Health Committee on March 11th, 2008

[Dr. James Gowing]

In my oncology practice, when a drug is administered to a patient, if it's not working, we stop. I think that's only good medicine. I think any other physician here would say the very same thing.

Why I think I've come to this committee is because we should learn from those experiences, and we're not. I'm recording that in my patient notes on computers. That information is being recorded, but nothing is being done with it. That's a terrible waste.

We could learn what works and what doesn't work. We could learn more about side effects and everything if we collected that data. That's why we're here.

[Dr. William Hryniuk]

A 15% improvement in survival is a statistical number; it doesn't relate to what really happens. It may be that 85 of the patients didn't respond and 15 responded beautifully and are living disease-free for many years; in fact, that is the rule.

The use of 15% improvement in median or average survival is meaningless in human terms. What we need to do is identify the 15 patients who respond and go on to live healthy lives and not treat the other 85. That's the real problem. It's not the 15% improvement in average survival.

[Robert Thibault, Liberal, West Nova, NS]

Thank you for that, because the information we've been provided was a little dire, in the way I have received it: that some of these drugs would be of very little use and yet were still on the market.

[Diane Brideau-Laughlin]

I think part of the problem in how we're evaluating the literature and evaluating the outcomes is with the outcome that's actually being looked at within the clinical trials. That may be what misleads the population.

We're not looking at hard end evidence; we're looking at what we refer to as surrogate markers. We look at a decrease in blood pressure as being an efficacy, with a blood pressure medication, for instance. But do we know whether that in fact is going to translate into decreased death at the end of the day?

That's what we're not looking at. I think with post-marketing surveillance we can start collecting this information, analyzing the data, and seeing whether indeed our patients are doing better at the end of the day. We're missing out on that end. Unless we have somebody who then takes on the role of doing that post-market surveillance or does a phase four with that intent as an outcome, we never know whether we're treating with a drug that really is going to have a benefit.

[Robert Thibault, Liberal, West Nova, NS]

Who do you see as having that role now?

[Diane Brideau-Laughlin]

I think it has to be multi-factorial. I think it belongs within industry, to a degree, and it belongs with the clinicians, to a degree. We're treating our patients for various reasons with various products. We are all included in this. I don't see it as any one specific group's role; I think it's all intertwined. But somebody, at the end of the day, needs to collate this information and provide it to the practitioners and industry, so that we have superior elements to work with.

[The Chair, Conservative, Joy Smith]

Thank you. I think our time is running out.

Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

I would like to come back to the off-label use of medications. When a drug is prescribed off-label, is the patient sufficiently informed of the side effects or adverse effects of the drug, or the fact that it could be dangerous? When we read in the newspapers that a drug has killed someone, one wonders how such a thing is possible. The people in the immediate entourage of the patient, or the parents, are shocked and often challenge that use of the drug.

[Dr. James Gowing]

It's incumbent upon and actually a legal obligation for the physician to inform the patient of the potential for benefits and the potential for doing harm. That's the only way you can get informed consent. There are many legal opinions on this. Certainly, as a practising physician, I tell the patients what could happen, and I'm obligated to do it.

One of the problems that you allude to is the family's not knowing. In my practice, I try to bring the family into it, but there's a confidentiality problem here between the patient and me. The patient may not want the family to know, and then I'm obligated not to tell them. But I am totally obligated to tell the patients what they can expect from any procedure I do to them, including giving them a drug.

[Dr. Yola Moride]

I am very pleased that you've raised this issue, because it has been clearly demonstrated that, by providing information to patients, they are necessarily more involved in their own treatment. That is the whole principle behind patient empowerment, and it is quite clear that, particularly in light of media coverage in recent years, patients are now demanding a lot more information. In fact, we have noticed that spontaneous reporting by physicians often occurs following a visit from a patient who has gone to complain about adverse effects. That prompts the physician to report the event.

So, it is very important that the patient be informed. Of course, in a doctor's office, the physician doesn't have time to provide all the information. That is what happened with antidepressants. So, additional programs are needed to provide patients with that kind of information.

