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Session III of a Council On Foreign Relations Symposium on Pandemic Influenza: Science, Economics and Foreign Policy

Panelists: John Lange, Senior Program Officer for Developing Country Policy and Advocacy Global Health Program, Bill and Melinda Gates Foundation, and Helen Branswell, Medical Reporter, Canadian Press
Moderator: Laurie Garrett, Senior Fellow for Global Health, Council on Foreign Relations
October 16, 2009
Council on Foreign Relations

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LAURIE GARRETT: If people could please take their seats.

Broadcast audience, we'll be starting momentarily.

Good morning, I'm Laurie Garrett, here as a senior fellow at Council on Foreign Relations. For those of you that may have just tuned in on the webcast, we've had two fantastic discussions preceding this one:

The first, chaired by my colleague, Jon Cohen, from Science Magazine, which is a cosponsor, with Council on Foreign Relations, of today's symposium on influenza, that really got into the scientific uncertainties that we see with this H1N1 pandemic.

And the second, chaired by Secretary Robert Rubin, who is also the chair of the Council on Foreign Relations, regarding some of the possible economic consequences and impacts for businesses -- the macroeconomic scale, government financing, and so on, that we will see with this mild epidemic, and some of the implications of what might happen if it were a more dangerous virus.

Everything that you're hearing is on the record. That includes your questions, so you better think about that before you open your mouth. We're going to have a conversation for about 40 minutes, and then open it up for a good half hour of questions from all of you, including the webcast audience. If you are a Tweeting, a Twittering aficionado, your tweet is: # or @cfrq&a -- #cfrq&a. And, once again, a reminder to those of you here, please turn off all your transmitting devices as they may interfere with the signaling here in the room.

Well, I think the take-home message from our first two panels is it's a darned good thing we're dealing with a relatively mild flu this time, because clearly we're ill-prepared at this moment for a more virulent, a more dangerous flu pandemic, either if this one takes on a more dangerous form, which fortunately Dr. Palese assures us will not happen -- I'll hold you to it, Peter, or if a second, totally different, virus does emerge.

Nevertheless, we've already seen some very hot-button issues emerge internationally, some of which have just been touched on. And I want to start with Ambassador Lange. John Lange has served for many years in the United States government. He was ambassador to Botswana. But in his last position, before his current (spot ?), working for the Bill and Melinda Gates Foundation, he played a key role as -- I don't remember what your exact title was, but the pandemic aficionado on behalf of our State Department dealing with what was then the key concern, H5N1, aka "bird flu," and our international relations, in terms of surveillance and preparedness.

And I want to start by asking you, there was -- there's been a lot of talk, why doesn't the government have a plan, so on, and so forth. But, indeed, you were part of a process that did promulgate a national plan for pandemic response in the Bush administration. And there's been a lot of talk at WHO, and at other tiers internationally, of trying to come up with a more rational, some sort of advanced planning that could coordinate the global response.

Where does that stand?

JOHN E. LANGE: Well, the previous administration, under President Bush, created a U.S. national strategy for pandemic influenza, and an implementation plan. The strategy was released -- (inaudible) -- in late 2005, an implementation plan in May of 2006.

And, from my observations, and that of many others, the fact that that plan was in place -- the fact that there had been international coordination, through the international partnership on avian and pandemic influenza; the fact that there were several years in which organizations, governments, international organizations, non- governmental organizations -- (inaudible) -- preparing for the possibility of the H5N1 pandemic -- really did a lot, and had a major impact on the ability of the international community to respond to the current pandemic of H1N1.

As we discussed, and heard from the speakers earlier today, it's not perfect, in terms of the response, but the world is much better prepared today than it would have been if this had occurred four years ago.

GARRETT: I should point out, one of the people who had been involved in a lot of that planning was Mike Osterholm, who we just heard from as a sort of "voice of god" in this room -- (laughter) -- in the prior session. And I need to thank Mike -- I hope you're on the webcast, for your valiant efforts to fly out of Minneapolis yesterday in the snow storm, and we're happy that you're able to join us, "telecommuting," in the absence of being here physically. But Mike had raised some of the same points, that we had some level of advanced planning, thanks to our concern about H5N1.

And, of course, the other thing we had in place, thanks in part to the sense of urgency around H5N1 bird flu, was the international health regulations, which form a sort of guidance of how the world should cooperate regarding infectious disease issues.

But, again, sticking with you, Ambassador Lange, we've had trouble seeing how that ends up actually applying, concretely, to compelling or nudging nations to truly share viral samples, open surveillance, outbreak investigation with the global community.

LANGE: Well ultimately the government of Mexico was very forthcoming in sharing samples, and really it could be used as a model for how other governments should react in similar -- a similar situation with the start of a possible pandemic.

There were difficult negotiations going on for two years at the World Health Organization. It was called an "Intergovernmental Meeting on Pandemic Influenza Preparedness." And it dealt with this is of sharing of samples, as well as sharing the benefits that come, such as vaccines and other aspects of pandemic preparedness and response.

And it would be wonderful if we could look at this just from a global health perspective, and the need to share these samples and to share the vaccines, et cetera. But in that context -- that took place at WHO, it involved many political issues, such as intellectual property rights and the sovereignty issues. And, regrettably, while there was certainly progress made, they did not come to a conclusion on some of the basic issues.

One of my personal hopes is that this pandemic, which is milder than we had predicted the H5N1 pandemic would be -- and let's hope it stays that way, there's no guarantee of that, but let's hope that this will be the wake-up call that is, as Jon Cohen said earlier in this symposium, "a teachable moment," and that we can be looking to the lessons learned from this and create systems whereby we don't have ad hoc mechanisms for trying to deal with this, but a more concerted effort.

As you know, I come from a foundation -- the Bill and Melinda Gates Foundation, where our basic premise is that all lives have equal value and that every person deserves the chance to live a healthy and productive life. And to answer Secretary Rubin's question from earlier, there is a moral obligation to help the poorer people of the world, the developing countries with access to vaccines, et cetera.

Right now there has been a very laudable effort on the part of -- at first announcement, nine countries, and few have been added, to provide some of their vaccines to the developing world, and WHO is working on that. But it's still being done in a way that is -- (inaudible) -- in a sense, ad hoc. I would hope that in the longer- run, these issues can be dealt with when looking at the experience from H1N1.

