HEAL Committee Meeting
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37th PARLIAMENT, 2nd SESSION
Standing Committee on Health
EVIDENCE
CONTENTS
Thursday, November 6, 2003
| ¿ | 0915 |
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The Vice-Chair (Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)) |
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Ms. Linda Silas (President, Canadian Federation of Nurses Union) |
| ¿ | 0920 |
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The Vice-Chair (Mr. Réal Ménard) |
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The Vice-Chair (Mr. Réal Ménard) |
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Mr. Rob Merrifield (Yellowhead, Canadian Alliance) |
| ¿ | 0925 |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
| ¿ | 0930 |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
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Ms. Linda Silas |
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Mr. Rob Merrifield |
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The Vice-Chair (Mr. Réal Ménard) |
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Mr. Grant Hill (Macleod, Canadian Alliance) |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Svend Robinson (Burnaby—Douglas, NDP) |
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Mr. Grant Hill |
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Mr. Svend Robinson |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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Mr. Grant Hill |
| ¿ | 0935 |
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Ms. Linda Silas |
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Mr. Grant Hill |
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Ms. Linda Silas |
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The Vice-Chair (Mr. Réal Ménard) |
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Mr. Svend Robinson |
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Ms. Linda Silas |
| ¿ | 0940 |
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Mr. Svend Robinson |
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The Vice-Chair (Mr. Réal Ménard) |
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Ms. Hélène Scherrer (Louis-Hébert, Lib.) |
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Ms. Linda Silas |
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Ms. Hélène Scherrer |
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Ms. Linda Silas |
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Ms. Hélène Scherrer |
| ¿ | 0945 |
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Ms. Linda Silas |
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Ms. Hélène Scherrer |
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Ms. Linda Silas |
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Ms. Hélène Scherrer |
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The Vice-Chair (Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)) |
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Dr. Sunil Patel (President, Canadian Medical Association) |
| ¿ | 0950 |
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The Vice-Chair (Mr. Stan Dromisky) |
| ¿ | 0955 |
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Dr. Michel Brazeau (Chief Executive Officer, The Royal College of Physicians and Surgeons of Canada) |
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Dr. Jean Gray (Vice-President, Executive Committee, The Royal College of Physicians and Surgeons of Canada) |
| À | 1000 |
| À | 1005 |
| À | 1010 |
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The Vice-Chair (Mr. Stan Dromisky) |
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Mr. Grant Hill |
| À | 1015 |
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Dr. Sunil Patel |
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Mr. Grant Hill |
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Dr. Sunil Patel |
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Dr. Michel Brazeau |
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Mr. Grant Hill |
| À | 1020 |
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Dr. Sunil Patel |
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Mr. Grant Hill |
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The Vice-Chair (Mr. Stan Dromisky) |
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Mr. Grant Hill |
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Dr. Jean Gray |
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The Vice-Chair (Mr. Stan Dromisky) |
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Mrs. Betty Hinton (Kamloops, Thompson and Highland Valleys, Canadian Alliance) |
| À | 1025 |
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Dr. Jean Gray |
| À | 1030 |
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Dr. Sunil Patel |
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The Vice-Chair (Mr. Stan Dromisky) |
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Mr. Gilbert Barrette (Témiscamingue, Lib.) |
| À | 1035 |
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Dr. Jean Gray |
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Mr. Gilbert Barrette |
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Dr. Jean Gray |
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Mr. Gilbert Barrette |
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Dr. Sunil Patel |
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Mr. William Tholl (Secretary General and CEO, Canadian Medical Association) |
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The Vice-Chair (Mr. Stan Dromisky) |
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Ms. Hélène Scherrer |
| À | 1040 |
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Dr. Sunil Patel |
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Ms. Hélène Scherrer |
| À | 1045 |
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Dr. Sunil Patel |
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Dr. Jean Gray |
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The Vice-Chair (Mr. Stan Dromisky) |
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Dr. Sunil Patel |
| À | 1050 |
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The Vice-Chair (Mr. Stan Dromisky) |
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Ms. Jean Gray |
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The Vice-Chair (Mr. Stan Dromisky) |
CANADA
Standing Committee on Health |
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l |
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EVIDENCE
Thursday, November 6, 2003
[Recorded by Electronic Apparatus]
¿ 
(0915)
[English]
The Vice-Chair (Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)): Order, please.
Mrs. Brown is coming, but I suggest we start, because we have a lot of things to do. Some people have to be in the House at 10 o'clock.
[Translation]
Our witnesses for today will be the Canadian Federation of Nurses Unions, the Canadian Medical Association and the Royal College of Physicians and Surgeons of Canada.
We will start with the Canadian Federation of Nurses Unions. You have ten minutes for your presentation, followed by a discussion with the members. I do not know who is going first.
You have the floor.
[English]
You have the floor.
[Translation]
Ms. Linda Silas (President, Canadian Federation of Nurses Union):
Good morning. My name is Linda Silas, and I am President of the federation.
[English]
First let me thank the committee for giving us this time to address you, and also for changing your procedures a little bit.
I'll talk to you on three points today: pharmacare, the solution; direct-to-consumer marketing, continue to ban it; and adverse drug reactions, we need to do more on it.
The Canadian Federation of Nurses Union is the largest nurses' organization in Canada. We were founded in 1981, and now represent 125,000 nurses across the county, including nurses who provide care in hospitals, long-term care, and in our communities. Our mission is to give voice to nurses' and patients' concerns nationally, and to protect and improve our not-for-profit health care system.
Nursing is not only about saving lives; it's also about providing skilled comfort and promoting healthy living. Men and women who choose nursing choose it because they want to make a genuine difference in the lives of patients. We stay in nursing despite the shortages and the pressure because making a difference still means a lot to us.
On the cost of prescription drugs, which is what we're here to talk about today, since 1989 the amount of money spent on drugs by Canadians, through their governments, private drug plans, or individually, has more than doubled. Prescription drugs make up 77% of all drugs sold.
Between 1997 and 2001, sales grew dramatically for patented medications as a proportion of total drug sales, due largely to the substitution of newer, more expensive prescription drugs for older, less costly ones.
The high cost of prescription drugs has led provincial drug plans to de-list medicine and private plans to limit coverage. But there is also a portion of Canadians without any drug coverage at all. Policy analysts disagree on the numbers, but they range from 3% to 26% of Canadians.
Of course, higher drug costs mean that people who pay out-of-pocket for some or all of their prescriptions will not be able to get the medicine they need. People who can't afford their prescription drugs get sicker, and stay sick longer. They make physician and hospital visits more often, and these could be avoided. They miss work, and they potentially spread disease.
As the Doctors Without Borders organization said again this week, put patients' rights ahead of patent rights.
The brand name drug-makers assert that the high prices charged for prescription drugs are necessary to finance the development of new drugs to save lives and improve the quality of life. A review conducted by the French journal, Prescrire, reported that only seven out of 2,693 prescription drugs reviewed in the last decade could be considered a major therapeutic innovation in the area where previously no treatment was available.
Further, we have only the drug companies' word for the cost of drug research and development, and experts disagree with drug company cost data.
As nurses, we claim no expertise on the costs of drug research and development, but we ask you to apply the same standard to your recommendations that we must apply to our work--the standard of unbiased evidence.
In terms of support for pharmacare, a national pharmacare program was recommended by the Royal Commission on Health Services in 1964, when most of us were only babies. Again it was recommended in 1997, by the National Forum on Health, and the Liberal Party of Canada endorsed it in the same year as the royal commission, in 1964.
There are other parties represented on this committee who either endorse, or at least do not oppose, a national drug program, and yet still we do not have one in 2003, almost 40 years after it was first introduced. We always talk about it, or refuse it because of the costs.
There is evidence that a national drug plan would actually reduce the cost of buying prescription drugs. In Australia, for example, there's a national drug plan that has kept its drug costs more than 30% below the OECD average at a time when Canada's were almost 30% higher.
There is also evidence that under the public plan, there could be significant savings in both dispensing fees and administrative costs. Acting together, the provinces could use their buying power to lower overall drug prices. Dr. Joel Lexchin, of York University and the University of Toronto, has calculated that under a national pharmacare plan, the savings in lower drug prices could be 10%, or $650 million.
How do we fund a pharmacare plan? Well, a national pharmacare plan that provides first dollar coverage for prescription drugs for all Canadians would cost the public treasury an increase of almost $3.2 billion per year, as calculated by Dr. Lexchin.
That's real money, but then there is real money in the federal surplus, and it has averaged $11.7 billion every year since the fiscal year of 1999-2000. While Finance Minister John Manley projected that this year the federal budget surplus would only be $3 million, the fact is that the government hasn't projected more than a $3 billion surplus of any budget since 1999.
We have the money. We need a little bit of will. Nurses are here to support you on this.
