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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Monday, September 29, 2003

0910

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

Dr. Barbara Mintzes (Centre for Health Services & Policy Research, University of British Columbia)

0915

0920

The Chair

Mr. John Graham (Director, Health and Pharmaceutical Policy Research, The Fraser Institute)

0925

The Chair

Mr. John Graham

The Chair

Dr. Bernie Bressler (Director, Vancouver Coastal Health Research Institute)

0930

0935

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Dr. Barbara Mintzes

0940

Mr. Rob Merrifield

Dr. Barbara Mintzes

Mr. Rob Merrifield

Mr. John Graham

Mr. Rob Merrifield

Mr. John Graham

Mr. Rob Merrifield

Mr. John Graham

Mr. Rob Merrifield

Mr. John Graham

0945

Mr. Rob Merrifield

Dr. Bernie Bressler

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

Mr. John Graham

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Mr. John Graham

Dr. Barbara Mintzes

0950

The Chair

Ms. Carolyn Bennett (St. Paul's, Lib.)

Dr. Barbara Mintzes

Ms. Carolyn Bennett

Dr. Barbara Mintzes

The Chair

Mr. Greg Thompson (New Brunswick Southwest, PC)

Mr. John Graham

Mr. Greg Thompson

Mr. John Graham

0955

Mr. Greg Thompson

Mr. John Graham

Mr. Greg Thompson

The Chair

Mr. Greg Thompson

Mr. John Graham

The Chair

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

Mr. John Graham

1000

Mr. Stan Dromisky

The Chair

Mr. Svend Robinson (Burnaby—Douglas, NDP)

Dr. Bernie Bressler

Mr. Svend Robinson

Dr. Barbara Mintzes

The Chair

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

1005

Dr. Bernie Bressler

The Chair

Mr. Svend Robinson

The Chair

1015

The Chair

1020

Ms. Colleen Fuller (President, Society for Diabetic Rights)

1025

The Chair

Mr. Brian Battison (Coordinator, Better Pharmacare Coalition)

1030

The Chair

Ms. Sylvia MacLeay (Second Vice-President and Chairperson of the Health Committee, Council of Senior Citizens Organizations of British Columbia)

1035

1040

The Chair

Mr. Rob Merrifield

Ms. Sylvia MacLeay

Mr. Rob Merrifield

Ms. Sylvia MacLeay

Mr. Rob Merrifield

Mr. Brian Battison

Mr. Rob Merrifield

1045

Mr. Brian Battison

Mr. Rob Merrifield

Ms. Colleen Fuller

Mr. Rob Merrifield

Ms. Colleen Fuller

Mr. Rob Merrifield

Ms. Colleen Fuller

Mr. Rob Merrifield

Ms. Colleen Fuller

The Chair

Mr. Réal Ménard

1050

Ms. Colleen Fuller

Mr. Réal Ménard

Ms. Colleen Fuller

Mr. Réal Ménard

Ms. Sylvia MacLeay

The Chair

1055

Ms. Carolyn Bennett

Mr. Brian Battison

Ms. Carolyn Bennett

Mr. Brian Battison

Ms. Carolyn Bennett

Ms. Sylvia MacLeay

The Chair

Mr. Greg Thompson

1100

Ms. Sylvia MacLeay

Mr. Greg Thompson

Ms. Sylvia MacLeay

Mr. Greg Thompson

Ms. Sylvia MacLeay

Mr. Greg Thompson

Ms. Sylvia MacLeay

Mr. Greg Thompson

Ms. Sylvia MacLeay

Mr. Greg Thompson

The Chair

Mr. Jeannot Castonguay

1105

Ms. Colleen Fuller

Mr. Brian Battison

Mr. Jeannot Castonguay

1110

The Chair

Mr. Svend Robinson

Ms. Sylvia MacLeay

Mr. Svend Robinson

Ms. Sylvia MacLeay

Mr. Svend Robinson

Mr. Brian Battison

Mr. Svend Robinson

Mr. Brian Battison

Mr. Svend Robinson

Ms. Colleen Fuller

Mr. Svend Robinson

Ms. Colleen Fuller

1115

The Chair

Ms. Hedy Fry (Vancouver Centre, Lib.)

The Chair

Mr. Stan Dromisky

The Chair

1120

The Chair

Mr. John Cameron (Chairperson, HIV/AIDS, Downtown Eastside HIV/IDU Consumers' Board)

The Chair

Mr. John Cameron

1125

The Chair

Mr. Malsah (Chair, British Columbia Persons with AIDS Society)

1130

The Chair

Mr. Malsah

The Chair

Dr. Steve Adilman (Clinic Coordinator, Vancouver Native Health Authority)

1135

The Chair

Ms. Joan Gadsby (Market Media International Corp.)

1140

1145

Mr. Svend Robinson

Ms. Joan Gadsby

Mr. Svend Robinson

The Chair

Ms. Joan Gadsby

1150

The Chair

Mr. Rob Merrifield

Ms. Joan Gadsby

Mr. Rob Merrifield

Ms. Joan Gadsby

1155

Mr. Rob Merrifield

The Chair

Mr. Réal Ménard

The Chair

Ms. Carolyn Bennett

Ms. Joan Gadsby

Ms. Carolyn Bennett

Ms. Joan Gadsby

Ms. Carolyn Bennett

Ms. Joan Gadsby

Ms. Carolyn Bennett

Ms. Joan Gadsby

Ms. Carolyn Bennett

Ms. Joan Gadsby

The Chair

1200

Mr. Greg Thompson

Mr. John Cameron

Mr. Greg Thompson

Mr. John Cameron

Mr. Greg Thompson

Mr. John Cameron

Mr. Greg Thompson

Mr. John Cameron

Mr. Greg Thompson

The Chair

Mr. Stan Dromisky

1205

Dr. Steve Adilman

Ms. Joan Gadsby

The Chair

1215

Mr. Svend Robinson

Mr. Malsah

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Ms. Hedy Fry

Mr. Ross Harvey (Executive Director, BC Persons with AIDS Society)

Ms. Hedy Fry

Mr. Ross Harvey

The Chair

CANADA

Standing Committee on Health

NUMBER 049

2nd SESSION

37th PARLIAMENT

EVIDENCE

Monday, September 29, 2003

[Recorded by Electronic Apparatus]

¿ (0910)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. It's my pleasure to welcome you to this beautiful old hotel in beautiful downtown Vancouver for the first session of our travelling public hearings as we look at prescription drugs and the various ways prescription drugs affect Canadians.

It's my pleasure to welcome as our witnesses this morning representatives from the Centre for Health Services and Policy Research at UBC, from the Fraser Institute, and from the Vancouver Coastal Health Research Institute. I believe we'll start with the university, with Ms. Barbara Mintzes.

Barbara, you have the floor.

Dr. Barbara Mintzes (Centre for Health Services & Policy Research, University of British Columbia): Thank you.

I coordinated a health transition fund research project to assess the potential impacts of direct consumer advertising on prescription drugs, and this involved a systematic review of the literature, original research, a survey of pharmaceutical policy experts, policy analysis, and economic analysis. We could not find any evidence of public health benefits or benefits to the quality of health care services in this overview. What we did find was evidence that direct-to-consumer advertising is linked to higher prescription drug costs. Given that legislative change is now under discussion to introduce direct-to-consumer advertising in Canada, I would like to offer a few myths and reality checks about this form of advertising.

The first myth is that direct-to-consumer advertising educates and empowers patients. By definition, advertising aims to sell a product, and this assertion often confuses health information and drug information with advertising information. A ten-year review of magazine ads in the U.S. found that most ads failed to provide the educational information patients needed. Nine times out of ten they failed to say how likely a drug was to work. Most times they also failed to provide any information on alternative treatment. Regulatory violations are also frequent in the United States. Since late 1997, when the FDA liberalized broadcast advertising, there have been over 90 violations. That's to mid-2001, so it would be higher now. The most common reasons are minimization of risk information and exaggerated benefits, and this is hardly patient empowerment.

The second myth is that ads inform the public at least about what products are available. This is assuming the public is skeptical about the information in advertising, but at least they find out what's available. Actually, advertising is focused on a very small subset of prescription medicines. They tend to be new, expensive products for long-term use in wide-target audiences. An off-patent drug will never be advertised to the public, as is the case, for example, with uncomplicated high blood pressure, where this is the most effective first-line treatment.

Myth three is that only the safest medicines are advertised to the public. In a survey of Californian residents, four out of ten people thought this was true, and the people who had misplaced faith in regulation were more likely to say they would pressure their doctor to give them an advertised drug they had requested. Drugs that have been withdrawn from the U.S. market for safety reasons have been advertised to the public, including a diabetes drug troglitazone, or Rezulin, that was a suspected cause in nearly 400 deaths. In Canada we've had advertising of Diane-35, a second-line drug for acne that has been the subject of safety advisories because of a higher risk of potentially fatal blood clots than with alternative similar hormonal products.

Myth four is that DTC ads lead to better health because people will seek treatment at an earlier stage. There is evidence that ads can bring people into doctors' offices to talk about advertised conditions. The strongest evidence has been for conditions people did not go to their doctor for very much before, such as toenail fungus. The hypothesis that ads bring in those most likely to benefit from drug treatment to a greater extent than those who are least likely to benefit has simply not been tested, and there is both broad under- and overtreatment of many medical conditions. One concern about ads is that they tend to cast a very wide net and focus on milder symptoms.

Myth five is that since a prescription is needed, the patient is protected. We surveyed patients in doctors' offices, over 1,400 patients in Vancouver and Sacramento, looking at how often people requested an advertised medicine and how likely they were to get it. Three times out of four people left the doctor's office with a prescription for the specific brand they had requested, and this in spite of frequent reports by physicians about ambivalence, unsureness about the choice of treatment. Half the time they judged it to be a possible or unlikely treatment choice, rather than a very likely one.

¿ (0915)

Myth six is that made-in-Canada ads would be more socially responsible than U.S. ads. The best example of what Canadian ads might look like is the New Zealand experience. Like us, they rely mainly on industry self-regulation of advertising. They have a more similar health care system to ours. Every ad I saw in New Zealand would have been considered illegal in the United States because of the inadequacy of the risk information, and often because of exaggeration of benefits.

Myth seven is that in Canada it is legal to advertise a prescription medicine to the public if you state the name of the product but not the indication, or the indication but not the name. This reinterpretation of a clause in the Food and Drugs Act began to appear in Health Canada documents in late 2000. The cited reference is a 1978 price advertising clause. This interpretation is consistent neither with the wording of the clause, which is restrictive, nor with the spirit of the law or the public health aims.

Myth eight is that we have to change our current law because it would not stand up to a legal challenge. This is based on a 1995 tobacco advertising case in which Health Canada was found not to have provided evidence that a full ban was needed, rather than a partial ban. Since that time, in fact, tobacco advertising restrictions have been increased. We have a new Tobacco Act. So far it has stood up to legal challenges up to the Quebec high court level. This is another rather questionable assertion.

Myth nine is that restrictions on advertising of serious illnesses are an historical anomaly that don't fit in with the 21st century. People who are seriously ill and are trying to prevent future death and disability are vulnerable in a way that people who are looking for a new car or a new pair of jeans are not. One has to look no further than a Pfizer ad campaign for its cholesterol-lowering drug Lipitor, which ran in Chatelaine last month, to understand why this is an important part of our law currently. World Health Organization staff wrote a letter to the journal The Lancet about this campaign, which was also running in France, charging that the advertiser was using fear of death to sell a product, was providing misleading information on cardiovascular risks, and the campaign was likely to induce medically unjustified drug use.

Myth ten is that prescription drug advertising is highly regulated in Canada. In Canada we rely primarily on industry self-regulation of drug promotion. We have no explicit requirements for the balance of benefit versus risk information in ads. We don't actively monitor advertising. Most violations go unpunished, and misinformation mainly goes uncorrected. If a complaint is made, the ad is allowed to continue to run until a decision is made. Why does this matter? You need to ask a 22-year-old UBC student who was admitted to hospital for pulmonary embolism. She was taking a drug that had been advertised to the Canadian public, Diane-35. She had mild pimples, which is an unapproved indication for this drug. It's been advertised on Canadian TV, in cinemas, in billboards, and in magazines. The most recent ad I've seen in a magazine ran in an August-September issue. The images in the ad are suggestive of precisely this unapproved use.

In conclusion, I would state that there is an ongoing public health rationale for maintaining the existing prohibition on direct-to-consumer advertising of prescription drugs. We need to look at our enforcement procedures more broadly to see whether they are adequately meeting public health goals. The Canadian public does need accurate, up-to-date comparative information on available treatment options, including both drug and non-drug options, and on the conditions they treat. The production and distribution of this information should be publicly financed, and it should be free of commercial interests.

Thank you.

¿ (0920)

The Chair: We'll move on to the representative of the Fraser Institute, Mr. Graham.

[Translation]

Mr. John Graham (Director, Health and Pharmaceutical Policy Research, The Fraser Institute): Thank you very much. It is indeed a great honour and privilege to have this opportunity to address this committee. So as not to hurt too much Mr. Ménard's or the interpreters' ears with my French, I will go on in English.

[English]

My name is John R. Graham. I'm director of health and pharmaceutical policy research at the Fraser Institute, an independent economic and social research and educational organization. The institute's objective is the redirection of public attention to the role of competitive markets in providing for the well-being of Canadians. It's a national, federally chartered, non-profit organization financed by the sale of publications and the tax deductible contributions of members, foundations, and other supporters. It receives no government funding. However, we have thousands of individual members, including politicians and civil servants, and I'll be happy to sign any of you up if you contact me later.

We're here to speak about prescription drugs. I'm very conscious of controversies around industry funding of research on prescription drugs. Interestingly, government-funded research does not appear to attract the same level of critical attention. Nevertheless, in the interest of disclosure, I'm pleased to state that a number of research-based pharmaceutical companies make donations to the Fraser Institute. To make it clear, we manage potential risks to our independence through a strict editorial policy. No donor--philanthropic, corporate, or individual--has any input into the collection, analysis, or interpretation of any manuscript we write, and neither does any donor preview a manuscript before publication.

I hadn't realized until this morning that Professor Mintzes was going to be our lead speaker. I would have had a whole spiel on direct-to-consumer advertising, where of course we differ. I will mention that, but I have a much broader brush to cover many of the areas that members wanted to hear from people on, it was stated, during your cross-country tour.

So I have a number of recommendations. I'm not making them here for the first time. I made them to Mr. Romanow, and it made no impact on him. I don't whether it will make an impact on you.

First, we recommend the repeal or significant amendment of the Canada Health Act to allow patients more freedom to spend their money directly on all health services or contract with private health insurers to do so, thereby allowing Canadians to determine the appropriate mix of spending on prescription drugs and other health services.

We also recommend abolishing the Patented Medicine Prices Review Board and investigating the barriers to entry into Canada's generic pharmaceutical market, and lowering those barriers to entry.