GARRETT: Helen Branswell has been one of a tiny handful of truly outstanding journalists on this beat, on this story doggedly. I think there are people all over Geneva, in WHO, that are terrified when they hear that Helen is calling. (Laughter.)

Secretary (sic) Lange mentioned this agreement that was brokered by the White House -- initially eight countries, now I believe it's up to 11 have agreed that they will donate 10 percent of their vaccine supply to WHO for distribution in developing countries. Before getting into what the real significance of that may be, your country is one that has not signed on. Why is that? Why is Canada not in the game?

HELEN BRANSWELL: That's a fascinating question and I don't have a good answer. I've been trying to get a good answer, and having just absolutely no luck.

I don't think you know, do you?

LANGE: No, I do not.

BRANSWELL: It's puzzling. It's really puzzling, because it's typically the type of thing that Canada does do. In fact, somebody on this side of the border -- I wrote a story about the fact that we were noticeably absent from that group of donating countries, and somebody from this side of the border called me and said, "Interesting story. You guys are normally -- (inaudible) -- and you're not there. What's going on?"

I don't know. I'm told that we're still looking at what the need is, and we're trying to determine what's -- how we could best fill the needs that exist. We're going to swimming in unused vaccine, and I'm not clear at all why we're not -- (inaudible) --

GARRETT: Do you have any idea how much vaccine Canada has ordered, and how much is likely to actually get used?

BRANSWELL: Well, we ordered 50.4 million doses. And that's enough to give everybody -- that was based on the premise that maybe 75 percent of people would want to be vaccinated, and we'd need two doses a piece. We don't.

We have a population of 33.6 million, and if they vaccinate half of that, they'll be very, very -- be doing dances. There's no chance that that's going to happen. Polls suggest somewhere in the low 30s right now.

GARRETT: You have a resistance to vaccination in Canada as we do here in the U.S. --

BRANSWELL: Yeah, there's a lot of fear about this vaccine, and particularly because in Canada we're using an adjuvanted vaccine for the first time. You guys aren't going that route. And there are implications, and pros and cons, but there is quite a bit of concern about whether or not this vaccine is safe, whether people need it, and I'd be very surprised, unless things get worse, if the numbers would be very high.

GARRETT: So we have the possibility of signaling to the world, 'We want everybody to sign on with globalization. And, in the context of pandemic-disease threat, that means we want every one of you, rich and poor alike, around the world, to let us know if you have any weird outbreaks; allow outside investigators to come in, and swoop in when you have an outbreak. We want all the civil society organizations and NGOs, the MSFs of the world to tip us off if there's outbreaks, even in failed-state areas, and so on.'

So we're globalizing this sense of threat. We're globalizing the responsibility to surveil and to observe threat, but we are not globalizing the benefits, in terms of those tools that can help protect societies against the threats. And then, on top of it all, you're saying -- and Mike Osterholm had hinted at this earlier, that when we get to the end of the day, out in January or February of 2010, we may well see giant unused stockpiles of vaccine in the wealthy countries, none having ever reached most of the poor countries of the world.

BRANSWELL: Well, some are going to reach the poor countries through this initiative that Gates was involved in trying to broker, I believe, and the WHO is also spearheading. And that's in real-time, which is really quite an achievement, I have to say. I didn't think that was going to be possible.

But that's a small percentage. They hope to be able to provide enough vaccine to developing countries to vaccinate about 2 percent of their population. And it's true that then there will be this large amount of vaccine elsewhere that isn't going to go -- be used.

John's (sp) question, about whether or not that might be a good thing, I just found was intriguing, because in the context of America, or Canada, or whatever, if vaccine isn't needed, and we bought it, and it was there, and it was an insurance policy, maybe that is a success. But I don't think the world's going to see it that way if, at the end of this, we're going to find that Canada had 25 million doses of vaccine that we couldn't persuade people to take, and we didn't free up to pass along to others.

Now, I will say that the Canadian authorities, I think, are already in discussions with the contractor that we're buying from, GlaxoSmithKline, to turn back the portion that we don't need, so that they can sell it to whoever is next on their list. But I'm not sure when we're going to say, okay, we feel safe to feel -- to say that we don't need this, and so you can sell it elsewhere. And that's selling, that's not donating.

GARRETT: John, I want to go back to you because we need to bring everybody up to speed, and they may not all know what, in particular, went down with the United States government and the government of Indonesia around this issue, and that remains unresolved at this time.

But you were actually there in Indonesia trying to negotiate with their ministry of health to get them to free up samples of bird flu viruses that had emerged in that country, that they were refusing to share on the grounds that, if a vaccine were made, they would never get the vaccine. Correct?

LANGE: Well, yes. It was quite a complicated (approach to the ?) negotiations. Some of them were between the United States and Indonesia, trying to see if we could come to an agreement that we could then pass on to the multilateral forum that I mentioned earlier, under the auspices of WHO in Geneva.

The thing is, once this came to the World Health Assembly in May of 2007, and this intergovernmental meeting process that I mentioned earlier was created, then it became multilateral. And so it was not just Indonesia that was negotiating. And then some other countries started bringing in other issues, whereas Indonesia was concerned with -- more focused on the control of the virus that had emanated from their country and benefits that they had hoped to receive in return.

But I'd like to actually look at this from what I think has been the change in the this -- over the last few years, particularly since this recent announcement there's up to 10 percent of vaccines that are going to be allocated by -- up to 11 countries now, to help the developing world.

There's been a lot of discussion on this and at the Gates Foundation our strategy -- our focus is to ensure that there's an effective strategy to address the pandemic in developing countries. Dr. Tadataka Yamada, the head of the Global Health Program at the Gates Foundation wrote an article that was published in the New England Journal of Medicine last month that listed eight proposed principles to help guide elevation of pandemic vaccine to really ensure that within the same time frame, developing countries receive the vaccine as well as the developed countries.

And if you look at what is happening, you can argue that we are moving in a very positive direction, that while the debate -- we can argue between the sterile debate in WHO over whether this should be done on a voluntary basis or a mandatory basis. Maybe we're now moving to a way in which it's expected even though it's not mandatory. Just as you have one of the huge programs in the world for HIV AIDS -- (inaudible) -- the president's emergency plan for AIDS relief, it's not a mandatory contribution, but it's certainly an expected one. Every observer believes it will continue.

