Disaster/Pandemic preparedness

indigo girl · Nov 12, 2007

Did I miss something? I thought Tamiflu was ineffective in survival for the H5N1 strain. If so why the discussion on stockpiling or increasing the dosage amount?

If I understand your two part question correctly:

No, it is usually very effective, and very much so. Lots

and lots ofTamiflu being used in Indonesia now. It is so effective, that

it is possible that by giving Tamiflu quickly enough, it will cause a negative

test result despite the victim being symptomatic and having family

members having died with the same symptoms.

Now, I did say that it is usually effective, but there have been

resistant cases in Northern Egypt, and these people all died. This is

truly the great fear, that the more the drug is used, the greater the

chance of drug resistance. Eventually, this will happen, and that will

be a terrible thing because it is all we have, for the most part, and it

is what is being stockpiled nationally by many countries.

The discussion about dosage amount has to do with the most effective dose

being higher than was initially thought to be appropriate. Research says we

have to give more Tamiflu, and the problem is that this then decreases the

stockpiles and limits the number of effective

(according to the latest research) doses that can be given. Using more

Tamiflu means fewer people will get it because we do not have enough.

The article sited in the post to which you were referring is talking about

the UK's national stockpile. The US has even less of the drug stockpiled.

indigo girl · Nov 15, 2007

Another Truth Bites the Dust

This information is important:

http://afludiary.blogspot.com/2007/11/another-truth-bites-dust.html

Antivirals don't work if administered more than 48 hours after infection sets in.
At least, that's the prevailing `wisdom'.
Now comes a study that suggests that older patients in particular
might benefit from antiviral therapy for influenza, even after the first
48 hours.

This is useful information for now if treating for seasonal flu in elderly

patients, BUT if we are talking pandemic, older patients are not likely

to be at the top of the list for a scarce and precious commodity like Tamiflu.

The studies used to win regulatory approval for the newer flu drugs
showed they were of little benefit after 48 hours. But those studies were
done in otherwise healthy adults whose immune systems would have
kicked in to halt the replication of the virus by that point, setting them
on the road to recovery.
But this work suggests older people and people whose immune systems
can't easily combat the flu virus can benefit from treatment past the 48-hour
cut-off.
"It's clear from this experience now that there seems to be benefit
even with later treatment," Dr. Frederick Hayden, an antiviral expert
with the World Health Organization's global influenza program, said from
Geneva.
Hayden said the study will "add to the body of evidence . . . that
hospitalized patients warrant therapy if there's evidence for ongoing
(virus) replication."

indigo girl · Nov 21, 2007

A Day of Cautionary Statements

Dr. Margaret Chan, Director-General of the World Health Organization

continues to warn of the possibility of a birdflu pandemic while

Doctor Narendra Singh, the Pandemic Preparedness and Training Specialist of the Secretariat of the Pacific Community gives the same warning.

http://afludiary.blogspot.com/

"Vulnerability is universal,"
"A pandemic will, by its very nature, reach every corner of the earth, and it will do so within a matter of months."
Dr. Chan emphasized that this shared vulnerability calls for shared responsibility, and collective action to fulfil that responsibility. "In terms of the risk of disease, we really are all in the same boat," she said.
That is why the international community has an obligation to use the advance warning it has been given to prepare for a possible influenza pandemic...

indigo girl · Nov 21, 2007

Pandemic Mitigation:

Always remember, we are not helpless. We can prepare ourselves and

communities

Two good commentaries with excellent graphics from SophiaZoe's blog.:

http://birdflujourney.typepad.com/a_journey_through_the_wor/2007/11/pandemic-mitiga.html

http://birdflujourney.typepad.com/a_journey_through_the_wor/2007/11/pandemic-miti-1.html

indigo girl · Nov 22, 2007

From Effect Measure with permission:

The Editors of Effect Measure are senior public health scientists and practitioners. Paul Revere was a member of the first local Board of Health in the United States (Boston, 1799). The Editors sign their posts "Revere" to recognize the public service of a professional forerunner better known for other things.

The virus sharing puzzle

Category: Big Pharma * Bird flu * Infectious disease * Intellectual property * Pandemic preparedness * Public health preparedness * Vaccines

