Effect Measure

Indonesia’s health minister, Siti Fadilah Supari, has answered the question whether the recently concluded Geneva summit on sharing of influenza viruses had produced sufficient agreement to induce that country to begin sharing again. Her answer seems to be “no”:

Indonesia’s health minister reiterated Sunday that she would not send bird flu specimens to the World Health Organization, saying poor nations needed assurances that any pandemic vaccines developed from the virus would be affordable.

Siti Fadilah Supari made the comments on her return from Geneva, where the WHO held an intergovernmental conference aimed at rebuilding a global system for sharing flu viruses following a months-long standoff with Indonesia.

“The meeting failed to come up with a material transfer agreement,” she told reporters in the city of Bandung. “So we have no obligation to send bird flu virus samples to the World Health Organization.” (AP via Jakarta Post)

This is a result Ed Hammond warned about in his detailed dispatches from the meeting (here, here, here, here, here and here.

Does this mean failure? Only if you view the Indonesian sharing refusal as the sole and only issue on the table. But as Hammond argued persuasively, there were shifts in position by the US and EU on other issues, shifts that may produce important changes in the influenza surveillance system. Those changes are important in themselves and they may also bear on the Indonesian response insofar as they isolate Siti Fadilah Supari’s intransigence. The strength of her position to date has been that it highlighted a genuine problem that Indonesia shared with other developing countries. With an interim agreement and plan to move forward, Indonesia’s sometime allies may split from the intransigent position the Indonesian Health Minister has taken.

This also puts pressure on the follow-up negotiations to make good on the potential for progress. If they scuttle the follow-up they will wreck the Global Influenza Surveillance System. The blame will then clearly fall on the US and EU.

Update, November 26, 2008: This report from Nature News corroborates Ed Hammond’s earlier dispatches. Remember, you heard it here first:

A deal is being negotiated that could see Indonesia end its policy of withholding samples from human cases of avian flu.

[snip]

Indonesia says it will share samples under a material transfer agreement that allows research use, but gives Indonesia sovereign ownership of the samples. The country also wants access to vaccines developed using its samples. An international meeting on 20?23 November in Geneva, Switzerland, ended without agreement. But a statement, still being thrashed out by negotiators, is expected to open the way to concessions. (Nature News)

Comments

  1. #1 Pixie
    November 26, 2007

    The US/EU and the developing nations may eventually come to an agreement. However, it’s neither the US/EU, nor the developing nations, that research, develop, produce, and distribute vaccines of any kind.

    Those national entities, and supranational entities such as the WHO, can create all the guidlenes or laws that they like. It’s still up to the vaccine manufacturers to decide whether or not they will take the deal, and whether or not it’s going to be worth it to them, as profit-making entities, to make this or make that instead. Vaccine manufacturers may just decide that they’d be better off devoting their resources to producing something else.

    It’s not as if we haven’t had problems with this before, and those existing problems should inform all of our strategies going forward:

    “In recent years there have been many significant disruptions of vaccine supplies. Between November 2000 and May 2003, there were shortages of eight of the 11 vaccines for childhood diseases in the United States, including those for tetanus, diphtheria, whooping cough, measles, mumps and chicken pox.

    Many drug companies in the United States have abandoned vaccine production in recent decades, saying vaccines were expensive to make, underpriced and therefore not sufficiently profitable. The production, sale and distribution of vaccines are handled almost entirely by pharmaceutical companies.”

    http://www.iht.com/articles/2004/10/17/news/flu.php

    Even a simple change in accounting rules was enough to endanger the US Pediatric Vaccine Stockpile:

    http://www.washingtonpost.com/wp-dyn/articles/A59516-2005Apr16.html

    The national reps at the table in Geneva can talk all they like, they can even reach any agreements they like, but if a deal is not struck that is attractive enough for the manufacturers, the reality is that they will continue to abandon vaccine production.

