I think Dr. Awang will amplify much better, but I want to mention the initial thing here that was in my letter, and that is the theme that I felt was deficient in the presentations hitherto: the important thing with herbals is botanical identification.

The DIN number means very little unless the substances have a history of being traced and confirmed—authenticated—by knowledgeable botanists. This is particularly important before the substances are subject to processing, to being destroyed in terms of their physical form, root, leaf, stock or whatever. Because once the substance is ground up and reduced to a powder or even to fragments, it's virtually impossible, even for the most knowledgeable and skilled botanist, to make the botanical identification. And without such a characterization, a botanical identification, you're completely at the mercy of the distributor and the packaging.

So I will conclude by saying that label information indicating botanical certification and identity of the constituents in the herbal preparation would provide the consumer with the proper assurance, which at present is totally lacking.

I'd be happy to entertain any questions.

The Chair: I feel that we rushed you a little bit there. I saw you looking at your watch. Do you have some more that you would like to say now rather than—

Dr. George Neville: All right. As I say, I was so rushed this morning without notification...I do want to tender as evidence this memorandum to the deputy minister with regard to the devolution of the bureau of drug research dated January 2, which gives the basis for the...this was originated by a lowly placed administrator, namely the acting director, Dr. George Mattok. It's signed by Joe Losos, MD, and Michol's name is here but not signed, and it has the words “I concur” written by Michèle Jean, the deputy minister.

In that regard, to supplement it and to take you through that, I also tender a letter prepared on February 16 for the Ottawa Citizen. It hasn't come out yet, but it goes with this because that explains it all.

And here is a very nicely illustrated article that was reproduced in the Chemical Institute of Canada News in December 1989, in which you will find a profile description of the work done in the natural products section by Dr. Awang and in the spectroscopy section by myself. There's a picture in full colour and so on and so forth.

The Chair: Give all the material that you can to the clerk, and then he'll make sure that everybody on the committee gets a copy of it.

Dr. George Neville: Thank you very much.

The Chair: The clerk's going to make sure everybody gets copies of it. Thank you very much, Dr. Neville.

Now, from the Canadian Herb Society, Dr. McCutcheon.

Dr. Alison McCutcheon: Thank you, Madam Chairman, and thank you to the committee for inviting us here today.

I'm here representing the Canadian Herb Society, which is a non-profit educational organization dedicated to the promotion of accurate information about herbs.

You'll notice that I focus only on herbal remedies. That's not only because I'm with the Canadian Herb Society, but because I feel there are fundamental differences between the herbal products and many of the other natural products, as well as fundamental differences between herbal drugs and pharmaceutical drugs. Because they are fundamentally different, we need a different regulatory framework to deal with them, a framework that is different from what is suitable or appropriate for other types of drugs or natural products.

We must consider, I believe, that the most important thing when we're addressing the issue of how to regulate these products is this: what are the risks? As a scientist, when I look at the documentation in the scientific literature of the risks associated with herbal remedies, it is clear that far and away the largest concern these products raise is poor quality of product.

• 0920

The second cause of risk or adverse effects arising from herbal drugs is the inappropriate use of these products by the consumer. It is only in last place that the issue or concern is the inherent toxicity of a particular herb itself.

So if we want to devise a regulatory framework that is logical, that is going to protect and promote Canadians' health, the primary focus of the regulation must be to ensure that Canadian consumers have products of good quality available to them.

How do we go about doing that? Again echoing what Dr. Neville has just said, first and foremost, the concern in this area is certification of botanical identity. All the serious cases of adverse effects we have seen are usually related to the wrong herb being included in the product, not the actual intended herb the consumers thought they were taking.

This is critical. Right now, in this industry, Canadian consumers have no assurance whatsoever that the products they are buying are actually what is stated on the label. No one is monitoring this industry, whether the products are sold as food or as drugs.

Purity is closely related to the entire issue of ensuring the products have the correct botanical substance in them. Again, testing requirements should be specified for these products to ensure that what is offered for sale in the market is of good quality. It would be specious to put out such regulations unless there was a way of ensuring the industry was complying. There has to be a system of quality audit, a post-market surveillance of the products on the market, actually to ensure this; and currently we do not have such a system in place. Again, as Dr. Neville has said, those capacities no longer exist within the Health Protection Branch.

When we talk about the issue of inappropriate use of products by the consumer, I have to say the greatest source of risk in this area is the Canadian regulation. That is because most products are sold as food and therefore these food herbal products do not carry the appropriate information on the label, the information the consumer needs to use the products appropriately and in a safe manner.

Furthermore, as the consumer, when you're looking at the products on the market, it is extraordinarily difficult to be able to compare products, because there is no standardization in the labelling process. Therefore we recommend very strongly that there be a requirement of standardized labelling for these products, both to ensure the consumers have the appropriate information and to allow them to make informed decisions about their purchases.

Finally, when we address the third source of risk, the inherent toxicity of a very few of the herbs that are used as remedies, again, the Health Protection Branch does not currently have, I do not believe, the expertise to make intelligent, scientifically informed decisions on the toxicology of the herbs or on which are appropriate for general consumer use and which should perhaps be considered as having restricted access. These types of decisions must be scientifically based and they have to be made by persons with expertise in pharmacology, toxicology and phytomedicine; that is, herbal remedies.

The other issue that arises around the whole question of inappropriate use is education. Beyond standardized labelling requirements, there is a tremendous need for education in this area, both for consumers and for health professionals. Again, we have no way of delivering that at the present time. Most scientists or medical professionals would tell you that there's a great need for more research in this area, and I could not concur more.

• 0925

As a phytomedicine researcher, I have to point out to you that it is impossible for us here in Canada—and in North America in general—to get funding to do the research that is necessary. I think it's immediately obvious that a project to evaluate the efficacy of an herb is not going to be able to successfully compete for scarce research dollars against, for example, cancer research.

We would like to be conducting this type of research. We're not able to do so without the appropriate funding and structure to do it. We therefore also recommend that we need a centre of excellence in this country to provide a leadership role in conducting the needed research, and also funding dedicated to that purpose.

The herbal industry has little incentive to conduct that research. It would be far more efficient if they were to do so. Compared to the pharmaceutical companies, however, you have to realize that there is no patent protection. There is very little reason for companies to invest unless you give them considerably more tax incentives for spending those research dollars, and perhaps also look at providing some sort of patent protection for particular formulations of products. I believe that under those bases, we would be able to generate a much greater amount of industry-supported research.

Finally, when we come out of these hearings with the best devised, best considered recommendations for regulations, all these things will still not protect and promote Canadians' health unless they're intelligently administered by people who are knowledgeable in the products that they're dealing with, and not simply persons who have been assigned arbitrarily to oversee these particular products. I most strongly recommend that there be a separate directorate to deal with the whole issue of complementary and alternative medicines in Canada in order to provide a leadership role in terms of education, research and policy.

Health Canada has recognized that self-care and the use of alternative medicines are some of the leading trends in Canadian health care, but we have no policy on these trends. We have no leadership and we have no planning to involve them in Canada's future health care system. Those things are essential. Canadians are going to continue to use more of these products and to seek out more alternative therapies. We have to be providing the leadership and the intelligent planning and policy decisions in order to make them as safe as possible, and to protect and promote Canadians' health.

Thank you.

The Chair: Than you very much.

Dr. Awang.

Dr. Dennis V.C. Awang (Director, Canadian Herb Society): I thank the committee for the invitation to attend and to give my views on this subject. I've been intimately involved in the regulation of natural products at Health and Welfare for a very long time. I was with Health and Welfare for 24 years. I met George Neville there. I've been out of Health and Welfare since 1991, when the program was cancelled and took my job along with it. After two years' worth of six-month extensions, I finally left in 1993 to establish my own consulting business.

I would endorse pretty much all that's been said by Dr. Neville and Professor McCutcheon. I should like to add some detail and a different emphasis on the regulation of herbal medicine and plant products as I have experienced it, both while resident in Health and Welfare and since then.

I would characterize the performance of the regulatory authority in this area as possessing a lack of good sense and an even greater lack of good science, and I should hope to illustrate amply to you my conviction in that regard.

• 0930

The areas most crying for attention are, as Professor McCutcheon has outlined, the lack of assurance of botanical identity of these commercial products and also control over the label declarations on these products. There is widespread violation of the law on the labels of these products. I have alerted Health Protection to this. Apparently one has to write a letter to get any action. I suppose if I were to inform them I felt somebody was dying from this stuff a letter wouldn't be necessary, but I believe the situation is bad enough that attention has to be paid to this immediately.

I reported, for example, that I had noticed a product—and these are not just in health food stores, they're in pharmacies as well, some under the house name of pharmacy chains—called Prostease. First of all, names are not supposed to reflect any indication for therapeutic application. That's a clear violation. But on the label of this product it actually recommended that this material should be used for treating prostatitis, and in parenthesis it was explained this was inflammation or infection of the prostate gland. This is clearly a schedule A disease and this is a clear violation.

I spoke with the director of marketing of that company and asked him if he wasn't aware of this. Sure, they were aware. His reaction was “We're not playing on a level playing ground.” That's an interesting choice of metaphor. In other words, other people are violating, so to maintain their competitive market position they're going to violate as well and nothing is being done. I heard people at the Health Protection Branch say they don't have much influence on the retail end of things.

To me, that's the business end of things, and I am at a loss when I'm faced with a variety of products and have to decide which one to choose. I'm familiar with research done on particular plants by largely European firms and I choose accordingly. But for many plants I have no idea. So I think the consumer has to inform himself or herself as best as he or she can and then make an act of faith.

Some years ago you may have heard of the hairy baby story. The eventual outcome of it would not be possible today because there's nobody with the degree of expertise to be able to address and solve this problem.

I read about this in the Journal of the American Medical Association, and as a result I followed up and got authentic standards from the Institute of Materia Medica in China and I solved the entire thing. We had three letters published in the Journal of the American Medical Association.

What happened was that this product—not this lot by a Canadian manufacturer—was purported to be Siberian ginseng. It turned out to be a fairly toxic Chinese plant called Chinese silk vine. There's no way one can confuse Chinese silk vine with Eleutherococcus senticosis, so-called Siberian ginseng. So clearly, along the route from grower to manufacturer either a fraud or an unwitting mistake was made.

The interesting thing is that when the Health Protection Branch got involved and traced the source, the supplier of this, it found fabricators had been making this product for other manufacturers. The manufacturer is the company that puts the label on it. It found, alarmingly, that one company in Montreal had asked for Siberian ginseng to be made for it. It turned out to be Periploca sepium, Chinese silk vine. Amazingly, they put it in a bottle and labelled it Panax ginseng, which is Asian ginseng. Now, I don't think this was a slip, because on the label it actually said this material came from seven-year-old ginseng roots.

• 0935

That's a graphic example of the kind of misadventure that can take place because of a lack of proper regulation. When somebody buys a bag of material that's supposed to be the leaf of an innocuous Brazilian plant and it turns out to be pure belladonna, as was sent to us at Health Protection while George Neville and I were there—you open the bag and you see black berries of belladonna, flowers, stalks and leaves—I mean, whose responsibility is that?

I would say we need to definitely establish a system of certification of botanical identity, to institute a regular program of testing of these materials, the more important ones, judged on the basis of market importance, health risk and so forth, such as we had at Health Protection. We'd been through at least four plans serving all commercial products on the market before our program was cancelled.

Finally, we need to get real scientific experts, not stakeholders. We need real scientific experts, the best we can get, to evaluate the basis for therapeutic claims and also the toxicological risk. I could give you a plethora of examples of miscarriage resulting from a lack of this sort of scientific authority and good sense. I have some examples here. Perhaps later on I'll get an opportunity to mention them.

Thank you very much.

The Chair: Thank you. Now from the Gatekeepers of Health, Dr. Burford-Mason.

Dr. Aileen Burford-Mason (Spokesperson, Gatekeepers of Health): Thank you very much. My name is Aileen Burford-Mason. I'm an independent research analyst, a health care writer, lecturer and educator. I have a special interest in the biological basis of complementary medicine.

I'm here representing Gatekeepers of Health, a new consumer organization recently formed to lobby for freedom of choice and access to reliable, safe and affordable—we do want to emphasize “affordable”—nutritional supplements, herbal remedies and other natural health care products. Our name reflects our interest in extending the rights and freedoms of individuals to choose health care options that they believe will promote and maintain optimal health status.

The group was actually formed out of dismay and frustration at the draconian steps being taken by the Health Protection Branch of Health Canada over the last few years to limit our access to nutritional supplements and natural health care products that we see as integral to our aims.

In the brief time available to me I cannot go into the background—but it is contained in our written submission to you—of the evidence that the natural products we're discussing here today do indeed have major health benefits. I'd be happy to go into it in more detail with anyone who has time later on.