On the direct-to-consumer marketing of prescription drugs, there is strong evidence that drug advertising leads to brand-specific requests for medicine and leads to more prescriptions overall. If the government seeks to reduce expenditures on prescription drugs, public drug advertising is absolutely the wrong thing to allow.
The CFNU also opposes direct-to-consumer marketing of prescription drugs, because direct-to-consumer campaigns for prescription drugs exploit our patients' hopes for a cure; their fears of loss of independence; and their desires for freedom from pain, discomfort, shame, and worry. The ads are designed to lead patients to actively lobby what would be, in Canada, often overworked and underresourced practitioners.
The federal government's obligation is to facilitate best medical practices and to protect Canadians in need of care by ensuring, among other things, that doctors, nurse practitioners, and patients get objective information about prescription drugs. To do this, CFNU believes you must preserve the integrity of interaction between those who seek care and those who give it, doing this by maintaining the ban on direct-to-consumer marketing of prescription drugs.
On adverse drug reactions, in 2001 we had the horror story of the coroner's jury examining the tragic death of a 15-year-old Ontario girl from an adverse reaction to a prescription drug. The jury's recommendations amounted to a call for a sweeping overhaul of the way in which all post-market prescription drugs are monitored.
To what extent have the changes recommended in that report been implemented? We believe it is time to repeat the Auditor General's 1987 investigation into post-market surveillance of prescription drugs.
In conclusion, we feel strongly about continuing the ban on direct-to-consumer drug advertising, and we believe we need to do better preventing of adverse drug reactions. The biggest change that Canada's nurses recommend in the prescription drug area is pharmacare, which is long overdue.
So please don't wait for the perfect policy clarity. The fix for inadequate prescription drug coverage and high prices will never be completely clear, but it never is for great, prolonged problems. You will see that some will recommend leaving the system alone. While these counsellors no doubt know the price of many things, they don't know the cost of suffering.
Thank you.
And I apologize to the committee members and to our colleagues, but I'll have to entertain questions now. It's my first national board meeting this week, and as you might understand, I can't arrive too late. Thank you very much.
¿ (0920)
The Vice-Chair (Mr. Réal Ménard): Are my colleagues agreed to opening first-round questions now?
Some hon. members: Agreed.
The Vice-Chair (Mr. Réal Ménard): Mr. Merrifield, you have the floor.
Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you very much for your testimony.
I think everyone around the table agrees with catastrophic drug coverage, as far as party position goes. I'm not going to argue the merits of a national pharmacare program with you. We could do that ad nauseam, but we don't have the time.
What I would like to ask about is where we're at with post-surveillance, because that's really the focus of this committee. Before we open it up to easier access to drugs, are we really doing the job properly in terms of utilization as well as adverse reaction to the drugs that we are using at the present time?
We've heard testimony in this committee that up to 50% of those individuals admitted to hospitals will have an adverse reaction before they come out of it. Really, you're at the front lines of that. Would you concur with those numbers? And then, how are you prepared to help us with surveillance in terms of your professional expertise at that level?
¿ (0925)
Ms. Linda Silas: The answer, really, is time. What's happening in the system right now is that regardless of the level of practitioner--I'm not speaking of my colleagues, but I'm talking about from the family doctor to the specialist to the nurse on the floor--there's no more time. And the adverse drug reaction or the surveillance of the reaction to treatment depends only on how much time you can have with that patient. You need time to make sure the tests are done appropriately, and you need time to review the tests. We're seeing too much, too quickly in the system.
So you need to add staff. You need to make sure the numbers of patients that physicians have are not too great, because this is not a fast-food market we're talking about. It's people, and people's reactions.
Mr. Rob Merrifield: Now, you come here and lobby for a national pharmacare program, easier access, and the same people who testify that they have the adverse reactions are saying that we lose 10,000 people per year in Canada because of it, within our institutions. And I'm a little confused as to why you would not come here to lobby for addressing that problem, where you see an acute problem.
Perhaps part of the problem--and maybe you can answer this one--is that we are also being told that the training to be able to discern whether it's an adverse reaction within the hospitals is not there with nurses and physicians. I'm not blaming anyone, I'm just asking, do you think some work needs to be done in that area as well, and are you prepared to help us?
Ms. Linda Silas: I wouldn't go so far as to say that the training is not there. I graduated 20 years ago and worked in intensive care, where I was fortunate enough to have only one or two patients who...and I knew my medications. I knew the reactions that could happen. I worked closely with physicians and specialists, and we were monitoring those patients.
These same patients who had one-to-one nurses are now on the floors, on ordinary, medical, surgical floors where the nurses have up to ten patients. So the same attention that was given is not given to the same degree.
We do lobby for more intense control on adverse drug reactions. I think we focused in our brief on the community, because we understand that patients will go to family doctors, get prescriptions, and if they don't know the adverse reactions, they won't come back to say--
Mr. Rob Merrifield: So if you see an adverse reaction, what do you do with it?
Ms. Linda Silas: You advise the physician. That's the direct point of it. Often there are procedures already established. If there's an adverse reaction, you stop the medication, and depending on the medication, it can be stopped immediately or gradually stopped. You need to advise the physician.
Mr. Rob Merrifield: Okay. So your role stops there. According to the procedures, you notify the physician, and that's it.
Ms. Linda Silas: Also, there are different nurses who work on pharmaceutical committees of the hospitals, which, in my last job, I participated in. As a team, we examined all the adverse reactions, the cost of the drugs, and what each hospital had on its formulary.
Mr. Rob Merrifield: We're asking consumers to report adverse reactions, and physicians, and pharmacists--everyone along the line. Would you be prepared to go to, say, a larger centre to record and report adverse reactions, and should that be part of the protocol?
Ms. Linda Silas: Yes, and it should be part of the accreditation of hospitals, sure. You're talking something happening directly in hospitals, nursing homes, etc., directly in that building.
Mr. Rob Merrifield: But it's not now.
¿ (0930)
Ms. Linda Silas: No, it's not now. Right now we have a lot of information coming from Health Canada. They're just starting to straighten out the rules on how to advise. At the facility I worked in, there were over 300 physicians. How do you advise all of them of an alert that just came from Health Canada...and they're working on those issues, never mind adverse reactions?
Mr. Rob Merrifield: These are some of the problems. I'm looking for some of the solutions.
Ms. Linda Silas: Yes, and I'm sure our colleagues will be able to explore this even more.
My answer is that you need time for these.
Mr. Rob Merrifield: Thank you.
The Vice-Chair (Mr. Réal Ménard): Monsieur Hill.
Mr. Grant Hill (Macleod, Canadian Alliance): Thank you.
You said that Médecins sans frontières made the statement “patients before patents”. Are you suggesting that the patent process in Canada be abandoned and we not have any patent protection for brand names?
Ms. Linda Silas: No. I do believe patent is necessary, and I think nurses across the country believe the same thing. Twenty years? I think it's too long. We have to look at the direct costs that have happened over the years.
In our brief, we do address how, before patent, the costs went up, and how, after patent, it quickly went up.
Mr. Grant Hill: From your perspective, how long should patents be, in Canada?
Ms. Linda Silas: I'd like to go back to before 1995. I'd like to go back to when Canada was more independent in terms of approving their own patent laws.
Mr. Grant Hill: How many years?
Ms. Linda Silas: That was seven years.
Mr. Grant Hill: You do know that it was seven years from the approval time--seven years of protection from approval--and you know that the 20 years today involves the whole time, from the moment the drug is presented for approval?
Ms. Linda Silas: My understanding is that it has also expanded to 12 years before new generic drugs come in, too.
Mr. Grant Hill: Sorry, I didn't understand that comment.
Ms. Linda Silas: There's about a 12-year period now before a generic drug, from the patent drug, can come into the market.
Mr. Grant Hill: Really?
Ms. Linda Silas: That's my understanding, yes.
Mr. Svend Robinson (Burnaby—Douglas, NDP): That's with evergreening and automatic injunctions and everything else.
Mr. Grant Hill: She doesn't need your help, Svend.
Mr. Svend Robinson: Just glad to assist.
Mr. Grant Hill: I don't think that's accurate, but if you have data that would show this, I'd be interested in seeing it.
You've suggested that national pharmacare would lower drug costs similar to Australia's drug costs. There's been quite a bit of talk about the Internet pharmacy lately, with U.S. buyers coming to Canada, because the prices here are lower than in the U.S. That seems a paradox, to me.
Could you explain how you think pharmacare would have lowered prices below Australia's level?
Ms. Linda Silas: Below or equal. If you look at a national pharmacare program, everyone's bidding together, so just there you should be getting a lower price. And then everyone's covered, so if you're covered immediately for a disease, you won't get sicker and you won't need the more expensive drugs. Your physician can treat you immediately. And that's dealing with, yes, perhaps not the people in this room but the section of society that's living below the poverty line--workers who have no health insurance and so on.
