Health Committee on April 1st, 2008

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

Thank you, Madam Chair.

I'd like to ask a question with respect to money and availability of personnel. This question has been asked to other people.

Right now, as I understand it, in Canada, the only mandatory reporting for serious adverse reactions is from the pharmaceutical companies. Of course, there are others who could do it. Doctors could do it. Pharmacists could do it. I suppose nurses could do it; I don't know. But then you get to the question—and I'd ask both of you to comment, you as a nurse and you as a doctor—that they're all saying we don't have enough doctors and we don't have enough nurses. I guess we have lots of pharmacists—that's probably not a nice thing to say, so I withdraw it. But that's a comment that's made, that we don't have the professional personnel you're talking about with respect to tests.

Dr. Carleton, you mentioned tests after vaccines, that the doctors should make some reporting right there and then, and one of you made a comment about professional trainers, to do this reporting. So the response we're getting back—and it's common knowledge, because all you have to do is look in the papers every day—is that we don't have anybody to do these things.

[Madeline Boscoe]

You're right. I think we need to be cognizant of the fact that we need to be managing our human resources in health care. We have some gaps, and we do need to develop a plan. I totally agree.

People my age are all hoping to retire, I think, but the act of reporting, itself, is not that difficult. We are, more and more, working in an electronic record process. Physicians frequently now bill the health system through an electronic process. So we're not talking about something particularly robust.

The professional training of physicians, nurses, and pharmacists, updating them on whatever it is, goes on all the time. This would just be in the queue of how to do effective surveillance, just as we are out there teaching them how to do an electronic medical record or whatever other new skill set they need. I think it needs to be implemented into that queue, but I don't see it as a huge challenge to operationalize, because they're in the business of reporting already. There are nurses in this country who count how many kids they saw with colds and flus. There are physicians who phone in odd things.

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

The Canadian Medical Association may disagree with you.

Dr. Carleton.

[Madeline Boscoe]

Well, I'm sure they would.

[Dr. Bruce Carleton]

We can train physicians and nurses and pharmacists to do their reporting. In the United States, where MedWatch came in with great fervour that it would increase reporting in 1996, in 1997 there was a 50% increase in adverse drug reaction reporting as a result of the online registry that FDA set up for consumers and health professionals to contribute reports to. That improvement, hundreds of millions of dollars in the creation, results in one report every 336 years per physician and one report every 26 years for pharmacists. So pharmacists are actually much more effective at reporting than physicians.

But it's getting the quality of reports in a thorough and standardized way. It takes me four hours to put together a cisplatin deafness case. This is not an inconsequential amount of time and energy for a health professional to put together. We need professional surveillors. At the moment, your hospitals across this country all have a clinical pharmacist. Clinical pharmacists all have the mandate to report adverse reactions. It's part of their job descriptions, I would bet, for all of them. If it isn't, it should be there. Unfortunately, it's just one more task added on to the long list of things they already have to do.

The best way to do this is to get a handful of people together and make it grow from there. I have 13 people across the country, and in three years I have more than 9,000 cases and controls, more than 1,000 serious ADRs and more than 8,000 controls, which is what I need in order to look at the heterogeneity and response—13 people.

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

I have a question, Dr. Carleton. A drug is approved—

[The Chair, Conservative, Joy Smith]

Mr. Tilson, I'm sorry, your time is just about up, so I'm just going to let you know that. You have about four seconds.

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

Four seconds.

[The Chair, Conservative, Joy Smith]

There you go.

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

I can't do it.

[The Chair, Conservative, Joy Smith]

Okay, thank you. I thought you could do anything, Mr. Tilson.

Ms. Wasylycia-Leis.

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

Thank you.

I want to come back to adverse reactions and reporting. We've heard a lot of testimony about the fact that mandatory reporting might not be the most effective way to go or the best use of anyone's time. Yet we have situations—and some of the things we've already talked about today—with drug companies that collected information around the world and yet chose not to report it. I think some of the information that came out around Vanessa Young's death has been helpful in that regard. I think some of the stories around EVRA, the oral contraceptive, where women are dying because of blood clots, suggest that there needs to be some way to hold drug companies accountable for information they garner.

What's the best way for us to get that? Is it full disclosure? If it's not mandatory reporting, then what is the next best way we can make sure that information is shared and consumers at least have the information they need to make sound judgments?

[Madeline Boscoe]

I guess I'm a believer in mandatory reporting as a component. Partially why I put my energy into supporting the drug research and effectiveness network is it would be the backbone that would support researchers like Bruce, doing what I would call communities of practice; that is, we would use the surveillance methodologies that are already in place to drill into practice communities--whether it's birth control providers, if we think about EVRA and the patch, cancer communities, if we're thinking about cancer--so that the providers that are working with those drugs understand their engagement and involvement in this post-marketing effort. It doesn't mean that we don't have a general information database.

