Evidence of meeting #33 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada
Okay, so can I wait for a moment and just compose my thoughts? I want to give a thoughtful answer.
Prof. Matthew Herder
Absolutely. Bill C-17 is strong as it stands. It could be made really strong if the amendments are included.
Professor, School of Health Policy and Management, York University, As an Individual
I agree with what Matthew Herder said.
Vice President and Chief Operating Officer, Institute for Safe Medication Practices Canada
I agree more can be done, and I think maybe we need to do it in a staged approach. My concern is that amendments could delay getting some of these key authorities in place sooner, so that's my only concern. I think there's always room to improve. There will always be ongoing improvement that's going to be needed, and there'll be more changes needed to the Food and Drugs Act. But I'm not sure we want to delay implementing some of these key components of Bill C-17.
I liked hearing that there's agreement that it's a very strong bill.
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
Thank you very much, Mr. Chair.
Thanks to our witnesses here.
Just a comment, as we get going here.... I have some questions for our witnesses.
The reason NHPs were removed from the bill is that NHPs are fundamentally different from prescription drugs in the following way. They're vitamins. They're minerals. They're natural molecules. They're common in biological systems—amino acids, and so on. Therefore, the practitioners would call them orthomolecular because they're in their natural state. Anything we have under the drug regime that is patented can't be used in a natural state. So they find that molecule and have to change it somehow, by methylating, hydrogenating, carboxylating, or somehow changing it so it's like the original but different, in order to patent the process. That fundamental difference makes a whole big difference in the profit that's available from a patented product, but it also increases the risk. Anyway, I just put that out there as one of the reasons why they're in a separate regulatory regime, which has been one of the strongest regulatory regimes in the world right now.
Dr. Lexchin, you referred to a couple of examples that are used. SSRIs, antidepressants, are often used off label for adolescents and children; and the published data and the unpublished data, when you compared them and put them together, gave a very different perspective. You mentioned HRT as an example, that it was learned, I think, that there is a 40% increased risk of cardiomyopathy and of ovarian and breast cancer. Maybe you can correct me on that. It seems to me 40% was roughly the increased risk. But are you aware, Dr. Lexchin, about studies linking stomach acid suppressants, particularly proton pump inhibitors, with C. difficile?
Professor, School of Health Policy and Management, York University, As an Individual
I've read a little bit about that, but I wouldn't be able to comment on—
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
Let me be more specific when I say the published literature—and this is on the FDA website—gives a 40% to 275% increased risk, dose dependent, time dependent, dose response fashion, because the longer you're on the medication the higher the risk, and the higher the dose, the greater the risk of an infection that could extend your hospital stay by three weeks and result in expensive treatments with antibiotics, and perhaps bowel surgery, and perhaps death.
Would you consider 40% to 275% to be clinically significant?
Professor, School of Health Policy and Management, York University, As an Individual
Definitely, yes.
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
Okay. Thanks for that.
Well, we have a nosocomial surveillance infection program here in Canada, 58 teaching hospitals. They've been monitoring this for more than a decade, but apparently they were not collecting data on the meds that people were on at admission, when they developed antibiotic-associated diarrhea or CDAD. Would you consider that a missed opportunity?
Professor, School of Health Policy and Management, York University, As an Individual
Yes. I think that we need better sources of data than we currently have.
For instance, in most provinces there is no single source where you can find out prescriptions that have been dispensed. British Columbia is an exception. Their PharmaNet program records every prescription that has been dispensed, regardless of who has been paying for it. That kind of information, coupled with the hospital and outpatient databases that we have, could certainly help in providing more information about drugs that are being used and their adverse consequences if they occur.
Conservative
James Lunney Conservative Nanaimo—Alberni, BC
Thank you for that.
I appreciate your remarks about the Cochrane Collaboration and what they determined about the increased risk, or at least when the studies were funded solely by pharmaceutical companies that there was more likelihood they would be more positive in the conclusions.