In terms of comparing ourselves with the U.S. and Internet pharmacies, I had a problem with that from the beginning. You lose the information that your practitioner can give you. The Internet can only give you information based on who puts it on the Internet, which often is the drug companies, not physicians and not other health care professionals.
Mr. Grant Hill: I was never very comfortable with the post-market surveillance that I was involved with when there was an adverse drug reaction. It seemed cumbersome, to me, and I think you've said that it's cumbersome for nurses as well. When you document on the hospital chart an adverse reaction, be it hives or a blood dyscrasy or whatever, you inform the physician informally. I don't believe you formally inform the physician.
Ms. Linda Silas: No, everything that's done, especially in the hospital, is formal. You have to take notes on everything--the time you called the physician, his or her reaction, and if no reaction, you record it. We always encourage our nurses that if you call a physician ten times during the night, you make sure you mark it, or you register in the chart that you called ten times.
Mr. Grant Hill: What you're saying is that the process is cumbersome. It's difficult for the nurse, is it not, to go through this? Or is it easy to go through a drug reaction and have the doctor and society end up knowing about it?
¿ (0935)
Ms. Linda Silas: I think it is very necessary. Regardless of whether or not it's time-consuming, we need to do it.
Mr. Grant Hill: Could you suggest a way to streamline this, to make it easier for the nurse to report an adverse drug reaction? That's where I'm trying to get to.
Ms. Linda Silas: No, I don't think there's an easier way. We're dealing with people, and sick people, and often it's the first time they receive this drug, so a lot of time needs to be spent on observation. The problem in the whole system is that there are not enough people. There are not enough nurses and not enough physicians. So it stays at that level. It never gets out of the institution. Sometimes it doesn't even get to the committees it's supposed to go to, because we're all too rushed.
But that needs to be done. The same time and the same energy we spend on intensive care patients needs to be spent across the building.
[Translation]
The Vice-Chair (Mr. Réal Ménard): Thank you.
Svend, do you have any questions?
[English]
Mr. Svend Robinson: Merci, monsieur le président.
Thanks very much for your evidence. On the patent issue, I know that Mr. Hill may be a vigorous defender of the existing patent system in Canada, but the reality is that it causes huge problems. We've heard evidence on that.
One of the most glaring examples is Losec. The patent expired in 1999, and we're coming into 2004. Because of the manipulation and abuse of the existing system, laws, by big pharma, that's still not accessible. Evergreening, automatic injunctions...all of this that I had hoped, frankly, we as a committee could at least make some recommendations on, all along with a ban on direct-to-consumer advertising, and strengthening the laws on direct-to-consumer advertising. But it seems that wasn't possible.
I want to thank you for your recommendations and just ask two questions.
One, on adverse drug reactions, you mentioned the death of Vanessa Young. I've certainly read the recommendations of the coroner's inquiry. I wonder if you could just talk a little bit about some of the recommendations that you believe are most critical to be implemented that have not yet been implemented from the Vanessa Young inquiry.
The other question is on the issue of shortages of personnel. In August 2002, Michael Decter chaired a committee--I believe, Ms. Silas, you remember that committee--that looked at how we can respond to not only nursing shortages now but the projection that there are going to be very serious shortfalls in the future. How does that affect your ability as nurses and front line health care workers to be able to respond in areas like adverse drug reactions and so on?
Yesterday I was up in the House, asking the health minister when she was going to move on those recommendations as well as the recommendations of the Romanow commission. I see Dr. Patel here, and I know that Dr. Patel has issued some strong statements suggesting that there's a kind of paralysis in the federal government because of all of the leadership machinations and everything else, and we're not seeing action to implement Romanow. We're not seeing action to implement the report of the CNAC.
How does that affect the reality of the work that you do in issues like responding to adverse drug reactions?
Ms. Linda Silas: How does that affect it? I think when you go in to work, every day you pray that nothing will happen, and that if something does happen, you can correct it quickly. It is a nightmare out there. I went back to the workplace, from working for a union, for two and a half years, and I came out saying, “We're not crying out loudly enough.” It's as simple as that. After ten years in New Brunswick with the nurses union, I said, “Are we complaining for nothing?” So I went back to the workplace, Georges Dumont in Moncton, and said, “No, we need to be louder, and very proud to be back here.”
The CNAC recommendation...I think recommendations that were too common sense. We talked about full-time jobs. We talked about more education, more time with patients. And they need to be there, for sure.
How does it affect...? To go back to the response to the previous speaker, we need to have time. You can't deal with sick patients, with the different drugs that are out there and the different variety of drugs that are out there, if you don't have time. And if you don't have time to do the education, to do the search....
After 20 years in the workplace I now see computers on every floor, with programs where you can go and get information on the drugs--information to give to patients, information on the different interactions--but no one has time to go to the computer and get the information. So why did they even spend the money for that? And then we have all the formularies imaginable to record the different reactions--without the time to record them.
I'm sorry I won't be able to hear the comments from the CMA, but I'm sure it's the same thing with the physicians I've worked with for the last two and a half years. They just don't have time. They receive briefs and briefs on drugs, but who has time?
So we need to find a way, and I think the way is to look at the numbers of patients that each practitioner looks after. We need to find streamlining--but it needs to be done.
¿ (0940)
Mr. Svend Robinson: Thanks very much.
[Translation]
The Vice-Chair (Mr. Réal Ménard): Ms. Scherrer.
Ms. Hélène Scherrer (Louis-Hébert, Lib.): Thank you, Mr. Chair. I am sorry for arriving late.
I did not hear the beginning of the presentation, but I heard enough to understand that, ultimately, you support an essentially universal or national pharmacare plan.
I am from Quebec and I can tell you that the cost estimates now represent an astronomical amount, as you probably know. Perhaps some factors were not taken into consideration, such as the advancement of science, as a result of which drugs are now extremely expensive, as well as the fact that this has not reduced consumption. On the contrary, perhaps accessibility has greatly increased consumption.
So, you have estimated, to some extent, the possible cost of pharmacare. In my opinion, this is exponential. Given that demand is set to increase, it will be increasingly important to reduce hospitalization costs. I dare hope that money will be invested in prevention too, which means even higher costs. In any case, it is not realistic right now to provide an exact estimate, as I am sure you know.
Ms. Linda Silas: No. Furthermore, most of the individuals researching the costs are unable to produce an exact estimate either. But, whether a plan is private or public, it is possible to control what is administered, for how long, and the long term impact, because either the company or the government is responsible for administering the plan.
Currently, various organizations administer various plans, and it is the physician signing the prescription who decides.
Ms. Hélène Scherrer: I know that the goal is accessibility, and this what we need to consider. However, when we think what this could cost after—
I have another brief question in relation to the preceding statements. I think that nurses have the most contact with patients on a daily basis. You say that each time a patient has an adverse reaction to a drug, you record it without fail, 10 or 20 times if need be. Does anyone tally the results? It is good to record it in the chart so that the physician knows that a particular patient had a particular reaction to a specific drug—and perhaps the drug will be changed—but does anyone read the charts at the end of the month? I know what medical charts look like. Not many people review them. To your knowledge, is there anyone, for example someone from a federation such as yours, who reports to an organization responsible for reviewing drugs? Do you produce an annual report? It is all fine and well to record the information in each individual chart, but if no one reviews the charts at the end of the month—and probably no one does, given how thick charts can get—to see which patients had an adverse reaction, under what conditions and when taken with what other drugs—none of which is likely done either— there is not much point in noting the reactions, except to help the patient but not to help society in general.
Ms. Linda Silas: It is true that not all the charts are reviewed. In the case of severe adverse reactions, the medical or nursing team is responsible for obtaining the necessary information from the chart. The person writing a prescription—often the physician or specialist—has a responsibility and must continue to work with the hospital's pharmaceutical committee, for example. But this is true particularly when it comes to severe adverse reactions; day to day reactions are not obvious. But that is how this reaches a higher level.
Ms. Hélène Scherrer: It is because an extremely severe adverse reaction often has very serious consequences. If, initially, the possibility of a specific adverse reaction, even a slight and not necessarily fatal one, could be noted, perhaps it would be possible to prevent certain other adverse reactions that could occur with consumption. Often, the effects of a drug become apparent with consumption. The first time, the reaction may not be serious, but the second time it might be significantly worse. Ultimately, action is taken only when the patient ends up in a coma or something like that. Consequently, it is somewhat unfortunate that there are no mechanisms to enable you to sound the alarm immediately, to say right from the start that we have to watch out for a particular drug or verify the reactions of other patients in the hospital to it. This kind of mechanism would make it possible to identify any common denominators. For example, if the drug causes a rash, does it typically appear everywhere? There is a real need for an alarm system, which does not currently exist. Action is not taken until patients, like that young girl, have a reaction that makes the headlines. It is a bit unfortunate.
