Health Committee on April 15th, 2008

[Christiane Gagnon, Bloc, Québec, QC]

On a completely different note, according to public health authorities, Gardasil is a vaccine for young girls from 9 to 15. It was announced in Quebec and everyone seems happy.

However, I was reading that young girls have died abroad, if I'm not mistaken; eight have died in the United States and in Germany. When we hear that, we can't help but wonder whether the drug might not be at fault. I realize we must be cautious. We cannot withdraw all drugs from the market. However, there have been eight deaths, and in Canada we continue to carry out massive inoculations. Apparently, this vaccine would counter the HPV strains responsible for cervical cancer.

Why do we continue to do this? Why isn't there a moratorium, why do we not stop this massive inoculation?

As a consumer, if I had a 9- or 11-year-old girl, I would be very concerned. Very few people know about this. We do because we sit on the Standing Committee on Health, we read more and try to be informed.

What type of information should there be? Does this raise a flag? A red flag? Nine-year-old girls cannot be concerned about developing cervical cancer 10 years from now. However, it is up to parents to make these decisions.

[The Vice-Chair, Liberal, Lui Temelkovski]

A short answer from one of the witnesses, please.

[Dr. Robyn Tamblyn]

I think it was an exciting new opportunity to prevent cervical cancer in kids, young girls. I think we lost sight a little bit of the fact that we didn't have a post-vaccine surveillance program in place. I think that was a terrible shame, that in fact the medication was funded without any follow-up, especially in young girls. Who knows what's going to happen?

Fortunately, vaccines by and large tend to be safe, although we've just been through this whole issue of vaccines and autism, as being a potential trigger for autism, and we really don't know the answer to the question.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

Madame Wasylycia-Leis.

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

Thank you, Mr. Chair.

Thanks to all of you for being here. It's a very informative panel.

I want to start with you, Alan Cassels. I've just been skimming through your book, Selling Sickness, and you make an observation that I think we've heard supported at other testimony, that the pharmaceutical industry is working very hard behind the scenes to define and design the latest disorders and dysfunctions in order to create and expand markets. You talk about that with the words “disease-mongering”.

I know we don't have time to get into that whole issue here today, but I would like you to relate that to what we're dealing with in terms of post-market surveillance and with respect to Bill C-51, which is actually about post-market surveillance, supposedly.

The fact that the drug companies that you refer to have been very supportive of Bill C-51 raises all kinds of alarm bells for me, but I don't want to just be subjective about it. I want to know if in fact there is some legitimacy to the argument we have made that the progressive licensing framework will in effect facilitate speedier approval of drugs into the market, and hence cause more safety concerns down the road, as opposed to being a neutral scheme, as the government claims it is.

[Alan Cassels]

It's a very good question. That goes back to Ms. Kadis's point: how interested are we in speed?

I would ask all the committee members to imagine themselves undergoing surgery where someone is taking out a tumour, or a uterus, and so on, and the surgeon is standing in the operating room and has people, bureaucrats, standing behind him and telling him, “Go faster, go faster, you need to do this procedure quicker and quicker.” Most people would say that's completely irrational. You want your surgeon to do a proper job. You want him to take his time and be careful.

Why would we expect a different standard when it comes to evaluating or reviewing the safety of drugs? We have the manufacturers and the industry-funded patient groups saying “Faster, faster.” So I try to ask, is there any legitimacy to the need for speed? My answer would be, show me the conditions in which we are being slow in approving drugs. Is it in the high cholesterol? Is it cancer treatments?

We already have a number of programs in Canada where people with rare diseases can get pre-market access to drugs under clinical trial conditions. There are already those ways to get speedy drugs if you're facing life-threatening conditions. I can tell you, if I were facing a rare, life-threatening condition, I would want faster access to those treatments too. But they're so rare and so beside the point.

Most drugs are not treating rare and life-threatening conditions; they're treating high cholesterol, high blood pressure, gastroesophageal reflux, and the pain of arthritis—long-term, chronic treatments on which we can afford to take the time to make sure those drugs are causing more benefit than harm.

I hope that answers your question.

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

I wouldn't be so worried about this notion of progressive licensing if I felt confident that all caution was taken at the pre-market level, yet we keep hearing all kinds of horror stories in terms of the drug approval process.

We know that the licensing framework allows for the industry to basically pay for its drug approvals. We know that there are many drugs like Vioxx out there, and it doesn't seem that the post-marketing surveillance, a big centrepiece of progressive licensing, is going to do much on that front.