That Canadians are using these products in greater and greater numbers is confirmed from a recent CTV Angus Reid poll. Canadians of all age groups.... In fact, in the age group 18 years to 34 years, there was a whopping 137% increase in the utilization of such products over the last five years. From that poll it can be seen that they're not using them as an alternative to conventional medical treatment but to improve their present health and reduce the risk of future illness. I think that's an important thing for all of us. This movement is all about promoting good health, and health promotion is an area that our governments have been very slow to pick up on. Our medical profession knows a great deal about treating illness but knows very little about maintaining health status.

With cutbacks and with the perceived switch in demands in our health care system to high-tech medicine and also with the change in demographics, we now find many Canadians are actually frightened that there won't be a good health care system there for them in the future when they need it. So they're beginning to take more responsibility for their own health and trying to avoid unnecessary illness. I think this committee should actually note that in doing so there is a great economic benefit to the country.

• 0940

When Dr. Rob Buckman presented his report on complementary medicine to the CPSO—recently they reviewed complementary medicine—one of the things he said was that in England it had been shown that where alternative and complementary medical treatments were actively promoted there was a tremendous saving in reduced access to specialty and hospital services. Recently in Quebec a study looked at escalating health costs and it said they were due entirely to that: increasing access to specialists and hospital services. If we can reduce that access, of course it has major economic benefits.

In our study we quote an Australian study that showed that just by promoting the use of three vitamin preparations their health care service could save $20 billion a year. The three situations were multi-vitamins and minerals in pregnant women to avoid low-birth-weight babies, folic acid in pregnant women to avoid birth defects, and vitamin E to prevent heart disease. Those are just three areas.

The problem we have in Canada in accessing these arises from the definition of a drug. I'm not going to reiterate that, because I'm sure the committee has heard that over and over again. Paragraph (b) of that says any substance that restores, corrects, or modifies organic function in man or animals is classified as a drug. This is clearly a nonsense; a total nonsense. Unless we're going to classify everything we eat or drink, we cannot use that classification of a drug.

Take, for instance, garlic. Good studies show it blocks the development of tumours in animals. It prevents the formation of blood clots, which lead to strokes in human subjects. It's as potent, at least in the laboratory, as penicillin or erythromycin. That makes garlic, just regular, old, plain, common garden garlic, not in any way adulterated by a manufacturer, a drug under the present definition.

In another study it has been shown that eating 7 ounces of raw carrots a day for three weeks reduces cholesterol levels by 11%. Under the present definition of a drug that makes carrots a drug.

Ginger, plain, old, common garden ginger, is more effective than pharmaceutical agents at treating nausea and vomiting, and it is the treatment of choice now for nausea and vomiting of pregnancy. That makes ginger a drug under the present definition.

It's really quite clear that we cannot sustain this definition. It must be changed to exclude the sort of natural products we're talking about. Phytochemistry has advanced so much in the last number of years that almost everything we eat has health benefits. This is the era of food as medicine. So we need very carefully to look at these definitions.

The Health Protection Branch have continued to support this definition in the light of its sheer lunacy. It just does not make any sense. Then they use it as a supplementary argument that such products are unsafe.

I listened to Dr. Awang with some consternation, because when we review the medical and scientific literature it's quite clear to see that the evidence that these products are unsafe—they may not be as potent as they say, but the evidence that they are unsafe—compared with normal pharmaceutical drugs, not just those available on prescription but those available over the counter, is so flimsy it is not supportable. The fact of the matter is that I asked Health Canada for some information from their database on adverse reactions, which they have maintained since 1965. I asked for any adverse reactions on herbal remedies. They have no records.

I then asked for the adverse reactions to two vitamins which we know, and have known for a long time, at very high levels over a long period can have toxic effects. That, by the way, is a good argument for putting upper limits on labels of vitamins and minerals. They are vitamin A, which can cause liver toxicity, and vitamin B₆, which can cause sensory neuropathy. By the way, for comparison, I asked for data on aspirin, just to see what was there.

• 0945

This is the data on B₆: 34 adverse reactions—all of them mild, all of them transitory—stopped when the product was stopped. This is the data on vitamin A: 4 listed cases. And this is the data on aspirin: nearly 1,200 cases, with 81 deaths. And by the way, it's impossible to commit suicide—there are 51 suicides in that figure—with any of these natural products that we're talking about here today.

So I'm concerned at the suggestion. There's no evidence through the medical literature or from the database that Health Canada itself maintains and has maintained since 1986. Some of those deaths from aspirin are polypharmacy: there are a lot of drugs involved. Many of them, though, are from one single agent used for a short time—aspirin used for a period over a couple of weeks—at regular doses, and many of them are in young people. These deaths are not confined to people who are 87 and in very serious and fragile health. I'd be happy to show that information to anybody who wants to see it.

The Chair: You can give it to the clerk.

Dr. Aileen Burford-Mason: I will, certainly.

The other thing that concerns me is that on the one hand, the HPB wants to limit our access to these natural products, but on the other they're happily sanctioning the de-listing of drugs that used to be available only by prescription and are now available as over-the-counter preparations.

And there are two groups that I'd like you to consider. One is the anti-ulcer drugs, H₂-receptor antagonists, like Pepcid, Tagamet, and Zantac. If you look at the well-recorded side effects of these drugs, which I appreciate are rare but nonetheless do exist, they are the following: impotence, gynecomastia (men growing breasts—that'll thrill them), confusion, hallucinations, grand mal seizures, anaphylactic shock, jaundice, and most important, serious blood disorders, including thrombocytopenia, pancytopenia, leukopenia, agranulocytosis and aplastic anaemia, some of which are irreversible on stopping the drug.

But Health Canada thinks that this is perfectly appropriate for self-medication, that we are grown-up enough to use these products responsibly, and yet we are not responsible enough to use vitamins and minerals, which we know from research—and the research is growing daily—are going to help us ward off some of the diseases that we've thought of in the past as the inevitable consequences of aging.

Smoking cessation products, like nicotine gum and patches, have the potential for addiction. The recorded known side effects include: sore throat and other oral health problems, hypertension, chest pain, tachycardia, skin rashes, respiratory diseases, convulsions, anorexia, myalgia (which seems to be the scourge right now—most of us know someone with a serious case of myalgia at the moment), dysmenorrhea, and liver toxicity.

If any of the products that you're discussing here today had those side effects, there would be no question of letting them be made available, no matter how rare those side effects would be.

So I think we have a serious problem here in that there is a lot of myth about safety of these natural products. I do appreciate the fact that many of these products may not be as potent, but I think that the industry...there will be fallout, and those companies that do not make sure their products are as potent as they ought to be or as the labelling suggests they are, can be...the choice will be the consumer's. The consumers will find out which ones.

I don't know how you're going to regulate. Already, food is not properly labelled. If you're food-allergic, you have a great deal of problem tracking down what's actually in foods. It's very badly policed.

I don't know how we're going to police creating a third category for herbal and other natural health care products. Are we going to have someone accompanying a herb from the field through to the factory, through to the preparation, through to the manufacturer? It's very difficult to do.

I do believe that we need a very strong Health Protection Branch with good quality scientists there who are prepared to evaluate the total risk of a product and put it in perspective with pharmaceutical drugs.

So our recommendations are the following—

• 0950

The Chair: Could you wrap it up as quickly as possible, please?

Dr. Aileen Burford-Mason: Yes, okay.

First, we recommend that the definition of a drug be revised to exclude vitamins, minerals, herbal remedies, homeopathic remedies and other safe, natural, nutritional supplements, which should be regulated as foods.

Second, we recommend that the government put in place meaningful legislation to ensure the accountability of the HPB to the public, and at the same time strengthen them, fund them properly, and keep good laboratories going that will manage to assess the quality control of these products.

Third—and I think this is where Gatekeepers feel most strongly; we feel consumers have been left out of the loop here and we're constantly reacting retrospectively—consumer panels should be set up that would represent the best interests of the public and should be part of ongoing discussions. I don't think these discussions are over with the final report of this committee. I think it should be the beginning.

Thank you very much.

The Chair: Thank you very much.

Now, Ms. Farano.

Ms. Joan Farano (Founding Member, Gatekeepers of Health): I'm not going to speak today, Madam Chair. Dr. Burford-Mason—

The Chair: Okay. We might have some questions for you.

Ms. Joan Farano: Yes, we may have.

The Chair: All right. Thank you very much, panel.

Dr. Hill.

Mr. Grant Hill (Macleod, Ref.): It's interesting to have the juxtaposition of these two groups here. I think in a sense these two groups encapsulate much of what we have heard.

If I might, on the one side we have scientific regulators who say that the government has a very specific role in this area, and who lay out good, rational, intellectual arguments for that. On the other side we have those saying there is need for labelling and for information to the public, but the public should be the ultimate arbiter on this region. In between that, we've heard that the industry could self-regulate—that there might well be a place for HPB to lay out the regulations, but the industry could self-regulate.

My question—and I'll direct this to Dr. Neville and Dr. Awang, if I might—is this. Do you see your suggestions as being the same suggestions that the pharmaceutical industry today is required to keep? Does the Health Protection Branch assay and check and look for the constituents in pharmaceutical products today?

Dr. Dennis Awang: Well, I think Dr. McCutcheon stated in her presentation that they regard the natural product as in total the active constituents. That's not as simple as it might sound, because we're doing more and more research and learning more about the activities of the constituent—

Mr. Grant Hill: Let me just interrupt. I wanted to direct you to whether the pharmaceutical industry—the chemical pharmaceutical industry—gets this treatment with HPB. Does HPB have the capability of assaying, checking strength, and so on?

Dr. Dennis Awang: Absolutely with the pharmaceutical industry. These are well-defined chemical entities, and we have those response relationships and all that sort of thing.

Mr. Grant Hill: Does HPB do that today?

Dr. Dennis Awang: I believe they do. They have periodic surveys of pharmaceutical drugs, but they have not done this for natural products, except for the survey that was done while the natural products section of the bureau of drug research was in operation. There's a good reason for this. It's complex, and very few people are expert at it and know how to apply this in any meaningful way.

Mr. Grant Hill: To Dr. Burford-Mason, does HPB do the same thing for pharmaceuticals?

Dr. Aileen Burford-Mason: We've just mentioned complexity. When you talk about assaying for a single agent, these products, these herbs that we're using that are shown to be so safe because they contain a myriad of substances, not just one.... It's a pointless task, assaying for single constituents. Maybe you can standardize that way if you're a company, as quality control, but we don't know which of the thousand constituents there actually are active. There may be constituents that prevent side effects of the active ingredient. We don't know.

Beta carotene, for instance—the one awfully bad study that was done on synthetic beta carotene was supposed to mimic the effect of eating lots of fruits and vegetables. Beta carotene is one of probably 600 carotenoids, if not 800 carotenoids, any of which can have activity.

This is nonsense. You're not going to be able to police this. If you're going to say let us set up assay systems that will protect the public, and say to the public, “We guarantee you that there are all these active ingredients there”, it is nonsense, because some of the active ingredients may be undiscovered as yet.

• 0955

Mr. Grant Hill: So from your perspective, if the regulator can find evidence of problems, the regulator should step in, but if they have no evidence of problems they should let the public be the public.

Dr. Aileen Burford-Mason: Actually what I'm really saying is that unless you can prove categorically that something is against our best health interest, let us as consumers decide which companies we'll support. We'll very quickly know that these products are active. You know whether they work or not. We will know whether they're working or not for us. If they're not causing serious health problems—as serious as aspirin, which you think we can self-regulate and we can self-medicate with—then leave us alone. Let us use them at whatever potency we want.

We don't need to look to the experts to tell us how much to take unless we're told that a certain level is really, really dangerous. Just to give you one example, a recent study, which tracked 80,000 nurses in the states over 14 years, found that those who took four times the recommended daily allowance—that recommended by all of their health care bodies in the States—protected themselves against heart disease if they took two vitamins, B₆ and folic acid or B₁₂ and folic acid. They reduced their risk of heart disease by 50%. Those who took the recommended daily allowance had no protection at all.

So even the experts are too slow to react. We as consumers feel that—that the experts either ignore the evidence that's coming out, or they react to it and want it to pile so high that it's too late for us to do anything. Unless it's really going to do us damage and it can be proven with scientific studies that it does us damage, I think the consumers should regulate themselves.

The Chair: Dr. Neville would like to answer.

Dr. George Neville: Yes, I'd like to get back to Dr. Hill's question. My answer is no, both in the herbal and the ethical drug situation. From the standpoint of the herbal situation, the Health Protection Branch, and the drugs directorate in particular, lost its resource and capability to investigate herbal substances when Dr. Awang's section was dismissed in June 1991.

The only situation wherein we would be involved with any kind of herbal concern would be of a very pressing emergency. In cases like that, as in the identification of most chemical substances, it would come to my section. We were very limited in our workforce, but there is no standing capability in that at all, certainly not at the present.

I will go on to say that the situation persists even to this day—since, say, by the end of February 1997—in the realm of ethical drugs. There is absolutely no analytical screening of any ethical...from the standpoint of new drug submissions, and the sort of thing that was going on before from the standpoint of product characterization, impurities in bulk drugs leading to the formulated product, and so on like this.

