HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, February 25, 1998

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[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): Can you hear me, Dr. Woolf? Okay. We'll go ahead.

Probably on the Wednesday we come back we may have some time in there when we can have a meeting. We can ask the researchers to bring their material and what we've studied up until now, and just talk together about the direction we're going in. I did mention that Mr. Rock said we could extend it to what we thought was necessary, but we don't want to go longer than necessary, either.

This is the 22nd meeting of the Standing Committee on Health, and we are studying natural health products.

Today we have four witnesses: Dr. Robert Buckman, from Toronto; Dr. Robert Woolf, from Medicine Hat, Alberta; Dr. Warren Bell from Salmon Arm, B.C.; and Dr. Elizabeth Kaegi from Toronto.

Welcome. If you can keep your comments at around five minutes, then you can go from there.

The Clerk of the Committee: I told them seven or eight minutes.

The Chair: Seven or eight? Well, if I say five, maybe they'll go ten.

Each of the members will get five minutes for questioning. As far as your answers, we're not really rigid, but if you go on too long with one answer, the members won't get the chance to ask their next question. We'll guide you along if we feel you're taking too long.

We'll just go in the order on the agenda. Dr. Buckman, would you like to start?

Dr. Robert Buckman (Individual Presentation): Sure, thank you very much.

Just quickly by way of introduction, I'm a conventionally trained medical oncologist of conventional practice, an associate professor. I have done lab research. I also have an interest in communication and talking about sort of sociological issues, and my last television series was devoted to the sociological phenomena of complementary medicine and why people are so attracted to it. I contributed that stance, as it were, to the committee on alternative medicines of the College of Physicians and Surgeons of Ontario. Our report was published last September, and it went down fairly well.

I just wanted to very briefly suggest to the committee that there are three issues that are very often mixed together, and it may appear as if they have to be dealt with simultaneously, but I don't believe that is the case. Those three issues are:

1. Efficacy—do any of the complementary remedies actually work?

2. Benefit—do they make people feel better?

3. Regulation and reimbursement—as it were, the mechanics of regulating production and paying for or reimbursing the costs of these medications.

The first point I want to make, and I'll be very brief, is that there are four complementary remedies that have been tested rigorously in double-blind studies and have been found to be beneficial. Those are: a traditional Chinese remedy for childhood eczema; the chiropractic manipulation for low back pain; St. John's wort, a plant that has an antidepressant in it; and acupuncture for pain control—not for addiction control or anything else. Those four have been rigorously tested, and their efficacy would be sort of beyond any reasonable doubt.

Apart from those four, there are either no data, or the ones that have been tested have not been proven to have any efficacy. However, approximately 100% of patients who take complementary remedies feel better, and this is a very, very powerful part. It might be 92%, but it's probably very close to 100% who feel better. An enormous number of people who have, for example, a progressive disease take a complementary remedy, whether it's Essiac, 7-14X, or something like that, and feel better. A large number of my patients are doing that.

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The third issue is if that is the case, what should a government or a country do about the regulation and reimbursement for those medications? I think the first point is that there are regulations covering a very large number of the materials that people are able to buy in the drugstore and swallow.

I go in and buy multi-vitamin capsules, vitamin C, aspirin, or whatever. There are fairly good standards to make sure that the people who made the vitamin C capsules haven't included cyanide in them. Those regulations are well established, and there's no particular reason to amplify them or alter them, as regards any other form of health supplement.

The second issue is reimbursement. A very useful model I think comes from England. In England there happens to be within the national health service various family practice and other units that are called budget holders or fund holders. The fund holders can basically dispose of the income they get from the government in any way they like.

A few of them, in particular the Marylebone Health Clinic in north London, have actually employed a group of complementary medicine people, a TCM person—traditional Chinese medicine—aromatherapy, and so on. When they feel they've done as well as they can with this patient and can't do any better, they suggest trying the aromatherapist down the corridor in the same building. So the patient tries the aromatherapist.

That clinic has been doing a research study, which was independently funded, and they've shown that their own pharmacy costs have gone down by 30%. Their referrals to the district general hospital for consulting opinions have gone down around 30% to 60%—it varies.

This is actually cost-cutting. Nobody is asking the government to pay for the aromatherapy; the practice employs the aromatherapist and the patients use less non-steroid medication, anti-inflammatories, and so on. It's a useful model.

My own feeling is that it is a valuable model. Take somebody with a hangover who feels absolutely rotten and has a lousy headache. That person goes to the pharmacy, buys some aspirin, takes the aspirin, and the headache gets better. Should the government pay for the aspirin? Merely benefiting symptoms doesn't imply that the government has to reimburse for any benefit.

That's my basic stance on the issue.

The Chair: Okay. Are you finished?

Dr. Robert Buckman: Yes, I'm done. Should I go home now?

The Chair: That was so short, and I'm so dumbfounded I'm going to ask that we take a five-minute break to enable the technician to go over the system so we don't have any problems.

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The Chair: I call the meeting to order again.

Our next speaker is Dr. Woolf, all the way from Medicine Hat. Please go ahead.

Dr. Robert Woolf (Individual Presentation): Thank you.

I am a conventionally trained physician, a medical doctor, a former emergency physician actually who now practises nutritionally oriented medicine.

After many years of practising emergency medicine—ER on television is the kind of thing I did for many years—and having taught it, I learned to appreciate what our high-tech machinery and high-tech drugs can do. I also learned to appreciate what they do not do, and that brings me to the case for natural medicines.

First of all, safety: If you search the worldwide literature for the past 25 years, you will see there are very few medical incidents with natural medicines, while U.S. health authorities estimate that each year in North America about 200,000 people die because of drug interactions and perhaps as many as ten million more are injured because of them.

According to a recent Ontario government study, 20% of hospital admissions in the elderly are due to drug interactions. Every year 2,000 to 3,000 people in Canada die of toxicity from aspirin and like medications alone.

Natural medicines are widely used throughout Great Britain, Japan, Australia, New Zealand—that is, other G-7 countries—and the Orient. Half of all European physicians routinely use natural medicines as their first-line approach, and most learn basic herbal medicine as part of their training. Widespread research, which is well done in these countries, documents the effectiveness of many of the approaches.

By contrast, North America medicine is crisis management with high tech and drugs. The Office of Technology Assessment, which is attached to the U.S. Congress, estimates that North American biotechnical medicine actually serves only about 20% of the people's needs and that 70% of our practices have in fact never been properly clinically evaluated.

Things seem to be changing, however. Currently 25% or so of the U.S. medical schools, including Johns Hopkins and Harvard, offer alternative medicine material to their undergraduate medical students. The colleges of physicians and surgeons in Alberta, Saskatchewan, and Nova Scotia now recognize the value of alternative therapies and have created registries for interested physicians. As well, Vancouver General Hospital is developing a whole wing devoted to alternative medicine.

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The World Health Organization in recent years has been championing the use of natural medicines because they are safe, cost-effective, and work.

Here is a quote from the World Congress of Natural Medicine, an organization to which I belong:

We should be able to combine the best of modern western biotechnical medicine with the best of traditional ways such as Chinese medicine, acupuncture and herbal medicine in order to provide the patient with the maximum number of choices in order to deal with the problem at hand in the least invasive manner.

It makes sense, does it not?

That brings me to our Health Protection Branch of the Government of Canada, which has systematically persecuted natural medicine. They create restricted lists in secret. Nobody really knows what's on them until inspectors turn up in stores to harass you or confiscate items. Their policy is one of harassment. For example, melatonin is no longer for sale over the counter in Canada but may be ordered by mail from the United States. Now, is it safe or isn't it? Make up your mind.

These restrictions, incidentally, were imposed after the release of information that melatonin did wonders with attention-deficit children and their very disturbed sleep cycles. Thus melatonin was a threat to Ritalin, which is given out like Chiclets in many communities.

Last spring the Health Protection Branch announced an alert on Ma huang, which is a Chinese herb, stating that it had killed 18 people in recent times in the United States. This is a blatant lie. No such documentation exists. It is the drug pseudoephedrine that has caused problems of toxicity and not the herb Ma huang.

HPB was challenged at the time and stated that the information they had came from the U.S. Food and Drug Administration. However, a follow-up with the U.S. Food and Drug Administration indicated they had no such information.

Meanwhile, Health Protection Branch is notorious for its hurry-up approval for process for drugs that have serious, if not dangerous, side effects. Many of the cardiac drugs come to mind.

In addition, the drug Cylert, which is used in ADD kids, has caused numerous deaths because of liver toxicity and necessitated liver transplants on several children. Yet all the manufacturer, which is Abbott Pharmaceuticals, needs to do is put a warning on the label. Well, herbs are routinely confiscated for minor infractions. Clearly the bias is evident.

Interestingly, during the Krever inquiry into tainted blood, when HPB was asked why better inspection had not been done, they excused themselves by saying they did not have the funding or adequate personnel. Yet it seems they do have funding and adequate personnel to go into health food stores across the country, two by two with RCMP officers, to harass the proprietor and confiscate harmless herbs.