Fourth, the health minister should be required to report immediately to the House of Commons every time Health Canada takes longer than a fixed period to approve a medicine after the U.S. Food and Drug Administration or the European Agency for the Evaluation of Medicinal Products have done so.

We also recommend--here's where Professor Mintzes will jump out of her seat--amendments to the Food and Drugs Act to deregulate direct-to-consumer pharmaceutical advertising in order to approve diagnosis and prescribing. And finally, you should use every legal means possible to stop the illegal trade--and when I say “illegal”, I'm referring to American law, not Canadian law--in prescription drugs from Canada to the United States, and to educate provincial governments, especially Manitoba, that this is harmful to Canadians' health.

The first issue in the statement of requirements that I got from the committee was the issue of rising costs. Provincial drug benefit plans have managed rising costs with a variety of mechanisms. I classify them into two categories, rationing by need or rationing by disease. In the first, the government allocates the drug benefit plan's resources according to the ability of a patient to pay from his own income--that is, a means test. In the second, the government tries to decide what drugs provide better value than others, and biases its subsidies in the direction of the medicines that it supposes do so.

The history of provincial drug benefit plans indicates that the former approach is superior to the latter. For example, in the 1990s, British Columbia and Manitoba both reformed their drug benefit plans in the face of rising costs. Manitoba implemented a means test whereby the government levied a deductible of 2% or 3% of a patient's income. British Columbia, on the other hand, imposed reference pricing for a number of therapeutic classes. Pharmacare subsidized less expensive drugs in the classes, and made patients pay the full difference in price for the more expensive drugs unless their doctor applied for special authority to prescribe the more expensive drug with full subsidy.

Manitoba's policy appears to have been a relative success. As you see, I'm not opposed to Manitoba in every case. In the ten years before the introduction of the means test, Manitoba's real per capita prescription drug costs, paid by both Pharmacare and privately, increased faster than B.C.'s. However, from 1996 through 2001, Manitoba's estimated total spending on prescription drugs grew slower than British Columbia's.

These two approaches reflect very different points of view. B.C. Pharmacare believed a government-appointed committee had the competency to pick the right drugs for patients. As well as performing poorly on spending, there are some indications that the reference pricing led to some negative health outcomes, although, perhaps tellingly, that research has not been very forthcoming.

The currently evolving common drug review--and this is where the federal government comes into play a bit, I guess--is managed by the Canadian Coordinating Office for Health Technology Assessment, which receives funding from Health Canada. It has strong potential to replicate the mistakes of B.C. Pharmacare, because it operates under the fallacy that centralized government planning can make better therapeutic decisions than the multitude of physicians and patients who are actually involved in using medicines.

¿ (0925)

One barrier to the effective use of prescription drugs in Canada is that governments do not have the incentive to determine what the effect of increased prescription drug spending is on other health spending or health outcomes. Nor do they have the ability to optimize the mix of prescription drugs as either complements to or substitutes for other health services. This is due to the same fallacy of centralization that inspires ideas such as the common drug review and national pharmacare, which I thankfully haven't heard of in the last few years.

Mechanisms for reviewing and controlling prices of prescription drugs. Controlling prices for patented prescription drugs is not an important issue in Canada. Prices of existing patented prescription drugs have not increased faster than the consumer price index for many years and actually decreased last year, according to the Patented Medicine Prices Review Board.

The Patented Medicine Prices Review Board regulates patented drug prices, but it does not contribute to keeping patented drug prices down and probably causes them to be higher than they would be otherwise. Evidence shows that the drop in the Canadian dollar explains virtually the entire drop in Canadian patented drug prices relative to other countries since the PMPRB came into existence in the late 1980s. Furthermore, because prices of newly launched patented drugs are set with reference to similar drugs that are already sold in Canada, the PMPRB inhibits brand name drug makers from competing by lowering prices of older medicines.

Non-patented, single-source prescription drugs are branded drugs that were never patented or whose patents have expired and where generic substitutes have not entered the market to compete against them. Their prices are not regulated by the PMPRB. In 1997 U.S. prices for these drugs were 96% higher than Canadian prices. In contrast, the U.S. price premium for patented drugs in 1998 was 60%. The Canadian discount for branded drugs not regulated by the PMPRB was far greater than for those that were regulated.

I know a couple of the folks at the PMPRB quite well. They are well-motivated and skilled individuals. But the body does not serve any real purpose and should be abolished.

Generic drugs are relatively expensive in Canada, often higher than even in the United States. That's even after you go through the exchange rate. Some have advocated price controls for generic drugs. However, that is not the solution to this problem, because there's no way for a government agency to decide what the fair difference between a generic price and a branded price for any given medicine should be.

The problem appears to derive from a lack of competition. I don't know the answer to this. Two generic drug makers account for over half the generic drug sales in Canada. Therefore, the government should investigate the barriers to entry into the Canadian generic pharmaceutical market and make recommendations for lowering them.

Mechanisms for approving new drugs and introducing them into the market. I'm going to skim over my notes now, because I'm running out of time. Canada takes a median 39 weeks longer than the FDA to approve drugs for sale. I'm at a loss to understand why that happens. Historically, the FDA has taken longer than the Europeans do. Canadians should be allowed to buy properly labelled medicines once they are approved by regulators in the U.S. or Europe. Patients' and doctors' willingness to use these medicines would indicate how much they value Health Canada's approval process. The results might be used to justify more fundamental reforms of the approval process. Certainly, the health minister of Canada should be held accountable. She should be forced to report to the House of Commons after a certain period of time, say 20 business days, after the U.S. FDA or the European Agency for the Evaluation of Medicinal Products has approved a product.

On direct-to-consumer advertising, I'll be very quick. I'm completely opposed to Professor Mintzes's point of view.

The Chair: Excuse me, you're well beyond your time.

Mr. John Graham: Sorry about that.

The Chair: We have your paper, though, and I'm sure people will ask you questions even on those parts you have not read. Thank you very much.

We'll move on to the representative from the Vancouver Coastal Health Research Institute, Mr. Bressler.

Dr. Bernie Bressler (Director, Vancouver Coastal Health Research Institute): Thank you very much.

My first sentence is not in the brief, and after saying it, I'll then move to the brief. I think I'm going to be somewhere in between, so I thought I'd better say what the primary theme of my presentation is, which is to ask the committee to look at striking a balance for maintaining a strong environment for pharmaceutical research in Canada while ensuring that the costs of pharmaceuticals are maintained and controlled, and new therapies, home grown, are available to Canadian consumers.

I want to thank the committee for the opportunity to meet with you today. As you heard in the introduction, I'm currently director of research at Vancouver Coastal Health Research Institute, and I'm also an assistant dean in the faculty of medicine at the University of British Columbia.

We are Canada's newest health research institute. Last year we conducted $70 million in research, $8 million of which was in clinical trials research, in partnership with and sponsored to a significant extent by Canada's pharmaceutical industry. I'll focus my presentation on the importance of this partnership with the industry if we are to sustain an active health research environment in Canada where citizens have access to the newest therapies.

Within the terms of reference of your committee, the first three items listed are rising costs, followed by mechanisms for reviewing and controlling prices of all prescription drugs, and mechanisms for approving new drugs and introducing them into the market with respect to their therapeutic value, their side effects, their interactions with other drugs, as well as a focus on clinical trials.

I feel it's important to review briefly what has already taken place in Canada in relation to the first three items in your terms of reference. In 1988 the federal government introduced Bill C-22, a change in our patent laws as they affected the discovery and patenting of new pharmaceuticals in Canada. With increased patent protection in time came an agreement between the government and the industry that the industry would spend 10% of its annual gross sales in Canada on research and development at Canada's research-intensive universities and affiliated hospitals and institutes.

Of course, an additional feature of Bill C-22, later strengthened and reinforced by Bill C-91, passed in 1993 with the creation of the Patented Medicine Prices Review Board. It had a specific mandate to ensure that the prices charged by manufacturers of patented medicines in Canada are not excessive. These events began a new and extremely important relationship between the traditional pharmaceutical industry in Canada and the biomedical research community.

Universities and their affiliated hospital-based research institutes across the country developed programs to partner with the industry to attract new dollars they had agreed to spend on research and development. Probably the most important feature of this new relationship was the ability to train a generation of highly skilled clinical trial specialists in Canada. This included physicians, nurses, and others providing the technical support that is required to carry out, monitor, and analyze trials.

In our institute, we currently have 125 clinical trial coordinators, mostly nurses, who support all aspects of the trials. We have recently established a clinical trials research unit within the institute, and the unit is designed to provide a complete range of services for those wishing both industry and academic clinical research. We have state-of-the-art electronic management data, biostatisticians, data managers, a senior position methodologist, an economist, and a pharmacal economist within our institute.

The changes to the Patent Act also witnessed the real start of a home-grown biotechnology industry in Canada, largely fueled by biomedical research in hospitals and universities. In that regard, it is noteworthy that Quebec and British Columbia were early leaders, and now, along with Ontario, continue to be the Canadian hubs for the development and growth of this industry. When Bill C-90, Bill C-22, and Bill C-91 were first introduced, the pharmaceutical industry was spending $165.7 million a year on research in this country--that's in 1988. In the year 2002, the industry spent $1.1835 billion on research in this country. While these expenditures are definitely skewed to phase three clinical trials and many in-house programs, $139.9 million was spent in the year 2002 by the industry at universities and hospitals.

New drugs that are effective do cost more money. It should be pointed out that investment in new medications is carried out by the traditional pharmaceutical companies, not the generic houses. The purpose of patent protection by countries throughout the world is to keep the discovery engine going and to allow for recovery of the almost $500 million Canadian it costs to develop a new drug. What is missing are incentives for the industry to invest in drugs for which society has the most need, but which might not provide the largest return, i.e., new antibiotics for the growing problem of multi-drug-resistant infections.

¿ (0930)

Much-needed antibiotic research is in a steep downward slope, as is evidenced at a recent conference that took place in Chicago on antimicrobial agents in chemotherapy. Both the industry and non-industry representatives expressed serious concerns in this regard. The trade-off against increased costs is of course increased revenue. In that regard, government departments tend to work in vertical silos. Provincial drug costs are increasing every year, and the health ministries look for ways to control these costs.

On the other side of the equation, increased investment in R and D by the pharmaceutical industry generates new revenues to provincial economies. Investment in research, both intramural and extramural, broadens the positive impacts by creating new value-added jobs, rising incomes, wealth generation in the public income stream, i.e., taxes for governments. Moreover, according to the survey on health care in Canada, Canadians are supportive of changes to enhance increased innovation in the health sector. When asked whether incentives should be put in place to encourage more private sector investments in health research at such places as universities, teaching hospitals, and other not-for-profit organizations, 76% of Canadians agreed or strongly agreed with the statement.

Solutions are needed to create a reasonable risk and reward for the industry and a clear direction as to areas where it is apparent more effective drugs are needed. This needs to be balanced by the government's need for a rational and ethical balance between the benefits of a strong biotech industry and the necessity for making available affordable and cost-effective drug therapy. It is clear that government needs to work with industry on a sustained basis to develop a framework. It cannot be a one-off consultation process.

I would recommend a two-pronged approach: establish a healthy climate for increased investment in research and development by the pharmaceutical industry and the general wealth of all the provinces will benefit. In fact, instead of using the word “establish”, I'd like to say we should maintain what we've already done and build on it. That's probably what those comments should be.

Certainly changes to our patent laws were a major step in that direction. Drug costs have increased to about 10% of the national cost of health care over the last decade, but it is important to emphasize that at least half that cost may be attributed to the cost of generic drugs--and again, half of that is for non-prescription, over-the-counter purchases of health care products.

The Romanow report makes the point that the price of prescription drugs is addressed primarily through the PMPRB created by the federal government, as we've heard already. At the time the board was established, Canadian prices for patented drugs were second only to those in the United States. There were fears that prices would go even higher as a result of new patent protection laws. Since 1987, Canadian prices for patented drugs have dropped in comparison to median prices in other countries, and are now less than in Switzerland, the United Kingdom, Germany, and the United States, which, by the way, has the highest prices among the OECD countries. But, yes, our drugs are higher-priced than those in France, Italy, and Sweden. In fact, patented medicine prices have either decreased or remained relatively unchanged in the past decade. In the case of generic drugs, the federal government does not regulate their prices, and the price of generic drugs in Canada today is well above the median of foreign prices and basically controlled by two large producers.

The point is that we are aging, and the overall utilization of pharmaceuticals is increasing. I believe 10% is still a rather small percentage of the total cost. Our system cost $110 billion or $112 billion last year across the country, and 10% of it was spent on medications. Yet we continue to make it a national pastime to target drug costs as a way of saving our system. With that, we are primarily targeting the traditional pharmaceutical companies.

I'm almost done. Stop? I see, I am done.

¿ (0935)

The Chair: Thank you very much.

We'll proceed with the questions. The members who ask questions only have a certain amount of time for both their question and your answer, so I would ask you to be succinct as you answer.

Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): I want to thank you for coming in and sharing with us. We have quite a difference of opinion on the panel this morning, and that's always great to see. We have an ability to be able to discern what is really out there as we ask you some questions.

When it comes to advertising in Canada, I'm always alarmed when I open up my Internet and I see the amount of advertising on the spam on the Internet. Somebody out there thinks I have a deficiency in body parts and they're attempting to grow them. I am rather offended by that.

I have a two-part question on the advertising. One, are we being influenced by the overflow of the American advertising--that is, direct-to-consumer? In the regulations on it, are there any penalties on advertising in Canada, and what are those penalties?

Maybe I'd ask Barbara if she'd answer those.

Dr. Barbara Mintzes: Sure.

I think you first posed the question about the Internet. In terms of laws regulating the Internet, Canadian Internet sites are subject to Canadian law. U.S. Internet sites are subject to U.S. law.

The Internet is often used as an excuse for opening up advertising. I'm not saying that I understood your remarks in that way, but in a way the argument goes that we already see it on the Internet, so it makes no sense to have a law against it.

If you consider how people actually use the Internet, they are seeking information about a condition or a product they already have. It is quite different from broadcast television advertising or print advertising that hits a passive audience. In turn, the latter is much more effective as a marketing tool. One of the advantages of the Internet as well is that you have a range. You don't only get the division body-part people; you get all kinds of things, and most of us delete those things.

I agree that there are problems.

The other question you asked was on whether we are affected by cross-border advertising. In the study that I and colleagues at UBC and in California carried out, we did find that patients in Vancouver had less exposure to advertising than similar Sacramento patients, but they did have exposure.

I've raised the question about why we don't consider cable broadcasting that is targeting a Canadian audience to be similar to a split-run magazine in terms of regulation. It's an open question in terms of whether we are enforcing our laws.

You asked about penalties for advertising. There have been no penalties so far for any illegal direct-to-consumer advertising in Canada that originates in Canada.

¿ (0940)

Mr. Rob Merrifield: Okay. We have a law, but it's not enforced and there is no penalty. Is that what you're saying?

Dr. Barbara Mintzes: That is certainly a concern. Advertising Standards Canada enforces OTC drug advertisements. When somebody makes a complaint about a prescription drug advertisement to the public, they are actually told that it will not be investigated unless they say they will not go to the press about it. There is actually a muzzling of people who raise concerns.