There is a little bit of monitoring of drugs in the five regional laboratories—Burnaby, Winnipeg, Scarborough, Longueuil and Halifax—but it's routine. It's looking for something that was established. But from the standpoint of undertaking new inquiry—true research—there isn't that capability. The expertise isn't there, the resources aren't there, the culture—the culture of research—is not there.

The Chair: I think we'll move on now to Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): We are here to study natural products and soft drugs.

• 1000

We would also like to shed some light on what is taking place at HPB with respect to the analysis of natural products. Many witnesses have told us that they are lacking in experts as well as in the required skills and knowledge for the study of such natural products. It is therefore very difficult to satisfy consumers as far as labelling is concerned and, as you mentioned, in relation to botanical identification.

Mr. Neville and Mr. Awang told us that labs were dismantled. You lost your job even though you seemed to have adequate knowledge to study such herb-based products and all these drugs. What happened? In your opinion, what was the reason for dismantling these labs and why is reliance placed at the present time on experts and inspectors who have no specific knowledge or background enabling them to determine whether a particular product is harmful or not?

I'd like you to feel comfortable and free to provide us information about these reasons. We are not here to judge. We are here to be enlightened about what is taking place in HPB.

[English]

Dr. George Neville: Madame Picard, you've raised a beautiful question. It's a can of worms.

The short answer is economics. The drug laboratories were closed effectively to save $2 million a year. It's peanuts, really, in terms of expenditure.

The other thing is that such a state of rot has set in at the higher levels of administration of the department in the last decade or 15 years that the whole upper echelon is simply caught up in an administrative process and is lacking scientific and medical understanding of issues.

To my mind it's just begotten from one situation to another, a worsening situation, to the point where there has been no effective leadership and no long-range planning, because the people who are making the judgments, the assessments, and the final arbitrary decisions are doing so in an ad hoc manner and without the necessary scientific, medical, and even regulatory knowledge. It's shocking the degree of lack of knowledge, within higher levels, of the regulations themselves and the implications of all this.

To my mind, we need to have a complete cleaning of the Aegean stable, right down to the directors level, right across the board, in foods, drugs, and environmental health.

We have a deputy minister who's shown no leadership whatsoever. The wonder is she's persisted this long.

We have an ADM right now who denigrated the work of a research scientist in the foods directorate who was responsible for making the discovery of dioxins in food products, particularly in milk cartons, and dismissed this work. He said this doesn't need to be done within the food directorate; it can be done by agencies such as NRC. This man was not even cognizant of the fact that the National Research Council of Canada does not do regulatory work like this. The only work it did was to set up a standard for dioxin, just as it sets up many standards for various substances and so on.

• 1005

So you have this lack of knowledge. It is incredible the way these people have been promoted for internal loyalty. And the problem is not at the working level of scientists. We have very good working scientists with good knowledge and good integrity, but it's a problem with management from the director level right up to the top. It's so thoroughly integrated and incestuous, it's the bane of the whole thing.

Perhaps Dr. Awang would like to say something, but that was a great question.

Dr. Dennis Awang: George's answer addresses the upper end of things, and it probably has something to do with economics, but for the life of me, I can't see how the cancellation of the natural products section had anything to do with economics, because as I have said, that knowledge base and lab capability in natural products could have been maintained probably 95% by the retention of my very talented chemist and me, who had been responsible for most of the work.

I really don't know the reasons. I do not believe it had anything to do with economics, because they re-hired two people of the 12 who were dismissed, the most junior people: someone who had only recently been elevated to a research scientist level and a technician.

I have suspicions, and people have expressed theories about it, but it's much too Byzantine for me to resolve. One should ask perhaps the people above me, up to the deputy minister, the director generals—whoever was involved.

However, the cancellation of that laboratory was recognized by people internationally as a mistake and a great loss. The chairman of the advisory panel, Dr. Frank Chandler, sent a letter to the dean of every school of pharmacy in this country protesting it. The then Liberal health critic, Rey Pagtakhan, wrote a letter protesting it, because this action was performed under the leadership of the Conservative Party. Professors from all across Canada and the United States, the most distinguished people, protested, lamented the loss, and said it would be very difficult to re-establish such expertise. We were regarded as the best lab of its type in North America.

It was interesting to me to see representatives of Health Protection at conferences as observers when I was invited to speak in this area, and later on to even have somebody from the drug research laboratory analytical section come to our lab at the University of Ottawa, where I run, with the University of Ottawa department of biology, a phytochemical lab for analysing natural products. They were coming there to try to find out how to analyse natural products. Of course that was very short-lived, because the whole bureau was cancelled after that.

So I don't know what's going on or what went on.

The Chair: Thank you, Dr. Awang.

Dr. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): Thank you all for coming.

As you know, the committee has now heard a lot about the problems, and we're now trying to figure out what are the solutions. There's no question—and even the people from HPB, who appeared before the break, accept and acknowledge—that the status quo is not okay.

What is interesting in the panel this morning is that people such as Dr. Awang are pointing out some serious gaps in the protection piece. If you buy ginseng, do you know it's ginseng? What's on the label? Is there an ability, if it's questioned, for the government to step in and say this is or isn't ginseng? Yet Dr. Burford-Mason is also saying there's been a draconian, unfair micro-managing, so there's a patchwork quilt that doesn't seem to make any sense, and we have to build it back.

We've been questioned at the committee as to what is the role of government. Can it be done by just properly enforcing the Food and Drugs Act as it is, by removing things that clearly, in your definition of paragraph (b), are really foods, not drugs? Or is there a third category in between, which is natural health products, because they have some claim or some traditional use that's different from buying orange juice or carrots at the grocery store? They don't have a claim on them. Even though they are known to prevent scurvy and help us see in the dark, it's not a claim. Once things get into a pill or capsule and have a label on them, does the Canadian public think we have a different role as a government in regard to them as compared to an orange juice container?

• 1010

Is there a role for the third category, which continues to be our debate, a role that would have expertise and would have consumer input, we would hope, in terms of how you would regulate that? That's my first question.

The second question is do you feel the government should have the capabilities to test and do all of that? Would it be okay to out-source this kind of testing to people like our University of Ottawa lab, or should it be in-house at Health Canada?

The Chair: Who would you like to answer your question? Do you have a preference?

Ms. Carolyn Bennett: Maybe one from each side.

The Chair: Dr. Awang.

Dr. Dennis Awang: I'd like to make a comment about this third category business. I think you can have a third category without creating a new structure.

I have said for a long time—and I think even the two former so-called expert advisory panels, which came out of the food directorate, suggested that—that a new category, traditional herbal medicines, be developed.

In fact, the Health Protection Branch does regulate on that sort of premise, but to me not in a very sensible way. They require you to provide two traditional references to a claim and two references to dosage of the actual form in which the preparation is. To me they don't properly judge the reliability or the scientific soundness of these sources, but they stick rigidly, mindlessly, to this two theory: two references to dose, two references to application.

What happens is that you get the ridiculous situation where you can buy echinacea with a DIN, but the only claim you can make for it, taken internally, is for relief of sore throat due to cold. I think this is patently stupid or silly. Why not just say it may be helpful in treating the symptoms of colds, as is done in South Africa by the South African druggists association. It's described as a traditional remedy and it says here, “traditionally used by healers for colds”. What's wrong with that?

This is what you have. I have said for a long time they should not give DINs to such products, the therapeutic value of which is based on such questionable scientific references. I've suggested they should have maybe a TMN instead of a DIN because the consumer, coming to a product and seeing a DIN on it.... And this is why the manufacturers want DINs, it's the cachet of the DIN that makes the consumer feel that Health Protection has examined this, the claim is justified, this stuff is of quality and it will work. But that's the problem, so just use a different number.

Ms. Carolyn Bennett: So we should take definition (b) out of what is a drug and then these products would not need a DIN? Is that what you're saying?

Dr. Dennis Awang: Give them a TMN. There should be some basis for judging whether the claim is reasonable or the application is worthy of any consideration.

Dr. Aileen Burford-Mason: Paragraph (b) is nonsense in the sense that everything, including the glass of water I've just drunk, can be regulated as a drug. What you need to do is put “except food and natural food products” in there.

If you're going to talk, you're going to create such a horrendous bureaucracy. Whereas I can buy ginger for culinary purposes, as soon as it's put into a capsule—and it hasn't altered one little bit—then we're going to police it because it's in a bottle? In fact, under the definition of “food” we are already protected. As a manufacturer, you are required not to misrepresent what's in the bottle, either through advertising or labelling. You're required not to adulterate it. So in fact consumers do have protections.

As a committee I think you have to decide whether any regulations you put in place are, one, going to be workable, because I do not believe you can analyse for active ingredients that we don't yet even know about in herbal products, and I really do not believe there is evidence. No one has shown me the bodies. I do not believe there's evidence that we are talking about serious adverse health effects here.

• 1015

Of course, we need teeth in any regulations so that if any company were found to adulterate or misrepresent a product, they could be put out of business. I would like to see that. But I really think the committee has to decide, if you put in place regulations that are impossible to police, that don't make any sense scientifically....

In other words, we're going to analyse this herbal product for this active ingredient when, later on, research may show there are five other active ingredients there, all of which work together with that original active ingredient. You can't get into that area. It's too complicated.

The Chair: A short question.

Ms. Carolyn Bennett: I think we're hearing two things. We have to strengthen the HPB—

Dr. Aileen Burford-Mason: Yes.

Ms. Carolyn Bennett: —but also there's some call for self-regulation. I think that's the thing that's hard for the committee to get around. Can you help us with that?

Dr. Aileen Burford-Mason: Caveat emptor. That's what, as consumers, we do all the time. We say this is not a good product, and word gets around. Someone writes an article in Time magazine because they have very good scientists like this to do an analysis. Word gets around, and that company doesn't exist any longer. It's where safety is concerned.

The Chair: I'd just ask Ms. Farano to make a comment on that, and then we'll go to Ms. Wasylycia-Leis.

Ms. Joan Farano: I'd like to speak as a layperson. I do not have a scientific background, so what I'm going to say to you is totally anecdotal.

The Chair: Keep it short, please.

Ms. Joan Farano: Okay.

I have been doing studies in energy medicine for about 12 years now, and I would like to say that each of us is a bunch of individually vibrating energy and we're going to react to everything on an individual level. There is nothing we can take that has an absolute and clearly defined reaction for us.

I just want to make that statement clearly, that as we learn more about energy medicine, this must be included in our conclusions, as supported by what Aileen said. Not all of us are going to react to aspirin; not all of us are going to die from it; it's going to work for some of us.

The Chair: Thank you.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you very much, and thank you to the presenters.

All of you have been very helpful to our deliberations today, because despite some obvious differences, I think there is a common thread running through all of your presentations. It seems to me that you're all saying that, as a minimum, in any kind of framework we develop or propose as a committee, we have to recommend that there be within the Health Protection Branch the scientific capacity to be able to deal with quality assurance, to be able to ensure control around labelling, and to be able to do research on a scientific basis when products appear to be creating problems on the market.

That's something we had in the Health Protection Branch but is gradually being eroded. So my questions revolve around how we develop a regulatory framework when the government appears to be going in the opposite direction, when everything that's happening in the Health Protection Branch seems to be deregulation, privatization and cost recovery, as we saw with the loss of the drug research lab just this year, as we saw back 10 years ago or so, with events leading up to the loss of the natural health products lab.

So my questions are as follows.

To Dr. Neville, I'm glad you are here, because in fact when we've raised the issue of the drug research lab before, the minister and his officials have dismissed this as an inconsequential decision. Is it not the case that the drug research lab provided a very important role on the safety front and played a role in terms of health and safety of Canadians?

To Dr. Awang, when we've raised the natural health products branch in the past, we've been told it was an insignificant little department and didn't play much of a role. How do we convince government that this kind of capacity is absolutely essential, whichever way we go in terms of regulating natural health products?

To Dr. Burford-Mason, I think I could probably move in your direction in terms of moving natural health products and homeopathic remedies out of the drug category, if we could be assured that we had that kind of—you used the word “strength”—at HPB, accountability of HPB, and so on.

Can I conclude from all of your presentations that, as a minimum, our report as a committee has to make strong recommendations in that regard?

I'd like each of them to make one comment, if possible.

The Chair: Only one question at a time.

Dr. Neville.

• 1020

Dr. George Neville: There is no doubt that food and drug laboratories established, in the last 30 years or more, but particularly in the first 20, an international reputation. They contribute greatly to the international regulation of drugs and harmonization in European, South American, and North American contexts.

As to what could be done, well, of course it's going to take more money, but I think what's more essential is that there has to be a change in the genre of management. We have to get recognized scientists back into the essential deliberations and management.

Unfortunately, in the last 10 years or so, and perhaps more recently, there has been a very marked trend to have business management types get into this role. They don't have the science background. So there isn't the culture there.

I think back to the days when Alec Morrison, for example, was the director general of food and drugs. Here was a person who came up through food chemistry. He was a pharmacologist and toxicologist by training. Older people here will recall him going on television whenever a problem arose. He was able to address the issues directly in a combination of scientific and lay terms that gave one an immediate assurance that matters were being addressed. There was credibility in the whole thing.