The government says nothing's changed, and yet we have a deputy minister or an ADM who comes to the committee and says, “We're implementing a shift in the focus from pre-market to this life cycle approach”. And we've got, of course, groups out there—and I think about the Best Medicines Coalition, with which I'm under some criticism for suggesting that it's supported by big drug companies—saying this bill and the progressive licensing system is great because it will get drugs that they want faster to market.

So is it not a worry? And what do we do in terms of our work as a committee to counter that possibility? This question is to all of you.

[Dr. Mary Wiktorowicz]

I think you're identifying a huge problem. Right now what I'm seeing, especially in the U.S., is that lawsuits are now taking the place of the regulatory role.

If you take a look at, for example, antipsychotic medications, one I'm familiar with is Zyprexa. A very significant side effect is weight gain. Patients put on about ten pounds, and then they get diabetes. Maybe ten pounds is too little. They put on a lot of weight right after going on the drug, and they get diabetes. Diabetes, as you may well know, is very serious. It leads to hardening of the arteries and all of the cardiac conditions and limb and eye problems. It sets you up for lifelong physical degeneration. This is for treating perhaps schizophrenia or perhaps depression. I have even heard of off-label prescribing of these drugs for children.

One of the reasons they say these side effects were not picked up is that the pre-market clinical trials were maybe three months. Maybe they were six months. I don't know what it is in this case. Thousands of patients in Canada and the U.S. now suffer from diabetes as a result of taking Zyprexa. There was a class action lawsuit in the U.S. settled out of court. Patients have now received a lot of money because now they're saddled with diabetes.

If you're telling me that we're not getting the drugs out there fast enough so patients can take them fast enough, I'm saying you're trying to get them up faster so that patients can acquire these illnesses or side effects that are far more deleterious sometimes than the conditions they're trying to treat. If you're telling me that is a better system, I don't see the logic.

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

It's been hypothesized that in fact it might be, from the drug companies' points of view, cheaper for them to pay off big lawsuits than it is to put the investment in at the front end to make sure that the drugs are safe beyond a reasonable doubt.

[Dr. Mary Wiktorowicz]

That's right, and you want to put patients' lives in the balance. As Robyn had pointed out earlier, you are experimenting on people. The administrators in the FDA have admitted, in a published journal, that in the first two years they don't recommend taking a new drug because we just don't have the experience.

We do have the systems in place for some of the life-threatening conditions now, and there are certain provisions in the bill that I would support for the post-marketing. I mean, you do need to allow Health Canada to share its information with committees that might be involved in setting up post-market surveillance studies and so on, taking advantage of the electronic databases. We need that post-market component, absolutely.

But on the pre-market, there is a clause in the bill that I noticed. Right now our Food and Drugs Act is very vague, saying simply that the minister will ensure that sufficient studies are conducted to ensure that the drugs are safe and effective, and it's similarly vague in the current proposed legislation.

Maybe we need more detail around that. Maybe we need more detail as to the kinds of studies, that the three phases of clinical trials need to be conducted, except for certain conditions, life-threatening conditions.

As Alan pointed out, it's not the majority of drugs that need to be fast-tracked; it's perhaps those that address the life-threatening conditions.

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

Do we perhaps...? Oh, sorry, Dr. Tamblyn.

[Dr. Robyn Tamblyn]

On the speed issue, I just want to say that you're either dragging your feet just to drag your feet because you want other countries to actually try it on their populations first and experiment, or you're going to say that you want to have something in the pre-market trials that will tell us, really, what the benefits and risks are on real diseases, not on intermediate end points. It seems to me that we should be pretty clear about what we really want. I don't think that's an excuse for saying we won't do post-market assessment of the drugs. You have to do post-market assessment of the drugs. I think it's a huge problem that you license it and then say, “Okay, you're good to go, and I don't want to see you again.”

The progressive licensing component, to me, was to say that there is a need--there has to be a need--to actually assess this drug, even if you were able to actually get international collaboration to look at end points, such as diseases, and not at intermediate proxies. Even if you could do that, is it still going to be used in populations of people on which it wasn't tested, and will there be rare outcomes that could never be identified in the pre-trial studies? You have to have both, in a sense. I would hope that we don't toss out the idea of progressive licensure just because we're worried that it's going to be fast-tracked.