¿ (0945)
Ms. Linda Silas: Yes, but that is the reality of working in a hospital; the team does not have the time for discussions. Sadly, the only cases that get discussed are the ones that make the news. The team becomes aware of a situation and the prescribing physician is responsible for gathering this information. He also needs to take the time to examine it. It is a question of human resources, because the knowledge is there; it is the human resources that are lacking.
Ms. Hélène Scherrer: The situation might be better in a hospital setting, which is responsible for oversight, but additional positions must be created; you are already short of staff just about everywhere.
Ms. Linda Silas: There are incident reports, but by then it is too late.
Ms. Hélène Scherrer: Thank you.
[English]
The Vice-Chair (Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)): Thank you very much.
My understanding, Madam Silas, is that you wish to leave early. You may be excused--and continue on with your task.
I apologize to the committee for being so tardy this morning. These are very hectic times on the Hill. As you know, we are going to be dismissing very early, and we're trying to squeeze so much in such a short period of time. It's hectic for people like me who sit on three committees. It's just a nightmare. It's hectic for everyone, really.
We will continue with the presentations this morning.
Dr. Sunil Patel (President, Canadian Medical Association): Thank you, Mr. Chair.
My name is Sunil Patel, and I'm president of the Canadian Medical Association.
Before I begin, I'd be happy to address some of the concerns that have been raised by committee members on adverse drug reactions and a national pharmacare program.
Nevertheless, on behalf of the Canadian Medical Association and its 59,000 physician members, it is my pleasure to address the standing committee this morning on health today, as part of your important and timely study of the issue of prescription drugs. While we do not have all the answers to all of the issues and questions being examined by the committee, we think one thing is very clear: Canada needs a long-term, sustainable prescription drug strategy.
The Canadian Medical Association's vision for a national, made-in-Canada prescription drug strategy is straightforward. Canadians should have access to the right drugs, at the right times, for the right prices.
You have my speech in front of you. I'm going to skip through some of the paragraphs that have been highlighted there.
The CMA has proposed 12 recommendations in three key areas that a national drug strategy should address--information, access, and safety.
Before I address this framework, I want to raise the concern that is at the forefront of the prescription drug issue and on the front pages of newspapers across Canada and the United States. That is the issue of cross-border prescribing.
Cross-border prescribing is a burgeoning export of pharmaceuticals. It has not been without any consequence. Pharmaceutical manufacturers have moved to stop or limit supplies to those Canadian pharmacies engaged in this activity, and brand name companies have held out the prospect of boycotting Canada. Indeed, just this week we heard reports of a pharmaceutical company delaying the introduction of an important new drug for HIV due to fears that it might trickle back into the U.S. at a lower price.
The CMA is very concerned that cross-border export will result in reduced access to prescription drugs in Canada. Therefore, the CMA recommends that the federal government monitor and, if necessary, regulate the export of brand name prescription drugs to ensure that their continued availability in this country remains.
In terms of the role of the physician in drug therapy, to be most effective, it requires a strong, ongoing professional relationship between patient and physician. This relationship is the foundation of medical practice. It is key to a prescribing decision, and it must be maintained.
Many Internet pharmacies offer the services of physicians who will sign prescriptions without seeing the patient in a consultation. The CMA has formally and repeatedly said that this activity is unethical and it is simply unacceptable.
Our second major point is that of information. Moving back to our recommendation for a framework of a national prescription drug strategy, the first key area to address is information. The CMA strongly believes that Canadians have a right to accurate, unbiased, direct-to-consumer information on drugs, otherwise known as DTCI, and other therapies to enable them to make decisions regarding their own health care.
The CMA maintains that direct-to-consumer advertising of prescription drugs is bad for our individual and collective health. It does not adequately communicate risks. It is for profit, not for information. It overstimulates demand. And it contributes to a culture of overmedicalization--a pill for every ill.
The CMA has developed a more direct and effective way to provide this information than brand name advertising. Our document attached to our written brief, on our principles for providing information about prescription drugs to consumers, offers a responsible and more thorough framework for relaying drug information to Canadians. These principles should be combined with a comprehensive national drug information program funded by the federal government, and the program should provide accurate, unbiased prescription drug information that would better serve the interests of Canadians.
Our next major area is that of access, which was identified earlier. In terms of access to prescription drugs, there are several recommendations in our brief that we put forward for the committee's consideration. However, I will focus my remarks on the drug review process.
Delays in drug approval mean delays in access to new, potentially life-saving medications. For example, 15 other countries approved montelukast sodium, commonly known as Singulair, a major breakthrough in asthma therapy for children, before it was approved in Canada, even though the drug was developed in Montreal.
¿ (0950)
Many drugs submitted for review are not fundamentally innovative but they could be more clinically effective. For example, they could have fewer associated side effects or be made available in a form that could increase compliance. While Health Canada has implemented a priority review process for drugs to treat serious life-threatening illnesses, we need to expand it to all drugs deemed to offer substantial improvement over what is already on the market.
Our third major area is that of safety. The final critical plank in support of a national prescription drug strategy is safety. One example of how the health care system can promote safe and effective prescribing is by increasing patients' compliance with medication regimes. Research tells us that only about 50% of patients comply with long-term drug therapy. We need to know why this is, and how to remedy it.
The CMA proposes that the health care system work to create a culture that promotes optimal prescribing by addressing the shortage of qualified health professionals, by closing the knowledge gap on drug utilization patterns, by creating and adequately funding a safety infrastructure, by strengthening post-marketing surveillance, by investing in supportive technology, and by enhancing privacy protection for patients and prescribers.
To conclude, it is vital to Canada's physicians that our patients receive the right medications for their conditions, at the right times, and at the right prices. We need to develop a comprehensive, made-in-Canada prescription drug policy to realize this vision--one that promotes optimal prescribing, puts the health of patients first, and respects the relationships of patient and physician and of patient and pharmacist.
Thank you.
The Vice-Chair (Mr. Stan Dromisky): Thank you.
The Royal College of Physicians and Surgeons of Canada will be next.
¿ (0955)
[Translation]
Dr. Michel Brazeau (Chief Executive Officer, The Royal College of Physicians and Surgeons of Canada): Good morning. Thank you for giving us the opportunity to speak.
My name is Michel Brazeau and I am the CEO of the Royal College of Physicians and Surgeons of Canada. I would like to introduce our spokesperson, Dr. Jean Gray, a specialist in clinical pharmacology from Halifax and vice president of our College.
Dr. Gray.
[English]
Dr. Jean Gray (Vice-President, Executive Committee, The Royal College of Physicians and Surgeons of Canada): Thank you very much.
The Royal College of Physicians and Surgeons of Canada is dedicated to ensuring the highest standards and quality of health care. The Royal College plays a central role in setting the standards for the training, evaluation, certification, and continuing professional development of specialists, physicians, and surgeons. It also contributes to the development of sound health policy. It has nearly 31,000 active members, certified in 60 specialties and sub-specialties.
In covering this brief, we hoped to talk a little bit about the changing research environment, address some of the issues to do with rising costs, the questions of review and control of prescription drug prices, the approval and introduction onto the market of new drugs, with some potential solutions at least for some of the research endeavours, talk a little bit about adverse effects and prescribing practices, with particular attention to post-marketing surveillance, talk a little bit about marketing and lobbying, and then about consumer and health professional access to drugs.
With that introduction, I'd like to say that we're very pleased to have this opportunity to contribute to the work of the Standing Committee on Health as it embarks upon a major review of prescription drugs in Canada.
Research conducted by medical and other health specialists is an integral part of the process of ensuring the highest quality of health care. Adequate regulatory and organizational frameworks must exist to allow for the conduct of quality research whilst protecting the patients and investigators involved in that research. The broad regulatory environment within which research and development and the approval and dissemination of drugs takes place is in many aspects in need of modernization.
Mindful of the need to address these and associated issues, the Royal College established a task force on clinical research in June 2000, whose report was issued in the spring of 2003. This brief draws on salient elements of this report and addresses other issues requested by the Standing Committee on Health. A complete copy of the report, as referenced above, is attached to this brief.
I would like to start by addressing the changing environment. Governments, industry, and the voluntary sector have steadily increased their support for medical research in recent decades. The establishment of the Canadian Institutes of Health Research in 2000 was accompanied by increased federal funding. However, research funding by the pharmaceutical and biotechnology industries has outstripped funding by government. This is also true in the United States, where 70% of the money for drug trials in that country comes from industry rather than from the National Institutes of Health.
The last decade has seen a change in the conceptual understanding of clinical research. The traditional academic model, the one that I grew up in, involves selective leadership by clinicians in academic health science centres developing hypothesis-driven, investigator-initiated studies. A decade ago, 80% of clinical trials were centred in academic health centres. That percentage is now 40% and falling as the academic model becomes replaced by a business model where time is money.