There's not a single director general today who could sit before a television camera and impart that kind of confidence. They haven't got it, and they shouldn't be in those places. We've had political appointees getting down too low into the system, for example.

Another person, Dr. Ian Henderson, was the director of human prescription drugs. He was a very accomplished medical doctor with training in medicine in third world country conditions, such as in Africa and so on. He afforded very great leadership and so on, but now we have people with very minimal scientific training.

The Chair: Dr. Neville, could we let Dr. Awang answer the next one?

Dr. George Neville: Certainly.

Dr. Dennis Awang: I've heard it reported that officials of HPB have come here and said that there was never an actual products laboratory and that there was just one individual with expertise. I think they mean me, but that's doing a disservice to the people in my section who have worked over those years and gained such a tremendous reputation for work in this area. In fact, that section did analyses for many, many other areas of government, like Customs and Excise and the regional labs.

I have heard it said that this capability is retained in the regional labs. I'd like Dr. McCutcheon to comment on that. They absolutely do not have the capability to analyse any natural products. They may analyse for well-established drugs that are contaminating natural products, but they have no idea, to the best of my knowledge, or any expertise in this area whatsoever. All of that was lost when that section was lost.

Dr. Aileen Burford-Mason: Certainly consumers are protected by a strong Health Protection Branch. I think you have to ask yourselves as a committee, do you not actually play into the hands of international, multinational pharmaceutical companies if you allow companies to regulate themselves?

I think we do need to retain it. It's very essential to the health of Canadians that we retain this sort of expertise.

I would support a strong HPB, but with all of the things that the other panellists have commented in place, and that is the scientific expertise. The real, hard, broad-based scientific expertise ought to be there. This could be a net benefit to Canadians. You export expertise. You're recognized the world over.

The Chair: Thank you very much.

Ms. Carroll.

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): Just a quick one. A lot of what I was going to ask has been covered by the witnesses, but I will direct my question to Doctors Neville and Awang.

• 1025

Dr. Burford-Mason has made it eminently clear that she has no fears of death by garlic. But I hear you saying, and it's been a common thread, that adverse reactions and data supporting those reactions exist, either with the pure substance or because it's not pure. Dr. Burford-Mason has agreed we are looking a whole myriad of substances and when they come together....

I'd like to ask you what's your worse horror story? What possibilities exist if we do not go back to a system that allows us to very carefully examine?

Dr. George Neville: There are many horror stories. About five years ago a vaccine was being prepared, and vaccines are lot tested in the bureau of biologics and radiopharmaceuticals. A new batch came through—

Ms. Aileen Carroll: Was it a natural product, Dr. Neville?

Dr. George Neville: You're asking about natural products? All right.

Ms. Aileen Carroll: Yes, sorry, and not on the chemical pharmaceutical—

Dr. George Neville: I've wasted some time. Do you want to take it? I have another one, but you can go ahead.

Dr. Dennis Awang: Some time ago I was reading a seniors magazine that was prescribing a remedy for treating ulcers and so forth using comfrey root. Now, this is an example of an area where there's need for scientific oversight, because in the 1950s in Jamaica a syndrome called veno-occlusive disease was described from young people drinking a bush tea that had species of plants containing pyrrolizidine alkaloids. It's a cryptic thing, so by the time it develops you don't associate the condition with the ingestion of these materials. At very low levels this sort of thing can be damaging.

As a result of the work done in my natural products section we persuaded Health Protection to declare echimidine an adulterant. Now, this was a concern of the Australians because bees were feeding on plants, Echium plantagineum, that had echimidine in them and they were concerned their honey would damage the health of people consuming it.

So echimidine is an adulterant and comfrey is not allowed in the law, but it's totally ineffective because there's no survey of the market to make sure comfrey isn't available. I'll bet you can go to a health food store and buy comfrey root in bulk, and this material has been responsible for fatalities across the world—in New Zealand and in other places.

So that's one example of the need for scientific oversight.

Germander is another example, which was banned by the French and the WHO because of severe hepatotoxicity. Of course you all know about poison hemlock, digoxin and so forth. So plants can be dangerous, but with the knowledge we have we can control that.

Ms. Aileen Carroll: Thank you, Doctor.

The Chair: Finished? Are there any more questions?

Dr. Aileen Burford-Mason: That's exactly what we're talking about when we bring the data on aspirin. Of course aspirin is dangerous. What we're talking about here is putting it in perspective. Almost every substance is dangerous if it's abused. I don't know whether this committee can actually control the risk of people abusing a substance. That's why we need proper labelling appropriate to use, and upper limits of safety as recognized in the scientific literature, and not some upper limit somebody's dreamed up.

We have papers now. Scientists are speaking out about recommended daily allowances of vitamins and minerals, saying these allowances have not been arrived at scientifically. They're clearly inadequate and have been arrived at for all sorts of reasons, but not science.

So aspirin is open for abuse, but we are recommending people take it now every day or every other day, so they may end in this database. I'm asking for a number of dead bodies. Show us the dead bodies. Show us the adverse reactions. Health Canada has nothing in its database on herbal reactions.

The Chair: Thank you.

We have just two more short questions. Mr. Myers and then Mr. Elley.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Madam Chair, my apologies for coming late. I was at the Young Offenders Act recommendation.

• 1030

I do want to ask Dr. Awang first, and then maybe Dr. Burford-Mason and others, whether there is any country we should be looking at where we could find some sort of model. Somebody said you mentioned South Africa in reference. I wonder if you could go on from there.

Dr. Dennis Awang: The two countries that seem to be advanced here are Australia and Germany. Australia seems to be getting a lot more support these days, but I think the German example can be very helpful if the science is upgraded in its references and so forth. Australia and Germany are definitely the two most important.

Dr. Aileen Burford-Mason: I really would like to comment on that. If you look at the German experience, it's quite horrendous as far as consumers are concerned.

My husband is going to Germany next week. He will stay with friends, dentists, and he will bring suitcases full of vitamins and minerals and herbal products, such as Pyconogenol, which are no longer available in Germany. In Germany they have managed to put the control of natural products under the pharmaceutical companies. Something like echinacea has gone from being $20 a bottle to $120 a bottle, which puts it out of the range of most consumers. Do not look to Germany as a model.

Dr. Alison McCutcheon: You also have to remember, though, that in Germany those products, even if they are drugs, are freely available to the consumers, and they are also covered under their health care plan.

Dr. Aileen Burford-Mason: At a horrendous cost now. They used not to be. Germans are complaining about this.

The Chair: Mr. Elley.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you, Madam Chair.

Both Dr. Neville and Dr. Awang, to my mind, anyway, have raised some very alarming concerns about the Health Protection Branch. The question it begs in my mind is this. As a committee we can do all the work we want to do here. We can make recommendations, which may or may not become law and then become legally binding on the Health Protection Branch. But if what you are suggesting is going on in the Health Protection Branch, some of the issues you've raised, could we ever expect that that branch would implement the things we would want to see without some very drastic action taking place—some bloodletting, all kinds of stuff? How would you do it? What do you suggest?

Dr. George Neville: I would like to begin by answering that. I think the concerns here go beyond the interest of this committee. It's all-pervasive, because after all, what is at stake is the health protection and the health assurance of Canadians.

To me, the best recommendation this committee could give, in addition to the more specific ones within its mandate of consideration, is to call for a full public inquiry of the Health Protection Branch and to relate that to what has been going on in the United States in the FDA and the changes there, and in other countries. So many problems are integrated within the purview of the Health Protection Branch that only a full inquiry can do justice to the questions that remain and obviously have to be raised. Too much is at stake.

Mr. Reed Elley: Could it be done before we could ever get any of the changes we're suggesting?

Dr. George Neville: It goes back to the management. It goes back to the people at the top who are controlling the situation. Until you get a change in the make-up, the culture.... It's as deep as that. It's an endemic cultural thing. You have incompetence at the top—that's what it amounts to—without the proper scientific and medical undergirding to enable appropriate decisions and questions to be raised. You can have as many competent scientists as you want in the under-layers, but you have that layer. It's like the blood-brain barrier. You have to break through that.

Mr. Reed Elley: You mean like the cart before the horse?

Dr. George Neville: Unfortunately, both have been destroyed. Right now you have no assurance in Canada for health protection. It's as bad as that. You're living on your laurels.

The Chair: Thank you very much, Dr. Neville. It's an interesting statement to close on.

We thank you very much for coming.

We'll adjourn for a few minutes.

• 1034

• 1042

The Chair: I call the meeting back to order.

Welcome to our second set of witnesses. I will introduce the groups that are here. First, from Shoppers Drug Mart we have Martin Belitz, Wendy Brown and Terry Creighton. From Gordon Piller Incorporated we have Kim Piller. From Hilary's Distribution Inc. we have Allan Ingles and Jennine Ingles-Rothblott. And from Maharishi Ayur-Veda Products of Canada, Russell Guest and Dr. Wolfson.

Normally I go in the order names are on the list because it's easier—I'm not picking one or another—but somebody here has requested that one group speaks first because she has another meeting to go to. I'll therefore do it in slightly different order and ask if Hilary's Distribution Inc. could go first.

Perhaps you would keep your comments short. We only have an hour and a half for all of you, so if we could have about five minutes from each group it allows for more questioning. As you saw, some of the MPs didn't get a chance to ask questions in the other session, so please keep your comments to about five minutes per group.

Thank you.

Mr. Allan H. Ingles (President, Hilary's Distribution Inc.): Shall I begin?

The Chair: Yes.

Mr. Allan Ingles: Thank you, Madam Chair. I'm Allan Ingles, president of Hilary's Distribution Limited. I'm a graduate of the Faculty of Pharmacy, University of Toronto 1965, and I've been an Ontario pharmacist in continual good standing with the Ontario College of Pharmacists since that year.

I'm also a member of the Canadian Pharmaceutical Association and the Ontario Pharmacists' Association and have been personally involved in the health care products distribution business for more than thirty years.

With me is Jennine Ingles-Rothblott, a graduate of York University, having majored in psychology, who is an officer and director of Hilary's with responsibilities for facilitating human medical research and medical marketing.

• 1045

Hilary's Distribution is a Toronto-based family business with about 90 employees and sales representatives. Our principal activity is the importation and distribution of pharmaceutical and phytopharmaceutical herbal-type products.

For example, we distribute Penaten Cream, a mainstream dermatological preparation which is one of the leading brands for infant rash treatment in Canada, and Kwai Standardized Garlic Powder Tablets, imported from Lichtwer Pharma in Germany, which are generally regarded as the leading garlic health supplement on the market, indeed in the world. The safety and efficacy of Kwai garlic tablets has been proven in over 100 peer-reviewed published clinical trials, most recently in Circulation, the prestigious journal of the American Heart Association. As well, through thorough good manufacturing practices and our commitment to recognized quality control procedures, we guarantee the standardized delivery of the active ingredients in the product that consumers purchase.

Hilary's is also involved in clinical and mode-of-action research activities. For example, we market Kira, the world's leading brand of St. John's wort, and we are currently assessing research proposals for the evaluation of the effects of the St. John's wort herb on various states of depression and other mood disorders. We are examining research protocols that have been proposed by some of the top psychiatric institutions in this country. This research will be funded by Hilary's and our German supplier, Lichtwer Pharma. We, the researchers, who are all prominent leading psychiatrists, and their institutions are also optimistic that the federal government will commit funding to this research.

My presentation does not include some of the material which is in the submission in order to keep it as brief as possible.

What we will propose to this committee today is not revolutionary or startling, but it is different in its emphasis on efficacy. Members of the standing committee will recall their first briefing on natural health products by Health Canada officials from the therapeutic products directorate. Officials provided you with background on the mission of the bureau. That mission is, and I quote:

To ensure that the drugs, medical devices and other therapeutic products available in Canada are safe, effective and of high quality.

It seems hard to argue with that mission. In fact, I do not. I think we can all agree in principle that the government ought to ensure that natural health products available in Canada are safe, effective and of high quality.

In our experience at Hilary's, Canadians have, by and large, been well served by our system for ensuring the safety of natural health products, indeed, of all pharmaceutical-type products. There is room for improvement, of course, but there is no need to revamp the existing system or even give it a major overhaul.

Where Canadians are not well served, and where we do need major revisions to our regime, is in meeting the part of the mission statement that refers to ensuring effectiveness. We need a system that ensures that Canadians get products that are proven to be efficacious and allows us to communicate the effectiveness of products through health claims.

Canada has an outmoded regime, originally implemented with the best of intentions, which today prevents consumers from getting vital information about products and the most critical and widespread diseases.

Schedule A of the Food and Drugs Act prevents Canadians from getting information they need to help them care for their health. Cancer, heart disease, depression and anxiety, and diabetes represent half the schedule A diseases that are listed, and one or more of these will strike the highest percentage of Canadians. Yet we are barred from giving vital information about these and other diseases to Canadians, even about the potentially controllable risk factors involved, if we are marketers of products that may be of value.

