HEAL Committee Meeting

37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Wednesday, November 5, 2003

¹

1540

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Dr. André Potworowski (Associate Director, Research and Development, Centre for Research in Biopharmaceuticals and Biotechnology, University of Ottawa)

¹

1545

The Honorable Judy Erola (Chairman, Advisory Committee, Health Management Program, School of Management, University of Ottawa)

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1550

Dr. André Potworowski

Mrs. Judy Erola

Dr. André Potworowski

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1555

The Chair

Dr. Mick Hitchcock (Vice-President, Health, Gilead Sciences Inc.)

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1600

º

1605

The Chair

Dr. Roger Korman (President, IMS Health)

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1610

º

1615

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Roger Korman

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1620

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

º

1625

Dr. Mick Hitchcock

Mr. Rob Merrifield

Dr. Mick Hitchcock

Mr. Rob Merrifield

Mrs. Judy Erola

Mr. Rob Merrifield

Mrs. Judy Erola

Dr. André Potworowski

Mrs. Judy Erola

Dr. André Potworowski

Mr. Rob Merrifield

Mrs. Judy Erola

Dr. André Potworowski

Mrs. Judy Erola

Dr. André Potworowski

The Chair

Mr. Grant Hill (Macleod, Canadian Alliance)

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1630

Mrs. Judy Erola

Mr. Grant Hill

Mrs. Judy Erola

Dr. André Potworowski

Mr. Grant Hill

Dr. André Potworowski

Mrs. Judy Erola

Mr. Grant Hill

Dr. André Potworowski

Mr. Grant Hill

Dr. André Potworowski

Mrs. Judy Erola

Mr. Grant Hill

Mrs. Judy Erola

Dr. André Potworowski

Mrs. Judy Erola

º

1635

Mr. Grant Hill

The Chair

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.)

Dr. Roger Korman

Mr. Jeannot Castonguay

º

1640

Dr. Roger Korman

Mr. Jeannot Castonguay

Dr. Roger Korman

Mr. Jeannot Castonguay

Mr. Gary Fabian (Vice President, Corporate Relations, IMS Health)

The Chair

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)

Dr. Roger Korman

Mr. Stan Dromisky

º

1645

The Chair

Mrs. Judy Erola

º

1650

Mr. Stan Dromisky

Mrs. Judy Erola

Dr. André Potworowski

Mrs. Judy Erola

Mr. Stan Dromisky

The Chair

Mr. Rob Merrifield

Dr. André Potworowski

Mr. Rob Merrifield

Dr. André Potworowski

Mrs. Judy Erola

º

1655

Mr. Rob Merrifield

Mrs. Judy Erola

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Roger Korman

Mr. Rob Merrifield

Dr. Mick Hitchcock

Mr. Rob Merrifield

Dr. Mick Hitchcock

Mr. Rob Merrifield

Dr. Mick Hitchcock

Mr. Rob Merrifield

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

»

1700

Mrs. Judy Erola

The Chair

Mrs. Judy Erola

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

Dr. André Potworowski

The Chair

»

1705

Dr. André Potworowski

The Chair

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CANADA

Standing Committee on Health

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NUMBER 070

l

2nd SESSION

l

37th PARLIAMENT

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EVIDENCE

Wednesday, November 5, 2003

[Recorded by Electronic Apparatus]

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[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen. It's my pleasure to welcome you to this meeting of the Standing Committee on Health as we pursue our study on prescription drugs.

    We'll get right to the testimony. I introduce to you today, representing the University of Ottawa, André J. Potworowski, associate director of research and development at the Centre for Research in Biopharmaceuticals and Biotechnology. He will be assisted by Judy Erola, chairman of the advisory committee, Health Management Program, School of Management.

    Mr. Potworowski or Ms. Erola, the floor is yours.

    Dr. André Potworowski (Associate Director, Research and Development, Centre for Research in Biopharmaceuticals and Biotechnology, University of Ottawa): Thank you, Madam Chairman, and thank you very much for inviting us here today.

    We would like to share with you the findings of a study we conducted late last year and early this year. It started out from a very business management type of question: why does it take so long to bring a drug to market, and who's looked at it? Another question has to do with innovation clusters, systems of innovation--that is, are there groups, organizations, or institutions that work together to promote innovation, and can you look at clinical trials using that filter?

    The reason it takes so long to commercialize a pharmaceutical product is that it has to go through a number of regulatory steps, one of which is clinical trials. This is where you have to test, with humans, the efficacy and the efficiency of the drug. Our approach was rather unique. We looked at it from a holistic approach--that is, what does the clinical trials system look like?

    In that study, I was very fortunate to have a superb team that included two former cabinet ministers, Judy Erola and Monique Bégin--Madam Bégin couldn't be here today, because she had a board meeting in Montreal--and George Wells, a distinguished epidemiologist and professor in the Faculty of Medicine at the University of Ottawa.

    I have to say that all of us rolled up our sleeves and worked as true researchers. We did interviews, each of us, and we all wrote it up. We had funding from Industry Canada and Health Canada. This was a feasibility study, so we tried to throw out the net as widely as we could and ask the basic question: what's out there?

    To our surprise, very few people have looked at clinical trials in this holistic and integrated way, in Canada or elsewhere. That came out loud and clear in our literature search. We also found out, very disturbingly, that there is a very significant dearth of information that could offer us any solid data on this system. We don't know how many clinical trials are running in Canada, actually, and we don't know how many patients are in clinical trials. We know that it represents economic activity of between $800 million and $1 billion, roughly. We know that there are a lot of stakeholders involved in running clinical trials. Initially, we thought there were only three, but it turns out to be at least 13, at the centre of which are patients.

    I'm going to allow Ms. Erola to talk about patients, because that was the area that she and Monique Bégin chose to focus on, what patients think and what they want to get out of clinical trials.

    We tried to focus on best practices. Are there ways in which we could improve the clinical trials system in Canada? Are there examples, or are there things we can learn about it, to make the innovation system work more efficiently?

    That has led, since we published the report, to a very interesting public policy question that, in our view, has never been asked systematically before: Do we want more clinical trials in Canada? That has never been debated in the public policy corridors. Personally, as a group of researchers, we think there should be, because clinical trials are beneficial. They provide valuable economic activity, ranging from $800 million to $1 billion, of foreign investment largely, from large multinational corporations. They provide health benefits to patients who are enrolled in clinical trials and have access to free drugs. They increase our knowledge and understanding of diseases.

    So there are all kinds of positive benefits related to that, but this has never been debated publicly.

    In our report, we describe the system. At the centre are patients, and then a subset of patients who are enrolled in clinical trials. We have large pharmas, biotech companies, clinical research organizations, private research clinics, and hospitals and university faculties where the clinical trials take place. And that includes, within that subset, research nurses, investigators, and ethics research boards, which tend to be considered by many a bottleneck in the approval of clinical trials, and could do with a great deal of improvement.

    Most of the conclusions in our study are in the form of recommendations for further study. It was a feasibility study. We cast our net very large. We said, hey, here's a system where lots of people are involved, with tens of thousands of people employed by it on a full-time or part-time basis, a lot of benefits, but nobody has looked at it as a system in a holistic, integrated way.

    In terms of the a drug approval process, we feel that the Health Canada approval of clinical trials is not that far off from international standards. We talked about research ethics boards. Provincial formularies, a major end point in the drug approval system, have not been studied at all. Very little is known about them.

    Allied health professionals, nurses, all the people who help in running clinical trials--very little is known about their professional career paths, what kind of training they need, and so on.