I've made a complaint to Health Canada about the Diane-35 ads, together with the women's health organization, almost two years ago. There has been no discernible effect from that. They have a problem with enforcement.

Mr. Rob Merrifield: I'm sure we'll get more questions on advertising, so I will leave that for a minute.

I would ask John if he would tell us where the physicians stand. I understand you and the Fraser Institute are saying that we should not get too hung up on advertising, and go ahead and advertise. Could you tell us where physicians are at on this whole idea? Do they see advertising, direct-to-consumer, as a benefit or a deterrent? Maybe your experience in looking at the States would give you some answers here.

Mr. John Graham: I'm the last person to ask, because I'm not a physician. You have at least two physicians here, and a nurse. Nevertheless, I can report that I believe the CMA officially opposes it.

In the States, I don't know if the AMA has an official position. I know Professor Mintzes has criticized the research the FDA did on this, but the physicians surveyed by the FDA were positive about it. On balance, they thought it was okay.

If you are asking what the physicians think, I'm not the right man to answer that.

Mr. Rob Merrifield: I'll ask a different line of questions on what you're saying.

It seems to me that you have done quite a bit of study and quite a bit of work on the whole area of drugs. You're saying that the pricing review board should be abolished. Maybe you could explain it to me then. You're saying that it should be abolished, it doesn't really work, and the difference between the patented price in Canada compared to the United States is there because of the differential in the dollar rather than the actual pricing. Is that what you said?

Mr. John Graham: I actually wrote a paper on this. You can follow the line of the Canadian dollar down. You can follow the line of the price difference for the overall economy. Prices of everything in Canada are cheaper than in the United States.

Mr. Rob Merrifield: Then why is generic not following the same trend?

Mr. John Graham: That's the mystery. I would say that it is not a competitive enough market. Dr. Bressler alluded to that as well. There are two generic manufacturers that are over half of the market.

It's primarily a market, in Canada, of privately held corporations. The ownership is not that well known. I've heard, and I can't say so myself, but even the other smaller generics are owned, to some degree, by the major generics.

Mr. Rob Merrifield: Are you saying that if generics were added into the review board as a total package on drug review, you would see that as not being beneficial?

Mr. John Graham: No. I guess maybe Dr. Bressler disagrees with me on this, but we should not be giving governments the authority to determine the price of anything.

Generic drug prices in Canada tend to be around two-thirds or so of the brand-name drug price. In the U.S. sometimes they drop down to a quarter of the brand-name drug price, or maybe even less in some cases. It depends on how many generic competitors enter the market when the patent expires.

What is the fair discount? I don't know. Let the patient decide, or the insurance company.

¿ (0945)

Mr. Rob Merrifield: Okay. Maybe I'll let Mr. Bressler answer.

Dr. Bernie Bressler: On that issue, if we are going to control drugs—that's not agreeing with John or not—if the government is going to exert some control, and we don't control the price of generic drugs, generic drugs form a huge cost within our system. In fact, it's almost always the place where health authorities, hospitals, and health care systems go.

Mr. Rob Merrifield: Can I have one more quick one, one little one?

The Chair: Yes, if it's a yes or no answer.

Mr. Rob Merrifield: Yes, it's just a yes or a no.

Thank you for your answer there.

This is to the Fraser Institute. You have quite a few comments on the review, whether the review boards or faster drug approvals should be there, and that sort of thing. You've done quite a bit of work on it.

Have you done a study on how severe addiction prescription medication is in this country?

Mr. John Graham: No.

The Chair: Could I have an indication of those who wish to question? Could I see your hands?

I have about 18 minutes. I wonder if we could restrict it to three minutes apiece, and we'll be very strict with it in order to keep on schedule. You have three minutes each, because I have six questioners and 18 minutes.

Mr. Ménard.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I have two questions. First, what do you think of the suggestion that this committee should ask Health Canada not to approve any new drug that does not bring at least a 50% therapeutic benefit over existing drugs? We are told that some 60 drugs get a notice of compliance annually, and that only 10% are new drugs. This creates enormous pressures on the cost of drugs, which increases by 15% to 20% each year. So, we could recommend specifically that, if the clinical monograph of a drug does not demonstrate a benefit of at least 50% over existing drugs, a notice of compliance should not be delivered.

Secondly, the Bloc Quebecois has been advocating for years that the price of generic drugs should be under the Patented Medicine Prices Review Board. We made that recommendation in our 1997 report. I understand that this meets with the approval of all witnesses, and I certainly hope the policies of the Fraser Institute never become the public policy, because I never heard anything more threatening for the public health system than what I heard this morning.

[English]

Mr. John Graham: Okay. That was a fast question, and what's the fast answer to that?

Mr. Ménard said that only a small number of drugs have a significant benefit over already existing drugs, and you should have a large difference before it's approved.

Again, maybe you have to question a doctor, who could answer better than I can.

As I understand it, even a minor improvement in a small side effect on an individual patient can be very meaningful. Surely the answer is to have the biggest variety and selection that patients and physicians can choose from, rather than having the government decide whether this is good enough or not good enough for you to prescribe or to use.

I don't know if I can add any more to my comments on the regulation of prices of either patented, generic, or other prescription drugs than I already have said.

Dr. Barbara Mintzes: Can I add to that, as well?

Currently there's no requirement for any evidence of a therapeutic advantage compared to existing alternatives. For the large majority of new drugs, there is no evidence of a therapeutic advantage.

In a large study published this last year, the ALLHAT trial, we've actually seen that older off-patent hypertensive drugs did better, in terms of preventing cardiovascular events, than the newer drugs they were compared with.

I do think that if we're looking at drug approvals, in terms of public health goals, we should be looking at whether there is evidence of a therapeutic advantage, in terms of outcomes that are meaningful to a patient's health. It is not simply whether a drug lowers cholesterol, but whether it actually prevents cardiovascular events.

¿ (0950)

The Chair: Thank you.

Ms. Bennett.

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

Just following up on some of the direct-to-consumer advertising, I was interested in the whole piece around patient empowerment. Obviously, there are some ups and downs as to how the education.... But have you looked at anything around pooled dollars from pharmaceutical companies, which would deal with specific conditions such as depression or the things that we think are under-diagnosed or under-treated?

The second thing is that I know that the World Health Organization felt very strongly about a carve-out for tobacco products. Seeing a war between big farm and big tobacco would be an interesting thing that may benefit Canadians. Perhaps the pooling of dollars by the pharmaceutical companies, in wanting people to feel they could stop smoking, would have a good effect overall in terms of.... I think the WHO has come out pretty strongly that it would like to see direct-to-consumer advertising on being able to stop smoking.

Dr. Barbara Mintzes: Actually, the WHO has come out against direct-to-consumer advertising in general, so I'm surprised about—

Ms. Carolyn Bennett: Yes, but I think the tobacco branch has a different view.

Dr. Barbara Mintzes: Has a different perspective....

Just to answer your question on pooling of pharmaceutical industry dollars, say, for disease prevention, if you look at the way the diseases are presented in a lot of the information that comes from pharmaceutical companies, you actually can see a very large conflict of interest in the way the diseases are presented. For instance, with depression, you often have very mild symptoms being presented. If I try some of those little self-tests, I've jokingly said that I always have whatever condition I'm being tested for.

We also have the recent experience with hormone replacement therapy, which should be a cautionary tale in terms of having redefined a stage of life as a condition needing drug treatment to prevent future risks. When that was actually tested in terms of health outcomes, particularly with the results of the women's health initiative trial last year, the results are quite striking that we were doing more harm than benefit.

I would argue more that we should be providing both health information about conditions and about drug treatments without the risk of conflict of interest, so that if there is a way, rather than simply pooling money from pharmaceutical companies and having them provide the information directly or in a public-private partnership, we should perhaps be looking at a tax on sales, which is then administered through a blind trust or in some way ensuring that the information people are getting is actually focused on the most important diseases, and doesn't end up leading to medicalization of normal life.

The Chair: Thank you.

Mr. Thompson.

Mr. Greg Thompson (New Brunswick Southwest, PC): Thank you very much, Madam Chairman.

I want to address my comment to John Graham. I fundamentally disagree with your analysis of patent drug prices in regard to the Canadian dollar; I think it's terribly flawed. I did read your paper, and I don't think it would stand the test of scrutiny.

But that being said, in regard to the approval process in Canada, where we're 39 weeks behind the European Union, I do agree with you on that one, and would be supportive of finding a way to speed up that process. In fact, I introduced a private member's bill in the House of Commons, and I'm very surprised that you and your group weren't here to support me on that.

Mr. John Graham: The reason we don't support any legislation per se is that we're a charity and we don't engage in political activity--

Some hon. members: Oh, oh!

Mr. John Graham: --so we would never say we support this private member's bill. But in terms of what you agree with and what you'd agree with here, one out--

Mr. Greg Thompson: Just for the record, Madam Chairperson, that's a pathetic response. I just want to let you know, because they do get involved in private members' bills, certainly.

Mr. John Graham: Well, it's a matter of lotto or registered charities, sir. If you don't believe it, you should take it up with Revenue Canada.

But anyway, let me get to the point rather than worry about these. Do you want me to continue to respond, or is it a waste of your time for me to respond?

¿ (0955)

Mr. Greg Thompson: No, it's probably a waste of my time--

Mr. John Graham: Then I won't respond. I'll respond to courteous questions.

Mr. Greg Thompson: That was a courteous question. You asked me a question and I responded; it was a courteous response.

The Chair: Mr. Thompson, if you have another question, please go ahead.

Mr. Greg Thompson: As to the approval process of 39 weeks--the question comes down to this, Madam Chair--if we respect the European Union and the process in those various countries, why is it so terribly difficult for Canada to get its head around that set of procedures, if you will? Again, I'll address it to Mr. Graham.

Mr. John Graham: I will answer because it's an important question.

There's a sort of critical mass; we're a small country, the United States is a large country, and Europe is a large super-country, so with its size the bureaucracy in Canada is not capable of dealing with it--I think.

Also, for the research-based pharmaceutical industry there's a user-pay facility in this thing. If I'm a manager at a multinational research-based pharmaceutical company, it's a high priority to get any new drug approved by the FDA, so I'm going to invest a lot of money in stickhandling it through the FDA. Canada is an important country, but it's about 2% of the world market. Our law presents an obstacle to launching the drug in Canada such that the person with a primary incentive to overcome the obstacle is not going to invest that many resources in it.

The Chair: Thank you, Mr. Thompson.

Mr. Dromisky.

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

I have a very simple kind of question. We believe in competition, and the Fraser Institute really nurtures the concept of competition. When we talk about the pharmaceutical companies, they're for it 1,000%, but if there is a threat or if any new strategy is introduced and they're losing out, especially in the sale and resale of drugs, they scream blue murder.

Now, in your paper you're telling us that there's a strong possibility they could punish Canadians and that sale and resale of drugs on an international basis is bad for our health. So really, there is something there that is very frightening, that companies can punish a whole nation simply because the companies don't have the freedom to gouge the public as much as they possibly can.

Mr. John Graham: A company is a voluntary association of shareholders who come together and hire a bunch of managers to do something that makes money, and it will respond to a bad incentive if a political system creates a bad incentive. Now, what's happening now is that in the United States you have American politicians at both the state and federal level saying they want this reimporting of prescription drugs from Canada wholesale. Well, you cannot force a person to act against his own interests for very long, can you?

If you're going to pass a law telling a manufacturer that they are forbidden from enforcing a term of sale that says these prescriptions should go to Canadians, if the American law changes to allow that, what would you do? If 37% of the sales in the world are to the United States, how much of the profit is from the United States? It must be that well over half of global profits are from the United States. And if you keep supplying this market--Canada is 2% of the global market--and we just allow all that supply to get sucked into the United States and cut the price in the States by 40% or half or whatever, of course I'm going to respond if I'm a pharmaceutical manufacturer.

I've written a full paper on that subject alone, and I'll be happy to give you copies of it. But there is nothing we can do about the American lawmakers. Look at the way they behave. What can you do about it?

I think we have to take the initiative and make sure Canadian law ensures that medicines that are destined for Canadian patients go to Canadian patients. I have a lengthy technical argument about free trade and all that stuff, but I don't want to go through that here. You'll have to read it.

À (1000)

Mr. Stan Dromisky: Thanks, John. Can we get a copy of it sent to the clerk?

Okay, fine.

The Chair: Mr. Robinson is next.

Mr. Svend Robinson (Burnaby—Douglas, NDP): Thanks very much.

Obviously, in three minutes it's tough to follow up on this, so I'm not going to make a long preamble. I will resist the temptation to go after the Fraser Institute. I think if we accepted their recommendations it would basically just lead to the destruction of medicare in this country and lead us down the road to an American style of health care system that is being rejected by more and more Americans. So I don't want to go there.

I'd just like a clarification from Mr. Bressler, and then I have a question for Ms. Mintzes.

Does your research institute receive any funding from a big pharma...?

Dr. Bernie Bressler: We don't receive any funding directly that isn't involved with a research contract or a clinical trial. The University of British Columbia has occasionally received funding toward, say, a fellowship program or a chair. So there are just charitable donations. All the other money comes through research contracts.

Mr. Svend Robinson: Ms. Mintzes, perhaps you could clarify two points. I was absolutely appalled to hear that there has not been a single prosecution of any pharmaceutical company for breach of direct consumer advertising, even though there have been some blatant examples. I brought one before this committee just recently, and it was a clear example of direct-to-consumer advertising.

Health Canada officials said, “Well, we like to talk these things over with the company, and if there's no risk to health there's no problem, as far as we're concerned”. I'm paraphrasing in the interest of time, but that's what they said. Basically it's a question of risk. What's the risk? If there isn't a risk it's no big deal. Why would we prosecute? I wonder if you could respond to that.

I also wonder if you could respond to the concern that I and some others have that if what drives pharmaceutical research is making money and corporate profits, as it is now, why would big pharmaceutical companies engage in research to deal with diseases that mainly affect the poor, like sleeping sickness in Africa?

Dr. Barbara Mintzes: I share your concern about the lack of enforcement for direct-to-consumer advertising. In terms of health effects, some of the drugs that have been advertised heavily to the public in Canada are leaders in adverse drug reaction reporting, like the antidepressant bupropion, or Zyban.

Diane-35, for instance, is a drug that was only approved as a second-line acne treatment in Canada after it had been restricted, for safety reasons, in the European Union. It's never been approved in the States, so I guess we're faster on drug approvals than the States on this one.

There are certainly very strong concerns. These are prescription medicines, and the kinds of images that are going out in these ads are trivializing them. That's true with the Viagra ad--jumping around--as well.

A number of consumer organizations have also raised concerns with Health Canada. If you make a complaint--I've been involved in complaints--you get a letter within 30 days saying it's being investigated, and that's it. Through Access to Information Act requests, we found out that there had been no correspondence between the company and Health Canada over Diane-35 advertising for a year and a half after our complaint. So it's quite a big concern.

