Health Committee on June 8th, 2006

[Dr. Supriya Sharma, Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health]

Just to speak about conflict of interest, and I'm sure Dr. Brown can speak to this as well, a lot of the concerns the committee has raised in the past about conflict of interest have focused on the plastic surgeons on the panel, that they somehow received some sort of remuneration based on their recommendations. I'm sure Dr. Brown will reiterate that. But we do have saline implants on the market, so there's no incremental advantage, in terms of monetary funds, for doing the surgery.

In picking the panel, there were equally patients, representatives, and other people who had opinions that were different from those of the plastic surgeons. It's important to remember that these panel members are volunteers. We actually do have a slate of plastic surgeons we go to, but there are always challenges in terms of finding people who are available and who are able to come and represent themselves.

With regard to some of the other conflicts of interest that have been raised, Dr. Brandon, I think, was another name that was mentioned. He is the North American expert on rupture data. To find someone who is the North American expert who has never given advice, for example, to other governments or to industry is definitely a challenge.

[The Chair, Conservative, Rob Merrifield]

Thank you.

Mr. Batters.

[Dave Batters, Conservative, Palliser, SK]

Thank you very much, Mr. Chair.

I appreciate all of you being here--and Mr. Brown by video conference.

As a new member of the health committee, I'm going to start by making a few observations from 35,000 feet, and then I'll ask representatives from Health Canada to comment, perhaps Dr. Zuckerman as well, on this first observation.

First of all, this is obviously a heated debate and there are some very passionate viewpoints on both sides. Being a new member of the committee, I think everybody could gain by dialling it back a little bit and looking at what's truly in the best interests of patients, and going from that perspective.

I'd say to Health Canada, looking at this issue and doing the reading, the entire process seems very arduous and awkward. Health Canada asked that these implants be pulled from sale in 1992--that's 14 years ago--and we're talking about 19,000-plus requests per year under the special access program. This looks like an absolute nightmare.

You've conducted multiple studies, and you've had more than one expert group look at this issue. There are studies on the issue. I'm anxious to hear Dr. Zuckerman's take on the experience in the United States. At what point do you make a decision and make some recommendations to the minister?

I tend to agree with Dr. Brown in that enough is enough. When you believe you have enough information...perhaps you're not at that point, maybe that's your argument, but we've gone 14 years. At what point do you say, “Here's the information, Minister, make the decision”?

Minister Clement is a very busy man, I'm sure he doesn't have time.... Maybe you can explain the process for this apparent minister's permit for the special access program. There are thousands of requests for this. Maybe you can tell me what I'm missing here. Multiple studies conducted, at what point do we make a decision and put this before the minister?

[Neil Yeates]

The member's quite right, the process has been extensive to date. We are nearing the end of the process in terms of our analysis of the studies that have been done and looking at the literature. As I say, we're approaching the end of that.

I should clarify that it will not be the minister making this decision; it's made by the department. That authority is delegated to Health Canada.

[Dave Batters, Conservative, Palliser, SK]

HPB?

[Neil Yeates]

Yes, to our branch.

We are nearing the end of what has been, yes, a long process, but as you've noted, there has been a lot of interest in this issue, a lot of concern regarding the products in question. So we want to make sure we do a very thorough job reviewing all the safety data, the efficacy data, the quality data, to make sure we have all the information we need to make a decision one way or another. And yes, we are reaching the end of that process.

[Dave Batters, Conservative, Palliser, SK]

Definitely, Dr. Yeates, but we talk about the backlog in drug approvals. This looks absolutely ridiculous to me. If I were a woman in Canada, whether I were seeking an implant for cosmetic reasons or, God forbid, for reconstructive procedure following surgery, this would be an absolute nightmare, and I don't know how I'd make this decision. It must be a nightmare for physicians as well, but I really commiserate with the patients.

If I have a little bit more time, Mr. Chair, I'd like to ask Dr. Brown a couple of questions. How much time do I have? One and a half minutes?

Dr. Brown, I just want to cover a few areas, if you could touch on a couple of things for me. In terms of esthetic procedures for breast augmentation, my initial concern was waiting to hear how that would affect wait times in our hospitals. You seem to indicate those procedures are done in your private clinic. Is that true, sir, that all these are done in private clinics? A primary--

[Dr. Mitchell Brown]

I can only speak for--

[Dave Batters, Conservative, Palliser, SK]

Sorry, I'm talking about primary surgery for augmentation.

[Dr. Mitchell Brown]

I understand. I can only speak for my personal practice. I use every bit of time that's provided to me at Women's College Hospital for my reconstructive practice. Any time on top....

Thank you.

[Dave Batters, Conservative, Palliser, SK]

Thank you, sir. I just want to keep going, because my time is very limited.

Maybe you'd agree with me that there's desperate need for it. Maybe there are firm guidelines in place.

Take this in the spirit in which it's intended, sir. I'm not trying to trip you up at all.

For a woman who is having problems with her implants, whether they were implanted under the publicly funded system or in your private clinic, if they're having problems with them, can these implants be removed if they pay to do so, if they decide they can't afford the wait for their scheduled surgery time in the public hospital?

