Health Committee on June 10th, 2014

[Wladyslaw Lizon, Conservative, Mississauga East—Cooksville, ON]

Thank you very much, Mr. Chair.

Welcome to all the witnesses.

I would also like, Mr. Chair, to have an indication when I have one minute left. Thank you.

The first question I have is to Professor Lexchin on the mandatory provision that the results of a clinical trial be made public within one year.

Who would have access to that information? It's useless for the general public, of course. In your view, who should have access, and under what rules? On the one hand, there is the greatest benefit possible for the potential patients, and on the other hand we don't want to have anybody using it for unfair commercial practices.

[Dr. Joel Lexchin]

I think that Professor Herder outlined some of the steps that Health Canada or Canada has already taken in terms of data protection to try to ensure that the information is not used for unfair commercial purposes. In terms of the full results of the clinical trials that have been undertaken, we could initially look at what I described with respect to the model that GlaxoSmithKline has committed to, which is that they will release all of the data on critical trials once researchers have made an application and that application has been vetted by an independent committee so that you get this information out there to the people who will be able to use it.

For instance, ISMP may be interested in that information in terms of developing strategies for better patient protection. CADTH, which evaluates new drugs and technologies, may be interested in that information so that it can write its reports. Other groups in Canada that develop guidelines for clinical practitioners may be interested in that information so that they can include all of the relevant information when they make their recommendations to doctors around how to prescribe drugs most appropriately.

[Wladyslaw Lizon, Conservative, Mississauga East—Cooksville, ON]

Professor Herder, you did mention that the trade agreements should not contravene this bill; however, you said it may be contested. I don't know what information is included in a clinical trial report. But in the trade agreements between the countries, there is a provision of data protection and patent protection for drugs—I don't know whether it's eight or 10 years.

Is there anything in a clinical trial report that would be under that data protection?

[Prof. Matthew Herder]

I think it's important to keep in mind a couple of things. One is that there are these international agreements that create minimal requirements around intellectual property. You have to have a patent system. You have to put into place, as you say, measures to protect data. But they don't necessarily determine what your patent system looks like and what the requirements in your particular country for patenting are.

If there are differences between countries, companies often contest those. There's always a fight around it, but there's flexibility for a sovereign nation to define its own standards. So in the case of data that might be in clinical study reports, yes, it could conceivably be argued it's data that ought to be protected. It is scientific information. The definition of data is pretty sort of literal. If it's been treated as confidential, then companies will make that claim.

But if we've taken steps that we have as a country to protect data, or, which I would suggest is also true in this case, it is necessary to protect the public health, you can override any data protection or make that information available for the public. So it might be treated as confidential data by the company but it remains open to Canada to disclose that information.

[The Chair, Conservative, Ben Lobb]

Thank you, Mr. Lizon.

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Thank you, Chair.

I'd like to ask Dr. Lexchin about off-label prescribing. You've written about it many times over the years, Dr. Lexchin. I know that approximately 70% of doctors prescribe off label at least part of the time or some of the time. I'm not suggesting that it's all bad because it's relatively common. But it can be much riskier for patients because first, the drug was not proven safe and effective for that condition. It's driven by or stems from, in many cases, illegal marketing. That is, the drug reps in the doctors' offices whispering in their ears or taking them to lunch or getting them to prescribe the drug for something that isn't proven safe. Third, it's driven primarily, on the drug company side at least, to create blockbuster drugs that sell $1 billion a year or $2 billion or $3 billion or $4 billion.

Recognizing that it's a provincial jurisdiction, do you feel that the powers included in Vanessa's law, allowing the minister to require additional testing, will be helpful in addressing inappropriate off-label prescribing?

[Dr. Joel Lexchin]

I definitely do.

For instance, if we have evidence of widespread off-label use of drugs, Bill C-17 would then allow the minister to require companies to undertake additional studies so we can gain better information about whether or not that off-label prescribing is or is not appropriate.

Currently, the estimates are that 70% of all of the off-label prescribing is not backed up by good scientific data. That doesn't mean, as you pointed out, that off-label prescribing is bad for people; it just means that we don't know. We need to be able to have the requirements to get that information to decide whether this off-label prescribing is good or not.

However, another provision we need to consider is that although Health Canada collects data in its adverse drug reaction reports about whether or not the drug has been prescribed on or off label, when that information is provided to them, that is not part of the online database. People don't really know how often adverse reactions are linked to off-label prescribing. That could be quite easily corrected by giving Health Canada the resources, or requiring Health Canada to post on its public database whether or not the drug was being prescribed on or off label.

[Terence Young, Conservative, Oakville, ON]

Thank you very much.

Dr. Lexchin, you've also written very extensively about the extent of adverse drug reactions in Canada, and, in fact, North America. We know, and you have written evidence from the Lazarou study, at the University of Toronto, that prescription drugs used as prescribed, the right way, are the fourth leading cause of death in North America and the cause of millions of adverse drug reactions.

If Vanessa's law was passed with your recommended amendments. or close to them, how would modern medicine change in Canada?

[Dr. Joel Lexchin]

We will never get to the point where there's absolute safety. That doesn't exist. But certainly the estimates are that somewhere around 60% of adverse drug reactions can be prevented, and one of the ways of preventing those is by having better information about when they occur and who they occur in.

By virtue of Vanessa's law and increasing the amount of safety information we acquire, we can probably prevent a significant number of those adverse drug reactions and reduce hospitalizations and mortality. The exact amount is difficult to determine, but there would be significant reductions, in my view.

[Terence Young, Conservative, Oakville, ON]

Thank you very much.

Could you please describe the worst-case example that you've seen of widespread off-label prescribing that has led to patient harm?

[Dr. Joel Lexchin]

I suppose what I've seen that's most likely to lead to patient harm is the inappropriate use of antibiotics for viral conditions or where there's no infection in the first place, or where the wrong antibiotics have been chosen and that leads to cases of C. difficile. C. difficile, especially in the elderly, can be very difficult to treat and can require prolonged hospitalizations, or as your colleague said, can lead to death.

[Terence Young, Conservative, Oakville, ON]

Thank you.

[The Chair, Conservative, Ben Lobb]

That concludes our meeting for today. We'll see everybody back on Thursday.

The meeting is adjourned.