A Journey Through The World of Pandemic Influenza

Viral Sovereignty

 

This morning we have an excellent offering from The Washington Post:

'Sovereignty' That Risks Global Health

By Richard Holbrooke and Laurie Garrett
Sunday, August 10, 2008; B07

Here's a concept you've probably never heard of: "viral sovereignty." This extremely dangerous idea comes to us courtesy of Indonesia's minister of health, Siti Fadilah Supari, who asserts that deadly viruses are the sovereign property of individual nations -- even though they cross borders and could pose a pandemic threat to all the peoples of the world. So far "viral sovereignty" has been noted almost exclusively by health experts. Political leaders around the world should take note -- and take very strong action.

The vast majority of repeated avian flu outbreaks the past four years, in both humans and poultry, have occurred in Indonesia. At least 53 types of H5N1 bird flu viruses have appeared in chickens and people there, the World Health Organization has reported.

Yet, since 2005, Indonesia has shared with the WHO samples from only two of the more than 135 people known to have been infected with H5N1 (110 of whom have died). Worse, Indonesia is no longer providing the WHO with timely notification of bird flu outbreaks or human cases. Since 2007, its government has openly defied International Health Regulations and a host of other WHO agreements to which Indonesia is a signatory.

[…]

A year ago, Supari's assertions about "viral sovereignty" seemed to be odd yet individual views. Disturbingly, however, the notion has morphed into a global movement, fueled by self-destructive, anti-Western sentiments. In May, Indian Health Minister A. Ramadoss endorsed the concept in a dispute with Bangladesh. The Non-Aligned Movement -- a 112-nation organization that is a survivor of the Cold War era -- has agreed to consider formally endorsing the concept of "viral sovereignty" at its November meeting.

 

I, along with my fellow PanFlu bloggers [see sidebar] have repeatedly commented on this issue, and I welcomed this piece by two rather "Big Hitters", Mr. Holbrooke and Ms. Garrett. My first post on "viral sovereignty", Viral Cold War, expresses my own, still operative, opinions on the issue.

 

Also from the WP article…

In this age of globalization, failure to make viral samples open-source risks allowing the emergence of a new strain of influenza that could go unnoticed until it is capable of exacting the sort of toll taken by the 1918 pandemic that killed tens of millions of people. As the world learned with the emergence of severe acute respiratory syndrome (SARS) -- which first appeared in China in 2002 but was not reported by Chinese officials until it spread to four other nations -- globally shared health risk demands absolute global transparency.

There is strong evidence from a variety of sources that forms of the bird flu virus circulating in Indonesia are more virulent than those elsewhere and in a few cases may have spread directly from one person to another. The WHO has tried for two years to accommodate Indonesia, without success. Under pressure from scientists worldwide, Indonesia agreed in June to share genetic data on some of its viral samples but not the actual microbes. Without access to the viruses, it is impossible to verify the accuracy of such genetic information or to make vaccines against the deadly microbes.

Outrageously, Supari has charged that the WHO would give any viruses -- not just H5N1 -- to drug companies, which in turn would make products designed to sicken poor people, in order "to prolong their profitable business by selling new vaccines" (a charge oddly reminiscent of the plot of John le Carré's novel "The Constant Gardener"). The WHO has elicited pledges from the world's major drug companies not to exploit international repositories of genetic data for commercial benefit, but this has not satisfied Indonesia.

[…]

The failure to share potentially pandemic viral strains with world health agencies is morally reprehensible. Allowing Indonesia and other countries to turn this issue into another rich-poor, Islamic-Western dispute would be tragic -- and could lead to a devastating health crisis anywhere, at any time.

 

Many of the consequences of the Cold War were morally reprehensible. That is not a "catch phrase" but the simple truth of the past follies of our governments.

 

Have we learned nothing?

 

Apparently not.

 

SZ

Indonesians test negative

 

The test results from the 13 Indonesians came back negative. This from Singapore's The Straights Times:

 

Indonesian villagers test negative for bird flu: health ministry

JAKARTA - THIRTEEN people in Indonesia suspected of having bird flu have tested negative for the feared disease, the country's health ministry said on Saturday.

Experts from the World Health Organisation (WHO) arrived Friday in the affected village in North Sumatra to help investigate a possible outbreak after three people died and the 13 were admitted to hospital.

'All specimens collected from suspect cases have given negative results'.

'They are all recovered', I Nyoman Kandun, director general of the ministry's communicable diseases department said on a text message.

Officials and residents in Asahan district in North Sumatra province said villagers began showing symptoms of avian flu after a large number of chickens died suddenly last week in Air Batu village.

The local husbandry office took preventive action this week by slaughtering and burning some 400 chickens and ducks.

The ministry, which has stopped giving regular bird flu updates, announced earlier this week that the human toll from avian influenza in Indonesia had risen to 112 following the recent death of a 19-year-old man.

 

 

I will not belabor the issues of accuracy of the tests. We all know they are fraught with false negatives. However, if all thirteen villagers have indeed already recovered then it is highly unlikely that they were suffering an H5N1 infection. Unlikely though it is, it is not guaranteed, however at this point in time, it's a good enough assumption.