Drug companies, impatient with the delays required by industry-investigator agreements in academic centres and the multiple responsibilities of academic physicians, outsource research to commercially oriented networks of contract research organizations and site management organizations. Those organizations recruit community physicians to collect patients for entry to clinical trials, usually conducted on the basis of prepackaged and industry-driven protocols. Report forms are later sent to the sponsoring company for data analysis.
Clinic research organizations have been criticized as being handmaidens of industry, concerned with the approval and marketing of drugs rather than with important research questions. Although infusion of industry dollars into industry-investigator partnerships can improve clinical practice, industry sponsorship has also brought with it concerns about data manipulation, investigators' conflict of interest, and the need for monitoring of research protocols.
A recent development is the purchase by large advertising companies of companies that perform clinical trials of experimental drugs. This adds to concerns that science is being sacrificed for the sake of promotion.
Patients must be able to trust their doctors during regular medical care. The same fiduciary relationship must exist when a physician conducts clinical research. If trust is lost, the entire research enterprise is put in jeopardy.
À (1000)
As to the issue of rising costs, for the last five years--as I know other briefs have indicated--total annual drug expenditures have exceeded physician expenditures. The share of public spending on prescription drugs has seen a sizeable increase since the beginning of the last decade, and now accounts for 80% of total drug expenditures, amounting to nearly that which is spent annually on physicians. Of total expenditures on health in 2002, CIHI data indicate that public spending on prescription drugs, 13%, consumed the third-largest amount of health care funds, just behind spending on physicians, 13.4%, and hospitals, 31.3%.
Rising drugs costs, however, are tempered by many tangible benefits for both patients and the health system overall. Medications such as anti-hypertensive drugs are now being used to prevent disease, such as cardiovascular disease and strokes, thereby reducing the requirement to use the health care system.
Medications such as cancer chemotherapy now make it possible to be more effective in treating disease. Other medications such as the proton pump inhibitors--Losec, as Mr. Robinson mentioned earlier--are now also used to improve quality of life and, most importantly, to preclude the need of surgery. In many instances, these medications also prolong life and often return the individual patient back to their family and even to their employment. Diseases that once had a very poor prognosis, such as heart failure or infectious diseases, are now compatible with a prolonged life, in large part the result of much improved drug therapy.
What remains is the need to develop the mechanisms to ensure that there is a return on investment, both for industry and for those parties who must assume the costs of this care. The Royal College recognizes that the medical profession must play its part in ensuring that prescription drugs are used in the most cost-effective way through patient education and appropriate prescribing.
This brings us to the issue of prescription drug prices. Canada is fortunate in that it has a number of mechanisms to assist in the control of drug costs, including a vibrant generic drug manufacturing industry and the Patented Medicine Prices Review Board, which establishes the sale prices for new agents entering the Canadian market. These developments have made Canadian drugs very attractive to seniors and others in the United States who have adopted both the availability of drugs through the Internet at Canadian prices and the opportunity to briefly visit Canada and purchase their medications directly.
The Royal College appreciates that American citizens may wish to access more affordable medications but does not support, under any circumstances, the co-prescribing of medications by Canadian physicians unless the physician has an established therapeutic relationship with the patient.
In terms of the approval of new drugs, specialists clearly play a critical role in catalyzing the introduction of new drugs onto the market, first by performing the appropriate discovery work in clinical trials and then as early adopters of new discoveries to enhance quality of life and health care outcomes. In addition to their contributions in the areas of research, education, and appropriate adoption of novel agents, specialists play a central role in the safe introduction of new drugs through the development of sound policy.
The Royal College is actively involved in various initiatives aimed at regulatory reform in Canada. Recently the Royal College participated in public policy forum discussions aimed at assisting Health Canada with the initial phase of their review of current processes and regulations for the approval and licensing of therapeutic products. The public policy forum's discussions were predicated on consideration of quality, effectiveness, and safety of the products.
Although the regulatory and process review initiated by Health Canada is encouraging, the approval process for new drugs remains hampered by ongoing lack of transparency. Deficiencies in feedback on the reasons underlying the refusal of recognition of new drugs only serves to frustrate both industry, ready to launch new products, and patients who are anxiously awaiting new therapies.
Greater transparency would easily contribute to building a knowledge base that could further enhance the drug in question or expedite the approval process. Further, the unexplained lag for approval of new drugs in Canada as compared to numerous other jurisdictions compromises access and research.
The Royal College welcomes the positive adjustments made by Health Canada to accelerate the time for drug approvals but remains concerned that the lack of appropriate resources, both human and financial, continues to undermine intended improvements.
One potential solution outlined in the report that's attached to this brief is the concept of a clinical trials group. This is a not-for-profit consortium or network of investigators and institutions that have agreed to collaborate. The clinical trials group may include investigators from the full spectrum of institutions--academic health science centres, community secondary and tertiary hospitals as well as from private practice, depending on the nature of the CTG and the types of studies it conducts.
À (1005)
A CTG has a central operations and statistical office, called a data centre, and is formally organized to perform multi-centre clinical trials. The core funding comes from a not-for-profit source, either a charitable organization or government, and thus it can operate at arm's length from the for-profit industry sector. Core support provides stable infrastructure funding for essential data centre personnel and functions and also per-case funding for a limited number of subjects accrued per annum.
In Canada there are several examples of such CTGs, including the National Cancer Institute of Canada--and the clinical trials group within that, which has core funding from both the National Cancer Institute of Canada and the National Cancer Institutes in the United States--and the Canadian HIV trials network, which is funded by the Canadian government. The Canadian critical care trials group has successfully coordinated studies in a particularly complex area of patient care.
Well-structured CTGs can provide solutions to all of the concerns cited above. CTGs can design trials and/or have input into refining the design of studies developed by industry. They can conduct a complementary cadre of studies to those conducted by industry, which increases the total number of studies on any particular agent. Through strong contractual arrangements, CTGs can hold the database for their studies and can guarantee the publication rights of their investigators.
In summary, efforts to bolster the resources available to existing CTGs, and to facilitate the creation of such groups in disease sites where none exist, should be a priority of government and other granting agencies in Canada. The benefits to investigators, patients and their safety, the public, and the pharmaceutical industry are clear.
Turning now to adverse effects and prescribing practices, and the issue of post-marketing surveillance, despite best attempts to ensure that original trials will product safe, effective drugs, the use of prescription drugs in the general population may yield different results, such as when they're prescribed to individuals who have other illnesses in addition to the one that was the focus of the original study or trial. Study populations in clinical trials are usually relatively healthy, middle-aged, and, until recently, almost exclusively male. Recent changes to legislation in both Canada and the U.S. have permitted both women and children to be included in clinical trials, but many medications commonly used in Canada today were never studied in females or in youth. Thus, the use of drugs in the real world is very different from the conditions of the original trial.
The methods in this country of studying drug effects and, most importantly, side effects, are seriously wanting. Currently the system is mostly dependent on health professionals reporting side effects, assuming that they recognize them in the first place.
Other countries have established and properly funded a good post-marketing surveillance system and have created databases to permit more careful study of this important phase of drug use. For many years, a well-structured database in Saskatchewan permitted scholars from throughout the world to follow up on drug therapy, and many important discoveries arose from this work. Unfortunately, the database was not maintained, and this work has shifted outside of Canada.
The usefulness of such databases is without doubt, and in our brief we've cited an example where an American group, that previously has used the Saskatchewan database, is now using a United Kingdom database in order to continue this issue of post-marketing surveillance research.
Given the differing drug approval practices between countries, Canada must develop its capacity to help its own research and regulatory communities to conduct post-marketing research and surveillance. Without such a system, the process of drug discovery, adoption, utilization, and monitoring lacks the final stage of monitoring.
This means that useful drugs risk being removed from the market because of one or two adverse effects after their introduction. Clinical trials are not fundamentally designed to detect rare side effects, something that occurs, for example, in one out of every ten thousand patients treated. Rare side effects can only be picked up by careful post-marketing surveillance.
The Royal College has played a leadership role in the creation of the Patient Safety Institute. Building on the work already begun by the National Steering Committee on Patient Safety, the Royal College remains committed to the establishment of a national system to address medication incidents through ongoing collaboration with the Canadian Coalition on Medical Incident Reporting and Prevention. The coalition is developing options for a comprehensive, viable, sustainable, and affordable medication incident reporting and prevention system for Canadians.
In the area of marketing and lobbying, it is important to differentiate between marketing and education, a concept that in the past was often blurred by the pharmaceutical industry. The medical profession welcomes the very positive support of industry for educational and professional development activities on the basis of mutually established conditions. All parties within the profession and industry now recognize that it is totally unwarranted for industry to pay for hospitality and transportation of physicians to simply attend an educational function.