    The investigators are the physicians, the scientists who run the clinical trial at a given site. There's a whole issue of how they relate to the pharma companies in terms of the question of confidentiality, of trust, of participation in the research. Hospitals and faculties, who see clinical trials as a source of revenue...but they've maximized the revenue so much that their contracting procedures now seem to be an impediment to the smooth running of clinical trials.

    Industry, large pharma--they are the people who fund about 80% of the trials in Canada. Again, more openness and more transparency is required.

    We identified two or three other organizations, about whom very little is known, who are very fast-growing in the performance of clinical trials. These are clinical research organizations, private research clinics, and site-management organizations. Very little is known about their statistics, or how fast they're growing. but we understand from the people we've spoken to that this is a very fast-growing sector.

    Now, because patients are at the centre of clinical trials--we produce drugs to heal patients and we need patients to run clinical trials--we made that a special part of our study. I'll let Judy talk about that, because that's the part that she and Monique Bégin looked after.

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    The Honorable Judy Erola (Chairman, Advisory Committee, Health Management Program, School of Management, University of Ottawa): The reason I'm smiling--and thank you very much, André, and Madam Chair and members of the committee--is that when the study was being designed, it was looked at primarily as a business unit. When we were brought into it, we said this is not just a business unit; you are using people, you are using patients. We are looking at a much broader question in terms of what is the benefit to patients, and the role of the patient. No clinical trial can take place without the patient.

    So we set about convincing our fellow researchers that unless we looked at it from the patient's point of view, and ultimately the benefits to the health care system, then we were only seeing a part of the equation. To get that view from the patients, Madam Bégin and I spent hours and hours interviewing individual patients, whose names were brought to us by various health groups, such as the arthritis organization--you'll notice they're footnoted in our study--who had participated in clinical trials.

    We had originally thought that we would be speaking to them for about a half-hour, but it ended up to be a half-day to a day, because they wanted to tell us about their experiences.

    Our conclusions are in the study, but on the whole, patients in Canada who have participated in clinical trials support clinical trials, and have--amazingly, to us--a very altruistic attitude toward clinical trials. Even though they themselves may or may not benefit from the trial, they believe they are contributing to that large body of knowledge and are very happy to participate. That's the positive side.

    On the negative side, it is clear that there is, in Canada, no real strategy. I would supplement what André was saying a minute ago, that in a number of countries, including the United Kingdom and Australia, they have looked at this as an industry, decided there should be a national strategy, and put in place policies that do indeed bring clinical trials into the country. A number of them, including the regulatory system, are extremely important.

    Clinical trials as such are, from the patient's point of view, beneficial, but they really want more transparency. Very often when a patient is involved in a clinical trial there is very little discussion, if any at all, between the principal investigator of a clinical trial and the patient's family physician. They're very upset about the lack of knowledge transfer that takes place between the two. They are very concerned that the transparency of the trial in terms of general knowledge is not always made clear. They feel that there should be a central registry. One of the things we found is that many patients are extremely sophisticated, particularly if they are in trials where there are life-threatening diseases, such as cancer, as well as chronic diseases, such as arthritis.

    If they're living with these diseases, they get on the web and they find out what's going on. We found out that they often know much more than their attending physician, but they're frustrated, because the body of knowledge accessible to the patient simply doesn't exist. If it does exist, it's in bits and pieces. They find a great deal of information.

    In cancer, for instance, we looked at best practices, and the B.C. Cancer Agency is probably the best in terms of a patient's access to information and access to trials. They feel very strongly that the results of a clinical trial--good, bad, or indifferent--should be made available to everyone. That doesn't exist in this country. They also feel that there should be a system by which they have access to this information...but they're not asking....

    I think there are a number of red herrings, and it may come up in our discussions, where people feel that much of this information is of no use to patients. Well, (a), patients are very sophisticated, and (b), they don't want much of that complex, scientific information; they want it in lay terms, very often, so that they will have some knowledge about what's happening to them and to the disease entity in question.

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    One thing that also screams out at us is the lack of uniformity and standards in research ethics boards across the country. In fact, at a seminar following our report, we met with a group of investigators and pharmacologists. One of the gentlemen said that there were over 500 research ethics boards in this country, and that, while a basic standard was developed by the CIHR, or the tri-council of the Medical Research Council, there is no auditing method. The FDA audits both research ethics committees and clinical trials. This does not happen in Canada.

    Very often a multi-site clinical trial is delayed because wherever there is a site—as you know, clinical trials now take place in multi-sites—there are very often significant delays simply because a specific research ethics board does not approve the trial. So there is a real call for some changes in this area.

    I'm going to leave it at that, because I think our time for presentation is up. Perhaps we can follow through with questions.

    Dr. André Potworowski: I just want to leave you with one concluding comment.

    On the question I mentioned at the beginning, about whether or not we want more clinical trials in Canada, that has not been debated publicly, but we have taken the implicit position that it would be a good thing. There are economic advantages, health advantages, research advantages, investment advantages, and so on.

    Mrs. Judy Erola: And patients agree with that.

    Dr. André Potworowski: Yes, patients agree with that.

    What we have seen—and this is the urgency of this issue—is that countries like Australia, the U.K., and Singapore have put in very aggressive policies and infrastructure to increase their capacity for conducting clinical trials and attracting foreign investments. We have only a superficial knowledge of these policies and they were all put within the last two years. They are moving very fast and very aggressively, because they see the bonanza that this brings to a country. I think there is some urgency in moving to this.

    We hope to move to a second phase of the study, where we hold regional workshops with areas where there are clinical trials to make people aware that there are all kinds of best practices they can adopt to increase their efficiency. Because no one single jurisdiction would govern that. It's not just Health Canada. It's Industry Canada. It's the provinces. It's the universities. It's the contracting. It's all these people working together, and that's why we call it an innovation system.

    That's why there is a certain urgency for Canada to adopt a clear position on that and make sure that we have our ducks lined up in that position.

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    The Chair: Thank you very much. That was very interesting, Some of the things you've said, but not all, we've heard from others in our hearings. Obviously, you have a specific perspective.

    Our next witnesses represent Gilead Sciences Inc., which is, I believe, a pharmaceutical company in Vancouver. We have with us today Mr. Mick Hitchcock, who is the vice-president, health, and Ms. Alix Israels, who is the marketing manager for Canada.

    Mr. Hitchcock or Ms. Israels.

    Dr. Mick Hitchcock (Vice-President, Health, Gilead Sciences Inc.): Madam Chair, members of the committee, thank you for the opportunity to address the committee today.

    My name is Dr. Mick Hitchcock. I'm the vice-president of medical affairs for Gilead Sciences Inc., a biopharmaceutical company.

    Gilead was founded only 16 years ago, and their scientific efforts have led to seven novel, commercially available products for the treatment of unmet medical needs, including HIV, influenza, and serious fungal infections. This month, the Patented Medicine Prices Review Board, PMPRB, will review our pricing dossier for Viread, the company's anti-retroviral for the treatment of HIV.

    I would like to speak today about the challenges that companies like Gilead face in commercializing our products globally, and in particular, the issues we face in bringing products to those patients in need here in Canada.

    Gilead has a strong international presence, and commercializes its drugs worldwide. We have a corporate commitment to ensure global access to our products through tiered pricing, which includes making Viread available at reduced prices in countries that are not capable of paying standard prices.

    To that end, late last year we announced a program to provide our HIV/AIDS drug, Viread, at a no-profit price to resource-poor countries, including all African and 15 additional countries classified as least-developed by the UN. To date, 15 countries in Africa have accessed Viread at the no-profit price. To be clear, “no-profit” means the cost of manufacturing and administration.

