STANDING COMMITTEE ON HEALTH CANADA

I have found this governmental document online and thought it be fitting to add it to my blog because it referes directly to us at Immunotec.

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ


EVIDENCE


[Recorded by Electronic Apparatus]

Monday, April 27, 1998

http://www2.parl.gc.ca

This section starts at 11:15 on time tabs if you want to find it via link above..

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"Mr. Chuck Roberts (President, Immunotech Research Limited): Yes. This is Dr. Bounous, one of my colleagues.

Ladies, I'll be very brief to start off, because I think we'd probably like the questions more than anything.

We're a research company that has been around for about 20 years in its research mode. We basically have a Canadian invention. I guess the word “invention” is a little hard. It's a Canadian finding. This was found by Dr. Bounous through McGill and Montreal General Hospital over the last, I guess, 20 years now. It's basically a milk protein isolate, which is an extract from milk.

We've been trying to bring this through some clinical studies for many years. Our frustration is where we stand with this. We do have a Canadian patent, four American patents, and a worldwide patent. We sell this product throughout the United States and Europe, through a lot of doctors, clinics, and cancer clinics.

Our frustration with the Canadian market is exactly what I'm sure you've heard all the way along: we're sitting in never-never land here with the product. Years and years ago, Dr. Bounous and his doctor colleagues tried to get a DIN number. We were refused because we're a food. So we end up back as a food, but we're actually probably a medical food.

We deal with the immune system. We prove what we say. Our patents are method patents. It's a little different from taking a patent for the formulation. This is for the method, for what it does. We do carry four U.S. patents, including AIDS patents. We've just been issued a patent that's been pending for four years, because they're worldwide patents, for cancer. It has started in Australia and will work its way down to the United States. We have patents for our method of raising the immune system of a human.

We market this product in other countries. For instance, Fresenius AG, which is one of the largest European pharmaceutical companies, has a licence of ours in Europe. They market this in the traditional way, through pharmacies. Their health care system does pick up the cost of this. In the United States, we do market this through the food supplement division. We've requested to try to go to nutraceutical. This is marketed also through a lot of medical doctors, and we think in about two or three months, medicaid will pick up part of the cost of this for AIDS and some of the people in the United States.

Coming back to Canada, we are a Canadian company. We employ folks here in Vaudreuil. We do sell this product as a food product in Canada. We're not even allowed to use our own name. We're not allowed to show anybody the patents—they are Canadian patents—because of the food regulations, which we do understand.

We do clinical studies. For instance, we're doing a double-blind study, a phase three study, at the Montreal Chest Institute with Dr. Lalonde. It has been going on for quite a while. We're just going to break the code shortly for AIDS. We're not allowed to tell anybody we're doing that, and this is costing the Canadian HIV network probably a couple of million dollars, a small fortune. We're putting a lot of money into this.

We're doing another study at McGill, through the Children's Hospital and Dr. Larry Lands, on cystic fibrosis.

These are serious clinical trials that we are paying for, but we can't tell anybody we're doing this. We're in a frustrating area, where we're going here. So we really need some sort of middle category to stay within this market here.

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Now, I'm from here, and I'm determined to stick out what we're doing in Canada here, because this is our head office and we're going to make many, many millions of dollars in exporting this product. This is a dairy product. We work with the local dairies. They're not up to the technology that we have yet, but we are working with them. We do bring the product here. We do all the packaging through the pharmaceutical plants in Quebec City and in the east end of Montreal.

We are going forward with our method of selling it, but as I say, it has been very frustrating. We are going by the rules in Canada, but it kind of holds back what the public should know about what we're spending. It's real. For instance, in the American market—I'm not using that as a criterion, because I don't think it's 100% the way to go—we're allowed to show people what we have as long as we can prove it.

These come from clinical studies done by doctors. Look at how Dr. Bounous's career has gone. I've given you folks some small brochures. A lot of the brochures are not translated because we're not allowed to translate this into French yet, because that's not allowed by the rules here. So we brought you some of the American things we have. I put in Dr. Bounous's CV. There's a clinical foundation there that was written by the doctors. That's real. Other doctors use it to deal with this thing.

I think the main thing that we have here.... I'll go back to this. It's an invention that was done in Montreal. We've got something really unique in its category. It's basically mother's milk for adults. This is what they've created. They've got a way to extract this particular whey protein and isolate it from milk and keep it together so you can get the effects form this. They've done the studies. We have the proof of what we're talking about here.

The pharmaceutical companies in the rest of the world do not take these licences on for fun. They spent millions of dollars doing this research. The European company will do something like 60 million Deutschmarks in the first year in their business over there. This is big. You're talking about a huge market share.