Posted on: November 20, 2007 7:23 AM, by revere

If a rogue H5N1 virus easiy tansmissible between people is to develop, the most plausible spot for it to happen is Indonesia, the world's fourth most populous with a vast reservoir of infected poultry (and who knows what else) and more human cases (113) and more deaths (91) than any other country. But Indonesia still refuses to share its human H5N1 isolates, contending they get nothing tangible from an arrangement which is likely to lead to vaccines they won't be able to afford. Under the current system, which allows intellectual property rights to cover vaccines developed from WHO supplied seed strains to Big Pharma, they are probably right. Their position is a grim example of how the crazy patenting system can come back to bite us. Of course Indonesia is acting with monumental selfishness, but they have some great role models in Big Pharma. What's sauce for the goose, is clearly sauce for the gander.
It's not just pandemic vaccine. The system in which Indonesia now refuses to participate also makes the seasonal flu vaccine possible. That system is now teetering on the edge. WHO and some member states will try resolve it this week at a four-day meeting in Geneva:
"The (WHO) secretariat is striving to listen to the needs of developing countries... Developing countries want access to vaccines on a long-term basis and we agree," David Heymann, WHO's top bird flu expert, told Reuters ahead of the talks.
[snip]
Jakarta has shared just two specimens this year, both from Indonesian women who died in the popular tourist resort of Bali in August, according to Heymann. China had shared samples from all of the human cases it had reported this year, he added.
"We have no specimens from the rest of Indonesia which we would like to have more so we can do proper risk assessment ... and preparations for vaccines," he said. (Reuters)
In Indonesia's corner are some who have been fighting for the rights of the developing world and are trying to make sure they aren't just forgotten as the rich nations see to their own first, leaving what ever crumbs remain to be divided up amongst the poorer countries. But their position and Indonesia's are not necessarily the same. The Indonesian Health Minister, Siri Fadillah Supari, is considered by many to be unstable and irresponsible.
And considering the issue as one of intellectual property rights is making everything exceedingly difficult. Indonesia is even claiming ownership of the virus under the Convention on Biodiversity:
David Fidler, an international law professor at Indiana University, argues the convention is meant to prevent outside exploitation of a country's biologic and genetic resources. That protection doesn't extend to viruses, entities affected countries are actually trying to eradicate, he writes in an article that will appear in the January issue of the journal Emerging Infectious Diseases.
But [sangeeta Shashikant of the Third World Network] sees things through a different prism. She insists the convention does cover viruses and in the current climate, H5N1 viruses are clearly a resource. "Without the virus you cannot have the vaccine. You could say it's a resource because it's what everybody wants now." (Helen Branswell, Canadian Press)
True enough. But does this mean that Indonesia should also share the liability for a festering environment that produced a global killer? This isn't a legal problem to be decided by how we porifice words on paper. This is a global public health problem.
So what to do? Our preferred solution is to remove it completely from the intellectual property arena, preventing any pharmaceutical company from patenting an influenza vaccine. If this means they won't invest in the vaccine business because they won't settle for a reasonable (as opposed to an obscene) profit, then there should be public development of vaccines through subsidized international vaccine laboratories and an effort to transfer vaccine technology to the global community by investing in a crash program of regional vaccine institutes (say ten or twelve). All of this should and can be financed by WHO or the UN from international contributions. Indonesia, with 230 million people, would be a logical site, with the condition and understanding it would be a regional, not just an Indonesian resource. Europe, the US and Latin America along with South East Asia, Asia and other regions should also have them. Technology for pandemic and seasonal vaccine should be freely transferable and without any intellectual property restrictions.
It is not clear this problem will be resolved. There is no reason it must be resolved, only many good reasons why it should be resolved. In my view, the international community is reaping the whirlwind of its profligate use of the intellectual property system and in some sense is getting what it deserves. Indonesia has the virus and we don't. They make the call.
But are most of the world who never benefited from any patents or monopoly practices by international drug cartels getting what we deserve? Not as far as I'm concerned.

indigo girl · Nov 22, 2007

With permission from Effect Measure and apologies as well as warning for

some profanity in this post. It is still well worth reading:

The Editors of Effect Measure are senior public health scientists and practitioners. Paul Revere was a member of the first local Board of Health in the United States (Boston, 1799). The Editors sign their posts "Revere" to recognize the public service of a professional forerunner better known for other things.

Day 1 of the flu virus sharing summit

Category: Bird flu * Intellectual property * Vaccines

Posted on: November 21, 2007 7:38 AM, by revere

The first day of the scheduled four day showdown in Geneva over sharing bird flu virus isolates is now over. What seems to have been accomplished is statements of opening positions. How moveable everyone is remains to be seen, as does whether there is an Alexander the Great around to cut the Gordian Knot (you can see the strands of the knot in some of our previous posts...
Here is Reuter's version of Day 1:
Indonesia, the nation worst hit by bird flu with 91 human deaths, has held back most of its virus samples and demanded guarantees that poor countries get access to affordable pandemic vaccines derived from them.
Speaking at the start of a four-day meeting hosted by the World Health Organization (WHO), Indonesian Health Minister Siti Fadillah Supari said developing countries were being denied their "sovereign rights" over bird flu virus samples sent to the WHO, a United Nations agency.
"We must have equitable sharing of benefits arising from the use of viruses through a fair, transparent and equitable mechanism. It is the moral thing to do," she said.
Jakarta has shared just two specimens this year, both from Indonesian women who died in the tourist resort of Bali in August, according to WHO's top bird flu official David Heymann.
Sharing samples is deemed vital to see if viruses have mutated, become drug resistant or grown more transmissible.
John Lange, U.S. special representative for avian and pandemic influenza, said "there should not be a one-to-one relationship between sharing of a particular sample and accruing a specific benefit".
"Countries that do their duty and share information and samples should not expect to receive something concrete each and every time they share," he said. (Reuters)
The Indonesian demand effectively wrecked the 50 year old influenza surveillance system used to predict what influenza A strains would be circulating in the next flu season and use isolates from them as vaccine seed strains for seasonal influenza. The isolates were given freely to WHO who made them available to researchers and drug companies for vaccine development. Usually no single country could be identified with a circulating strain, but with H5N1 the situation is changed. Indonesia has emerged as the world's hotspot for the virus although human cases exist in many other localities as well. None, except for China, has the resources of a developed nation however. So if a human pandemic strain develops from the current avian versions, it will likely come out of a particular country and Indonesia is at the top of the list of possibilities.
Because of the Indonesian position WHO has to revamp the old system and that is what the meeting is about. It was probably overdue, but prior to H5N1 the developing world was not much interested in seasonal influenza (although it probably killed many of their citizens). Now they are. And Indonesia's interest has taken the form of demanding something "concrete and specific" for providing the virus to the international community. In particular they want it recognized as their "property" and they want to retain intellectual property rights over it. Since 16 companies are now busy licensing pandemic flu vaccines, what Indonesia wants to do isn't so different. The US is one of the world's most vociferous defenders of a stupid and broken and dysfunctional intellectual property system, so they should support this insanity. But it all depends on whose ox is being gored. Here is how US representative Lange approached it:
Lange said countries must look beyond the issue of access to pandemic vaccine and have contingency plans for school closings.