I think the philosophy of HPB is best summed up by quotes of two of its senior officers. Dr. George Patterson has been quoted as saying that the HPB and the pharmaceutical industry have a shared purpose and that the drug companies should not be in a situation where their competitiveness is compromised. Dr. Donald Landry of HPB was quoted in the Toronto Globe and Mail on May 28, 1997, as stating that the HPB considers the pharmaceutical industry its primary client.

Now, that seems odd to me, because as a regulatory agency of the Government of Canada I would have thought their primary client would be the Canadian people.

With regard to regulation, we have adequate laws on the books currently with good manufacturing practices, truth in labelling, and so forth. I'm not at all convinced that further regulation of these products is required. Their safety record is absolutely unmatched. Our pharmaceuticals are absolutely appalling in terms of safety by comparison.

However, if this committee deems that some sort of regulatory situation is further required, perhaps a third category of traditional natural medicines may be a sensible place to begin, provided that, in my view, the HPB is not involved. The third category must be governed, in my view, by another body, which is autonomous and out of the reach of HPB personnel, who in this whole matter have shown no integrity.

Second, it should not be controlled by medical doctors. Unlike in Europe, in North America medical doctors have no training in natural medicine, and most physicians or at least a large number of them are more likely to criticize patients and ridicule them rather than help them in this regard.

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In addition, if physicians are the gateway to this third category, it almost certainly would result in some sort of prescription status, which is just an elitist status and is not acceptable. These medicines are natural medicines that must be available readily to everyone.

Third, I think legislation is seriously required to put the onus on the Health Protection Branch to demonstrate harm before they are able to take action and ban a product from the shelves.

Last, I've provided you with a chart, which you'll see in front of you. My apologies to the francophone members of the committee. I was not able to have this translated. Believe me, no offence was intended; it was simply a matter of logistics.

The chart is a series of statistics, recent data, for one year from the National Capital Poison Centre, Department of Emergency Medicine, George Washington University. On the left side you'll see several commonly used herbs; on the right side, several commonly used medicine categories. The death toll from the herbs, zero; the death toll from the medicines, numerous. This is one poison control centre. When you take the total of North America, let me reiterate, 200,000 people dead and perhaps as many as 10 million injured—that's U.S. Health Authority's figures, incidentally—and most of these incidents occur when the people are actually taking the medications according to directions.

In addition, of the herbs you see on the left-hand side of the chart, we know that several are on HPB's hit list: Ma huang, garlic, cayenne pepper, hawthorn, ginkgo, St. John's wort—all for no other crime than that they may threaten a pharmaceutical. That's it.

That, I think, is a fairly impressive view of the difference between the two categories of medicinals and concludes my opening remarks.

Thank you.

The Chair: Thank you, Dr. Woolf.

Dr. Bell.

Dr. R. Warren Bell (Individual Presentation): To carry on from what Dr. Woolf has said, perhaps I could propose an image that I think would summarize some of what he said and something about what I'm going to say.

I was thinking about a quiet afternoon in the Gatineau Hills in spring. Imagine this scene invaded by thousands of all-terrain vehicles and motocross bicyles zooming around, chewing up the ground, spewing out exhaust fumes, and making an incredible racket. A single, solitary hiker walks through the woods. Because he had a cup of tea before he started and his bladder is full, he goes behind a tree and relieves himself. He is arrested for pollution and disturbing the peace.

That's the kind of analogy I'd like to suggest to you characterizes the situation with regard to conventional medical remedies and to natural medicines.

I'm a general practitioner. I live in a small town of 15,000. I'm entirely involved with clinical work. I work out of my office with patients. Over the years it's become clear to me that there exists a vast amount of information verifying and supporting the use of a variety of natural medicines, some recently developed and some ancient, equal or at least approximately equivalent to that which exists for many conventional medical remedies we use with great freedom.

However, there is a divide between conventional and unconventional or alternative remedies. I believe it is more a matter of economics and politics, or, to be precise, probably primarily centred around patent law, than a matter of efficacy or safety. A patent is a monopoly. It is the antithesis of a free market approach. It permits a radical dissociation between production and development costs and profit taking. And that's precisely what has driven the conventional drug industry and made it the stunning and breath-taking financial success it is today. It has also led to a culture focused on synthetic medications.

The drug industry frequently comments on the purpose of patents, which is to stimulate creativity. It really doesn't necessarily stimulate creativity, so much as profit taking.

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The net result is that all non-patentable remedies become by definition alternative if the dominant culture in the healing professions is focused around synthetic medications.

Ayurvedic medicine, Chinese traditional medicine, vitamins, herbs, homeopathic medications, various kinds of manipulative therapies—none of them are susceptible to patenting when you think about it. That is why they end up being classified in another category.

I'm going to give you three examples of the problems I've run into in clinical medicine while dealing with alternative so-called remedies, primarily because of the Health Protection Branch's total acceptance, as Dr. Woolf has pointed out, of the industry's point of view.

First is public access. He mentioned melatonin. Melatonin is a natural substance. It's produced in our bodies. It's in direct competition with Valium, with Serax, with Ativan, and with some of the antidepressants such as Imovane, which is another kind of sedative. It's in direct competition with them.

Well, the HPB initially allowed it to be marketed. Then they took it off the market except for personal use, which meant you could order it from the United States. Then they wouldn't even allow you to order it from across the border. You would be arrested in the old zero-tolerance style. Recently they've backed off from that. About six months ago, in a climate of intense consumer concern and frustration, they backed off to allow it to be imported across the border for personal use.

This rigmarole, this merry-go-round of change, has been done behind closed doors without justification. I, as a practitioner, knowing that melatonin is efficacious, have all sorts of trouble knowing when and how to recommend it to people. One minute it's available, the next minute it's not.

Second is the emergency drug release. It's a technique, a methodology, used by the Health Protection Branch originally to allow a patient to obtain a small amount of a drug prior to its release in Canada. It has become a perversion of its original purpose. It is primarily used now to limit access for patients to natural remedies. They have to go through their doctor. The doctor has to send a form from wherever in the country to Ottawa. The form has to be filled out and sent back to a pharmacy or another dispensing entity. I know what my colleagues are like: if you have to complete three or four pieces of paper to get one little bit of medicine, it has to be really good or they're not going to do it. In effect, you can't walk into a store and get the substance. You have to go through this rigmarole. It limits access.

A perfect example of that is salmon oil, the oil of the salmon. I live in Salmon Arm. We don't see people dying in the streets from consumption of salmon oil. Salmon oil has been used for some time for cardiovascular problems and other related issues. Originally, it was freely available. Then it was classified under the EDR, the emergency drug release program, and now it's released again to the general public. Well, I didn't know that for 10 years. I found out just three days ago that I don't have to fill in an EDR form, and no one in the HPB ever told me this. I'd been faithfully sending EDRs to the government here and found when I went to Costco, of all places, that they have great walls full of salmon oil available. No one, when they received my EDRs and sent me back my bill forms, even mentioned it to me. I mean, it's very peculiar.

Spurious toxicity is another issue that has led to the inability of people to obtain natural medicines, and Dr. Woolf referred to this a bit. A perfect example of this is L-tryptophan. L-tryptophan is an amino acid. It comes from protein. We have it in our bodies. It is an essential amino acid. It's also a precursor of a brain transmitter that makes you feel good, and it had been used for approximately 20 years as an antidepressant and sedative. Very good head-to-head studies with common antidepressants showed it worked just as well.

Well, a contaminant was introduced approximately 12 years ago by a new manufacturing process, which, by the way—I don't know if this is part of what the committee will be addressing—was a bioengineering process. And I can assure you that the Health Protection Branch has very little capacity to analyse and understand genetically engineered medicines, which are the new wave of medicines and have incredible potential for adverse effects and danger.

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At any rate, L-tryptophan had a contaminant in it that caused a serious illness. It was clear after four or five years that's what was happening. They took it off the market and it has not been back since, except for one drug company's product.

I have six suggestions.

First, the Health Protection Branch in its deliberations must become completely transparent. No decisions should be made without full public disclosure.

Second, there should be citizen oversight of the Health Protection Branch. Every medical college in the country has accepted the principle of citizen oversight. Why can't the Health Protection Branch accept it too?

Three, there should be specific, evidence-based, relative risk assessment for all new substances. I use the analogy of the Gatineau woods. We should be careful that we don't over-regulate and over-restrict access to natural remedies, because they are by and large, in relative risk terms, very safe. Not everything is safe in the natural world, but relatively speaking, they are safe.

We should acknowledge the involvement and intimacy between the Health Protection Branch and the drug industry. I would say it is time for a public inquiry into the labyrinthine affairs of the Health Protection Branch and its intimate involvement with the drug industry, as Dr. Woolf has clarified.

We should also adopt a proactive approach to research in natural remedies. There's no money to be made in natural remedies, because you can't patent them. There are no windfall profits. The government could do so through a research entity distinctive from the Medical Research Council, which will not touch products that are on the market.

Lastly, we need trust. The Health Protection Branch, the regulatory agency, need to trust the Canadian people to make sensible decisions about what they consume if they have adequate information to guide their decision-making. If they do that, then I think the average citizen will start to trust the regulatory agency to simply restrict where there is an issue of major safety and potential danger. At the present time that trust does not exist on either side, and it's time it was generated.