The people who run the Gates Foundation Global Health Program is not required. It's not mandatory. There's no legal requirement for it, but it certainly is a very real positive program to help global health, and I wonder if we've now set some precedents just for the last few weeks, actually, whereby when the next pandemic occurs, a serious and possible more severe pandemic than this one, but that there will be that expectation that those vaccines will be shared.

BRANSWELL: I'm -- (inaudible) -- and I think that's true and I think -- but the issue remains. The issue that Secretary Rubin brings in the last session. This -- it's easy to commit this time because it's a relatively mild disease. Most people aren't getting very sick. Most people -- Australia got through their wave -- you know, they managed to get through their wave and they had no vaccine at all. But if this were -- this were H5N1 or even something not as bad as H5N1, would your government have felt that it could say, let's broker a deal and give away 10 percent of our vaccine in wartime. That's a very hard thing to do when it's a crisis and I think -- I agree with you that a precedent has been set and that expectations have been created and I -- but I'm not certain how hard -- or how easy it will be to deliver on that in a time when things are more difficult.

GARRETT: Well, you know, one of the interesting things here is the question of sovereignty. And David Sidler (ph) has raised this from the University of Indiana, Professor of Law, as the bottom line challenge that we face going forward in this age of globalization when facing pandemic threats -- any kind of disease threat -- the question of sovereignty is if he could get a two-edged sword. On the one hand the government of Indonesia can say we've declared viral sovereignty. It did say this. Any viruses that we find on our soil are our viruses, not to be seen by the rest of the world unless there's some contractual understanding, and any profits derived from said viruses down the road go to Indonesia. That was an interesting perspective.

We conversely could have sovereignty declared in the context of Canada may have ordered vaccine from, let's say, the U.K., but if it turns into a super virulent flu, the Brown government could very well say no vaccines made on British soil will leave British soil -- full stop. And when you consider kind of the chain of production that we were talking about in our prior session that the raw ingredients for most pharmaceuticals are actually coming from China and India, but the masks and protective gear our hospital workers depend on come from outside the United States. You start to be -- imagine a very quick multiplier effect all based on the notion of sovereignty that could make any kind of moral understanding that you and -- (inaudible) -- are talking about completely collapse.

And Sidler argues that we have no legalistic mechanism in place or one that we can even immediately imagine that can get us past this moment. How do you see that?

LANGE: I actually don't have high hopes that there could be some legal mechanism that could be put in place because the negotiations that went on in Geneva were so difficult and positions were so attractive on all sides. And so -- but I guess -- my thoughts in terms of what Helen was saying well what happens in a more severe pandemic when there is the pressure not to give up the vaccine and what Secretary Rubin said earlier.

It seems to me that that argues for actions in the next months and years with that in mind, that if there is the expectation that has been developed that, yes, developing countries do deserve vaccines and we can't have the rich countries first in line and developing countries last in line and this kind of situation.

Well, how do we deal with that? Maybe there are ways, for example, to increase the production capacity for influenza vaccine in some developing countries, not because we expect that there -- that you can have a robust plan just to do pandemic influenza vaccine production once every 25 or 40 years, or whenever the pandemics occur, since there were two in the last century, but also for seasonal influenza flu vaccine.

And so if you increase the global consumption of seasonal influenza vaccine, you could keep these plants going. There may be other ways to do this, whether there's advanced purchases or whatever, so that the political issues that were discussed earlier are mitigated even in a severe pandemic. It's in a sense -- and it's too early right now. I talked to WHO this week and they have twelve task forces going just H1. They're not about to look at lessons learned as they're still in the middle of learning them, but in the coming months and years, we may find a real opportunity in the international community from this wake up call to try to put in mechanisms for that expected, or not mandatory system to benefit the developing world.

GARRETT: Well, Canada is going to be hosting the next -- what we would have called until a year and a half ago G8. Now it could be G20, I assume -- summit will be Ottawa or outside Ottawa and, you know, traditionally when we've had these sorts dilemmas there's some shurpa (sic) on the part of all the G8 shurpiteens (sic) to try and come up with an outline of what might be a proposed mechanism, but then the heads of state at the summit could agree to. Now if we expand to G20, we're bringing in players with very antagonistic perspective.

Indonesia is in G20, Brazil, Egypt, India, China, some of the biggest generic manufactures who have opposed any tightening or even the existing standards of patent protection for the pharmaceutical industry.

Are you aware of any kind of idea what might float at the a Canadian summit?

BRANSWELL: No, I'm not. I'm afraid I'm not here. I don't know about you, but again I share -- I was going to say pessimism, I guess maybe skepticism would be a nicer word. I think these are really tough issues and I'm not clear how much political will there will be going forward on this.

I share the concern of the man from Save the Children that we can't want a more severe pandemic. I'm delighted that this one is playing out the way it is, but I think that one of the things that's it's doing is creating in the minds of most people, and most taxpayers, perhaps that pandemics are not necessarily such a big deal, that we have been over-hyped them, that they're not as scary as we thought or that modern medicine.

The argument that we heard about 1918 that if we had modern medicine in 1918, it would never have been severe as it was. I think it's sort of being overlaid here, and people are saying, oh, well if you have -- (inaudible) -- and ICU's and what not, you're going to be fine. You can get through a pandemic, and I wonder whether the lesson going forward will be we found all these holes because we have found tons of holes and as you pointed out in the beginning when we discovered that we were -- we thought we were preparing for the worst case scenario and actually in fact we are not prepared a very mild pandemic, but I'm concerned that people won't take that lesson going forward, that they'll say, you know, we spent a lot of money. We threw away a lot of vaccines. We've had a pandemic. Another one isn't coming for another two or three decades, let's move on.

GARRETT: Well, the -- you know, Ambassador -- (inaudible) -- that there's about 12 panels advising WHO right now. I know one of them has to do with control of message.

They're -- you know here we have a situation where unlike in 1976 and certainly unlike '68, '57, and 1918, we have the Internet and we have the ability for claims, counterclaims, light insanity to be transmitted globally overnight.

I was in a meeting at the Institute of Medicine where one commissioner of health from New Jersey stood up and said, "Look, let's be frank about what we're up against. The odds are that some woman somewhere in the world will have a miscarriage the same day she gets a flu shot.

BRANSWELL: Actually, that could be 1,000 women; it's not going to be one.

