Health Committee on Feb. 14th, 2008

[Dr. Jeff Poston]

I can perhaps jump in and give my view from a practice perspective. I think ideally you want quality and quantity. An observation from the World Health Organization's adverse drug reaction reporting centre recently expressed the need to actually focus on quality. I think one of the challenges in terms of analysis of reports is that if they're missing information and they're incomplete, they don't really contribute.

The quantity argument comes in as one of the challenges that we know in relation to drugs at the clinical trial stage: they only get tested in a very narrowly defined population. I think a critical benefit of post-marketing surveillance is that you are seeing drugs used in a much broader population, so you do want to encourage reporting from a very wide range of people exposed to the drug. That's clearly desirable.

The critical piece—and I think it's the crux of the issue around mandatory reporting—is that if people feel they've just got to send reports in, and there's no attention paid to the quality of those reports, we're no further ahead. The critical piece is that we need to educate people to report better, but also we need to get better quality.

Denis, would you like to comment?

[The Chair, Conservative, Joy Smith]

Would you also like to make a comment? Go ahead.

[Denis Villeneuve]

From a practitioner's perspective, it is already very difficult to explain adverse drug reactions to patients. It would be all the more difficult if we had to then say that a given ADR is experienced by one patient in a million. How do you make this sort of information accessible to the patient? It is a real challenge.

[The Chair, Conservative, Joy Smith]

Madame Lambert, do you want to comment as well?

[Manon Lambert, Director General and Secretary, Ordre des pharmaciens du Québec]

One of my colleagues pointed out earlier that an integrated system is required. This is because even if we have the best databases available, offering both quality and quantity, we cannot always avoid ADRs if the information does not get—in a timely fashion—to the professional who has a patient standing in front of him. We all know that health care professionals often experience difficulty in getting feedback on the ADRs that they report. Although Health Canada's decision to make the MedEffect's database available on its website constitutes considerable progress, it would seem that health care professionals do not always consult the information that is sent to them and, as such, experience difficulties when using the system.

Our ultimate goal is to provide better treatment for our patients and to have a better understanding of the medications. A lot of emphasis has been placed on mandatory reporting, but I believe that the system as a whole should be addressed. Obviously, mandatory reporting has its role, but patient feedback also has to be considered. In the long run, changes may well be made to change monographs, but that takes time. Amending a monograph involves negotiating with the drug manufacturer, and it really does take a very long time. It is therefore very important to ensure that the link between health care professionals and the body receiving the reports is very strong. It is something that needs to be integrated into pharmacists' daily practice.

[The Chair, Conservative, Joy Smith]

Thank you, madame.

Now we'll go on to Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

What you are telling us here today is very interesting. For our part, we want to understand how the system works and how the Department of Health is involved.

Mr. Gagnon, you talked about subjects which to me are worrisome. We see that there are medications on the market with known undesirable side effects. You mentioned Vioxx. You said, among other things, that certain products should perhaps be withdrawn from the market, given the data from countries where they have been withdrawn. Gardasil caused the death of five people. I do not know if it was in Belgium, but it was in Europe.

The other day, I asked someone from Health Canada whether, given the five deaths that occurred in Europe, there shouldn't be a moratorium on this product, and whether we could use the data. I was told that this was not up to Health Canada but rather up to the Canada Public Health Agency. Already, this is complicated. Health Canada has told us that this is not the department's responsibility because it is a vaccine that comes under Public Health, and yet, Health Canada approved the marketing of this product.

You are saying the product should be withdrawn, but does this have to be immediate? What kind of tests could be done? I know that in Europe, they are analyzing the effects of the product and the reason why it may have caused deaths.

I am putting the question to Mr. Gagnon, but other witnesses can shed light on this subject for me. For our part, we are going to have to recommend steps with regard to Health Canada, and that is one of the issues at stake.

[Claude Gagnon]

Allow me to respond. I omitted part of my speech. That was precisely my point.

I would not want people to lose their trust in the system, be it the professionals or the general public. When we offer a product for sale in our pharmacies, it is because we think it meets the standards for protecting the public. Of course, we know that there are adverse drug reactions, but that they are not major ones; they are supposed to be minor and acceptable. In fact, patients are informed about them.

What is serious is that products that may lead to death among certain people can get through a gate that we can't imagine. We think that the tests done in advance by the manufacturer should be able to detect that kind of thing. Right now, marketing may be accelerated. Post-market surveillance is being demanded in order to detect problems. However, I do not think it is normal that we wait for deaths to occur before we take action, regardless of where they occur on the continent. Whether there are one, two or three deaths, a red light should flash and we should temporarily suspend the sale of that drug until we have the answer. It is up to the company to provide that, and it should not be the public who pays the price. This is where we want to raise public awareness.

