I would like to welcome the witnesses who are here today.
What we're going to do is listen to the witnesses, but before we actually hear from the witnesses, I want to remind members that we will be discussing committee business in camera, beginning at 12:30. We will go in camera at that time for discussions.
The witnesses have heard this as well. At 12:30 we will ask you to leave the room so we can go into our business.
We really want to welcome you. We feel very privileged to have you in front of the committee today, and pursuant to Standing Order 108, I'd like to welcome you to the eighth meeting on post-market surveillance of pharmaceutical products.
You know, members, that our panel today consists of representatives from the Anemia Institute for Research and Education, the Consumers' Association of Canada, and PharmaWatch.
Just to get started, I would like to remind the witnesses that witnesses have 10 minutes per organization to make their presentation. What will happen is that the committee will hear all presentations first before proceeding to the members.
Let us begin with Ms. Durhane Wong-Rieger.
Thank you very much. I really appreciate the opportunity to be here.
I am here as the president of the Anemia Institute for Research and Education. I will also speak, though, in my role as president of the Canadian Organization for Rare Disorders.
Let me just put into the context, in terms of post-market surveillance, that for us this really means all the collection, analysis, and utilization of data on the impact of health technology. Certainly we're very pleased to see the health committee moving forward on this. At the moment, I think our major concern is that we believe the way it's being done currently is really not very useful to patient decision-making, and in fact, in some respects it may actually be quite harmful. As patients, we're well aware of the need to balance safety and efficacy, the risks and benefits, costs and affordability, but at the end of the day, patients really have one bottom line, and that is to be able to have access to medicines, and certainly to the most appropriate medicines, as soon as possible.
The second need for us is really making sure that, at the end of the day, the therapies we're getting are perceived to be working. Currently I would say that most of the system around post-market surveillance is really not very helpful to what we would call patients being able to make the trade-offs between risk and benefits, partly because in many respects we just aren't given that information. We're not given it usually from the physician, who may prescribe a medicine and not necessarily talk about it in terms of risk and benefits, and certainly we're not given it from the point of view of the government or from the manufacturers in truly understanding what the trade-offs are in those decisions around trade-offs.
We expect that post-market surveillance, though, is not only going to answer the question, is this drug safe and does it continue to be perceived as safe, but also, is the drug effective? So what we're directing back is to say, in terms of post-market surveillance, that the information, the collection of data, needs to be as much geared towards assuring that drugs are effective, and certainly effective for the specific patient populations for which they're being used, as well as whether they are continuing to be safe. That, to me, is one of the first challenges.
Let me briefly give a couple of scenarios that help drive our thinking.
Certainly the Anemia Institute has been very much concerned, in moving out of an area that the institute grew out of, about the issues around tainted blood. I think what we were keenly aware of, of course, is that at that time, even when the post-market data were very clear that we had a problem with the blood system, there was no uptake in terms of that information. There was no decision-making that actually took advantage of that information as it came down.
I was very pleased, as we went through the reforms of that system, to be named to the first board of directors of the Canadian Blood Services. However, I walked off that board two years later, in part because it was my sense that in setting up the new board of directors and the new Canadian Blood Services, we had certainly abandoned science and logic as a reaction to what had happened and, in fact, became hypersensitive to the issues around the post-market “safety”, to a point where it became very detrimental.
I'll give you two examples. One was the whole issue around banning donors who had accumulated more than six months of stay in England. At that time, the reason for the ban was because of the concerns around BSE among cattle. There was a concern that people who had been in England over a period of time might in fact actually have been exposed to contaminated beef and may be at risk for CJD, and there was a theoretical risk that CJD could be transmitted through blood.
At the end of the day, we made a fairly draconian decision to ban donors who accumulated more than six months of stay. I won't go through all the details of what was wrong with that decision, but I will say that decision was made fully in the face of no science, and actually a lack of common sense. Even today, some 15 years later, when it is very clear that there is in fact no such risk and there has been maybe one potential case of transmission of CJD, and we have in our own country now evidence of BSE in the cattle and we have evidence of it in the U.S., we continue to keep this ban. That, for me, makes no sense.