But the other side--and this is what I call phase two if I had a work plan in front of me--is to build communities of practice, and I'm using those words, because I think it is about reflection, discussion, and having a closed feedback loop. It's what we knowledge-brokers call communities of practice, because that gets to the specificity and the richness of the data, but it allows us a sentinel function. When you put a canary down a coal mine, it doesn't tell you what killed it. It just tells you it's dead. Well, in a similar way, we need a canary methodology--that's what adverse drug reporting in a broad way is--but we need to support these communities of practice that will actually do the day-to-day detailed development and the rich analysis that's needed.

I infer that Dr. Carleton's work is also around saying we need some of the biologics to help us inform that. That should be part of the road map plan too, with the sex and gender analysis.

[Dr. Bruce Carleton]

My comment is that mandatory surveillance is great in concept but very poor in execution. It's very difficult. How are you going to regulate it? How will you know if somebody didn't report? How are you going to enforce it?

The difficulty for physicians, nurses, and pharmacists is that we have things like suicidal ideation occurring with antidepressant use, but those are background events that occur as a consequence of the underlying depression as well, so how do you separate out what really is an adverse effect of the drug--a negative health outcome--from an underlying disease? Those issues become very difficult to sort out. We spend an awful lot of time trying to regulate and manage clinicians to report things whose basis we don't really understand.

I prefer a solution-directed approach, which says that this is a particular reaction we're worried about. In the case of EVRA, I think we're probably going to find out it has to do with the delivery system--that we may have an increase in the release of hormones that's inordinately high from this particular patch. I don't know the answer to that, but a solution-directed approach would try to uncover the specific problems related to EVRA. I think we would do better if we concentrated on finding specific health issues and specific drug issues that we were concerned about and worked towards specific solutions. They're going to be different, depending upon the issue.

I don't favour mandatory surveillance, because I don't think it's going to work. It would be great if it did; I just don't think it's going to work. You need quality reports as well as numbers. Getting numbers isn't sufficient. You have to have quality in the reports; otherwise, it's useless.

Look at how many reports manufacturers provide already. They're mandated. There are hundreds of thousands in the United States; they're virtually useless because the lack of clinical information that's included about the patient is a predominant problem.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Carleton.

Go ahead, Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Madam Chair.

If you're looking for a canary, I can always volunteer my colleague here, David.

I'm going to show my Manitoba bias by asking Ms. Boscoe several questions. I'll ask them all at once, and then my time will be up, I'm sure.

The HPV issue is something the government takes very seriously. We invested $300 million in the vaccine. I am intrigued by one of the statements you made right off the bat, and that was--I hope I wrote it down correctly--“They die of lack of care, not of the disease”. I wonder if you could expand on what that actually means. Perhaps the vaccine isn't the whole solution. If you were to take the vaccine and also follow up with diligent care, that would reduce the mortality rate significantly, I would hope. I'd like to hear your point of view on that.

Also, in your opening statement you mentioned that you co-chaired a committee on Infoway. I think everyone agrees that there's an importance in post-market surveillance; it's the mechanisms on how to do that....

Do you have any insight or recommendations for this committee that we could put in our report that deal with Infoway or e-pharmacy or e-health records, insight or recommendations that would allow data mining or make it easier for medical practitioners to report? Four hours on one issue is a long time. You could see a lot of patients in that time, and you're probably not getting compensated for the time you're spending on reporting. Are there ways through Infoway and e-technology to make this an easier process? You seem to be in a good position to comment on that, given your background.

Those are my questions.

[Madeline Boscoe]

Okay.

Vis-à-vis the HPV issue, as I said before, this could be the best thing since sliced bread. Our position at the clinic has been that it's premature to have put it into the population base until we knew how long it lasted and whether or not the viruses that are in it actually are the ones that women and men are being exposed to. We have some sense in Manitoba that they may not be.

Those are big issues, because if it wears off, what are we going to do? If we take the model of chicken pox and others, you actually get sicker when the vaccine wears off. And as you may know, repeat vaccination after school in adults is totally related to socio-economic issues; that is, people who are poor and the children of people who are poor are much less likely to revaccinate or to become vaccinated. It's a health equity issue, and the reason that's important in sexual and reproductive health is that the other burdens of problems with sexual and reproductive health also are borne by people of lower socio-economic areas.

What we know about access to cervical cancer.... And we have made such a huge impact. The rates of death in Canada have plummeted. In Manitoba, we have about eight to eleven deaths a year right now. Of those women, the vast majority were in care but didn't have a Pap test in that timeframe. How can that be?

I would plead that some of that investment needs to go to places that are women-friendly, that provide female physicians, that do outreach to women to get them into care. That's what I meant by “They died of a lack of care”. They saw a doctor; they just didn't get what was needed. Women with disabilities, poor women, and women with addictions are particularly challenged in this area.

Regarding the info highway, I have two pieces I can speak to on that—which gets me to the part I didn't even get to talk about. How convenient is that?

It is true, the electronic medical record will help us with this. These investments that are being made to help develop these systems will help.

The other piece is an electronic reporting process itself—not a web-based one, but in the same way that physicians can use a Palm Pilot to send off a bill to every provincial government, they could fill this out as well.