Thank you.

The Chair: Thank you very much.

Dr. Kaegi.

Dr. Elizabeth Kaegi: Good afternoon, ladies and gentlemen.

In compliance with the instructions I received to restrict myself to comments that would not go over two pages or last more than five minutes, I'm going to try to deal with two topics. The first is my own background and experience with unconventional therapies and the second is my own recommendations with respect to government involvement in the regulation of herbal remedies. I'll be pleased to address any other issues, including the role of government perhaps in registering or licensing unconventional therapy-providers, in the question period as appropriate.

As noted earlier, my name is Dr. Elizabeth Kaegi. I was trained in medicine in New Zealand, graduating in 1969 from the University of Otago in New Zealand. Following early post-grad training, I immigrated to Canada in 1971 to continue my clinical training at McMaster University, and then pressed on to my master of science degree in design, measurement, and evaluation in the Faculty of Medicine at McMaster University, graduating with that degree in 1976.

During my subsequent career I have applied my training to the development of health policies in a variety of settings: university; government, both in Alberta and Ontario; the private sector; and most recently the charitable sector as director of medical affairs and cancer control for the Canadian Cancer Society and the National Cancer Institute of Canada.

I am now retired, although I continue to be very active in the cancer field as a volunteer. In this capacity I have a number of current projects related to the use of unconventional therapies. I'm preparing a series of articles on unconventional therapies, at the request of the editor of the Canadian Medical Association Journal. I am preparing a guide to assist patients in accessing and evaluating unconventional therapies. This guide will accompany the above articles. And I'm serving on the steering committee of the National Forum on Ovarian Cancer, specifically for a session on making treatment choices, in which unconventional therapy choices will be included in the discussion. In that connection I'm preparing for forum participants a background paper on issues connected with unconventional therapies.

I want you to know I have no commercial or other conflicts of interest with respect to any conventional or unconventional therapy.

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My experience with unconventional therapies has occurred largely in the context of my work with the Canadian Cancer Society, National Cancer Institute of Canada, and Canadian Breast Cancer Research Initiative. Approximately 20% of all patient inquiries to my office were related to the use of unconventional therapies. We established a database to allow us to respond to these inquiries more effectively.

It was evident that while many patients had a great interest in exploring the role of unconventional therapies for cancer as it might play in their own situation or that of their children, they found it extremely difficult to find the information they needed either about products or about providers of these therapies. Even with the resources of a speciality cancer organization, we found it difficult to meet the information needs of our callers.

We found they had two questions: Is it safe or is it likely to be safe for me? Is there any chance that it might work for me? Those were the two issues that people were trying to address.

I would like to say in this connection that we noted during this period a growing willingness on the part of physicians and other health care providers to consider unconventional therapies. They also reported frustration with the absence of readily available, reliable information about these therapies and their resultant inability to provide useful guidance to patients.

The urgent need for reliable information on both the safety and the effectiveness of a wide variety of unconventional therapies available in Canada was highlighted in the recommendations that flowed from the 1993 National Breast Cancer Forum, which had patients, providers, researchers, and public policy people all present.

Following the forum, the Canadian Breast Cancer Research Initiative, funded in part by the federal government, embarked on an ambitious research agenda, which included a commitment to address concerns related to the use of unconventional therapies in Canada.

As part of this program, literature reviews for selected agents were completed. This is actually one of the six booklets we produced. This one is on escador, or mistletoe product.

We reviewed the international literature. It was mostly English literature, but we also looked at English abstracts from foreign literature, including the European data, which as other people have pointed out, tends to have more information about unconventional therapies than North American literature.

We also held a research methods workshop in Vancouver in October 1996 to try to discuss the issues around research methodology for unconventional therapies. That's because it's clear that other research methods are required from that which we typically use for conventional remedies.

Last, there has been a special research competition held to award grants for research in this area, focusing on research that is both innovative and collaborative. There is in excess of one million dollars being set aside by the Canadian Breast Cancer Research Initiative to support research into unconventional therapies. I think that's something we Canadians should be very proud of.

The results of this research will be helpful but they won't be available to assist patients and providers for some years. In the meantime, the public must struggle to make their own treatment choices with respect to unconventional therapies.

I believe that the government has an important role to play in this area. I believe that a responsible government can and must find the balance between protecting the freedom of individuals to make their own health care choices and protecting the public from harms that they're not able to detect even if they are prudent and diligent. Individuals need to be encouraged to take responsibility for their own health choices, but they cannot be expected to do so if the dangers are unknown or unknowable and the information on which to base those choices is unavailable.

The available evidence suggests that many, if not most, unconventional therapies are not harmful, particularly when taken and used as directed. However, they may be harmful to individuals who are particularly susceptible by virtue of age—I'm thinking here of children and the elderly—and individuals who have pre-existing medical conditions, including allergies; chronic diseases, such as diabetes, liver disease, and heart disease; pregnancy; and lactational breastfeeding.

Finally, they may be harmful to those using conventional therapies concurrently. This is true in the case of some cancer therapies where we know unconventional therapies can interact adversely. In addition, in the absence of manufacturing controls, the potency of unconventional therapies may vary considerably. There's also a risk of contamination with other agents that may cause harm. I think these are some issues that other members have referred to.

I believe that patients who are considering the use of unconventional therapies or natural remedies deserve the assurance that the use of any therapy that is available in Canada will likely not harm them if used as directed. They also deserve the assurance that appropriate manufacturing and standardization procedures have been followed in its preparation and production so that it's free of contaminants and that different batches of the agent will have similar and predictable effects. That is, I think the public deserves to have the question of “is it safe?” addressed for them.

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I consider that the public's need for both the freedom of choice and protection from unpredictable harms would best be met by the establishment of a third category of agents that would be regulated by the government. I won't speak to which arm of government it would be or how it should be organized—other members have done that—but I believe that this third category should rest between the current classifications of food and drugs.

Agents in this new category I believe should carry a unique identification number that would be distinct from a DIN after a satisfactory assessment indicating the availability of core information on the product, compliance with acceptable production, storage, and distribution practices, and a reasonable assurance of safety.

The demonstration of reasonable safety for a product is not trivial, but it is a great deal less arduous and much less costly than the demonstration of clinical effectiveness, which is required of drugs. Other countries, including several European jurisdictions, have regulatory frameworks that allow for safety to be established using historical data that confirm extensive public use without adverse effects, acceptable laboratory data, or clinical studies.

I consider that product labels should detail at least the ingredients, recommended dosage, contraindications, possible side effects, a manufacturer or supplier address, and at least one source of additional information. Accompanying information, such as package inserts, should repeat the above information, and this may also indicate the types of conditions for which the agent is thought to be of value.

It should be made very clear that the scientific evidence of its effectiveness is not available at this time, and that the product should therefore be taken cautiously, under the supervision of a registered and trained health care provider, and for a limited time period.

In the absence of available and accurate information to guide consumer choices in this area, I believe regulations such as these, which provide a reasonable assurance of safety while leading individuals to assess effectiveness in light of their own needs and preferences would provide the appropriate balance between the freedom to choose and the protection from unknown and unknowable harms.

Thank you.

The Chair: Thank you very much. I thank all of you.

Mr. Hill.

Mr. Grant Hill (Macleod, Ref.): I thank each one of you.

I'm particularly interested in the two colleagues who are practising outside the standard realm of medicine. I'd like to know from you what you did to establish credentials in this area of natural health products beyond your medical training. Both Dr. Woolf and Dr. Bell, could you comment?

Dr. Robert Woolf: Thank you. The College of Physicians and Surgeons in Alberta developed about a year and a half ago a registry for complementary-care physicians. These are the folks who are interested in offering complementary care along with regular medicine. They've had a registry for acupuncture and such for several years, and this was a parallel registry to that.

Over the period of the last three or four years, I've increasingly become interested in this. First, the need was there. These products are efficacious; they work well for many people, but not all. Penicillin doesn't work well for everybody either, but we'd hardly throw it away. So there is a need for this.

Consequently, I ended up doing a fair amount of studying with herbal medicine through one of the natural colleges by correspondence, obviously, because I'm engaged in actual medical practice. I did a number of examinations and so forth, and presented those credentials to the College of Physicians and Surgeons, which was satisfied with them.

Mr. Grant Hill: Excellent.

Dr. Warren Bell: I think I followed the same method for learning that I followed in all postgraduate learning: once I finished my medical degree, I then took courses and read and consulted the literature.

But I would also add that in this area, I think I learned and gained a great deal of insight from patients. It's a wonderful source of information. People come in who are intensely motivated to restore their own health who have tried something that has worked for them and tell you about it. Sometimes they bring me a paper from The New England Journal of Medicine. They ask whether I read this, and tell me to get off the pot.

That source of information gave me a lot of guidance, but I did resort to conventional texts in nutrition in various other kinds of healing arts. So it was similar to what I've done for conventional practices, but it had to be a little more self-directed, because until recently, there have been no courses or schools that you could attend that would teach you the spectrum of alternative medicine.