 

It's "good enough" because the Indonesian government has proven to be less than fully transparent with the rest of the world, we have a test that is officially only presumptive at best, but mostly because there isn't a thing any of us can do about what is or isn't happening in the village of Air Batu and to its residents.

 

Can we take comfort in the fact that WHO arrived on the scene and if there were a genuine cause for greater concern we would be well served by their presence and actions? Maybe. Maybe not.

 

As I typed that sentence it came as something of a surprise to me that I actually do take comfort in the WHO's presence. Perhaps a sign I have not lost all of my naïveté, or perhaps my expectations have eroded so severely that the World Health Organization represents, at least to me, our Last Best Hope for anonymous Indonesian villagers and their 6.x billion neighbors.

 

Then again, perhaps it's a combination of being naïve with very low expectations. Hey, isn't there a term for that? Yeah, I think there is, and I think it's something along the lines of "clueless".

 

SZ

It may or may not be H5N1

 

 

Wouldn't you know, I am swimming against the tide of "month end" and Indonesia becomes a news item.

 

Reuters UK is running the story of 13 people who have fallen ill and suspected as being infected with H5N1:

[Excerpt]

JAKARTA (Reuters) - Thirteen people from a village in Indonesia's North Sumatra province have been hospitalized after suffering symptoms of bird flu, a media report said on Wednesday.

Sinar Ginting, a spokesman for the Adam Malik hospital in North Sumatra's capital Medan, was quoted by Kompas.com as saying that two patients from the group had been transferred to the hospital early on Wednesday morning.

The other 11 from Air Batu village were being treated in a local hospital, he said.

"They have bird flu symptoms such as fever and breathing difficulties," Ginting was quoted as saying.

Not all the patients were believed to have had contact with fowl, which is the most common way of contracting the virus, but Ginting said some chickens in the area had died suddenly and were found to have had the deadly H5N1 virus.

Indonesian health ministry officials could not immediately be reached for comment.

 

 

This early in a situation half a world away it is impossible to know if this is something to be concerned about or just another "something" from a long list of potential "somethings" that are of no concern beyond those connected to the situation. I would be less than honest if I said that this story didn't cause me at least a modicum of concern. Three dead of an unidentified illness in a short span of time, along with somewhere around a dozen others ill would always cause me to watch a situation. But, this is after all, Indonesia, and we are painfully aware of some rather glaring shortcomings when it comes to efficient and proactive actions in the face of H5N1.

 

I would like to say this however, it is not at all likely that all of these cases are H5N1, even allowing that a few might be. For the answer to that we may have to wait weeks or months if this is an isolated outbreak that will settle right down as they have in the past. If, however, and is emphasis if, this is a significant cluster with human transmission involved, we will not have to wait very long at all. With that many cases of a transmissible virus and the cases begin to mount rather rapidly, even if only locally.

 

Finally, it has been my long held belief that it is not so much a single person infecting another person or two, or even three that we have to worry about, it is when we see transmission onto a third and fourth generation. And it is that that I, and others, will be watching for, the third and fourth generation in a connected chain of transmission.

 

Unfortunately, it is only a few watching. Indonesia's problems with H5N1 have become such a common story that it is no longer even much of a story. Tomorrow is the eve of the Olympics' opening ceremony and the world's attention will be riveted to the happenings in China, not unwarranted mind you, but the Olympics will drown out much of any other international news.

 

Added to the natural draw of the Olympics is the "side story" of the media and the Chinese government. Nothing captivates the media's attention more than stories about the media being victims of censorship or ill treatment. China appears to be willing to weather their wrath with all the contempt of outsider's opinions that China has shown historically. I suspect a few anonymous villagers ill and dying in Sumatra Indonesia cannot compete for journalistic attention when said journalists will be a "news item" themselves.

 

And so the "few" watch.

 

SZ

Rules

Life has rules. They are everywhere and cover pretty much everything. Some rules are loosely defined and others immanent (Natural law), the nuances of Hobbs and Locke aside. International Treaties fall closer to the Natural Law side of the sliding scale, if not solidly upon it.

International Treaties generally fall into two categories, those that agree to perform a specific action and those that agree to refrain from a specific action. Countries can adopt a mutual defense treaty with others [action] and countries can adopt a treaty banning above ground testing of nuclear bombs [refrain from action]. The Kyoto Treaty [alternately known as The Kyoto Protocol] is an example of a treaty that parties agree to both action and inaction with its ratification.

Historically it has been the treaties of restraint that carried the greatest probability of international penalties or sanctions. These certainly have not been evenly and consistently enforced, and often countries gamble as to what the international community's reaction will or will not likely be. A few examples of reaction testing can be found in the nuclear development programs of some countries, and not one suffered (Iraq was a broader issue).

In fact, it has been demonstrated several times in our recent past that flaunting a treaty produces positive outcomes for countries as the international community resorts to what amounts to bribing a country to cease offending actions. There are few enforcement options and pretty much zero will to enact those few. Either countries live up to their treaties or they don't and the rest of the world pretty much has to accept it.