"While important, such vaccines will not even be available until five or six months into a pandemic, and by that time the entire world is likely to have experienced the first wave of the pandemic," the U.S. envoy said in a speech.
[snip]
Research and development of new drugs and vaccines was "very risky, time-consuming and extremely expensive" and it was critical to protect patents to ensure their continued development. "We cannot accept any approaches that would undermine intellectual property rights," Lange said.
The US apparently believes the proper way to fight bullshit is with bullshit. Lange is saying the vaccine won't do Indonesia or anyone else any good anyway. So what's the fuss about? Let's get something straight. Under the rules of the market place, Indonesia is doing what the US and every other predator in the global public health jungle has been doing all along. They've got control of the virus, and as a sovereign nation they are insisting on their right to act like a bad global citizen, a right exercised by the US and many other nations whenever they feel like it.
If vaccine development is so risky and expensive, let's turn it over to an international collaboration outside the market system. Why keep it in private hands? Why is it OK for the vaccine to be in private hands with the price set by private parties but Indonesia can't keep the virus in its hands and set the price the way the drug companies do, by the highest bidder? Here's why: Because the stakes are too high to let the hidden hand of the market decide everyone's fate. That hand isn't invisible. It's hidden, by design and intent.
Both the US and the Indonesian positions are reprehensible. We should be saying so.

indigo girl · Nov 22, 2007

UK to Double Antiviral Stockpile

http://afludiary.blogspot.com/2007/11/uk-to-double-antiviral-stockpile.html

The UK was one of the first nations to actually stockpile enough Tamiflu to provide a 10-pill course of treatment for 25% of their population. The United States, in comparison, is still at least a year away from reaching that goal.
...Some scientists worry the virus could develop resistance to antivirals during a pandemic, rendering the remaining stockpile useless.
The traditional 10-pill course (2 pills/day for 5 days) appears to be inadequate for most bird flu patients. Clinical trials are underway to determine the most efficacious dose, with double the dose for double the duration (4 pills/day for 10 days) suspected to be a more realistic treatment regimen.
If adopted, this protocol would quadruple the amount of antiviral medicine each patient would require, cutting the number of patients that could be treated by the existing stockpile by 75%.
Added to that, the initial estimates that 25% of the population could be affected by an influenza pandemic have been called into question. Some scientists have put that number at 50% or more.

indigo girl · Nov 22, 2007

With permission from the editors of Effect Measure:

The Editors of Effect Measure are senior public health scientists and practitioners. Paul Revere was a member of the first local Board of Health in the United States (Boston, 1799). The Editors sign their posts "Revere" to recognize the public service of a professional forerunner better known for other things.

Day 2 of flu virus sharing summit: participant account

Category: Bird flu • Intellectual property • Pandemic preparedness • Public health preparedness • Vaccines

