Health Committee on June 12th, 2014

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

It's time for the federal government to act on it.

[Nancy Abbey]

Totally.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

I'm wondering why this wasn't mentioned in the bill, but maybe we'll be informed of that over the course of today.

Mr. Robinson, you mentioned that clinical trials have to be registered with Health Canada. I believe this bill would make it mandatory to register them publicly. I'm a guest to this committee. I'm subbing for another member, so I'm just getting up to speed.

[Walter Robinson]

The ones that are approved by Health Canada, which are our trials, are already public.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

Registration?

[Walter Robinson]

They're publicly.... There is a portal on the Health Canada website today with those trials.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

With the registration of each trial?

[Walter Robinson]

As I understand it, yes.

Could I add, though, that one of the challenges—and I refer back to the work done in the Senate committee—is that these are global trials involving multiple companies, multiple countries, 5,000, 10,000, or 12,000 patients, and multiple sites across Canada. One of the things to come back to, because it relates to Ms. Adams' question, is to ensure that we have harmonization of research ethics boards or simplification of that, so that everybody has the same standards and the same research protocols and so on and so forth.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

So there are standard research protocols that are published?

[A voice]

Yes.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

Well, then, I'm at a bit of a loss here, because we have people who have testified at the committee and were saying—and it was mentioned here today, I think by Ms. Davies—that sometimes a trial will be abandoned if it's not going well, but the public is not aware of that. One would think that a standard research protocol would require the company doing the trial to report if something was abandoned because it wasn't giving good results, or whatever the reason, but you're saying that this is all hunky-dory, that these are standard protocols that come with the registration—

[The Chair, Conservative, Ben Lobb]

Mr. Scarpaleggia?

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

Yes?

[The Chair, Conservative, Ben Lobb]

You're over your time.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

Okay. That's fair enough.

[The Chair, Conservative, Ben Lobb]

Thank you.

Mr. Young, go ahead, sir.

[Terence Young, Conservative, Oakville, ON]

Thank you.

Mr. Robinson, Mr. Keon made a comment, and I'd like to hear your comments as well, after I explain what my question is. Referring to safety issues with drugs, he said that thoughtful, risk-based dialogue is the best way to approach these matters. Yet, through a journalist that did a film about Vanessa's story, back in 2001, I was able to get copies of e-mails that went back and forth between the vice-president of Janssen-Ortho—part of Johnson & Johnson—and senior Health Canada officials. Health Canada officials were asking them to either take the drug off the market or put a very clearly worded warning or do their utmost to make sure the drug wasn't prescribed to patients it shouldn't be.

I have those emails back and forth. Of course you can imagine it broke my heart reading them and seeing the Health Canada officials struggling to get Janssen-Ortho to recognize that this drug should be taken off the market. This was prior to Vanessa's death. These emails went back and forth right into March 2000, and Vanessa died on March 19, 2000.

I was shocked to find out that this is normal in the industry. This happened with the other 26 drugs that have been taken off the market since 1997. This is supposed to be thoughtful, risk-based dialogue. In fact it is the pharmaceutical companies, your members, trying to keep a blockbuster on the market longer because they're selling $100 million a month or something and pretending that the drug can be prescribed safely. The hands of Health Canada officials and the minister were tied prior to this bill. In fact, thoughtful, risk-based dialogue was really just a way to delay the withdrawal of the drugs so the companies could make more money.

Could you please comment on that?

[Walter Robinson]

Through you, Mr. Chair, to the honourable member, I cannot comment on specific product decisions or specific company dialogue. I can speak at a policy level with respect to risk-based communications.

I'm going to ask my colleague Keith McIntosh to walk us through what some of that communication would look like and the principles around that, but I would agree with Mr. Keon's comment in that regard.

[Keith McIntosh]

First I would note that we support the authorities that are proposed in Bill C-17 to provide the minister with the authority to compel label change or to compel a recall if that thoughtful dialogue isn't conclusive.

I think that reasonable scientific debate is a valid exercise, and I know that our members have patient interest at heart when they have that debate, regarding what the label should contain or when to conduct a recall. I think if we only require a mandatory recall or a mandatory label update, the regulator is not necessarily the most rapid vehicle. The manufacturer is in the best position to initiate one of those changes quickly.

[Terence Young, Conservative, Oakville, ON]

Thank you.

Mr. Robinson, I previously read to you a list of drugs that have been taken off the market just since 2004 for having injured or killed patients. You say you support Vanessa's law, which I'm very glad to hear, but I want to ask you whether there is anything in Vanessa's law that your members, the big pharma companies, could not have implemented on their own, voluntarily, years ago. Was there anything stopping them from having plain language labelling and issuing proper safety warnings? Was there anything that stopped them from acting sooner to get dangerous drugs off the market in order to reduce injuries and deaths? Was there anything to prevent them, to stop them, from reducing the injuries to Canadians caused by their products?

[Walter Robinson]

I would start by noting that many aspects of Bill C-17 already codify the manner in which Rx&D member companies have been interacting with Health Canada and other regulatory bodies, not only here in Canada but similarly with Health Canada's peer agencies, for a long time.

Regarding the issue around the specific article you mentioned—and I think that had to do with Dr. Lexchin and a few other journalists—you were cut off before when listing some of those products. As I noted, I can't speak to individual product issues. It would be best to address the companies to speak to those. From reading about it and from the research, I can tell you that some of those recalls were voluntary. They were not mandatory recalls. The companies themselves pulled them from the market.

You had a very clear question around plain-language labelling. I'd like to ask my colleague Keith McIntosh to speak to the things we've done around that and the things we've urged Health Canada to do. Some of these things have the best weight of suasion with regulatory authority.

[Terence Young, Conservative, Oakville, ON]

I'd like to get another question in first, if you don't mind.

If you can, please explain the thinking within your member companies when the FDA or the European Medicines Agency orders a drug off the market for injuring and killing patients. What is the thinking in your companies that they can still leave that drug on the market in 100 other countries, including Canada sometimes?

They have essentially been ordered to take the drug off the market, or they put up a facade that they voluntarily took it off the market because they're about to be ordered to, and they maintain this facade that the drug can be prescribed safely and they just keep it on the market until they're ordered to take it off. What is the ethical thinking in those companies?

[Walter Robinson]

I can't speak, again through you, Mr. Chair, to individual products. The question is more of a broader policy question. I appreciate that, and I can speak to recent examples where you're seeing more global recalls or voluntary withdrawals of product.

I'll ask Keith if he has anything further to add on that—and he did want to answer the other question, because it was an important one, on plain language labelling.

[Keith McIntosh]

On this last question, I will only add that when there is a change in market status in a foreign country, in Europe or the U.S., for example, the first thing that a manufacturer in Canada will do is notify Health Canada and have a discussion with them about what the appropriate response for the Canadian approval would be.

[Terence Young, Conservative, Oakville, ON]

What is the thinking behind changing the drug label, which is a 50-page or 60-page document, in 8 point size print that doctors don't even read—