 

This week Indonesia caused yet another stir with Health Minister Siti Fadilah Supari's interview statement that her country will no longer announce H5N1 deaths as they occur, but rather on some yet to be officially determined schedule, from a month to upwards of six—or so. Here is a representative story of the many that covered the incident, but since I am late to the table I suspect I don't need to post on yet again.

 

Supari's gamble may pay off, literally as well as figuratively, and hey, more power to her. I hope she is successful in whatever it is that is driving her actions. The world moves on, and it's time that it move on without Indonesia. But I can't help wonder what Hobbs and Locke would think of these developments.

At one time a person's word was nothing short of a sacred bond, broken only by the lowest of scoundrels and a country's word was pretty much a bankable asset. Yes, the world moves on, and not always in the right direction.

 

SZ

Did She or Didn’t She

The influenza virus undergoes continual evolutionary change.  The swapping of whole genes between strains of influenza, reassortment, is known to be the mechanism that produced the 1957 and 1968 influenza pandemics, and therefore considered the main mechanism of producing our pandemic strains. 

Scientists, along with the “Flu Obsessed”, have been concerned that H5N1, currently a wholly avian influenza virus, would reassort with a human influenza virus. H1N1 and H3N2 being the two current human type A Influenza viruses in circulation.  In order to accomplish this sleight of hand on the genetic level a single virion (a single virus) from each different strain of virus, one from H5N1 and one from a currently circulating strain would have to infect the exact same human cell at the same time.

Now, without getting into a whole bunch of mind numbing scientific minutia there are tremendous hurdles that the second virus would have to overcome in order to infect a cell already co-opted by another virus.  For those curious, the mechanisms of those hurdles at work are cell apoptosis and cell superinfection; high points relevant to influenza can be found at the links. 

For those satisfied with the broad-brush strokes nature has it set up so that it is almost impossible for more than one influenza virion to gain entry into a cell, and apoptosis (the death of the invaded cell) occurs within hours of influenza entering a cell, variable, but 4 – 6 hours is probably the operative range.  Combined they form rather strong prima facie evidence that a single cell being infected by two different influenza strains is generally an extremely rare and difficult happenstance.

Yesterday CIDRAP’s Maryn McKenna reported on a bombshell that was dropped at the International Conference on Emerging Infectious Diseases by Indonesia’s Vivi Setiawaty of Biomedical and Pharmaceutical Research and Development about a 16 year old Indonesian girl who is reported to have been infected by H5N1 and H3N2 at the same time, known as a co-infection.

A snip from Ms. McKenna’s report offering an excellent glimpse into the confusing issues presented by this paper:

Throat and nasal-swab samples that were taken on the 6th day of her symptoms tested positive by reverse-transcriptase polymerase chain reaction (RT-PCR) for both avian influenza H5N1 and the seasonal flu strain H3N2 at the Indonesian National Institute of Health Research and Development. Serology test results were less clear. Antibody titers from serum samples taken the 6th day provided a weak indication of H5N1 infection (titer of 1:10) but were negative for H3N2; convalescent sera, on the other hand, gave a strong indication of H3N2 infection (titer of 1:640) but were negative for H5N1.

RT-PCR testing, the first test performed, and the one that came back positive for both H5N1 and H3N2, is the most prone to false results, and officially treated as presumptive pending further testing.  Blood was drawn the same day (6^th day of illness) and it came back showing a weak titer response for H5N1 but none at all for H3N2.  Blood tests that early in an infection are notorious for giving “false negatives” as the body generally hasn’t had enough time to produce antibodies that would be freely circulating in the blood.  This is true for human influenza infection, and as far as I am aware, at least generally true for an H5N1 infection.

The later blood test, referred to as “convalescent sera” (blood taken later or after recovery) was strongly positive for H3N2, and would be what one would expect to see after an infection since the body has had time to produce the freely circulating antibodies.  This same test came back negative for H5N1.  Blood tests several weeks after an infection are considered definitive when proving infection or non-infection, with the caveat that the tests were performed correctly of course.  Lastly, it is worth noting that H5N1 has historically produced a strong- to- excessively strong human immune response, so a lack of climbing antibody titers would seem unlikely in the extreme for an infection in a sixteen year old.

We have two choices when deciding what to believe.  We can believe the most prone to error test shows the correct results and believe that the most definitive test was done incorrectly producing a “false negative”.  Or we can believe that the test results as this report states are what they are but the interpretation of them may need further review.  Since no independent verification from a WHO reference laboratory was conducted we may never know for sure, but I choose to class this as a “maybe, but highly unlikely” case of a co-infection of H5N1 and H3N2 until I have more information.

I would be remiss if I didn’t say that being ill with two different strains of influenza at the same time is probably not impossible, and may not even be that terribly unusual when multi-strains are co-circulating in the population.  However, I am trying to say that those two strains would not likely infect the same human cell within such a short time span, something evolution has mechanisms in place to guard against. 