Acknowledging, however, that specialists play a pivotal role in the discovery and early adoption of new agents, specialists also run the risk of becoming a tool for industry marketing. It is thus necessary to define an appropriate balance. Building on constructive dialogue, the medical profession and the pharmaceutical industry are continuing to address this issue as well as other important ethical and practical issues relating to the relationship between the medical profession and industry. It is interesting to note that from the outset, discussions have always been anchored on the public good rather than on the self-interest of the parties themselves.
Finally, in terms of consumer and health professional access to drugs, the overarching objective of health professionals must be to ensure that Canadians have access to the best possible drugs, through research, education, policy development, and appropriate practice patterns. Escalating drug costs are driven by two classes of drugs. The first is commonly used drugs that are not all that expensive and that are used by many, many patients. I would be prepared to bet that if we did a poll in the room right now, at least somebody in this room has a Ventolin or Berotec inhaler in their pocket. That's an inexpensive agent because so many people use it.
The other class of drugs is uncommon drugs, very expensive, that are infrequently used, but they cost both the patient and the government substantial amounts of money. Examples of this are drugs used in the management of HIV-positive patients, and particularly some of the newer cancer chemotherapeutic agents.
Various approaches, both educational and restrictive, can be used to control costs in the first category. Many formularies are attempting to control the cost of individually expensive agents by restricting prescription-writing capability to only those specialists most knowledgeable about the disease and the agents.
Although each province and each hospital currently review drugs separately and make their own decisions about what they will and will not cover on the plan for which these groups are responsible, there is now a move to have a common drug review process. Although in the early stages of development, the approach is a good step forward, as it will assure a common standard for review while still leaving discretionary decisions to those who must pay the bills. However, successful implementation of this promising process is greatly at risk. The Royal College renews its plea made to the Romanow commission that federal and provincial and territorial governments need to resolve jurisdictional disputes and agree to solutions that best serve the people of Canada.
In conclusion, the Royal College greatly appreciates the opportunity to present to the committee. The task of improving the quality of health care in Canada, including appropriate access to the right drugs at the right time, demands attention from all health care leaders and agents, governmental and non-governmental alike.
À (1010)
The Royal College remains committed to contributing whenever appropriate to health protection and legislation renewal under way in this country. We hope the committee will continue to count on the Royal College's support and advice as it continues its review of prescription drugs in Canada.
The Vice-Chair (Mr. Stan Dromisky): Thank you very much for that comprehensive report.
Dr. Hill, please.
Mr. Grant Hill: Thank you.
I'd like to go back to the issue of clinical trials. We've heard testimony at this committee that there are clinicians who manipulate data and who are given trips and gifts, as the college just mentioned, and that these clinicians are in fact in the pockets of big pharma under the current situation.
What can we do, other than the comments that have been made here in relationship to the broad principles for clinicians, and what has been done, if in fact these activities do put physicians or clinicians in a conflict of interest?
À (1015)
Dr. Sunil Patel: The Canadian Medical Association has for a long time in fact established a policy statement on the relationship between physicians and the pharmaceutical industry. In fact, it was revised just recently. With the pharmaceutical industry, it has broadened or stiffened the guidelines pertaining to physician practices in relationship with the pharmaceutical industry. We're very cognizant of it, and certainly in that area there is an ongoing challenge, with a need to continue to increase the vigilance and appraisal of such activity, which may be perceived to be influencing physician behaviour.
Clinical trials must continue, and ethics boards have been established across every university and in every province. They are mandated to look at and survey any particular research project.
I would also at this time like to introduce my colleagues. Dr. Isra Levy, an epidemiologist, is with the Office of Public Health at the CMA. Mr. Bill Tholl, the secretary general of the CMA, can help us in answering some of the questions.
Mr. Grant Hill: Could you point to any physicians who have been disciplined in Canada for inappropriate clinical trials? Have there been any instances where privileges to do clinical trials have been withdrawn from clinicians?
Dr. Sunil Patel: I'm not aware of any specific instances, but certainly if there was a formal complaint.... As you know, this is a licensing issue, and is handled by the colleges of physicians and surgeons in each and every province. So in the event that there was a formal, written complaint, then the college would investigate that. That is their role.
Dr. Michel Brazeau: Although I would like to point out that the Royal College is not a disciplinary body, we've been running into problems...as in the recent Globe and Mail. We are something else; we're in education and health policy.
I have two comments. First of all, has a physician ever been sanctioned in any given way? Yes, I remember, and I think Dr. Gray remembers, a particular case in Montreal of a researcher, Dr. Poisson, who was very much involved in North American research of very high calibre. That led to a specific sanction.
So yes, I do know of at least one example of that.
I would like to offer further comment about action being taken at this present time. There are two pathways for action that are being explored currently. One of them is the profession, as we both alluded to, engaging directly with industry. I think we've come to a common understanding that we should not be indulging in complaining about each other's ethical principles and how we apply them, that we need to work together and deal with some of the issues that relate to what you're mentioning, manipulation of data and things of that nature, which are clearly not in the public interest and should be dealt with directly, by both parties. We're very encouraged that both parties are sitting at the table and have engaged in discussion to deal with specific issues of that nature, and we're very encouraged that we will be able to effectively deal with some of these.
We do see another action, and we are pressing very strongly for that to occur. The regulatory framework is fine to have in Canada. It's going to be reviewed and it's going to be improved. That's also something we're very supportive of. However, we could not count on the regulatory framework to monitor and intervene on everything that goes on.
Let me be specific. In relation to research involving human subjects, the regulatory framework of Canada can set some very baseline principles, some basic rules, that must be respected. But we are convinced...and are lobbying very strongly for additional activities to occur, such as the accreditation of ethics review boards, be they operating in the public sector or the private sector. We're pressing Health Canada, we're pressing the Government of Canada, we're pressing the tri-councils and all of the research industry right now to engage in putting in place in Canada an accreditation or certification framework for research ethics boards, particularly to deal with research involving humans.
We see that as a very necessary, complementary activity to the regulatory framework.
Mr. Grant Hill: To both groups, I appreciated your comments on Internet pharmacy, as it relates to the clinician prescribing, that this is inappropriate behaviour. Is it my understanding that action is also now being taken against individuals doing this without a patient contact? Of course, it would be provincial colleges that would do this. Do I understand that correctly?
À (1020)
Dr. Sunil Patel: Absolutely. In fact, four physicians were identified and censured by the college in Manitoba, and others are currently under investigation.
We've actually been aware of this for some time, but the colleges are powerless to act unless they get a written complaint in a formal manner. They cannot go out on a fishing expedition under the medical act. So certainly that is on the radar screen. We have jointly put out statements, as long as 18 months ago, that clearly the co-signing of prescriptions is not an appropriate activity without a doctor-patient relationship existing. The examination of a patient is the most important necessary standard that one has to abide by to provide good patient care.
Mr. Grant Hill: Do I have a moment to ask another question?
The Vice-Chair (Mr. Stan Dromisky): Yes, go ahead.
Mr. Grant Hill: I'd like to go back to the questions that I asked the nursing association relating to what I still consider to be a cumbersome process for adverse reactions and the reporting. You've been very, very good about making suggestions for improvement in almost every area of concern that you have. I'd still like to, from the associations, get some indication on whether or not we could improve the process of adverse drug reaction reporting. That's something I obviously don't have a solution for.
Dr. Jean Gray: That's absolutely mandatory, in my estimation. The process we have now is totally dependent on voluntary reporting. I think Ms. Silas was very effective in making the point that time is an issue. Finding the forms can be quite complex. If you've seen it before, you tend not to report it another time, so you don't get proper numbers. The patients are usually quite complex, and they're on multiple medication, so it may be difficult to identify which was the actual medication that initiated the response in the first place.
So you fill in the form. It goes into some black hole. No one actually ever checks out what's happening. It then gets funnelled through to the national adverse drug reaction reporting system here in Ottawa, and it subsequently reappears in the CMAJ as a two-page notice, that these things have been noticed. The reality is that there is never any proper investigation of what's gone on that might be useful.
Now, there are a couple of units in this country that, as an academic exercise, do make an effort to do that. There is the pharmacovigilance unit at the University of Montreal, which does make an effort to do that. It is probably producing some of the best information we have at the present moment in Canada. But the reality is that it is very restricted to a single hospital, a single academic health care centre, and that information is not widely disseminated.
It's that kind of thing that we need to have across the country, a mechanism that actually checks out what's going on, that monitors the process, that doesn't just depend on voluntary reporting. If that happens, then we will come into line with several other countries in the world that have these kinds of systems in place already, including New Zealand, Australia, Sweden, the entire European economic community. We are behind the ball in that respect.
The United States is about half-way between where we are now and where the rest of the world is, with a program called MedWatch, but that still is very dependent on voluntary reporting. It doesn't have a true monitoring role at the present time.
The Vice-Chair (Mr. Stan Dromisky): Thank you very much.
Madam Hinton.
Mrs. Betty Hinton (Kamloops, Thompson and Highland Valleys, Canadian Alliance): Thank you, Mr. Chairman.