A hard and ugly fact is that some of us sitting around this table today are going to be struck by these diseases. I strongly suspect that you, like me, want information to help you reduce the odds of these diseases striking you and members of your families.

The system we have today, a system that stops people from obtaining that information, does not serve the interests of the public. Schedule A of the Food and Drugs Act has to be removed.

In the process of developing a new regime that allows consumers access to more information about disease, we must obviously ensure that the information is accurate and not misleading. The Food and Drugs Act tells us that and common sense tells us that.

This brings us back to the part of the mission statement of the therapeutic products directorate that pledges to ensure that products are effective. Members of the committee have undoubtedly heard many stories of natural products that do not contain the amount of ingredients they claim to contain. You've also heard that sometimes the ingredient may not be in an effective form of the ingredient.

It is clearly not in the public interest to let this situation continue. My proposition to the committee is this. First, revoke schedule A of the act and allow products to carry health claims. Second, to control the claims, institute a firm requirement that every product carrying a health claim must have clinical evidence, including reasonable human trials and data, to support that claim.

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That proposition would certainly not startle consumers. They expect companies to be able to back the claims they make for their products. Consumers expect the information on the label of the product they take home to be absolutely true and accurate. They do not expect the information to be true about a general class of products. Rather, they expect the information to be true about the specific product they are going to use.

You will hear objections from people in the health products industry about the expense of proving efficacy. I have difficulty accepting the argument that it is too expensive to demonstrate that your product does what you claim it does. Both Hilary's and our partner company in Germany, one of many companies that supply Hilary's, are small companies and are successful. We are successful in spite of the cost of clinical trials to back our products. We are successful in large part because of the money invested and spent on trials and studies.

Having advocated strict proof of efficacy to back health claims, I understand this is not an approach that can be implemented tomorrow morning. This requirement should be phased in over a period of up to 10 years. In the meantime we should rely on monographs and rule changes in labelling while developing reasonable criteria for efficacy by product categories. But at some point, and we are suggesting it should be within 10 years from now, all individual products carrying claims should be required to support those claims.

Products meeting requirements for safety and quality but unable to demonstrate efficacy may continue to be offered on the market to the public, but without clinical label claims. Advertising claims would be restricted because they have no claim to make. Clinical claims include both preventive and therapeutic claims. If we are going to increase our reliance on monographs for the time being, we are going to need better monographs than we have to get accurate and helpful information to the public.

This brings me to Hilary's final point to the committee. I hope the committee will recommend to the Minister of Health strong support for increasing the expertise on natural health products within the Health Protection Branch. The branch needs expertise to update and develop new monographs, to evaluate health claims on individual products, to develop new policy, and to manage the change that is upon us.

The problem should be addressed in four ways. First, the Health Protection Branch should be given resources to hire new expertise. Second, existing staff should be given training in the natural products field. Third, the Health Protection Branch should make greater use of the wealth of outside expertise we have right here in Canada and elsewhere in the modern world. Finally, a workable form of open appeal and process is vital to ensure the expertise in the industry gets full and appropriate opportunity whenever needed to demonstrate efficacy.

In summary, we recommend these six points:

First, schedule A should be replaced.

Second, the government should implement a new framework for natural health remedies, for that matter all remedies, which allows expanded health claims.

Third, over a 10-year period we should move to a system requiring that the health claims carried on products be backed by clinical evidence for each individual product.

Fourth, in the interim, and beginning immediately, Health Canada should begin updating existing monographs and developing new monographs to improve the information that is made available to consumers.

Fifth, the level of expertise in the Health Protection Branch related to natural health products should be improved by adding new staff, training existing staff, and making more use of outside expertise.

Finally, the mechanism for appeal by manufacturers for fair and complete review of their clinical data in support of claims should be established with industry and the process begun.

Madam Chair and members of this committee, I thank you for your kind attention. Jennine and I will gladly answer your questions.

The Chair: Thank you very much.

Now, from Shoppers Drug Mart, Terry Creighton.

Ms. Terry Creighton (Shoppers Drug Mart): Good morning, Madam Chair and honourable members of the committee. I'm vice-president of corporate affairs for Shoppers Drug Mart. I'm joined by my colleagues Marty Belitz, who is vice-president of pharmacy operations and immediate past president of the Ontario College of Pharmacists, and Wendy Brown, director of marketing of health products. Wendy is our product expert on natural health products.

We prepared a document for you. It has been handed out and we will be referring to some of the exhibits.

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We're very pleased to be here today to talk to you about the need for better—and not necessarily more—regulation of natural health products, which I'll refer to as NHPs. We think we can provide some clear and simple recommendations about the best way to regulate these products, because we have been involved in all aspects of this industry. Shoppers Drug Mart and Pharmaprix together are one of the largest Canadian retailers of natural health products, including our own Life Brand line.

Our 2,500 pharmacists from coast to coast are asked about NHPs everyday by their patients. We've heard from consumers about what they want and need to know. Our product experts like Wendy and the pharmacists in our stores are doing their best to provide objective and reliable information to consumers, but they're struggling within the confines of the current regulations.

It's very clear that Canadians are using NHPs for their medicinal qualities regardless of whether they are classified by the government as food or drugs. In fact, they're not being consumed as food, and it's inappropriate to regulate them as such. Others are classified as drugs, and this imposes a rigid regulatory process that, for the risk level inherent in most of these products, is really unnecessary in many cases.

We believe NHPs are unique, and they should therefore be regulated as a third and distinct classification based on some common principles. Consumers should be protected from harm. Consumers should be provided with the information they need to make an informed decision. Manufacturers should expect a timely response from the government in approving these products so that consumers are not denied access.

Let me give you a very brief illustration of the situation today. Picture a young woman who has heard about alternative medicines through word of mouth, and has read about miracle cures in magazines. She has a cold, and she is also thinking about getting something for her dad's arthritis. She also wonders if there is anything she can get for her mom, who is going through menopause and is on hormone replacement therapy. After all, she believes these products are natural, so they must be completely safe.

Now let me ask some questions. What is this woman going to learn from looking at the labels of the products in her local drugstore? Would they at least tell her the main uses of the products? Will there be any warnings? Will the store personnel be qualified to discuss each of these medical conditions and to explain the uses? Once she chooses a product, can she be assured that the bottle actually contains the right NHP in the right label strength? Was it tested by the manufacturer? Finally, what regulatory framework should be put in place so that consumers like this woman get the appropriate information and protection that they deserve?

Marty is going to talk a little bit about the history available to aid in this process.

Mr. Martin Belitz (Vice-President, Pharmacy Operations, Shoppers Drug Mart Limited): Previous groups—and you heard one earlier today—have suggested that regulations and the establishment of standards for these products are unnecessary and maybe even unwarranted. As health care providers and advisers, we feel that standards are vital to protecting consumers' health. Historical precedents exist for standards and other specifications for NHPs.

In the early 1900s, when the medicinal products industry was developing, a determination was made that consistent purity standards were required for the manufacture of these products, and the United States Pharmacopoeia and the National Formulary, are North American examples of the collected bodies of standards. At that time, the use of herbals was still extensive, and many of them are included in this 1920 version of the National Formulary. You have a copy of the monograph for echinacea in your handout.

Mr. Lynn Myers: The original?

Mr. Martin Belitz: That's the original.

Since then, many of these products have fallen out of common use, they were deleted from the USP and the NF, and they were replaced by modern chemical alternatives.

With the resurgence today of natural health products, standards are once again required. There are many current references from all over the world that can be used to develop Canadian standards and other information for the regulation of products. Today, we have the modern British Herbal Pharmacopoeia and we have the British Herbal Compendium, and these are compilations of studies and other information about various NHPs that are gathered together into monographs. There are also others, like the ESCOP monographs, the Lawrence Review of Natural Products, and many more. We believe these types of references can be used to develop Canadian references. You don't have to reinvent the wheel.

Wendy will now take you through our recommendations.

Ms. Wendy Brown (Director of Marketing, Health Products, Shoppers Drug Mart Limited): Since neither the current food nor drug regulations properly cover the needs of natural health products, we strongly recommend the establishment of a third regulatory category that takes into account the diverse types of NHPs, acknowledges the use of claims, and incorporates label standards and industry regulation in order to fully inform and protect the consumer. The key to making this happen is to establish an agency or a board. Let's call it a Canadian nutraceuticals standards board.

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The board would be made up of experts such as naturopaths, pharmacognosists, herbalists, and other scientific experts from the natural health products industry. There are many such specialists available in Canada. In addition, representatives from NAPRA would also be an asset on the board, to help assess the place and conditions of sale for NHPs and ensure they are treated in the same way in every province, as they do now for OTC medicines and Rx.

The mandate of that board would be to determine comprehensive monographs for each product. Each monograph should include—and I refer you to page 7 of your proposal—elements that define the product and its purity standards. It would include all potential claims and contraindications, drug interactions, and other warnings. The monograph would also define labelling, manufacturing and testing standards.

The beauty of such a comprehensive monograph is that all information is gathered in one place. The risk level of any individual product, which is an important safety consideration, would be inherently contained in the established warnings, drug interactions, and conditions of sale within each monograph.

As Marty stated, there are ample existing references from which to build such monographs, and once completed, these would then become the basis by which all products are regulated.

All companies with products in the NHP category would have to conform to established GNP guidelines and product quality testing requirements in order to ensure a basic level of consumer safety. These same companies, however, would have a choice about whether to apply for a claim on the bottle, which would trigger the addition of other label information, such as warnings, contraindications, and so on.

Once the board has set up such monographs, it would be the responsibility of Health Canada to administer the regulatory system as follows:

First, Health Canada would review pre-market applications for products. Approved products would be given a clearance number that signals the consumer that the claim on the bottle has been reviewed and approved.

Second, such reviews would need to be speedy, to be fair to the needs of the marketplace. Products that conform to the monograph should be approved within 45 to 60 days, just as OTC applications with established monographs are now.

Third, Health Canada authorities would be responsible for inspection and approval of manufacturing facilities, along with follow-up re-inspection. They would also carry out appropriate inspections of manufacturer quality control records.

Let's go back for a moment and answer those questions that Terry posed in the example at the beginning of our presentation.

What will the consumer learn from the labels of the products in the store? Almost nothing right now, but under the proposed framework, those bottles could have full information.

What advice is she going to receive from store personnel? This depends on the knowledge and expertise in each store, but in Shoppers Drug Mart we can assure you that our pharmacists are continuously trained on all NHPs, and they already have the expertise to inquire about the patient's existing medical conditions, as they have access to prescription records.

Once that consumer chooses a product, will what's in the bottle match what's on the label? Right now, there's no guarantee. But under the proposed framework, yes, it would.

Finally, did the manufacturer test the product? Right now, if it's classed as a food, he doesn't have to. But under the new category and regulations, he would.

In conclusion, we feel our proposal presents a sensible and moderate approach to this issue that is good for consumer safety, as well as being fair to all parties involved. We thank you for your attention and consideration of our proposal and are happy to answer any questions.

The Acting Chair (Mr. Lynn Myers): Thank you very much. The next presenter will be Kim Piller, from Gordon Piller Inc.

Mr. Kim Piller (Gordon Piller Inc.): Mr. Chairman, members of the standing committee, it is an honour and a privilege to be here as part of the democratic process in Canada.

My name is Kim Piller. I work in a family business called Gordon Piller Inc., named after my father. My father is in his early seventies and is still actively involved in the business on a daily basis. I'm also a member of the steering committee for the Canadian Coalition for Health Freedom. Today, though, I am here representing the company and myself personally.

Our company was one of the first companies in Canada to supply natural health products to the professional market. The professional market is comprised of doctors of chiropractic, naturopathic doctors, and medical doctors that recommend nutrition.

Gordon Piller Inc. began in 1967. Last year we celebrated our thirtieth anniversary. Many people have congratulated us on this milestone; however, when they hear of the challenges that the industry has faced by food and drug, they are amazed that we're still in business.

Gordon Piller Inc. is classified as an importer-distributor. We import natural health products from two suppliers in the United States: Anabolic Laboratories; and Metagenics. The products are pre-packaged. We do not manufacture, bottle, any of our products.

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The natural health products industry is not new. Anabolic Laboratories began in 1922, our company is in its thirty-first year, and the owners of Metagenics have been in the industry for approximately 20 years.

I would like to start with a comment made by Liberal MP Carolyn Bennett at the hearings in December with the therapeutic products program staff when she posed the question, how did we get into this pickle? I believe the answer is largely due to strong, biased opinions against natural health care products from the food and drug department. This is said in light of years in the business and having no rational reasons given for the over-regulation of the business or of the industry.

Part of the problems that I see us dealing with started, for us, on September 28, 1984. Our company was inspected by a food and drug inspector by the name of George McDonald. Mr. McDonald asked to see our catalogue.

