Health Committee on March 6th, 2008

[Dr. Michèle Brill-Edwards]

Yes, I think that your question is very pertinent, and it demonstrates the limitations of post-marketing surveillance.

On the early part of your question about how we establish a link, a causal link, between a marketed product, a vaccine or a drug, and the adverse events that we see, the answer is that it is with extreme difficulty and a great deal of time and effort. Once the drug or vaccine is out on the market, it becomes almost impossible to do the randomized control trials that are done prior to marketing and that should be done in a manner that is sufficient to identify problems. Once the drug or vaccine is on the market, randomized trials are not really an option, so the ability to demonstrate a causal link is lost. You can demonstrate an association. This is a scientific term that means on a balance of probabilities this is a causal problem.

The second issue is that once a drug becomes politicized, the science behind the drug and the surveillance done on the drug or vaccine becomes secondary. There is evidence both in Canada and in the U.S. that this particular product became the subject of tremendous political pressure, to the point that the company's own top researcher for the clinical trials spoke out publicly to say that both the company and the regulator were taking action to provide the vaccine to very young girls--as young as nine, 10, and 12 years old--when in fact none of the studies was done in that population and there is no evidence that the drug will be helpful or what harms might arise.

Lastly, your point about informed consent is crucial. As a parent, I've had my daughter announce in grade school that she was getting a vaccine the next day. When I asked, what have they told you? She gave me a little pamphlet that had nothing about the vaccine, just a public health message that it was to be given, and she, at the age of 12 or 13, was going to sign for her own vaccination. It was a vaccine that I did not particularly feel confident about.

You're absolutely right that we are taking tremendous liberties with people's health in a manner that would be offensive to the average citizen if they understood what is really going on.

[The Vice-Chair, Liberal, Lui Temelkovski]

Mr. Young.

[Terence Young]

Thank you, Chairman.

Gardasil is three painful needles over a period of time. It costs $450, is effective on 70% of the viruses that can be cancer causing, and may only last five years. Would you buy a television or an automobile that works 70% of the time and only lasted five years?

It's an unproven drug that was only tested on less than a hundred 12-year-old girls, which is the market they're selling it to. Remember I said before, are we sure that the benefit outweighs the risk? There's no way to tell at this point.

I just conclude by saying that Gardasil is brought to us by the same people who brought the world Vioxx.

[The Vice-Chair, Liberal, Lui Temelkovski]

You have one more minute.

[Christiane Gagnon, Bloc, Québec, QC]

Another undesirable side effect, aside from death, is spontaneous abortions. The drug can also cause blot clots and vascular bleeding. How should Health Canada react to this serious news?

[The Vice-Chair, Liberal, Lui Temelkovski]

Please make a half-minute response.

[Terence Young]

Health Canada should respond by saying exactly what Dr. Michèle Brill-Edwards just said to you. They should post it on their website. They should make Canadians aware.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

We will now move on to Madam Wasylycia-Leis.

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

Thank you, Chairperson.

Thanks to all of you for your presentations.

I'm going to start with Best Medicines Coalition. I always get a little curious when I see a brief that presents unequivocal support for a present government policy without any equivocation and any kind of concerns, especially given what we've heard from Terence Young and Michèle Brill-Edwards, and especially what we've heard from so many individuals out there who have been hurt, and hurt badly, as a result of lack of vigilance in our system.

So when I see this kind of unequivocal support for the progressive licensing framework, I either think you're a mouthpiece for the government or you're a mouthpiece for big pharma. I looked back and I realized you had been asked to declare your funding sources in a previous health committee meeting, and you did not do so again today. So I want to clarify that, according to the last record, you get half your money at least from big pharma, brand name drug companies.

[Linda Wilhelm]

That is correct, and I believe I thought where we get our funding was included with this submission—

[Gail Attara]

It's in our brief.

[Linda Wilhelm]

--and we are trying to balance that funding. Nonetheless, all our members are volunteers, and we don't receive any money for what we do. In fact, many times it costs me money to do what I do.

To support the progressive licensing framework is a process that's been ongoing for—

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

You've answered my question.

Thank you.

In your brief you say something about getting support from the drug industry. I'm looking for it right now: “The pharmaceutical industry is a major supporter.” You didn't declare your financial support, so I think that's important for everyone to know. As Terence Young said at the beginning, none of his money for the coalition comes from the corporate sector.