[Christiane Gagnon, Bloc, Québec, QC]

As regards antidepressants, I remember that, a few years back, patients were unaware of the fact that there has to be a period of desensitization before the treatment is discontinued, and that you can't just suddenly stop taking antidepressants. That can even lead to suicide, because the patient feels very badly and there are psychological effects, as well as an effect on a person's mental balance. Few physicians actually told their patients that. Again, that was something that appeared in the headlines, and that is how we found out that some patients were experiencing extremely adverse effects, which could even lead to death.

I would like to come back to Dr. Gowing, who says that he is collating a lot of information and has a lot of data about adverse effects that are not really being passed on. There seems to be a number of different ways of reporting the information, in order for people to be made aware of the adverse effects of certain drugs. I am a little surprised to hear you say that, because we are always told that the practitioners, who most often are professionals, are the ones reporting the most information to Health Canada through the various data banks, including MedEffect, but there is also the Canadian Health Network, which collates certain kinds of information.

Could you suggest a mechanism that would be more efficient, since the information does not seem to be getting out, and that is exactly what we would like to see happen?

[Dr. James Gowing]

I think what someone really needs to be looking at is how health care information can be collected and disseminated appropriately. Health care management across the country, in terms of information technology, is about 10 years behind the rest of industry. Why that is, I really can't answer, but it seems odd that I can get money out of my bank account using a card in the middle of the jungle and I can't get information on a patient who is seen in the next town. There's something wrong in our system here.

I don't think that is what I came here today to talk about with post-marketing, but it is a huge problem and you've identified it. I don't have the solution for it.

I have two sons who are computer engineers. They might have a better answer for you.

[Christiane Gagnon, Bloc, Québec, QC]

It's true that there are clinical trials before a drug is marketed, but we would like there to be greater vigilance. One of the Committee's objectives is to increase post-market surveillance. So, there is a need as well to know all the details of what happens when a medication is taken, once a product has been marketed. You are very important players, just as important as the patients, when it comes to delivering that information, so that people know exactly what to expect when they take a drug. Very often, the clinical trials conducted on certain drugs may have been shortened; I'm thinking in particular of Gardasil, which has apparently caused a number of fatalities in Europe and the United States. It is currently available on the market, but we have to continue to be vigilant.

[Dr. Yola Moride]

That is also the principle behind active pharmacovigilance. For example, we can use sentinel physician networks for new products coming on the market. We can also consult specialists who are likely to be caring for this type of patient, and solicit active reporting, rather than relying on a passive system.

[Christiane Gagnon, Bloc, Québec, QC]

But, do you think that…

[The Chair, Conservative, Joy Smith]

Your time is up, Madame Gagnon.

Ms. Wasylycia-Leis.

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

Thank you, Madam Chairperson.

Thanks to all of you for your presentations.

I want to touch a bit on the off-label question and the whole area of what I would see as a problem, and that is the involvement of the industry throughout the process of post-market surveillance.

There have been concerns raised about the government's new direction around risk management and the progressive licensing system as it relates partly to the off-label issue. That is, it might actually lead to a fairly rapid approval of already approved drugs for new indications without that company having to go through the rigour of the clinical trials and the surveillance and full disclosure before an old drug just gets automatically licensed for new indications.

Is that not a problem, from any of your points of view?

[Diane Brideau-Laughlin]

That is a significant problem, particularly in the older drugs that have been on the market for several years. Most of these drugs are not even available through the originating company or industry that actually created the molecule. Aspirin comes to mind. It's ancient, yet it's used primarily now for indications completely separate from what it was intended for years ago.

The difficulty then lies in who's responsible for the clinical trials, who is going to do the research, and where the funding is going to come from for the research. So, yes, it is definitely a problem.

In terms of new medications, I think that should be included within the progressive licence process. As indicated by my colleague, if at the outset, within phase two trials, within that licensing it's implied that off-label use for predictable other uses should be considered, that needs to be in the plan for the continuation of that product so that the evaluation continues.

