Health Committee on April 22nd, 2010

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

He referenced the last committee hearings, where I said I was embarrassed to be a Canadian, which was about tuberculosis. We were not in discussions on HIV. I have never said that I am embarrassed to be a Canadian in any other context, except in the face of this government's absolute inaction on serious issues.

[The Chair, Conservative, Joy Smith]

This is not a point of order, Ms. Wasylycia-Leis. It's a debate.

Dr. Carrie, go ahead with your questions.

[Colin Carrie, Conservative, Oshawa, ON]

Madam Chair, I want to allow Dr. Butler-Jones to answer, because I know he's gone through this in the past.

We've heard a lot about the application process and the impact of the independent study commissioned by the Gates Foundation. Could you take this opportunity to be uninterrupted and take the committee through the process?

[Dr. David Butler-Jones]

As we identified before, there was an interest on the part of the Gates Foundation and the Government of Canada to move forward on the HIV vaccine initiative, recognizing that because of the complexities Mr. Malo has identified in dealing with an HIV vaccine and the multiple unsuccesses, it would require a concerted effort around the world of linked researchers, linked organizations, and government involvement to get there. It wasn't something you could do with the usual processes, a few researchers here and there being generally interested.

This came together in the announcement of joint funding between the Government of Canada—multiple departments in the Government of Canada, not just ourselves—and the Gates Foundation. That led to an invitation for the submission of applications in April 2008. In June we received letters of intent from interested applicants. On November 10, four were informed that their LOIs were successful, in terms of their being invited to submit full applications. In March 2009 the Gates Foundation initiated a study on the global supply, again to review the original assumptions to make sure, before we committed dollars, that we still had the need.

In March 2009 the applications were received, and from April 2009 to January 2010 there was a comprehensive review that included external reviewers, done between April and June of 2009, that looked at everything...and they had expertise in everything from vaccine research to facility construction, vaccine manufacturing, etc.

In 2009 the Gates Foundation had completed the supply-and-demand study. It pointed to our needing possibly to think about a different decision: if the capacity is now out there, did we want to go down this path? They contacted us; we reviewed the study with them and looked at expert opinion, in terms of what else was out there and how valid it was, recognizing again that this was a major commitment of the Government of Canada and of the Gates Foundation and that to change course would require a significant event, and of course, because people expect you to hold to the same idea even if the circumstances change, that we needed to be very careful that it is the right decision.

So from July until January, a full internal review was done taking into account all of those aspects. In the third week of January I called each of the proposal proponents personally, because I wanted them to hear from me what the real circumstances were. Then we jointly communicated that we would not move forward on a facility but that we were continuing to move forward to make a significant contribution on the development of a vaccine against HIV/AIDS.

So that's where we are.

[The Chair, Conservative, Joy Smith]

Dr. Plummer, would you like to make a comment on that?

[Dr. Frank Plummer]

Yes, I would, Madam Chair. I would like to remind the committee that the identification of a gap in manufacturing capacity was the result of an analysis done in 2003. It became part of the strategic plan of the global enterprise. So considerable manufacturing capacity came on-stream between 2003 and 2009.

It's understandable that things have changed, and I think the decision to not proceed with the facility was the right one, although disappointing to everybody involved. But it gives us an important opportunity to re-invest in other areas that are important.

I would submit to the committee that probably the biggest gap in access of academic-based researchers to getting vaccine manufacturers for clinical trials is really due to the cost of it and not to whether there is a facility or not.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Plummer.

We'll now go to Monsieur Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you, Madam Chair.

I would like to thank the witnesses who are here today.

Mr. Butler-Jones, a moment ago, when you finished your remarks, one thing you said in particular surprised me. You told us that the less time the committee spent on completing the study of this issue, the faster you would be able to continue your work on HIV.

Do you think the study the committee is currently doing on cancellation of the facility is slowing down or impeding your work? That is the impression I got.

[Dr. David Butler-Jones]

Your committee has its responsibilities. That is its business. I am not going to say otherwise. However, the fact is that a large part of Steven's activities and the activities of other people and myself, who are working with the Gates Foundation, consists of replying to the committee. Consultations are continuing to move forward, but our attention is divided between the committee and progress on the program. That is the reality. If you have decisions to make or questions to ask, that isn't a problem for me, but my answers to the committee have been the same for the last five hours, and I have nothing else to say. That is the truth.

[Nicolas Dufour, Bloc, Repentigny, QC]

On our side, we have questions to ask and answers to get. I have one that relates specifically to the process.

Like Mr. Plummer and a lot of other witnesses, you have told us from the outset that in terms of combating HIV, the situation changes virtually from one month to the next. We have to know how to adapt, given that everywhere in the world there are so many initiatives, new studies and new projects for combating HIV. I think we have an example here. Virtually every month, there are changes. So then you have to readapt. You have to be very flexible.

Given everything we have heard about combating the H1N1 virus and producing vaccine against it, would you follow the same process over again today? Do you think there were flaws in the process? Should changes be made so that next time we aren't caught in the same pattern, making an announcement and then ultimately realizing that it may not have been that major?

[Dr. David Butler-Jones]

Is your question about HIV or the vaccine intended to combat the pandemic?

[Nicolas Dufour, Bloc, Repentigny, QC]

It is really about the facilities to be used for manufacturing an HIV vaccine.

Would you follow the same process over again?

[Dr. David Butler-Jones]

No. The process is different from the one for the vaccine that was used to combat the pandemic. Production capacity was geared to the entire population, which is not the case now. This case involves manufacturing a vaccine intended for clinical trials. That is very different. It involves the science and the means of production.