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Mr. Grant Hill: Have any of you been looked at askance by your traditional colleagues who think you've lost your marbles and gone off into some crazy field?

Dr. Robert Woolf: Yes. Although, again, it's an issue of doctors doing what doctors are taught. In North America, the simple fact of the matter is that we are taught that regardless of how trivial the patient's complaint, our first approach is to attack them with a drug. That's basically the way medicine is taught in North America. Therefore, there's an ignorance of what's available as alternatives. As I said earlier, most European physicians learn the basics of herbal and natural medicine in their training.

I've had some feelings—it's nothing I can't handle—like that, although there are several physicians who are actually sending me patients now for consultation in this regard. So it seems to be gradually increasing.

Actually, the statistics show that. I don't know whether you're aware of this or not, but the statistical data show that probably half of Canadian people are now using alternative approaches regularly. Personally, I think those numbers are shy. I think it's much higher than that. Colleagues of mine think that, too.

Part of that same study shows that about 40% of younger doctors feel that these natural approaches should be readily available. So you can see the shift is coming, but it's a process.

Dr. Warren Bell: With respect to my experience in a small town—I live in a town of 15,000 people—the dynamics in a small community work a little differently. People know you as a person as much as they know you as a professional, and relationships are more important. Human interactions are more important.

I know some of my colleagues have raised eyebrows and made a few comments over the years. At the same time, they quietly refer people to me semi-anonymously when they come in with complex allergy, digestive, or psychological—that's how they would interpret it—problems that need to be unravelled.

Actually, compared to obstetrics, it's a pretty quiet area. That's where you get the real action.

Mr. Grant Hill: Should traditional medical practitioners be trained in this area in their university training?

Dr. Robert Woolf: In my view, yes.

Dr. Robert Buckman: I don't think it's to be included at the moment in every physician's training. Also, there would be an enormous amount of argument about what it would be.

I think the people who are interested in, for example, learning acupuncture analgesia can do so. That's fairly easy.

To include naturopathy, for example, alongside endocrinology is somehow to imply that there is a body of scientific evidence supporting naturopathy, let's say, that matches that of endocrinology. I think that's a very big step.

For me, getting better versus feeling better—we encourage both—is something that should be taught. I would like to put person-doctoring skills, as it were, into medical school curricula, as they are being incorporated. If that includes some alternative medicines as well, I have no problem.

Dr. Elizabeth Kaegi: I think there should be some component of conventional medical training that includes unconventional therapy. The reality is, as several people have noted, that 50% of patients or thereabouts—some people say it's higher certainly with cancer patients—are going to use these therapies, and we can expect that trend to grow.

I think conventional physicians need to know something about the range of unconventional therapies that are out there, the philosophy regarding disease, and how you deal with diseases that are different with respect to unconventional therapies and conventional therapies if they're going to be able to help guide their patients and maintain open communication with their patients with respect to the use of unconventional therapies.

So I would say that at least an introductory overview should be incorporated into medical training for everybody, with opportunities to pursue different aspects of unconventional therapy on an elective basis for undergraduates and on a more extensive basis for postgraduates.

Dr. Warren Bell: I think we also need to teach physicians how to be open-minded as a technique. I'm not being facetious here. It's how you approach an unknown area and adapt to a lot of new information.

The Chair: Thank you. If Madam Picard has no questions, I'll go to Joe Volpe.

• 1630

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): I have a series of questions. I found the presentations all very interesting, so thanks to all four of you. By the way, I'm not saying that to set you up.

I think at least of couple of you have raised one issue in very strong language. I'm wondering whether you see a coordinated effort, or an attempt by some of the various regulatory bodies, the colleges of physicians and surgeons, naturopathy, homeopathy to—how shall I put it delicately?—maybe weed out some of the unscrupulous types, or the unethical entrepreneurial-type practitioners who take advantage of probably the elderly mostly.

I can't remember who mentioned the statistics on the elderly, but certainly the sick, and especially those who are looking for an urgent cure.... What we do is sell you this stuff more or less under the table, probably following the line of Dr. Buckman that it will make you feel better. You won't be better, but you'll feel better.

Dr. Robert Buckman: If I may respond briefly to that, Mr. Volpe, I agree with the sentiment, but quite genuinely I don't think you can do anything about it.

As I mention in my draft, a million of our grandmothers had copper bracelets that they put on for their arthritis. I mean, my grandmother had it, and everyone's grandmother had it. She'd put on a couple of bracelets, and she felt fabulous, and she probably took fewer non-steroidal anti-inflammatories. If she forgot it by the bedside table, she'd send me upstairs to run up and bring down a couple of bracelets, and she'd exclaim, oh, that's better.

Somebody was making a large amount of money manufacturing and selling copper bracelets. And I think that in some respects one can get hypnotized by the idea that you should be regulating it merely because it's not right.

It may or may not be right, but I don't think it's regulable. I think the ability for somebody to wander into a pharmacy, buy a copper bracelet, and put it on because it may help their arthritis is just one of those things.

You know, they have the right to buy a Shirley MacLaine book about reincarnation. I don't happen to believe that reincarnation is a very good thing, but I wouldn't necessarily want to ban the book. The fact that she might have made millions out of those books wouldn't necessarily motivate me to say that this should be prevented by legislation.

Mr. Joseph Volpe: But can I take advantage then for a moment? In the second round I'll probably pursue some questions with some of the others, but can I take advantage of the fact that you come here as an oncologist, and that your book, Magic or Medicine...? One of my colleagues cited you as pretty expert in your field. Are you familiar with the Di Bella protocol?

Dr. Robert Buckman: The Di Bella...?

Mr. Joseph Volpe: Protocol.

Dr. Robert Buckman: No, absolutely not. If I'm expert in anything, it's definitely not that.

Mr. Joseph Volpe: Okay, I'll shoot another one. I see that Dr. Kaegi is. Are you as well, Dr. Bell?

Dr. Warren Bell: No, I'm not.

Dr. Elizabeth Kaegi: I know a little about the Di Bella protocol, because I've actually been on the Internet to pull up all his articles in response to a question by an Italian patient in Windsor who wanted to try it.

What do you want to know? I'll help you if I can. I have also worked with HPB around it.

Mr. Joseph Volpe: I wanted to get a doctor's view, one who is sufficiently skeptical to be challenged by the literature from the three of you, when he says....

I don't want to do you an injustice, Dr. Buckman, but when we're talking about efficacy.... I think you had only four areas, but I thought I heard the others say there are a heck of a lot more. Perhaps they have a different definition of efficacy.

As you know, Dr. Kaegi, there is a substantial number of people who claim that his protocol doesn't necessarily work wonders, but it's certainly efficacious, and the base of most of that protocol is herbal or natural.

Dr. Elizabeth Kaegi: Dr. Di Bella uses a mixture that includes somatostatin, which is actually in clinical trials here in Canada.

Mr. Joseph Volpe: But only in its—

Dr. Elizabeth Kaegi: It has melatonin in it, it has ACTH, and it has couple of other substances that I've not been able to fully identify. It is quite a complex formula.

He has never claimed in the literature that it is effective. He has tried it on a number of patients, mostly on lung and other solid tumours, and he maintains it seems to have some effect.

There is now a special expert committee being established in Italy to examine his records and to work with him trying to do it collaboratively to look at the real evidence.

At this point there has been no real evidence presented either by Di Bella or by anybody else. You're right, though, a number of individuals have reported that they feel much better on the Di Bella therapy.

• 1635

Mr. Joseph Volpe: I'd like to pursue the idea of feeling better and being better, because this is the first time somebody has actually introduced the distinction. So perhaps, going back to Dr. Buckman, we can use the same kind of language when we pursue some of this discussion about the effectiveness.

Should we continue to use the term “feeling better”? I can tell you, I feel better when I drink hot water than when I drink coffee. But is it good for me to drink hot water, or is it good for me to drink coffee in the morning?

Dr. Warren Bell: I think the distinction you're trying to elicit is a false distinction in bio-psychological terms. I'm sorry to say this, because there's a ton of evidence. The whole field of psycho-neuro-immunology has put a lie to the notion that there is sort of a mind and body separation. If your head feels good, it does so independent of your body; and if your body feels good, it can do so independent of your head.

I think there is actually a lot of research showing that if you do feel better, if you are in a better state of mind when a certain remedy is offered to you, or when you do something for yourself, you actually have biochemical changes that improve your bodily health.

Mr. Joseph Volpe: So you don't buy Dr. Buckman's approach then.

Dr. Warren Bell: I beg your pardon?

Mr. Joseph Volpe: You don't buy Dr. Buckman's—

Dr. Warren Bell: Well, I—

Dr. Robert Woolf: Just expanding on it, just because we don't know why you feel better doesn't mean there isn't a reason that is not yet identified. We don't know everything. We just don't know everything.

Dr. Warren Bell: Further, I comment specifically with regard to Dr. Buckman's remark about copper bracelets. I think it was intended as a humorous remark.