So we're doing something as a post-market reaction to an incident that happened, but we're unable to actually correct that once we're into it.
The second one I will give is continuing to ban donors who are men who have sex with men. Sure, in the early 1980s that was a problem, but now, some 25 years later, we are overreacting. It's not only a case of shutting the barn door after the horses have left; we're actually not even opening them up again when the horses are desperately needed. We have to be able to set up a system that works on the basis of science and logic and doesn't just become reactionary.
My other concern, as I say, from Anemia Institute, is that one of the recommendations coming out of the blood system was to be able to use alternatives to blood whenever possible, and we've had a real problem now with the erythropoiesis-stimulating agents. Yes, there are really very important issues that post-market surveillance has actually been able to find, and we give full credit to all of the agencies that have been examining that and understanding some of the risks that have been exposed.
Our problem right now is the way in which the process is being done, and certainly the U.S. FDA is a very poor example, in how they're reacting to it. I think it's a reactionary response to what happened with some issues like Vioxx. It does not help patients, and certainly I don't think it helps clinicians, when you have ongoing rolling reviews, ongoing restrictions that are taking place without full evidence. We think there needs to be a systematic approach towards this, understanding how much new information to gather—at what point do you come up with a decision, at what point do you put that out—and not constantly putting out little red flags and sending out DHCPL letters every time you have a new piece of information. It doesn't help us. We have to do this much more systematically.
We have developed some fairly good systems in terms of pre-market clinical trials and how to assess them. We have to apply that to post-market.
Finally, I'll go back to my issues around rare disorders. I think this is a very important opportunity for us to take advantage of what we see as a very positive happening in Health Canada with the progressive licensing framework—the ability to begin to provide some approval around drugs even as the evidence is continuing to be developed. We think the progressive licensing route is a very progressive way of working, and we have been very pleased to see some of the opportunities.
We're hoping that with this progressive licensing framework, as we bring in drugs—especially for the rare disorders, which continue to pose a great deal of difficulty in meeting the kinds of standards that your normal clinical trials would have—we'll be able to set up a very robust post-market system for these drugs, as they're coming in with much earlier evidence.
Certainly we see patient registries as being a very powerful tool to that. Again, I would argue very strongly that we need to have some systematic rules around how we're going to set up those patient registries. I really urge that those patient registries be internationally based, not just for rare disorders but for all—whatever we're doing in post-market surveillance has to be international—and that we also need to fully engage the patients. I think this is where the system has failed the patients. We still do not have a system in which patients are fully aware of where they can report adverse events. They don't get any feedback even if they do report them, and they certainly are not part of the whole post-system of communication and dissemination. Patients need to have information at a post-market stage that is patient friendly and fully understandable.
We applaud Health Canada for the patient-friendly monographs that are coming out with the new drug licensing. We think this is a very positive move. We think that the same thing needs to apply in post-market.
I also applaud very much what Health Canada's doing in terms of allowing people to have direct access to adverse reaction reporting as it's coming out. So as a patient, I can sign up. I can get the warnings. I get a very quick synopsis of it. I can decide whether it's useful to me. I urge, too, that this information also be patient friendly, because what we get is sort of just standard; it's not necessarily fully intelligible to a patient.
In conclusion, I will say that we don't easily praise what is happening in government, so when we do, it means a lot to us. We think that Health Canada has done some very significant things over the past few years, including setting up the post-market, engaging patients fully, and developing the progressive licensing framework that sets up an ongoing opportunity to no longer call it just post-market surveillance, but to have ongoing input.
We do think the patient registries could be a very important part of it, and I would really urge that we more fully engage patients in the reporting of adverse events, in terms of receiving that information, having direct lines into the government, and certainly direct access to that feedback and information.
I would also encourage Canada to do something that we think they're very remiss in, and that is to support patients and patient groups to help disseminate that information. We're one of the few countries I know of in the developed world that does not directly support patient organizations, and it makes it daunting for us to do our work. It's no good casting aspersions on the patient groups for taking industry funding when there are no other sources of funding. I really encourage the government to take a look at that.