    Thus, we have demonstrated our support of tiered pricing between developed and developing world markets. We understand the need for differential pricing to ensure availability of treatments to HIV patients worldwide.

    In order to achieve our mission of ongoing innovation and widespread drug access, we believe our industry should adopt consistent pricing strategies for developed nations through narrow price bands. Consistent pricing strategy in developed nations such as Canada and the nations of the European Union will allow us to develop and support, along with the governments, programs that enable access to drugs in the developing world.

    Before I speak about a specific case study involving Gilead's HIV therapeutic, I would like to underscore that Gilead is committed to its business in Canada. We have had a long and active history in Canada, dating back to 1992. We have collaborated with our Canadian colleagues through all stages of research and development, have made significant investments in manufacturing in Canada, and have recently established operations in Vancouver.

    In recent years, Gilead has invested more than $100 million in Canada, and supports jobs for Canadians in the manufacture of Viread. In fact, the majority of the global supply of Viread is manufactured in Canada. We look forward to continuing to work together, and internal projections expect the investment in Canada to increase to over $550 million by 2008.

    We are now in the process of commercializing Viread, our first product launch in Canada, and are working with the PMPRB to achieve clarity on the price.

    Gilead's HIV drug, Viread, was approved in the U.S. in October of 2001. At that time, recognizing that there would be a need for the medication, pending approval in Canada, we opened up an expanded access program that makes Viread available free of charge to patients who are most in need, otherwise referred to as “salvage” therapy.

    At the same time, we worked with Health Canada for product approval and received such approval, the notice of compliance, in Canada in March of this year. Over the past two years, Viread has been commercialized in 35 countries worldwide, including 15 countries in Africa.

    During this time period, the Canadian expanded access program has enrolled over 1,600 patients, which is 10% of the patients in Canada receiving HIV medication. Because of the strict criteria for enrolment, this demonstrates that Viread is fulfilling an unmet medical need for Canadians.

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    Of course, maintaining this program presents a significant cost to Gilead, of approximately $2 million this year alone, but it also demonstrates our commitment to providing access to patients in need. Therefore, we are continuing to enrol patients and to support this program while we work through pricing mechanisms on a federal and then provincial level, which we require in order to commercialize. We are currently awaiting a price recommendation from the PMPRB, and in fact expect initial feedback later this month.

    Traditionally, companies market their drugs once they have approval. They will negotiate with the provinces to get on formularies, and are then subject to pricing review by the PMPRB, which determines the maximum non-excessive price at which a product can be sold in Canada.

    If determined excessive, companies that are already on the market are forced to reduce prices and refund governments for excess revenues. Our approach in Canada, which is consistent with our worldwide approach, is to negotiate a price before we go to market. It is our expectation that the PMPRB will agree to a price that reflects the value of the product to patients, as demonstrated by our expanded access program. That is consistent with Europe and other developed countries where Viread is commercialized.

    Let me say a few words about the unique clinical benefits that Viread provides to HIV-infected patients. Because HIV can now be managed as a chronic disease, the potency, tolerability, and resistance profile are of utmost importance to the long-term success of treatment. In clinical studies, Viread has demonstrated an ability to safely suppress HIV through 96 weeks of treatment.

    During this time, there is minimal evidence of the development of drug-resistant mutations, and limited potential for drug-drug interactions, which is particularly important given the number of medications that patients with HIV take concomitantly.

    Unlike many other therapies, Viread is dosed as one tablet taken once daily. Studies have shown that adherence to anti-HIV medications directly correlates to treatment success, and patients must be at least 95% adherent. Certainly that is a significant challenge with medications dosed multiple times a day.

    Importantly, Viread is effective in patients who have failed other available therapies, and may be the only treatment alternative. That is the reason we established our expended access program and have 10% of the treated population on Viread. Taken together, the characteristics above make it an ideal treatment option for all HIV patients.

    As I noted before, our mission as a company is to provide therapeutic advancements to patients worldwide. The profile of Viread makes it uniquely suited for use in the developing world, where the HIV/AIDS epidemic has hit the hardest. To that end, we launched the Gilead global access program, where we provide Viread to resource-challenged countries at no profit.

    Given this perspective, it is important to understand the position of a small publicly held company such as Gilead in considering the best approach to commercializing a product in Canada. According to the current pricing system, companies are expected to market drugs initially without the security of a set price. We could be subject to a unilateral price reduction mandated by the PMPRB. This is inconsistent with our global pricing strategy and narrow band for developed countries. It puts our company at risk, especially with the reference-based pricing that exists within governments and other health care providers in developed countries.

    We are concerned that the PMPRB guidelines place high hurdles for innovation. It is our understanding that the PMPRB uses a categorization process to evaluate pricing dossiers. Therapeutics are classified essentially as either a “breakthrough” product or a “me-too” product--that is, one that essentially provides moderate therapeutic advantage over comparators.

    Importantly, products not classified as breakthroughs are by default included in the me-too category. The limitations of these two categories may mean that therapeutics that represent significant advances but do not meet the criteria of breakthrough, as set forth by the PMPRB, are pushed down into the me-too category and capped by the price of much older drugs, despite significant innovation.

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    In short, the current model places the risk on the companies that introduce new medicines, especially for those smaller companies that are, in many cases, at the forefront of pharmaceutical innovation. Most new therapeutics have incremental benefits that may not be rewarded when the price is limited by the price of older drugs.

    In order to continue to make innovations in critical therapeutic areas like HIV, and to continue to provide access on affordable terms to people in need in all parts of the world, the price for Viread in developed countries must be set at a level that permits the return of, and on, the company's investment.

    There's been a lot of press about re-importation. This is not our issue, or why we're here today. Prices in other developed nations are set, as with any other commercial product, based on the inherent value of the therapeutic. The same metrics should be applied consistently in Canada.

    We believe a workable solution is for prices to be set for the developed nations of the world within a narrow band that supports innovation and allows for price reductions for those nations in need. We encourage the Canadian government to consider these issues as well as the global impact of its actions, and we stand prepared to work with the government in every way possible, with the expectation that fair and reasonable solutions can be developed.

    We believe the PMPRB needs to apply its system in a flexible manner to recognize the value of innovative products like Viread, and needs to respond more quickly so that innovative products such as Viread will be accessible to patients in need more quickly.

    I would like to thank the committee for its time today and for this opportunity to share our perspective on these important issues.

    Thank you.

    The Chair: Thank you very much.

    Our next witnesses represent IMS Health. We have Mr. Roger Korman, president; Mr. Gary Fabian, vice-president; and Ms. Anita Fineberg, corporate counsel and chief privacy officer.

    We'll begin with Mr. Korman.

    Dr. Roger Korman (President, IMS Health): Thank you, Madam Chair.

    IMS Health has provided statistical research and analysis to the pharmaceutical industry, government regulatory bodies, and health research organizations for nearly 50 years in more than 100 countries. We track disease and treatment by one million products for more than 3,000 drug manufacturers worldwide. IMS is the largest non-governmental provider of health information, processing more than one billion transactions monthly into vast knowledge banks on disease diagnosis, prescribing trends, sales of OTC and prescription products, and pharmaceutical promotional activities. In all of these endeavours, it is important to note that IMS never collects any identifiable patient data.

    As a neutral and authoritative source of health information, IMS describes what is happening in pharmaceutical health care so that policy- and decision-makers can decide what should be happening.

    In the course of these hearings, the honourable member for Yellowhead, Mr. Merrifield, asked, “When we look at some of the dollars and cents on some of these estimates, we always have to ask the question, 'Are we getting value for our dollar, or are we just throwing money into dark holes that just gobble it up?'” This is a fundamental question. As we are all well aware, both public and private payers already devote a major share of our health resources to pharmaceutical care.