[Dr. Mitchell Brown]

My understanding is that if a procedure is to be covered as a medically necessary procedure, it would contravene the Canada Health Act for a person to be able to provide payment and have that procedure done quicker in a different method. That's my understanding.

[The Chair, Conservative, Rob Merrifield]

Thank you, Mr. Batters.

I'm informed that Mr. Yeates and Ms. Stachenko have to leave at this time. I thank them for coming forward. I appreciate that very much.

We'll continue the questioning with the remaining panel.

Ms. Keeper.

[Tina Keeper, Liberal, Churchill, MB]

Thank you.

I had a question for the Public Health Agency, so I'm wondering if Ms. Sharma would be able to answer that question, as she works for Health Canada.

[Dr. Sylvie Stachenko]

I'll answer.

[Tina Keeper, Liberal, Churchill, MB]

Thank you, Doctor.

The results of the cancer incidence in a cohort of Ontario and Quebec women study have found that there was, as you mentioned, no correlation between increased rates of cancer and women who had received breast implants. Is that a position or a statement that is going to be made by the Public Health Agency of Canada? Will that affect how you promote safety or risk around breast implants for women in Canada?

[Dr. Sylvie Stachenko]

We will simply state what the study says, that is, there is no increased rate of cancer, from the study. Obviously if you're looking at safety and other issues, which is really with the regulations, we're only one input. This is a population study that is one input among others in terms of the very complex decision-making process.

There's more than just the issue of the long-term impact; there are other issues that we've discussed here. Basically, our position is from the population-based study, which is consistent, by the way, with other cohort studies. One of the things that are very important to note is that this one allows more statistical power because we have more women than in any other cohort study. In practice, it is important to say that in terms of looking at specific categories and subgroups it has more power to make some assertions.

Secondly, and it was mentioned by Dr. Zuckerman, when you're looking at long-term impact you have to have follow-up periods that are more than five years, particularly when you're talking about cancer. This study actually has a mean follow-up time of 15 years, some of which is even 25 years. In terms of this specific study versus other international cohort studies, we had more power and a fair follow-up period to be able to validate the other studies. What we're finding is very consistent.

When we discuss population health impact, it is going in the same direction. We are adding to that base of knowledge and we're adding it from a point of a view that has actually got more statistical significance, given the statistical power of the study.

[Tina Keeper, Liberal, Churchill, MB]

You also mentioned you found there is an increase in the suicide rate among these patients. From a public health perspective, have you looked at other factors in terms of maybe fibromyalgia, immune system disorders, or others?

[Dr. Sylvie Stachenko]

One of the issues around these studies is that we are looking at mortality. Obviously from that perspective we weren't able to look at morbidity, and that's a bit like the question you're asking.

[Tina Keeper, Liberal, Churchill, MB]

Does the Public Health Agency or the federal government plan to seek additional studies to examine these other issues?

[Dr. Sylvie Stachenko]

Given those results, we will be discussing the next steps with our provincial, academic, and federal government partners. Obviously this is a cohort study. As you know, there are many databases in this country. There are risk factor databases through the community health survey. What we can do is perhaps see if there are any opportunities to link and do further linkage, to understand some of these questions that you're raising.

So it's in discussion, no firm decision, and we are just now looking into opportunities for further research.

[Tina Keeper, Liberal, Churchill, MB]

Dr. Zuckerman, you found that there were, indeed, increased rates of cancers. Could you explain a little bit about that study and how you came to those conclusions?

[Dr. Diana Zuckerman]

Sure.

It's not my study; it's a study by the National Cancer Institute. It's comparable, but perhaps not quite as large as the Canadian study that was just described. It involved women who had implants for an average of 20 years rather than 15 years. So it was a little longer.

I put the slide up. They had a doubling of brain cancer deaths, a doubling of lung cancer deaths, and a doubling of suicides. This was compared to women with other plastic surgery. Women who have plastic surgery are more likely to smoke. So it's important to look at them compared to each other, and not to the general population.

When they looked more carefully at lung cancer, for example, they found that the women who smoked and had breast implants were more likely to die from lung cancer than women who smoked but did not have breast implants. Perhaps it was that double vulnerability of smoke and leaking silicone that made the difference, but who knows?

It's possible that if they study these women for longer periods of time, things will look different. If you look at people who have smoked for an average of 10 or 15 years, most of those people will not die of lung cancer yet. But if you study them for 25 years, many of them will. It takes time.

[The Chair, Conservative, Rob Merrifield]

Thank you.

Mr. Dykstra is yielding his round to Mr. Batters.

Mr. Batters, you have five minutes.

[Dave Batters, Conservative, Palliser, SK]

Thank you again, Mr. Chair.

I want to follow up on my earlier line of questioning with Dr. Sharma and then with Dr. Zuckerman.

Regarding the process that's in place, Dr. Sharma, what can we expect to see as the next step in all this? How does Health Canada move from its consideration of scientific and other evidence to a regulatory policy decision on this device? Where are we, and what are the next steps? Can you give us a timeframe?