Posted on: November 22, 2007 7:37 AM, by revere

We have an on-the-ground view of the critical influenza virus sharing summit, provided by Ed Hammond in Geneva. I am promoting his comment thread notes from earlier today and a fuller account from late in the evening on Wednesday (Geneva time) sent me by email. It is clear that the atmosphere is tense and not convivial.
First, if you haven't been following the issue here or elsewhere, here's a bit of background from an excellent piece at Intellectual Property Watch (h/t Agitant)
http://www.ip-watch.org/weblog/index.php?p=832
The politically explosive issue of ensuring everyone benefits from vaccines in the event of an influenza pandemic is the subject of a negotiation underway at the World Health Organization this week. The work of the member governments calls into question a longstanding WHO system for global sharing of disease strains, and involves questions of limitations on access from patents imposed on vaccines, in some cases developed from flu strains shared under the WHO system.
[snip]
Under the Global Influenza Surveillance Network (GISN), countries are expected to send H5N1 virus strains from avian flu victims to WHO-operated regional collaboration centres. But this mechanism has been called into question by some developing countries, who suggest it may not be fair to them in case of a crisis.
[snip]
The government of Indonesia took a strong position at the outset of the meeting in favour of ensuring equal access for developing countries, and charged unfairness in the WHO system. Indonesia has come under pressure for withholding samples of the avian flu strain occurring there out of concern that sharing it to the WHO process would lead it to be expensive and unavailable for its population.
[snip]
Supari named three ways in which her country was treated unfairly. She charged that when Indonesia needed to procure Tamiflu, seen as potentially effective against avian flu, it had all been stockpiled by developed countries. Secondly, the DNA sequence for risk assessment and vaccine production was held exclusively by WHO-affiliated scientists, which Indonesia corrected by releasing the H5N1 sequence data to gene banks. Finally, Supari said, several developed country companies offered her vaccine and diagnostic kit developed from the Vietnamese flu strain.
[snip]
The United States said the "sense of urgency" must be maintained, and pointed to a variety of preparations for a possible pandemic that reach beyond access to vaccines, such as rapid response or measures to mitigate the spread at the community level. It also criticised any withholding from the global system, but said countries sharing their samples should not expect something in return every time. Instead, they could get technical assistance. Finally, the US said, "We cannot accept any approach that undermines intellectual property rights."
Edward Hammond of the Sunshine Project prepared a report on IP issues related to avian flu viruses that tracked the recent "dramatic rise" in patent applications related to influenza. As developed countries funnel public funds into a biomedical research and development system based on patents, "some key government players in the WHO GISN are fuelling the patent surge and, in fact, are politically and legally obligated to encourage such claims because they are an integral component of their health systems," Hammond wrote. (IP Watch)
The IP article has an excellent account of Day 1. We are now through Day 2, and Ed Hammond sent along the following observations.
10:30 am, EST, 4:30 pm Geneva time:
We're actually late into the second day of negotiations and we appear to headed into a late night.
Here is another article on the 1st day.
Some other countries are coming forward with constructive proposals, such as Brazil and Thailand and Nigeria, which, regrettably, are being lost in the Indonesia vs. US-focused coverage.Sadly, the EU and US remain quite unhelpful.
1:29 EST, 7:29 pm Geneva time:
Things take a turn for the worse in Geneva.
In addition to other uncertainties, a new problem has arisen. Two parallel working sessions have been formed, one working on "principles" and "scope", with the other working on "operational", or nuts and bolts issues.
Unfortunately, about a dozen representatives of the vaccine industry have been permitted to attend and speak at the "operational" working group, and all other non-governmental groups (i.e. the "real" NGOs) have been ejected.
The closed working group is working on critical issues and, unfortunately, the press and NGOs will not be able to see and hear what transpires.
1:51 pm EST, 7:51 pm Geneva time:
Still worse news from Geneva
In the all-important text for the operational provisions for sharing influenza viruses (the real nuts and bolts of how the system will work), the WHO Secretariat is accepting submissions of new text overnight.
I have just received an e-mail from the WHO Secretariat (in response to a question), stating that WHO plans to produce a text on the basis of those submissions that does not attribute text to the country that proposed it. In other words, unlike the usual transparent UN procedure in which it is clear who is proposing what text, WHO will hide the origin of language that may wind up in its resolutions.
Procedurally, this makes negotiation very difficult and frustrating. Because new text can - and is - introduced into negotiating documents by the WHO Secretariat, yet the source of that text is not revealed. This is not a modus operandi that is promising for working out the underlying problems that have led us here, and portends for continued problems.
Then this at 3:30 pm, EST, 9:30 pm Geneva time:
US Plays "Chicken", Runs into Strong Oppostition
Late on Wedesday the first open fight between the US and Indonesia broke out. Indonesia, with support from other countries, had bracketed the word "mandatory" when it comes to sharing viruses. The idea was to see what the system looks like before deciding whether virus sharing will be mandatory or not, i.e. to see the whole package of requirements and benefits. Many developing counties do not want to see a system in which providing viruses is mandatory; but GISN providing benefits is optional. As proposed by Thailand, virus sharing and benefit sharing should be either be "mandatory-mandatory or optional-optional", and not "mandtory-optional".
In response, the US crafted a paragraph saying that countries would not receive benefits from the WHO system unless it was in "good standing", a clear jab at Indonesia. What the US probably did not expect was that it's attack on Jakarta prompted criticism of the US by every other country in the room that spoke. First, Indonesia immediately retorted by inserting the same US language into the paragraph on virus sharing. Indonesia proposed a rule saying that Collaborating Centers must be in "good standing"( a reference to patent applications by St. Jude, among others) in order to receive virus.
In short order, the rest of the room that spoke weighed in on Indonesia's side. Switzerland said that even if a country misbehaved, that public health required that WHO provide network benefits to to all, and that this was a principle of the new International Health Regulations. Mexico called on the US to reconsider. Argentina agreed. Germany supported Switzerland and called for a retreat from polarizing proposals. The UK supported its fellow Europeans.
Asked by the Chair to withdraw its proposal, the US refused to budge, offering that it would submit a definition of "good standing" tomorrow (Thursday). Indonesia said it would define "good standing" as well.
Indonesia has not said that it will not participate in a mandatory virus sharing, mandatory benefit sharing system. It has said, and other countries such as Brazil have agreed, that whether or not virus sharing should be mandatory should remain in brackets until the result of other negotiations here are clear. Until the whole package is apparent. The US attack and subsequent inflexibility left it isolated on the issue and ended the day (at 9:30PM) on a relatively sour note.
Sounds like some fireworks. As long as the US and its allies stay wedded to the current IP system this will either be an insoluble problem or one where the solution is unsatisfactory (e.g., each country decides who licenses and gets its viral isolates).
There is a good case to be made that the current bird flu problem has been greatly exacerbated by industrial poultry farming practices. We can make another case that the current vaccine problem has been greatly exacerbated by US and Indonesian intransigence and allegiance to a system of intellectual property rights that is dysfunctional and doesn't work for a global public health problem of this kind.
We'll bring more of what's going on in the important meeting as we get it.

--------------------------------------

I just wanted to add some commentary that was attached to the day 1 post

at Effect Measure. The poster Andrew Jeremijenko, is an Australian scientist who formerly worked with NAMRU 2 in Indonesia. He made the important discovery that cats were being infected with H5N1 in Indonesia. For those who do not know, NAMRU 2 is a US Naval Lab that is still located in that country.