I think what we're finding is that there are some legitimate concerns that people are having a difficult time raising because there's been such a hold over this agenda from the brand name drug companies. We saw it with many of the presenters, and we're very concerned.

In fact, the importance of this meeting here today is not to focus simply on adverse drug reactions, although that's an important part of it. The point of this meeting actually should be to understand what the government is really about, and Michèle Brill-Edwards will have a sense of this. So will Terence Young, because we've been through this many times before, and this is a government bent on totally revamping the Food and Drugs Act in the name of modernization.

What we're seeing is a move away from the precautionary principle, which most Canadians actually support, the “do no harm” principle, to the risk management model, which is to let the drugs on the market and then worry about the impact. If there's a reaction, then let's just allow people to sue the drug companies, because that's a lot better and a lot cheaper than having to really make sure our products are safe beyond a reasonable doubt.

So I want to ask Michèle Brill-Edwards—I know you've been active on this file for over 10 years—how many times you've seen this agenda item come to the fore, how you and the coalition have helped stop it in the past, and what we can do now to bring some light to this whole issue.

Terence, you identified Vioxx as a good example of what's wrong with the progressive licensing system, and other concerns around transparency and accountability, which I think we need to hear about as much as we need to hear from you about mandatory adverse drug reporting.

So Michèle and then Terence.

[Dr. Michèle Brill-Edwards]

Regarding the history of Health Canada's attempts at what is loosely termed “legislative renewal” for the Food and Drugs Act, you're correct that there have been numerous attempts in the past. For example, in the late 1990s there was an intention to roll the Food and Drugs Act into an omnibus act with 10 other acts of Parliament, which failed miserably, but only because of the actions of non-profit groups in bringing to the attention of Canadians the abysmal destruction of regulatory powers that was about to occur.

So the track record is not good. The issue here, in historic perspective, is that we have been through roughly 30 years of deregulation, beginning with the deprofessionalization of the agency in the 1970s and 1980s, removing people with expertise who could challenge drug companies. At the same time, we had regulatory indifference publicly. It was politically voiced as red tape--safety and so forth are nothing but red tape to regulators.

In the more final phases, we've had the dismantling of the actual department, the destruction of the drug research labs, the half-destruction of the food research labs, and the farming off of environmental health to a different department.

Now we are in the true final phase, fourth phase, of deregulation, which is dismantling the very legislation that creates the power to do such things as create a moratorium. We have that ability at the moment. It would be quite possible to do, but Health Canada not only does not enforce the regulatory authority it has, it now seeks to actually dispel itself, to dismiss the regulatory authority so it can no longer be held accountable when things go wrong.

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

Terence.

[Terence Young]

Thank you.

About a month after Vanessa died, I had a call from a pharmacist at an Ontario hospital. She told me she did a report on the cancer ward in her own hospital and that seven out of nine patients who had been given Prepulsid had died. They were very sick patients. They were cancer patients. Many of them, if not most, were going to die anyway. But they died after taking Prepulsid, when it was contraindicated.

She sent that report to Health Canada. Health Canada covered it up for a year and a half. This is a result of the partnering direction they had with the industry.

We did an FOI for a CBC film. We discovered a memo from a senior Janssen-Ortho executive, directing Health Canada officials how to answer questions on this drug, Prepulsid. It was telling them what to say after a CBC Marketplace show--coaching, working together.

At the inquest into Vanessa's death, the vice-president of regulatory affairs and linguistics was giving testimony. She said, “We view Health Canada as a key customer.” In another quote, she said, “Health Canada doesn't warn Canadians about drugs; it helps them take them.” This is a vice-president of Janssen-Ortho, which is a Johnson & Johnson company.

I believe it's not what the drug companies tell us that harms patients; it's what they don't. They also withhold a great deal of information they classify as “commercial” in the summary basis of decision. It's humorous, because they get the same drugs approved in the States, and the FDA will publish the same information on the Internet. So Health Canada is hiding it, saying they can't talk about it, they can't tell us.

I'm optimistic this new act will provide all that transparency, including the clinical trials, as I mentioned to you as well. In researching my book, I found probably 40 or 50 different ways clinical trials are biased. The most obvious is publication bias. They bury the bad ones and get the good ones published. They omit washouts, people who start the drug trial and then stop because the drugs affected them badly. They pretend they were never in the trial. Another is what they call non-responders, people who say they didn't feel any difference with the drug. So they take them out of the trial as well.