Many products are currently at the pre-marketing stage. They have not been licensed and are sold illegally, in theory, since they are accessible to the public. This year, 64 products were withdrawn from the market. Of these, sixty were contaminated by bacteria, contained toxic heavy metal and had not undergone the pre-marketing process. Post-marketing is all very well, but the pre-marketing rules should also be respected. A product should not be sold if it has not received all the authorizations, all the patents necessary to guarantee its quality to the public.

That is the main message we want to convey, and I think it is important for you to take a look at this.

[The Chair, Conservative, Joy Smith]

Madame Lambert, would you like to comment?

[Manon Lambert]

As health care professionals, we always have to strike a balance between risks and benefits.

Earlier, this lady said she had received cancer treatment. Usually, when a patient is suffering from a potentially deadly cancer, the health care professionals treating that patient will accept a higher level of adverse reactions and potential risks of mortality, because this is a somewhat desperate situation.

Let's take the example of a nonsteroidal antiinflammatory drug which relieves pain for certain people suffering from rheumatoid arthritis, a very debilitating form of arthritis. We accept somewhat higher levels of ADRs. However, if it is used to cure a tennis elbow, we do not want to have this lead to liver problems and liver transplants down the road. It is in that sense that we have to evaluate the data that is given to us. It is not because a drug has been withdrawn from the market in another country that we should absolutely have it withdrawn here, because the context for its use may not be the same.

As health care professionals, that is the kind of information we like to obtain in terms of feedback. In the final analysis, we are the ones who are faced with the patients, and we have to advise them and inform them of the risks and benefits involved in taking a given drug.

[Christiane Gagnon, Bloc, Québec, QC]

Do you think that it is acceptable that the public are aware of only a small percentage of potential ADRs? As I understand it, the public are aware of only 10% of ADRs. People get the impression that everything is being done in secret and that they only find out the real story when it makes the papers. What is Health Canada's role? Could Health Canada be more proactive? There was pressure to get Gardasil onto the market quickly. When an industry is above the law when it comes to certain measures, there is no way of knowing who...

[The Chair, Conservative, Joy Smith]

Madame Gagnon, time is running out, and you have many questions. Perhaps, Madame Lambert, could you try to sum up some answers for madame.

[Manon Lambert]

As a general rule, the pre-market review reveals the most common ADRs.

Normally, between 2,000 and 3,000 patients will have tried the drug before it is marketed, although, of course, it all depends on the type of drug. In light of the number of patients who participate in trials, it is clear that we endeavour to strike a balance between getting the drug onto the market and having adequate knowledge of it. Obviously, asking manufacturers to test the drug on a larger number of patients will delay its introduction to the market. Nonetheless, in some cases, I think that is what needs to be done. In spite of pressure brought to bear by manufacturers for financial reasons, in some cases, that is indeed what needs to be done. As I said earlier, however, in other cases, depending on the type of disease, or whether the drug constitutes a therapeutic breakthrough, or whether the patients have no other options available to them, it is sometimes preferable to accept a greater degree of risk. I think that is important to assess the risks and the benefits, and to take stock of what constitutes acceptable risks in a given situation. I do not, therefore, believe that it is appropriate to use the same approach in all cases.

[The Chair, Conservative, Joy Smith]

Thank you, Madame Lambert. I appreciate your answer.

Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Madam Chair.

I truly agree with what Mr. Gagnon and Ms. Lambert said about addressing safety issues before drugs are made available on the market.

That's one of the questions we really have to deal with today. The government seems to be fixated on this notion of progressive licensing. Some believe that a part of it's being designed to get drugs on the market faster and thereby minimize the safety precautions at the front end. And that's a big part of what we should be looking at and what the government is out there doing anyway.

We need to get some comments from all of you on this whole new approach to licensing and its impact in terms of drug safety.

Jeff, do you want to start?

[Dr. Jeff Poston]

Yes, thank you.

The progressive licensing concept is an attractive concept, because I think we know from our experience and the drugs we've talked about—Vioxx, Cisapride, and there's a long list of drugs that we've had over the last 20 years—that we really only truly learn about drug safety through use. Conceptually, there's lots of attraction around just getting the drug into the market as soon as we feel it's reasonably safe, and then monitoring its use in 10,000, 20,000, or 30,0000 patients in order to know whether it's truly safe or not.

So I think the concept of progressive licensing is probably where we need to go. I think the challenges are around actually making sure the systems are in place at a practice level to ensure that we can effectively collect all of the relevant data to make sure we can make a good assessment of safety. And then further, on top of that, there is this need to really better develop systems that support the safe and effective use of drugs.

We've just published a book written by a Canadian who won the Harkness Scholarship this year. It is called Safe and Effective. The Eight Essential Elements of an Optimal Medication-Use System. It deals with issues around the evaluation of drugs prior to marketing, but more importantly, it deals with what needs to actually be done in practice to make drug use safe. We can make a copy of this available to committee members.

I think that conceptually, progressive licensing is probably the way we need to go. But a lot of work has to be done in terms of building the systems that would actually support that in the practice environment.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Does anyone here agree or disagree with that notion of progressive licensing?