As an example of the kind of folderol that sometimes is presented, there are people who have actually worked at transdermal absorption of copper from a locally applied piece of metallic copper. There are also people who have looked at copper aspirinate, which is a salt of aspirin—ASA, acetylsalicylic acid—and copper, and there is quite good evidence from the medical literature that it's far more effective as an analgesic and anti-inflammatory than ASA itself.

However, no one can patent copper aspirinate, and of course you can make copper bracelets in your own backyard. So there's very little incentive to pursue that kind of initial research and see if there is in fact a solid benefit to be obtained in the case of osteoarthritis or other forms of arthritis.

What I'm trying to suggest is that we have a mythology about treatment that is based on some of our cultural and patent experiences. It has led us to believe that certain kinds of things are bound to be crazy and silly and other things are very sensible, logical, and scientific. I don't see that distinction appearing as clearly when I have looked on both sides of the fence.

The Chair: Dr. Woolf.

Mr. Robert Woolf: I would agree with Dr. Bell. I don't see the distinction as clearly either. It's more a mark of the closed-minded attitude of the North American culture than it is anything else.

Physicians in North America have a lot of ignorance, and I'm speaking of my own profession. They have a lot of ignorance, while at the same time they manage to steep it in absolute arrogance. We are notorious throughout the rest of the world for this attitude, and it's not a good one. It's not a good one at all. Unfortunately, it does damage where we have closed minds towards people who have needs and have the right to make choices with regard to their own health care.

Now, I want to address what you said just a few minutes ago, Mr. Volpe, about some protection for these poor elderly citizens or others who are taken advantage of. In fact, that has shown not to be the case. Most of the people who seek alternative or complementary care are not poor innocent people who are duped by someone's unscrupulous manufacture at all. By and large, they are females. They have higher than average education and higher than average incomes. I speak to these people every day.

I know that the parents talk to me about immunization for their children. Is it the right thing to do, or is it going to harm the kid? These people are well read. They have searched the literature. They have searched the Internet. They are concerned, conscientious parents.

So they are not stupid people who are about to be duped, not at all.

Mr. Joseph Volpe: I appreciate your response and the response of others. I'm being a bit arrogant in taking so much time. I hope you'll be patient and come back to me when my turn comes again.

• 1640

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Joseph is doing this just because he knows I have to leave to get back to the budget debate, and he's eating into my time here.

Mr. Joseph Volpe: Go ahead, Judy.

Ms. Judy Wasylycia-Leis: Before I run, I just have a question for Dr. Bell and Dr. Woolf. The issue of the influence of the drug industry over the Health Protection Branch is certainly a theme that has been raised periodically throughout our deliberations. The observation is that as long as this is the case, proactive response on natural remedies and alternative medicine is fairly difficult. It may be difficult for you to answer this, but I'm searching for help in terms of how we can actually pursue this further as a committee or in Parliament.

How deep-rooted and pervasive is the problem? Do you have any examples, evidence of how much control the drug industry has over regulators in the Health Protection Branch? Is it a question of drugs getting speedy approval, is there collusion, are there even bribes going on? What would you advise in terms of how we pursue the idea of a public inquiry?

Dr. Robert Woolf: Dr. Bell mentioned earlier that he feels the need for a public inquiry into the activities at HPB. I would heartily second that idea.

Mr. Joseph Volpe: Heartily?

Dr. Robert Woolf: Heartily.

What I have come to understand about HPB's activities in the last three or four years since I've increasingly become involved in this.... If you hear frustration and anger in my voice, you're reading it correctly.

The Health Protection Branch's mandate to protect public safety largely arose out of the thalidomide disaster of some 35 years ago. Since that time HPB officials have taken that agenda and twisted it about so that in practical fact what they do today is rig the marketplace in favour of the pharmaceutical and chemical industry.

I mentioned earlier the lies about Ma huang, an absolute blatant lie that was put out last spring by HPB. There are other examples. Dr. Bell mentioned tryptophan. Some 10 or 12 years ago it was banned from the marketplace because of a contaminant by a Japanese manufacturer. The contaminant was isolated and removed, but all the tryptophan was banned. That's akin to two or three of you people going and having supper at a local restaurant and getting sick and the health authorities close down all the restaurants in the national capital region because two or three of you got sick in one.

Interestingly, the time was crucial, because Prozac was coming on the marketplace at around the same time, acting similarly to tryptophan. The opportunity was there to ban the competition to Prozac. There are people who think that in fact the contaminant was seeded; it wasn't part of the manufacturing process at all.

The Health Protection Branch acts in active collusion with the pharmaceutical industry and the chemical industry. In my view, they are guilty of lying to the Canadian public. They are guilty of fraud, guilty of collusion, guilty of influence peddling, and guilty of corruption. Most of all, they are guilty of betrayal of the trust of the Canadian people, because they actively, knowingly, and deliberately conspire with the pharmaceutical and chemical industry for the purpose of obstructing the Canadian people's access to safe, effective, cost-effective remedies.

Now, as I said earlier, about 50%—I think much more than that, and growing exponentially, incidentally—of the Canadian public are now using alternative cares. I talk to these people every day. I'm in touch with practitioners all over the place across the country who also talk to people.

The Canadian public is well aware of the corruption in the Health Protection Branch. In my view and the view of many others, it is the most glaringly corrupt department in the federal government. The Canadian public is well aware of this, and they are no longer willing to accept this kind of obstruction in dealing with the choices they want to make for their own health care.

Furthermore, it is my observation that the Canadian public is becoming increasingly mean-spirited in this whole approach. It is my observation, frankly, that in the near future any politician who is deemed to be supporting of the HPB is going to pay a terrible political price for that judgment.

• 1645

Mr. Joseph Volpe: Let me put on my hat as a parliamentary secretary to know who has to do that.

The Chair: Dr. Woolf.

Dr. Robert Woolf: I'll just finish and let you go on.

There is enough evidence of wrongdoing with the HPB to disband the entire branch right now. Let me put it bluntly: if the task of cleaning up HPB were left up to me, they would be lucky to have a receptionist left to answer the phone by the time I finished. Furthermore, a number of personalities in HPB would be running for their lives to escape prosecution and probable jail terms for their activities.

The Chair: Dr. Bell.

Dr. Warren Bell: Perhaps in somewhat milder language, I would still like to reflect what Dr. Woolf is saying in a general sense. I believe that the Health Protection Branch is part of a culture that has grown up in our society that sees better living through chemistry, which was in fact a slogan, as we all know, back in the 1950s. It was carried to the point where now it's become the opposite: it's become ill health and general environmental and unsustainability problems through chemistry.

My suggestion of public inquiry into the Health Protection Branch and its association with the industry is to bring this to public awareness. I believe that were public awareness to be cast upon, as I have called them, the byzantine and labyrinthine dealings of the Health Protection Branch a whole bunch of things would happen quite quickly and fairly automatically. A lot of things would change. People would say “My God, did you do it that way? That's ridiculous. Nobody asked you? You just went and did it on your own?”

I've heard of files being taken away from one research team and given to another because they were dragging their feet and talking about side effects.

The short-acting nifedipine is the classic example. It shouldn't have come on the market. When it came on the market it should have had big black letters all over it saying this may kill you if you have cardiovascular problems. It had to happen that people were killed. It still is out on the market, with only little tiny black letters on page three of the pamphlet that goes with it.

It's bizarre. If anyone's concerned about health and safety, and the Health Protection Branch is supposed to be doing that, then they shouldn't have allowed that to happen. They not only allowed it to happen, they also expedited it.

The Chair: Dr. Kaegi.

Dr. Elizabeth Kaegi: I have perhaps a slightly different perspective on HPB that I'd like to share with the committee.

In years gone by I've been very frustrated by HPB. When we were doing our review of the six agents, of which I mentioned iscador, I went to the HPB to ask them what information they had about herbs. We did Essiac and 7-14X, which as you know are unconventional therapies made in Canada. I was appalled by how little information they either had or were prepared to make available to me. I found that quite frustrating with a regulatory body.

However, once I managed to connect with them recently through e-mail rather than the phone I have found them very cooperative. Let me use as an example the Di Bella situation that Mr. Volpe referred to earlier.

We have a terminal patient in the Windsor Cancer Centre who wanted to try the Di Bella formula. HPB were very helpful in trying to help us find out where the components where. They indicated to us that even a lot included melatonin, which as you know is a bit suspect by HPB to say the least. They agreed that if we could find a source they would allow it to be used in that case. So they were cooperative in terms of trying to help us help a patient who wanted to use it.

I'm not saying there were no barriers. There were still a lot of barriers. But they were exhibiting a more helpful approach than I have certainly experienced in the past. I just wanted to share that with you.

Dr. Warren Bell: When was that?

Dr. Elizabeth Kaegi: Last week. That was very recent. In the last six months I have actually had a much more positive interaction with HPB than I had prior.

The Chair: In our hearings tomorrow we'll find out why that six-month period has been a little bit different.

It's time I asked a question that I have on my mind. As chairman I'm going to take the prerogative to do it. When they came in to talk to us the pharmacists suggested that they should be the only ones who should be given permission to sell natural products. Would you like to comment on that?