Added to the time and biological improbability is that now, to the best of our knowledge, avian influenza and human influenza do not infect the same types of human cells.

Since it is that, the two strains meeting up in the same cell(s) and exchanging genetic material, which makes this case such a potential bombshell I felt it important to list out all of the issues as I understand them that would argue against it, both in general and with this case specifically. 

Who knows, perhaps next week more information will be available and I will revise my opinion and assessments.  I would be the last person to say I have the answer to this puzzle, but I do have an insatiable appetite – an appetite not likely to be satisfied any time soon – to understand the myriad pieces spread out on the table before us.

SZ

Politics and bird flu are not a good mix

I make no secret of my disdain for the Indonesian Health Minister Mdm. Supari and her actions and policies regarding Indonesian samples of H5N1. Yesterday a "voice" from Indonesia was heard.

This from the Jakarta Post:

Politics and bird flu are not a good mix

Emmy Fitri, Jakarta

People will do so much to be called a hero, even if it's too late or way too early to be one. That's a dreadful afterthought having read an interview in the journal Nature with Indonesian Health Minister Siti Fadilah Supari.

In the interview, published online on Dec. 19, Siti explained why Indonesia has persistently refused to share its H5N1 virus samples with the WHO until it is assured of a vaccine supply in the event of a pandemic.

She was quoted as saying "Indonesia is open to international collaboration but this must be fair, transparent and equitable. The WHO's Global Influenza Surveillance Network system is obviously unfair and opaque. Samples shared become the property of the WHO collaborating centers in rich countries, where they are used to generate research papers, patents and to commercialize vaccines. But the developing countries that supply the samples do not share in these benefits."

With those strong words against the world, are we off the hook simply because we are be poor and bear the huge burden of a population over 220 million? Are we excused for being ungrateful after so long relying on the generosity of donors and international agencies in fighting diseases, including the big three -- AIDS, tuberculosis and malaria?

Most of all, is it the right time to challenge a long-standing protocol after decades of compliance? Why now? Why not 10 or 20 years ago, or next year?

By and large, are we really aiming at contributing to a better world by stubbornly holding the samples with one hand while the other hand fumbles about so clumsily for international aid?

[snip]

Isn't it natural that if we want to fly, we cannot just wait for angels to lend us wings? We have to learn how to make aircraft. There is so much to be done to show the world that we are not so poor and needy.

Preventing more deaths by educating the public about proper poultry handling is the top concern. Unlike diplomacy and politics, viruses don't discriminate. It is just irrelevant to bring up a political perspective in the name of the nation's dignity. The minister could have better used a little politics to butter up parliament members and provincial and regental officials in order to get more funds and resources to battle the virus.

[snip]

A tropical country, Indonesia is a hotbed for germs, viruses and bacteria. Yet people show scant awareness of good sanitary practices. They are not the only ones to blame for their ignorance, since apparently the government's development and education programs have not yet picked up on the fact that we are all living with lots of microbes.

Not only is there no effort to translate the threat of disease into public policies and educational content, but generally speaking, health issues are treated as second-class.

It's not surprising that Indonesia is so dependent on the private sector and the international community' generosity in containing diseases, even those endemic to this country. It stems from the government's failure to prioritize money and strategies to strengthen the health sector.

[snip]

Globally, bird flu has vaulted into the limelight because of fears that the H5N1 virus could mutate so that it can be transmitted from human to human, thus laying the groundwork for a pandemic.

The 1918 flu virus caused one of the worst pandemics in human history. It's frightening to think how quickly a disease spread through a cough or handshake might travel today, as people fly from one continent to another at the drop of a hat.

To imagine a pandemic hitting Indonesia -- heaven forbid -- is unbearable.

Do we need human vaccines in a time of pandemic? Even if we do, the global production capacity, currently estimated at less than 500 million doses per year, will never meet the need.

A down-to-earth effort which is less costly than waging war against the world must be devised. As recommended in the December Ministerial Meeting in New Delhi, non-pharmaceutical measures must be pursued vigorously.

[snip]

If anything has to be politicized, let's use political diplomacy to convince state officials that the threat is real and people's lives at stake because of their ignorance.

The author is a staff writer at The Jakarta Post.

 

How refreshing. It is also only one voice to counter HM Mdm. Supari and her fanning of Nationalist flames that have included blunt statements that H5N1 is a creation of the West, and specifically, the US.

WHO Fails to Sway Indonesia

Reuters released a tiny blurb a few hours ago: WHO fails to reach an agreement with Indonesia over sharing H5N1 viral samples. No surprise.

GENEVA, Nov 23 (Reuters) - Health officials have failed to reach agreement on a new system to ensure developing countries benefit more from sharing bird flu viruses used to develop vaccines, the World Health Organisation said on Friday.