When trials are going badly, they shut them down and pretend they never existed. They test drugs on homeless people who have a range of illnesses like liver damage, etc. And they test drugs, in some cases, in uncontrolled conditions. In some cases, to get better results, they test a drug and compare it with another drug in a higher dosage than they're going to be selling.

I haven't lost my sense of humour in all this. You have to see them to believe them.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Mr. Chairman.

I've got a few questions for Mr. Young.

Thank you for your testimony here today. Certainly you were able to share a very powerful story with us. I appreciate your doing that.

I was interested in a few things you mentioned. You mentioned that big pharma has information from 192 countries around the world and that some of that is not shared with Health Canada. Could you elaborate a little bit on that?

I'd also like you to elaborate on this. You mentioned that Mr. Dosanjh, when he was health minister, announced some policies, but they weren't implemented. What were those policies? I missed that.

[Terence Young]

In doing the investigation into Vanessa's death, I found out the regulators in each country. Janssen-Ortho, for example—their head office is in Belgium, Janssen Research Foundation—would only communicate with each regulator in each jurisdiction individually and talk about the deaths or injuries within their jurisdiction. And so at the inquest into Vanessa's death, our counsel asked how many deaths there had been worldwide. The vice-president could not answer because it was not routinely part of her job to investigate and find out how many people worldwide had died from a drug.

These companies have more money than many countries—I'm not exaggerating—with capital values of over $100 billion. There are more than 100 countries in the world that have nowhere near that kind of money. They deal with the regulators on a one-to-one basis.

In 1998, Prepulsid had a black box warning on it, the highest level of warning, coordinated with the FDA, but they didn't put that warning on the drug in Canada because no one told them they had to.

These are the games the pharmaceutical companies play. If they're ordered to do something, they do it. If they aren't, they maintain the drug is safe and keep selling it.

Minister Dosanjh announced he was going to move forward with compulsory adverse drug reaction reporting for doctors, but nothing ever happened. I can only assume he received huge lobbying pressure from the Canadian Medical Association and the pharmaceutical industry to not bring it forward.

[Patrick Brown, Conservative, Barrie, ON]

Another interesting statistic you raised was that adverse reaction deaths were the fourth leading cause of death in Canada. What information is that comment based on? Was there a study done?

[Terence Young]

The primary study was done by Lazarou et al., three professors from the University of Toronto, in 1998. It was a macro study of hospitals. I don't remember the number of hospitals, but I have a reference for you in the printed material. They determined that 104,000 people die from adverse drug reactions in the United States, in hospitals alone, from prescription drugs taken as prescribed—not in error, but as they were prescribed. Others have extrapolated that figure and asked about the deaths that occur outside hospitals. They think that may be as high as another 100,000, although it's very difficult to prove.

So using the population ratio, that would be 10,000 in Canadian hospitals and then potentially another 10,000 outside Canadian hospitals.

[Patrick Brown, Conservative, Barrie, ON]

It is certainly a chilling statistic.

One thing we had talked about in this committee was electronic devices and how they might equip doctors more effectively. As a general comment, how much would it help if warnings were communicated by Health Canada in real time to those in the medical profession who are prescribing drugs?

[Dr. Michèle Brill-Edwards]

Again, the problem is not the reporting process; the problem is the very delayed analysis of reports at Health Canada. Real-time reporting already exists. When you go to the website and fill out the adverse reaction reporting form, it's transmitted almost instantly to Health Canada. When does Health Canada get around to analyzing the collection of reports? That's the problem.

You have to understand that a single report does not tell Health Canada anything. It's just a report. The adverse event could be due to the drug, or it could be due to something else. The only way you can begin to separate a true red-flag report from the noise that's coming in from many reports is when you start to see a pattern. You have to take reports that are similar and start searching and sifting and looking for a pattern, and that is what Health Canada is not doing promptly in a timely fashion.

Having real-time reporting is already there, but it's not enough.

[Patrick Brown, Conservative, Barrie, ON]

The reason I raise that is that one of the comments, when I asked the Canadian Medical Association the same question, was that when there's a new warning, sometimes it comes in by fax and sometimes it's mailed. So that real-time reporting is not there. It could be a span of weeks.

[Dr. Michèle Brill-Edwards]

I'm sorry. I misunderstood your question.