GARRETT: All right. It's a statistical probability, and since we're targeting pregnant women specifically to get vaccinated, then all it will take is one lawyer or a talk-show host or whomever it may be to go on the Internet and start screaming and WHO has lost control of the message; your local health commissioners have lost control of the message.

BRANSWELL: (Inaudible) -- here have control of the message now.

GARRETT: Talk about that.

BRANSWELL: I mean, the blogosphere is going crazy about this vaccine. I mean, that's another -- if you want to talk about concerns going forward, I'm really concerned that this campaign, this biggest probable vaccination effort ever could be -- you know, if anything goes wrong, and things will go wrong -- and whether or not they have anything to do with the vaccine or not, thing are going to go wrong and it could have enormous repercussions for people's willingness to be vaccinated against any number of things.

And if we don't -- in the developed world -- if we don't buy vaccines and if our children aren't vaccinated, there won't be vaccines available for the developing world.

GARRETT: And if you think about it in the context of countries where the capacity to control messages is even more difficult, for example in Africa, we've already seen how going to the Internet prompts an e-mom to say that polio vaccines have HIV and/or a sterilizing agent in them and now we have lost ground on our attempts to eradicate polio worldwide, which is -- and if there's a claim of a health effect in, let's just say Germany, is that likely to resonate around the world and even into the poorest countries of the world, so that we have a globalized sense of incorrect threat, incorrect perception?

BRANSWELL: Certainly. I mean, it's very, very possible. The probable being, you know, something happens that they're looking for. In '76 I think the problem was that nobody knew what the baseline rate of GBS was -- (inaudible) -- syndrome. So when all of a sudden people said it seems like the rate is higher you had to answer the fundamental question, what's the baseline rate?

I think now they know that so they might be able to say, "Okay, this is just actually normal or just maybe if something increased" -- but what if something we're not anticipating happens, something out of left field, like the multiple sclerosis and those Hepatitis B vaccination program in France. If something that you wouldn't think of materializes, and people are starting to say, "okay, so what is the baseline rate for that in children?" And nobody really knows. It's going to take, I don't know, years?

And maybe, as Mike mentioned in the earlier session, people won't know the answer. But at any rate, if something materializes, the decisions, the blogospheres will go crazy and will connect it, cause this. The scientists will spend weeks, months, whatever, trying to figure what has caused this. But the public will make up its mind in the interlude. It's going to be a real problem.

GARRETT: Last question to you before we open up to our audience. The United States would be perhaps in a better position to look like a global player. Your boss Tadataka Yamada, has suggested -- and many others have as well, if we were willing to do what Canada and all of Europe and Japan have done, which is use adjuvants to stretch out the efficacy of our limited antigen supply so that the vaccines, any given amount of antigen could go to 10 times more human beings, therefore greatly expanding our vaccinations capacity.

That would mean that then we would be in a position to not donate, say 10 percent of our vaccine supply, but perhaps 90 percent of our vaccine supply, to developing countries. The United States stands alone among rich countries where it's using to entertain that. And off the record, most the folks at FDA say it's because of the antivaccine movement and fears that people in this country who want 100 percent safety will never allow an adjuvants to go in, even though it means your denying any vaccine, even a one in a billion risk factor vaccine, to the majority of the world population.

How do we resolve that, and can we continue to give a message that says we are a global player if we continue to also refuse to stretch our vaccine supply?

LANGE: I mentioned earlier the poll is principle to guide allocation of pandemic vaccine and one of those principles was to try to develop a consensus on the safety and efficacy of the use of adjuvants. But it has been very difficult within the U.S. government and the Food and Drug Administration to get approval for that and acceptance for the reasons you said.

From our perspective at the Gates Foundation, that is a very important aspect to be able to allow much more that's in production because, as you pointed out, even a -- (inaudible) -- times much vaccine available. And therefore it makes it easier for developing countries to receive it. But it was clearly focused on domestic issues here in the United States in terms of the decision that was made on this. Whether that means the U.S. government isn't the global player that it should be, I'm not so sure because I've heard of other ways in which the U.S. government has been forthcoming, including President Obama's effort with other countries the concept of up to 10 percent of the vaccine going to the developing world.

But it's a serious aspect of this and maybe as time goes on, there will be studies that will allow for the use of adjuvants -- even though the U.S. could change its policy? Could I just mention one other thing we do? We talked a bit about Africa, and if you look at World Health Organization's recent listings of the number of deaths from H1N1, you find the least number in the Africa region and it may be because it hasn't yet spread to certain parts of sub-Saharan Africa. But from my personal view, it's far more likely because of the weak surveillance system.

And there have been studies that show that in a severe pandemic the vast majority of deaths are likely to occur in the developing world, which have the weakest health infrastructures and the fewest number of ventilators, people with already weakened immune systems, et cetera. We talked earlier today about children and youth who are more likely to get H1N1, to become infected. Pregnant women is another concern from some statistics.

We don't know how serious this pandemic will be on a global scale yet. It may turn out to be mild all around the world, but you may find that the death rates are going to be significantly higher than anything close to seasonal influenza, serious problems in the countries that have the weakest health infrastructures. So we shouldn't make an assumption at this meeting that it's a mild pandemic, let's worry about the next one.

GARRETT: That's probably true but we probably have no idea in some of those countries what the toll from seasonal flu is. If they have weak surveillance, they may not know what the burden of disease for seasonal flu is, so we won't even have a totality. Even South Africa, which does have the strongest surveillance system on the continent, is having a hard time keeping a clear idea, partly because they're now in a third wave already of flu. One regular seasonal flu, then an H1N1 and now apparently H1N1 again.

And we've all been really hoping to get good data from South Africa so we'd know about the implications for people with HIV. Though it looks like they are at great risk, the numbers are still not solid enough to say much of anything. Let me open this to the audience, because you've all been very patient. And I'm sure you have many questions. And let me remind the tweeting crowd it's pound CFRQ&A, and that's the A -- ampersand, is that how you say that -- not write out the word and. Pound CFRQ&A. Please be sure to identify yourself when you ask your question.

QUESTIONER: Hi. Isaac -- (inaudible) -- New York City Health Department. How would you rate the vaccine manufacturers in terms of their strategies or activities in dealing with this shortage of vaccine in the developing world?

GARRETT: Anybody want to take that on?