After reviewing the products, he gave the catalogue back to my father and said he would like us to stop selling the products he had marked off. When we asked why, his reason was that the four products marked off all contained amino acids and may be classified in a new drug status. We asked if there was anything wrong with the products and he said no. We asked what would happen if we kept selling the products. He said that if we did not put them into voluntary detention he would call the RCMP and seize them. So we decided to put them into voluntary detention.

On November 20, 1984, we received a letter from Mr. McDonald stating that Dr. Armstrong, the then assistant director of the bureau of non-prescription drugs, had deemed one of our products, called tryptophan—it had tryptophan in it—to be in this new drug status.

The letter stated “The product's label does not guide the prospective consumer in any way in selecting the product or knowing how to use it.” We found this puzzling since we are not allowed to make any claims and now a product was being taken away because we didn't make any claims.

Further noted in this letter, we were invited to submit a proper drug submission. A proper drug submission would take several years and possibly several million dollars. That was not an option for us. Incidentally, tryptophan as of this date is available via prescription at approximately $115 per bottle. We have not carried this product since 1984, but if we were able to sell it, possibly it may retail for $30 to $50. But I don't know what the current costs are for us right now.

On May 3, 1995, HPB sent out information letter number 685, which I actually attached to the brief that I dropped off. HPB stated that due to increasing numbers of queries pertaining to the status of amino acids, they were publishing this information letter. I would suggest that it was not casual queries about the status. Our business alone was losing 10% of our sales and other companies were losing more.

There were several more letters back and forth and a meeting with Dr. Armstrong, but we're still waiting for their safety results.

Why are we in this pickle? It is because there is a growing interest, knowledge and use of natural products for the consumer and the Canadian government is saying no to many substances based on safety concerns. We are still waiting to hear details of these safety concerns.

This industry was founded on the basis of improving health, not destroying health. When our company began, there was very little government intervention. It was appropriate for the low-risk nature of the products. What happened in between? Did the nutritional products suddenly become unsafe? We're not sure. The food and drug department has not acted in a democratic environment with this industry.

I would like to end by saying that safety is an issue for anything we do. However, it is time to regulate this industry appropriately. I do recommend a third category. The nutritional industry is not a passing fad. It is an industry that will continue to grow. It is an industry that is not the drug industry and it is not the food industry.

Great leaders are great visionaries. I look to this committee and the Government of Canada to look ahead and create a regulatory process for the natural health care industry that is appropriate and a model for other countries. The natural health care market is an incredible industry. It should be encouraged to flourish. Centuries ago, people were actually killed for suggesting that the earth was flat. Today, I'm threatened to have my business closed and actually fined if I tell a consumer the benefit of our products.

I have attended several of these hearings and heard members state many times that they are not quite sure or that they really do not understand. Possibly, if the food and drug department had not restricted what we could say over the last number of years, then the committee as well as other Canadians would be well informed.

No person and no government has jurisdiction over the health and well-being of my body. This issue also involves freedom of choice and personal responsibility.

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When the government regulates any activity, five things happen: one, you shift the responsibility to the government; two, you give the government the justification to increase spending; three, you lose control; four, you lose your choice; five, you now become dependent on the government.

Yes, I do support a third category. However, I support minimal responsibility placed on the government, which will keep spending down. I support industry and stakeholders' participation to not lose control and choice and not to become dependent on the government.

Thank you.

The Chair: Thank you.

We now have our last witnesses today, Russell Guest and Dr. Wolfson. I'm not sure who's speaking.

Mr. Russell C. Guest (Director, Maharishi Ayur-Veda Products of Canada): Good morning, Madam Chairman.

My name is Russell Guest and I am the director of Maharishi Ayur-Veda Products. It's a bit of a mouthful. You've heard from our educational branch in the past.

I would like to preface our remarks by saying it hits me squarely when I hear all the various companies involved here talk about natural products as if they were one homogeneous mass. In fact, there are great traditions in natural products that have never been lost. These are the Chinese and the Indian traditions—particularly the Indian tradition, where you can go to university in India at a number of universities and get a PhD in ayurvedic medicine.

We are not talking about folk medicine. We are not talking about lack of systematization. We are talking about systematization and testing that has taken place in the laboratory of human physiology for the last 6,000 years.

Maharishi Ayur-Veda Products of Canada is the largest importer of ayurvedic products in Canada. We have been incorporated in Canada for 10 years, and are affiliated with Maharishi Ayur-Veda Products International of India. We manufacture traditional ayurvedic formulas.

In an earlier presentation to the committee, Dr. Richard Wolfson recommended that ayurveda, including Maharishi Ayur-Veda, be included in its entirety into the Canadian health care system under an expanded definition of the Canadian health care system. He also recommended that ayurvedic herbal and mineral preparations be considered a newly defined traditional medicine category subject to its own GMP, labelling claims and standards of potency and purity, and that this category be developed by a committee of experts.

We would like to further clarify these two recommendations. One, with respect to incorporating ayurveda into the health care system, we wish to first emphasize the importance of including ayurveda in its entirety, including Maharishi Ayur-Veda.

The dilemma that the committee is now facing in regulating herbal products can be traced to the limitations of the current medical system. Therefore, the solution needs to be addressed at its most basic level, the systemic level.

Because there is no dependable and officially recognized source of knowledge in Canada on natural medicine, the public diagnose and treat themselves by referring to the claims accompanying natural products. Clearly this is not for the best. What we need is a system for assessing and disseminating true, useful and complete information to the public. We also need a system in place for certifying and overseeing natural practitioners who are competent at recommending traditional medicines and educating Canadians in other effective traditional approaches.

Fundamentally, we need to educate the public and provide them with resources so they can make more informed choices rather than forcing them to rely on claims written on the sides of bottles.

We acknowledge that Health Canada's jurisdiction does not cover health practitioners. Nevertheless, it was the federal government that originally proposed universal health care. Therefore, we feel this committee should seek solutions that will actually resolve these fundamental problems without being restricted at this stage by issues of jurisdiction.

Maharishi Ayur-Veda has the support of the leading ayurvedic experts in India, as you have gathered from our previous presentations. There are a number of experts, including the head of the All-India Ayurveda Congress, who are watching these hearings. We would be pleased to assist in setting up this system and providing knowledge on ayurveda.

Number two, with respect to our recommendation that ayurvedic preparations be considered as a newly defined traditional medicine category, we would like to emphasize that this recommendation should not be taken as support for a new general third category of health products as discussed by the committee earlier. Ayurvedic preparations neither fit into such a third category nor are they well served by the current system, as we will discuss.

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We will first look at the limitations of the current system with respect to evaluating ayurvedic preparations. First, the existing system of evaluation and categorization is not suited to complex herbal formulations. The current system is designed for evaluating pharmaceuticals, which typically contain single or few active ingredients. However, ayurvedic herbal preparations may contain many minerals, dozens of herbs and many thousands of separate phytochemical components that function synergistically and cannot be understood by analysing only the separate components.

In addition, the manufacturing processes of these preparations can be highly complex. I'll give you one example. The main traditional product under Rasayana, called Chyvan Prash, which was denied a DIN formulation, requires six months of harvesting, 24 hours and 250 steps of processing before it can be analysed to find out whether it actually works or not.

In addition, the manufacturing processes of the preparations can be highly complex, with some ingredients requiring over one year and hundreds of steps to properly prepare. Assessing even one ayurvedic product is beyond the scope of current reductionist protocols for evaluating single drugs. There are more than 12,000 such ayurvedic products.

There is a second limitation of the current system. Because of the impracticability of performing extensive scientific experiments on each herbal product, when evaluating such products, for example for DIN purposes, Health Canada's bureau of non-prescription drugs relies on a literature search of individual ingredients. How do you like this—a non-scientific process to try to resolve scientific problems?

However, because herbs have different effects depending on which other herbs are present in a compound, a literature search is inadequate to evaluate a complex herbal preparation. Consequently, evaluators often conclude that even the most renowned traditional formulations are irrational combinations of herbs.

This flies in the face of existing scientific research that shows multiple beneficial effects. So on the one hand we have an internal system of assessing and evaluating these products that says they're irrational, and on the other hand we have a scientific body of literature that says they have multiple beneficial medicinal influences.

Clearly, the findings of a one-time literature search do not do justice to the time-tested formulation of the world's most ancient system of natural medicine.

What is wrong with the third category, as is propounded? In considering the wide range of products involved, it is not practical to put all of these products in one homogeneous category for evaluation. There is no single effective evaluation process for determining the efficacy and safety of products as different as homeopathic tinctures, new single-ingredient protein derivatives, and extremely complex ancient herbal formulations.

Further, under the existing system and under the third category there is no protection whatsoever for herbal products. Naturally, our pharmaceutical cousins would love to have scientific testing for efficacy as the prime article of your interest because it's in their best interest. I saw a wonderful heading in the Star three days ago that said “Traditional Herbal Medicine the Basis of New Drug.”

In addition, a third category administered by the government according to the same types of evaluation protocols currently in practice and the limited expertise of existing HPB personnel would be subject to the same limitations as the current system. Given that neither the third category nor the current system works, what is an effective alternative for ayurvedic formulations? Fortunately, these traditional formulations have been extensively tested for over 6,000 years as being both safe and effective. This knowledge resides with the traditional practitioners rather than with the scientific community. Excellent pioneering research has also validated the efficacy of many of these traditional preparations.

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Because of these inadequacies of evaluating these remedies according to current protocols, we recommend that new methods of ensuring safety and efficacy be developed by traditional practitioners and research scientists expert in the area of natural ayurvedic products.

In fact, Maharishi Ayur-Veda already utilizes a council of leading ayurvedic experts for preparing, assessing, and utilizing ayurvedic botanical and mineral products. We recommend that an industry committee be formed from these experts and scientists to evaluate and set standards for ayurvedic products.

Maharishi Ayur-Veda Products manufacturers more than 12,000 different products, each according to its own authentic ayurvedic process. It possesses an extensive database for phytochemical footprinting, analysis, and processing, as well as for scientific and academic expertise. We would be pleased to assist in establishing such a standard for all ayurvedic products in Canada.

Maharishi Ayur-Veda Products stands prepared to help in this endeavour to better systematize the manufacturing, analysis, and appropriate use of ayurvedic products.

Thank you, Madam Chair.

The Chair: Thank you very much.

Mr. Elley.

Mr. Reed Elley: We have another interesting juxtaposition of witnesses. I'd like to address these comments and this question particularly to our representatives from Shoppers Drug Mart, the pharmacists and people you represent there.

It seems to me that in your presentation, in some ways, the pharmacy has been a johnny-come-lately to this whole natural health product thing. Of course you are now carrying a lot of natural health products in your pharmacies. I think it's safe to say that this is a fairly recent development.

You seem to be saying, in the kinds of things you're suggesting, that people within your industry suffer from a lack of knowledge in this area and that you really don't know what to say to the consumer when he comes and asks a question about something on your shelf. From that standpoint, there seems to be a safety issue here. I'd like you to comment more on that for us.

Mr. Martin Belitz: Let me try to answer that one for you. There are a couple of different things that you mentioned.

One is that we're kind of a johnny-come-lately on this. I think what we're looking at here is a cyclic type of thing. If you go back to the early 1920s, the only products that pharmacies carried were products of a natural base.

Then as modern drugs, chemical entities, became available, or there was a synthesis of natural drugs into chemical entities, we kind of forgot about the natural products. Now there is this renewed interest in natural products.

Part of the problem has to do with the way pharmacists have studied drugs and their effects on the body. For example, I have a bottle of Advil here in front of me. It says “Ibuprofen USP”, so I know that this meets certain standards as set out by agencies. All the techniques of testing, assay, and bioavailability are here. It also says on the bottle that it's effective medication for pain, and that it has a standard strength of 200 milligrams, so we know that's what it is.

Now I take a look at all the herbal products that are on the market today. What I have here is about eight different bottles of the same product called devil's claw. I see there's very little consistency in strength. This is 200 milligrams, but it has 5% natural ingredients. This is 400 milligrams, but with 3.5% natural ingredients. I could go on and on, and each one of these products is different.

Yet nowhere on here does it say anything about how the standard is being met for these products. I see “premium quality”. Whose premium is it? I'm not putting down the manufacturer, I'm just saying that I don't know where this thing has been tested or what standard has been applied. Also, there's nothing on here that tells me even its intended use. It's in classes of food, so you can't even make a claim. Why would you take this product?

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To get back to one of the examples we gave earlier, if a consumer comes looking in a pharmacy or in a health food store or a food store or anywhere and they see this, and they've heard or read in a lay publication or across the backyard fence that this is good for something, who is to say it really is good for something? Just because it has been used for thousands of years historically...no one has ever measured the effects of that drug over the past 6,000 years when taken in combination with new chemical entities. That just hasn't been done.

Slowly, in some of these publications, we are seeing monographs and some evidence that these older herbal remedies do have interactions with certain other products and certain other drugs. For example, ginseng now has been found to increase the heart rate. This is documented in many of these formulations.

Mr. Russell Guest: Ginger increases the heart rate.

Mr. Martin Belitz: Ginger increases the heart rate.