    Getting value for our prescription dollar means essentially three things: medications are prescribed to Canadians in a safe manner, medications are prescribed to Canadians in an appropriate therapeutic manner, and medications are prescribed in a cost-effective manner.

    To advance these issues, IMS has tabled five recommendations. I draw your attention to three--namely, establish a comprehensive risk management, “pharmacovigilance”, post-marketing surveillance program; provide feedback to individual physicians about their prescribing practices; and leverage private resources through public-private partnerships. All of our recommendations centre on the health care system's ability to gather the information to monitor how medications are being prescribed, which I'll refer to in this presentation as “prescriber practice” data, and make it available as required, in a transparent manner, to all stakeholders. For our ailing health care system, accessible and timely information is one of the best medicines and truly one of the most critical.

    The unifying principle of IMS's recommendations is feedback. Any system--an organization, a country, a human body--maintains itself, its equilibrium, its ability to adapt, through feedback. Conversely, no system will remain healthy without feedback. So much of what you have heard in the course of these hearings centres on the need for feedback mechanisms in our health care system. It is essential to understand that feedback entails the systematic collection of information and redistribution to all parts of the system or it just doesn't work.

    Risk management, pharmacovigilance monitoring, and post-marketing surveillance are three approaches to system feedback. While there are important differences in emphasis among the three approaches, they all work to improve safe pharmaceutical care. This should be our first objective, to protect the public. Once a product is approved in Canada, how many mechanisms do we have to regulate price and access versus how many do we have to ensure that, day in and day out, pharmaceutical products are used in a safe manner?

    It's not that market access policy is not important--of course it is--but we lack systematic feedback mechanisms to ensure public safety. As a result, we lack a means to monitor urgently needed therapies in the general population, which delays their introduction. There is unnecessary injury and loss, first to the individual and ultimately to our society as a whole. As well, we lose access to important medications.

    Peter Honig of the FDA has stated that in the U.S., eight of the last ten product withdrawals were due to misprescribing. There have been 12 high-profile product withdrawals since 1995, and there may be as many drug warnings in any one year. How much suffering could have been avoided, and in some cases, how many lives could have been spared, had faster and better communication been used to convey early warnings about the risk of these drugs? It only makes sense to ensure that drug warnings are targeted to physicians who are prescribing these drugs so that they are understood and acted upon.

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    Post-marketing surveillance should pay for itself, because not only can safety be monitored but cost-effectiveness as well. In our brief, we note the case where a new once-a-day dosing was approved for reimbursement by our province on the basis that the manufacturer took responsibility for ensuring that it was not mistakenly over-prescribed according to the previous drug regimen.

    Risk management, pharmacovigilance monitoring, and post-marketing surveillance are important to not just good heath but also good economics. These kinds of programs will increase the responsibilities of all parties--that is, government, regulatory agencies, researchers, physicians, and the pharmaceutical industry.

    For feedback to work on the system level, it must begin at the individual level. We strongly urge the implementation of feedback and self-evaluation programs to physicians for the purposes of quality assurance. Prescribers continually need access to statistically validated, evidence-based information in order to optimize prescribing and correct the most common prescribing errors.

    Many witnesses appearing before this committee, such as Dr. James Wright of the UBC Therapeutics Initiative, have testified to the effectiveness of prescriber feedback and self-evaluation programs. Such programs would provide physicians with the information about their own practice, and provide comparisons to the practices of their peers and to such best practices as clinical practice guidelines.

    Feedback and evaluation remain the best forms of learning in order to change physician prescribing behaviour. You have already heard about the “Do Bugs Need Drugs?” program in Alberta. Alberta doctors use their own prescribing profile, provided by IMS, as part of a community education program to address the problem of anti-microbial resistance.

    The program was successful in reducing the prescriptions of oral antibiotics and in increasing the selection of first-line therapies. IMS Health today is the only organization, public or private, that provides physicians with their prescribing profile and with normative information at their request. We are filling a void in the health care system that must be addressed, timely feedback to each and every physician in this country--feedback for the system, feedback for the individual physician. Can government do it all? Do you have the resources? Can you invest in the technology?

    Obviously, part of the answer lies in leveraging OPM, or “other people's money”, in the form of public-private partnerships. And I am not just talking about IMS Health's resources, however great, but those of the pharmaceutical industry as well. This cycles us back to the availability of information for all participants in the health care dynamic.

    Allow me to tackle head on the question I've ready heard debated around this table, and that is, should prescriber practice data be available to the pharmaceutical industry and other stakeholders such as consumers--with, I emphasize, appropriate caveats?

    My answer to the question is a resounding yes. One principle that trumps all in the debate--and in the interest of time, I am bypassing significant issues in drug marketing and physician education--is the principle that in order to hold someone accountable, such as a person, an organization, or a company, that person or organization must know what is going on.

    The availability of information brings with it, inexorably, an obligation to act upon it. You just can't say any more, “I didn't know, so I'm not responsible.” Shared insight into physician prescribing brings shared responsibility for safe prescribing first, and then for appropriate prescribing, and ultimately cost-effective prescribing.

    Don't complain about the promotional resources of the pharmaceutical industry; learn to use them, learn to leverage them, for everyone's benefit. In order to do so, we all need access to physician-based information to make better decisions, starting with physicians and physician organizations themselves. Let's not kid ourselves; with respect to all of the government's programs and policies, our health care system is still driven by the decision of physicians, and we need access to this information so that we can help physicians make better decisions.

    I leave you with these three recommendations embodied in just two points: systematic feedback for the individual and for the system, and shared information.

    Thank you.

º  (1615)  

    The Chair: Thank you, Mr. Korman.

    We'll move to part two of our meeting, ladies and gentlemen, and begin the question and answer period.

    Our first questioner will be Mr. Merrifield.

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you for coming in. I think we could spend a whole round of questioning with each of you, but perhaps I can pick up where IMS left off.

    You're saying that you need the feedback from the physicians and the system. I'm wondering how you're getting the information from the physician. In terms of going in and asking a physician his prescribing practices, or getting that information, can you enlighten us on how you're doing that?

    Dr. Roger Korman: The information we receive is obtained through pharmacies, not through the physician himself or herself. I think there are many mechanisms by which the information is collected and available in this country. Obviously, the provinces collect information about the drugs they reimburse for. In British Columbia, data on all prescriptions are collected. Information is collected by other parties in this country through insurance company data. Our source of information is through pharmacies.

    I think the source of the information is less material, in respect to the point, rather than the idea of collecting reasonably comprehensive information. One doesn't have to collect every single prescription in order to have an understanding of patterns of practice...and most importantly, that the information be returned back to the practitioner.

    Mr. Rob Merrifield: So you're getting the information via the pharmacist, through the pharmaceutical companies, I would imagine, and then feeding it back to the doctors. Is that what you're saying needs to be done or is being done?

    Dr. Roger Korman: It comes from the pharmacy or pharmacy-system vendors to IMS. We then make this into usable information in many different ways--by geography, by practitioner--and then we provide that information to the individual practitioner when the physician requests it. Then we group the information for other applications, including for those of the pharmaceutical industry.

º  (1620)  

    Mr. Rob Merrifield: That would perhaps enlighten the system and physician on prescribing practices, but it doesn't get to what we've heard a lot of testimony on in this committee, which is the adverse reaction of a lot of the prescribing. I'm just wondering, from your perspective, how we're going to get to the bottom of that.