I wonder if Indonesia is using this as a way to distract people from the fact that they are continuing to do poor investigations, failing to isolate the virus in many human cases, failing to identify matching viruses and thus the source of infection, and failing to effectively control the disease in their own country. The best form of defence is attack.
I do not deny they are debating an important issue. A much more important issue is the need to control the disease. Many other nations have shown this disease can be controlled, Thailand, Vietnam, Turkey, etc. Indonesia is focusing not on controlling the public health threat but on who owns the public health threat. To me it is a poor use of the health departments resources and it should be redirected. Indonesians and the rest of the world may pay a heavy price for this misdirected energy.
The article on the limitation of international law below is interesting http://www.cdc.gov/eid/content/14/1/pdfs/07-0700.pdf and gives little hope for a speedy resolution of this problem.

indigo girl · Nov 23, 2007

With the permission of Effect Measure:

The Editors of Effect Measure are senior public health scientists and practitioners. Paul Revere was a member of the first local Board of Health in the United States (Boston, 1799). The Editors sign their posts "Revere" to recognize the public service of a professional forerunner better known for other things.

Day 3 of flu virus sharing summit: participant account

Category: Bird flu * Intellectual property * Pandemic preparedness * Public health preparedness * Vaccines * WHO

Posted on: November 23, 2007 7:21 AM, by revere

The critical summit on sharing influenza viruses entered its third day... The big media outlets covered the opening but not since. ... Ed Hammond is there and is keeping us abreast of developments.
A participant's view at the start of Day 3 (5:30 am, Thursday, Geneva time):
Halfway Through and No New Ideas from the US and EU
To be sure, Indonesia has not been the most effective leader for its cause. Its multiple failures at this meeting (if not previous ones) to put forward clear language describing what it wants has held potential allies at a distance, sometimes out of concern that Jakarta has hidden agendas. In fact, in terms of new proposals for how a reformed virus sharing system would work, it is Thailand and Nigeria that have been most concrete, with frequent contributions from clear-minded Brazil and Chile. These countries have laid out important principles and practical proposals for virus and benefit sharing.
But if those four countries are making a strong constructive effort from the perspective of the developing world, where are the new ideas from wealthy countries? Sadly, there are none to date. Halfway through this important meeting and neither the US nor the EU have put forward a single new idea about how to make the system more just. Sure, Indonesia has not been the most articulate; but at this point nobody can say that they don't understand that the inequities of the old GISN [Global Influenza Surveillance Network] have led us here. It's a mantra of the WHO Director General (who has thus far sat in, full time) that the system needs reform to be more transparent and responsive to poorer countries' influenza needs. So where are the US and EU's ideas? Apparently, they don't have any. The wrongs of the current system are widely acknowledged but the US and EU are refusing to show any leadership by saying how they are prepared to address them. What changes they are willing to make? Instead, they have so far proposed to leave an unacceptable status quo intact.
Indonesia and other countries with similar concerns are taking notice. Instead of negotiating, the US and and EU are stonewalling, pretending the current system can continue fundamentally unaltered. The US might say that if from its point of view GISN "ain't broke", so Uncle Sam is "not gonna fix it"- after all, it's a pretty effective virus vacuum - but that's a recipe for disaster, because that self-centered position will cause alienation in the developing world. There are many countries watching closely, like China and India, to name two large ones. The longer time passes without the US and EU putting new ideas on the table and signaling a real willingness to work to address Indonesia's concerns, the more likely that GISN will suffer severe consequences.
End of Day 3, 7:42 pm Geneva time:
With the exception of the final few minutes before breaking for supper, the entirety of the morning and afternoon plenary sessions on Day 3 (Thursday) was dedicated to discussion of principles for virus sharing. Meanwhile the "operational" working group has also been working in parallel. What it has done nobody but governments and WHO know, or said more accurately, governments and the 19 industry lobbyists who have been permitted to to enter the closed working group under the banner of the International Federation of Pharmaceutical Manufacturers and Associations (IPFMA).
Much more transpired than can be adequately captured here, so I will focus on a couple of important points and hope that more can be covered later.
First, there is a possible conflagration brewing with respect to influenza (and, by inference, other diseases) and the new International Health Regulations (IHR). It goes like this:
The WHO Counsel has conceded "preliminarily" that the IHR does not require sharing of viruses with WHO. Fidler's recent EID article concurs (even if Fidler is badly wrong about the Biodiversity Convention [Revere note: see quote from Fidler here along with our take on it]). Despite these legal opinions, it is abundantly clear that the US is trying to manufacture language in the products of this meeting to suggest that the IHR requires virus sharing. The US hasn't stated its intent in so many words; but it is coming. The US is repeatedly seeking to introduce language referring to the IHR inappropriately in the principles related to virus sharing. They might think they are getting somewhere; but this is a strategy likely to backfire.
It's not that your correspondent is hostile to virus sharing or the IHR. Rather, it is a fact that the IHR simply does not require WHO Member States to hand over disease agents. The US should stop trying to misconstrue the IHR in this discucssion about flu. Because once Member States completely grasp what the US is up to, there could be a serious backlash. This will not only further polarize the flu discussion; but it could be dangerous to the IHR itself.
Second, this meeting is not getting very far. The results appear unlikely to move us very far forward. Not only is there too much hotly contested text resulting in too little time to properly work through the issues, but the main players that need to pony up their ideas for fixing the GISN (namely, the US, EU, and Indonesia) are not articulating solutions. For much of the meeting, it has seemed more like a struggle for tactical advantage than a real attempt to resolve conflict. There are dangers in that some countries are tiring, and in that there is no clear way forward. It's perhaps a bit premature, but it is quite possible WHO Member States may be forced to schedule another 4 day grope in the dark before the next World Health Assembly. Remember the closed Working Group is a wild card for all of us not allowed inside -- but the whispers are not encouraging. In the halls there are ideas being circulated about possible interim measures for GISN ... but it is unclear if they will see the light of day or if there will be time enough to adopt them in the little more than one day that remains.
Finally, there is the big question of Benefit Sharing's relationship to vaccine stockpiles. It can be read or inferred that the rich countries are pretty much in agreement that a big benefit of the system, probably "the" benefit, for developing Member States is access to a (pre)pandemic vaccine stockpile, unless one counts the opportunity to buy vaccine or medicine on the market as a "benefit" (some would cynically suggest that being able to shop is a benefit.)
There's another probable problem here. It's clear vaccine stockpile will happen -- is happening, in any event. Inclusion of a stockpile as a "benefit" in a new GISN might make a vaccine stockpile bigger and possibly better managed, but without regard for the GISN, it would be much preferable to the US, EU, Australia, Japan, et al. to fight an incipient pandemic on a Southeast Asian isle rather than in Chicago ... or Rotterdam. So what vaccine is not completely reserved for rich countries will be rushed to the developing world in the event of the appearance of a pandemic-type strain .... in a desperate attempt to stamp it out before it spreads too far.
But beyond the fact that a stockpile may not properly be a GISN benefit, some developing countries (and NGOs) see other benefits, among them, knocking down the obstacles to vaccine production in developing countries -- not only by stopping the injustice and ominous surge of proprietary claims on flu virus pieces and vaccines, but through access to vaccine technologies like adjuvants and cell culture systems and the know-how to use them. Put the tools to make vaccines in more hands than a few companies focused on rich markets.
Put simply, the idea, at least as this NGO [the Sunshine Project] endorses it: If companies want access to the viruses of the system, then they need to let poorer countries have access to their production technologies. (The companies can make their money from the rich.) [NB: In essence, this is also our position here at Effect Measure]. That benefit does not make the vaccine, but it's just about access to the ability to do so.
But there's not enough vaccine to go around. Fixing GISN is not the same thing as fixing the pandemic preparedness problem. Pandemic preparedness is still bigger.
This is not to say that vaccine stockpiles are not important; but it is to say that more benefits can and should be expected from the WHO system. And it seems unlikely that there will be broad satisfaction with a reformed GISN in which vaccine stockpiles are the sole major benefit. The lack of practical new ideas from governments is a major problem.
This summit wraps up later today (Day 4). We hope to have some additional comment on results or lack of results.