[Myrella Roy]

I would support as well what Jeff has just mentioned, because right now the current system we have focuses only on pre-marketing surveillance, not post-marketing, although there is a little bit of effort there, but not as much, and as Manon mentioned earlier, because there are only a small number of patients who are exposed to the medications pre-marketing, we have limited information.

It seems that progressive licensing will be able to address some of the failures of the current system. We will be able to address issues related to adverse reactions more quickly if we have a system, however that will work. And again, it remains to be determined how exactly we are going to proceed with this progressive licensing, but we will be able to identify reactions sooner and be able to react sooner.

[The Chair, Conservative, Joy Smith]

You had your hand up. Would you like to make comment?

Then we will have Mr. Villeneuve, following Ms. Wolfe.

[Karen Wolfe]

In the same regard, in my experience in attending some of the progressive licensing workshops and getting a better understanding of what it means, from my perspective, it doesn't seem as if this is going to take away anything from the pre-market. However, it's going to add to the post-market and put a greater onus on industry, manufacturers, and albeit health professionals to be more accountable, transparent, and aware of what's happening in the post-marketing system. I don't see it as taking away anything from what currently exists, but enhancing what's already there to make it more robust.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I think there's been a lot of criticism of the pre-market surveillance system, to begin with, in terms of its rigour and ability to really make sure that drugs on the market are safe beyond a reasonable doubt. Even taking into account your qualifying words around risk, I think we have to be careful that we don't lose anything, and in fact try to enhance the pre-market end of things as well.

With respect to adverse drug reactions and mandatory reporting, I've heard you all. I think you make a very strong case about not pushing the envelope on that front, despite the coroner's report in Vanessa Young's case. The coroner recommended a number of other measures. I'm wondering if you think that the recommendations from Vanessa Young's case have actually been acted upon. How are we going to overcome what I see as a deep failing in the system, and that is, when we do get information, how do we make it more transparent and open so that doctors and patients actually make the connections?

In the case of Cisapride, there were adverse reactions, but no one connected the dots. Vanessa shouldn't have died. I don't think mandatory reporting may have helped that. But with regards to getting the information out and getting it connected in people's minds, getting young women to understand, if you're facing bulimia, what this could mean, is there any advice on that front?

[Dr. Jeff Poston]

Specifically, that was such a tragic case, but I think it illustrates many of the challenges we face. The hard thing there was, apart from Vanessa and her friend, nobody really knew how bad her bulimia was, even her gastroenterologist who was treating her.

There was information. Health care professionals had some of the information, and it was very, very early in terms of our known risks around that. It goes really to the point of the need for patients to be well informed. Certainly when it's children who are involved, parents need to be well informed and there needs to be a much more constructive dialogue between patients and health care providers. It's very much a part of that process we have to build to improve safety.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Poston.

Mr. Tilson.

[David Tilson, Conservative, Dufferin—Caledon, ON]

Thank you, Madam Chair.

This committee made a report in 2004. It's called “Opening the Medicine Cabinet: First Report on Health Aspects of Prescription Drugs”. The chair was the honourable Bonnie Brown. I don't think any current members of Parliament were on that committee. I think all you people were. Mr. Poston gave testimony.

Anyway, I'd like to read something from page 6 of that report, which deals with pharmacists, and which I'd like you all to comment on. Only a small portion of this report was on the topic we're on now. There are only several pages of the report that deal with post-market surveillance.

This particular paragraph said:

...witnesses called for more fundamental changes. They argued that complete reporting of adverse drug reactions would only take place if it were made mandatory for physicians and pharmacists. They insisted that the pharmaceutical industry should have more extensive mandatory reporting requirements and be required to invest in the post-marketing and adverse reaction reporting process. They suggested the establishment of an independent agency, like the Aviation Safety Board, to investigate drug safety.

I'd like you all to comment. In other words, this report is saying the pharmacy industry should be more active than they've been. Could you all comment on that, starting with Mr. Poston, since he was present at that?

[Dr. Jeff Poston]

I'm glad you didn't find something that was completely opposite to what I'd said this morning.

We know development happens slowly. I think, from the profession's perspective, we recognize that we actually have to try to change and develop better systems.

One of the things we've done as an association that publishes a lot of information about drugs is actually shift a lot of our material into a digital format. It can be accessed through a web portal and made available online to health care professionals at point of care. So from our specific association's perspective, we've done a lot to improve the delivery of information to health care professionals.

I think the other thing that's happened is that we, and most of the associations represented here, have actually started to build our links with two groups—other health care providers, in our case particularly physicians, and also patient groups—to begin to understand some of the issues that consumers have. We have made some progress in terms of developing more collaborative approaches.

I think the question of an independent agency comes up fairly frequently. I think that's an interesting one that we may have to look at more closely.

Something that we've called for, as an association, is what we've called a national medication management centre that would look at drug safety, effectiveness, and appropriate use, and that would be a stand-alone, independent agency. I think we've made some progress, but obviously there's still more work needed.