    I mean, prescribing is just one thing. In a lot of people's eyes, that's just marketing. What we really need to get to is whether we're using it appropriately, and if, when there are problems with it, we are reporting it so that we're not repeating the same problem. When we hear of statistics of 10,000 deaths within our hospitals every year because of it, and 10,000 to 20,000 outside, these are remarkable numbers.

    Is your information...or are you moving there? Do you have some idea as to how that would work?

    Dr. Roger Korman: In a word, you're right, but let me take the two in tandem.

    When one monitors adverse drug reactions, the proverbial horse is out of the barn door. By examining prescribing information, one can identify many preventable issues before they produce adverse drug reactions. For example, physicians who are using drugs that may have an adverse reaction when combined ought to be especially aware and sensitive and knowledgeable about the potential negative effect of those two drugs used in combination.

    So I think the prescriber information can be used preventatively to address potential problems in prescribing.

    Mr. Rob Merrifield: But is it? To give you an example, we've heard testimony on benzodiazepines. Health Canada would say that they should be used seven to fourteen days, maximum, as a recommendation. And we know of people who have been on it from seven to ten years, and more.

    If you're flagging this, as a prescriber, what are we doing with the information? Who are we alerting? Is Health Canada listening? Are you talking to Health Canada?

    You know, you're working for pharmaceutical companies, actually--

    Dr. Roger Korman: We've made our information freely available to health researchers, and we have urged health departments and health ministries on the provincial level to access our information.

    The kinds of data that you describe I think are so obvious in the information that we collect, it is almost frustrating to see a lack of connection between the information we collect and policy-makers right now. The information is there, and one can read it as plain as the nose on one's face--

    Mr. Rob Merrifield: So would you say that Health Canada is not acting on that information? They're aware of it, but they're not acting. Is that fair?

    Dr. Roger Korman: I think that's a fair statement, and I think neither are the provinces that we've spoken to. I would tell you that with regard to the regulatory bodies of physicians that we've approached, we have said that this information is positively scary, that there are drugs that haven't been promoted in 20 years that have such high rates of utilization....

    If you understand the ratio of new prescriptions to refill prescriptions, in the case of benzodiazepines, for instance, in short-acting therapy, one should not see many refill prescriptions, because the therapy should be short-acting. But where you see ratios of refills that obviously indicate that a patient is taking these drugs for a lifetime, by reading the data, there is a world of good that can be done. And that information is not getting--

    Mr. Rob Merrifield: So from your perspective, what's limiting that in terms of action?

    Dr. Roger Korman: Commitment.

    Mr. Rob Merrifield: From Health Canada? Is the Minister of Health aware of this information?

    Dr. Roger Korman: We have made representations in the course of various policy forums at different levels of government, to bodies of physicians, to regulatory bodies. I think this is one of the tougher issues to tackle, and that is accountability.

    Mr. Rob Merrifield: I would agree. I would love to question you more, but I know my time is going to be limited, and I want to get a couple of more questions in to the other witnesses.

    To the witnesses from Gilead, the PMPRB was here before committee, saying that there is no product that is held off the Canadian market because of delays in their getting a price, or having the price that they have brought on a product. But that's not really what you're describing here, is that right?

º  (1625)  

    Dr. Mick Hitchcock: We have not gone to full commercialization. We have made the drug available to patients through this expanded access program such that those who are the most in need can get it available. However, our commercialization has not been opened up, so we are not able to market the drug to a number of patients who still would like to be on the drug.

    Mr. Rob Merrifield: How long have you been waiting for the PMPRB?

    Dr. Mick Hitchcock: We had the NOC in March of this year, and we're anticipating a decision, or at least a preliminary decision, from PMPRB in November.

    Mr. Rob Merrifield: So that's from March to November. That's interesting, because they said a couple or three months normally is the case, and it's been much longer than that.

    I just want to get one more question in, because I know my time is going to be limited here.

    Judy and André, can you tell me, how do we know that when it comes to clinical trials, the information that is collected is correct? You talked a lot about clinical trials and a lot about what's going on there, but who is auditing those trials? How do we know that it's there? You're saying what we really need are more trials in Canada, and perhaps there's an advantage in that. But I'm a little concerned that in the trials we're doing out there, they're not transparent, we're not monitoring, we're not auditing them, we don't have open disclosure of what's going on, and we have confidential agreements with some of the clinical trial people who are doing it.

    So I'm not so sure that just opening it up is the answer.

    Mrs. Judy Erola: That's not what we're suggesting. What I'm saying is that there is methodology. There's absolute scientific rigour applied to clinical trials. I think Canadians can really relax, generally speaking, about the quality of clinical trials.

    While Canada may not be auditing the trials as much, any major trial that takes place in Canada is audited by the FDA. And there are protocols in place by our major institutions that are, by and large, of first-class standard. What we are saying is that in Canada we do not have an auditing process, which we think should be in place for the benefit of patients and everyone there.

    Mr. Rob Merrifield: So the FDA is doing our auditing. Is that what you're saying?

    Mrs. Judy Erola: The FDA audits those trials that are taking place in multi-sites. Yes, they do.

    Dr. André Potworowski: For the sites or trials for the products that are going for FDA approval.

    Mrs. Judy Erola: Yes, as they all do.

    Dr. André Potworowski: So FDA, for example, will audit trials all over the world.

    Mr. Rob Merrifield: Do they use that information, then?

    Mrs. Judy Erola: Of course.

    Dr. André Potworowski: It's on that basis that either FDA or Health Canada may reject a trial because it does not meet scientific requirements. So I think part of the methodologies that the statistical data...which can represent sometimes 300 boxes of filing cabinets shipped to Health Canada or to the FDA as part of a hard copy report, and are being reviewed very carefully by reviewers, and strictly from a scientific point of view.

    Mrs. Judy Erola: Absolutely.

    In order to have a clinical trial take place in Canada, it must be approved by Health Canada for an IND, an investigational new drug, for instance. These protocols have to be approved by Health Canada, and they're very rigorous.

    Dr. André Potworowski: Canada, by the way, is considered among the top nations for quality of information.

    The Chair: Thank you, Mr. Merrifield.

    Mr. Hill.

    Mr. Grant Hill (Macleod, Canadian Alliance): Thank you, Madam Chair.

    Perhaps I can just carry on with this discussion of clinical trials. We've heard a lot of information in the committee that's been quite critical of clinical trials. Some of the critiques have been a manipulation of data, and confidential agreements such that if a worker found data that looked like it was unsafe and they made that data publicly known, they would lose their job, become a persona non grata. We've also heard of conflict of interest, of physicians receiving gifts, travel, education.

    The mindset of those people who come in here is that the clinical trials, and the people who carry them out, are in some cases in bed with “big pharma”.

    Could you comment on that mindset about clinical trials?

º  (1630)  

    Mrs. Judy Erola: I am very happy to say that although I think this is the mindset, the evidence is not there to support it. Clinical trials are conducted according to, as I said earlier, very strict protocols.

    The criticism you mentioned really comes from the transfer of knowledge, of information, that doesn't take place in many areas. That transfer is not always made available to the patient or to the doctor, although from a scientific basis, all of this is very clear.

    Patients are a little concerned about the relationship between the investigator and the trial. We have no evidence that there is any malfeasance taking place at all.

    You will occasionally find a problem with the clinical trial. People are human, researchers are human, and there have been instances indicating that data have been manipulated, but they are very much in the minority. The scientific community, I have to say, is extremely vigilant and very observant of protocols. That's why, when there is a manipulation of data, it's usually found out very quickly.