  2. #2 M. Randolph Kruger
    November 26, 2007

    Annnnnd from waaaaay out in right field comes Pixie! That is what I pulled from the convention and you hit one to the 429 line! Its also one of the major problems with UHC as well. What if the purveyors (doctors, hospitals, medical equipment, vaccine and pill makers) dont take the deal? The time to haggle in something like BF alone to manufacture it is equated in lives. In UHC it would be a slow grinding equivalent but unlike the purveyors of everything but pills and vaccine, you likely would see those guys looking for liablility caps, disclaimers, the usual, “Caution: The Surgeon General of the United States has to say in all good conscience that this vaccine for xxx might just kill you. ”

    I am verbose sometimes (well a lot of the time), but this covers this pretty well Pixie. I can only hope that Supari goes back to Indonesia and has a pair of handcuffs waiting on her. Not so much for virus sharing, but corruption. She is now a political liability in Indon for Habibie and the people there apparently hate her worse than Hillary at a Republican fundraiser.

    Time will tell. If BF jumps up then they will be SCREAMING for help. If not it gives her time to regroup.

  3. #3 the Doctor
    November 26, 2007

    It would be best if everyone shared but obviously that is not happening. It appears to me that positions on this issue are hardening rather than otherwise.

    Since pandemic influenza will be everywhere about a month from its achievement of efficient H2H anywhere, all nations will have an abundance of domestic samples for vaccine development. What’s more, these samples will be the real thing rather than the antigenically distinct precursors currently circulating. What those with the means must focus on now is not wringing their hands over this issue but focusing instead on being sure that when H5N1 becomes pandemic a truly efficacious vaccine can be produced as rapidly as possible.

    Grattan Woodson, MD

  4. #4 SusanC
    November 26, 2007

    Well, there are lots of useful insights coming out of this meeting, and a lot of important issues that at least have gotten onto the table, to be dealt with more thoroughly.

    But the bottomline is, this is NOT, has never been, a virus sharing issue. It is a vaccine-sharing issue.

    Or rather a vaccine production capacity issue.

    What the Indonesians want, is vaccines. Unless someone can find a way of getting them vaccines, they are not going to give. Everything else, is important, but is extraneous, IMHO.

    Since the Indonesians don’t have the $$$ to pay to build vaccine plants nor the expertise on their soil to get then going, they play the only hand they can get.

    The only way to solve the impasse is to massively increase global production capacity AND at low cost. And that is only possible with new technology and abandon the egg-based system, which at the moment is being propped up by the mantra of ‘increasing seasonal flu vaccine production capacity in order to meet the needs of producing pandemic vaccines’.

    Well, guess what? The shortfall is so astronomical that only the most blinkered will continue to pretend that it is a viable goal.

    As long as western governments, (and the WHO) continue this pretense that increasing seasonal flu vaccine capacity is the way to go, the system will continue to favor existing companies that dominate the seasonal flu market.

    These big companies have the correspondingly big dollars to pay lobbyists to cover every single part of the US government that has any part to play in these decisions. And if these same companies happen to NOT be the front-runners for the most promising cell-based technologies? Tough luck for the whole world!!

  5. #5 The Doctor
    November 26, 2007

    I agree with Susan. It is incomprehensible why those with the means have not caused a revolution in the ability to produce influenza vaccine. It is painfully obvious that the only people with “the means” are the developed nations. What is also obvious is that we now live in an interdependent world and a catastrophe in the 87% of those living outside the developed world will not be well tolerated by those living in the developed world. Even if there was no economic self-interest in providing an efficacious vaccine blanket for those living in the third world, there would be an even more urgent ethical reason. We can do this but if we fail to do so we risk being complicit in the perishing of half of humanity, The cost of Dr. Osterholm’s “influenza vaccine Manhattan Project” is incredibly small compared with the losses we will all face from the coming pandemic.

    Grattan Woodson, MD

  6. #6 M. Randolph Kruger
    November 27, 2007

    You know guys that the vaccine production capability has come up time and again. WADR Susan and Gratt I am told it would cost upwards of a billion bucks by Dr. Webster and there is NO guarantee that said facilities would work. The process is known but the conundrum is that we can do it on an extremely small scale now and the costs for that alone are enormous. To build a facility for BF it would have to be able to make “boutique” vaccines to be cost effective, pre and post panflu.