Thank you very much for the opportunity. We're very pleased to see the Standing Committee on Health take up this issue. We encourage very robust scientific methodologies for linking post-market surveillance to the pre-market data, but we also urge that the information be considered in a very systematic way, certainly considering the patients at the end of it.
Thank you, Madam Chair.
We at the Consumers' Association are very pleased to have this opportunity to appear here today.
By way of background, for over 60 years the Consumers' Association of Canada has represented the interests of ordinary Canadians in their role as consumers of goods and services as provided by both the public and private sectors. We are not a professional medical advocacy association, nor do we represent persons with specific medical interests or illnesses. Our mandate is to inform and educate consumers on marketplace issues, advocate for consumers with government and industry, and work to solve marketplace problems in beneficial ways.
I am one of those 33 million Joes and Janes—to be politically correct—on the sidewalk mentioned by a committee member. And in fact, I am a volunteer. Since I am a layman, I will speak in those terms and not in medical jargon, in which I am not well versed.
Canadian consumers expect that the goods and services of which they avail themselves will be safe. This particularly applies in the medical arena. We at CAC recognize that the term “safe” is an absolute that can rarely, if ever, be guaranteed, and that a more appropriate term would be “to do no harm”. Consumers instinctively recognize this distinction, since they are aware that overdosing on even relatively benign products can have harmful effects and that many medications have potential side effects or contraindications, to use the technical term, I believe, even though they may not be familiar with the specific details.
We are extremely concerned that apparently an increasing number of pharmaceutical products that have been deemed safe, in that they were available for purchase, have subsequently been found to be anything but. Additionally, consumers are confused by the frequent media reports purportedly based on sound information that tell us that pharmaceuticals that had been promoted yesterday as life-saving are now seen as likely to harm or kill us. All of this raises the question: who, if anybody, is minding the store?
It is our understanding that the current system for approving pharmaceuticals is analogous to the way drivers used to be licensed. After a specified test or tests, the privilege to drive, or in this case to sell, is bestowed and is not revoked except for egregious circumstances. There is no attempt to determine if the capability to perform as required or expected still exists. Unfortunately, the analogy breaks down because there is no capability to revoke the right to sell pharmaceuticals.
Health Canada is proposing the introduction of a progressive licensing regime. To continue the driver analogy, this is similar to the graded drivers' licences that have been introduced over the years, whereby a young driver, after passing a test, is allowed to drive under limited circumstances. As time passes and additional tests indicate enhanced performance, the limitations are reduced until they are completely removed. But again, there does not appear to be a mechanism for following up over time or for revoking the privilege to sell.
Instead of a progressive licensing system—and part of the problem, I think, is interpretation of what that system is—we would prefer to see a continuous one. This would be one in which it is clearly recognized that an authorization to sell pharmaceuticals to Canadians is not an absolute, but that Health Canada can revoke that privilege if at any time it has cause to believe that the health and welfare of Canadians would be better served by removing that product. This means that there has to be an ongoing surveillance of the products. This would include the regulatory authority to require new or additional studies if clinical trials or data gathered either domestically or internationally suggest that there are safety risks for Canadian patients.
We do feel there is merit in allowing some products, as alluded to by Durhane, to be used in limited circumstances during the early stages of evaluation, and maybe evolution. These are cases in which the need for a drug is critical and the risks can be well documented by the manufacturer sufficient for the patient and doctor to make an individual risk assessment and decision.
We have noted during the course of these hearings numerous objections to the establishing of a post-authorization or post-market surveillance system, with reasons ranging from the idea that it would impose too great a burden on the reporters to the idea that the mechanism doesn't exist, how would Health Canada cope with and be able to sort through a multitude of reports, and how is it to be funded. There seems to be surprisingly little thought given to going beyond the excuses to how this can actually be made to work. The starting point has to be a positive one.
We think the Canadian Medical Association has got the right approach, which I think is worth repeating:
||...to effectively monitor the safety and effectiveness of the country's drug supply, ...a strong post-market surveillance system should include an effective process for gathering drug safety data coupled with a simple, comprehensive, and user-friendly reporting system; a rigorous process for analyzing this data to identify significant threats to drug safety; and a communications system that produces useful information distributed to health care providers and the public in a timely and easily understood manner.