indigo girl · Nov 23, 2007

UK: DOH Statement On Flu Plan

http://afludiary.blogspot.com/2007/11/uk-doh-statement-on-flu-

plan.html

[quote name=http://www.gnn.gov.uk/environment/fullDetail.

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Health Secretary, Alan Johnson, today published a new plan to increase preparedness and better protect the public against a possible flu pandemic.

A new clinical countermeasures strategy has been developed to offer increased protection against the effects of a flu pandemic if a 'worst case scenario' happened. The Department has already signed agreements with two pharmaceutical companies to supply enough pandemic specific vaccine for the entire population once the pandemic strain has been identified.

The new countermeasures include plans to:

- Double the stock of antivirals to cover at least 50 per cent of the population

- Buy 14.7 million courses of antibiotics to cover at risk groups

- Purchase 350million surgical masks and 34m respirators for NHS and social care staff on the frontline.

The Government also has an existing stockpile of 3.3 million doses of H5N1 pre-pandemic vaccine for healthcare workers and will be considering all the latest scientific evidence in relation to future decisions on pre-pandemic vaccines.

"Our new plans provide the first national blueprint for the UK's response to a pandemic flu. We are strengthening our countermeasures to ensure we have the necessary vaccines, antibiotics and antivirals to protect the population if the worst were to happen.

Alongside the countermeasures a new National Flu Pandemic Framework, which coordinates the responses of all government departments, regional assemblies and all public and private bodies, will set out how the UK will respond if a flu pandemic occurs.

The Framework will help public and private organisations to be as prepared as possible for a pandemic and make sure their arrangements are resilient enough to cope

Although previous pandemics during the last century have resulted in infection rates at or around 25 per cent, the new plans consider a possible 'reasonable worst case' scenario to ensure a robust response. This means considering an infection rate between 25 per cent and 50 per cent of the population.

"We may not be able to prevent a pandemic, but with good planning we can reduce its impact on all aspects of society. This framework will enable organisations such as schools, businesses, transport, and the NHS to prepare for a pandemic in an integrated manner, with the full support of cross-government policy and planning.