• 1650

Dr. Warren Bell: Yes. It reminds me of doctors wanting to control midwives. My blessed profession saw itself as a source of all wisdom on the subject of how babies should be delivered. Fortunately, midwives in a number of provinces and across the country have attained autonomy. It's nothing against physicians. As physicians we do very well with our emergency, synthetic drug, surgery, critical care medicine. If I had a broken leg or I was shot by an assailant, I would rush off to an emergency room and get taken care of.

As Dr. Buckman has indicated, physicians are not only not trained but there's also not even a general feeling that physicians should be trained in alternative medicine. The control should be an autonomous body.

The Chair: You understand I was talking about pharmacists.

Dr. Warren Bell: It shouldn't be pharmacists.

Dr. Robert Woolf: I agree. When you establish gateways to access here, what you're doing is applying restrictions to the availability of these things to people. The safety record is absolutely unmatched by comparison with the pharmaceuticals. With natural medicines we have the largest clinical trials ever undertaken by way of hundreds of millions of people and hundreds of billions of doses over time. Where are the bodies? Where is the carnage caused by these things? It doesn't exist.

By the same token, though, in contrast to the pharmaceuticals, by the time they come to the market, there are a few hundred or perhaps a few thousand people who have been dosed with this thing in clinical trials. Usually the clinical trials are incomplete enough that when it hits the marketplace there is usually a post-marketing trial time period of up to about two years when the real carnage begins to unfold. Pharmaceuticals are often withdrawn because of that difficulty.

The Chair: Did you answer no to my question?

Dr. Robert Woolf: Yes, the answer is no to the question. I think they should be freely available to people, because the safety record is there.

The Chair: Dr. Kaegi.

Dr. Elizabeth Kaegi: I don't think pharmacists should be the only people who make them available either. As long as there is some evidence that they are safe they should be available through multiple sources. One of the reasons pharmacists are so keen on them is that they're making such a lot of money from them.

Pharma Plus in their annual report just recently indicated that the natural products section of their stores is associated with the highest profit margin and the highest growth of any other section in their pharmacies.

The Chair: Dr. Bell, I'll let you give just a brief answer. We have to go on.

Dr. Warren Bell: And that's why the Codex Alimentarius process has been initiated. It's a way for large, primarily German companies to take over the market by setting such stringent standards that only the largest and most well-endowed companies can meet them.

The Chair: Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Thank you, Madam Chair.

I want to start with Dr. Kaegi. In your presentation you indicated that there should be a reasonable assurance of product safety. I wonder if you could explain that a little and give an example of that.

Dr. Elizabeth Kaegi: When safety of a conventional therapy is established it's usually done with a small number of healthy volunteers to get the first pass at whether it seems to have any side effects. When you're making a substance generally available you have to also be reasonably assured that you know it's likely to be safe for people who are perhaps taking other drugs, who have other problems. It needs a bigger sample than just a few healthy people to try to identify a clear dose. Some of that information should be able to be drawn from historical data of extensive use, where such data are available.

For example, I do not think the marketers of green tea should have to pay large sums of money for animal studies, cell cultures and human studies of safety. We know the substance has been in very widespread use for a long time and there has been a systematic approach to gathering adverse-effect data. This has not been done in North America, but it has been done in China, for example, where green tea is very widely used.

Where a manufacturer can demonstrate that an agent has been in widespread use without any adverse effects, that's the sort of evidence that HPB or its equivalent should be able to accept.

I'm not looking for an absolute assurance of safety under all circumstances. I'm looking for a reasonable assurance of safety when an agent is taken as directed. The manufacturers themselves have said that they would like to indicate to people what the contraindications are. So it doesn't matter how much you go through a safety test. If you have renal failure, for example, you need to use any agent under extreme care and under control. Information about general safety plus contraindications is what I was looking for.

Mr. Lynn Myers: Thank you very much.

• 1655

Not to reopen the wound here, I'm genuinely disturbed by what Dr. Woolf and Dr. Bell are saying with respect to the Health Protection Branch. I wonder if you genuinely had evidence that could support your claims and your allegations—if you had specifics or first-hand knowledge, or whether this is simply a trading of stories and rumour and innuendo between people in your area. I don't know, I'm really at a loss in terms of what you're saying here.

Dr. Warren Bell: I had made some presumptions about inconsistency and unbalanced handling of the sort of conventional synthetic drug world versus alternative drugs for a long time, but it wasn't until Dr. Michèle Brill-Edwards came forward—and I've spoken to her personally on a couple of occasions—and actually described what she actually saw happening, specifically about short-acting nifedipine, which is a huge scandal.... It was a drug that should never have been allowed on the market without very stringent restrictions, and it came out. She was in Florida when the first deaths appeared in the newspaper. She had said before it was released to market that this drug was probably going to cause death. You get a rebound hypertension when the drug wears off that causes vasoconstriction—shrinking of arteries and blood vessels—that will challenge the circulatory system of the patient radically. She said she didn't think it should be out on the market in that state, but it did come out, and deaths occurred. It's still not restricted in the way it should be restricted. That's a specific and concrete example that I know of from the horse's mouth.

But I certainly have my suspicions. I can tell you, in terms of regulation of natural remedies, that it is completely arbitrary and capricious. It's on again, off again. This week it's this, next week it's that. I don't ever know why they're doing what they're doing, except they never do that kind of thing with patent drugs.

Dr. Robert Woolf: I agree. I mentioned the example of Cylert, which is used by ADD kids, put out by Abbott Pharmaceuticals, and it's killed a number of kids. This is documented in the United States. Several liver transplants were necessary because of liver poison. All the manufacturer has to do is put a warning on the label now that it's a dangerous drug.

A couple of other examples: the one I gave you on Ma huang—that was absolutely a blatant lie. If you check with MEDLINE, which is probably the most sophisticated medical database in the world, with over five million entries, a computer database that's updated weekly, I believe, and jointly supervised by Harvard Medical School and several of the hospitals in the area, you will find no references there whatsoever to toxicities of Ma huang. You will from pseudoephedrine and other semi-synthetics. But even when the FDA in the United States was contacted about having given the information to Health Canada, they knew nothing about it. This was blatant fraud in the details that were put out with Ma huang.

The progesterone-based creams were disallowed from the market last spring, after a well-known physician who uses this product for middle-aged women and menopausal symptoms and osteoporotic symptoms and so forth happened to be speaking in Nova Scotia. The trail is right there. There was a phone call from the pharmaceutical retailers in Nova Scotia to the Health Protection Branch. Boom—it's off the market. They've been on our shelves for 20 years. All of a sudden they're gone. There is clear evidence of collusion in that instance at least. I mean, it's there. It's there.

As a physician trying to help people make choices about their health care, it's extremely frustrating to me and others to find this kind of arbitrary obstruction. The products are safe or they're not. Melatonin you can mail-order from the States, but you can't buy it on the shelf. It's ridiculous, absolutely ridiculous.

With regard to the products that Dr. Kaegi was mentioning with respect to indications, the Germans have probably the most extensive material on herbal medicines in the world documented. German Health Ministry Commission E has a document of monographs that now includes almost 400 herbs. They have taken historical evidence—again, billions of doses over time without problems—and felt that if there was historical evidence of reasonable safety, along with the expectation that used in the proper manner with the proper dosages there was reasonable expectation of some efficacy, that was enough to warrant usage. They have created the monographs with such indications, contraindications and so forth.

• 1700

Well, lo and behold, aren't we fortunate: that has now been translated and is about to be published, actually, by the American Botanical Society. Commission E monographs would offer a wonderful starting point for cheap, sensible, and logical regulation to be put in place very quickly, which could then be adapted to the particular marketplace in Canada, as opposed to middle Europe, for example. They are well documented and highly respected throughout the world. It's a document that could be very useful.

The Chair: I have three more people. Mr. Hill, do you want to ask a question too?

Mr. Grant Hill: No, I just want to make one comment, rather than a question. That is, when we hear comments like this, I sense that somehow some members of the committee take them as personal, as though they own the HPB. Surely if there are problems with the HPB, all members would want to fix the dang thing, and not be defensive. The HPB will be here tomorrow, and some of these comments and questions should be directed to them. That was a statement rather than a question.

The Chair: Okay. I think we'll all agree.

Mrs. Ur.

Mrs. Rose-Marie Ur (Lambton—Kent—Middlesex, Lib.): Thank you, Madam Chair.

Dr. Woolf, you are a doctor of what sort of practice? I think the other people introduced themselves as GPs or whatever.

Dr. Robert Woolf: Yes. I actually did in the introduction as well. I am a medical doctor. I was formerly an emergency physician. Now I'm a general practitioning physician.

Mrs. Rose-Marie Ur: Okay, good.

You've provided us with stats as to the annual deaths due to natural products versus other traditional medicine. Do you have any negative stats? I'm a user of herbal products, so I'm not against natural products, but is everything positive on the natural side? You have never had any stats where it's been negative?