    Mr. Grant Hill: So you basically are refuting--I'd love to go deeper into this, but we don't have much time--those allegations here today.

    Now, we have had brand name companies say that they would agree to open up the process and allow the clinical trials to be publicly available if the regulator, at the same time, was open and had their regulatory process available.

    Would you agree with that comment?

    Mrs. Judy Erola: Yes, I would.

    Dr. André Potworowski: But just going back to your question about confidentiality between investigators and the company--

    Mr. Grant Hill: Be quick, please.

    Dr. André Potworowski: --it's very similar to the problem of confidentiality of intellectual property between any industry research and academic research. It's a very sensitive area, and you need to be very up front as to who owns that intellectual property, what are the contractual relationships, and how you do that.

So it's not just limited to the pharmacy, it's limited to any company, such as Nortel doing research with an engineering faculty or GM or anybody like that.

    Mrs. Judy Erola: It's a fine line.

    Mr. Grant Hill: Fair enough. I do understand.

    You also said that the ethics standards are uneven in Canada. Now, I presume you mean that province to province, university to university, there is a variation.

    Dr. André Potworowski: Institution to institution. And within an institution there may be even two or three ethics review boards that would operate differently. There aren't uniform standards.

    The same study--

    Mr. Grant Hill: I'm interested, though, in a solution to that. I recognize the problem, but I'm interested in the solution to that issue.

    Dr. André Potworowski: A number of initiatives going on right now are trying to establish either common governance on ethics review boards or mutual standards...and a number of associations have started up, including CAREB.

    One of the problems is that ethics review boards are made up of volunteers. They're not paid. If you paid them for the time they spent, especially highly qualified physicians, you might get a much higher level of ethics review, and a much faster one. There's a very interesting operational standard set by private research ethics boards that are being paid for their time. They come up with much faster and much harder decisions.

    But that's based on what we've heard. We have no hard evidence on that.

    Mrs. Judy Erola: There's a real role for Health Canada or CIHR. There was division amongst the people we interviewed, who felt there should be one body responsible for the research ethics boards. That does not exist in Canada at the moment.

    Mr. Grant Hill: Do you think there should be, or could be, one body?

    Mrs. Judy Erola: Yes, because I think it would give the patients involved in clinical trials the reassurance that there is some oversight. As well, if it were done appropriately, it would speed up the process so that companies would be able to do trials and move them along much faster because there was some uniformity.

    Dr. André Potworowski: And they should have the resources and training. They should be paid.

    Mrs. Judy Erola: Yes.

    I would add that there also should be the involvement of lay people on research ethics boards. There are lay people involved, but the patients felt that there should be more patients involved in the research ethics committees, and that they should be trained appropriately.

º  (1635)  

    Mr. Grant Hill: Am I at the end of my time?

    The Chair: Yes, you are.

    Dr. Castonguay.

[Translation]

    Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair. Thank you also to our witnesses for their appearance.

    I've heard talk of the importance of feedback in a number of areas. I agree that feedback is important. Often, it's how progress is made. When feedback is given on a ongoing basis, adjustments can be made along the way.

    We've heard how it's important to find out how physicians prescribe drugs. This would result in a safer, more appropriate and more cost-effective approach to prescribing medications. I see this as part of the equation.

    It's also a fact that consumers are exposed to a considerable amount of advertising. This puts a great deal pressure on the person prescribing the drugs. At some point, the pressure becomes so great that lapses may occur, resulting in the overprescribing of medication.

    I'd like to hear your views on this subject. How do you feel about drug advertising? We've heard a great deal about Direct to Consumer Advertising in the United States and various positions on the matter have been stated. Should measures be taken to provide information to consumers about the importance of having access to adequate treatment rather than having access to drugs?

    I'd like to hear your views on the subject.

[English]

    Dr. Roger Korman: I'm afraid my answer is more information.

    I think what we suffer from today is perhaps a lot of information from a few sources. By that I mean, much of the information that is available to physicians, for example, comes from the pharmaceutical industry, and there will naturally be a sense that this information is only there to promote the use of the drug, whether it's available direct to the consumer or to the physician.

    So I think one of the things we need in the system is a balance of information. Just as information can be targeted towards a physician by the pharmaceutical industry, as well, other information can be provided to physicians to balance it. So at both the individual physician level and the consumer level, the availability of information from all sides can restore or provide a level field, a balanced judgment, as to whether the drugs are appropriate.

    Now, with respect to DTC, it's an enormous question. I think over time the question will be less important, simply because of the general availability of information and the ability of the consumers to go and get it themselves--that is, principally we know through the Internet, but it's not necessarily the only source.

    So I don't think the focus today should be on direct-to-consumer, or necessarily a change in that particular area of policy. I think it's just going to become less important. It's going to overwhelmed with the general availability of information. I think from a policy point of view, you want to ensure that there is balance and that the people who require the information are getting the best information that can be brought to them.

[Translation]

    Mr. Jeannot Castonguay: We see just about everywhere, in magazines and on the Internet, how drugs are promoted in such a way that people are given the impression that they could conceivably live forever and enjoy an amazing quality of life. I'm curious as to the role Health Canada might play in further emphasizing to consumers the importance of having access to quality health care, rather than access to drugs.

    Certain witnesses, in particular one representative of a provincial college of pharmacists, observed that perhaps we had focused too much on accessibility, instead of looking at steps we could be taking to keep people healthy. Maybe we should be focusing on health promotion, not on the drugs used to treat illnesses.

    Do you think either Health Canada or some other body has a role to play in this area?

º  (1640)  

[English]

    Dr. Roger Korman: I'm less clear on which body should do it, but I come back to this central principle of balance, whether you're talking about one therapy versus another therapy or whether you're talking about a drug being prescribed at all. If the role of Health Canada is to promote the health of Canadians, then I think Health Canada has to take responsibility for making sure that balance of information is available to the general public, and to physicians, and to all health care practitioners.

    That's a long way of saying “yes”.

[Translation]

    Mr. Jeannot Castonguay: Do you think pharmaceutical companies also have a role to play, working in partnership with Health Canada?

[English]

    Dr. Roger Korman: I think they certainly have a great amount of the resources to do it. I come back to this question of using “OPM”, or other people's money. I know that in many of these forums, too often there's a sense that, well, the pharmaceutical industry has vast means, and one cannot compete on that field. I think someplace in this debate there is an intersection between public policy, public interest, and the resources of the pharmaceutical industry. Perhaps part of the solution lies, in working with the industry, in making sure that information is balanced, brought to consumers and to practitioners as well.

    I think too often we necessarily say, well, this is going to be another government program, or this is going to be another government expense, and of course, budgets are always in short supply. My recommendation is that Health Canada and policy-makers look at using the resources of the pharmaceutical industry to ensure that the information is balanced.

[Translation]

    Mr. Jeannot Castonguay: Thank you.

    Mr. Gary Fabian (Vice President, Corporate Relations, IMS Health): With your permission, I'd like to come back to something you said initially about the importance of feedback. I'd also like to come back to what Dr. Korman said about the importance of striking a balance. We have a marvellous example of this to share with you. I'm referring to a initiative we undertook in partnership with the Collège des médecins du Québec. We shared our database with the college to help it draw up improved guidelines for the treatment of attention deficit disorder in children. The data was used to establish guiding principles for treatment. The initiative provided them with some perspective on how they prescribed drugs, an area that we are currently reviewing. Again, this shows the importance of the availability of this information.

[English]

    The Chair: Mr. Dromisky.

    Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much.

    It's very interesting, the information being presented here today.

    First of all, I'd like to thank you very much for the contributions you're making to the control of HIV. You have to be commended, on behalf of your firm, for that type of effort and so forth.