In the case of the H1N1 virus, there was a consultation with the provinces, experts and others. We have production capacity here in Canada, and that is very important. The value of it was clear during the pandemic. However, we are also considering other possibilities.

[Nicolas Dufour, Bloc, Repentigny, QC]

I may not have worded my question to Mr. Butler-Jones clearly enough.

An announcement was made about facilities to be used for manufacturing HIV vaccines. An extremely lengthy process took place in relation to tenders and verifications. It cost a lot of money, including for the people who were interested in submitting bids.

Given everything that has happened and the evaluation done of the process, I would like to know whether, in your opinion, changes should be made to any future process of the same nature relating to facilities. That is what I want to know.

[The Chair, Conservative, Joy Smith]

Okay, time is up. We'll just have that answer, Dr. Butler-Jones.

[Dr. David Butler-Jones]

Maybe, but I don't see anything that could be changed. There is a government of Canada procurement process and a process for evaluating the scientific aspect. It is a lengthy process, but it is important to devote the time needed to it in order to make the right decisions.

[The Chair, Conservative, Joy Smith]

Thank you.

Mr. Del Mastro.

[Dean Del Mastro, Conservative, Peterborough, ON]

Thank you very much, Madam Chair.

I want to thank the witnesses this morning. I have great respect for both of these individuals.

Dr. Plummer, perhaps you'll recall—it was memorable for me, anyway—that I met you at the celebration of Dr. Kellie Leitch's receiving the Order of Ontario some months back, and we had an opportunity to discuss your work that evening. I want to again congratulate you for all the work you're doing on behalf of Canada and in leading research on behalf of those globally.

I took some notes while you were testifying earlier. You said there was no trouble finding capacity to manufacture trial lots right now. You also indicated that you had full faith in the Gates Foundation's findings. This may be loosely quoted, but it's what I pulled out of your earlier statement.

Madam Bennett said earlier that she felt we should do another study to verify the last. Do you think that doing another study at this point to verify the findings of the Gates Foundation is in fact prudent, or is it something that would merely slow us down if we're trying to make progress on this initiative more broadly?

[Dr. Frank Plummer]

I don't think there is a requirement for further study at this point. It's my own experience, from where I sit at the National Microbiology Laboratory, that there is manufacturing capacity for trial lots, including some in Canada, and that further study is not required. I think we need to move on and figure out how to use this $88 million to advance HIV vaccine research and development, with the recognition that there isn't a need for another bricks and mortar manufacturing facility.

[Dean Del Mastro, Conservative, Peterborough, ON]

Thank you very much.

I just heard the member indicate that all politics is local and I frankly agree with that. But I am scared to death of the day that we start to drive public policy, especially health public policy in this country, based on nothing but the interests of local politicians trying to eartag projects for their local ridings. I think we should be looking to try to accomplish something that's of net benefit.

Dr. Butler-Jones, you said earlier that if we had followed some poor strategies, people could die. It's your responsibility, as a chief public health officer of Canada, to undertake, using all of your knowledge and that of your department, the best possible approach to ensure that we are using our money in a way that is prudent and that will deliver results, and I appreciate that a great deal.

You indicated that none of the applications passed the bar. Even if they had passed the bar, there seems to be agreement that we were working based on an initiative that in 2003 was seen as being needed but in 2009 was seen as no longer being the right way to go.

If we entrench ourselves in thinking that we must maintain whatever direction we determined at some point in the past, regardless of any advances, of any increases in capacity, of any new findings that are made in science, is that prudent public health policy, in your opinion?

[Dr. David Butler-Jones]

I'm afraid there is an obvious answer to that: the short answer is no. Through H1N1 I certainly came under a lot of criticism, as did the public health community, for—in the popular vernacular—having “changed our minds”, which really was a matter of applying new science.

I used the example of Tamiflu. Previously it was not considered effective, and we found that it was, no matter when you started it. It transformed the face of treatment in the pandemic.

We were accused of changing our minds about vaccine when we introduced an unadjuvanted vaccine. Well, we were seeing that some pregnant women were not comfortable with adjuvanted vaccine. The manufacturer was willing to produce it, and WHO was recommending it, if we had it. Initially it looked as though that would be a very smooth transition. As it turned out, it was much more complex than even the manufacturer anticipated, so we had some glitches. But we were able to provide that option for pregnant women.

So as we moved forward, yes, there were changes, but they were changes based on new science, and we have to apply that. I think it was Vincent Lam, who is an emergency room doctor and the author of Bloodletting and Miraculous Cures, who said that in the emergency department, if someone comes in with heart failure and doesn't respond to the usual drug, you don't say we have to use more of the usual drug; you have to change your strategy to respond to the patient in front of you. We have to change our public health strategies in response to the patient—which is the community—that we face as we go along and apply the best science we can, often in an environment in which we don't have all the data but we have good enough data to make a decision. And if we don't make a decision, that does condemn people to death.

[Dean Del Mastro, Conservative, Peterborough, ON]

Thank you.

[The Chair, Conservative, Joy Smith]

Dr. Plummer, did you want to make a comment on that?

[Dr. Frank Plummer]

Yes, I would, Madam Chair.

I will just illustrate to the committee how rapidly things change. The failure of one vaccine trial, the so-called STEP trial--I believe it was announced in 2008--cast a tremendous pall over the whole field of HIV vaccines. The vaccine that people thought was the best possible candidate actually probably increased the risk of people becoming HIV-infected, and it was a tremendous disappointment. But late last year there was a very encouraging result from Thailand that showed that a vaccine that nobody expected would work actually provided significant protection for a relatively short period of time.

So the field changes dramatically in relatively short periods of time and you have to be prepared to adapt to that.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Plummer.

We'll now go to Ms. Duncan.