The Indonesian vaccine arrangement

When Indonesia withdrew from the longstanding system whereby countries shared influenza virus with WHO there was widespread consternation in the public health community. The sharing system has been used for many years to determine the candidate strains for the following year's vaccine. The regular seasonal flu vaccine has three components corresponding to the prediction of which of the influenza A H1N1, H3N2 and influenza B strains will be circulating during the next flu season. Usually the guess is correct, although sometimes it misses. In any event, global surveillance of circulating virus is critical to this effort.

But the prospect of an H5N1 ("bird flu") pandemic has upset the system. The virus is not circulating everywhere nor is the current versions causing human illness the ones that will be a pandemic strain, if one emerges. Thus if you want to make a stopgap prepandemic vaccine that could be used to protect a population you need to use a particular seed strain from a particular place. Indonesia is currently the world's bird flu hotspot and many think the clade 2 strains infecting birds and people there are the most likely to be the seed for a pandemic strain. Thus, unlike seasonal flu, if Indonesia's virus is used to make a prepandemic vaccine which will be the only vaccine available during the first wave of a pandemic, and, they and other developing countries cannot afford the vaccine, it is understandablethey do not feel a special obligation to provide "their" resource to help rich nations protect their citizens. So the Indonesians stopped sharing their virus until they could get some assurances that the isolates they shared would be used only for research and diagnostic purposes, not the development of commercial vaccines.

Indonesia is set to resume sharing bird flu virus samples with the World Health Organisation (WHO) under an interim deal that ensures they are not used for commercial purposes, the health minister said on Thursday. In a controversial move, Jakarta declared last month it had stopped sharing H5N1 samples with the WHO. The two sides then struck a deal on Feb. 16 to resume sharing samples, but under a new framework to give developing nations access to vaccines.

Health Minister Siti Fadillah Supari said that WHO director general Margaret Chan had accommodated Indonesia's interests.

"WHO will send a letter which guarantees that virus samples sent by Indonesia will only be used for reassesment (diagnostic) and not for commercial purposes," the minister told a national meeting on bird flu in the capital.

She said that companies that wanted samples would have to make a request directly to Indonesia.

"Once we get the letter. We can start sending our bird flu samples until the right mechanism is put in place."

[snip]

Indonesia had previously said it had restricted sharing samples with foreign laboratories because it was unfair for foreign drug firms to use the samples, design vaccines, patent them and sell the product back to the country.(Reuters)

The details of the new assurances have yet to be worked out, so we don't know what will be involved. However we have some general comments.

There are two core issues here. One is access to a vital resource (a scarce vaccine) on the basis of need. If the market will determine who gets the vaccine, Indonesia has a legitimate position. After all, they also have a resource to use in bargaining for access to the vaccine, the virus itself. But the other core issue is more problematic for us. Is it ever proper to patent or license a naturally isolated viral strain. I know that patenting genes is something US patent courts and patent law seem to allow. That doesn't mean we approve and the Europeans are much less inclined to honor these alleged property rights than the US is.

Given that position, what are the consequences for the Indonesian position? One would be that while companies could license a vaccine, they could not license or patent the viral seed from which it is prepared. As we understand it this is the current situation with seasonal flu vaccines. But as we noted, H5N1 is different. So Indonesia is moving to withhold the virus for vaccine use ("commercial purposes") except under a licensing or patent agreement with a company, and we believe this is a bad position. A virus isn't "property," intellectual or otherwise, particularly, a virus whose use may be critical to the health and welfare of most people on the globe. Yet this would leave the Indonesians and other poor countries last in line for vaccine, as before, not just because they couldn't afford it but because it would be scarce and used first by the rich countries whose companies made it.

WHO's proposed temporary solution is to build a "virtual stockpile" of vaccine:

A so-called virtual stockpile, in which countries would pledge to donate a portion of their vaccine, is one short-term strategy that could guarantee at least some vaccine would be equitably distributed within poor countries in the event of a pandemic, David Heymann, WHO's top flu official, said Friday.

A long-term goal would be for poor nations to receive enough technology and training to produce vaccines themselves, he said.