    To IMS, you made comments time and time again in your presentation...and I wasn't too sure whether your comments were pertaining to just clinical trials or were a sweeping generalization about the population in general. I'm not too sure.

    Dr. Roger Korman: It certainly pertained not to clinical trials, which is not our area of expertise, but rather to the day-in and day-out practice of medicine.

    Mr. Stan Dromisky: Okay.

    Then we heard from Judy about the very strict protocol that is followed.

    I can agree, and I'll accept the fact that pharmaceutical companies do follow very strict protocol. There's no doubt about it. And maybe that's why everything is so secret, why they reveal no information, why they can very tightly control the information they're going to share with the general population regarding any clinical trial--or anything else, for that matter.

    When I was a professor, and students were working on their master's degrees, if they were using or quoting information from a researcher who was sponsored by, for instance, a government agency...and knowing that the researchers who were involved in that field of study, and the kinds of things they do, in order to produce the results that will guarantee them ongoing--ongoing, year after year--grants for continual research. Because professors need that research in order to survive and get promoted.

    Now, that same model could apply to the pharmaceutical companies. What variables, if you look at the bell curve on any study, at the end that are most undesirable are thrown out? Yes, protocol will be followed; we'll give you the information after it is cleansed--cleansed.

    The next question I have pertains to the information that is received. I have talked to pharmacists. I've been interested in this for 16 years because of the kinds of conditions I have had to go through personally in my family unit. I've talked to doctors who were pharmacists. I've talked to agents who travel from doctor's office to doctor's office, peddling their drugs.

    My question is, who really pays attention to the information that is given to the pharmacists about the reaction of a certain chemical prescribed by some doctor? Does that information really get on somebody's desk in terms of the decisions being made pertaining to it?

    Where is the cut-off point pertaining to the number of reports? I don't care whether it's in a clinical study or a sweeping generalization across the country. If you have a clinical study of 1,400, when do you know that a drug should not be given to people, should be taken off the market, or never be considered for the general market? Is it two people, five people, 400, 600--or never?

    I have no faith in the pharmaceutical industry's dispensing of information pertaining to drugs in general. I think that, because of their secrecy, because of the patterns of human nature, the quest for the holy dollar, the fear of being no longer part of the team, of losing your job....

    So many factors come into the picture here that I cannot accept the general statements you people are making pertaining to protocol, safety factors, and so forth. I think an independent model should be set up to do all of the trials for the pharmaceutical companies, and the pharmaceutical companies pay for it.

    Can I have some reactions to the comments I've made?

º  (1645)  

    The Chair: Very briefly.

    Mrs. Judy Erola: I can't answer all of your questions holus-bolus, but perhaps I can start by saying that clinical trials are independent. While the pharmaceutical industry pays for the trials, they go to the best investigators in the business, who are at the universities, who are in academic institutions, who are recognized for the quality of their work. So we're talking about the finest researchers in the country, whose ethics are beyond reproach. This is generally speaking; I will agree that every once in awhile you will have an outlier.

    I'd like to go back to your other issue about continuing grants. The pharmaceutical industry will never pay for studies that don't provide them value for money--and I don't mean the results that they want.

º  (1650)  

    Mr. Stan Dromisky: All right. That's very important.

    Mrs. Judy Erola: That's not the kind of thing that happens in institutions, where grant-writing, I agree with you, becomes an art of its own. That does not apply to the industry.

    But the independence of the researchers, I think, is critical, and that's part of the protocol in doing a study. It's part of the research ethics committees.

    I hope I have not given you the impression that we do not have research ethics committees. We do, and we have rigorous research ethics committees. We have good protocols. What I'm saying is that Canada lags behind in having some kind of uniformity in it.

    I think you can sleep well at night, sir. The independence of those people in the system is rigorous and beyond question.

    Perhaps, Dr. Hitchcock, you would like to add to that....

    Dr. André Potworowski: Or perhaps I can add something.

    We found in our study that if you look at every institution, be it a hospital, a faculty of medicine, or a clinic that runs clinical trials, it's usually contracted by the pharmaceutical company. No pharmaceutical companies run their own trials. They contract that out to a set body. That body has to seek the approval of a third party, a research ethics board, which is independent, that will review the protocol, will review adverse effects, will review the reporting.

    We find that these research ethics boards work unevenly. They're underfunded. They don't get paid. They don't put in the amount of intellectual effort to look at the state-of-the-art clinical trials. But there is a mechanism that ensures independence and objectivity in that.

    So the system works relatively well.

    Mrs. Judy Erola: And the regulator, Health Canada, plays a very important role in reviewing these data. These data don't come out of the sky, manufactured. They have to be reviewed, and they're extremely rigorous at Health Canada.

    We have learned that perhaps there is too much duplication. We should have more harmonization within the regulatory process, which would speed it up and perhaps give us more value for our money. Clinical trials are extremely expensive, and going through the hurdles of the regulatory system is extremely expensive. So harmonization could play a very real part in this.

    Mr. Stan Dromisky: Well, I know the pharmaceutical companies....

    Oh, I'm sorry, Madam Chair.

    The Chair: You're now about four minutes over.

    We're going to go to Mr. Merrifield again. He has a couple of quick questions.

    Mr. Rob Merrifield: Thank you.

    I just want to clear up in my mind exactly where we're at with the clinical trials.

    You're saying that we need transparency, and I couldn't agree more. When it comes to confidentiality agreements for these clinical trials, should that be common practice? That's confidentiality agreements, for those doing clinical trials, on the information that comes out.

    Dr. André Potworowski: If you look at the broader issue, which I started addressing at the end of our first round of questions, if I'm a company and I'm contracting a university researcher, and I'm paying for that research, there is the touchy issue of intellectual property. Do you as an academic have the right to publish it indiscriminately, and therefore give an advantage to my competitor, or am I allowed some confidentiality--

    Mr. Rob Merrifield: So how would you put parameters around it that would work? You've examined this, I'm sure. What kind of parameters would work, or are the parameters that are there appropriate?

    Dr. André Potworowski: I think there has to be an understanding so that the academic can publish his work and the private company still can maintain its competitive advantage, whether I'm Nortel, General Motors, or AstraZeneca.

    Mrs. Judy Erola: By and large, the system has worked. When we talk about transparency, we're talking about the data. Patients are very concerned that if the clinical trial is not a successful trial, then very often it is not published. They think that once all of the material is available, it should be made available to everyone. This means that data that aren't particularly useful to the industry are still useful to the patient and to some of those other people in the system.

º  (1655)  

    Mr. Rob Merrifield: Would you recommend a U.S. model on that side of it?

    Mrs. Judy Erola: Well, I don't know that there is a U.S. model. We really recommend some sort of database that would give you access to what trials are in progress and what trials are finished. There's the Cochrane Collaboration, but it's very time-consuming and takes place very long after the fact. Its critics say it just takes too long.

    Mr. Rob Merrifield: Okay. Thank you.

    To IMS, this question comes up because of some of the misinformation we've had at committee.

    We had some witnesses from Health Canada tell us that the prices of generic drugs in Canada are quite a bit higher than they are in the United States. We also had the generic firms here, just the other day, telling us that this is absolutely false, that they're 28% lower.

    Now, that's a big difference. You're into the tabulation of information. In fact, I think they quoted some of your numbers, Can you tell us what the actual truth is?

    Dr. Roger Korman: It reminds me of the famous Samuel Johnson saw about lies, damned lies, and statistics.

    I think it's a question that I'd rather answer with the support of the research staff, in a more comprehensive way, than try to capture it at this moment.