Dr. Robert Woolf: You're almost correct. Things are almost totally positive. Certainly people can have a reaction—I mean, people can eat strawberries and have an allergic reaction. You can eat something and have an upset stomach. Those things do occur. But in terms of actual pharmacological side effects, they are really rare with the natural remedies. As I said, if you search the worldwide literature for the past 25 years, you'll find very, very few medical mishaps when the natural remedies are used according to recommended purpose and recommended dosages.

Mrs. Rose-Marie Ur: How often would a mishap occur, then? They're okay if you use the dosages properly.

Dr. Robert Woolf: They're even okay if you don't. That's the point. The toxicity is so small with them. Let me give you some numbers that will sort of—

Mrs. Rose-Marie Ur: I don't want a lot of numbers, as I've got a lot of questions, so could you just be as concise as possible?

Dr. Robert Woolf: Okay—very quickly. Most of the herbs have toxicities ranging upwards of 1.5 or higher grams per kilogram of human body weight. Common coffee is a lethal dosage in 50% of the population of 600 milligrams—in other words, about a third of what the most toxic herbs are.

Mrs. Rose-Marie Ur: Your percentage of practice, conventional versus unconventional—what is your ratio?

Dr. Robert Woolf: It's shifting. I would say that now, between 80% and 90% of the new patients who come to see me, who have not specifically been sent for that purpose by a physician but come because they hear or they've talked to somebody—80% to 90% of the new patients I see are looking for alternative care.

Mrs. Rose-Marie Ur: Okay.

Dr. Bell, you're still practising?

Dr. Warren Bell: I am. I hope to get better one day.

Some hon. members: Oh, oh.

Mrs. Rose-Marie Ur: Good. You probably never will, because doctors always practice.

Dr. Warren Bell: Yes, I'm a general practitioner.

Mrs. Rose-Marie Ur: Yes, I understand that.

Dr. Warren Bell: You want percentages?

Mrs. Rose-Marie Ur: Yes, of your practice.

Dr. Warren Bell: Good Lord. It's about 50-50, maybe 50-70, 70-50.

A voice: 50-70?

Dr. Warren Bell: Numbers that don't add up—that's my specialty.

Mrs. Rose-Marie Ur: Dr. Buckman?

Dr. Robert Buckman: I'm a part-time medical oncologist. I treat all of my patients with conventional medicine, and probably 60% to 80% of them are also taking Essiac and unconventional remedies.

Mrs. Rose-Marie Ur: Some of you aren't from Ontario, I can see, but for those who are, does this go beyond your cap, when you practise unconventional therapies?

Dr. Robert Woolf: I'm not clear on the question.

Mrs. Rose-Marie Ur: You have a cap in Ontario. So is this beyond the cap, when you use this kind of therapy?

Dr. Warren Bell: No, no; it's within the cap.

Mrs. Rose-Marie Ur: So when you prescribe a natural product or natural therapy for one of your patients, do you also sell the product?

Dr. Robert Woolf: No, we can't do that.

Mrs. Rose-Marie Ur: I didn't think you could, but I wanted to make sure that was on the record.

• 1705

Dr. Warren Bell: I have on occasion made, at wholesale cost, my cost, something available to a patient quietly, because some of them are expensive. But I do that without trying to interfere with the market locally.

Mrs. Rose-Marie Ur: I don't want to be rushing you, but I have a lot of questions.

Dr. Kaegi, I was reading as you were speaking to us. I believe you said that patients who are considering the use of unconventional therapies or natural remedies deserve assurances that the use of any therapy that is available in Canada—in the written text it says “will not harm them if used as directed”, but when you read the text you said “will likely not harm them if used as directed”. Is there a reason you used “likely” in your statement and not in the written text?

Dr. Elizabeth Kaegi: I was trying to reflect a reasonable assurance that it won't harm them—not an absolute certainly, because you can never give that. I was just trying to reflect that. I was also trying to stick to the two pages I was told to, so I whipped through the thing trying to get rid of words—

Mrs. Rose-Marie Ur: This was actually an addition.

Do you have any stats as to the success rates for therapies you are using for cancer patients?

Dr. Elizabeth Kaegi: We did the review of six commonly used therapies in cancer. For each of them we found some biological evidence that they could work, but we did not find very convincing evidence that they do work. Lots of people take them complementarily with conventional therapy and feel that it helps them. Again, it's this issue of feeling good, feeling like they are taking some control and having some influence on their health care, which I think is helpful.

Mrs. Rose-Marie Ur: Having been a health care professional in my previous life, I find that statement most interesting—it's okay if they take it as long as they feel better. In my era of going through the medical business, that was not the attitude we had.

Dr. Elizabeth Kaegi: There is much more concern now about quality of life rather than just quantity of life, and that's in conventional as well as unconventional. The issue for me in the advice that I give is that if I can be reasonably sure it won't harm them in financial terms, delay terms and biological terms, then I will try to support patients in their use.

Mrs. Rose-Marie Ur: I'll go to Dr. Woolf for a minute.

In one of your statements you said that perhaps a third category should be set up, but that it should not be involved through HPB, or that medical people shouldn't be involved. I find that rather a scary statement. Perhaps not all the members do, but I think there should be some medical input in there, even if it's a professional person such as yourself who practises conventional doctoring versus the natural therapies to accent your practice. Are you suggesting that we have a lawyer, a minister, or whatever else?

Dr. Robert Woolf: Not at all. Perhaps you misunderstood. I practise both conventional medicine and alternative medicine. I use whatever is available to help the patient at the time, from the choice that I have. That may involve some herbal medicines and Chinese medicines, or some regular medicine or antibiotics—whatever works.

I think the danger is in getting into over-regulation of products that—through the largest clinical trials we know of, hundreds of millions of people and hundreds of billions of dosages—have shown themselves to be impeccable in terms of safety record. Where is the need for regulation? Where are the bodies and carnage caused? They don't exist. I think we have adequate laws on the books currently—with good manufacturing practices and truth in labelling and so forth—that may be suitable.

If further regulation of natural medicines is deemed prudent, and that would be up to this committee and others, I suppose—it's really a political issue more than having to do with patient efficacy—then the creation of a third category seems to be sensible, where there is a third category detailing traditional, natural medicines. The regulation of that category should not involve control by a gatekeeper physician, a gatekeeper pharmacist, and so forth, because now you're making an elitist system and limiting access, and I don't think that's reasonable, given the safety record.

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Secondly, HPB has a long history as we got into some of this of a bias against the natural medicines. I think that if the government regulatory agency is involved with a third category, it should be under auspices other than HPB.

Mrs. Rose-Marie Ur: Thank you.

Dr. Robert Woolf: I would like to add something on an important point that Mrs. Ur raised.

As physicians we are here today and we're talking about natural medicines versus conventional. None of us have a financial axe to grind one way or the other. We are absolutely forbidden by the College of Physicians and Surgeons to sell these products. Perhaps if something is hard to get and I can bring it to the office because I know of a source, I may pass it on to the patient as a convenience, but strictly at my cost. There's no profit-taking here and we have no financial incentive whatsoever. It's strictly to try to do the best we can for the patient with the choices that we have.

The Chair: Mr. Volpe has a couple of questions, but I'm going to ask a short one first.

Several of the witnesses have suggested that there should be some kind of reporting system by the consumer. They go into a drugstore somewhere and buy some natural products. Some of them feel there should be a way to report back to somebody about how they reacted to it. Do you have any suggestions on how that could be done?

Dr. Warren Bell: There is a system for drugs—

The Chair: I'm asking you about herbal products. Do you have a—

Dr. Warren Bell: I'm using an analogy to say that system doesn't work very well, and I'm not sure.... Any system that's designed has to be extremely user friendly. People don't have to feel a prejudicial response. If you go back to a health food store where you bought a product and say this made me sick, the health food store owner might look askance. If there's ever going to be a system of feedback like that, it should be very easy—little checkouts in grocery stores, press a button and stuff like that. And that's what there should be for drugs too.

The Chair: Dr. Kaegi.

Dr. Elizabeth Kaegi: Although most therapies are safe as used, I think there are some situations where you can get adverse effects. So my recommendation is that we work to encourage open communication between individuals and appropriately trained health providers. It may not be your corner physician. It may be a properly trained herbalist or naturopath if that's the type of therapy you're using. I think supervision and monitoring should go on, but there should be open communication with your conventional physician as well.

I think it would be nice if there were some easy method of the sort Warren talked about where the public could report back to some agency if they had adverse effects. Because some adverse effects do exist and people don't know where to take them. I used to get them in my previous job. People would call me and say this has happened, what do I do? So I think it would be a good system, although I agree that the current adverse drug effect thing doesn't work terribly effectively.

The Chair: Joe.

Mr. Joseph Volpe: I want to thank our witnesses for staying on. Even though our ranks might be thinning, I can tell you that the interest is not.

Dr. Buckman, a moment or two ago you said that 60% to 80% of your patients use complementary therapies in addition to whatever it is that you prescribe—presumably that's chemotherapy.

Dr. Robert Buckman: Some of them do.

Mr. Joseph Volpe: What assurance do you have that it's your prescription that is working rather than what we've called complementary medicine?