"What we need to do and want to do is develop mechanisms that will permit countries to have access to vaccines if they need it," Heymann said, adding that Brazil and India are involved in projects to produce vaccines with help from experts. (AP)

If I were in the developing world, I would worry that the virtual stockpile would result in virtual vaccinations if a crisis were to develop. The best solution, as far as we can see, is to remove influenza vaccine entirely from "the market." We advocate a series of a dozen or so regional international vaccine institutes, financed by UN member states and having the technical and productive capacity to produce vaccine at cost for their region. At the moment we are stuck with the current market-based system and some temporary arrangements will have to be jury-rigged. But in the near term it should be possible to establish the kind of system we are talking about.

So far, such solutions aren't even on the table. It's time they are and we got started implementing them. You can build capacity pretty fast when you have an urgent reason. Like the Fourth Horseman galloping through the Land.

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Revere, that is a good and noble idea, but there will be great difficulties implementing it in the Asia region, because none of the countries there trust each other, and they all have to deal with the 800 lb gorilla that is China.

I base my statement upon the reaction of the region after the Indian Ocean Tsunami.

The Indian Ocean had no tsunami warning system prior to the 2004 Boxing Day event. In the months afterward, alongside the rebuilding efforts, an effort was made to create a tsunami warning system for the region. The result was intensive bickering among the countries of the region, with none trusting the others to host the tsunami center for fear that the host country would fail to warn others in the region who might be economic rivals--that they would warn their own citizens but allow those of neighboring states to be killed.

I don't know the ending of this story, whether they ever came to agreement on where to site such a warning center; I know Thailand was highly favored by those in the West who were involved in trying to help them set it up (primarily the USGS scientists).

My point is, if you try to make a regional vaccine center in the region, well, good luck. Not only do they not trust each other enough, but some of the countries are militaristic enough to overrun any neighbor that might house a vaccine plant and take the whole kit and kaboodle if a catastrophic pandemic occurred.

By Lisa the GP (not verified) on 03 Mar 2007 #permalink

Lisa: It would have to be under international control and protection (as are current UN forces), have sufficient capacity (possible) and be designed in ways that certain very large countries, e.g., China, have their own facilities. This is not an insoluble problem. This is just a money problem and the money involved is a pittance compared to a month's worth of the Iraq War.

Sometimes for no apparent reason.....China has had several nuke tipped cruisers in the S. China Sea traveling into the Java Sea back and forth for months. No landing craft or helicopter support. We of course have been shadowing them as have the Brits. Those tubs are full nuke and bio hazardous capable and can run for weeks in that environment. Now why would they be almost 2000 miiles from home?

They might not be there to help if bird bug breaks out. Perhaps though they might if the flu takes away the Indons capability to stop an invasion.

As for the Indonesians and their sharing... They can always just pony up that money that we sent in there and give it back. 500 miillion would go a long way for preparing the states a little better. We can also use it to buy up some infected birds and/or an Indon or two and shuffle them off into the night in a sub. Whtas the guy going to say, "I want to be treated in a third rate hospital, in a third world nation and have a 80% chance of not making it"?

The Indons are right about one thing, there isnt going to be a vaccine available to them. They can count on that. When the bowling ball starts to roll its going to be every nation for itself. If there is a pre-pan team of nations sitting there in wait all they have to do is wait. This is where Maria Chen is going to fail and miserably. Its also likely the reason the Chinese are sitting there off the coast. It breaks and they go in and take their nationals out (happily infected of course). They have all the excuses in the the world now and it all make sense Revere. Those people are there to get infected. They would do it under the guise of protecting their people.

All too easy. A+ to Lisa. Indirectly she has figured out why the military presence. Those cruisers could be back to Hainan island or port up in S. Vietnam within 36 hours after an extraction. They for sure could keep someone alive that long as those tubs are floating bio labs.

By M. Randolph Kruger (not verified) on 03 Mar 2007 #permalink

MRK - Where do you get this stuff?

Do they have neutron bombs there?

the Indonesian position is not legitimate.
They have no disadvantage from sharing samples
and they break longterm agreements, so it's just extortion.
In contrary, sharing samples makes it more likely
that they will have some vaccine too.
Of course, maybe only after
the rich countries had secured their own share.
But giving vaccine to Indonesia also helps the
rich countries, because it makes a pandemic less
likely, so there is some chance that Indonesia
would get some vaccine too.
Now, they claim for priority because they have the samples.
How does this sound to countries like India ?
India gets down in priority because they have no
samples which they could withhold, so it makes sense to
"produce" some outbreaks in order to threaten to
withhold those samples and climb in the world-vaccine-priority-list.