We need to look at the establishment of a simple, cost-effective reporting system for reactions to pharmaceuticals that may be indicative of potential harm. We are not medically qualified to suggest what the cutoff point for reporting should be; however, much of the discussion seems to have been revolving around whether reporting only severe adverse drug reactions should take place. We understand that a working definition of an adverse drug reaction is “a noxious or unintended response to a drug occurring at doses normally used or tested for the diagnosis, treatment, or prevention of a disease or modification of an organic function”. In some cases we understand that this is qualified by some practitioners who add “significant morbidity or injury to patient, but did not directly cause death”.
We feel that in the interest of patient safety, the lower threshold should apply. We would even express some concerns about the limitation of doses normally used. There will be instances in which patients frequently exceed the specified dose either because they feel that an increase will help them get better faster and/or they were not made sufficiently aware of the dangers of doing so.
The system has to be able to track patterns of behaviour as well as low levels of unintended responses, which may be indicators of a widespread or imminent problem. In some cases, solutions may be as simple as including more, better, or more understandable information with the drug. Of course, if there are indications of a pending serious problem, appropriate stronger action would have to be taken.
We also note that there have been many comments about international harmonization of testing requirements and suggestions that Canada should not proceed on its own but should work only within that environment. It is our fear that this approach would most likely result in extreme delays in moving forward. The work of international bodies' attempts to achieve common ground or consensus usually moves at a glacial pace and with a great deal of politics involved—usually.
One last comment that doesn't appear to directly relate to the topic at hand is that we are adamantly opposed to consumer advertising of pharmaceuticals. In fact, in the context of this current discussion, we think that such advertising has an extremely detrimental effect on the efficacy of the medical system. It can lead to increases in misuse and inappropriate use, leading to overloading any reporting system that may be devised and diverting attention from more substantial concerns.
Thank you very much. I'd be pleased to try to answer any questions you might have for me.
I'm representing PharmaWatch. My name is Colleen Fuller, and my colleague Carol Kushner and I are both going to present.
First of all, thank you very much for inviting PharmaWatch. We're really pleased that the standing committee is looking at post-market surveillance. Of course, we have been following the work of the committee for many years and we are looking forward to your report.
PharmaWatch is a consumer advocacy group. We were founded in 2001, like a lot of other consumer groups, to begin pushing Health Canada to do a stepped-up ADR monitoring. We are focused on adverse drug reaction collection, although we obviously recognize that post-market surveillance has a much broader lens than that. We would take the position that the rest of the responsibility within the marketed health products directorate isn't going to get done if there is no data collection. So we do focus on adverse drug reaction reporting, and we are specifically focused on consumer reporting of adverse drug reactions.
Consumer reporting is a relatively recent development both in Canada and internationally. In Canada it wasn't really until the year 2000 that there was a focus on consumer reporting. Consumers began to be identified as a category or a source of report in 1998. That was the first time there was any ability to know how many reports were actually coming from that source. In 1998 it was estimated that 7.1% of reports were contributed directly by consumers, and by 2006 that had increased to 24.2%. So there has been a significant increase in the number of reports coming directly from consumers.
However, the contribution of consumers to the overall collection of data is very, very low, and what we are mostly focused on is increasing the contribution of consumers to the database. One of the reasons is that both our information and an increasing number of international papers that have been published in the last five years indicate that consumers are really able to make a significant contribution to our knowledge about the safety of medicines that are being prescribed. They are often overlooked as a source of information, or the information they contribute is often downplayed because they're not health professionals and physicians and so forth, but they actually are able to make a significant contribution.
Although the level of consumer reporting has increased in the last four to six years, overall, as I said, the number of consumer reports is quite low. We have conducted in the last three to four years a number of focus groups across the country. What we know is that awareness about Health Canada's ADR program is very, very low in Canada amongst consumers. In fact, if you say the term “adverse drug reaction” to most consumers in Canada, they won't know what you're talking about.