"Nobody can fault you for not trying ... It is so close, yet so far away," WHO director-general Margaret Chan told the final session of a four-day meeting. (Reporting by Stephanie Nebehay; Editing by Jonathan Lynn)

It reminds me so much of Turkey's stand with the US when it requested that US troops be allowed to stage on their border, and launch an invasion from it into Iraq. Turkey kept telling us no because they wanted thus and so, and couldn't imagine that the US was in any position to deny whatever they requested, the US kept saying no because they couldn't imagine that such a good ally would deny us such a vital request. In the end, neither got what they wanted. Turkey was shocked the US turned down their demands, the US was shocked Turkey refused their request.

From this side of the issue I found the wording quite interesting. According to WHO the international body "failed to ensure developing countries benefit more from sharing viruses used to develop vaccines". Reading those words it is easy to interpret that the world does not want to share any of the scarce vaccines, which is simply not the truth.

Depending on whose figures you choose to read—and believe—the world will have between 500 million and 1.2 billion vaccines should the pandemic happen in the near future (1 – 3 years). The low figure is pretty much where we are now, the high represents a year or two out and if everything happens perfectly with new processes and adjuvants (still in trials and not yet approved). Therefore, I would assume the true figure rests somewhere in the middle of the two figures.

Indonesia has a population of ~250 million so that breaks down to either half or twenty percent of the entire world's yearly production of PanFlu vaccine.

Indonesia has complained that when it wanted to buy Tamiflu the "rich countries" had bought up all of the supply. Perhaps… but Tamiflu was supplied by Roche on a first-come-first-serve basis. Moreover, there is the simple fact that Roche donated 3 million Tamilfu treatment courses to WHO for rapid deployment. To say nothing of this little tidbit:

From USAToday 07Dec05:

[snip]

Tamiflu is not patent protected in some countries, including Indonesia. That means the drug can be made there without compensation to Roche. Indonesia has said it would make its own Tamiflu for domestic consumption.

This from People's Daily Online 16Dec05:

[snip]

Indonesia has sufficient stock of Tamiflu tablets for remedy as well as license from the Swiss drug maker Roche Holding for production of the tablets.

According to Health Minister Siti Fadillah Supari, Indonesia would produce anti-bird flu vaccine for human next year. "We will produce the vaccine in January and the vaccine can be marketed in December."

Indonesia is also nearly free from polio outbreak, after the country vaccinated over 24 millions youngsters nationwide in three rounds during the last three months.

The World Health Organization says that the drives have significantly decreased the development of the polio virus and recommended two more rounds soon, in order to completely reach the possible un-reached youngsters during the three rounds.

"We will continue [polio] (the immunization). All funds needed have been obtained, " Health Minster Siti Fadillah Sufari said, adding that 70 percent of the funds was donated by the World Health Organization (WHO), the United Nation Children of Funds and international rotary organizations, while the rest was from state budget.

"After March we will be free from polio," said Fadillah.

In addition, let us not forget the (USD) 10 billion for Tsunami relief in international aid, Indonesia being the recipient of much of that aid.

The country of Indonesia is a mess, there is no arguing it is a country in need of international aid, which it receives, as much of the world is generous to people in need.

I am in favor of free enterprise, capitalism, and all that; if you have something that someone wants there is generally an exchange of value, monetary or otherwise. However, at the same time I subscribe to the belief that when there is need those that can remedy the need should do so, most religions have the concept of "good works", some integrated as a required tenant. Indonesia has been the recipient of many "good works", governmental and NGO; it's Indonesia's turn to answer a call of need.

Roche gave up its patent so that Indonesia could manufacture a drug that the world is scrambling for; I applaud Roche for such action. Had they not I would be, and have previously, advocate for patent busting where Tamiflu is concerned. People's lives should not depend on a further fattening a corporation's coffers, not when there is no reasonable ability to pay.

The simple fact is the world needs the samples for monitoring changes not for pandemic vaccines. A pre-pandemic vaccine will be akin to a bucket brigade fighting a burning barn, better than nothing, and a slim chance of working. The world could just as well make up the less-than-perfect pre-pandemic vaccines from virus samples from Egypt.

Pandemic specific vaccines will come so late and to so few that the issue really isn't an issue at all. Should an influenza pandemic happen before 5 years have passed we will face it naked, or at least the vast majority of the world's citizens will. I will be just as lacking in vaccine as the average Indonesian. As will my husband, and daughter-in-law. Maybe, if we are very lucky, my grandbaby might get one around month 8 or 9 of the PanFlu—maybe. Oh, my son will get one when they vaccinate the First Responders/Law Enforcement—if he avoids infection long enough—and lives long enough. But given his dealings with the public and his age neither of those things are very likely.

No, Indonesia gets no sympathy or understanding from me.

However, the real issue is we need the virus samples to know what is happening with the virus itself. We need to know the changes the virus is undergoing in Indonesia. Is it moving closer to human adaptation—or farther away? Stasis in a virus is not to be hoped for so I do not even consider that a possibility. Is it time to pull out all the stops and gird ourselves for a pandemic or do we still have time? Only analysis of the virus itself will answer those questions.

Of course, I have said pretty the same things many times before. I admit the issue is a "hot button" with me. Mdm. Supari's rhetoric spawns mine, the difference is though, mine represent a few bits and bytes in cyber space, hers may well represent human lives, perhaps even lives that I treasure above my own.