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

I just worry that it might be, under this present government, a progressive term that is used to actually make a very bad public move in terms of drug safety. So I'm trying to make sure that we have the right precautions to prevent that in the bill and in this report we'll end up doing.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Madam Wasylycia-Leis.

We'll go on to Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Mr. Chair.

Thank you for the comments so far.

I was actually looking forward to your testimony, Dr. Tamblyn. One of the previous speakers before this committee said that you were an authoritative source on technology and how to bridge the divide in getting knowledge to physicians a lot sooner. So I've been anticipating your comments.

One question I've asked previously, as this committee has heard, is about using mobile devices and how we can use technology better. I started asking that question because the CMA said that real-time access was an issue. When they came before us they said that doctors routinely get updates in the mail or even sometimes electronically. But by the time they get them, they're not as time-sensitive as they should be.

I heard one comment a few weeks ago that they've tried mobile devices--I think it was in New Zealand--and I wanted to get your comments on that. All of us around Parliament walk around with BlackBerries. Could we use that type of vehicle to have that real-time access so it isn't a matter of weeks or months or days to get immediate updates to physicians as they prescribe?

Also, that repository of information you spoke of, would that be something feasible that we could link to on an instant electronic level?

[Dr. Robyn Tamblyn]

My take on this is that there is a very elegant way of doing this, which is that you connect the warning to the drug at the time it's prescribed. Every drug actually has a unique identifier in Canada. It's nationwide. We're in a delightful situation when it comes to drugs--low-hanging fruit, for sure. Actually, if you link it within the context of an electronic prescribing system, that means you actually set it up so that any time that drug is prescribed, that alert comes up to say that this drug has this warning attached to it. That means that you can actually change that at midnight tonight and it will be online, in real time, for everybody who's prescribing that drug tomorrow.

It's just like the parking meters in Montreal. They change the tariffs overnight from $4 to $6 an hour. I mean, bingo, they're really in good shape. That's what you can do. That's what technology can do. It means that you have to get every physician prescribing electronically, and that's where we have lots of very valuable lessons to learn from Europe, where, effectively, they've accomplished that.

The thing I worry about, if I carry around a portable book, is that it will become like this e-mail nightmare we're in right now. Everybody's e-mailing you, and now it takes your entire day to work through all your e-mail. It would just be another morsel of information arriving on your BlackBerry. It's not integrated--I have ten warnings already on my BlackBerry, but now I'm prescribing to so-and-so, and I'm trying to remember what that warning was. There's a more elegant way of doing this.

[Patrick Brown, Conservative, Barrie, ON]

It's almost like you need a device so you can just put the patient's name in it and then link into what dangers might exist based on the prescription.

You mentioned that there have been some accomplishments in Europe. Where could we learn about them? Which countries have had successes we could potentially research a bit more?

[Dr. Robyn Tamblyn]

This is what's interesting about it. What we've done in Canada is we've had a very technology-driven solution, which has put together the vaults of repositories. We're state of the art when it comes to that, but what we haven't dealt with is asking what the user wants. So the countries that basically said okay, what are we going to do here, went from the grassroots up.

Now, it's interesting that in England and Scotland they said the thing that's really inefficient for them is doing all those refills, especially with those older people who are on eight or ten medications. They've got diabetes, they've got hypertension, then they've got COPD, and then they're good to go on twelve medications. That was what was taking them time, and they were doing it wrong. The pharmacist couldn't read it and therefore they called them back. So what they did is they actually made refill medications easier to do, and that's what actually allowed them to integrate electronic prescribing into their system in both Scotland and the United Kingdom.

When it comes to Denmark, they did a different value-added, again growing out of sort of the grassroots experience. The value added in Denmark was to be able to communicate effectively with the specialists, primary care physicians and their patients, and actually to consolidate that. So that's what got people up to delivering care, a part of their care, using computerized platforms, and that's where you integrate these messages. You integrate it right in there at the time you're prescribing.

So this is the message: that you have a value added that is essentially defined by the professionals themselves. They can tell you, and then you deliver that at the front end, through your computerized interface. That's number one. Number two, you have to help them get trained up and ready to go.

When we first tried to do this--and I'll be very short--it was in 1990, and we hooked up 150 primary care physicians to the government's database and said, “Look, you can have access to the information on each and every patient, what the drugs are that they're being prescribed.” Well, they were horrified. They were horrified because they didn't realize all the medications their patients were taking and all the other physicians that were involved in their care. They didn't realize that.