(Laughter.)

When you say rate, what do you mean?

QUESTIONER: (Off mike.)

GARRETT: I think perhaps a way of putting it to you is one of the discussions was to move more manufacturing to encourage multinational companies to locate some elements of their manufacturing in developing-country areas. Has that happened?

LANGE: Well, there's an effort that was done through WHO for several years now called the Global Action Plan to increase pandemic vaccine supply. And there have been contributions to that from -- (inaudible) -- governments -- the U.S. government, Japan and some others have contributed -- to try to build the capacity in the developing countries.

And secondly, you have an effort on the part of Sanofi Pasteur and GlaxoSmithKline to contribute vaccine, 150 million doses, to the World Health Organization. WHO expects to receive that in the coming weeks, so that it can be used for the developing countries. And WHO has gone through an elaborate process, actually, to try to determine which countries are ready to receive it so that they have the delivery mechanisms in place, et cetera. And they've been working with the U.N. System influenza coordinator, Dr. David Nabarro, on this.

But in terms of rating the companies, it's a little difficult, because in the end they've been responsive to the orders that have come in.

GARRETT: Helen, did you (want to add ?)?

BRANSWELL: I know, in addition to the work that WHO has been doing, there's been some discussion of technology transfer to some of the developing countries. I believe Sanofi has signed a tech transfer agreement with Gutaten (sp) in Brazil, have they not?

So, I mean, I think there's some of that going on, but none of that work happens very quickly. It's laborious, long, legal negotiations. And building and certifying a flu vaccine isn't a quick enterprise.

GARRETT: We've got another question in the back.

QUESTIONER: Hi. Isobel Coleman, Council on Foreign Relations. Thank you both for your very interesting comments.

My question is about lead time, or lag time, I guess. If we, in fact, find out that the flu is more severe in some of these developing countries and the death rates are higher, is it possible at that point to take some of these unused vaccines in Canada and the United States and move them at that point to the places where they're most needed, or have they kind of missed the window if that, in fact, emerges?

BRANSWELL: I think that's a two-part question. One, is there a political will in mobilization capacity? And two, on the ground, is there a distribution capacity?

I would jump in with this -- and I think there's a more complex answer that Ambassador Lange can give you. But it will depend on who owns the vaccine at that point in the distribution process. Canada has the first stream coming out of the plant in Quebec City and is buying its vaccine.

If by, say, December we decide we don't need 50.4 million doses, we're going to turn back 25 million or whatever, then GSK starts delivering to the next person on that list. And at that point, I guess it's whether that country is willing to give up a share of their vaccination delivery to pass on. I don't know. I don't know if --

GARRETT: (Inaudible) -- contractual.

BRANSWELL: Yeah. There are lots of contracts that have been signed, advanced-order contracts that have been signed. It's quite a shadowy process. There's not a lot of transparency. A lot of countries haven't really, you know, declared many of the details, whether or not they have options to put further orders in afterwards. And the Americans must have, because you ordered some and then you ordered a whole bunch more. But there isn't a lot of clarity about those contracts. And that, I think, will have a big impact on whether or not there would be available vaccine if things change.

LANGE: But there isn't a process going on that WHO is working on (with ?) contributed -- (inaudible) -- some pharmaceutical companies as well as governments. And the goal that WHO has is to provide enough vaccine for 2 percent of the population, focusing on health workers and other essential personnel. And they expect to be able to do that for all (but ?) the countries with the largest populations.

The idea then of additional vaccines after that would be for other people in the country, including women and others, who could go up to 10 percent. So there are systems in place. WHO is very much working on the logistics of this with various entities within the U.N. system to ensure that the vaccines get delivered and the governments themselves have -- (inaudible) -- systems for delivery to rural Tanzania or wherever the case may be.

And it strikes me that this idea of if there's some leftover vaccine, shall we say, in the spring in some of the countries in the northern hemisphere, that would fit into that same delivery system.

GARRETT: We'll take another question. Let's move over here. Charlie, you had your hand up.

QUESTIONER: Charlie MacCormack from Save the Children.

I'm going to ask the question I asked earlier in a different way, and this is about using this moment to strengthen the ongoing system. And it does seem to me, here in the U.S., it's pretty clear what works in strengthening systems, and that is essentially it starts with private-sector-driven campaigns and celebrities and websites and mass mobilization and social networking, and so on and so forth, with some pump-priming from the foundations that are most interested in all of this. And we've seen it with malaria and we've seen it with HIV, with breast cancer.

It seems to me this could be amenable over the coming several months to that kind of a campaign to get the pretty modest investments that would be needed in strengthening the ongoing system, because the one thing we do know is we're going to get severe pandemic influenza sooner or later. This is not your particular call to make, Ambassador Lange, but would the Gates Foundation and other foundations think about underwriting, priming the pump on a campaign like that?

GARRETT: Not to put you on the spot.

LANGE: It's hard for me to predict exactly what the Gates Foundation view would be on a campaign like that, but if I could give a personal perspective on this. In the period that I was the special representative on avian and pandemic influenza at the State Department, from March 2006 until February 2009, we had a series of international conferences on avian and pandemic influenza. And the first one of these actually was before I took over the position in Washington, D.C., and after that Beijing and Vienna, Austria, and on and on.

And the Egyptian health minister, before the conference that took place that the Egyptian government hosted in Sharm el-Sheikh, talked about flu fatigue. And he was concerned that the focus on H5N1 was waning and it was harder to get governments and various other entities to keep that focus on the pandemic preparedness.

So it seems to me that, in any kind of campaign that you are envisioning, you have to take into account it's not like malaria and HIV-AIDS and other issues that are present on a daily basis. It's preparing for something and you don't know when it will occur.

And, in fact, I used to give speeches saying that if we knew for a fact that the H5N1 virus would cause a global severe pandemic a year from now, we would be acting much differently and we would be writing our last wills and testaments and doing all kinds of things because of the possible 1918-level pandemic that would be so severe and kill so many people.

But we didn't know that, and we're fortunate now that it's a much milder pandemic we're dealing with. I think it is a wakeup call. I think there will be many actions taken that will put us better prepared. But we still have that fundamental issue to deal with of how much money can you put into preparedness when you don't know when it will occur.

GARRETT: Well, we always have that. I mean, when do you build the levees of New Orleans? Oops.