Just as Turkey tried to extort a critical need, so too Indonesia. Perhaps Indonesia would be well served to look up what Turkey got for all of its intractable and exorbitant demands.

SZ

Indonesian Viral Samples and WHO

I have addressed the issue of Indonesia and its refusal to share the H5N1 virus samples that WHO needs more times than I ever thought there would be need of, much less have the words for. However, this issue refuses to go away or find a resolution. My last post on the issue was just last week.

WHO convened a four day meeting in Geneva on Tuesday (20Nov07) to address Indonesia's claims and demands with respect to H5N1 viral samples and vaccine end products, the fifth such meeting this year.

Indonesia claims ownership of any H5N1 virus that exists within its borders. As reported in Reuters:

[snip]

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. (Emphasis added)

A(H5N1) is a virus. A(H5N1) is not an invention or a product of manufacture. A(H5N1) is not an idea, or the product of talent or creativity. A(H5N1) is a virus, oh, and by the way, viruses do not even meet the biological requirements of a life form.

Put bluntly: The sovereign country of Indonesia did nothing to invent, create, manufacture A(H5N1), nor did any of its citizens. In fact, just the opposite, a great deal of effort and money has been expended by Indonesians to eradicate the virus, much of the funding, expertise, and equipment to do so was donated by the international community.

In my previous posting I quoted the WIPO (World Intellectual Property Organization) finding (PDF link) explaining the fallacy of holding Intellectual Property rights over a naturally occurring virus, and I won't belabor the point once again—although I am sorely tempted just to express my own personal indignation over this entire concept.

Now, as far as I'm concerned, Indonesia can KEEP the damnable virus, as long as they KEEP it within the confines of their nation's borders.

For the "moral" aspect, I will draw upon a few comments by some of the other major players:

Pacific News Center Correspondent 11.NOV.07
12:04 p.m. Avian influenza continues to worry the Asia Pacific region's health officials. "One of the greatest threats to the survival of the human race," is how Dr. David Nabarro, the senior UN Coordinator for Avian and Human Influenza, told told reporters in Bangkok, and that while "Nations have made progress in containing the virus' spread, there remain some problem areas." [Emphasis added]

Opening remarks at the Intergovernmental Meeting on Pandemic Influenza Preparedness
Geneva, Switzerland
20 November 2007

Dr Margaret Chan
Director-General of the World Health Organization

[snip]

The prospect of an influenza pandemic raises some very big issues for public health. For WHO, the biggest issue is the threat that an influenza pandemic poses for global health security.

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. As I have said on several occasions: this shared vulnerability calls for shared responsibility, and collective action to fulfil [sic] that responsibility. In terms of the risk of disease, we really are all in the same boat.

[snip]

We must never lose sight of what a pandemic can mean under the unique conditions of the 21st century. SARS taught us how much the world has changed in terms of its vulnerability to the economic and social disruption caused by a new disease.

And SARS was by no means a global event. It was not a pandemic. SARS was largely a disease confined to the hospitals of wealthy cities.

Think of what may be in store. The last influenza pandemic began in 1968. At that time, airlines were not carrying more than 2 billion passengers each year, as they do today. HIV/AIDS was unknown in 1968. Tuberculosis had not resurged as a global threat.

At that time, in 1968, the world did not have the internet, which has spawned global interdependence in so many areas. This interdependence has greatly amplified the economic and social disruption that new diseases can cause.

Pandemics are recurring events. Countries need to brace themselves for a situation where up to 25% of the workforce may be ill at a given time. They have to brace themselves for a possible meltdown of basic municipal services and a slowdown of economic activity.

And this situation will be occurring globally. There will be no fortunate unaffected parts of the world.

[snip]

Analysis and comparison of viruses allows WHO to update reagents and test kits. This contributes to diagnostic precision and sharpens surveillance. The sharing of currently circulating viruses is the only way to monitor the emergence of drug-resistant strains.

But above all, the sharing of viruses is the foundation of risk assessment. The analysis and comparison of viruses give us the first clues, the first early warning, that the virus may be evolving in a dangerous way.

This is our key difference from the past – this capacity to pick up the signal that tells us to gear up our defences and prepare our populations. This is one of the biggest advantages of the advance warning we have been given.

[snip]

We have been given a unique opportunity in the form of an advance warning. We must not – I can say, we dare not – squander this opportunity. The stakes are too high.

How will history judge us, collectively, as an international community, as an agency like WHO, responsible for safeguarding international health security, or as individual countries? As I said, we have a shared responsibility to pursue collective security.

With this question, I also want to give you a challenge. This is now the fifth large meeting, held this year, concerned with the sharing of viruses and access to vaccines and other benefits. Millions of people outside this hall depend on us to make progress. [All emphasis added]

Heartfelt and impassioned pleas from people who carry a heavy burden.

Quoting again from yesterday's Reuters article:

Experts fear the constantly mutating virus could change into a form easily transmitted from person to person and sweep the world in months. A pandemic could kill millions of people, shut down businesses and overwhelm health care systems, they say.