On the financing of drugs for poor countries, that's a serious global problem. I think there's recognition that there has to be a different mechanism of financing that research from reliance on the market, because that hasn't worked. I think in Canada--

The Chair: Thank you, Ms. Mintzes. Thank you, Mr. Robinson.

Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair.

Dr. Bressler, if I get it right, the drug cost increases are not necessarily linked to higher prices, but to the fact that we use more drugs. This is factual. Do we have evidence at the present time, at the provincial level, for example, that show savings in other areas of the health system that are linked to this cost increase, which does not necessarily flow from the price of drugs?

You have also told us that it was important to have incentives for the research-based companies to work on drugs that would not sell very much. Just what kind of incentives do you have in mind? Could you explain?

À (1005)

[English]

Dr. Bernie Bressler: With respect to your first question, about savings elsewhere in the system, one of the examples I often use when I get asked that question is that there has actually been a significant downsizing, at least in British Columbia, where I know the facts, in terms of the hospital beds available. Hospitals are shrinking, not getting larger, and some hospitals are closing. For instance, we're servicing an ever-increasing population with fewer beds. That has been shown--and for sure John will know this better than I do, so I hope I'm right--in this piece. What I've seen is that those patients are being serviced by medication. It's cheaper to put a patient on a drug that costs $1 a day than it is to put the patient into a bed. That I have to say. That's, I think, very strong evidence from within the system, never mind the other parts of the system I was alluding to in my talk--the economic advantages of doing research within our own country.

The other question was related to incentives. I really think that is a problem, creating incentives for our pharmaceutical industry. You know, we can talk down.... It's a private industry. I can't talk down any academics at the university--trust me, that's not possible. You can't easily tell them what to do research in. But you can certainly talk down private companies, and you can certainly create incentives rather than conflict about how they should benefit from doing more research in antibiotics, for example, which is a real world problem right now. You speak about problems in Africa. That is a problem. Antibiotics are a big part of that problem, as I know you know.

I'm trying to keep my remarks within our time limit.

The Chair: Thank you very much, Mr. Castonguay and Mr. Bressler.

That brings to a close this first portion. I'll just remind people that for the next set of witnesses--I think we have four or five at the table--I will be keeping the remarks to five minutes. The rules of this committee are that the official opposition usually gets ten minutes. Whether Mr. Merrifield splits them with one of his colleagues or whether he holds onto them is his choice. Everybody else gets five. That is the usual rule.

So we'll proceed apace, with the small restriction of what I did this time. When I see how much time is left, what I do is cut everybody back. I cut Mr. Merrifield back to seven, and then split the rest of the time evenly, which was three minutes apiece.

Mr. Svend Robinson: I have a very brief point.

I wonder if perhaps the steering committee might review the allocation of time on the first round. If we could put that on the agenda, I think it would be appropriate.

The Chair: Thank you.

We'll call a short recess now and resume at a quarter after the hour.

À (1015)

The Chair: I call the meeting back to order, ladies and gentlemen, for our next round of presenters.

We'll begin with the representatives of the B.C. Health Coalition, Terrie Hendrickson and Patt Shuttleworth. I remind you that you have five minutes.

À (1020)

Ms. Colleen Fuller (President, Society for Diabetic Rights): Hello again. Thank you very much.

I am going to speak very briefly, because you have our brief and I think probably most of the members of the committee are pretty familiar with the situation concerning biosynthetic insulin, since hearings were conducted by the committee earlier this year.

I want to go over very quickly the recommendations we're making. We focused on two areas. One is the area of drug approval and the other is the reporting of adverse drug reactions in Canada. Although we could comment on the other points that the committee is studying, we chose to focus on those two areas in our submission.

We represent people who have had adverse reactions to biosynthetic insulin, as you know. There are a number of reasons that situation arose. In addition to the fact that the insulin causes these effects, we think there are certain things that could have been done by Health Canada to protect people so they wouldn't have experienced these really devastating consequences of using biosynthetic insulin, beginning at the drug approval process.

We feel that the evidence that was submitted to support the approval of biosynthetic insulin was questionable to begin with and that there should have been something in place so Health Canada would have done a much more penetrating review of the evidence--identify witnesses in the evidence or at least address questions to the manufacturers of insulin. In our view, that did not happen at the high level that we would expect to protect our health.

We feel that since Health Canada was not able to do that, we should have been able to do it. We should have had access to the evidence that was submitted by the companies. It wasn't until the Cochrane review, with which most of you would be familiar, that we really had evidence to suggest that we weren't the only ones asking the questions we were asking about the evidence submitted to Health Canada. But we should have had access to the evidence, because this would have strengthened our resolve, I suppose you could say.

The other thing is, we know, because of discussions we've had with a number of physicians who were involved in clinical trials in Canada, that there are some questions about those trials and the evidence that was collected during them, and these physicians are not able to disclose the evidence because of confidentiality agreements. This has really hurt us, because whenever we report adverse reactions to doctors or other people, our evidence doesn't weigh as heavily as evidence that's collected during clinical trials.

A lot of doctors who would have spoken up in support of us, based on evidence they had collected, were prevented from doing so because of these confidentiality clauses. This has really hurt a lot of people, and this is not the case just with diabetics, but with other people as well. These confidentiality agreements should be banned in Canada, so those doctors have not only a responsibility but a right, as well, to disclose all of the evidence collected during clinical trials.

We support also the establishment of external advisory committees to work with Health Canada and be able to have a more open and public discussion about drugs that are being considered for market approval. If people with diabetes had been able to participate in such committees when biosynthetic insulin was being approved, I think we would have been much better informed as consumers in terms of what kinds of insulin we would be using to treat our conditions.

Moving to ADR reporting, the Society for Diabetic Rights is the only organization in Canada that was specifically focused on collecting adverse drug reaction reports on biosynthetic insulin. We had no help from anybody. In fact, all we did was meet a lot of grief and resistance from Health Canada, as far as we're concerned. We had no support from Health Canada to undertake this. This is a hard job--collecting adverse drug reaction reports. It's horrible actually, day after day talking to people who have had these horrible reactions to biosynthetic insulin.

À (1025)

In our recommendations, as you can see, we are really urging that Health Canada put more resources and more funding into the collection of adverse drug reaction reporting in Canada so that consumers who are experiencing these things and who are on the front lines of finding out whether drugs are safe have that option and have the knowledge so that they can report adverse drug reactions.

Thank you.

The Chair: From the Better Pharmacare Coalition, we have Mr. Battison.

Mr. Brian Battison (Coordinator, Better Pharmacare Coalition): Good morning. This is who makes up the coalition. We are national and provincial health organizations and consumer advocacy groups. Our members include the Arthritis Society, the B.C. Lung Association, the B.C. Schizophrenia Society, CARP, Canada's Association for the Fifty-Plus, the Heart and Stroke Foundation of B.C. and Yukon, the Parkinson Society of British Columbia, and others.

Our mission, really the common denominator that brings us together, is our belief in access to medications. It is vital to the patients and to the consumers we represent. It's vital that they get the medications they need. Their quality of life is tied to those medications, and in some cases their lives depend on it. So we concern ourselves with health policies that interfere with patient access.

Our aim today is to try to get the committee to think of themselves not as legislators or politicians but as patients. Let's say later this afternoon, tomorrow, perhaps next week you go to your doctor and you're diagnosed with a particular illness. The good news is that your illness, with treatment, will not be terminal, so there's something that can be done about it.

First thing you're going to do is this. You want to find out as much information you can about what challenge you're facing. You're going to go to the Internet, you're going to talk to friends, you're going to go to health professionals, and you're going to find out what you're up against.

The treatment that you're likely going to be prescribed will involve medications. So you talk to your doctor about those options and you want to eliminate anything that might be standing in your way to keep you alive. You don't want interference from governments in the decisions that you and your doctor are going to make. You want the best medicines, the best drugs, you want the best fighting chance for yourself.

Now, many in Canada brag about the health system that we have here that it's among the best in the world, and you cross your fingers and you hope they're right.

Imagine that it's somebody more important than yourself, that it's your daughter or your son. Now you're really going to be diligent about getting the right information, the right medicines for them.

Here's how we view pharmaceutical products. They save lives, they prolong lives, they enhance the quality of life, they shorten hospitalization periods. They often eliminate the need for more expensive treatments, for some surgeries, for treatment regimes, tests, for repeat doctor visits. They prolong independence; they keep you out of requiring assisted living or immediate care or extended care. Most often the fastest way to cure a treatment or an illness is through medication, and the fastest is always the best, always the cheapest in the long run.

In our view, medicines represent some of the best value in health care today. A dollar spent on medicine is likely the best, most effective dollar you will spend in health care. So increasing the drug budget is not necessarily a bad thing. It might be the best dollars that you're spending.

Governments have two choices to manage the costs of pharmaceutical products. These are your two choices: you can restrict supply or you can manage demand. We support managing demand through disease management programs, as opposed to restricting supply.

We'd like to make six recommendations. The first is always think like a patient, don't necessarily think like a politician or a regulator.

The second recommendation is view medicines not solely as cost centres requiring control and restriction but rather as valuable scientific advancements that improve the quality of life, that conquer illness and disease, and that help reduce costs in more costly areas of the health care system.

The third recommendation is control costs by managing demand, not by restricting supply.

Fourthly, don't allow government policy to interfere in the doctor-patient relationship; nothing can kill quality faster than that. The vital doctor-patient relationship is the heart of the health care system.

The fifth recommendation is give patients their best chance by allowing their doctors access to a full arsenal of weapons to help fight their battles against illness.

Finally, the sixth recommendation is accept the commonsense notion that access to medications is good for health and it's good for taxpayers.

Thank you.

À (1030)

The Chair: Thank you, Mr. Battison.

Our next speaker is from the Council of Senior Citizens Organizations of British Columbia, Ms. Sylvia MacLeay.

Ms. Sylvia MacLeay (Second Vice-President and Chairperson of the Health Committee, Council of Senior Citizens Organizations of British Columbia): Hi. I represent COSCO. And when I say that, people always say to me, well, are you going to get us a deal at the box store, or else they say do you have something to do with those big barges that say COSTCO on them that are really Chinese shipping?

No. I represent about 42,000 British Columbians from across the province, seniors from all walks of life. I guess my approach is a little different from some of the others.

We know that modern science is now changing the nature of medicine as a result of mapping the human genome. The knowledge of gene location and nature and function is going to allow for the development of many designer prescription drugs. Better quality and increased lifespan will follow, as we get the ability to control diseases and perhaps cure some of them.

However, these are our concerns. Escalating high costs of prescription drugs will be inevitable, because they won't be developed cheaply. Seniors have fixed incomes, or most of us do, and they're not all very high. We all need more information about health problems and prescriptions and treatments. We don't get enough of that, and there's a strong feeling that we need more accountability for how the tax dollar is spent on medicine and medicare, including prescription drugs.

We have eight recommendations to make. First of all, we think the health committee should take a very close look at the patent drug laws. We recognize that the cost of development is something drug companies will wish to recover, and certainly Canada should pay its share of whatever that is. We're a small market for global drug companies—multinationals—so we should be paying our share but we shouldn't be paying any more than that. If we're only 2% of the market, that's what our share should be. Once the price is paid, the drug price—whatever the first one is—should be adjusted so that the company makes a reasonable profit but doesn't gouge the whole paying public worldwide for their product.

We feel that patent drug protection should be shorter and should not be extended once the period has gone by, and that should include a look at how generic drugs are regulated, because well-set-up generic drugs would be an advantage, I should think, to everybody. That's one.

Second, we think we need to have a national prescription drug formulary under the federal government for these reasons: to allow bulk purchasing at reduced costs; to ensure consistency across Canada of availability and cost of drugs; third, to provide an objective assessment of prescription drugs by experts—and we sure don't have that now; fourth, use computer technology and other advances to monitor drug effectiveness, side effects, costs, drug interactions, etc.; and fifth, we think there should be reporting annually to all Canadians on the costs and values of the program.

We're concerned about the speed of testing and certification of new drugs. Quite frankly, seniors often get in the position where death may be the alternative to being able to access something new that may prolong their lives, perhaps not cure, but prolong their lives and make them better. So naturally, we'd like to see that happen expeditiously.

We wonder about whether we have enough people to do the testing the way they should do in our Health Canada setup and whether we're reinventing the wheel, if in fact the European markets and the Americans have ratified them. We should look at those things.

We should encourage Canadians to be proactive about their health, and for that reason we should make available to them as much information as we can about health conditions, diseases, treatments, drugs, etc. We give lip service to that, but we don't do much about helping people to be better informed. For that reason, I would disagree with our lady from UBC that we shouldn't do any advertising of drugs.

À (1035)

Knowledge is power. The more people know about things the better they're going to be able to deal with their own health situations. She reminds me of the NFL. They couldn't use any technology to look at plays that were in doubt for years, because they couldn't figure out how to use it, even though the cameras would show exactly what the play was. So the same thing applies.

There are two more, if I may. We need to try to cut down, because there is some over-prescription of drugs and some abuse. Obviously, you have to deal with the prescribers and the pharmacists on that. But seniors have different drug level needs perhaps from other people. Their bodies change. We should try to reduce interactions that people have or tendencies to forget to take their drugs properly, even maybe with the best intents, regardless of age, I would suggest, by developing time-release products and patches and implants that may make it more efficient.

In addition, at times I think we should de-list. We should de-list drugs that are ineffective or have very serious side effects.

À (1040)

The Chair: Questioning will begin with Mr. Merrifield.

Mr. Rob Merrifield: Thank you.

I'm going to pick up where you left off a little bit on prescription medications. You're saying that there is some addiction.

We had testimony last week actually come in from Health Canada telling us that somewhere between 19% and 36% of our population has mis-prescriptions per year. That's a significant amount. If you balance that off, almost 30% of our population have mis-prescribing of pharmaceuticals. You couple that with what has happened with the health accord. Looking forward to a national pharmacare program, or catastrophic drug program, which has been recommended under the accord, you have to examine and ask this. If we're going to open this up, if we're going to allow easier access to pharmaceuticals, then what kind of a problem are we going to run into when we know that already 30% are being mis-prescribed? What kind of a problem are we going to have?

We've been challenged by a number of you to think as a consumer. That's exactly what I'm doing. The number of deaths per year in Canada because of pharmaceuticals.... Now you're advocating for more pharmaceuticals. I'm not here to challenge that, except to say that you have to look at the other side of it. How are we going to deal with that? Do you have any ideas?

Ms. Sylvia MacLeay: You're really talking to the wrong people.

Mr. Rob Merrifield: You are a consumer.

Ms. Sylvia MacLeay: Yes, I'm a consumer, but seniors don't prescribe their own drugs. Doctors do that, or other prescribers. Those are the people who have to somehow or other get their heads together and think about....

For example, I had a call over the weekend from a lady who is 87 years old. She has six different health problems. She's taking nine prescriptions per day to manage these things. Does she have drug interactions? Probably. Is she getting too much of something or other? Probably.