"But many changes can be made now. Developing habits for respiratory hygiene - using tissues, disposing of them carefully, and cleaning hands - are all good practice even before a pandemic arrives."

indigo girl · Nov 24, 2007

Planning Based on the Reality of the Case Fatality Rate or Wishful Thinking?

http://afludiary.blogspot.com/2007/11/variations-on-theme.html

From Avian Flu Diary with permission:

When you strive to prepare for a disaster, it is generally prudent to plan for a worst-case scenario. No, you can't always predict how bad an event will be, but you can, based on past histories and current trends, make educated guesses.
For the past couple of years government agencies have been adamant that a worst-case pandemic scenario would involve an attack rate of 25%-30%, absenteeism rates of up to 40%, and a CFR (Case fatality ratio) of 2.5%.
Roughly what the United States saw in the 1918 Spanish Flu.
Officially, for many nations, that's the `worst-case scenario'. Anything more is, frankly, `unthinkable'.
Amazingly, here in the United States, it has been left up to each state to decide what their `worst-case scenario' would be, and that is what they are planning for.
Some states, like South Carolina, have decided to plan for a far lesser event than the Federal Government. Their assumptions are for something akin to the 1957 Asian Flu. This is from their State's Pandemic Preparedness web site.
It is impossible to accurately predict what effect a pandemic would have on South Carolina. Experts believe 15% to 40% of the state’s population could be infected in the first wave of the illness. Also, hospitals and physicians’ offices could expect to see many more patients than normal. There is no way to know how many of those cases would be severe or deadly. However, it is almost certain that more people would die during a pandemic than during the usual seasonal outbreaks of human influenza.
South Carolina could experience approximately 3,600 deaths due to complications affecting a greater number of people.
With a population of around 4 million, the federal assumptions of a 25% attack rate and a 2.5% CFR would generate 25,000 deaths in South Carolina. The `worst-case' South Carolina is publicly willing to consider is 1/7th as bad as the Federal assumptions.
And that is a recipe for disaster.
Even in states where planners assume a `1918 scenario', preparations lag.
In Florida, the legislature failed to approve funds to purchase Tamiflu under the Federal Stockpiling plan. Right now, should a pandemic erupt, Florida would be entirely dependent upon receiving their share of the Federal stockpile, and would have only enough Tamiflu for about 12% of their residents.
A far cry from the UK, where their government is procuring enough Tamiflu for 50% of their population.
If we see a severe pandemic, your survival, and the survival of your family, could well be determined by where you live.
Nations, and states within nations, that prepare for a severe pandemic are likely to suffer fewer casualties than those that fail to prepare adequately.
A few notable scientists, along with a handful of bloggers, have tried to raise awareness of the possibility of a worse-than-1918 case scenario. Few governments will even consider that.
While we cannot know what the next pandemic will bring, or even what virus will be the causative agent, we do know the H5N1 virus currently kills 60% of all reported patients. And that should be a sobering warning.
Right now, the UK's decision to double their stockpile of Tamiflu is leading the news. They are also procuring 35 Million N95 respirators and 350 million surgical masks, and are looking seriously at pre-pandemic vaccine options. Instead of a 25% attack rate, they are assuming that 50% of their population could be stricken.
So far, however, they are still looking at a 2.5% CFR. With up to 30 million people stricken in the UK, that would mean as many as 750,000 could die. A horrific number.
The United States, on the other hand, hasn't adjusted their assumptions upward as the UK has. We are still working on a 25% attack rate and a 2.5% CFR. We're we to adopt the UK assumptions, our estimates of up to 2 million deaths would be doubled.
While the US and the UK won't publicly entertain the notion of a higher CFR, scientists in other countries aren't so reticent. Dimitri Lvov of Russia's Institute of Virology has spoken of 1 billion deaths worldwide from a pandemic, and from Norway we get this story (Translation courtesy of Urdar on Flu Wiki).
Norwegian scientist and member of national pandemic committee Olav Albert Christophersen is critisising government for underestimating the danger.
"Spanish flu" is not considered worst case scenario anymore, It could be much worse, half the population could die based on what we know about H5N1 in Indonesia and Egypt. The plans must be based on this, and not a milder scenario than Spanish flu. We now have airtransport and huge city populations, this will make things worse.
He is cowriter on a report with John Fredrik Moxnes, scientist at the Defence institute of science to be published in "Microbial Ecology in Health and Disease".
http://www.newfluwiki2.com/showComme...ommentId=73933
I've no idea how bad the next pandemic will be. Despite all of the statements and assumptions, no one does. The next pandemic might not even stem from the H5N1 virus. We could see a repeat of 1968 or 1957.
Or we could see an event that makes 1918 seem mild in comparison.
But even if we see an event no worse than the Spanish Flu of 1918, with many nations and states failing to prepare for even that level of a disaster, I can make one prediction with a high level of confidence.
After it's over, for those officials who failed to take preparations seriously, there will be hell to pay.

indigo girl · Nov 24, 2007

With permission from Effect Measure:

(Final) Day 4 of flu virus sharing summit: meeting ends in qualified success

Category: Big Pharma * Bird flu * Genetic sequences * Infectious disease * Intellectual property * Pandemic preparedness * Public health preparedness * Vaccines * WHO