    Therefore, those same facilities funded by someone else in Indon if there was one based there would give them the keys to the city so to speak. And patents. Stockholders would revolt and throw the corporate bums out across the planet if they bought into that. They are corporations, not the Red Cross. Nor will any country in the business of vaccines fund it. They arent stupid, just greedy.

    Look at this way, on one hand you get vaccines and the world survives, on the other you lose your grip on what you do as a vaccine maker. Who has the technology to do it besides the vax makers?

    Then there is the other thing. Vaccines are great but how much money is in them such as seasonal flu vax? Zip as best I can tell due to the costs, chances that no one will take them, liabilities. Net is less than a buck or so. On the other hand if you are able to make a fast vax for BF and in quantity, what would you pay to get one if it was dropping them like flies in your country?

    Here’s something. The UK has made a decision to vax everyone in the country and its based on the latest and greatest seasonal flu and a bit extra that they have. Okay, but does it really DO anything for BF? What is the UK doing right now? They have moved to trivalent vax for everyone according to the news. So why are they doing that? Here is the possible answer.

    The UK is basically acknowledging Pandemic Level 3, Stage 1 for those of you who are not in the response business for this. So lets start to pay a bit more attention here and dissect that decision.

    Pan Level 3 is where we are but there is a sub-level to this. Stages 0- 5. The UK is effectively moving to Stage 1. Here are the equivalents under the US plan.

    Goals-Rapidly investigate and confirm or refute. Coordination and logistical support

    Actions-Initiate dialogue with WHO. Deploy rapid response team
    Amplify lab-based and clinical surveillance to region. Prepare to implement screening and/or travel restrictions from affected area

    Policy Decisions-Pre-positioning of U.S. contribution to international stockpile assets. Use of pre-pandemic vaccine begins.

    Now it kind of grabbed me a bit when I saw this. Its an open determination that they believe it IS coming IMO. Some may have another read on it. But indeed thats what this is. Do they have intel we dont? Dont know. But noted today from the WPRO web page that the graphics that Revere has posted from time to time has been removed. Conspiracy theorists could have a field day as a result. I did email them and request an answer as to why they did that. It could be an omission on their part. I will post that up as soon as I get it, or not. I expect a week. After that, they’ll be getting a phone call from me in the Phillipines.

  7. #7 anon
    November 27, 2007

    > Since pandemic influenza will be everywhere about a month
    > from its achievement of efficient H2H anywhere

    months from pandemic detection until 1% of people were infected in London:
    1918(1st wave):4
    1957:4
    1968:5
    1977:3(?)
    2004(Fujian):7(?)

    ———————————-
    The latest simulation by imperial college,UK assumes:

    2-4 weeks to build up in the country of origin
    2-4 weeks to spread from Asia to UK
    peak in the UK 50 days later, but less than 1% affected after 2 weeks
    (2 months in average until restrictions)

    and that is without any countermeasures, without seasonality

    90% reduction of air travel to UK : 1-2 weeks
    99.9% reduction of travel to UK: 2 months
    90% reduction of travel from countries with epidemics to all countries:3-4 weeks
    99.9% reduction of travel from countries with epidemics to all countries:3-4 months
    preventing travelors with clinical symptoms:1-2 weeks
    ————————————-

    in USA it seems to be slower:
    http://www.pnas.org/cgi/content/full/103/15/5935
    (my estimate:50% slower)

  8. #8 SusanC
    November 27, 2007

    WADR Susan and Gratt I am told it would cost upwards of a billion bucks by Dr. Webster and there is NO guarantee that said facilities would work. The process is known but the conundrum is that we can do it on an extremely small scale now and the costs for that alone are enormous. To build a facility for BF it would have to be able to make “boutique” vaccines to be cost effective, pre and post panflu.

    Um, I’m not sure that Webster is the best person to give a proper estimate of the amount of money needed to scale up vaccine production. Last I heard, he is not in the vaccine production business. Nor is it obvious to me what type of vaccine technology that calculation is based on.