As usual, this has been an education. It's always very interesting to hear from witnesses, whether they're on the professional side of it or on the consumer side of it.
There are two or three things I would like to raise, and then I'll wait for responses from you.
And I want to assure you, with this first question, that I am not an advocate of Internet prescriptions. I am playing the devil's advocate in this position.
I'm wondering if you could explain to me why there is such a concern. If a patient has gone to their own physician and has been put on a prescription--let's say it's something for a long-term disease--what is the difference between that patient getting their prescription over the Internet for less money and their getting it at their regular drug store? I mean, there always is a physician involved. So I just would like to hear comment on that one.
The second thing I'd like to ask comes from a comment that was made in one of the presentations. You talked about an ethics board that's established to oversee physicians. I'm wondering if there is anyone other than physicians on that ethics board. Is it self-policing, or are there people from the outside? I think the public would like to understand a little more about that.
The third thing that I found absolutely amazing, which came from Dr. Gray, is the comment she made that there have been no trials that included women and children. Physiologically, women and men are very different, and if we're doing trials to determine how a medication will affect people, then from my perspective, I would have thought that this would have occurred long ago. I'm amazed that it hasn't. You're telling me, I believe, if I heard you correctly, that it is starting to happen now. So I would like to hear some comments on that.
I have a last comment I want to make. This has been raised a number of times today. You talked about the fact that there are multiple medications being used on some patients, and that this is a difficulty for the tracking. I would like to suggest, and then hear your comment, that the fact that people are on multiple medications may be the problem.
À (1025)
Dr. Jean Gray: On your latter comment, in part I share some of your concerns. People call me a “therapeutic nihilist”, because I have spent most of my lifetime trying to encourage physicians to take their patients off medication.
I think one of the dilemmas we have encountered in recent years is the fact that some very revolutionary breakthroughs in, for example, the drugs to treat HIV, often call for the drugs to be used in substantial numbers. You need entire packages of medication in order to turn this from a life-threatening to a chronic disease. The end result is that you end up with a side effect, and you're not sure which of the three or four or five or six medications the patient is taking is to blame.
Part of the study going on at the present time is attempting to see if you can actually begin to withdraw some of those medications and still get the same survival benefits that you get with the whole package. So oftentimes we embrace new technologies, and we embrace them because the disease is so life-threatening, and then go back later to find out whether or not you could get away with three drugs instead of five for the same end purpose. That's part of the evolution of the research into the drugs.
On the issue of women and children in clinical trials, a number of dilemmas faced both academic health centres and the pharmaceutical industry with regard to enrolling women in clinical trials because of the very real risks of exposing a drug to a fetus, if the woman didn't appreciate that she was pregnant. So the easiest way to deal with that was to just simply exclude women from clinical trials.
Fortuitously, approximately ten years ago, give or take a year or two, it was recognized that women actually had the capability to make their own decisions. As a consequence, first in the United States and then about a year later in Canada, legislation came into being that said that everybody had to be accessible in clinical trials, regardless of any paternalistic view about whether or not they should be in clinical trials. So for the last decade or so, all clinical trials in Canada have included women.
A number of the drugs that we use commonly, every day, actually were never tested in a female population--just so you're aware of that. But that has changed.
I will leave Dr. Patel to deal with Internet pharmacies, but I would like to address the issue of the ethical oversight of clinical trials, because that's a very important issue.
Just prior to the establishment of the Canadian Institutes for Health Research, the three research councils in Canada--the Social Sciences and Humanities Research Council, the National Research Council, and the MRC, as it was at that point--got together and developed what are known as the tri-council guidelines for the performance of research of any kind, not just clinical trials, in human subjects. These were implemented right across the country. It was made clear that universities would not have access to federal funding from any of these agencies unless they put in place these tri-council guidelines.
The tri-council guidelines are a major step forward in terms of the oversight of human research, whether it be clinical trials or other forms of human research, but they're also very time-consuming to implement. The committees that oversee this include all health professionals, not just physicians; they include ethicists, that being individuals with a background and professional experience in ethics; they almost always include lawyers; and they include representatives from the lay population. So it is in fact quite a wide-reaching array.
The problem is, however, that the volume of material they have to oversee--and it's all voluntary activity--is horrendous. There is a lot of human research going on in Canada. Many of these committees now find that they have to devote oftentimes up to a half-day to a whole day a week just to oversee the new protocols coming through. Remember, this is all unremunerated, voluntary activity, from a wide variety of health professionals. And then the opportunity to monitor what happens after the projects are undertaken is very limited.
So there is a big call right now to re-examine and to accredit, as Dr. Brazeau has said, the process. It might in fact require investment of dollars in order to provide an infrastructure to enable this to proceed properly instead of just tumbling in on itself because of the volume of work that has to be done.
I'll ask Dr. Patel to deal with the Internet pharmacies issue.
À (1030)
Dr. Sunil Patel: Thank you.
I would like to have a long response, because I think there are multiple issues that you've brought up, and not specifically to those three issues. They're very much linked to each other. We've heard about the multiplicity of drugs, about adverse drug reactions, about monitoring trials, and why Internet prescribing is bad for patients.
I'll start off, and I'll ask my colleagues to add something, because I think they have some valuable points that we want to bring to the committee's attention.
In my opinion, there is not a single drug that does not have a side effect, or the potential for a side effect or adverse drug reaction, which underscores the importance of a monitoring system that is currently not available. We have technology in Canada and we have not embraced it.
In looking into your methodology of instant communication, at a real network, the CMA proposed it in the public health strategy, with the Senate committee, with Senator Kirby. That same system now could do double-duty for, (a), the reporting of adverse drug reactions, and (b), the monitoring.
The second point I want to alert you to is that if a drug is introduced today, such as erythromycin, which has been used for well over...it would not qualify, under current strict guidelines of side effects and potential hepatotoxicity, for use in humans. So medication therapy has become much more complex.
The third issue is the multiplicity of drugs. I've been practising primary care for thirty years. Why am I prescribing more drugs today? The reason is that we have the issues of lifestyle disease, such as a multitude of diseases existing simultaneously--diabetes, hypertension, and a myocardial infarction. Now you have a multiplicity of drugs, and the monitoring of that becomes very important.
You asked a question...apart from the multiplicity of drugs, Internet prescribing would not allow us to continuously review. I sit down with my patients every three months and look at whether they need to be on those medications. So the monitoring agency becomes...that's the doctor-patient interface. Without that, we do not give carte blanche refills of drugs.
Internet prescribing would allow that. The patient would never see a physician or a pharmacist and get the drugs. It's fraught with danger. So Internet prescribing has a number of issues regarding safety of the patient, the quality of the drugs, the potential for fraud when medication is shipped across different borders, and where the medication is originating from. There is a whole host of issues beyond the immediacy of cost savings. So it may not help the access.
I'm going to ask Mr. Bill Tholl and Isra Levy, if I may, to--
The Vice-Chair (Mr. Stan Dromisky): Unfortunately, I'd like to get two more questioners in before the time is up.
Mr. Barrette, please.
[Translation]
Mr. Gilbert Barrette (Témiscamingue, Lib.): Thank you, Mr. Chair.
I am not a specialist in any field; I am an ordinary consumer. I was involved in the field of health as a volunteer on a regional board for some 15 years and therefore have a great interest in health issues.
Dr. Gray, a bit earlier, in reply to a question from Mr. Hill, you said that there should be some sort of monitoring. Who should take the leadership for that? Should Health Canada take it on? What other bodies should be responsible for supervision and follow-up?
I read one of the recommendations on the effectiveness of these drugs. We heard more than once, and therefore too often—I consider once to be too often—that the drugs were expensive, that they were not necessarily effective, and that they sometimes had unexpected side effects.
That is my first concern and question.
À (1035)
[English]
Dr. Jean Gray: In response to the first question, in terms of who should take the responsibility, in actual fact at the present moment Health Canada assumes that responsibility, but it's underresourced to do the job properly. It farms out the local responsibility to collect the data to five regional agencies across the country, one of which I'm very familiar with, because it collects all the data for Atlantic Canada. It's in the hospital in which I work, in Halifax. But the reality is that this is just data collection. It doesn't go any further than that, and as I've already pointed out to you, there is no actual monitoring.
I think Health Canada may well be the appropriate organization to do it if it were properly resourced. That would be my suggestion, primarily because I think that if any other organization gets involved, it looks then as if it's that organization that's running the show when in actual fact I think all health professionals have a responsibility to contribute, not just one particular group.
I apologize; I don't remember what the second question was.
[Translation]
Mr. Gilbert Barrette: It had to do with follow-up on the effectiveness of drugs.
[English]
Dr. Jean Gray: Well, I hope I've answered the question. I think it's a question of resources. There is the will, but there aren't sufficient resources.