Posted on: November 24, 2007 7:16 AM, by revere

Yesterday was the fourth and final day of the important Geneva summit on sharing flu virus isolates. Like premature news of Mark Twain's death, the Reuters report the meeting had failed was exaggerated. On the contrary, the summit appeared to have moved things forward. We have the latest, below. You can find previous happenings and background here, here, here and here.
Status mid-day, Day 4 (3:26 pm Geneva time, November 23), as reported by Ed Hammond:
Some Things That Happened in the Night Session of Day 3 and Morning Session of Day 4
These sessions were the final negotiations before returning to Plenary sessions to review the entire meetings' work and decide what to do next. A final report will follow, but here, in no particular order, are some observations about these two sessions:
Spin Control
The Chair (Australia) noted that members of the press were calling delegates and WHO for information. The Chair suggested that delegates not speak to the press and that, instead, a Declaration be prepared and released to the media. This NGO had never heard the Chair of any intergovernmental meeting suggest how governments should deal with the press. We'll reserve judgment on the intent of Australia and the WHO Secretariat until the text of the Declaration appears.
US Deletions and an insertion
While US and EU participation here are most notable for being totally devoid of any new ideas, deletions to text proposed last night (22 Nov) and this morning (23 Nov) say quite a bit about US intent. In discussion of principles with respect to intellectual property rights (i.e. patents), the US proposed to delete everything. According to the US, patents in influenza and influenza vaccines should be discussed elsewhere. This obviously did not meet with approval from other delegations, so the items were bracketed. But with so much support for the language raising concerns about patent claims on influenza, lifting some of the brackets was eventually proposed. Unbowed, the US replied "We are not today and essentially never prepared to remove brackets around whole items."
And last night (22 Nov), when it came to discussing benefits for developing countries from the WHO system, the US inserted "voluntary" around many kinds of benefits. Given the opportunity to remove "voluntary" today, the US insisted that it stay.
Notable Appearances
#1: Heretofore elusive Vietnam took the floor today and expressed support for proposals by Thailand and Indonesia. (Note this was a generalized expression of support, as there are nuances that separate the positions of the latter two.) In language similar to that of many other developing countries, Vietnam asked for urgent development of a new system for virus access and equitable sharing of benefits based on sovereign rights of member states.
#2: India, which has also been quiet, waded into the fray as well and expressed its displeasure with the current system's inequities, especially patent claims. India's proposals on virus sharing were aimed, it said, to ensure that "/nobody takes more than their share of the benefits and takes away from the rights of the contributors /[of viruses]."
#3 And China, which has been engaged but not overly talkative, piped up more on Friday morning, in particular, advocating technology transfer and establishment of WHO Collaborating Centers in developing countries. (Full disclosure: China would like to have a CC itself.)
The Glossary/Dictionary Definitions Game
The WHO Secretariat and some countries have been up to terminology games. The final status of the documents being developed at this meeting is unclear - the range of theoretical possibilities extends from being tossed in the UN garbage can to being enshrined in a new international treaty (something in between is obviously most likely).
Behind the scenes and off the floor of the meeting, the WHO Secretariat, at the request of the Chair, has been drafting paragraphs varyingly described as a "glossary", "dictionary", or "definitions". Whatever they are, they could be very important. For example, consider Canada's professed inability to comprehend terms like "Material Transfer Agreement". Is Canada really confused about what an MTA is? In our view it is feigning confusion because the exact definition, in these documents, could become important if they eventually emerge as a binding agreement.
The governments here have not been working on definitions because it's too soon to define most terms in legal language. Consequently what terms to define and the definitions themselves have not been subject to discussion and consideration. Despite this - and this comes as no surprise - at the end of the penultimate session of the meeting, the Chair informed delegates she intends to insert the Secretariat's glossary/dictionary/definitions into the final document of the meeting, giving this selective and undiscussed text status as having come under agreement. In our view the choice of terms it contains is suspect, although the details why are too complicated to explain here.
While it my be acceptable to have the Secretariat produce a glossary/dictionary we believe it should not be formalized without discussion. We'll see what happens to it in the final plenary.
Somewhere around 7 pm Geneva time, Reuters reported the talks had failed, but two hours later (9:45 pm Geneva time) we received this from Ed Hammond:
As of 9:45PM we are still working. We are at an impasse. The impasse does not threaten to collapse the whole meeting result; but concerns a statement on interim measures between now and the time when this process completes a new global system.
Several hours later the impasse was broken:
The meeting ended shortly before 11 PM as a qualified success for all concerned with public health. I regret it's too late to explain in detail but there was a significant step forward. The IGM will reconvene, likely for 5 days (probably July 2008) to consider the draft text it hammered out here, which is lengthy and detailed, but heavily bracketed [i.e., with designated items still to be clarified]. It includes provisions on prior informed consent, material transfer agreements, patent rights, etc.
There is also a statement that sets out two main actions to be taken "in the interim before final agreement is reached on virus sharing and benefit sharing": First, a tracking mechanism will be created so that virus movements (and virus piece movements) into and out of WHO CCs [Collaborating Centres, reference laboratories for diagnosis of influenza A/H5 infection] can be tracked. Second, a balanced interim oversight group will be convened by the Director General to look into the functioning of the system and guide on its improvement.
A proper assessment of the final text cannot be given here. The text will not be a formal product of the meeting for another few days because of understandable procedural issues to allow the Chair and some other countries to consult properly with African countries.
However this is a positive result. Where there was no prior structure for building solutions to this problem, we now have one. There is agreement on the need to reform the GISN [Global Influenza Surveillance Network]. There is text, heavily-bracketed, that has ideas for doing so. There are interim procedures that affirm the need to share viruses (more on this later) and which enable the Director General to look more closely at how the system can be made more transparent and equitable. The IGM itself will meet again to work out differences.
Qualified but definite good news. We'll have to see the details, but the bottom line seems to be we have moved forward on this vexing problem.