LANGE: After Katrina.

GARRETT: And it seems that you look around the world and you can see that all governments have the same, you know, problem anticipating a long-term risk and spending, without the risk materializing or the threat going to frank presentation.

You know, certainly China has undergone vast changes post-SARS. Its modus operandi before the SARS epidemic and even during it was cover it up; don't let the world know about it. There cannot be flaws in the health apparatus of the communist state. And then, oops, now we go to the total opposite. We're going to start screaming about transparency and being a global citizen.

We certainly had a shift in our U.S. government concern about flu at all, and bird flu specifically, after Katrina, right? I mean, the threat existed before Katrina, but Katrina pushed our government. Is that not true?

LANGE: The initial evidence for this came before I took that position, so I don't want to speculate on what the motivations were. But the whole idea of preparedness, you can look at it from an all- hazards perspective, all these possible things a government needs to prepare for and how we prioritize them.

And my personal view actually is governments don't do a good job of really objectively determining probabilities and then planning for those. There's a tendency that those with the biggest clout in the government can put more effort into their kind of preparations, what their biggest concerns are, not necessarily in looking at it in a broad perspective. "All right, if you're the head of state, what are the probabilities that things may befall us? And if that's the case, how do I prepare for them?" That broad objective analysis is something that's very hard for governments to do.

GARRETT: Back there.

QUESTIONER: Howard Zucker, former assistant director-general for WHO. And I lived through that for two years with the issue of intellectual property.

Actually, this question is for Laurie, but whoever on the panel would like to answer it. I'm really curious as to whether you believe that we can overcome the (inertia ?) of the issues of getting vaccines out there, even antivirals. The WHO announced this morning that, for all people who get sick with swine flu -- or H1N1, I should say -- that they should immediately get access to antivirals -- antivirals may not be available -- until there's really a crisis.

Having lived through this whole thing for two years -- '06-'07 -- and those meetings, it seemed that the intellectual-property issue is critical. And if we can overcome that, then we'll be able to get people to sort of get on board. I'm just curious -- (inaudible) -- the other members.

GARRETT: Well, my personal perspective has changed quite a bit on this issue. I used to think, in my naive days, that these could be incrementally negotiated, that one could take on a given patent dispute, a given equity dispute, and weigh the various concerns, finding an appropriate balance that would both find a profit center for the pharmaceutical industry, deal with sovereignty questions, and increase equity on the ground.

I don't think that anymore. I have seen it fail too many times. I think HIV was the aberration, not the new trend, in terms of widening access to ARV drugs. And I'm now increasingly persuaded that the whole question of equity of access to the benefits in the face of a health threat is part and parcel of equity of access to adaptive technologies and measures for climate change and mitigating energy- conserving measures for climate change.

It's part and parcel of the Copenhagen negotiations and a whole host of transnational-threat issues that find that, not surprisingly, rich countries are able to cope better than poor countries. And most of the coping mechanisms may involve some form of patented technology or a lack of technology transfer and private-sector interests that stand to lose a great deal of money, or at least market position, if access to the tools is broadened across a larger segment of the global population.

And therefore, I think that the answers weigh at a far higher level than the minutia-level decisions we're coming up with. That said, you know, Ambassador Lange has been head-on in these negotiations and may have some differences with my view.

LANGE: Well, it was very clear in the negotiations that we were engaged in through this WHO intergovernmental meeting that some countries were using the same arguments and had the same agenda against intellectual-property-right protection that they were using in other fora. And there were some other conventions, such as the Convention on Biological Diversity, that they were trying to bring into these discussions.

So you could not deal with it as a discrete case involving viruses with pandemic potential. They really have broader applications than this. But the problem is, if you're going to try to look at this holistically and bring in the things that you, Laurie, suggested, such as climate-change issues, et cetera, there is no one global body that deals with it. You're not going to have some broad magic solution on this.

One of the things that I was asked at one point when we were involved in these negotiations is regarding the sharing of samples and the sharing of benefits. Were we coming up with some tinkering, some small changes to the global system and WHO's Global Influenza Surveillance Network, or was it a fundamental change?

And in the end, countries, including the United States and like- minded countries, would not accept fundamental changes. They wanted the tinkering and were happy to be helpful in that regard, but it was tinkering. Whether there will ever come a day when fundamental change occurs, it's very hard to predict. But if you really look at what's going on and what has been going on in these negotiations, it's very hard to see a consensus building for something beyond the tinkering.

GARRETT: Well, I think it kind of -- it's interesting; we sort of see us coming back full circle. Secretary Rubin asked, you know, "Can the U.S. government say that I shouldn't get a vaccine so that there will be some for somebody off in Indonesia?" Charlie MacCormack asked, "Can we not mobilize some sense across a broader range of public outside of government that these sorts of issues need to be addressed and that there need to be kind of global solutions?"

And I think we are at a kind of frustrating spot with all of this where there isn't an easy immediate solution, though there are symbolic gestures -- or a little better than symbolic -- such as the Obama administration pushing to have the 10 percent of vaccine donated. And one would hope that Canada will join the symbolism at some point. (Laughs.)

BRANSWELL: Now I know why I was asked to be on this panel. (Laughter.)

GARRETT: I'm blaming you personally. But it does seem like we're taking on something much larger than we can possibly resolve beyond that sort of, as you say, tinkering level at this time.

Did you have anything you wanted to add to that, Helen?

BRANSWELL: I guess I just think of -- well, I'm not really optimistic that many of these things will be solved in the short term. But, you know, it's the issue of my self-interest, and how far does my self-interest expand? And when is it in my interest that your interests are met? You know, do I feel it's okay for me to forgo getting a vaccination so that somebody in Indonesia can get it? I don't know. I mean, I think those decisions are made in the heat of the particular moment, and it's hard to sort of create a paradigm that will fit all circumstances.

GARRETT: (Inaudible) -- I had H1N1 in early September. And I was talking to Tony Fauci, who runs our National Institute of Allergy and Infectious Diseases, and I said, "Shouldn't we maybe consider, if we're not going to have enough vaccine in time to address the peak of this outbreak in North America, shouldn't we consider possibly saying that everybody like myself that has had H1N1 should not -- should voluntarily not get vaccinated, assume we're naturally vaccinated, and for the sake of the greater good we won't get a vaccine?" And he said, "Well, no, because, first of all, you're not in a risk group, so you shouldn't get the vaccine anyway." I said, "But I have it, so I must be in a risk group."