    For example, with the recombinant haemagglutinin vaccine by Protein Sciences, a tiny company with only 20 people on staff, their own 10,000L bioreactor can make 1 million doses of 135ug rHA vaccine every 5 days. (Treanor et al, Safety and immunogenicity of a baculovirus-expressed haemagglutinin influenza vaccine: a randomized clinical trial. JAMA Apr 2007).

    Fedson and Dunnill estimate that the total world bioreactor capacity is 2 million L, with 60% located in the US. Even if only a fraction is diverted to producing this vaccine, the capacity is enormous.

    As to whether there is any guarantee that the process will work, sure, there is never any guarantee, but the baculovirus-expressed recombinant technology is already being used successfully for the human papulovirus vaccine, and the seasonal rHA vaccine in the Treanor study has completed clinical trials and is in the last stages before BLA submission. There is therefore reason for optimism, with the only obstacle being political support for stepping out of the existing status quo, of favoring current seasonal vaccine manufacturers.

  9. #9 M. Randolph Kruger
    November 27, 2007

    Susan, in context he might have meant that if you just went out and built it, it would cost 1 billion to cover the world that is if you didnt pull all of the other offline from what its already doing? I dont know on this one.

    Are they flipping out over that egret in HKG?

  10. #10 M. Randolph Kruger
    November 27, 2007

    Anon-is there a link to that progression from the imperial college? With the UK effectively moving from PanLevel 3, 0 to level 3,1 I wonder what the time of transmission would be if it started in country?

  11. #11 SusanC
    November 27, 2007

    Rand.

    Are they flipping out over that egret in HKG?

    Nah, they don’t scare easy, over there…

  12. #12 SusanC
    November 28, 2007

    anon

    The latest simulation by imperial college,UK assumes:

    2-4 weeks to build up in the country of origin
    2-4 weeks to spread from Asia to UK
    peak in the UK 50 days later, but less than 1% affected after 2 weeks
    (2 months in average until restrictions)

    A few things to note about the Imperial college study. This is from the supplementary information:

    Optimally one would model the seeding of infection in a single country (such as the US or GB), with detailed predictions of numbers of infected people entering the country from different foreign countries derived from a global transmission model. However, building a truly global model is a daunting undertaking. The best that has been done so far are a range of so-called ‘patch’ models which have modeled spread of epidemics in different cities and the transport of infection between those cities through air travel. That class of models have been used to examine global spread of the 1968 pandemic, and travel patterns were found to be somewhat predictive of the order in which cities were affected22. However, in that case the source was known, at least approximately (namely Hong Kong), and overall travel volumes were much less than today. Given the huge uncertainty about where the next pandemic model will start, the slight predictive advantage given by use of a patch model disappears.

    For that reason, we use a much simpler ‘global’ model here – one which just assumes homogenous mixing of the world population – a so-called SEIR model23 – a much simpler model than the detailed simulation used for within country spread. It gives reasonable estimates for the total numbers of infected individuals that might be expected to enter each country during a pandemic (as it matches expected attack rates), and is qualitatively reasonable in terms of how it distributes those infections over time. However, it cannot be viewed as quantitatively accurate in terms of the projected time course of infections expected to enter GB or the US (which depend on the details of which region is first affected and detailed connectivity patterns between countries).

    http://www.nature.com/nature/journal/v442/n7101/abs/nature04795.html

    The gem in all of this, is that the model is based on assuming homogeneous mixing of the world population, and ignore the fact that there are certain high volume travel hubs, or ‘connectivity patterns’ as mentioned in the article – Heathrow being one of them.

    Draw your own conclusions.

  13. #13 M. Randolph Kruger
    November 30, 2007

    First of all I cannot praise E. Hammond enough to head to Geneva to get the inside track of what was really going on. Expensive to say the least Ed. As most of you know E. Hammond, Revere and I disagree on many things but its all based upon information and he was sending out what the media wasnt…real news. It allowed for different bents to be taken on this and I commented to my wife on Turkey Day that I thought that Indon would clam up immediately on Supari’s arrival. Seems to be the case.