[Translation]
Mr. Gilbert Barrette: I have another quick question. It is addressed to the five witnesses. What do you think about advertising? This question has often been raised. Out of kindness, we might call it information, but we might well wonder. I would like your opinion on this. I know that you recommend that direct-to-consumer advertising not be allowed, but what do you think about what we see on a daily basis in newspapers and magazines?
[English]
Dr. Sunil Patel: Thank you for asking that question.
Direct-to-consumer advertising is something that does not lend itself to accurate information. In our opinion, it is a marketing tool. I do not believe consumers and Canadians can learn much from an advertisement that lasts 10 seconds, or has a jingle, or lasts 30 seconds. We are not, however, opposed to good, sound, impartial information to Canadian patients and Canadian consumers. In fact, we need to establish a system of direct-to-consumer information as opposed to advertising.
So when we can embark on that, patients will be much more aware of the medication they're taking, the potential for interactions, and also to ask questions.
Mr. Tholl.
Mr. William Tholl (Secretary General and CEO, Canadian Medical Association): Just very briefly, on that same point...and I want to respond to the comment that was made earlier in terms of the United States, that they wouldn't be spending this money if it wasn't worthwhile. I worry that Canada is riding south on a north-bound horse in the sense that for every dollar that's spent on direct-to-consumer advertising--we have a study we have just commissioned--even the industry in the United States gets only 19¢ back on that dollar. Relative to other ways that they could actually sell their products, it's a cost-ineffective way to do that. Why would Canada adopt a U.S. solution that in fact the United States is going to be abandoning?
I would be happy to provide the committee with the study that shows that if you were going to spend a dollar in the United States, based on what's available in the United States, including direct-to-consumer advertising, DTC advertising ranks dead last relative to medical publishing and face-to-face communications with physicians.
If you'd like a copy of that, we'd be happy to provide it to you.
The Vice-Chair (Mr. Stan Dromisky): If you could forward that to the clerk, we'd appreciate it very much.
Madame Scherrer.
[Translation]
Ms. Hélène Scherrer: Thank you, Mr. Chair. I too wanted to speak about advertising.
In your presentation, I believe that you said that the most important thing is that consumers have access to sound information so that, when taking a drug, they are able to identify possible negative side effects. I also note that you are completely opposed to advertising of the sort we are now seeing on television and in the newspapers, aimed at the general public. You say that that would not produce the desired results.
Yet television, the written press and daily newspapers are the way to reach the average consumer. Should advertising take another form? Right now, it is produced by the pharmaceutical companies, whose sole objective is to make money. Would it be possible for you to do some advertising, using the same media?
The very relevant advertising you now do appears in the American Journal of Medicine or the Canadian Journal of Medicine, which the average person does not read. The information they contain is relevant, but consumers watch television, consult the Internet and read magazines. Should you not take a leadership role and put out advertising that is not produced by the pharmaceutical companies? This would ensure that relevant advertising was available.
À (1040)
[English]
Dr. Sunil Patel: Thank you. I think you're absolutely right. Television is a good medium for advertising to Canadians and for providing good information.
The CMA has actually taken leadership in providing information to their physicians, their 59,000 members, on the web. This is information that's accurate, on drugs of first choice and so on. That information's available for physicians to print out and provide at the point of service, when you prescribe a medication to the patient. When you look at the blue book of the Canadian pharmaceutical society, there's a tremendous amount of information that is not comprehensible. So really, the information has to be independent, credible, and legible, and understandable by the patient, in language that they can understand. Certainly, we can recommend a number of ways to work with Health Canada to establish a system.
I would not want a pharmaceutical company to advertise directly to my patients, because that, in my mind, would only drive further demand that may or may not be appropriate. You can provide information in a medium that is accessible to the average Canadian, which can give them good information on medication, in conjunction with other lifestyle modifications. I think medication is just one tip of the iceberg, because without the other aspects, the medications do not work.
So I would agree with them.
[Translation]
Ms. Hélène Scherrer: I would like to make a comment and get your reactions. We often hear the views of the medical community on drugs. We have heard from nurses, the pharmaceutical industry and pharmacists.
As a consumer, I always have the impression that there is a conflict between doctors and pharmacists. When my doctor gives me a prescription, I go to the pharmacy. The pharmacist gives me lots of information. He takes the trouble to tell me when and how I should take the medication, but very often he suggests a substitute. I have the utmost confidence in my doctor and I have trouble changing. I have the impression that sometimes the two professions are not really working together, that they are going their separate ways.
Do you really work together with the pharmacist? Would there not be some way of letting your patients know that the pharmacist also has a very important role to play? Many people see the pharmacist as someone who transfers pills from a big bottle into a little one. I think that we must change this perception of a profession requiring five years of study. I think that pharmacists can play an extremely important role in providing information, without necessarily being on the payroll of a company. They are just doing their job.
In a hospital setting, you can follow up on patients, but do you not think that a pharmacist could play a complementary role, such as asking patients renewing prescriptions whether they have experienced any side effects, headaches or whatever, and produce a daily report? We all renew our prescriptions somewhere. The pharmacist becomes a bit like our hairdresser; we are in his establishment all the time.
À (1045)
[English]
Dr. Sunil Patel: Merci beaucoup. I think you've made an excellent case for not having Internet prescriptions.
I have the luxury of practising in a small town, where I know both pharmacists. There are two pharmacies. There's a good relationship of interaction and sharing of information.
The Canadian Medical Association and its doctors, and the Canadian Pharmaceutical Association and the pharmacists of Canada, have made a joint statement on the scopes of practice. We complement each other as opposed to competing against each other. There's a sharing of information. There's an acceptance of where the biomedical model is, where the physician has all the information on the patient and the interaction of a drug in that particular patient. That's what we call the in vivo model, because drugs have been studied in vitro, which is in the laboratory.
The pharmacist also looks at medication. If you have a good relationship with that pharmacist, you can work together, both in the field as well as in the hospital.
Dr. Jean Gray: If I may--tongue-in-cheek, I might add--there isn't anyone in the room who works more closely with the Canadian Pharmacists Association than I do. I have published several books, with them as the publisher, so I think there is a good relationship with the pharmacists.
Also, historically, pharmacy sprang out as a separate.... It was part of medicine. There were dispensing physicians. In 1865 in Britain, when the legislation was first passed that separated pharmacy from medicine, in fact the very specific intent of pharmacy was that they would provide information to patients.
So I think what we've tried to do is respect that this is one of the major roles that the pharmacist plays, the provision of information to patients about drugs. That does not preclude the physician from doing it, but it is a very clearly defined role for the pharmacist.
The Vice-Chair (Mr. Stan Dromisky): Because of the time factor, that will conclude our rounds, but I would like to make a statement in conclusion.
As you know, we have x number of clinical trials taking place in the country right now. We're not too sure how many. There could be 200, there could be 500, there could be 20. But the point is that these clinical trials are going on.
Dr. Gray, you made some very, very pertinent points pertaining to the industry-driven protocol that many of these people who are involved...and I'm talking about professional individuals who are involved in these clinical trials. It's a question of ethics, as has really been raised already on the opposition side here, the ethics of the pharmaceutical industry and the ethics of the physicians who are involved in the clinical trails, in the other professional group.
Now, which is more important in that ethical code of yours--your allegiance to the pharmaceutical company or your allegiance to the safety and better health of the individual patients who might be involved in a clinical trial and also possibly in the society in general in the years to come?
You see, I see a conflict there. The pharmaceutical industry seems to be the driving force, you might say. They say that they have to have no transparency, that everything must be secret because of the competitiveness of the industry. So the competition is the driving force that stimulates the pharmaceutical industry to make those kinds of decisions. In other words, the holy dollar becomes far more important than the health of the individual patient.
I don't expect a response from you. I would just like you to think about it. Because that, to me, is a crucial problem here in clinical trials--the question of transparency and the allegiance to your code of ethics, where the patient comes first and not the pharmaceutical companies.
Dr. Sunil Patel: Absolutely. That code of ethics has been developed by the Canadian Medical Association and has stood us well for a long, long time. It puts patients first, and really, the health of the patient becomes paramount. I think you've identified perhaps an area that needs to be strengthened further.
I could not agree with you more that we need to put the interest of the patient first as opposed to the interest of the pharmaceutical industry and the physician.
À (1050)
The Vice-Chair (Mr. Stan Dromisky): Thank you very much for that comment. I'm hoping that we will be able to deal with this in a very, very effective manner in the years to come, because right now it is a problem.
Dr. Gray.
Ms. Jean Gray: And that's why we would advocate for the concept of the clinical trials groups, because they are independent of, or at a distance from, the pharmaceutical company. They represent a consortium of all of the individuals involved.
The Vice-Chair (Mr. Stan Dromisky): Yes.
Thank you very much for your very comprehensive and profound presentations. We really, truly appreciate the kind of information that you have given us. Thanks.
The meeting is adjourned.