[Dr. William Hryniuk]

However, if I can just add to that, the history of the indications for these drugs is such that you get it into the marketplace, you find that it works for the initial indication, but you soon find with off-label use that it has many other, completely unexpected ramifications. So it's not always possible to predict which off-label use is going to come up in your post-marketing plan. That's the good news.

The bad news, as you pointed out, is that it may occur in an unrestricted, unorchestrated way, and you have to strike a balance between these two. But I would hate to see that off-label use was prevented, particularly since—in response to another question—many of these indications are for rare diseases or uncommon conditions, and clinical trials would not ordinarily be conducted for those indications. They're either too long or too expensive, and you wouldn't want to prevent the use of these drugs in an off-label situation when it was quickly discovered that it was effective. The balance has to be struck in the legislation and the handling of this issue.

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

I appreciate the balance that we have to try to strike. I guess what I'm worried about is that we have a system with an incredible lot of influence by the brand-name drug companies over the whole drug approval process. I want to make sure that we end up with recommendations that actually protect against that. So what I want to know from all of you is, how do we do that? What is the best way?

I'm especially curious because the Cancer Advocacy Coalition of Canada does get a lot of backing from drug companies. In fact, I think every drug company in the western hemisphere has donated to your organization.

From the Expert Advisory Committee's point of view, I don't know about your committee, but some advisory committees in Health Canada have indicated that there are industry members on those committees. So how do we ensure that if we move to this risk management model and this progressive licensing model, we have that independence of opinion and surveillance right across the board, every step of the way?

I think that's what Canadians are most interested in, so we're grappling with whether or not we need an independent board or body that actually evaluates prescription drug safety. We've grappled with the need for a complete listing on the government's website of all drug approvals and non-approvals. We're grappling with whether or not there shouldn't be a complete review of all clinical trial data used to reach any decision made and that being made available to the academic community.

Those are a few ideas. Are there other—

[The Chair, Conservative, Joy Smith]

Ms. Wasylycia-Leis, just to make you aware, we have only two minutes left for them to answer.

Who would like to take that question on for Ms. Wasylycia-Leis?

[Dr. William Hryniuk]

I'd just like to address one point you made.

The Cancer Advocacy Coalition of Canada gets unrestricted grants from the pharmaceutical companies. We provide them with a list of things that we're going to do, and they either do or don't support them. As you can see from this year's report card, only two of the 10 articles had anything to do with drugs, and our emphasis is on much wider aspects than that.

That said, I think we also have to say, on behalf of the drug companies, that they're not all bad people. They have their interests, and this is a capitalist society, after all. If they didn't work, we wouldn't get the drugs. So I don't think it's fair to impute motives to them that are beyond the ethical boundary.

That said, I agree with your point. An independent body needs to be doing this surveillance, but the essence of the success will be draining off the information from all the electronic systems that are already getting this information in medical records across the country, particularly for cancer drugs. The information is there; we're just asking that it be drained off for surveillance and addressing the issues you've just raised.

[Dr. Yola Moride]

There were several issues raised, and I don't think I can discuss each of them, but the first one you brought up was the question of a new indication. You felt that maybe the system would allow the new indications to be evaluated too fast.

I think what we've seen so far—and I'm talking about my experience at the international level by other agencies—is that the same level of rigour in terms of clinical trial data must be provided to the assessors. It's important also to realize that the risk management plans afterwards not only include or concern the new indication but also the older indication. So basically pharmaceutical companies must make sure they really want to have that new indication, because the ramifications are very important in terms of drug safety surveillance.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Moride.

We'll now go to Mr. Tilson.

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

Thank you, Madam Chair.

I'm trying to determine the issues you've raised. Obviously you all seem to think the system needs to be improved; we need to expand on the system.

My questions to you may have been asked in another form by some of my colleagues. I have a number of questions with respect to that. Who should do this? Should this be government? Should Health Canada take it all on and do everything? Should it be privatized? Should one of you do it?

I say that with a twinkle in my eye. Should someone other than the government do it, or should a partnership do these things?