What drives this fear and passion? The simplest answer it's all in the numbers.

Using round numbers:

There are six+/- billion of us

If 30% of us become ill that equals 1.8 billion

If 2% of the ill die that equals 36 million dead.

Those figures represent the Centers for Disease Control's (CDC) threshold for a severe pandemic, termed a Category 5 Pandemic on their severity scale of 1 – 5. And, just like with the Safer-Simpson scale for hurricane strength classification, which the pandemic scale was modeled on, there is a lot of severity above the threshold, but once that threshold is breeched it becomes, in many ways, academic. Catastrophic is—catastrophic.

Further reducing human beings to numbers and percentages: Every 1/10^th of 1% of six (+/-) billion equates to six (+/-) million Men, women and children. Living, breathing, laughing, loving and loved, souls.

Those figures (human beings) would drive heartfelt impassioned pleas from my lips as well. Dr. Chan is correct when she framed the issue, not in pre-pandemic or pandemic vaccines, but in seeing this monster come at us. Again, the hurricane analogy is apropos: with several days warning generally afforded for a hurricane people have the opportunity to get out of harm's way. Without knowing a hurricane is coming loss of life is needlessly compounded, even for a moderate hurricane. Pandemics are no different.

In order to see what is (or is not) headed our way pandemic wise viral samples from every human occurrence must be analyzed and vetted by the scientific community. Indonesia has a moral obligation to participate in the scientific early warning system; or to use Mdm. Supari's own phrase: "it's the moral thing to do".

SZ

Indonesia’s Viral Samples: Still and Again

Some days it's just not a good idea for me to read the news. I am barely coherent due to pain from an injury I sustained yesterday because I wasn't paying attention due to mental fogginess from illness, (in other words: this day finds me pretty much a mess) and yet—and yet—Indonesia, or I should say Indonesian Health Minister Supari, has once again driven me to nearly apoplectic fits of rage and indignation.

From The Jakarta Post:

RI demands WHO return bird flu samples

JAKARTA (JP): The virus sample sharing deal between the Indonesian Health Ministry and the World Health Organization has been criticized after the ministry's repeated requests for the return 58 bird flu viruses have gone unanswered.

Health Minister Siti Fadilah Supari said Thursday the ministry asked for the return of the samples three months ago, but had yet to receive any response.

"We have been demanding the return of our viruses since August, but the WHO has never replied," Siti told a media conference regarding National Health Day, which falls next Monday.

Siti said Indonesia did not keep a stockpile of seed viruses because international regulations did not allow it.

"The regulation is actually detrimental to us, because it obliges the source country to give up all its samples." (Desy Nurhayati)

 

Those who have been reading my humble blog for any length of time and regularity know that I suffer no patience when it comes to Indonesia sharing, or not, the H5N1 virus samples with WHO (World Health Organization). Too much is at risk for the entire world's population for any one country to act in a wholly selfish manner, but I admit that that view is strictly driven by a sense of "fairness" informed in no small measure by a generalized belief that when one can do something to prevent human suffering and/or death one is morally obligated to do so.

Morality is not universally defined across individuals, or even across societies, so an appeal on moral grounds serves nothing more than recording a personal belief. For appeals that carry the weight of policy we have to look to our international organizations, in this case the UN, and more specifically WHO.

Since I could do no better I will quote from CIDRAP's Oct 17, 2007 piece on where we stand in regards to Indonesia's claim of "ownership" of the viral samples.

WHO report explores patent issues concerning flu viruses

Oct 17, 2007 (CIDRAP News) – The World Health Organization (WHO) yesterday released a report on patenting issues related to influenza viruses, following up on a resolution adopted by the World Health Assembly in May to address the concerns of Indonesia and other developing countries about access to pandemic flu vaccines and treatments.

The report was prepared by the Geneva-based World Intellectual Property Organization (WIPO) and will be presented at a WHO intergovernmental meeting on virus sharing and access to vaccines, which will take place in Geneva from Nov 20 through 23. Like the WHO, WIPO is a United Nations agency.

Indonesia stopped sending H5N1 samples to the WHO last December as a protest, saying the country couldn't afford the vaccines that drug companies would develop from the virus samples they submitted. Since then Indonesia has shared only a few samples.

Indonesia's action raised the possibility that it and other countries affected by H5N1 flu might claim legal ownership of H5N1 isolates. Researchers need H5N1 samples to track the virus's evolution and drug susceptibility and to develop vaccines.

The 41-page WHO report emphasizes that its purpose is to provide technical background information on patent issues related to influenza viruses, not to address questions such as benefit sharing, virus surveillance, or vaccine production.

[snip]

The authors, while not making definitive legal assessments, highlight several observations. Among them:

Early, open publication of the gene sequence of a newly isolated flu virus strain would preclude patent protection, but would facilitate broad-based research and development.

Sequencing a gene using regular laboratory techniques is not likely to be considered inventive or nonobvious enough to warrant a patent.

Unless there is a clearly disclosed and defined new and useful function, most countries deny patent protection for gene sequences.