But the other thing that we realized--to our horror--is that they had rudimentary understanding of computers. They would say “Come fix my computer. It's not working.” And you'd arrive, and the computer was all in bits and pieces all over the desk and they'd say, “Well, I was trying to figure out how it worked, so I just took it apart.”

They would have their grandsons come in and help them prescribe for their patients, and actually use the computer, because those are the kids who knew how to do it, right? They would just fiddle with the dials and say, “Grandpa, use this. This is how you have to do it.”

So we learned a lot of lessons from that, and the lesson we continue to learn is that our health professionals are way back in the 1930s and 1940s in terms of the way they do work. In fact, we do not have an industry that's robust here--neither do they really have it in the States--to essentially understand the complexities of care and build solutions that will solve some problems.

We've got huge problems. When it comes to the drug management process, we have huge problems that can kind of be lightly fixed without going deeper in terms of the investment technology, deeper than the heavy investment we've already made to build these repositories, so we can leverage those with now more policies--strategic investments--and not technology investments.

[Patrick Brown, Conservative, Barrie, ON]

Well, let's hope that 2008 is different from 1990 in terms of compatibility with computers. Governments have sort of thrown money towards the goal of making health records electronic, but the reality is that we're still a fair way away from that.

What challenge would that present, in terms of having this repository of accurate information? Would it at this point be incomplete, or would it still be at a state where it would be extremely beneficial?

[Dr. Robyn Tamblyn]

The repositories...right now, by and large, the pharmacies are all electronic. They're all computerized. It's good for their business. They do online adjudication of drugs--what am I going to pay for it, yada yada yada. So they're pretty much computerized. So now it's just a matter of saying okay, how are we going to get the physicians computerized? And we don't have a plan.

[Patrick Brown, Conservative, Barrie, ON]

What could be helpful with the federal government in terms of moving that yardstick forward? What recommendations would you have for us, if we did develop that goal to have this dream?

[Dr. Robyn Tamblyn]

That's a tough one. I'll just take a few things I think we've learned from other countries.

The one thing that for sure seems to be driving rapid adoption is that you're somehow paying for quality. And then you need to ask, well, where are my diabetics? Have I actually done their annual foot check, ophthalmology check, their biannual glycosylated hemoglobin check? Where are they? And you need a computerized system to find them. Right now, you can't find them very readily without it.

The physicians we have in this fairly large prototype we run tell us, “Can you give me my list of diabetics? Can you give me my list of asthmatics?” So you need a computer to get the work done.

The second thing they did, and you could think of a kazillion creative ways to do this, is they put in place, either through the professional coalitions or through the government itself--so in Denmark, the professional coalitions, in the U.K., the government--deep investment to support the training and transformation of practice. So the computers, the network, the Internet and that kind of thing, paying for my staff to migrate to a new.... That's all on the providers' end. That's their business. They have to do that. So that isn't a solution that's going to work, for sure.

The third thing is this issue of value added. What problems are you trying to solve for me, the practitioner? What we realized is that they have fragmented information, so that's where our repositories will help. They actually want to have decision support, they want to have alerts on the 33,000 drug interactions that are available. They want to have that information. So there are some strategic value-adds, which I've added in my handout. If we build solutions along that line, in collaboration with the professional groups, I think we would be in better shape than we are now.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Dr. Tamblyn.

Now we'll move into our second round. It will be a shorter round in order for us to finish our committee business--three minutes each party.

Mr. Regan.

[Geoff Regan, Liberal, Halifax West, NS]

Thank you, Mr. Chair.

I'll be very brief, and then if there's time my colleague Mr. Thibault may have a question.

I want to ask the witnesses about the notion that Health Canada seems to be proposing to do not only what it already does in terms of the pre-market approval of drugs, but also to do the post-market surveillance of drugs. To what degree do you see a conflict of interest in doing that? What problems do you foresee because of it? Do you think this process of post-market surveillance should be at arm's length, and how would you achieve that?

Mr. Cassels is keen to answer.

[Alan Cassels]

Yes, it's an easy answer.

I would say, absolutely, they need to be two separate functions. The group that approves and regulates the airline industry is not the same group that goes and inspects the crash sites and looks for the black boxes after they crash. We set that up for a reason, and that reason is very sound. To have one agency doing both activities I think is not the way you want to go. I would agree with what previous speakers in other sessions have said, that the best way to go about it would be to have an independent drug safety agency, funded at arm's length, separate from Health Canada.