We think this situation really needs to be addressed with dedicated resources and funding by the marketed health products directorate. I concur with Durhane that patient groups, consumer groups, really have to be utilized by Health Canada in a much more significant way than they have done so far. We also believe that the priorities within the health products and food branch are focused on approval of drugs and expedited approvals within 300 days and so on, and that this focus needs to be shifted, obviously not entirely, but there has to be a reorientation and a greater allocation of resources and staffing to the marketed health products directorate.
In the summary I have provided a table comparing the resources and staffing that are allocated between the two directorates, the therapeutic products directorate and the marketed health products directorate. In terms of funding, TPD gets triple the funding that the marketed health products directorate gets and almost four times the staff.
We feel there needs to be a rethinking within the health products and food branch about where their resources and funding are being dedicated.
Finally, in our report I've listed our recommendations. I'm just going to finish by highlighting a few of them.
We make two types of recommendations. One is to increase consumer awareness about ADR reporting, and the other is about the actual collection of consumer ADR reports.
On the awareness side, we think there has to be dedicated funding for community-based promotion of consumer reporting and that there has to be a lot more investment in educational materials and promotion through television, radio, and through the media. We think the toll-free number that consumers can use to report ADRs should be listed on every package insert and every prescription label; that there needs to be a source of government-approved, unbiased information about drug safety and adverse side effects; that there has to be material published and geared towards different literacy skills, because this is a major problem in trying to communicate not only information about the reporting system, but about the risks that are detected in the collection of the ADRs. We also need to think about establishing a national clearing house for patient and consumer information on drug safety that is independent of the pharmaceutical industry.
On the collection side, it's obvious that people need to be trained. When we were first set up, we collected adverse drug reaction reports, and believe me, this is not an easy task for anybody. You have to be trained; you have to be educated.
I'm here to support a proposal that has been made to the federal, provincial, and territorial ministers of health. It comes out of a need to make clear how to improve post-market surveillance. There are recent news stories about Vioxx, hormone replacement therapy, and SSRIs--the selective serotonin re-uptake inhibitors--which don't seem to work better than a placebo. There are news reports that lowering cholesterol may not be all that it's cracked up to be for large numbers of patients taking certain medications. Apparently it's not helpful to the elderly, and it has never been demonstrated to be helpful to women. Yet large numbers of people in these groups are taking these products and exposing themselves to serious risk.
Canadians desperately need unbiased information about how well drug products work in the real world—information from outside the clinical testing environment. We need to know if they live up to their early promise. We're getting indications that some of these products are not living up to their early promise, that they're not safe when taken as directed. We need clarity about the risk-to-benefit profile of each product as it's approved. We just don't know at this point, and what we don't know can hurt us.
This proposal that I'm urging you to support—PharmaWatch supports it and has been involved in its development—is to create a five-year program of post-market surveillance that could, if approved by these federal, provincial and territorial ministers, fill some important knowledge gaps.
It's being supported by a broad-based coalition of researchers, medical providers, consumer groups, and other health providers. It would be a pan-Canadian project. It would build on existing structures, so there would be no need to invest heavily in new infrastructure. You could use bodies like ICES, the Institute for Clinical and Evaluative Sciences, in Ontario, which already has built-in expertise in this arena. Of course, we need approval from the ministers of health in all the provinces and the federal government.
I see Carolyn Bennett smiling, because she knows how easy that is to achieve, right?
All I'm suggesting is that endorsement of this proposal from this group would be helpful in opening that door.
There are specific advantages to be had from this proposal.
First, there would be a broad-based committee made up of consumers, professional pharmacists, regulatory agencies, research centres, industry, and government, all working together to set the strategic direction and to identify the first drugs that would be part of the investigation.
Another advantage is that it could produce much more timely results. We waited four years to find out about Vioxx, 15 to 20 years to find out about HRT. We're waiting too long to find out what we don't know and what we need to know.
The results could also help provincial drug plans figure out which products they should include in their formularies. We need to know that we're getting our money's worth when we put out those government dollars.