Gingko should not be taken with blood thinners; but 2000 years ago nobody knew what blood thinners were.

I'm saying there's a constant learning process here.

Mr. Russell Guest: Who is combining these new things with ancient, traditional things?

The Chair: Address your questions through the chair, please.

Ms. Wendy Brown: I wanted to add one more thing. You commented that we are recently in the industry. We've been in it constantly, certainly on the vitamin side. Where you've seen an expansion recently is with the burgeoning consumer interest in natural health products, specifically things such as herbals and homeopathy. We have certainly expanded those sections in order to serve the consumer better and obviously also we have got into more intensive training of our pharmacists.

I just want to point out that at this point, according to consumer studies that have been done, 65% of consumers are actually buying natural health products from drugstores. We just wanted to make sure we're handling them properly and—to Marty's point—that the product quality and standards we've come to recognize in other products can be present here and that the consumers, if they don't want to talk to us, can at least get off the bottle the information they need to make an informed and safe choice.

Mr. Reed Elley: What I hear you then starting to zero in on here is the problem of contradictions between taking something my doctor, my GP, says I should take for this disease, and then going to the health food store, or even into your pharmacy, and taking something that anecdotally I've been told will also help this. What we don't have the science available from the Health Protection Branch to tell us is if those two things are bad for me if I take them together. Is that what you're saying?

Ms. Wendy Brown: In some instances the information exists and in others it doesn't yet. I would say the drug interaction information out there is incomplete...to Marty's point.

The Chair: Ms. Bennett.

Ms. Carolyn Bennett: In a number of the presentations, recent ones, even in Mr. Ingles' presentation, there seems to be a call for moving over a 10-year period, that health claims be backed up with clinical evidence. I think some other people are feeling that way. I guess what the committee has been struggling with is safety versus efficacy—safety for sure, efficacy...will we ever be able to afford that? If something has been traditionally used for a couple of centuries, are we really, even in a 10-year period, going to be able to spend the money it would take to get the clinical evidence, or should we actually just relax about this?

The second piece is that I think drug interactions are a different thing. Just to comment on Mr. Guest's remark about who is taking both things, I think lots of people are taking both things, and I think one of the problems we have in family medicine is that we don't even ask the question in our history-taking procedure. We don't have an education program to help practitioners who even remotely think that might be relevant in a normal history-taking with somebody coming to the GP. Also, I think the pharmacists are having trouble: as they hand over the Coumadin, should they be asking, are you taking any other things? Maybe we do need research on drug interaction, but maybe we should do that first, before we start demanding clinical evidence on these things which have been used for centuries.

Is there some comment?

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Ms. Wendy Brown: One of the reasons we handed out the monographs from various places is to show that to some extent, information on toxicity contraindications and drug interactions has been researched in other countries and has actually been evaluated and gathered into these monographs that summarize a lot of it. The ESCOP monographs that Marty has here, I notice, have a particularly huge body of evidence behind them.

So I guess what we said earlier was that it isn't that there's no drug interaction information and so on available; it's just that it may as yet be incomplete, with more modern things coming out all the time.

The other comment I wanted to make is about the issue of clinical evidence and whether we will ever have it. I think it would be nice to believe that would be so, but since these products are in the public domain and the chances of them becoming prescription products are perhaps both less desirable and less likely, I think the chances that the money will be made available to do heavy-duty clinical research, with the costs that imposes, is also less likely. We are pretty much reliant upon things that have been done already, like doctors' studies such as the ones that have been done on vitamin E and heart health. Those kinds of studies can help to provide us with more data. And it will accumulate over time, but, I think, just not at the rate we perhaps need it to.

The Chair: Mr. Ingles, do you want to comment?

Mr. Allan Ingles: Yes, thank you, particularly in response to your question with regard to whether studies of a clinical nature would be done. I think if the rules were changed—such as the elimination of schedule A—there would be an incentive for manufacturers and marketers and their suppliers from overseas, or local American and Canadian manufacturers, to do the research in order to take the marketing advantage to the consumer.

This is a market-driven issue in the first place. The government doesn't have the funds to do all of this studying and never would be expected to. It didn't do all the studying for pharmaceuticals either. What it created was an environment in which pharmaceutical companies had a reason to do their research and to push that research through to the doctor, the pharmacist and the public, in one way or another. The same thing would be true for this arena. All we have to do is look at Europe right now, and key countries like Germany, Britain, France, Holland and Belgium, where a considerable amount of research on natural products is published daily.

Ms. Carolyn Bennett: The one other thing the committee's been struggling with is this importation thing that has two different sets of rules. Obviously people are buying a lot of things for personal use over the border and then ticking off a lot of other things, which is obviously bad for our Canadian companies. If you have to import a couple of things, then you might as well import the whole shopping list. Would you say the rules for importing for personal use should be the same as the rules that the committee comes to for Canadian companies?

Mr. Allan Ingles: I would say not at all until we have our own house in order. I think Canadians have the right not to be cheated out of the opportunity of bringing in things that they require—or believe they require—for themselves unless they violate a specific thing, like the Narcotic Control Act. But Canadians should have every right to have the best possible health care. They have every right to read the Internet to learn about these products and they have every right to read books in libraries—

Ms. Carolyn Bennett: I guess the issue the committee is struggling with is this: if it's safe to import, why isn't it safe to buy at your local health food store or your pharmacy?

Mr. Allan Ingles: I don't think the issue is where to buy it. The issue is how to police it so that when you buy it you're getting something of considerable value that you can have faith in.

Ms. Carolyn Bennett: Right. I guess we're hoping that this committee will enable that house to get itself in order.

Mr. Allan Ingles: That's what we're asking.

The Chair: Did you want to ask something else?

Ms. Carolyn Bennett: On drug interaction, did you have something to say over there?

Mr. Russell Guest: I'll defer to Dr. Wolfson.

Dr. Richard Wolfson (Representative, Maharishi Ayur-Veda Products of Canada): First, at the meeting a couple of days ago, one point was brought up that seems really relevant here, which was that perhaps we should be focusing more on education than on regulation.

What's happening now is that the pharmacists are complaining that information is not supplied on the label, and they're using that in order to prescribe this drug, which makes it seem a little like there should be more information in the public domain. It should be more readily available. We should be training practitioners in things such as ayurveda, which has thousands of years...though I can't train in a weekend seminar, or the limited expertise one gets in one's training in western medicine. The focus should be more on educating than on sitting around trying to decide on what little information is available and giving that to a pharmacist so that he's able to prescribe it. If all this information was readily available—

Ms. Carolyn Bennett:

[Editor's Note: Inaudible] ...is starting to do this population clearinghouse website project. Do you think that eventually information about all these sorts of products should be...? Do you think the Health Canada website should be able to take a consumer to your website and other places? Is there a role for Health Canada to help be the clearinghouse of this kind of information?

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A voice: Well, sure.

Mr. Russell Guest: The reason I reacted earlier to this is yes, I think there is a role for Health Canada, but in support of what you said, we have entirely underestimated how complex this whole thing is, from the point of view of what is being placed in the person's body.

I attempted to suggest earlier that you may be putting thousands or tens of thousands of phytochemicals in your body if you take one traditional ayurvedic product. What happens is my colleagues over here are saying, “My God! Help me. People are coming into the store. As a professional pharmacist, I am trying to make a recommendation, and they're saying there is some body of research that says watch out for this and watch out for that, but there is not an overall compendium that will help me prevent a person from walking out the door and collapsing from a reaction.”

The reason I reacted is that it's going to be very difficult to do this. There are tens of thousands of these things. Each one at a different time could be considered an active ingredient. This whole active ingredient paradigm is something that should come under the scrutiny of the scientists who are attempting to analyse. It does not, in the final analysis, work for complex interactions.

All I'm trying to say is that scientifically speaking, there are problems with our present paradigm of analysis. There are traditional ways of analysing terribly complex drugs and medicinal effects that have not been in the purview of western analysis. It's time to look at these things. In aid of our friends who are trying to do their job in pharmacies, it's time to take a look at more traditional systems as a methodology, and potentially utilizing their methodology, to prevent these kinds of accidents from taking place.

The Chair: Thank you very much.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Assuming that degree of complexity and difficulty in putting in place a regulatory system that ensures that every product has that scientific analysis and the information is conveyed to all players in the field, it begs the question and it sort of leads to the assumption that government won't be able to do it all, no matter how much we try to beef up a bureau in Health Protection Branch.

My question is, what would be the role for retailers in this whole scheme of things? You've talked about the range of products. One particular product, devil's claw, you mentioned. Is there a role for retailers? Is there a role for Shoppers Drug Mart in deciding what products to let into your store or not?

I want to raise one example. In my Shoppers Drug Mart on Main Street in Winnipeg there's a wide range of products, but I noticed recently—and I've mentioned this before—a whole range of these Homeocan products. It says right on the thing that this is a homeopathic remedy. According to the homeopaths we've talked to, this is not a homeopathic remedy.

My question to you would be, is there a role for the retailers to play in consulting with the professionals in areas such as homeopathy, ayurvedic medicine, naturopathy, or whatever, to actually use that body as the expert source by which you determine what products should be on your shelf or not? Or is it something you only see government restricting, as being the gatekeeper?

Mr. Martin Belitz: You've asked about four questions. I'm going to try to do this.

Let me preface it first by saying that the longest journey you take starts with one small step, and just because we're talking about drug interactions with phytochemicals and multiple ingredients doesn't mean we shouldn't start with the simplest step. For a product such as St. John's wort, which is used for depression in some cases, or it's alleged to be used for depression, will that one main ingredient we're looking at interfere with other anti-depressant drugs that someone may be taking? You start with that, and then gradually you work up to some of these products Mr. Guest has spoken about, which may never get to drug interactions in 1,000 years.

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I think we have to start somewhere. I guess what we're suggesting, what we're recommending, is that you establish this third category of drugs and start the process.

To answer your second question about education, health care practitioners absolutely do need education in this. Beginning with the physician, as Dr. Bennett has said, maybe we have to start screening patients by asking the appropriate questions. Pharmacists are now starting to ask what other drugs patients are taking. At one time, we only checked the prescription interactions. In our practice now, we are starting to ask about what non-prescription medications patients are taking, because there are known interactions. In addition to that, I guess we have to start asking what natural-source products they're taking, because we may be able to spot some. For example, psyllium seed should not be taken by women who are nursing, by lactating mothers, yet they may think psyllium seed is safe to take because it is a natural product. So there are things in which education is required.

About your question about homeopathy, the manufacturers of these homeopathic preparations claim they are homeopathic-knowledgeable people. Prior to putting these products in the stores on the shelves of pharmacies, they provide educational series. As a pharmacist who is going to invest in a line of products that I never studied in university, I want to know what's in there. Companies like Homeocan, like Hyland, offer continuing education programs to pharmacists so that they can then sell the product with some confidence.

The Chair: Can I just interrupt here for a minute? I just want to do a little bit more on Judy's question.

You mention that a number of bottles don't say what's in them. I see two sides to your situation here. Do you feel any responsibility about putting something out on the counter when you don't know what's in it?

Ms. Wendy Brown: We have to give our pharmacists a lot of information because the consumer at the moment can be given none. Take a product such as devil's claw, which is actually regulated as a food. According to food regulations, devil's claw is a food and is therefore completely safe. There couldn't possibly be any interaction.

The Chair: I understand that. I'm just wondering if you, as pharmacists, feel any responsibility at two levels, first to have to go out to inform yourselves by maybe taking a six-month course or something, and then also when selling a product when you don't know what it can do, what it can't do, what's in it.

Mr. Martin Belitz: There is a bit of a conflict, but what we are saying is that consumers are buying these off the shelves of non-drugstores right now, for example—and we're not casting aspersions on anybody. They're buying these things in a totally unregulated environment. As exemplified by Terry's little scenario, they may be getting information that this person has other conditions, is taking other prescription drugs, and is being given information by a salesperson in a retail establishment. Pharmacists are saying that consumers are demanding these products. They're legal products, I'll sell them in my pharmacy to satisfy the consumers' needs, but I have to do some educating on my own part to learn how they're being used. The only thing is that there's a block on education.

The Chair: I would think most ordinary people walking around would have greater faith in or a different regard for a pharmacist. When I go to a pharmacist, I like to think he's qualified in a certain way. I might put more faith in him than in, say, an herbalist, but maybe I shouldn't because your people aren't trained. Yet you're willing to sell it regardless of the gap there.

Ms. Wendy Brown: They are getting training now, not only from all of the companies that manufacture these products but by going back for courses as well. The problem is that for the last thirty years it hasn't been necessarily a requirement. In pharmacy school, it was termed “weeds and seeds” in the 1960s or whatever.

At this point, it is being put back into curricula at pharmacy schools, and a lot of pharmacists have gone back for training because they recognize that now that these things are becoming more mainstream, more people are coming in asking these questions. They had therefore better be prepared with the answers, whereas they weren't before.

The Chair:

[Editor's Note: Inaudible]

Mr. Russell Guest: I kind of feel for their situation.