And secondly, (he ?) said, "Well, we would never be able to handle the liability question. How do I know you definitely had that virus?" and so on. "So we can't make those recommendations." But as you go down the path, how do we get an altruistic sense that is also mixed with a sense of shared risk, shared benefit for the global community? And that is our challenge.

We have time for one last question. David.

QUESTIONER: Hi. David (Wills ?). Really interesting issues.

I thought the point that you were talking about -- do countries, particularly poor and middle-income countries, decide to allocate health resources in this versus other, you know, horrible challenges? If you look at what happened with India just in the media recently with H1N1, they were closing down malls. There was a sense of panic. Yet in the coverage, if you followed it, in some of the newspapers they reminded that "So far 20 people have died from H1N1 and a thousand people are dying every day from TB, basically."

What you see in the global health community is, kind of, some people who are working in different diseases, kind of, roll their eyes. They're like, 'Okay, H1N1, look at all the money that's going in it. Is it really cost-effective in a time of horrible challenges and financial (questions?' ?).

(Inaudible), the point that you made is, how do you, how do you advise countries, and how do we, as a global community -- not just the people who are passionate about pandemics, and the threats, and the true believers; I suppose you could put the AIDS activists on the other side, who really believe that their disease needs to go first, that it's the greatest threat to humanity -- how does a country fairly allocate, based on what you said are the risk probabilities, to make rational decisions, understanding that it's a guesstimate, you know, (taking into some account, that is, ?) and you publicize that, that 'we don't have all the answers. We're making allocations' -- risky.

And the second question is, I'm fascinated by the example of Indonesia -- kind of, maybe it's the lawyer in me, or whatever, saying, okay, this is part of our intellectual property and we don't want to see these samples used to develop products that help people in New York get vaccinated against an illness, while our people have no chance of it.

And I think one of the lessons from AIDS, and from other diseases, countries that do take aggressive measures, even when it offends our sensibilities sometimes, there's some benefits to that. So I was wondering if the panelist have any -- is there any examples in any of the middle-income countries, and the emerging countries, and in the -- (inaudible) -- poor countries that you think have been somewhat modeled, or have tried to deal with this in a way that we can look --

GARRETT: Well, Ambassador Lange, you spent a lot of time in Botswana. There's a country that's grappled with setting priorities more clearly for health than just about any country in the world right now.

LANGE: Well, in Botswana, from the time of President Festus Mogae onward, has really shown tremendous leadership in dealing with this huge HIV problem that they have.

But actually that brings up one of the difficulties I had in my position in the State Department, when one could go to a health minister in Sub-Saharan Africa and say, 'I know you're dealing with your people dying from AIDS, and your people have malaria and tuberculosis,' and maybe it's -- and maybe polio, and other things, 'but what you really need to do is to prepare for a pandemic influenza that may or may not occur in the next decade.' It's very hard for them, in their very resource-constrained environment, to do the preparations that were possible and necessary, I believe, in much richer countries, such as the United States.

There's no easy formula for figuring out, how do you deal with these possibilities. But all you have to do is read books about the 1918 pandemic to realize that a severe pandemic would just be a disaster for the world, and a catastrophe, and you could have tens and tens of millions of people dying in it. So these are not easy efforts and decisions to make.

But one of the things that I had hoped to do in my efforts -- and I think we've succeeded to some extent, was to do our best to ensure that even if there were no pandemic, the monies had been spent for good purposes; not 100 percent of it, because some of it actually was spent to cull chickens, in terms of the avian flu that was going around; and if you cull chickens and reimburse the farmers, you're back to zero; you haven't really gained anything -- but to build laboratory capacity and surveillance systems.

And I remember talking to some of our U.S. government experts in Nairobi, who were working regionally, and they had a built-up capacity to monitor for what had been the concern of H5N1, but it also had that laboratory capacity, and training that was done, et cetera, had much broader capabilities.

So the more you can build your structure to withstand these shocks, wherever the shock may be coming from, the better off you are. And that, I think, is one of the answers to how you deal with these potentially catastrophic events such as a severe influenza pandemic, but you don't know when it will occur.

GARRETT: Now, as you were saying this, and as David was asking his question, I had two thoughts in my mind at the same time and thought, oh, my goodness, if I was the minister of health of South Africa, how would I balance these two thoughts:

On one side, you have the world's largest extremely drug- resistant TB outbreak, and your scarcities of supplies is so great that in the key hospitals -- (inaudible) -- nurses are issued an N-95 mask and they are required to wear it for 30 days -- the same mask. Anybody that's ever worn N-95 knows that'd be pretty horrible. And the risk to them, of course, is extreme, because the mask deteriorates, and so on.

In contrast, you may say, well, this H1N1 thing is all kind of overblown, compared to our HIV catastrophe, and TB, and so on and so forth, but the historical record shows -- now that Chris Murray's (sp) group, and the University of Michigan group have really gone in and parsed the data that we could find for developing countries, shows 1918, the low-ball estimate of 30 million dying in 1918 and 1919 was based on the rich world; and that when you really start looking at what records we have for South Africa, and India, and handfuls of other countries we have records for, a figure closer to 100 million is probably the reality.

So if I'm the minister of health, or if I'm a USAID director trying to figure out where to allocate resources -- we don't have one, by the way, allocate resources to help poor countries, I would have a tough time, day in and day out, balancing those two.

(Pause.)

BRANSWELL: Absolutely. I mean -- (laughs) -- what more can you say, really. There are no answers to that one, I don't think.

GARRETT: Do we have any tweet questions? Apparently not.

Hi, tweeters. Apparently, you're not chiming in.

I could take another question or two from the audience. I was looking incorrectly at the clock.

Here you go.

QUESTIONER: Ryan Scalise, from Control Risks Group.

Just curious to determine -- and, by the way, thank you all for your comments, your insightful comments, wanted to know what your thoughts were on the prospect of the private sector, and their role; what role they can play, in terms of the surveillance effort, globally. There are infinitely more multi-national corporations in the world than governments, although governments have the primary responsibility for dealing with these issues -- public health issues.

It strikes me as, it's interesting that companies that are operating internationally have an obligation to -- a "duty of care" obligation to protect their employees, as well as being mindful of the operating environment in which they're in. What sort of role, how could this go forward, and what sort of private-sector role do you see in that effort? Thank you.