I wanted to ask you, sir, and our other witnesses here, about a point that Elaine Gibson raised. I'm sorry she's not here to develop this. That was the question about expanding the application to all holders of therapeutic products, rather than only the sellers. Is that an issue?
Maybe I'll turn to Mr. Herder. Is that something on your radar? Do you think that's a point we should follow up on?
Prof. Matthew Herder
Yes, I do.
That was in the paper that Joel, Janice, Elaine, and myself, and Barbara Mintzes published. That was one of the points we thought should be addressed in the bill, simply to make it absolutely plain that other corporate actors in the production chain and distribution chain that have pharmaceuticals, if they have them in their hands and there's a recall on that particular drug, they're subject to that recall as well.
Conservative
Libby Davies NDP Vancouver East, BC
Thank you very much.
I'd like to come back to one of the points you made, Matthew. You laid out your four points about transparency, registration of all clinical trials, that there should be mandatory disclosure of all studies and reports, penalties for non-compliance, but the third one, Health Canada to report all decisions and the reasons behind the decisions.
I think we've been looking at this issue and sort of saying there has to be a lot of onus on the pharmaceutical companies and so on, which clearly is critical. In fact, the more we learn about this issue, the more it is so disturbing about how little knowledge there is in the public realm about what goes on. Hopefully, this bill will be able to address that.
In terms of the role that Health Canada plays, we haven't focused on this a lot. What happens now? If your amendment or your suggestion is incorporated, how would you actually see that working in terms of timeliness in getting information out? You may be familiar that the Auditor General, in 2011, issued a report saying that it could take up to two years, even under the status quo, for information to get out to people about adverse reactions.
If we adopted this in principle and tried to get an amendment, how would you see it working in terms of ensuring that there's a streamlined flow of information, and that the system doesn't become, in effect, paralyzed because everybody is waiting for somebody else to get their piece of information out there?
Prof. Matthew Herder
Thank you for the question.
I think it's critical to think about transparency in terms of the institutional picture that Health Canada presents, compared with other regulators. Just thinking about it on its own, it clearly does not necessarily have as many resources as would be helpful to deal with some of these issues.
But when we're thinking about writing decisions in particular, the best evidence we have so far, which Dr. Lexchin mentioned in his remarks, is around the summary basis of decisions. Those documents tend to suffer in terms of what they actually contain, but also they're slow and they don't come out readily.
To me, what I'm trying to get at when I say “the reasons behind them” may be a lot of the data, more so than the logic and the description, although that would be nice, too. But if it's a matter of describing and just putting forward the data that was shared with them by the manufacturer, in theory that might be more efficient than what we have now, where you have this sort of very technical process. You're drafting, probably revising, a tonne, the reasoning. I think there could be a more simplified form that talks about the reasons why the risks were considered to outweigh the benefits, and then the actual data as being the reasons as well, so that is more carefully reported. As Dr. Lexchin showed, the very basic information about the sex of the participants in the trial, how long they stayed in, and so on, is often missing. Just putting information that actually shouldn't be that resource-intensive to collate would be very helpful.
NDP
Libby Davies NDP Vancouver East, BC
That is very helpful.
Just to follow up, are you concerned at all about the level of resources within Health Canada to take this on?
We did ask this of officials last Thursday, and the response we got was, “Well, they've made some efficiencies and they've changed the way they do things since 2011, so things are better now”. But I think this bill will only be as good as how it is implemented, and that does require resources to do the follow-up work, particularly when it comes to transparency at Health Canada.
Do you have any concerns about the resourcing for this bill in terms of who the heck is going to stay on top of it and follow up all of this work that needs to be done?
Prof. Matthew Herder
Absolutely, but it's not clear to me that fewer resources means less transparency. I think it might mean the opposite.
But specifically, disclosure of clinical study reports—these are things that are provided by the company—if Health Canada is looking at this as something that they have to craft and massage and at the resources that will take, yes, that is scary, and they may never get those resources. But if it's empowered to release information that by definition, under the statute, it already has to have from the manufacturers, then you could have greater transparency, in theory, with fewer resources needed.