The program would also provide a concrete demonstration of the usefulness of the national pharmaceuticals strategy. It has been around for four or five years, and I don't know that it's produced much.
Can I make one additional comment on that? I think it's a perfect question and it's a perfect example of the disconnect between what happens in terms of Health Canada and their approval for marketing and what actually happens in terms of the availability and marketing.
It goes back to the federal-provincial divide. At the federal level they approve it for safety, approve it for efficacy. I think when Health Canada does that approval it means something, and it means something significant. The problem is that then when we talk about making it available, that information is not necessarily carried over in the right way, but as other people have said, the availability becomes totally disconnected. And it's almost impossible to call it post-market surveillance anymore, because as we're talking about progressive licensing and continuous licensing renewals, we have to be talking about ongoing surveillance.
So this is a perfect opportunity to ask, based on the uncertainty of the information—there is always some uncertainty—based on, as you say, the patient populations it's been tested on, what else do we need to do in order to be assured that if we're going to roll out the program, we're going to collect, in a continuous way, the information that is going to feed back into that decision?
And again, Health Canada, in their progressive licensing framework, has set it up perfectly to say that as we get more information, we can re-evaluate where we are. So as this program rolls out, as we collect not only safety information but efficacy information, we should be able to feed it back into the approval process to ask, where are we, and do we agree? And that should also feed back into the accessibility or the marketing process to ask, is it still being marketed in the right populations?
So it's an ideal opportunity to set up that integrated framework, and this is really where we do have to have that close cooperation between all of the stakeholders, including the patients and the clinicians, but also between the various levels of government.
As we're looking at it, it's an example where we can really take advantage of what we're trying to do in terms of setting up a much more robust, continuing surveillance of both efficacy and safety, but also the appropriate patient populations. And I would agree that I don't think it has been done.
Thank you for your presentations here today.
Certainly this committee has been fortunate to have heard many distinguished presenters as we've studied post-market surveillance, and one thing I heard suggested early on in the testimony thus far was mobile devices, electronic devices, as a way to have real-time exchanges of Health Canada updates. I heard from the Canadian Medical Association that sometimes their notices to physicians are mailed out or faxed out, and that there is a block of time involved there that could be hazardous when prescriptions are made.
Secondly, we heard from Terence Young on behalf of some victims, including his own daughter, who suffered, unfortunately, from an adverse drug reaction. One thing he suggested, which I wanted to get your comments on, was better pooling of international information. He said there was a timeline—and I forget what it was, but I think he said it was six or eight months—within which studies by a pharmaceutical company had to be shared if their products were being used in Canada. He thought that if study results were found, they should be shared within 48 hours with Health Canada.
I wanted to get your impressions, one, on how mobile devices would be useful, and two, what we could do to better exchange internationally the studies done on pharmaceutical products. They may be sold in Canada, and the study may have been done outside of Canada, but there should be a requirement on that pharmaceutical company to share that information in Canada.
I think you're quite right that there is a huge responsibility on Health Canada to become more effective as communicators of this information. Right now, the ways in which doctors are advised about problems with drugs don't appear to be that effective, necessarily. They are probably more likely, frankly, to react to a front page news story than to an official report from Health Canada. That's a problem.
One thing that will happen, I can assure you, is that when patients read that the drug they are taking is on the front page of their newspaper, they will then inquire about what else they could be taking, what the alternatives are, whether this bad thing is likely to happen to them too.
So I take issue a little bit with the gentleman from the Consumers' Association of Canada, with all respect, because I think that no one has a greater interest in the safety of drug products than the person who is taking them. Especially if it can be easy for them to make a phoned-in report, they have a perfect interest to do so.
The question is, what then is the response? Is it going into a black hole, or is there going to be some reporting back of how their information was used? I think there needs to be more of a quid pro quo.
In other words, if I tell you my story, you have to tell me how it helped fill in the history of this particular product; you have to tell me what steps are going to be taken to advise the larger community about this problem.
Or if my story is a one-off and really wasn't very relevant, I'd like to know that too. I don't mind negative results, but I'd like to know something was done with that report.