GARRETT: Let's break this up. There's two pieces to that:

One is, what duty to report may there be, or role may there be for multi-national companies to report interesting infections, or what have you, among their labor force, even in far-flung places; and even if the government, in a far-flung place is not interested in having that reported?

BRANSWELL: Or if their competitors aren't -- would get a leg up if they acknowledged that they've had problem going on.

GARRETT: A very good point.

And the second would be the question of -- how did you phrase it exactly, it was "engaging, as a global citizen, in preparedness in developing policy?" Is that what you were getting at?

QUESTIONER: (Off mike.)

GARRETT: Duty and care to protect your own employees?

QUESTIONER: (Off mike.)

GARRETT: And so it seems --

QUESTIONER: (Off mike.)

GARRETT: Okay, you're off-mike for the Web cast, so I'm going to cut you off.

(Inaudible) -- just put it this way, that we've seen in the HIV experience a lot of private-sector sense of obligation and duty in both these areas has arisen. We have the Global Business Coalition on AIDS, Tuberculosis and Malaria, which I believe is now about 280 corporations around the world. And it's both a duty to develop a strategy for your own employees, to protect them, and then it ends up also being engaged in the activities of the communities in which your company sites may be nested.

And certainly in Botswana you had that with several external company players on the ground in Botswana, feeling they had an obligation to provide treatment to their employees for HIV.

LANGE: There were various activities the U.S. Chamber of Commerce, through their international focus, had been doing a lot with multi-national corporations that were trying to prepare for a pandemic. And you can look at various ways in which the private sector, because of the concern for their employees, were dealing with, and engaging in some pandemic preparations, (coming at the ?) personnel policies -- what do you when people are sick? You don't want to have people coming to work because they show an obligation to do so. If they're sick, you want them to be home. And then you give them sick leave. It gets very complicated, very quickly, as we heard earlier, about some of the Department of Labor issues here in the State of New York.

So there were various efforts, over the last few years, to deal with these issues, but I have to say that I had the general impression that the larger multi-national corporations were focusing more on this than smaller companies; and that the smaller companies had much more difficulty trying to devote the resources to this kind of contingency planning when they weren't sure when or where it would occur.

So there is a role, clearly, for the private sector in its own pandemic preparedness. And as we learn the lessons from the current H1N1 pandemic, I would expect additional opportunities to come up, in various, as we try to -- to whatever extent the world community can do it, to build better preparations for a possible future pandemic.

Could I say one thing on something that no one mentioned earlier, about the self-interest issue? I would hope that, coming out of this H1N1, governments would realize that there is going to be an expectation of a contribution of vaccine to developing countries, just as 11 countries have now made clear they will do for this current pandemic; that in the future they -- well, it's a different situation than had existed in the past because of the precedents that are being set right now, and, therefore, the calculation of self-interest will be different.

If you knew that you would be expected to provide vaccine for the developing countries, how would you deal with this if you had a severe pandemic coming about in your -- the United States or another developed country? Maybe then you'd say, well, let's help (for ?) laboratory capacity in developing countries, or maybe we'd so some advance purchases, or whatever. But if you -- the self-interest could be a different calculation in the future than it was in the past, because of precedents we're setting now.

GARRETT: Okay, interesting point, but it could go either way. As Andrew Jack pointed out, you know, the pharmaceutical industry gets a kind of expectation and pressure on them that isn't on -- I think the example you gave was Citibank. Nobody expects Citibank to give out free money from its ATM machines in Africa, but Novartis may be under pressure to give out free drugs in Africa.

And, of course, the retort that the industry would make is, 'We can't afford this. You're pushing us to the wall.' But I saw a report in the Wall Street Journal estimating that GSK alone is going to make about a $3 billion nut off of the H1N1 vaccine. So that doesn't sound like 'pushed against any wall.'

I think we're heading into a confrontation in this area. And where this will sort out is going to be really tough. I don't think that you can say to the industry, 'You should now have an expectation, every time you make something, that you're going to have to ultimately give away some of it.' (We don't think ?) industry will play that game.

BRANSWELL: I actually think the paradigm is shifting as a consequence of the Indonesia situation. It used to be that the vaccine manufacturers got viruses for free. They didn't pay. They were developed for them -- (inaudible) -- and that was the way it worked.

I don't think that's necessarily going to be the way it is, going forward. I suspect that there's going to be an expectation of a quid pro quo of a sort. And I don't know if -- not suggesting that that means, you know, you're going to get -- 'You want the -- (inaudible) -- (strain? ?) Okay, here's what it costs.' But I think that there's going to be an expectation that industry has a role to play in this kind of response; and, by benefitting from the continual share of viruses for seasonal vaccine, that there's going to be an expectation (of something before very long. ?)

LANGE: I'm not so sure that the quid pro quo, though, is going to come forward. In part, because Mexico, which had been -- in the negotiations, been kind of an intermediary between those who were very much insisting on the control of the virus, versus others who thought that it should be given freely to the -- (inaudible) -- surveillance network for the benefit of global public health.

Mexico, it's my understanding, has now been much more forthcoming on 'we've got to share it for the benefit of everyone' -- it does benefit global public health. So if you look at the very strong and positive responses from Mexico, when they first discovered H1N1, I'm not sure the world would move toward that quid pro quo requirement.

BRANSWELL: Maybe I shouldn't have characterized it in that way, but I do believe that WHO is -- (inaudible) -- that there is an expectation that there will be -- that this, you know, the donations into their funds are not going to be a one-time thing.

GARRETT: Well, that's quite a note to end on. And I'm afraid that we are out of time. This concludes the Web cast and our basic meeting, jointly sponsored by Science, and the Council on Foreign Relations.

I want to say, on behalf of the Council on Foreign Relations, that Science has been a wonderful partner to work with. We hope that we'll have an opportunity to partner again in the future; and that the staff, both here at the Council, and at Science, and the American Association for the Advancement of the Sciences, have performed in stellar fashion in pulling this very ambitious event together.

I want to once again thank Richard Brown (sp), who made a kind donation that helped subsidize this event.

This concludes the webcast.

For the rest of you, we will now have lunch, and you can continue your discussion on an informal basis. Thank you very much for joining us. (Applause.)

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