"remove influenza vaccine entirely from the market" ?
That's a vote against capitalism, for socialism,
against USA political system, WTO etc..
UN to produce their own vaccine, without the existing research,knowledge,investment, facilities of the pharma-industry ? That would throw us back many years and many $$$.
And, what if UN fails and the vaccine doesn't match ?

Jakarta flooded badly a couple of weeks ago.
The Indonesian people said that the elite built Jakarta so full that the water couldn't find a way out from the town.
If the Indonesian elite cares so little about their own people, how would they care about some abstract people of the outside world...

ThinL-Indon is not a nuclear power. They could build one if they wanted but it would be only one or two. Several months ago I postured that a nuclear option to stop a spread of bird flu would be to use neutron weapons against the disease but not so much as the Indon people.Regretable but perhaps necessary? At that time it had not spread so flagrantly. Revere said that it wouldnt work anyway and I agreed it wouldnt stop it, but it would slow it to a crawl.

Neutron radiation for the layguys is that penetrates deeply into the ground and uses enhanced radiation to kill. When it kills it kills everything including bacteria, viruses, people but leaves the buildings standing. The US is the only group that has ever tested one, we still dont know whether it is truly in the inventory but the technology is there if needed.

As for the Chinese Thin, I wouldnt put anything past them. They did month before last surface a diesel boat that was nuclear tipped with torpedoes and missiles inside of a carrier battle group defensive perimeter. Specifically in the Pacific, inside the exclsusion zone and we didnt know it was there. New technology on an old Russian sub? I dunno. But the move was provocative at the least.

Are they up to no good? China is now the worlds largest oil consumer. Indonesia is lousy with oil. The have made no moves towards the Indons. If Iran goes into a fight with the US the Chinese will be in deep oil trouble fast. Do the math as they say.

By M. Randolph Kruger (not verified) on 03 Mar 2007 #permalink

"Several months ago I postured that a nuclear option to stop a spread of bird flu would be to use neutron weapons against the disease but not so much as the Indon people.Regretable but perhaps necessary? At that time it had not spread so flagrantly. Revere said that it wouldnt work anyway and I agreed it wouldnt stop it, but it would slow it to a crawl."

MRK, yes I remembered your comment and actually that's why I asked now :)

But "Iran goes into a fight with the US"? Isn't it another way round? The US is threatening Iran, if the news are of any accuracy.

Well, anyway, do you think the Chinese are backing Iran? If so, then the US doesn't have a chance, because aren't the Russians backing Iran, too?

Revere, I think you'd need three plants for Asia--one (or more) for China, one for Indonesia, and one in Thailand or Vietnam to cover for everyone else in the region.

Even if China has its own facilities to manufacture vaccine (as it should be able to afford on its own without WHO help other than sample virus), I am not convinced that they wouldn't use military rumbles to try to extort more out of other states in the region, as in a pandemic I think everyone would run short.

And then you have North Korea to deal with. Not that big a population to cover, but how are you going to cover them? And how they'd react militarily is utterly unpredictable.

Randolph, I often like your posts, and I don't know much about China's military other than that it is a credible threat to us, but I do get the impression that you're treading in the tinfoil direction on some of your conjectures here.

PS: I got the article but haven't read it yet, thanks.

By Lisa the GP (not verified) on 03 Mar 2007 #permalink

anon: The Indon position is no less legitimate than the market mechanism. They have something to sell (control of the virus) and want something for it. Why that is OK for rich countries and not for poor ones I don't know. For a flu vaccine the market it wrong for everyone.

I'd like to ask everyone to stop talking about using a neutron bomb to stop a pandemic. As Randy agrees it wouldn't work and I think it is certain it wouldn't even slow things. It would cause chaos in the world and delegitimize the US for all time as the worst kind of rogue state (and properly so). It isn't going to happen and only harms this site even taliking about it. I don't censor people around here but you might consider the consequences of talking about something that only brings discredit on conversation here. Randy already stopped talking about it long ago at my request, so let's close the subject.