Prescribers are the people who need to keep themselves well informed. Average citizens are not going to prescribe their own drugs, no matter how much they know about them. They may look at the TV and see the ad, ask their doctor, but the doctor is going to prescribe.

Mr. Rob Merrifield: I would concur. I have no argument there, but I do go back to, I believe it was Brian who was suggesting thinking as a consumer. Not to get in the way of the patient-physician relationship, but we have the majority of family practising physicians in this country who are so stretched to the max that they will not take any more patients on because of that. The relationship between that patient and physician is compromised to the point that I believe they're prescribing pills when they should be consulting. From your perspective, because you challenged us by saying think as a patient—I'm doing that—how much of the stress of that relationship do you think comes on the amount of pharmaceuticals that are being prescribed?

Mr. Brian Battison: Put yourself as the patient: it's your doctor and you who are going to decide how to manage your illness or the number of illnesses. It shouldn't be anybody else. You have a responsibility to comply with the prescription you've been given, to take the one pill a day with food, to take it three times a day, or whatever the prescription is. So patients have obligations to this system as well.

Disease management programs help to educate physicians about proper prescription writing practices, to educate patients about how they should take their medications, when they should take them, and when not to take them in the case of asthma, perhaps, whether you take a rescue medication or whether you take a long-lasting medication. Rather than your just getting handed a prescription by a doctor and then getting handed the drug by the pharmacist, maybe the pharmacist should be saying, look, you've got asthma; this is the medication you should take. Your first stop should be down to the Asthma Society of Canada to learn about asthma, learn about these medications, and learn about how and when you should take them and what they do. Those are disease management programs, and that's how they operate.

Mr. Rob Merrifield: Sure.

Would you, then, as consumer advocates, recommend your medical records following you into the doctor's office, every doctor, every office, disclosure of that information?

À (1045)

Mr. Brian Battison: I think they do follow you, don't they?

Mr. Rob Merrifield: No, they don't. And that comes back to Colleen Fuller. You're suggesting that this is a problem you had with mandatory reactions. You said something about Health Canada actually giving you a difficult time in finding this out because of confidentiality agreements. I'm a little confused as to exactly what you're saying and why that was happening.

Ms. Colleen Fuller: It's the physicians who are involved in clinical investigations under contract with the pharmaceutical industry who are bound by confidentiality clauses in the contracts, so that if there are adverse reactions that are seen in some of those clinical trials, they're not necessarily at liberty to disclose them. All I have to do is point out what happened to Nancy Oliveri when she did try to break out of that confidentiality thing around her neck so that she could disclose some of the adverse reactions her young patients were experiencing. That also has happened in the area of biosynthetic insulin in Canada. We know that's the case, but those physicians are not at liberty to disclose their findings, because they want to continue to get contracts.

Mr. Rob Merrifield: So it's the agreement with the pharmaceuticals?

Ms. Colleen Fuller: That's right.

We've obtained some of the evidence of the trials that was submitted to Health Canada. We had to go through freedom of information. We didn't even know how to apply through freedom of information to get this type of information, but we learned how to do it. We had to pay money to get the information we wanted. It's cumbersome, then we get the information and a lot of the most pertinent data are missing, because they're being blacked out. And that's because the drug companies are the ones who give the okay about whether this information is going to be released or not.

Further, a lot of the studies have not been published. All the studies should be published, not just the ones the drug companies think are going to support their application for marketing approval.

Mr. Rob Merrifield: That tells me the problem with the pharmaceuticals, not with Health Canada.

Ms. Colleen Fuller: Health Canada is part of the problem, because they're--

Mr. Rob Merrifield: You're saying there's a link there?

Ms. Colleen Fuller: There's a link on that end of it, and also I think on the reporting side. The drug approval process is one thing, but the whole clinical trial process includes post-market surveillance, and Health Canada has some responsibility to ensure that post-market surveillance is a really good system, I think they have, particularly in the last two years, put in more resources. The regional offices for ADR reporting have, I think, really supported increased access to that service. And the data that come out of Health Canada indicate that the fastest growing numbers reporting are consumers. I think that's really a positive thing, but it's not anywhere near what it needs to be.

I know there are also some problems with people who feel that consumer reporting is somehow a poorer quality of report than you would get from your physician or from a pharmaceutical company, and I think that needs to be reassessed by Health Canada as well.

The Chair: Thank you, Mr. Merrifield.

Mr. Ménard.

[Translation]

Mr. Réal Ménard: Thank you, Madam Chair.

My question is for Mrs. Fuller. At the beginning of our proceedings, we got a bit of information. Obviously, what we are interested in is your specific example concerning the Eli Lilly Canada and Humulin, a drug that got a notice of compliance and was approved by Health Canada.

You may know that this committee will visit the Health Canada installations to actually observe the approbation process. We have been told that it has four stages, that it is a very complex process that is paid for by the drug companies and that it could take up to a year and a half to two years.

I wonder what went wrong. I am not talking here about the drug companies because once their clinical trials are done, examiners and officials in Health Canada take over and examine the findings of clinical monographs. What to you thing went wrong? Please give us as much information as you can so we can raise this case. We could even call the officials before the committee. What is the present status of Humulin?

Once you have answered, I would like to ask a question to the witness next to you.

À (1050)

[English]

Ms. Colleen Fuller: We only have, I think, part of the story with the evidence that was submitted to Health Canada, but what we do have now is a very important study that was done in England. Several members of the committee will be familiar with the Cochrane review that looked at the evidence used to support approvals, not just in Canada, obviously, but in different countries, for human insulin, as it's referred to. That evidence was very weak, we feel. The Cochrane review concluded that the methodologies employed to test the insulin were--

[Translation]

Mr. Réal Ménard: Usually, Health Canada makes a decision on a notice of compliance on the basis of Canadian evidence. Do you mean that in this instance, Health Canada relied on evidence that was not collected in Canada? If it did, this is completely against the regulations.

[English]

Ms. Colleen Fuller: I can't answer that question, but one of the studies we did get for human insulin that was submitted to Health Canada was, I think, based in Wichita, Kansas. I don't know all of the studies that were submitted to Health Canada by the two companies, Novo Nordisk and Eli Lilly. One of the studies, as I understand it, that was submitted to Health Canada by Novo Nordisk was referred to in the Cochrane review as the Gardner study. In the review it says that some of the data were missing in that study. We know one of the physicians who was involved in the study, and it was his data, according to him, that were missing. If Health Canada knew about that information, they should have been inquiring more vigorously about what it meant, because a lot of it confirms the later experiences we had once that product was on the market. This is according to the doctor. We think Health Canada was not vigorous in reviewing the evidence, that the Cochrane review did raise a lot of serious questions about the quality of the evidence that was submitted. We had to wait almost 20 years after this product was on the market to find out about the poor quality of the evidence that was put together by these companies to get approval.

[Translation]

Mr. Réal Ménard: One last question. When you list in your brief, which I have in French here, the ten most prescribed drugs in 2001, I suppose this is for your province's pharmacare plan, in BC. It would be interesting to know whether they are all patented drugs or whether there are also generic drugs in the list. I imagine the health of senior citizens is not very different from one province to the next.

[English]

Ms. Sylvia MacLeay: The ten drugs were published by the British Columbia health ministry as being the ten that are most used in B.C., and I believe none of them is generic, though I really can't swear to that. I guess the question would be, if they're used in large quantities, why wouldn't they, at one point at least, become generic?

The other thing I would say in relation to that is that in B.C., and I don't know if it's the same all over Canada, we have something called PharmaNet. This enables a druggist to connect with the provincial government and it enables transmission of information back and forth about the client, the prescriptions, etc. That gives druggists, I think, the possibility of helping to be a watchdog against over-prescription, because the druggist, when he pushes the client's name into the computer, sees the full range of what that person is taking. The doctor should know that too. Whether he keeps up to date with it or not is another thing. That's a control that is quite easy to do.

The Chair: Thank you, Mr. Ménard.

Ms. Bennett.

À (1055)

Ms. Carolyn Bennett: Thanks very much.

A lot of what we're talking about is accountability and consumer input. I wonder if each of you would just give me an idea of your response to the Romanow recommendation of the separate drug agency and how you would see the accountability to Canadians of such an industry. Some of us have seen a lot of independent agencies that don't seem to have the accountability. Would that be accountable to Parliament? Would you see it some other way? And what would be the role of consumer input into such a drug agency? FDA has this separate arm where consumers get to green-light and red-light drugs based on international evidence and whether they think their country needs to go through it all again or whether there's enough international evidence to satisfy consumers that they need quicker drugs, particularly for things like cancer HIV/AIDS, those kinds of things. Can you help me with this?

Mr. Brian Battison: We have a tough enough time keeping after the provincial government, let alone watching the feds as well. I'd like to make a couple of comments about that.

If you're talking about a common drug review, which may be part of this agency--

Ms. Carolyn Bennett: And a common formula such as the EU has.

Mr. Brian Battison: If the Government of Canada approves a drug for use in Canada and then informs the provinces, the provinces still have the right to deny coverage for that product. It's the coverage of that product that impedes access to medications on occasion. If there's going to be a common drug review for all of the provinces, if the provinces still have veto power over whether or not they cover it, I don't know how much further ahead you're going to be in public coverage.

Ms. Carolyn Bennett: I was hoping for some collaboration. Seeing that VISA could do it with feuding financial institutions, we're wondering why the provinces can't.

Ms. Sylvia MacLeay: I don't know what all the complications might be in setting up a drug formulary that would be effective, but it seems to me that the advantages would have to be positive ones. I have a very strong feeling--perhaps I'm a pessimist--that many of the people who purchase from drug companies or receive documents and brochures pushing certain products that are being produced don't take the time to research them very well, as Romanow said in his report concerning the purchase by health care facilities of expensive pieces of equipment like MRIs. He implied that we needed a central purchasing agent for that kind of thing, because the folks who were buying didn't know enough about the things they were buying, and they were expensive. So I presume that if we could bulk-buy drugs and get a really good price on them, which we ought to be able to, if you could put the demand from the whole country together, at least for the commonly used drugs, there would be a cost incentive. Brian is right, it's quite possible that an individual province could say, we have control over this, and we're not going to use this, even though it's been recommended. Somehow I don't think that would happen if the price was right.

The Chair: Thank you, Ms. Bennett.

Mr. Thompson.

Mr. Greg Thompson: Thank you, Madam Chair.

I have a question for Sylvia MacLeay. I took great interest in your presentation. There are just a couple of points I want to bring out.

You mentioned that doctors prescribe, and there was already a question put to you regarding the pressure that doctors are under to prescribe. I reference this simply because you're talking about advertising. Knowledge is power, and we understand that, but the point I'm trying to make is the exaggerated claims of some drugs that are advertised, exaggerated advertisement that might entice someone like myself or older to go to the doctor immediately and request that drug.

I'm talking about, for example, the drug Viagra. My wife gets pretty excited when she sees people jumping over fences and leaping tall buildings in a single bound, which obviously is somewhat exaggerated, although we should hear testimony from those who have actually taken the drug.

The point I'm making is that I think Mr. Merrifield is correct in suggesting that doctors are under a lot of pressure. We have some doctors here with us today in the committee, as you well know. Someone goes in saying, well, this might work, but it could be very dangerous for that person's partner, for example--not to mention the patient himself or herself.

What I'm suggesting is, at what point do pharmaceuticals treat advertising as McDonald's Corporation might? For example, this morning I saw the Swiffer Dusters, a feather duster, advertisement. This was the one where the woman with the blonde hair came in, and she was the smart one this morning in that particular ad, suggesting that her friend with the dark hair should have one, but exaggerated claims in terms of what that product can do. So how can we possibly keep away from those types of exaggerated claims?

There is a lot of evidence out there today to suggest that pharmaceutical companies will do just like any other corporation, with exaggerated claims simply to sell their products, with a great risk to consumers.

Á (1100)

Ms. Sylvia MacLeay: Well, I would advocate for truthfulness in advertising. That implies that you have to have a watchdog. You have to have some group or some person who would cause a company to withdraw an ad or modify an ad if the claims made were outrageous. That would have to be done at a governmental level, I presume, either provincially or, I would suggest, probably federally. But assuming there is truth in what is advertised, then I think that's a positive thing for the public in general.

I do know, because I've just gone through a five-year period with my husband, who passed away a couple of months ago.... I found out that I could go on the Internet and find out all kinds of information about his cancer problems, his medications, his chemotherapy, radiation, and so on. When I went and talked to his oncologist, the oncologist was not as informed as I was in certain cases. That's scary.

Mr. Greg Thompson: Just to reference that point, because I too at one point was diagnosed with cancer and went through treatment, some of the information on the Internet is not accurate, as physicians will attest to.

Ms. Sylvia MacLeay: That's probably true.

Mr. Greg Thompson: So I don't think we can assume that all doctors are wrong.

Ms. Sylvia MacLeay: No.

Mr. Greg Thompson: But again, in terms of knowledge, I think a regulatory agency by the government in terms of drug ads would be very problematic. I'm not sure, because I think you'd have to agree that if you're watching a Viagra ad on television, as the one example with which most of us would be familiar, those ads are somewhat comical in nature, certainly exaggerated, and they don't really quite reflect the effectiveness of that drug in many, many cases. So I guess the question is, how many people run to the doctor for the magic cure, only to find out that the magic cure doesn't work?

Again, the other side, Sylvia, is the point referenced on the cost of advertising for drug companies, and what does that do to the price. Again, a McDonald's hamburger would cost less if McDonald's didn't put on a massive campaign to promote, say, the double cheeseburger, or whatever.

Ms. Sylvia MacLeay: I can't answer those questions, but I still maintain that the more people know about their health, the more proactive they will be, or can be and should be. The day has gone by when the patient would calmly sit down and the doctor would speak from on high, like the Lord himself, and pronounce whatever he or she pronounces.

Mr. Greg Thompson: It's interesting how the pharmacist is still elevated a foot and a half higher than the consumers when they get their drugs.

Ms. Sylvia MacLeay: Yes, and I'd like that changed too.

Mr. Greg Thompson: Good. Thank you.

The Chair: Thank you very much.

Dr. Castonguay.

[Translation]

Mr. Jeannot Castonguay: Thank you, Madam Chair. I listened carefully to my colleague's remarks.

Several witness have emphasized the need to empower the consumers. We have also been asked to step into the shoes of the consumer. It seems obvious to me that when I go to the doctor, I should tell him which drugs I am taking. Our system appears to be somewhat lacking in that regard. We think it is good enough to rely on what we see on the television and on what the physician prescribes. We shop around and decide that for a medical condition of some kind, we should use such and such a drug. Ultimately, we end up in situations where some people use a tremendous amount of drugs, up to ten or twelve drugs. It is crazy. Besides, there is the problem of interaction between drugs. I am sure it is the case.

Do you think the Government of Canada could, through Health Canada, play a certain role concerning the education of the public?

Do you think that, in our present system, there is room for more education on the need to empower the consumer as far as health care is concerned?