This is great for a little Canadian company that's coming out of nowhere. It was a small research company. We put it together and we marketed it. We licensed 20 countries in the last eight months, so these pharmaceutical companies know what they have. We would love to have this middle category put down somehow so that we could basically show what we have. I'm sure a lot of other people would do the same thing.

That's my brief thing. I'm sure that if you would like to ask some questions, we would certainly try to answer them.


The Chair: Thank you very much. Ms. Caplan.


Ms. Elinor Caplan: Yes, thank you.


[Translation]

I'll put my question in English because it's easier for me.


[English]

I'm going to ask my questions in English, and I have many.

One of the things this committee is considering is how we deal with those products that are foods, or have been traditionally categorized as foods, that want to make a health claim. I've often described them as those things that look like a drug, make a medicinal or therapeutic claim like a drug, but in fact, are not synthetic.

Your product is a natural product?


Mr. Chuck Roberts: It's from milk.


Ms. Elinor Caplan: The question I have is this: is there any risk involved with your product?


Mr. Chuck Roberts: None, if you drink milk or take protein. For instance, we've even taken the lactose out of it. A lot of this is dealt with in very extreme cases and through their clinical studies through feeding tubes and stuff, so you have to deal, especially in the AIDS community, with people who are lactose-intolerant. So there's no fat or lactose in this.


Ms. Elinor Caplan: So your product is an example of the sort of natural product that the committee is considering in terms of what we should do with it—


Mr. Chuck Roberts: Right.


Ms. Elinor Caplan: —and how, if at all, it should be regulated. One of the concerns I have is not so much with the notion of the development of a third category, but of an alternative process for regulating—I guess that's the word I would use—to ensure safety and quality.

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But for me, the real question, if you look at the mandate of this committee, is to enhance consumer access and freedom to products while ensuring quality and safety. You'll notice in that mandate that it doesn't mention efficacy. So I guess the question I would ask to begin with is: do you believe that if a product makes a health claim it should have to present evidence appropriate to the claim it's making?


Mr. Chuck Roberts: Yes, absolutely.


Ms. Elinor Caplan: And if we have an alternative method of regulating those products that traditionally have been viewed as food that would fall under the food part of the Food and Drugs Act, but they wish to make therapeutic claims, do you believe it's the responsibility of Health Canada, as the regulator, to assure the quality of the product as in GMP standards?


Dr. Gustavo Bounous (Medical Director, Immunotec Research Ltd.): Yes.


Ms. Elinor Caplan: Would this also be the case for the safety of the product and, in other words, that what the product says it is, that's so?


Mr. Chuck Roberts: Yes, absolutely.


Ms. Elinor Caplan: Would you favour a method that would allow for a disclaimer so that you didn't have to get into all of the kinds of trials and research that in fact you're getting into?

One of the concerns is that many of these products are in pharmacopoeia, and evidence has been presented on other products that says there are thousands of years of history and monographs and so forth, but they're not the traditional, double-blind research trials, which as you said, are so expensive. Could you see a place for a disclaimer that would allow for a natural product that hasn't done all of the research, or do you believe it should all have the same kind of research?


Dr. Gustavo Bounous: I would like to first mention what a natural product is. It's an overused term. Most of the poisons are natural products, such as arsenic, cyanide, etc. So it's natural in the sense that it comes from a natural source and doesn't contain additives. What I would like to see personally is a verification of the claims in a university setting. That can be done probably in the same way as for drugs.

Now, as Mr. Roberts said, we face two trials that are going on in Montreal and at U.S. universities. We are waiting for the results. Some are already forthcoming. But certainly, only an independent verification by qualified clinicians will give us that.

Now, what the government would do with this is a different question. The definition of food is that it's a material that provides for physiological structure, function, and growth. It doesn't make a claim. The definition of a drug is that it's a material that provides a benefit to health and does not include food. It's easier to define drugs than it is to define a medical food.

My definition of a medical food, if I may, is that it's a food that, in addition to and independent of nutrition, provides some benefit to the treatment or prevention of diseases.


Ms. Elinor Caplan: But what about the use of a therapeutic product, as opposed to food, if it's a therapeutic product or a natural therapeutic product?


Mr. Chuck Roberts: But if you're looking at the definition in terms of where we market this product, it does help a lot of people who are sick, obviously. It's obviously for prevention, which is probably the biggest part of your market if you are a company trying to do business here.


Ms. Elinor Caplan: One of the concerns of this committee that I'd ask you to address is the fact that there are many products that have been traditionally used for many, many years that don't undergo the kind of processing that your product undergoes. Also, they have a history of use internationally or among different cultures. So if you were to subject these products to the rigours of research, it would make them prohibitively expensive for consumers.


A voice: Could be.