"we have something to sell" was not the argument.
It was : "you would use it to produce vaccine for your people and we would have none".
So : if we have none you should suffer too.
"Something to sell" have other countries too,
as you elaborated, but there is (was?) an agreement to share
samples for the common benefit. Indonesia benefits from
other nation's samples too. Vaccine research is good for
Indonesia in whatever country it happens.
Breaking treaties or agreements for better profit is not legitimate.

And I think it's unmoral to use the neutron bomb. It would also probably be too late to use it anyway, because when the epidemic would be noticed, the disease would have spread already. Let's speak of something else.

What about the viral strain put into an adenovirus vector? It's claimed to be cheap, fast and effective as a vaccine-like immune booster. And it doesn't require eggs.

Lisa - Conjucture? Tinfoil? Just recently you've noticed this? Do you remember the BF patient in Canada?

Revere - The idea of regional vaccine centers makes sense. Could UN member states afford such a plan? I have no idea what a facility of that capacity would cost??

Thinlina:

Re: "If the Indonesian elite cares so little about their own people, how would they care about some abstract people of the outside world..."

Substitute "American", "Chinese" or "Russian" for Indonesian-same results. Elite vs poor, simple as that. Middle class=poor nowadays.

The CHIP (Children's Health Insurance Program which provides health insurance for kids whose parents can't afford is being "cut back"-gotta pay for that war somehow. Same for the cutbacks at the VA system until the media jumped on it.

I understand, but don't condone, what the Indonesians are doing. Our gov't said we'd given them $$ to help fight bird-flu then didn't fork it over. Elite vs poor again. And the poor are trying to fight back.

Problem is, the pandemic will be worse for them. Indonesia, IMHO, is Ground Zero for the next pandemic.

Patch, one of the first things they teach you on the psych rotation in med school is never touch somebody's tinfoil.

By Lisa the GP (not verified) on 03 Mar 2007 #permalink

revere,

We advocate a series of a dozen or so regional international vaccine institutes, financed by UN member states and having the technical and productive capacity to produce vaccine at cost for their region.

Do we have an existing model for that? If not, we may need to bear in mind that any institutional change will need many years to work the bugs out of the system, even assuming you have the political will, resources, consensus, etc etc. I don't see any of the UN agencies having a remotely viable model for this purpose.

Even for a domestic agency such as the creation of the Department of Homeland Security in the US, when it was first announced after 911, a prominent professor in politics and government in the UK commented that such a change will need about 10 years for the agency to be fully functional, producing the desired results, and fully integrated into the rest of government. I think his estimate was spot-on. But that was only at a national level, with enough support AFTER a major national crisis.

Unless we already have a similar program on a comparable scale with a proven track record, with a multi-lateral agency like the UN, and BEFORE we see massive fatalities, the chance of that working is going to be very remote indeed.

While you see removing the 'market' as a solution, I see removing or changing the current distortions being placed on the market as a more viable one. The biggest distortion is the paradigm called 'building seasonal flu vaccine capacity as the way to build pandemic vaccine capacity'. What this paradigm does is overwhelmingly favor current seasonal vaccine manufacturers and their egg-based technology and variations of that such as the addition of adjuvants, which, irrespective of efficacy and safety, adds another layer of production difficulty as well as extra costs for their IP rights, making it even more out of reach of poor countries, even if the production capacity gap can be bridged (which it can't, not by egg-based adjuvanted vaccines).

The WHO needs to go back to the drawing board with a clean slate, and ask the question,

what do we need to achieve that will have maximal effect in either reducing the risks or mitigating the direct effects as well as the secondary and tertiary consequences (including wars between nations) of a pandemic for the world as a whole?

What are the technologies available, how do we regulate them, what incentives should we build into the process so that we can have the largest quantity of vaccine available in the shortest time, whether prepandemic or pandemic. It is only when we have solved the problem (or at least narrow the gap a lot more) of global capacity can there be any real hope of sorting out who should get it first.

Or, put it in another way, equity problems are much easier to solve if there is enough to go round to start with, or the gap is not the current 150-200 million 2-dose courses for 6+ billion people.