Á (1105)

[English]

Ms. Colleen Fuller: I think consumers should, and I think most would like to, be better able to make informed choices in the marketplace and so forth. I do think there is a real role for Health Canada in ensuring consumers are as educated as they can be.

I say that also knowing that the market can't be the answer for everything. You can't go to the marketplace and trust that it will be able to solve all your problems. Nonetheless, consumers should be as informed as possible.

One of the ways to inform consumers is to set up a mechanism so they can share the experiences they've had with the prescription medicines they buy through a really good, strong, effective post-market surveillance set-up. That's a responsibility that Health Canada has.

I'm the president of the Society for Diabetic Rights, but I'm also the executive director of an organization called PharmaWatch. We strongly believe in and support the right of consumers to report adverse drug reactions. The people who use prescription medicine are on the front lines a lot of times, and they have no way of communicating with one another.

Consumers should not be depending on the pharmaceutical industry. I disagree with Sylvia's comments on direct-to-consumer advertising. I think that's just deadly. I don't think we should have that system. But I do think consumers should be telling each other what their experiences are. That is really effective, and it's also a very empowering thing for consumers to have that information.

Mr. Brian Battison: I think individual responsibility is a big part of health care, and probably we don't take our individual responsibilities as seriously as we should, whether it's diet, smoking, drinking, or lifestyle. That has to be a big part of the future.

What role does the federal government have in making us aware of our responsibilities? Maybe there is a role for the federal government to do that. Just like when the 40-year-old Canadian was as healthy as a 60-year-old Swede--I remember that one from years ago--we became more aware of our health condition and our lifestyle, and we made adjustments. I think there are big savings to be made there.

The PharmaNet program in B.C. was mentioned earlier. Druggists and all doctors have access to every individual's drug history record through PharmaNet, and it follows you wherever you go.

I had a recent experience where I needed to see two different specialists in addition to my family physician. When I went to the specialist, I asked him what he knew about me. He said “Well, I have your records here. This is what I know. This is what I've been told. What can you tell me?” I gave him my story and he did his work. When I went back to my family physician, I said “What do you know about me now?” He said “Well, your specialist has given you these tests. These are the results. This is the course of action he's recommended to you. I concur with that.” And away we went.

As a consumer, as a patient, I asked for that information. I wanted to know that my GP was informed. I wanted to know whether my specialists were informed, and if they were talking to one another. I think that was some individual responsibility on my part. I don't see why anybody couldn't take that kind of interest in their health care. It's an important thing.

I agree with the notion that effort should be made on individual responsibility in our health care system.

[Translation]

Mr. Jeannot Castonguay: Now, while respecting the various--

Á (1110)

[English]

The Chair: Sorry, your five minutes are up.

Mr. Robinson.

Mr. Svend Robinson: Thanks very much.

I just wanted to follow up on the questions of my colleague, Mr. Thompson. I think there's something frankly obscene about organizing our pharmaceutical drug availability on the basis of maximizing corporate profit. I remember the articles in the Wall Street Journal in the mid-1980s, with big pharmaceutical companies just thrilled at the AIDS epidemic because they were going to make a lot of money. It was pathetic, and frankly, I think we have to find a different way of doing things other than just looking at the bottom line.

Now the same companies are fighting against the attempt by the government to actually change the patent legislation to ensure that we can make affordable generic drugs available in Africa. I saw just on the weekend that they're squealing that this is going to...they're threatening us again. They're going to pull out on research and development. Frankly, it's shameful.

Those are the companies, Ms. MacLeay, that you want to allow to advertise to Canadians, and I say with great respect that it ain't going to work. This idea of setting up some government body that's going to look at whether or not the ads are truthful and so on.... Look at the experience in the few jurisdictions in which it's allowed, the United States and New Zealand--it doesn't work.

So I'm a little surprised to hear a seniors' organization advocating that. I'm not sure if that's the position of the health committee, or has COSCO as a whole taken this position?

Ms. Sylvia MacLeay: The health committee has. You don't talk to 42,000 people individually.

Mr. Svend Robinson: Has this been supported by the board of COSCO?

Ms. Sylvia MacLeay: They're aware of the report, yes.

Mr. Svend Robinson: But they haven't voted to support it or anything like that, just to be clear.

Ms. Sylvia MacLeay: No.

Mr. Svend Robinson: I have two quick questions then. One is for Ms. Fuller.

The work that PharmaWatch is doing I think is incredibly important in terms of post-market surveillance. I'm wondering whether you get any support at all from Health Canada in this. They should be welcoming this with open arms, providing some resources to assist you, because you're representing consumers who are on the front lines, who can report directly.

Could you tell us what kind of support you get and if you've had any dialogue with Health Canada?

My question for Mr. Battison is this. You mentioned that this coalition is made up of a number of different consumer groups, the Lung Association and others. One of the concerns that has been raised, and I'm sure you're well aware of this, is that some of these groups--and I'm thinking here of the Cancer Society and others--have a very cozy relationship with big pharma and get a lot of money, frankly, from big pharma as well. I saw a Canadian Cancer Society newsletter that had an ad that blatantly violated the law in Canada with respect to direct-to-consumer advertising. I was disappointed that the Canadian Cancer Society and its newsletter didn't reject that outright.

How do you respond to the suggestion that because your member organizations get lots of money, in many cases, it compromises your ability to speak out independently on these issues?

Those are the two questions.

Mr. Brian Battison: Our organizations take their independence very seriously. You're arguing on one hand that public support for PharmaWatch is okay, but pharmaceutical support for organizations is not okay, because it will somehow taint the message, and I don't agree with that. Political parties receive funds from individuals, from organizations, from corporations who share a common view or share a common ideology.

Mr. Svend Robinson: We're getting rid of that.

Mr. Brian Battison: And that's okay. That is seen to be a long-standing acceptable practice in our political system.

Just because you accept donations from individuals who share a particular view doesn't mean you're going to alter your view to satisfy them. Organizations get funding for intervenor status from government so that they, if they lack the capacity to represent themselves, can seek capacity from others, including governments--provincial and federal--and that seems to be acceptable to everybody in society.

Just because you receive contributions or support from those who have like-minded principles it doesn't mean you take up their cause.

Mr. Svend Robinson: Ms. Fuller, did you want to respond to the issue?

Ms. Colleen Fuller: On that particular one, or on the PharmaWatch issue?

Mr. Svend Robinson: If you have time to respond to that one, yes, but on the PharmaWatch support.

Ms. Colleen Fuller: First of all, if I followed what you were saying, I think some of the relationships between the pharmaceutical industry and certain entities in Canada have been negative relationships. What really comes to my mind is the relationship between the drug industry and groups that are charged with the responsibility of advocating on behalf of patients who use those drugs. To me, that's really one of the problematic relationships. I don't think it serves the interests of patients who are represented by the organization funded by the drug industry, and more generally, it also doesn't serve the interests of the public at large. It just doesn't. I wouldn't have time to get into all of the details of it, but if you want to talk to me about it afterwards, I can talk your ear off.

Regarding PharmaWatch, we were founded two years ago. Actually, our formal launch is taking place in mid-November, so we haven't developed a relationship with Health Canada, as an organization, although a number of our board members do have a relationship with Health Canada in this area of prescription drug policy.

We are set up to do two things. One is to develop a database on consumer experiences with prescription medicine. We intend to encourage consumers to report to us adverse drug reactions, and we will maintain a database on those experiences and also use that information to try to better inform the public and physicians. So we want to raise public awareness about what those experiences are.

I think there will be some support within Health Canada, but not across the board. However, we know there are a lot of people in Health Canada who have concerns about the under-resourcing of the post-market surveillance. We know that's the case; they want consumers to report and they realize that's very valuable. There are concerns about the quality of consumer reporting, but there is some support—but not enough....

Á (1115)

The Chair: Thank you, Mr. Robinson.

I still have two questioners on the list, but we're actually at the end of our time, so would anyone like to withdraw or wait till the next time?

Ms. Hedy Fry (Vancouver Centre, Lib.): I'll wait till next time.

The Chair: Thank you, Dr. Fry.

Mr. Dromisky.

Mr. Stan Dromisky: I'll withdraw.

The Chair: Thank you very much.

On your behalf, ladies and gentlemen, I'd like to thank our presenters this morning and ask them to be at our call, if we want to ask further questions of them, perhaps by long distance telephone, as we move through our study.

So thank you very much.

Á (1120)

The Chair: I'd like to call this next session to order, please, and introduce the witnesses who will be presenting at this time.

Our first organization is the Downtown Eastside HIV/IDU Consumers' Board. Representing that group we have the chairperson, John Cameron, and I guess it's the chairperson of the methadone program, Melissa Eror.

Mr. Cameron.

Mr. John Cameron (Chairperson, HIV/AIDS, Downtown Eastside HIV/IDU Consumers' Board): First of all, you people are in for a real treat, as you will get to hear from a worn-out old queen with AIDS and hepatitis, suffering from incontinence and dementia.

I have to apologize that Melissa Eror couldn't be here today; she's not well. I apologize for not having French versions. The typist decided to change the brief that was submitted, and I had to redo it again last night.

The Chair: I suggest you just get into the meat of it, because you time is so limited.

Mr. John Cameron: This report is on methadone. The substance of the report is not to trash the provincial methadone program but to suggest that it needs improvement and to ensure that there is some venue for improvement.

When I was on the provincial AIDS advisory board, which is now defunct, a number of individuals from the methadone realm came to it with a presentation. Their objective was to put the approximately 8,000 hard-core heroin drug addicts in the province on a methadone program. I was rather suspicious because they reminded me of car salesmen in little white shoes, and most of the people listening had only a theoretical knowledge of methadone and what happens at the street level. I asked a number of questions. They weren't well addressed.

So over the last few years I've been asking everybody in the downtown east side at my AIDS support group and the consumers' board, which is a needle exchange and so on, about methadone and the realities on the street. This short brief is an overview of some of the problems at street level.

I should point out that the provincial government did a methadone assessment. There was a rather long report about three years ago. It was rather fair, but in a sense it was inadequate because it's rather sanitized and doesn't really reflect a lot of the problems at street level.

So rather than going on and on, what I would ask you people to do is to read this report when you're watching Jerry Springer tonight, or whatever, so that you'll get some idea of the realities of the methadone program.

One thing the consumers at street level ask for is some venue where they can talk with some impunity to the professionals about the problems. Most people who are on methadone never complain; they never talk about their problems, because they're worried the doctors will cut them off their methadone or that other punitive measures will happen. So that's the one thing we would ask for, to have some provincial venue where professionals and consumers can sit together and hopefully come up with provisions that will improve the program.

I think that's all I have to say. Thanks.

Á (1125)

The Chair: Thank you, Mr. Cameron.

Next, from the British Columbia Persons with AIDS Society, is the chair, Mr. Malsah.

Mr. Malsah (Chair, British Columbia Persons with AIDS Society): Thank you. Thank you for this opportunity to be here today to present to you.

As time is limited, we're not, of course, able to really speak to the brief in its entirety, so we've really focused on some elements of it here that are important.

I have accompanying me here today Mr. Ross Harvey, who is the executive director for the B.C. Persons with AIDS Society. He's here to support me if there are questions, because he is much more versed in some aspects of this than I am.

The British Columbia Persons with AIDS Society is one of Canada's largest organizations of people living with HIV and AIDS. It has over 4,000 HIV-positive members. BCPWA wishes to appear before the Standing Committee on Health regarding prescription drugs because pharmaceutical products are a key component to staying alive for most HIV-positive persons.

As costs continue to rise, provincial formularies and private insurers have started to refuse coverage of the higher-priced new drugs, limiting treatment options. Canada comprises about 2% of the international market, so any interference in the setting of prices in Canada is of course fraught with challenges. Responses by pharmaceutical manufacturers may range all the way up to choosing not to sell their products in Canada, creating an even larger barrier on treatment access. Such a move by industry would also have enormous implications for research and development of new treatments in Canada.

BCPWA recommends that the Government of Canada immediately engage with selected potential international partners, Australia, and certainly members of the European Union, for example, to explore ways to ensure that prescription drug prices are contained while at the same time not restricting access to new medicines; that the federal, provincial, and territorial governments collaborate in the bulk purchase of prescription drugs through the creation of a national pharmaceutical purchasing pool to leverage their enhanced purchasing power and market share, and so keep prices down, enabling reduced costs and improved patient access.

We would recommend that in the bargaining undertaken by any such pool, due consideration be given to matters such as research and development costs and a reasonable return on investments; that consideration be given to adapting the common drug review so that it may be converted into a national formulary system, which would more or less absorb the bulk purchasing pool recommended above.

Mechanisms for reviewing and controlling prices of all prescription drugs: Canada's drug market is approximately 2% of the world's total, while that of the U.S. is over 50%. Both generic and brand-name drugs should be subject to the same pricing review for purchasing and distribution in Canada. This system needs to prohibit what is known as drug reimportation, as this practice has limited access to drugs in Canada. Where manufacturers are concerned that they may not get a Canadian price in line with the U.S. price for a drug, they are beginning to refuse to market drugs here until PMPRB provides a price review, or they are simply deciding not to market it at all here in Canada.

Á (1130)

The Chair: You have one minute left, Malsah. You might want to just go through your recommendations.

Mr. Malsah: BCPWA recommends that the pharmaceuticals manufacturing industry should consult with the affected stakeholders as part of its process for PMPRB review. The federal ministry of health should expand the PMPRB mandate to include non-prescription and generic drugs. The ministry of international trade should continue to appeal to WTO and NAFTA rulings that restrict Canadians' abilities to direct its own health care. Health Canada should take the steps necessary to ensure that PMPRB processes are transparent and that PMPRB is accountable to Canadians.

Mechanisms for approving new drugs and introducing them on to the market with respect to their therapeutic value, their side effects, their interactions with other drugs, etc., as well as a focus on clinical trials.... Our recommendations are as follows. The Government of Canada should immediately allocate sufficient resources to enable the implementation and maintenance of the recommendations of the working group on HIV/AIDS. Health Canada should ensure adequate resourcing of its review divisions with individuals having the necessary qualifications and expertise.

Health Canada should establish and implement mandatory timeframes for review performance and for the quality of a review, with appropriate mechanisms for ensuring accountability. In recognition of the variance and the complexity of drug submissions, there is a need for a different timeframe, depending upon the drug class. Timeframes should be reduced over time as long as quality of a review is not compromised.

On monitoring of adverse effects and prescription drugs, the recommendations are as follows. Health Canada should develop a post-approval monitoring system that is consumer-centred and includes effective reporting mechanisms from consumers and health care professionals, including anecdotal evidence. Ensure as a critical first step in the implementation of a post-approval monitoring system that the data management system adopted is robust and will accommodate the increased numbers and timeliness needs of reports. Develop a post-approval monitoring system that meets Canadian needs, paying particular attention to the hard-to-serve populations, e.g., a Canadian database, developing Canadian strategies for data collection, etc.

The Chair: I'm sorry, but you're well over your time. I'm going to have to move on to the next presenter, who is from the Vancouver Native Health Authority. We have Steve Adilman, the clinic coordinator.