Dr. Robert Buckman: That's not a difficult question. There have been very few studies of complementary remedies in cancer, and the ones that have been done properly have shown no effect in prolonging survival. Recently there was one from California, the Livingston-Wheeler Clinic, where they use a variety of things. There was the infamous study from Britain, the Bristol Cancer Help Centre, which was stirred up into a huge political issue. It showed that the Bristol cancer patients, even though they had been vetted for early death in the study, actually did worse than the conventional ones. And Bernie Siegel's two studies, in 1984 and 1993, both showed no benefit.

As I said, when my patients asked whether they could take something, I said take whatever you like. If I feel I have something that's effective.... Let's argue about a victory in ten years' time; we'll have a dispute about whether the stuff from Athens actually did it or not. So far it's the exact opposite. We have patients documented where the progress is getting worse but they feel better. But there's no situation in which one could have a huge argument about which kind of remedy cured the cancer.

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Mr. Joseph Volpe: This is interesting. I say interesting from a personal point of view, because when I asked earlier about the Di Bella protocol, this is precisely the question at issue.

You'll excuse me if I introduce you back into the conversation parenthetically, Dr. Woolf.

Dr. Di Bella has been using the language that Dr. Woolf has been using, and he's become a national hero, whereas the parliamentary secretary felt he had to defend a particular position today.

With some regret, you weren't able to tell me anything about this Di Bella method. I already had some great regard for your expertise, because one of my colleagues told me that if anybody would know anything, it would be Dr. Buckman.

Dr. Robert Buckman: I'm very sorry to disappoint you with my feet of clay, but there we go. You have me on that one, kid.

Mr. Joseph Volpe: No, Dr. Buckman, I don't mean to embarrass you. If I have in any way, I apologize.

The point I was trying to make, and I didn't start off by wanting to make that point, is that it appears to me that even a person of great renown, such as yourself, may not be seized of all of the facts of any of the studies being done in the field by others in other places in the world. I'm encouraged by that. I'm encouraged by that because it means that, as Dr. Woolf said earlier on, those who are arrogant patently don't have the answers.

I'm not making any reference to Dr. Buckman, nor to the profession in general. On the other hand, it's unnerving. As legislators we're looking to come up with a balanced view on how to address this issue of natural products, alternative and complementary therapies, and how to bring them into the realm of conventional practice. Yet the only answer I had to this issue was when Dr. Kaegi said that she had gone to it on the Internet, and there she learned about this issue, and there she—

Dr. Robert Buckman: When it becomes published in a peer-reviewed journal, we all know about it. It's fascinating. Of course I don't expect everyone to have heard of the guy in Athens, Dr. Alivizatos. I expect very few people in Europe have heard of Essiac and 7-14X. There will always be people somewhere, with local fame, people making statements that do not reach peer-reviewed literature that hasn't been studied.

A vast number of people in the United States have heard of Dr. Bernie Siegel. Very few people know that Bernie Siegel did two studies of his approach at the E-CAP Clinic in New Haven, Connecticut, neither of which showed a prolongation of survival. The general public believes that “Bernie Siegelism”, as it were, does make you live longer. The actual data that was published in 1993 and 1994 are not known.

It doesn't surprise me that there are people all over the world making statements and talking about their treatment with great renown. I haven't read about it yet, because it hasn't actually had a study in the peer-reviewed literature.

Dr. Issels practised for 30 years, and there was nothing in the peer-reviewed literature at all to show that the Issels method did anything, and there still isn't. Alivizatos is the same—about 40 years now.

Mr. Joseph Volpe: The British Medical Journal is pretty good, isn't it?

Dr. Robert Buckman: There's no data on that either. If you can show me the Di Bella data in the British Medical Journal, I'd like to see that, if it's a study.

Mr. Joseph Volpe: Dr. Woolf.

Dr. Robert Woolf: I agree with Dr. Buckman. There is a lot of literature documenting these things. They're not always available to everybody. Everything that is published in France or Germany or Sweden isn't available here; everything that's published in Britain isn't either, and vice versa. So there's lots going on out there in different countries and different cultures.

The Chinese have done tremendous studies. Their herbal medications are as complicated as our pharmaceuticals, with thousands of years of history, and they work.

With regard to the issue of cancer and cancer patients, there are lots of therapies available in Europe. For example, there is extensive nutritional counselling and so forth that is widely done in European clinics that is not really done here at all, to speak of. There are therapies available that are not available here largely through HPB's regulation or some other nonsense that is going on.

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To my mind, to withhold anything from a cancer patient that may help them feel better is absolutely unconscionable. It may not extend life. And nobody's touting here that natural medicines cure cancer; that's ridiculous. Nobody is saying that at all. However, they may offer an opportunity for the patient to feel better for the time span that they have left and to have a better quality of life.

Whether it's Dr. Buckman's chemotherapy or someone else's herbs that help them sleep better or increase their sense of vitality, who cares? The fact of the matter is the patient feels better for the time period they have left. Everybody knows we don't cure cancer. Everybody knows that. And the stats are getting worse—more and more cancer.

Dr. Robert Buckman: It's 50% of all cancer patients who are cured. So it's half, but you're absolutely right on every other point.

Dr. Robert Woolf: The number of people getting cancer is expanding.

Dr. Elizabeth Kaegi: As the population grows and ages....

Dr. Robert Woolf: Exactly, so there are more folks with it. Again, who cares whether it's the chemotherapy or the herb, as long as the patient is feeling better for the time span they have left and it improves their quality of life.

Mr. Joseph Volpe: Dr. Woolf, both you and Dr. Bell, in particular, have taken direct aim at where you think is part of the problem. Part of the problem is that the marketplace—and I'll use some of your words—is essentially rigged by HPB's practices. And I don't want to be judgmental. I take that to mean that the regulations under HPB essentially deprive the marketplace of the opportunity to explore all of these other alternatives you're talking about.

I'm wondering whether there is, as well, another “rigging of the marketplace”, if I can reuse those words, and whether in fact we ought to be looking at something that's not within the federal sphere. I want to see what you think about the regulation of those “gatekeepers”. I can't remember which one of the three of you used this word. Whether physicians, pharmacists, or colleges of surgeons and physicians, they're the ones essentially who are also suggesting that certain therapies or certain products can, should, may not, or cannot be used.

I'm wondering whether you would apply the same kind of vigorous criticism towards those organizations and bodies. If you would, what do you think the federal legislature ought to do or could do?

The Chair: Can we just have a short answer and then we'll close? You can carry on afterwards if you want, but let's have an answer to it.

Mr. Joseph Volpe: I would just like to get it on the record.

The Chair: We're over by 25 minutes.

Dr. Warren Bell: The medical profession in general has acted as a restricting influence on natural medicines, very definitely. I just reviewed the annual statement of the president of the College of Physicians and Surgeons of British Columbia. He wrote a long editorial. What you could tell was that he really thinks there is a bunch of young whippersnappers coming up who are using all these wild and crazy natural things. He doesn't really like it. They're nipping at his heels and it really ticks him off. We'll have to accept that they are out there and do something about it.

In other words, as I said earlier, there's a cultural bias. It's grown up as part of a reflection of institutions. I mentioned patent law, which plays a principal role in this kind of division between alternative and conventional remedies.

I don't see it as a conspiracy, but doctors are sometimes extraordinarily stubborn in accepting some of the new ideas, when they're really new, not if they're variations on a theme. When they involve, for example, patient initiatives being taken, that really is quite unnerving for many physicians. So doctors have actually limited access in this area. They've been an obstruction in many ways. The hierarchy, the mass of medicine has been an obstruction. Individual physicians have sometimes been quite open, but in general that's the way the profession has played it.

The Chair: Dr. Woolf.

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Dr. Robert Woolf: I would agree with Dr. Bell. There is lots of criticism. And to answer your question, yes, I would level serious criticism at various colleges of physicians and surgeons. However, that shift is changing, and the college in Alberta, as I said—

A voice:

[Inaudible—Editor].

Dr. Robert Woolf: Yes, it depends largely on the philosophy of the registrar who rules the roost at the college. If you have a registrar who is forward-looking and open-minded, you're in business. If you have someone who isn't, you're stuck.

The College of Physicians and Surgeons of Ontario is engaged in a contest of immense proportions with Dr. Jozef Krop, with really a lot of disgraceful behaviour, frankly, on the part of the college. In other jurisdictions—Nova Scotia, Saskatchewan, Alberta—there's more of an open-minded attitude.

The conspiracy theory doesn't really exist with the colleges. It's more of an entrenchment of ideas, stubbornness to move on, narrow-mindedness, and arrogance, quite frankly, that sticks the situation.

The conspiracy situation is more applicable to the alliances between the HPB and the pharmaceutical companies for availability of products and that kind of thing. The colleges don't make products available or not make products available; that's a federal jurisdiction. What they do is regulate physicians.

Things are changing, but they're slow.

The Chair: Thank you very much.

We hope the HPB is also changing, but we'll hear from them tomorrow. We've certainly enjoyed today and enjoyed your comments. We will have your notes available to us when we start our meeting tomorrow morning at nine o'clock.

The meeting is adjourned to the call of the chair.