ThinL-Yes we are threatening them. Kind of crazy threatening to use force to induce peace now isnt it? But many believe that peace is based in the lack of war. Its not. Its the lack of hostilities between one or more. Yes, the Rus and the Chinese are supporting the Iranians who in turn send weapons down south to Iraq to use against us. Iraq is NOT GOING TO BE ALLOWED TO HAVE NUKES. Its as simple as that. Sanctions are pure unadulterated bullshit and the UN Security Council members are happily selling them shit, just so we can go in and break their toys.

As for the Chinese/Russians and a can of whupass being opened up. I think that we have too many of our ground troops in harms way in Iraq... Unless the plan is to go air mobile and take down the leadership of Iran. There isnt a soul on this side of the planet that doesnt worry about what would happen if they launched a weapon towards a NATO nation, much less Israel. Israel is a 3 bomb country. It would of course take out Jordan and a goodly portion of Lebanon and Syria. Lots of desert to buffer a weapon from our troops but again, thats if they were allowed to use them.

Lack of UN support for this operation was based in large part in the fact that the French were selling to the Iraqi's. They are currently happily selling machinery to the Iranians that can make gas centrifuges. You get the centrifuges, you get the bomb. They arent making small pellets with this stuff they are making full 2-3 pound hemispheres. You dont use that in anything but a bomb. But we are drifting off course here.

Quickly though, the Chinese are backing the Iranians and they are going to have to make a decision either on or about April 7th, or sometime in October during the dark of the moon. The NATO nations AND they UN Security Council are very happy that the Straits of Hormuz are in US control right now. They have their rhetoric, but the facts are that they are sleeping mighty happy. Think back, remember when Laura Bush visited Chirac? All of a sudden, the game was up and if you get caught taking cheap oil at the rest of the worlds expense someone is going to get pissed.

By the way, use of a nuke at this time is totally worthless now. If the cases had broken out in mass numbers on say Java, the Indon government might have requested it. Too late... out and running like a mad dog.

Welcome Lisa.

By M. Randolph Kruger (not verified) on 03 Mar 2007 #permalink

Grace-the Indon government indicted several people three months ago for stealing the bird bug money that the WHO sent them which came from everywhere in the world. The rest of it was put into compensation and they culled birds.

Now they are getting nothing and growing new endemically infected birds. This is likely the reason they say its inevitable. Its inevitable that they will do it from ignorance or poverty or both. So if there are infected birds they are going to act as the infection vector hauling them up and down the roads.

Saw a story posted in Indon about the Aceh area that said that teen kids who lost their parents in the Tsunami were picking up culled birds from the dumps and eating them. Bad news awaits. Its just timing for when it happens.

By M. Randolph Kruger (not verified) on 03 Mar 2007 #permalink

"Now why would they be almost 2000 miiles from home?"

I ask again, Kruger, don't they teach you anything bootcamp anymore?

They are there for pretty much the same reasons as "We of course" and "the Brits", half way around the world.

Sort of like the Indonesians, imagining that "common benefit" means coloured people as well as white.

The Indonesians are just plain crazy, but I'ld like to have a toke of what the Chinese are smoking.

MRK, you said "But many believe that peace is based in the lack of war. Its not. Its the lack of hostilities between one or more."
Do you mean that deleting the "more" i.e. solving the "others" problem, i.e. eliminating the holder of the wrong opinion, the hostilities can be made to disappear?

MRK, why are all those other countries backing Iran? I'll citate Grace RN (on March 3, 2007 11:04 PM) because she said it very well:
"Thinlina: Re: 'If the Indonesian elite cares so little about their own people, how would they care about some abstract people of the outside world...'
Substitute 'American', 'Chinese' or 'Russian' for Indonesian-same results. Elite vs poor, simple as that. Middle class=poor nowadays.
The CHIP (Children's Health Insurance Program which provides health insurance for kids whose parents can't afford is being "cut back"-gotta pay for that war somehow."

One of the most skewed thing is that these war lords are taking not only from the children of the others but also from the children of their own.

Thinlina, it may be that those, whom you regard as "the children of their own", are regarded by the warlords as "the children of the others".

The topic is the vaccine agreement... or really the lack of it. Cite whatever you want about CHIPs I dont even know what it is.

Greg-In boot we are taught one particular thing. That is to win... even if you find out you are wrong on the back end. This war was inevitable. If it wasnt WMD they would have come up with the asshole clause in the UN somewhere.