Dr. Steve Adilman (Clinic Coordinator, Vancouver Native Health Authority): Thank you. I have to apologize that Lou Demerais cannot be here. He's sick today.

Thank you for the opportunity to address the committee. For the last seven years I've been the clinic coordinator at the Vancouver Native Health Society medical clinic. The clinic is located in the heart of Vancouver's poorest inner city neighbourhood. Nearly all of our patients are on income assistance and many of them have substance abuse problems.

My comments today will focus on some of the prescription drug issues of inner city medicine that impact upon our ability to manage drug addiction, HIV, and hepatitis care.

In an effort to further confront the issue of abuse, misuse, and dependence of prescription drugs, consideration should be given to placing strict limits on the quantity of drugs of abuse potential that can be prescribed at any one time. Specific criteria should be met before long-term prescribing of drugs of abuse is permitted.

Tobacco and alcohol misuse lead to more disease and disability than any other substances. The annual cost of dealing with the complications of these dependencies is enormous. It's an enormous burden on the health care system, and more money should be directed at the prevention of these two preventable addictions.

Smoking cessation strategies that clearly show clinically proven success should be a medical benefit. In order to control expenditure and still show health benefits, limitations should be placed on the number of trials and the total costs of these strategies.

In regard to heroin dependence, methadone maintenance remains the most effective medical treatment for opiate dependence. Yet the quality and reputation of the program in this province are being jeopardized because the dispensing fees that pharmacists are able to collect reward those who provide high-volume, low-quality service. Addiction care should not be a for-profit business. Stricter regulations should be placed on the licensing of pharmacies. Limits should be placed on the total number of methadone-dispensing pharmacies in a given geographic area. Better training and education of pharmacists about addiction care should be implemented, and mandatory auditing and other measures that would reduce the practice of offering incentives to patients to attend certain pharmacies must be implemented.

Direct-to-consumer advertising should be forbidden. Marketing is not education. The public should be informed about health and disease prevention in an unbiased way. It is not in the best interests of the public to allow pharmaceutical companies to be the providers of this information. Hollywood-calibre advertising and commercials that are prevalent in the United States are examples of strategies that do more harm than good.

Lifestyle changes, including diet, exercise, and stress reduction, are among the most important components of healthy living and disease prevention and need to hold the most prominent position in the education of the public, not pharmaceutical marketing of fixes for specific diseases.

Here in British Columbia we have referenced-based pricing for pharmaceuticals. This policy provides full coverage for a referenced drug and partial or no coverage for similar but costly alternatives. The policy has been effective in reducing expenditure on drugs, without adversely affecting patient outcomes. Physicians and consumers are forced to be more cognizant of specific drug costs and thereby costly alternatives are less likely to be prescribed. If this policy was more widespread in Canada, it might force pharmaceuticals to be more competitive with their pricing than they currently are.

Thank you again for this opportunity. Those are my comments for today. I'm sure Lou would have had some other comments, but unfortunately I was not given his notes.

Á (1135)

The Chair: Thank you, Mr. Adilman.

Our next presenter is Ms. Joan Gadsby, representing her own company called Market Media International.

Ms. Gadsby.

Ms. Joan Gadsby (Market Media International Corp.): I'm going to focus on issues related to prescription drugs. First of all, I'm sure many of you are aware of the fact that I did a book called Addiction by Prescription, which won international awards and which I'd like to circulate. It's my story. I'm a survivor. I almost died from prescription drugs prescribed to me after my son died from a brain tumour. I've spent the last 13 years of my life rebuilding and trying to do something about a horrendous problem, but I'm not making any progress.

Two weeks ago a 41-year-old woman died. This is a copy of a television documentary in video format I did with Jack McGaw, which aired across Canada.

Another very important document about these drugs is this one, produced by Health Canada and distributed through Monique Bégin, Minister of Health at the time.

What I'd like to do is introduce to you Mr. John Constible, who is sitting with me and whose daughter died from prescription drugs. It was four years after I presented on this issue to the Standing Committee on Health in Ottawa. She died with something like ten different drugs in her system.

Á (1140)

I tend to deal with a number of issues. Five minutes is totally inadequate to deal with this issue.

By way of summary, I would like to state that I presented to the Standing Committee on Health on April 22, 1997. I've done 30 proposals for funding for a strategic action plan. I sent a letter to Prime Minister Chrétien dated October 1, 2000. On March 4, 2001, a letter was sent to the standing committee, to Bonnie Brown, and I had a written response. I spent hours with Rob Merrifield, who is sitting on this committee. I presented 24 different recommendations to the Senate committee, which I'm assuming have been circulated to you. I presented to the non-medicinal use of drugs committee, who was not the least bit interested in the creation of accidental addicts, those innocent people who trusted their doctors to do no harm.

In my letter to Prime Minister Chrétien, I stated, please, do not let this fall into the deep black hole of inaction, delays, stonewalling, bureaucracy, politics--which it has over the past decade.

What I'm sharing with you here is part of my presentation. The most enlightened province in this country is P.E.I. A doctor who found out about my book called me and arranged for me to go to P.E.I. I made seven presentations in three days about this particular issue.

I've taken actual excerpts. What drugs are we talking about? We're talking about the benzodiazepines, the tranquilizers and sleeping pills, Xanax, Rivotril, Ativan, Serax, Restoril, Dalmane, etc. Those are the drugs. This presentation was sent to you members of the standing committee by e-mail.

I'd like to also go into the adverse effects.

Cognitive impairment. I have suffered cognitive impairment. I have worked with four of Canada's largest companies in the consumer products field--food marketing. I had to leave my job. I went through $2 million regaining my health. Other people are affected the same way, with behavioural problems, paradoxical reaction, and psychomotor effects, which affect driving. When I wrote to the attorney general, he said, keep up the good work, Joan. That's not a good enough response.

The creation of depression, the creation of anxiety caused by tolerance withdrawal between pills, this is why I have requested more time to present on this issue. You cannot do justice to the mandate of your committee nor to me as a presenter.

Addiction, cross-addiction to alcohol and other drugs, emotional anesthesia. My son died Christmas of 1966. I did not deal with it until I was going through the withdrawal. I also recently lost my oldest daughter to breast cancer. No pills were ever needed.

Floppy baby syndrome. Bonnie, I contacted you when the House of Commons was dealing with fetalalcohol syndrome and labelling alcohol products. I had no response. Floppy baby syndrome is the same thing caused by these prescription drugs. I'm talking about sleeping pills and tranquilizers, and now more recently the anti-depressants, which are simply the follow-up to Valium 30 years later.

Withdrawal. Withdrawal was horrendous, all documented within my book. I'd like to focus on some of the statistics. I've looked at it from a total macro standpoint. What do we have? Prescription drugs fast exceeding the cost of physicians' services. Benzyls were the most widely prescribed drugs in the world. Up to 30% of the population are hooked, or have been prescribed, these drugs.

Hedy, you and I met and discussed this way back when I was going through withdrawal. When I presented to the Standing Committee on Health in Ottawa, Anne Carter, who is with the CMA, presented point 7, “By law, when a physician prescribes drugs for a patient, the physician is required to ensure that the patient is fully informed....”

Some of the stats are iatrogenic illnesses and 250 deaths caused by these drugs. Sixty percent of users suffer a mixture of adverse effects and suffer withdrawal. What is addiction? The inability to discontinue the drug without going through withdrawal symptoms.

In my case, I went through withdrawal for two years. This very confident woman who was also on the council of the district of North Vancouver was trying to pretend nothing was the matter. I couldn't begin to take in anything. I was scared shitless--pardon my French--that I was going to die.

Forty percent of impaired drivers have these drugs in their systems. When I wrote to the attorney general about the impaired driving, he said, just keep up the good work.

Á (1145)

It's your responsibility as members of Parliament to do something about it.

Why is there a problem? It's money for the drug companies. My presentation includes specific international data on antidepressants, including the States and Canada. That was supplied to you. But it's basically money.

Why does it exist? Doctors create the problem. People trust the doctors. I have friends who are doctors. A Columbia University study shows that fewer than one-third can diagnose prescription drug addiction, and yet they create the problem. The guidelines say two to four weeks. Infrastructure is not available to help people get off the drugs. I flailed around on my own going through the horrors of withdrawal.

What's the cost? It's not just to the health care system. The whole socio-economic system is involved with the over-prescribing of drugs. There's health and safety in the workplace; career devastation, as occurred in my case; floppy baby syndrome; lost years of people's lives; and lost lives. A daughter of a friend of mine died two and a half weeks ago. She was on eight different drugs. She had ballooned with the effects of antidepressants. There's the cost to the legal and justice systems, including WCB claims and life and disability insurance claims. Manulife paid me something like $350,000 when I was on disability. There are welfare costs, the implications of rage created by these drugs, drug costs, and the cost of detox facilities.

The elderly receive twice as many. Why? I was 26 when I was first prescribed the drug. I would have been one of those older people later on. Thank God I'm off. Non-psychiatric conditions account for the prescribing, and there are cross-addictions.

When I was in P.E.I., which is the province that brought me there to present--

Mr. Svend Robinson: Sorry, Joan. I just wanted to get some clarification from the chair. We do have a number of witnesses here, and I'm wondering, given the time, if we could get some sense, Joan, of when you might be wrapping up so that we can ask questions of all the witnesses.

Ms. Joan Gadsby: I'm going as fast as I can. After I finish this part--

Mr. Svend Robinson: Maybe two or three more minutes?

The Chair: She's over 10 minutes now, which is double the time. But I'm thinking that Mr. Merrifield might give half his time to her, which would leave all of us with five. But we really have to close up. Other people have questions--

Ms. Joan Gadsby: That's why I asked if you had received this information because it was all sent by e-mail.

When I was in P.E.I., 80% of suicide overdose victims showed these drugs in their system, and it's hidden. And on and on it goes. Have a look at the DSM3 and 4, the psychiatric bible. Mental illness and addiction do not go together. You have alleged substance abuse and anxiety disorders and mood disorders caused by the drugs. Look at the criteria. We have the concurrent prescribing of all these drugs.

There is not much time to talk about antidepressants. There was the Columbine school disaster. I presented in Philadelphia on suicide, seizures, and psychosis around antidepressants. I met one of the male teenage victims of prescription drugs.

You have received my recommendations to the Canadian government on benzodiazepine. I'm not going to go into it because you have it in front of you. Basically, what we are asking for here is a national public inquiry; the multi-stakeholder strategic action plan; and the awareness program, which I started in P.E.I. We need financial compensation for the people whose lives have been devastated and financial support for treatment programs. Independent funding for research is a long-term aim, and we should look at contributions from the research-based pharmaceutical companies. I've talked with Murray Elston, the former Minister of Health for Ontario. That is the focus, how we deal with the problem. I'm hoping that eventually José will have this distributed to you.

Obstacles and solutions. This is 95% of the strategic action plan. There is no time to go into it. You have it. But the fact is that the problem continues. In my presentation to the Senate, which took place on October 18, Madam Chair, there were 24 recommendations for the standing committee. My colleagues, Mr. Constible and Madelon Albulet, and I want action. We want accountability.

The next step is to have a full criminal investigation, something like the Red Cross blood scandal.

Thank you very much.

Á (1150)

The Chair: Thank you, Ms. Gadsby.

We'll begin the questioning with Mr. Merrifield.

Mr. Rob Merrifield: I thank all of the witnesses for coming in, but particularly Joan. I have spent a little bit of time on the phone with Joan. One of the reasons we're doing this study is because of the alarming information...not just from Joan's testimony but from physicians' quarters, which have started to ask, what kind of a problem do we have with prescription medication? We have been finding out that certain individuals may have had an auto accident, causing us to look at what kinds of medications that individual is on, and we realize the problem is a lot more intense.

I've asked this question of every one of the individuals from Health Canada: How many deaths a year from prescription medication? I asked the Fraser Institute this morning whether they have ever done a study. No, nobody has done a study. There is almost a blank stare from Health Canada and from anyone who has ever looked into this. What is the actual problem? How serious a problem do we have out there from addiction to prescription medication?

Joan, you've done some work on it. Can you give me your numbers? I think I have them here somewhere. Can you tell the committee your estimate of the number of deaths per year from addiction to prescription medication?

Ms. Joan Gadsby: Within a matter of a few months there were 27 deaths that I was personally aware of. Within the last two weeks, Karen Brownlow, a 41-year-old young woman, died of the same kinds of things.

What is happening in the state of Maine, which I tried to refer to but there was no time, is they have actual documentation of overdose deaths caused by prescription deaths. We need to do the same thing here in Canada. These are buried. With regard to the young woman who died two and a half weeks ago, the coroner's report makes reference also to heart attack. Well, why the weight gain, the antidepressants?

My best estimate in terms of the number of deaths per year from prescription drugs is probably in the area of 15,000 to 20,000.

Mr. Rob Merrifield: Yes. It's really interesting.

I used to sit on a regional health authority. The reason I bring that up is because one of the alarming stats that I found out from our region is that the number one reason we hospitalize people in this country, in our region, isn't cancer, isn't heart, but mental illness. When you start looking at what makes up mental illness, you realize the amount of people who are depressed, who are stressed, who need consultation. Usually in most of the provinces--and I think we can say this without too much exception--mental illness is really in a disastrous state as far as treatment is concerned.

I'm wondering from your information and from the studies you have done what you think the correlation is. On one of the slides you alluded to the fact that mental illness is different from addiction and that most physicians cannot detect addictions. I think you said only a third—you remind me of the stat—of physicians can detect an addiction. Can you give us the information—where those numbers come from and how you get your stats on that?

Ms. Joan Gadsby: Yes. The statistic that less than 30% of doctors know how to diagnose prescription drug addiction is from a Columbia University study. In fact it also was reported in the Canadian Centre for Addiction and Mental Health in a publication talking about my work on benzodiazepines.

On the point about mental health and addiction, this is not a link. The tie-in was that 60% to 80% of people in the mental health system have addiction problems. It's a chicken-and-egg thing. It has to be evaluated in terms of what the person was like before the prescribed drugs. Was there any kind of mood disorder? Was there any kind of anxiety disorder? In the majority of cases the answer is no.

What we have—I didn't have time to even touch on it—is the pharmaceutical companies creating alleged diseases and finding the pills that people must be on. Even for depression, to have 25% of people suffering from depression is a lot of crap. If they are depressed what they need to do is get out and run, swim—lifestyle issues. But on the mental health issue, take the person off the pills and you'll find there's no diagnosis for mental illness.

Á (1155)

Mr. Rob Merrifield: According to Health Canada--

The Chair: I think we have to move along.

Mr. Ménard.

[Translation]

Mr. Réal Ménard: I will pass.

[English]

The Chair: Pardon me? Is he passing to you or to the next person?

Ms. Bennett.

Ms. Carolyn Bennett: Thank you.

I guess one of the problems with government is that we deal well with solutions, but we don't do too well with problems. So I guess I'd like to know, what would you like in our report in terms of what Health Canada could do? Frankly, one of the problems around even prescribing is that it's provincial, it's professional, and whether it's methadone or whether it's...we have a lot of jurisdictions that collide on this file.