I hope I answered that piece. But I also wanted to talk a little about increasing Canadians' capacity in drug policy.

Canadians believe right now that if it's approved for use, it's a great drug and should be on a provincial formulary—I'm sure, if you talk to your provincial counterparts. They can't believe and they don't believe, if it's approved for use, that it is much of a risk for them, because they believe that has happened.

So we have a huge problem in what our patients understand an “approved” drug to be and what it means. This means increasing their ability to be thoughtful consumers and understand what's going on in their own bodies.

[The Chair, Conservative, Joy Smith]

Time is running out. Can you...?

[Madeline Boscoe]

Yes.

The other big ticket I think we can do is to take the intellectual property rights for the patient insert and the drug label and make it a public good. Health Canada can put this information up on the website, change it when it needs to, and send out alerts tied to that information.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Boscoe.

Monsieur Thibault.

[Robert Thibault, Liberal, West Nova, NS]

Thank you very much.

I want to thank you both for your presentation.

Last week I was convinced that we wouldn't hear anything new, and we did a bit, Dr. Carleton. I think you're taking a new take on something we've heard.

One of the things we've heard from many practitioners is that making it mandatory without making it useful has no value, and if you make it useful you don't have to make it mandatory: people will voluntarily participate if they derive benefit from it. Practitioners, if they have some activity happening and can go to one page or site and say “This is the adverse event I'm experiencing with this patient” and get back useful information, would participate.

But what you're advocating is a little different, I think. What you're advocating is a specialization across the country of people who are doing in-depth research on individual cases to build the database.

Have you talked about bringing it that one step further and marrying the two, such that you would have online reporting of incidents by practitioners and then the information that you have discovered could be the feedback? It would serve as a database for you on where you send your specialist to do these studies of cases. You might start seeing a lot of commonality, a lot of bunching. Those would be the first cases you would want to investigate fully.

[Dr. Bruce Carleton]

It's a worthwhile goal; it's a worthwhile thing to pursue. The difficulty is resourcing this, because physicians, pharmacists, and nurses report the information they think you need to know. The four hours to put together one cysplatin case comes from experience and looking at many, many of these cases, and understanding what information I need, and specifically how to deal with differences in the information that's collected. Audiograms, the way you measure hearing, are done with different equipment, different standards, different thresholds across the country in different hospitals. Those kinds of differences have to be accounted for. If physicians just report reactions or Palm Pilot reports, it's not that useful. We need the in-depth information surrounding the case. If there's a way to identify the case, the physicians can give us a case and help us identify them, fine, but I can actually do that within hospitals fairly effectively now.

I would like to involve as many people as possible in adverse drug reaction reporting, but I think it's better to start small and then move to a bigger palette across the country and involve more and more practitioners. I think if you show some key successes with a few people, small projects, you'll get more people who want to participate and then a groundswell of participation continues. I think that's way better than building a national system of reporting and then having to staff all the sorting out of the reports. The difficulty with sorting out the reports is that they don't give you all the information you really need.

[Robert Thibault, Liberal, West Nova, NS]

The other information, the other difficulty, is what is “useful information”? What is going to be useful to the practitioner in his day-to-day practice, and what is going to be useful to the patient in the decisions they have to make as to what level of risk they're willing to take? I remember when you were opening your presentation you made a distinction between adverse effects and side effects, but one can be the other. If I have a child who is at great risk of dying of cancer, and they have a drug they can give him, but the chances are, I believe you said, 60% that he'll have some heart disease because of that drug, if it's going to give him a reasonable chance of living, I'm going to consider it a side effect. If I know in advance that I'm taking this decision, that there is a risk, it becomes a little bit of a line as to what information you have as a practitioner or as a patient in the decision that you make. If I have severe enough pain, I might want Vioxx, and I'll accept the risk of the cardiac event that could ensue.

[Dr. Bruce Carleton]

The holy grail of pharmacogenomics would be to determine alternative drugs or different doses of the same medication that should be used, based upon the patient's own genetic profile and how they process the drug. The difficulty in getting there, though, is still a problem.

Even predicting in whom the reaction will occur is of benefit, because in our very large provinces, getting people for routine testing, for cardiac testing, from the Queen Charlotte Islands, for example, is a bit of a problem for us, getting them all the way down to Vancouver. We sometimes can't get them to Vancouver for cardiac testing, so we have to wait until their next scheduled visit. If we knew predictably that they were at a higher risk of a reaction, we'd ensure we did more routine testing, and perhaps even have testing facilities and the right kinds of qualified professionals in a closer location to where they live so that could be done routinely.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Carleton.

I want to thank both our witnesses today, Ms. Boscoe and Dr. Carleton. This was a most interesting and informative presentation. It's very exciting to hear some of the new ideas that have come forward. I think the whole committee can substantiate my comments, because we were truly taken with both your presentations.

We have committee business now, and I'm going to ask that you leave the room rather quickly so we can get to that committee business, because at one o'clock sharp we have to get back into the House.

I want to thank you again so very, very much for your contribution today. Thank you.

[Proceedings continue in camera]