I fully blame the UN for NOT presiding over this deal and its about to get worse. Al Baradei in a couple of off the beaten path rags has been saying that they are getting very close. They wont wait in Israel for that train to pull into the station. The big question is whether the Russians and Chinese would support Iran directly and out in the open with troops. I dont know. Back to the topic though.

By M. Randolph Kruger (not verified) on 04 Mar 2007 #permalink

IIRC, the reason given by Indonesia for restricting access to H5N1 samples was because of the actions of CSL (Commonwealth Serum Laboratories) in Australia. CSL used to be a government owned institution that was privatized and now has a virtual monopoly on vaccine production in Australia. The Indonesian government does not particularly trust Australian private companies and the fact the current Government here is dominated by business interests.

I don't know what CSL or the Australian Government specifically did or said to cause this lack of confidence.

By kyangadac (not verified) on 04 Mar 2007 #permalink

kyangadac: The CSL announcement was the pretext (or trigger, maybe) for the Indon vaccine dust up. I don't think CSL handled it very well and was surely insensitive, but the basic problem had been brewing for a long time and is independent of it.

"In boot we are taught one particular thing. That is to win..."

That explains why the 'military solution' so often fails.

Regardless of how you think or feel. He who is able to impose his will by either peaceful or miltary means wins Thin and Greg. Its not a position. Its just the facts of the world. We sent too few troops into Iraq, we didnt impose anything but the presence. Greg, pot shotting like that in a different time or place would get you stomped into a small pile of grease. Maybe you should run for office in your state or prefecture. Be sure to make that your planks in the platform... I am sure you'll be elected but only if you are from Berkley. You are entitled to your Clinton opinion on everything, but to do so would make you ascribe to Kosovo where they dont even report the killings each day any longer. Hell son, I would defend your right to say the crap you say to the death. Almost had to once or twice already. Good that you have people around like me to defend you.

Thin-If a military power decides that to pacify an area one has to completely scorch the earth then obviously the power wins. Its all about how much resolve one wants to put into it and being Swiss I dont think you really have any concept of what we could do from a conventional standpoint if the green light was given. We could destroy in a conventional manner just about anything on this planet and they know it. Would the Rus get involved? Only if they are dumb or radiation falls on their territory. This test is likely to come into play soon on the ground near Bushehr Iran. Personally I dont think it will do anything but escalate a situation that started wth the first hijacking of an aircraft by extremists nearly 40 years ago. They started to lose their fear of us and with it our global reach became weaker. If we do it, then it wont be nuclear unless its a nuke bunker buster. I dont think we need it though. On the other hand if the Israeli's do it, they have to shoot the big potato in there. They might not do anything but poison the earth for several thousand years.

I am not afraid of the Russians, I do especially respect them though. One of the reasons that the Cold War ended was that the stealthy B2 flew over Moscow undetected and they arent stupid. Besides its bad for business to fight wars with superpowers. Better to sell them arms and let them whack each other up.

Now come on guys... the subject is vaccine and not an ideological debate of the efficacies of neutrons or whether to use them. The time has come and is LONG gone for that. A year ago just maybe if it had broken out in massive cases across the islands they might have done it and likely only on the command of either the people in Beijing, the US and with the concurrence of the Indon government. The Chinese dont have neutron weapons, only dirty nukes. Same effect though. Greg FYI those ships sailed in there pushing on a year ago and Revere was made aware of them by me. We disagree on many things but even in the intel community the smart guys pass the information to the opposing side to see if they come up with a better or different read in our countries interest. You have a real snap whit to your judgements that is nothing as far as I am concerned but designed to bait people. How about contributing something other than snarky little posturing comments? I would truly appreciate that.

By M. Randolph Kruger (not verified) on 05 Mar 2007 #permalink

Sorry, Kruger. I was responding to the other Kruger, the one who first injected "China has had several nuke tipped cruisers [...]".

It's hard to tell you apart, having the same name, the same grammar and vocabulary, the delusions of potence.

Exactly my point about you Greg......

By M. Randolph Kruger (not verified) on 06 Mar 2007 #permalink

MRK, I think I have at least a vague idea what they are capable of. But the core idea isn't destruction: It's always much more difficult to grow than to damage. And the life wins always. After all. Maybe not humans, if the war lords decide so. But life in some form, anyway.