One of the reasons we've never approached Shoppers Drug Mart about selling ayurvedic products is that we just don't feel it's appropriate. It takes a lifetime's study to become a proper vaidya. It involves understanding non-invasive techniques of analyses of imbalances. It involves dealing with the human physiology as its most subtle level. It involves a pharmacopoeia that's larger than everything combined in all the rest of the tradition.

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How is it possible that a three-credit course at the University of Guelph—presented according to this reductionist western viewpoint—will actually qualify a poor pharmacist to determine the particular ayurvedic formulation for that particular person with particular imbalances in his or her particular point of life in his or her particular medical history?

I keep raising this notion of complexity. I feel for your situation, but the bottom line is that when we talked about education we meant in the broadest sense. When we talked about changing the system, we meant in the broadest sense of addressing these things by introducing the new traditions in a parallel fashion to the existing western tradition.

All of us have been brought up in the west here. We really have this view of how things work, and things are not necessarily working that way all the time. I'm suggesting that education be much more broadly based. Perhaps Shoppers Drug Mart and companies like that should consider hiring, as you said, or consulting, as someone said, people who have expertise in these traditions instead of attempting to be all things to all people.

The Chair: Judy, do you have any more questions?

Ms. Judy Wasylycia-Leis: I have another set of questions, but I'm sure my time is up.

I want to eventually come back to the idea of the third category, because I'm still not convinced. It seems to me that whether we go to a third category or amend the Food and Drugs Act so natural products and homeopathic remedies are not under the drug category but in with foods, it would work the same. As long as you have the requirements around warning labels and clear parameters around claims and scientific surveillance in the Health Protection Branch, you could accomplish the same thing. So I throw that out.

Ms. Terry Creighton: We may be splitting hairs in terms of what we're trying to say. They're not being consumed as food; they're being taken for their medicinal qualities. I can't really speak for the products these gentlemen represent, because we don't carry those products, but we're talking about the mainstream vitamins, minerals, herbal remedies and nutritional supplements. They're not being consumed as foods and it seems crazy therefore to regulate them as foods.

Currently we have a situation where many of our Life Brand products that are defined as foods are currently being reviewed by the inspectors. We're being told some of the information we put on the label, such as “does not contain gluten,” which is useful for people who have celiac disease, can't be put on this product because it's considered a food.

We're recommending this third category, but in it there would be monographs defined for all of these products so the risk of those products would become inherent in the requirements of that monograph. Each product would be assessed individually and there would be some amount of risk assessed by that expert committee. It would therefore say, “warnings such as this must be included on this product”. Allergen warnings are optional but should be included on this product if you want your celiac patients, for example, to get that information.

We're really trying to say they need to be treated differently. They are not foods. If anything, they're pseudo drugs, but we don't think they require that kind of rigid regulatory process either.

The Chair: Okay. Mr. Hill.

Mr. Grant Hill: Mr. Ingles, we've heard quite a number of times there is no money for research for these products. You have stated that your company and your supplier in another jurisdiction have found the money, and I'd like you to round that circle up for me, if you could. How is it possible for you when others say it's not?

Mr. Allan Ingles: It's possible because we have made a commitment to it and understand the subject we're dealing with. If for the moment I can use one product as an example, we're well known for the largest-selling garlic supplement in Canada, the United States and Europe. It didn't exist seven years ago as a formal herbal supplement that had a major market share around the world. The whole product didn't exist 15 years ago.

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When the company, Lichtwer Pharma, was formed, it was formed with people who have a pharmaceutical background and an understanding that in the European marketplace, particularly Germany, garlic is considered a medicine when it's taken outside the food table, that it's taken for medicinal purposes, as our colleagues at Shoppers Drug Mart have suggested, and that certain qualities of garlic would be more effective than others because the product comes from the soil, and what it contains is determined by what's in the soil.

For about several hundred years, it has been understood and is in the traditional literature that garlic has some cardiovascular benefit, that it thins the blood, that it may reduce some of the fats in the blood, and that those could possibly be aids in reducing the risk factors associated with heart disease.

In Germany particularly, and in England and many other European countries, and also now in a Canadian series of studies and a United States series of studies, certain garlic products have been shown—these are standardized garlic powder tablets—to consistently reduce cholesterol, consistently thin the blood, consistently produce certain other benefits, a whole myriad, the most important of which was recently published in Circulation, which is the most premier, prestigious circulatory periodical in medicine, by the American Heart Association, which rejects 95% of the material that is submitted to it. So the material has to have extraordinary peer acceptability. That's on the basis of garlic possessing the potential to reduce the loss of elasticity in the aorta that takes place with the healthy population as they age.

The studies that have been conducted over two to five years, involving both patients on a placebo and on verum, have demonstrated that those who took this quality of garlic preparation can expect 15 to 20 more years of heart-healthy life. That's the same kind of data that was published for a very major drug called Provacol, with studies in Scotland that received worldwide attention, because it helped reduce the incidence of death with regard to heart attacks.

If you add the epidemiological studies that have been done with the human clinical studies that have been recently done, you determine that the same conclusion that applies to Provacol applies to certain garlic. But it does not apply to all garlic—it never will—because not all garlic is the same, and this is the reason this company takes the position that if you're going to make claims, you should be talking about something that's proven to have efficacy.

If you're offering garlic as a well-being ingredient for everybody to take, you don't need those claims. You just know that in the literature, and on television, and in the magazines, and in discussion with your doctor, your pharmacist or your local health food store, you've heard how good garlic can be for you.

You can take any garlic you want. Some garlics will still be better for you than others. If the garlic you're taking is not standardized on something, it will contain so much of the active component this trip and none of it next trip that you might as well chew on a leaf.

The Chair: Mr. Hill, did you want anybody else to answer that question?

Mr. Allan Ingles: Have I answered your question?

Dr. Grant Hill: Well, what I was really getting at was that your company really hasn't done the research that said garlic was beneficial.

Mr. Allan Ingles: I have contributed to that research, sir, yes.

Dr. Grant Hill: Okay, you may have contributed. Your research has been to your product and your claim that it's the best garlic that mankind has ever seen.

Mr. Allan Ingles: No, the research I'm referring to—

Dr. Grant Hill: I'm putting words in your mouth.

Mr. Allan Ingles: You are.

Dr. Grant Hill: But you want your garlic to be the garlic that everyone looks to.

Mr. Allan Ingles: No, you are putting words in my mouth.

The research is with a standardized garlic powder formulation, and that standardized formulation has call letters, just like any other pharmaceutical material has. In this case, it was LI 111 or something like that.

LI 111 is a certain standardized extract of garlic. It meets certain very strict criteria from batch to batch. That substance has been tested in somewhere close to 200 studies now, at universities right across the world, at hospitals across the world, with doctors and hospitals in the city of Toronto, hospitals in Montreal, hospitals and universities in Guelph, Tulane University, and various other universities and hospitals in the United States.

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The bulk of all those studies have been reviewed by peers. Those peers have produced meta-analyses of those studies, and the conclusion of those studies is that a benefit is to be expected from using that extract. Whether that benefit is also received from other extracts has never been challenged. What I will tell you is that studies have been done for commercial purposes, comparing that extract with certain other products in the marketplace, and they have concluded that this extract works and the other products do not, particularly with garlic oil capsules.

Mr. Grant Hill: The summation, then, is that if you have a product that works and it can be proven to work, there is research money and should be research money.

Mr. Allan Ingles: In a marketing sense, the ability to tell the world that your product works and is backed by clinical studies gives you a much better share of the market than just putting the name “garlic” on the label.

Mr. Grant Hill: Should that be regulated by government or should it be regulated by the market, by public intelligence and ability to discern?

Mr. Allan Ingles: The regulation of the claim, the review of the claim, whether the claim has merit?

Mr. Grant Hill: Research, the claim.

Mr. Allan Ingles: Yes, the government has that responsibility with pharmaceuticals and should have the responsibility for anything that can make a claim. It is appropriate, however, to add that the expertise at Health and Welfare Canada today does not have that ability. But that does not mean it couldn't have that ability with a small amount of adjustment.

Mr. Martin Belitz: Mr. Hill, just to clarify this, I believe what Mr. Ingles is saying is that if the garlic were of a standard that was in the U.S. NF, then for something to be labelled as garlic USP it would have to have so much of this active ingredient it would be the only product that could be labelled as garlic with a claim.

Mr. Allan Ingles: Not quite, in my experience.

Mr. Martin Belitz: That's what I understood is a peer.... That's what we're suggesting.

Ms. Carolyn Bennett: A lot of us believe food should be properly labelled and people should know whether it has gluten or sucrose or lactose or peanut oil. Clearly we have some work to do on food in this country.

If we tidied up the food part, could the natural health products be dealt with over there, or is it still a special enough category, because of claims, that you would still vote for a separate natural health product? What I'm hearing from the ayurvedic people is that it's almost as if the natural health product would have subsets of people with certain expertise under them, whether that's on their products or the homeopathic expertise, and there would be a group under the natural health products, but you would still prefer it wasn't food.

Mr. Kim Piller: I would like to comment for our company, but also as being on the steering committee for the coalition. It's still on the standpoint of supporting the third category, along with what Shoppers just said. We deem that the products still are not a food, and not a drug.

As I alluded to in my presentation, I believe even though this industry started back in the earlier 1900s and there's a lot of interest in it now, we're only at the beginning, the cusp, of what this is. I think we have the opportunity now to look at the products as what they are, but more as what they will be to the Canadian population in the future.

Again, very simply, they are not a food and they are not a drug, and I think they should be regulated separately.

Mr. Russell Guest: I liked your summation of maybe having sub-categories here. One of the reasons we reject the notion of a third category—the homogeneous notion of a third category—is exactly what our pharmaceutical colleagues gave expression to, that this existing scientific method, the existing paradigm of active ingredient, is the only way to ensure consistency of potency and quality of ingredients. It is not the only way. And I congratulate the pharmaceutical firms for discovering the 5,000-year-old knowledge of ayurveda, which explains exactly when to pick, how to process, and how to achieve consistent standards of quality and potency in a natural product. However, our problem is that they get patent protection out of this and we do not.

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Ms. Carolyn Bennett: The burden of proof, say, in bringing a new drug into the market.... What we're hearing is that drug interactions quite often are sorted out. Clearly these natural products are virtually 100% safe if you're not taking something else with them. So if you're going to bring a drug to market, we do tell people to take it with milk, or not with milk. We do tell them to not take spinach or do not do whatever.

Do you think the pharmaceutical companies should have more responsibility in exploring...? If they're putting an anti-depressant on the market, this person may already be on St. John's wort. Should they actually also have to investigate any potential contraindication on things people may well be taking at the same time?

The Chair: Do you want to answer that, Ms. Brown? You've had your hand up for something else. I don't know if you answered that one.

Ms. Wendy Brown: It's long gone by at this point, but yes, honestly I do think that to some extent if there is a new drug put out we can certainly play catch-up on various things like that. They do it now to some extent certainly with OTC medications and with other prescription medications. If anything new comes up, the problem is of course going back and doing the backtracking, which exists to some extent, as I've said, in those monographs—

Ms. Carolyn Bennett: Maybe the generics will want to do something for it with their profits.

Ms. Wendy Brown: I would like to go back and pick up on one more statement that was made when we talked about whether food regulations should be slightly modified. We went through a situation recently with our Life Brand products where the Food Inspection Agency came and told us we were doing all kinds of things wrong. This came as rather a shock to me because I thought I'd read the rules. I was living by the rules. I thought I had it all right, and it turned out that, for the best of reasons, we weren't doing things right.

We had said on a food-regulated product “no sugar, no gluten”. They came back to us and said we now had to have a little label on there, just like that on a loaf of bread, that said how many calories and how many carbohydrates, because it says that in the rules. It's not that the consumer needs to know most of this information, because most of them will read zero, but it says that in the rules. They said that certain binders we use in some of our tablets could not be used because they're not allowed according to the list that's in the food regulations.

That's all fine and dandy, but the food regulations were meant to regulate food. They never thought about food being in a pill format. Therefore, they've never really taken it into account, and yet, while it's not safe to use it in food regulations, believe it or not, if you look at the drug regulations it's a permissible product for ingestion. So we went through a whole bunch of these, and I honestly have to say that in my opinion the food regulations don't do the consumer a bit of good.

Right now we have a situation where in the brochure we developed for these products we tried to warn people that just because products are natural does not mean they are safe. We said that herbs are medicine and should be taken and treated like any other medicine, that is with caution, and left it at that. We were told to take that out because half my line have DINs and half don't.

I don't understand the food regulations as they stand right now. So my suggestion would be that they'd need a lot of changes.

The Chair: I think Mr. Ingles had his hand up and then we'll stop after that. Can you just be one minute or so?

Mr. Allan Ingles: I just want to remind this committee that one of the most popular natural products out there is tobacco. It's a drug. Thank you.

The Chair: Thank you very much, and thank you to all of you for appearing.

The meeting is adjourned to the call of the chair.