Perhaps I can ask you, Joan, what actually is P.E.I. doing that is making you happy, and what should we be doing? In terms of your recommendation on a national public inquiry, I mean, you've written a book, and you've done a video, so how much of a public inquiry would be there that we don't know already? And then how would we move to a...? I think a multi-stakeholder strategic action plan is obviously what we need on so many of these things, where everybody takes their responsibility and moves forward on optimal prescribing and accountability.

Ms. Joan Gadsby: These solutions...and I didn't have time to put it up there. What I prepared for my presentation in P.E.I. was this document--

Ms. Carolyn Bennett: No, no, but what are they doing now that you like?

Ms. Joan Gadsby: They're following up on my presentation. The doctors are getting together and they're looking seriously at the prescribing habits. There's a support group that has been set up. They're looking at proper detox facilities. Doctors don't know how to withdraw people--

Ms. Carolyn Bennett: Okay. So it's around education and resources in terms of detox and professional collaboration, is that right?

Ms. Joan Gadsby: Yes, but the doctors are basically into denial, ignorance, and apathy. There is also the fear of lawsuits. That's a problem. P.E.I. is one of the smallest provinces in Canada. As a result of Dr. Cameron.... This gentleman, who is 75 years of age, has been fighting this alone in the province. A long-time member of the Society of Addiction Medicine, he took the leadership.

So what we're saying in my resolution here is that a national inquiry.... If you have an inquiry on this issue, you'll have hundreds of Canadians come out and say, yes, I'm affected and I don't know where to go for help

Ms. Carolyn Bennett: And in the call for a patient safety institute, is this something you think should be part of that?

Ms. Joan Gadsby: You bet. That's why I mentioned it up there.

I'm hoping, José, through the chair, Bonnie Brown, that you will replicate for this committee the 24 recommendations I made to the Senate committee.

Those are all available to you. You have them. They can also be e-mailed to you again. It's very wide in focus in terms of my thoughts on direct-to-consumer advertising and what needs to be done. The 24 recommendations took a lot of time and thought to put together.

Carolyn, when you and I met at the Minerva Foundation, I went specifically to meet you and to give you a copy of my book. I haven't heard anything from you since I gave you the book.

Ms. Carolyn Bennett: That's because--

Ms. Joan Gadsby: How many more deaths...?

I met with Hedy Fry--she's disappeared now--nine years ago. It was up at Whistler, where I went purposely, when she was president of the BCMA.

As doctors and as women--I don't wish to be discriminatory--you are in a leadership position. I mean, all we're getting from the B.C. College of Physicians and Surgeons...who, by the way, are going to have a hearing into Christina's death. This doctor who killed her--and it's not alleged, he did kill her, because there was a coroner's inquest--took off to Scotland.

You are a doctor, and as a doctor you need to speak to your colleagues about doing something. I've talked to the CMA. The past president of the College of Family Physicians of Canada happened to be in P.E.I., and I had a beautiful opportunity to talk to him about what needs to be done.

That's for people who are on the drugs, or people who might be put on the drugs, but what about those of us who have...? And God kept me alive, thank God. I sold the other house with the swimming pool and went through $2 million regaining my health. What about those people who call me on the phone and ask me, “Joan, where do we go for help?” I have to tell them, “Sorry, I can't help you. I've got to earn a living.”

With regard to compensation, for example, there are two websites. Please jot these down. Have a look at www.benzo.org.uk, because it's the best in the world. It goes into the problems around the world, at what's happening in the U.K. The European Community is now looking at guidelines. My own website is www.addictionbyprescription.com. I get 25,000 hits a month.

The Chair: Ms. Bennett's time is up.

Mr. Thompson.

Â (1200)

Mr. Greg Thompson: Thank you, Madam Chairman.

Joan, I'm compelled by your testimony. I know we could listen all day and talk, but I want to put a question to John.

I'm interested in your methadone program, John. I was overwhelmed by your presentation, and I've had a chance to look through it since. There's some similarity, I think, between what Joan is saying and what you're saying, that when you prescribe something as a cure for something else, that in itself can create problems.

So what would you like to see done, John? I guess it's probably good that you could put this on the record, and I have had a look at some of your recommendations. What precisely could be done to improve that program or come up with an alternative? What are some of the suggestions you've thrown out to the public?

Mr. John Cameron: First of all, create some venue for forwarding complaints or concerns. Two, set up a situation where the consumer is willing to talk to the doctor about problems. Three, get some standards in terms of piss tests, for example. That varies from doctor to doctor. With some doctors it's once a year, and then other ones not. So we need some standards there. And start looking at other alternatives. They are looking at heroin maintenance. Many long-term addicts like laudanum.

There's something wrong when most of the long-term, hard-core addicts, people who've been around for years and survived, won't touch methadone. That really says something.

Mr. Greg Thompson: John, just out of curiosity, are you speaking from experience on the use of methadone? You mentioned your health problems when you came in this morning.

Mr. John Cameron: No.

Mr. Greg Thompson: Okay. Obviously you see those people every day because of your involvement with the community.

Mr. John Cameron: I started the first AIDS support group in the east end before AIDS had hit. That's one of the topics that comes up regularly. So at the Consumers' Board, which is a needle exchange run predominantly by practising IDUs, we have people there for whom methadone works and other ones for whom it doesn't work.

Mr. Greg Thompson: So the bottom line is that it's not a cure-all or as much of a miracle drug as we're sometimes led to believe. Would it be fair to say that?

Mr. John Cameron: Yes, and if you go to detox, one out of three now are in there to overcome methadone, so that tells you something.

Mr. Greg Thompson: The medical complications that creates are really your biggest concerns—liver problems.

Thank you for your testimony. I appreciate it, and I appreciate the overview.

Thank you, Madam Chair.

The Chair: Thank you, Mr. Thompson.

Mr. Dromisky.

Mr. Stan Dromisky: Thank you very much.

With all the information you've been presenting to us this morning, and all of the recommendations and so forth, I doubt very much that even if many of them are implemented there will be much success.

I'm going to tell you two quick stories.

My father died. My mother went into a deep depression. We thought it was because of her loss, but in a very short period of time I discovered that she was getting antidepressant drugs from six different doctors in my community.

Wednesday morning of this week the police were in my office to stop a woman who came in to cause harm to my staff. She came from Vancouver. She was getting methadone from six different doctors. She would not go into a program in Thunder Bay and she would not listen to reason. She went berserk and felt that I, as a federal representative, could do something about it.

Those two stories tell me something. The most important recommendation that should come from the federal level, as well as the provincial level, is that every single dispenser of any kind of prescribed medication should be put on a computer program. I can go to my druggist and get a printout on all the pros and cons of any kind of drug that has been prescribed to me. They have that information about their patients already, but they do not share it, and doctors do not share it.

Doctors must start sharing information and saying, “Hey, I'm giving the same medicine to that woman or man as you are--and he is, and he is. Let's do something about it.” None of that is happening, so all your recommendations are going to be in vain unless those two things happen.

I don't know what your reaction to that is. You're spending a lot of money, a lot of time, and a lot of energy, but you're not going to be very successful.

Â (1205)

Dr. Steve Adilman: On your last point, here in British Columbia we have the kind of computer program you're talking about. It's called PharmaNet. So doctors do have access to dispenses that have taken place for a particular patient. They are made aware if another prescriber has prescribed for that person. We make use of that here, but I'm not aware of what's happening in other provinces.

It's been very worthwhile. It is not available in very many doctors' offices, but if that were to become something that was funded in all doctors' offices.... Not all doctors have computers, so we'd need to discuss the whole issue of financing physicians so they have Internet access in their offices.

My clinic is fortunate to have that, so my staff and I can check, before we dispense a medication, if someone has received something from someone else. Very few doctors have that in their offices. They usually have to pay a lot of money to have that ability in their offices, so most people don't do it.

It would be a good recommendation to require all doctors to have access to that, because it takes extra time for a pharmacist to pick up the phone and alert the doctor. Obviously, that's a problem. They don't even necessarily reach the doctor when they phone, whereas if doctors can have quick access to those people when they are prescribing medication like you are talking about--antidepressants or a drug that is more risky than just antibiotics or a refill for high blood pressure pills or something--it would be very helpful. We have found it to be very helpful.

Ms. Joan Gadsby: Stan, I'd also like to respond to that. I am dismayed and appalled by your comment that you don't know whether anything will be done.

First of all, the statistics show that 68% of people get their prescription drugs from the same doctor. There is some double-doctoring, but the actual figure is 68%.

On the point about it being a provincial responsibility--no. The health and safety of Canadians is a federal responsibility.

On the scope of the recommendation--and I will check with you, José, to see, because you said the committee had the medicinal drug recommendations--this is wide in scope, dealing with advertising and all aspects. But it is for sure that the federal government, Health Canada, and, with due respect, members of Parliament, keep passing the buck, and more people will die. If it's necessary to implement criminal activities for what Health Canada knew and should have known, going back decades, such will be done in the name of having safe and effective health care.

The Chair: Mr. Robinson.

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Mr. Svend Robinson: Thank you very much.

It's been a very compelling hour. I want to thank the witnesses and also, on behalf of all of us, extend our condolences to Mr. Constible on the death of his daughter. I remember the circumstances. It was absolutely appalling.

Joan, you came into my office and laid it all out with that passion and anger. I still remember it so well. We're talking about legal drug pushers here; that's really what it comes down to. I remember at the time thinking, yes, society talks about drug pushing, yet we have legal drug pushers who profit from people's sorrow, anguish, and despair.

I can assure you that we will certainly review your material carefully to see what falls within federal jurisdiction and what we can do to reduce that incredible toll of tragedy and death you spoke about this morning.

I must say I'm delighted to see my old friend Ross Harvey here. Members around the table may not know it, but he's a former member of the House of Commons. He was a member of this House--Greg will remember--from 1988 to 1993, representing Edmonton East. Then he came to his senses and got out of the House.

I have just one question on direct-to-consumer advertising. Dr. Adilman has spoken clearly in opposition to direct-to-consumer advertising. I see that in the brief from the PWA side, you also strongly oppose direct-to-consumer advertising.

You state in here that the Government of New Zealand has banned direct-to-consumer advertising. I believe this is the first I've heard of this. We've heard all along that two jurisdictions, the United States and New Zealand, allowed it. You say they've banned it, and I'm delighted to hear that. I know there's a progressive labour government there headed by Helen Clark, and I frankly wondered why they allowed it.

Could you just elaborate on when that happened, and if not, perhaps get back to the committee on that? I obviously will want our researchers to follow up as well. I think this is very good news. When did this happen?

Mr. Malsah: I'm not able to give you an actual date at this point. We will get back to you on that. From our understanding, it was obvious they explored the issue extensively, as did the European Union, and they remain opposed to direct-to-consumer advertising.

The United States is currently the only country in the developed world that does consumer advertising and targets consumers. We'll get back to you on the actual date and specifics of the decision of New Zealand.

Mr. Svend Robinson: Perhaps we could ask our researchers as well to check that, Bonnie.

The Chair: Our researcher has departed, due to the....

Mr. Svend Robinson: I'm thinking of the clerk.

The Chair: The clerk is trying to get it, but he can't do everything. Maybe you could make a note to check with Nancy when we get back.

Thank you, Mr. Robinson.

Dr. Fry.

Ms. Hedy Fry: Thank you very much, Madam Chair.

There are two questions I want to ask. They go back to the issue of post-market surveillance and a national formulary that was sort of floated earlier by Dr. Bennett.

I also just want to say we should be a little careful about how we bandy about words like “legal pushers”. No physician gets a penny for prescribing a drug, you need to know that--not a single penny.

I do think that Joan made a very important point, and I think this ties into post-market surveillance. We need to look at education programs for physicians on benzodiazepine. She's right that it's one of the most addictive and used drugs. People give it like candy to people when they have grief, or when they have something going on in their lives. There's something we really need to hang onto here. I think Joan is absolutely right. If Health Canada under Monique Bégin produced that first book, then we could start doing those kinds of things.

That ties me into post-market surveillance. We do not have a really good system of post-market surveillance. I think it is absolutely necessary for physicians and nurses to be reporting adverse drug reactions. Nurses aren't involved in this; no one has ever talked about them. But nurses see a lot of the adverse drug reactions on a day-to-day basis. I think there should be some way of dealing with that.

We talked to Health Canada. They said it was going to cost money. I think it is worth the money to give them the resources to do this and make it user friendly so that people will.... I'd like to hear your comments on that.

My second question is on the national formulary. This is a very important idea that's being floated about. I know we can't do it unless we get the provinces to come onside. But take, for example, access to HIV/AIDS drugs. This committee did this study just before we rose for the summer. We found some very clear and important information that we weren't able to follow up on fully because we just talked about increasing the amount of money for the HIV/AIDS strategy.

There are 4,000 new people each year with HIV/AIDS. Not every province gives out the drugs, so we don't have a national ability for everyone across this country with HIV/AIDS to get the drugs. The drugs cost an arm and a leg, so there needs to be some way to talk about how a national formulary might be possible, and how we can ensure that there is some kind of standardized ability and access to drugs for persons with really severe and terminal illnesses like HIV/AIDS.

I just want to hear what you have to say about that and how you see this happening, given that formularies are a provincial jurisdiction right now.

Perhaps Ross and Malsah might answer.

Mr. Ross Harvey (Executive Director, BC Persons with AIDS Society): As we tried to point out in our brief, the sort of embryonic national drug formulary is there in the form of the provincial health ministry's common drug review. There are many problems with that common drug review that we needn't rehearse before this committee, but it at least shows that there is an inclination on the part of the provinces to work together to do something in this instance about rising, insupportable drug costs.

A creative federal administration should view this as an opportunity to work with the provincial health ministries toward the implementation of a national formulary that can include some kind of pooling of buying. That's where your strength is going to be. It's a standard market mechanism that should appeal to the incoming administration, and as such can be used to leverage advantages in the Canadian market. This is really an opportunity not to be missed.

I'm sorry, what was the first element?

Ms. Hedy Fry: Even if you buy in bulk, how can you ensure that in every province people have access to HIV/AIDS drugs? Everyone doesn't have access across this country.

Mr. Ross Harvey: Given the restrictions in the British North America Act, that's true. There's not much you can do to get around those. Of course, the bluntest and most obvious instrument is the federal spending power. Just as that gave us medicare, there's no reason it can't also give us pharmacare. I would refer you to the Romanow commission for elaboration on that.

The Chair: Thank you very much, Dr. Fry.

Seeing no further hands, on your behalf I will thank our witnesses for coming and sharing their ideas with us.

If you handed in a brief in English only, the clerk will make sure it is translated and then distributed. Briefs act as a good reminder of your presentation for us, a week or so later, to have in our records as we move forward and try to write a report on this subject. We hope to maybe put out some kind of an interim report, because we think this topic is so broad it could take quite a long while.

Thank you very much for your input.

This session is adjourned.