Initial searches did not find any patents for wild viruses, though there were several for newly engineered genetic materials such as synthetic virus-like particles (VLPs), methods of producing them, and vaccines produced from them.

Patent rights are not absolute. For example, many national patent laws allow researchers to use patented inventions for certain purposes related to research but not to commercial application.

 

 

My day job is in the accounting department of a local branch of a publicly traded corporation. As such we have to operate by what are known as GAAP (Generally Accepted Accounting Principles) and SOXS (Sarbanes/Oxley) standards and regulations. These standards and regulations do not benefit our location in any way, but are required to meet the business obligation that any publicly traded entity has to its stock holders.

 

Clearly a sovereign country is not a public corporation, and yet the analogy has merit in my estimation. A country has obligations to its citizens, its shareholders if you will, as well as to the wider community, in this case the rest of the world, and analogous to the stockholders that find themselves at the mercy of oversight to ensure, with best practices, the overall health of financial investments in general.

So not only do I find Indonesia's behavior offensive on a strictly personal moral level, I find it offensive and in violation of best practices for the health and wellbeing of 6.x billion world citizens, of which 250 +/- million happen to be Indonesians. That's 3.8% to the 96.2% rest of us.

The world needs Indonesian virus samples to be submitted to the governing body of such things, WHO. The world needs them because the world, all 6.x billion of its human inhabitants, risk being either direct victims of an influenza pandemic or its ancillary and tertiary effects. In order to help monitor the threat and plan mitigations, we, all 6.x billion of us, require the knowledge locked away in those virus samples to be made available to those that will further the goals of monitoring and mitigating.

 

As I have said any number of times before:

Indonesia: Cough up those samples! (Pun fully intended).

 

Attempting to frame the argument in such a way as to say that WHO already has 58 (willingly submitted) viral samples, that by your opinion it has no right to retain, thus divesting any further requirements of viral submission is intellectually bogus as well as insulting.

 

SZ

What Is Going On In Indonesia?

Over this past week we have seen a flurry of new H5N1 reported infections and deaths in Indonesia.

Has H5N1 changed and that is why we are seeing more cases and more deaths?  Could it be that the situation hasn't changed, but Indonesia is being more forthcoming about the severity of their problem?  Or, could it possibly be that Indonesia is attempting to scare the world into buckling under to their vaccine blackmail campaign?

I don't have the answers to the questions, and I don't believe that anyone outside of Indonesia does.

 

As a self described Information Junkie it drives me crazy to have questions that I have no means of answering.  Questions that I feel are vitally important, not only to me, but to the world at large.  And, since I am also an Internet Junkie, I am spoiled by having the world's public knowledge pretty much at my beck and call.  I am just not used to having a quest for information stymied and frustrated.

It would not be so bad if I thought there was someone, or a group of someones, who had a factual understanding of the situation, but since I don't believe there is anyone that fits that description, and that goes for the government of Indonesia itself, I am suffering a junkie's unrequited hunger.

 

A week ago I was not at all concerned about Indonesia.   I was irritated and angered over their viral sample blackmail shenanigans, but I was not overly concerned about what H5N1 was doing on the human infection front.  It wasn't that I didn't appreciate the danger that the Indonesian sub-strain could suddenly obtain the ability to readily transmit from one person to another, but H5N1 seemed to have reached a long held level of stability even with the gross mismanagement by the government.

 

Indonesia is demanding free Pandemic Influenza vaccines from the pharmaceutical industry that would use the virus samples coming out of their country.  Viral samples that Indonesia says it owns because they happen to exist within the confines of that country's boarders. 

Indonesia says that the pharmaceutical industry must meet their demands because the world needs the their viral samples.  The world needs the Indonesian samples because the sub-strain is such an immanent and deadly threat to the entire world.

Yes, it quite possibly is an immanent and deadly threat to the world, but almost exclusively because Indonesia has done such an abysmal job of controlling the outbreaks.  No, that is an incorrect statement.  They haven't done an abysmal job at controlling H5N1, that would connote that they have actually attempted control measures.  They have not, not with any sincerity anyway, and certainly not with any effectiveness.

 

There is a model used when one nation threatens the world, or another nation's security, nay, very existence as a nation. 

Indonesia's gross mismanagement of their virus threatens the entire world.  It's time the world's more responsible governments, governments that actually deserve to be called governments, put real, and substantial, pressure on Indonesia to release those viral samples.  It's not the world that owes Indonesia, it's Indonesia that owes the rest of the world for putting us at the edge of the abyss.

 

How close to the abyss are we standing?  Have we already fallen in and just don't know it yet?  No one knows.  The last announced agreement I saw was that Indonesia has agreed to forward samples for analysis only within two months.  Two months.  Two months with no answers.

President Sisilo Yudhoyono should probably be comforted that I am not sitting behind President George W. Bush's desk.  It's a very dangerous thing to stand between a junkie and the item of their addiction.

 

SZ (still as vaccineless as the average Indonesian, and as ill-informed as President Yudhoyono)