    But back to Ed H. He posited as did Revere that something productive would come out of Geneva and there was some working group stuff and some nuts and bolts but nothing substantial came out of it. It was as if I could hear Supari’s wheels turning from long distance and that is especially where Ed H. was most helpful. I got nothing from the news, only him and it was danged good stuff. It reminded me of some really shitty war game meetings and how we were going to do the other side. I called it in advance of what would happen but that didnt make me a seer, it was plain as to what the outcome would be because there was nothing to push the pharma people. In fact it was the opposite, it gave rise to the pharma people pushing their various representatives and I would have LOVED to have a mike in there when those vax and pill makers went in as part of the advisory NGO’s. Sorry Ed. we cant get it all, but damned good job old son.

    Since then I have consulted with my friends at a certain newspaper in Indonesia over the last few days and they say there has been apparently a deliberate move to suppress bird flu information going out. That seems to be true. I have hit every english translated paper, and some of the ones that are fairly easily translated using the computer but de nada, nothing, zip. A squatty reference here and there but nothing else. Bird flu has fallen off the planet in Indon. I asked my friends if they knew of anything and they said a police officer apparently has it along with his family but they are not allowed to interview anyone to confirm or disprove it.

    So what is Indonesias next gambit? They played their card at Geneva and were hoping that it would work in this game of Texas Hold ‘Em. It is a wild card at best and a deuce at the worst. The key here is that they might have something that useful and MIGHT is a very big word. It is Clade 2 that seems to be whacking people with some efficiency. If they contract it then pretty much they die (about 93% CFR) for the last quarter, but it doesnt seem to be escalating. That we know of…Thats the problem here. We dont know anything right now. Supari got brushed aside and with the demeanor and body language on Indon TV I would say she is royally pissed off. She has to use the class warfare thing to assert her point and from what I can see on this, she did and now she is silent.

    I paused today after hearing about the police officer and said to what end would this be not reported? For me it was to get get time to set up a situation. This is a Charlie Sheen/WTC of course but I am putting it out there now, so if it happens later we can call a big bullshit on it here and everywhere else if they do it.

    So lets see if I can put it out there for everyone to hack up and comment on. Please do hold this in your in basket for when we start the approach to the New Year. Things will be evolving rapidly then and likely with a media blitz.

    For Supari’s card to work, they have to have active BF in the country. We know that. They also have to swing world opinion to get what they want. This they havent been able to do.They have a lot of sympathy but they want the West to fund their step up onto the world stage. Later on they would compete with us. As for the regional facilities to produce vax the only way to do that is to have an actual or suggested escalating BF in Indon or some crazy bugshit virus like SARS appear on the horizon. Added to that you have to have an implied threat that it will get out. This they MUST have to scare the world via the media.

    They will also have to have control of that media and WHAT gets out to them. In other words they have to feed the media actual info mixed with hype. The WHO does all of the confirmations and it is to their advantage to allow it as it is a socialist group responding to a socialist state. Not a slam Revere, its just a throw out there for people to read. As for the “news”, since its such a hot topic they have to report it. Its a government. They wouldnt lie to us would they? They can report cats, dogs, chickens, humans in flurry of BF information or it might be BS information. We wont be able to know. Note this. For three days there has been zero info coming out of there so therefore I am positing this now so we dont get hammered later and buy into a lot of hype. Its almost perfectly set for a disinformation campaign right now.

    There is a problem with this. That is that perhaps they have been witholding information all along and that is a possible second card to play in the game. They are witholding samples we all know, but how about the number of cases? Do we really “know” anything. There seems to be a real disconnect down there on that. They are entering their vacation season for the people into Bali and Indon in general and they arent crazy. They report it now and they will stay away. They might hold it until that begins to wane in a couple of months and then flurry us with BF data, but still no samples. It is conveniently in July that they will meet again and the lead up to that during May and June might just be what I say a flurry of BS or BF.. Andrew J. was there for years and might have a take on this better but it is something to truly consider. Mind for the last six or eight months there has been SOMETHING coming out of Indon nearly every day. Now there is squat….Some may not find that strange… I do.

    Conspiracy Theory? Maybe, but its a lot more solid than the WTC deal.

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