Immunocompetent

Here are some notes, updated when I feel so moved, from the resumed WHO Pandemic Preparedness Intergovernmental Meeting (WHO PIP IGM).  This is the continuation of previous WHO PIP IGM meetings on the topic that is commonly understood to the be the conflict between Indonesia and the US over virus sharing, but which in fact is broader and much more complicated.  The meeting reopened on Monday, 8 December and will last until this Friday or Saturday.

This is not a comprehensive report.  It's a collection of thoughts about issues, particularly when they are amenable to being dealt with discreetly.  A more comprehensive piece will, hopefully, follow.

The mini blog posts here here are:

Pretending You are In Charge (WHO)
America Insults the Scientists of the Developing World - Or Is It About Patents?
Japan's Big Bluffer 

Pretending You are In Charge (WHO)

To any careful observer of the WHO Global Influenza Surveillance Network it is clear that labs in the powerful countries - like the US, Japan, UK, and Australia - just do whatever they want with H5N1 samples  and call it a WHO activity.  They are "WHO labs" in name only. So, for example, the US "WHO" lab in Atlanta just starts some practice - say use of a particular diagnostic - and then the real WHO just acts like it planned this all along.

This "WHO Veneer" is subtly apparent all the time when looking at the GISN's operations (some of the WHO-endorsed labs don't even have the loosest terms of reference). But it must be particularly painful for the pride and credibility of the WHO when its ancillary status breaks out into the open.  Like when the real WHO doesn't know the details of how its "own" system operates, which happened in public today.

A controversial class of laboratories "inside" the WHO system are the so-called "Essential Regulatory Laboratories" (ERLs), like the US FDA.  These labs are essential for licensing vaccines; but their WHO status is ambiguous. WHO has long said that there are three "essential regulatory laboratories" that should get special global treatment - NIBSC in the UK, the FDA in the US, and TGA in Australia.  Nevermind that these labs don't have standardized capabilities and nor uniform responsibilities in the WHO system, never mind that they don't have terms of reference.  It shows you how loosey-goosey WHO has been in its so-called "oversight" of the GISN.

The system is supposed to be controlled by WHO. But today, in response to a question from Indonesia - and a year after it started declaring in official documents that there were three ERLS - WHO suddenly decided that there is a fourth ERL. This newly-discovered ERL is located in Japan.  And what's more, WHO's influenza leaders aren't sure where it is and if it is separate or the same as the WHO Collaborating Center in Japan.

What an embarrasssment.  The PIP IGM is supposed to be negotiating the roles and responsibilities of labs the constitute the WHO global influenza surveillance system, which allegedly is oveseen by a functional and vigilant WHO.  But WHO doesn't even know its own system very well and, in this case, doesn't even know where one of its allegedly "essential" labs is!

After this embarrassing revelation, I shot the following e-mail to a senior WHO official from North America who was sitting on the dias across the room from me:

 "The [Essential Regulatory Labs] and [WHO Collaborating Centers] obviously do whatever the hell they want to do and then you guys get up and pretend that WHO actually knows what is going on and approves of it.  What an embarrassment. You guys don't even know where all your labs are nor do you have a clear idea of what they all do"

Sometimes he answers my e-mails.  No reply yet; but I'll let you know if I get one.

America Insults the Scientists of the Developing World - Or Is It About Patents?

The American delegation in Geneva seems to take a dim view of the capabilities of developing country influenza scientists. Or is it up to something else when it insults their intelligence?

Although the US says "it is imperative that we have as many viruses from human cases as possible", itself not an unreasonable position (assuming "we" means WHO, and not the Pentagon), the United States of America does not think that the countries that provide those viruses should have a right to see the full characterization data that is generated from them.

Instead, the US just wants to give "summary information" about the virus characterization to the donor country, and it doesn't want to the WHO PIP IGM to try to define what that summary information is (thereby leaving it up to .... you guessed it .... the CDC in Atlanta - acting as a "WHO lab" - to decide what to send).

So, if you are a developing country with H5N1 cases, Uncle Sam insists that you must send all your virsues, but Uncle Sam is unwilling to commit to sending you back the full results of the characterization that is performed on those viruses.  What a stinking double standard.

It's gets even "better".  The reason why it has a double standard, said the US delegation this morning (Wednesday), is that developing country national influenza centers are too stupid or incapable to understand the output from the CDC's sophisticated science.  The data would not, the US condescendingly noted in open working group, be useful for other labs.  Chalk another one up for the Bush administration's efforts at international cooperation and understanding.

What's going on?  Immunocompetent suspects that the Americans are actually up to something more than insulting other countries. We suspect that they are trying to keep intellectual property rights and even perhaps protecting rights to publish or possible proprietary diagnostic procedures and results. Or CRADAs, perhaps?

And seing that this would NOT be an acceptable reason to keep secrets in the WHO public health system, the rather politically-unpalatable excuse that they've come up with is to say that developing countries are too stupid to understand it anyway. (After all countries aren't sending viruses to CDC so they can be patented.)

The above is just a hunch; but Immunocompetent's hunches are often pretty good. The US is either obfuscating its attempts to acquire intellectual property rights with insults, or it just being insulting out of arrogance. Either way, it's bad.

(The EU, meanwhile, is maintaining pretty much dead silence on this issue and many others, mainly because it really doesn't seem to much care. "We need their virus, they need our vaccine, nobody needs this framework", two EU delegates were heard to emphatically agree outside the room. The EU is on track to easily win the award for being the largest group of countries to make the smallest leadership contribution to these talks.

What can be positively said about the Americans is that if it weren't for Japan and sometimes Canada, the US would be the only rich country that at least has taken care and undertaken serious preparation for these talks. Not necessarily constructive preparations; but at least they've got a plan that they've thought about, which is more than it seems possible to say for many other developed countries.)

Japan has been unusually vocal at this PIP IGM, perhaps in response to its domestic influenza vaccine producers, like Biken.  While Immunocompetent has no problem with the usually quiet Japanese talking up a storm, we're not so sure about the quality of their contributions. 

The evidence is to be found in how Japan is swerving and dodging.  Japan seems to have little purpose but to see what it can get away with in watering down the text. Japan weighs in, for example, to delete language on benefit sharing.  Or to complain (inappropriately) about not wanting to see new text.

When confronted with opposition, however, Japan usually beats a hasty retreat. But this certainly doesn't seem to be because Japan is unsure of itself. It is quick to the mike when new items open up, with its watering down usually clearly thought through in advance.

At this PIP IGM, Japan has seemed like a heckler to the process, stirring up little problems where it can, but often with little serious constructive intent behind its proposals.