Ms. Elinor Caplan: That's a concern they have. Would you like to address that concern?


Dr. Gustavo Bounous: I understand that. On the other hand, I think the ultimate decision will be made by science and the scientific method.

What our company is saying and what we're demonstrating in animal experiments will be verified by independent clinicians. If so, if the results are positive, then we ought to be able to claim that.

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Ms. Elinor Caplan: The question I have is, could you see an alternative process for regulating products that would give you the freedom, if you wished, to do the trials or that would also allow for the more traditional use and the compendium—


Mr. Chuck Roberts: Yes.


Ms. Elinor Caplan: —that would allow for a disclaimer if they didn't have all the trials and research?


Mr. Chuck Roberts: I think you're on the right track. Nobody wants to spend all this money on things, but we're still sitting in the middle of nowhere because of the fact that we have done the trials, and we have done this over many years.

We're dealing with the medical profession, and they do things in a different way. Everybody has to make sure they agree with everything else, and it all has to go through its due process. Dr. Bounous is no different from that.

It's a situation where I'm sure there are lots of other good products around that could fall into a category of the nature of ours, but I think we really believe there should be some proof before you go ahead and market things with claims. We would obviously like the middle category, to be able to make just a claim that we can prove. That's all.


[Translation]


The Chair: Thank you. Ms. Picard.


Ms. Pauline Picard: I'm sorry, but I don't think I quite got what was being said and I'd like some clarification. You're presenting a natural product that is sort of becoming a synthesized hormone and you want to get it approved by Health Canada as a therapeutic product. From that point on, the product is not considered as food any more, but as medication. Normally, Health Canada should examine your product, ensure its efficacity and safety and grant you the permit so you can label it as a product for therapeutic use. What is the matter with that? What hasn't worked? Did you ask for your patent on that hormone as a food?


Dr. Gustavo Bounous: Yes, as a food. One should clearly point out what falls under the definition of a drug or a food. It's a matter the Americans have been examining for at least two decades and they still haven't managed to identify where the nutritional aspect ends and the therapeutic aspect begins.

Our product is perhaps an illustration of what I'm saying. In this product, the active ingredient is the precursor of glutathione, which is the specific antioxidant of the cell. Normally, an ordinary diet will provide you with everything needed in the way of glutathione precursors. So, if an animal or an individual is dealing with the ordinary conditions of life, an ordinary diet will provide enough. But when you're dealing with a viral or bacterial infection, your lymphocytes have to produce many more antibodies and multiply. Then you need the antioxidant glutathione which is specific to the cell. This antioxidant must be reconstituted as soon as it is depleted or used up. So the supplementary addition of precursors, like the ones we find in this milk product, allows you to deal more easily with the bacterial invasion.


Ms. Pauline Picard: Fine.


Dr. Gustavo Bounous: Some products of inferior quality have the same food value, but they don't have the aspect that we call biological activity. Some proteins have the same nutritional capacity, but don't have that other property. This distinction is the next step up. It's easy for the pharmaceutical industry because it deals in molecules that have no nutritional value. Everything it does has an effect, whether it's useful or not, as long as it's properly documented.

We're faced with a mix of factors. There's an ingredient that has an activity and we're not sure that it's the only active ingredient because there's interaction between the other proteins in the milk. It's a long story, but there is, of course, a preventative therapeutic effect that's dissociated from the nutritional aspect.

I hope I answered your question.


Ms. Pauline Picard: Yes, yes.


Dr. Gustavo Bounous: It's difficult to define what it is.

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The Chair: Thank you very much.


[English]

Thank you also, Mr. Roberts, for your presentation today.

We have your documents. If there's anything else you think we should have....


Mr. Chuck Roberts: We have tons of it. You wouldn't have time to read it all, but it would be a pleasure to give that.

The only other thing I could tell you, briefly, is that we will be doing a trial, which was set up quite a while ago, with the Department of National Defence of Canada. It will be in their labs, wherever these labs are. They understand what we've had here, and we'd use it for their defence department and maybe off in some of the countries when they send the troops.


The Chair: Thank you very much.


Mr. Chuck Roberts: Thank you.


Ms. Elinor Caplan: As you're leaving...what I found interesting is this. My understanding was that for a food, if you make a health claim, it becomes a drug and you then have to go through all the processes.


Mr. Chuck Roberts: We tried. Because we're a food and there's nothing added to this, they would not let us become a drug. If we add something to it, then we'd be fine. The rule is food or drugs; there's nothing in between. We need something in between.


The Chair: Thank you very much.


Dr. Gustavo Bounous: The American solution has been to not put the claim on the label.


The Chair: Thank you. "


Posted by

Randy Grover
Immunotec Consultant.
www.immuotec.com