    Mr. Rob Merrifield: Could you send us that information?

    Dr. Roger Korman: Yes.

    Mr. Rob Merrifield: Thank you, because it's fairly important that we get that.

    I have just one last quick question on patent law, and on the way in which it looks like we're going to have legislation when it comes to HIV drugs and Africa. Can I get your take on what's happening there, and Gilead's view on that?

    Dr. Mick Hitchcock: We believe global access to life-saving drugs is extremely important, which is why we've developed our global access program for no-profit pricing.

    Mr. Rob Merrifield: Yes, but it sounds like you're doing it already, and that's why I'm wondering.....

    Dr. Mick Hitchcock: Yes. Well, basically we have no thoughts in that direction, because it doesn't impact what we're doing.

    Mr. Rob Merrifield: So you're doing it with the existing patent law rules, and what I'm saying is that we're about to change some of that. You're okay with that?

    Dr. Mick Hitchcock: Yes.

    Mr. Rob Merrifield: Okay.

    Thank you, Madam Chair.

    The Chair: Thank you very much.

    I have a question. I'm wondering what André Potworowski's academic discipline is--chemistry, physics...?

    Dr. André Potworowski: I have a doctorate in physical chemistry from the University of Toronto and an MBA from Harvard.

    The Chair: Okay. So it's a combination of science and business.

    Dr. André Potworowski: That's right, and management, yes.

    The Chair: Okay.

    Dr. André Potworowski: My research interest is in systems of innovation, research management, and that sort of thing. I'm not a pharmacologist specialist.

    The Chair: No. I just wondered if you were an economist.

    I love the questions you've raised and the points you've made, which actually coincide with what we're finding out, which is that the system is more complex than we thought, and information is far less easy to locate. While you're just talking about clinical trials, and that's an area of interest for us, some of these comments apply to other parts of our study, that it's far more complex and it's harder to get the information than we thought. It's just simple things--for example, we don't even know how many trials are going on, who is recruiting whom and for what purpose, for what disease, for what drug, and all those things.

    You also point out for us in your little summary that patients want to know more. We have heard that consistently.

    You talk about the unevenness of research ethics boards.

    In other words, in my view, the questions you have raised fulfill what is probably your next step, which is trying to get further funding for a better study. Is that correct?

    And I would back that. I would really back that.

    Dr. André Potworowski: Yes. We have a proposal that we're now trying to get funding for.

    The Chair: So now the proposal is in for further funding to get at those answers, which we would love to have you get.

    Dr. André Potworowski: Can we count on your support?

    The Chair: Well, you can count on a letter from me. I can't speak for the committee on that.

    The thing I'm concerned about is not the questions you raise, which are excellent, but the fact that this executive summary is essentially based on 40 interviews, including both patients and opinion leaders, and a review of the literature based strictly on the web.

    To me, that's probably what four researchers can do. I'm not saying that you didn't work hard. I'm just saying that four people can probably only do 40 interviews and a web review as opposed to a real literature review.

    All of that is fine with me--and apply for more money and get these questions answered, because we'd like to know too--but the thing that bothers me is the fact that having listed all of the things you couldn't get a handle on, and the unevenness of all this, you also drew a conclusion that clinical trials are great and we need more of them.

    That's why I thought you perhaps were an economist, because if you were an economist, the $800 million to $1 billion a year it brings in would be the deciding factor. But seeing as you don't know much about this yet...and neither do we, and neither does anybody except the little clinical trial they're involved in. They know all about it and nothing about any of the others.

    Nobody knows about all these things, so until you do this study, how can you recommend that clinical trials are definitely a good thing and we want more of them? What is your reason besides the $800 million to $1 billion a year and a few patients--not many, fewer than 40--who said, “We really like this and we think it's good for us”? What is the academic basis for your conclusion when your whole paper is full of questions--questions that we agree need to be answered?

»  (1700)  

    Mrs. Judy Erola: Let me go back. When I said “patients”--and we may not have interviewed as many as we wanted to, because we were limited by the scope of the funding we received--these patients were extremely knowledgeable. They were not just patients, in some areas, but people who represented health charities, who had worked for a very long time in the health field. So they were extremely knowledgeable.

    To give you an example, the HIV community has an intimate knowledge of the conduct of clinical trials and the regulatory system, and an incredible knowledge of what's happening worldwide. I would say it's probably the most sophisticated patient community in the world.

    They provided us with so much information that indicated--and I'm just taking that one patient group--the value of clinical trials, that they are of enormous importance to the health of the patient community, and that the money, from a purely economic point of view, which André refers to, was another factor. But in terms of the broad base of knowledge it brings to the patient, to the practitioner, and to the health community in the country, it is enormous.

    Therefore, the value of a clinical trial cannot be estimated only in terms of the economic benefit, which is a very important factor, but also in terms of the knowledge it brings to your health community, your hospitals, your academic institutions, and the research community.

    I might add that the research community in Canada has an outstanding reputation in terms of medical health. We have niches in Canada. Even though we are a very small country and represent a very small part of the entire clinical trials industry, it is considered a first-rate place to do medical research and to do clinical trials.

    I hope that answers your questions.

    The Chair: So it's those two answers, the patients themselves and the money.

    Mrs. Judy Erola: Yes.

    Dr. André Potworowski: From a methodology point of view, Madam Chairman, this was a feasibility study.

    The Chair: I've done them myself, yes.

    Dr. André Potworowski: Are we pounding our fists on the table, saying that we want more clinical trials? I don't think so. But I think we're coming with a sense that it may be a good thing. We're also pointing out--

    The Chair: To be fair, you didn't say that, Dr. Potworowski. You said, three times, we are strongly in favour of more clinical trials in Canada.

    Dr. André Potworowski: But we also pointed out to you--

    The Chair: And yet you don't really have the information yet to draw such a very strong conclusion.

    Dr. André Potworowski: --that we don't think the public policy question has been asked.

    The Chair: No, we agree with you on all of those things, except we're not sure about your conclusion.

    Dr. André Potworowski: I'm very envious of your position, because by listening to all of these witnesses you probably have a better big picture than we do at this point.

    But I think the patients tell us, the investigators tell us, it's a good thing, because they get research funds and so on.

    We interviewed 40 people, but we didn't interview 40 random people. We went through--

    The Chair: I understand that, and I'm not criticizing that. I'm just saying, there are so many questions raised, I was surprised at the strength of your recommendation.

    What you said the last time was, “We feel, from what we've gathered so far...”, which I would accept as a conclusion, but not the very strong wording you used at the beginning.

»  (1705)  

    Dr. André Potworowski: I think when we reviewed those who were against clinical trials, who thought they were a bad thing because there was exploitation and so on, we felt that, on balance, based on what we saw, the benefits outweighed any costs or damages. It's like any major industrial endeavour. Yes, you will have car accidents--more people die from car accidents than from any other cause in Canada--but on balance, cars are a good thing for society.

    So on balance, our perception is that it is a good thing.

    The Chair: Okay, that's fine.

    Thank you very much. On behalf of the committee so far assembled, I want to thank all of you for attending today and bringing your presentations. I haven't had time to read all of IMS's, and we may have more questions once we read it, but we thank you for the work you do and for what you're going to do for us in terms of, I think, Mr. Merrifield's request.

    Also, thanks to Dr. Potworowski, Ms. Erola, Mr. Hitchcock, and Ms. Israels for coming and informing us today.

    Sometimes it takes us some time to absorb all of the information, and we might want to phone you with another question. We hope that would be all right.

    So thank you very much.

    The public portion of the meeting is now adjourned.