Immunocompetent

WHO, NAMRU-2, and Indonesia According to the US Pacific Command

perezoso — Tue, 02 Dec 2008 09:41:35 -0500

Stashed away in a somewhat obscure corner of the .mil webzone are an interesting set of H5N1 reports. Prepared about every week by the US Pacific Command (PACOM) and the Australian Army's Land Headquarters (LHQ), the reports summarize recent developments with H5N1 with an interesting twist. Who they are prepared for isn't clear; but Immunocompetent thinks they look like a slide that goes into scheduled briefing for higher-ups somewhere on the military food chain, probably at the Office of the US Secretary of Defense, on whose website the files can be found.

We have some choice extracts below; but there's plenty more interesting reading that you can download. (And if the OSD "disappears" this information off its website, we have a complete archival copy.)

The reports, marked "unclassified", provide abbreviated updates H5N1 cases worldwide; but they are more interesting for what they select as newsworthy H5N1 politics.

Recently, PACOM has been very interested in the NAMRU-2 negotiation and the WHO PIP IGM, and the reports have included information not public elsewhere. For instance, details on conversations between WHO staff and US government representatives, and on the (apparently failed) bilaterals between Indonesia and the US. (These were facilitated by Australia.)

The reports, at least recent ones, appear to be prepared by Air Force Lt. Colonel Peter Breed, who was recently listed as the PACOM's Chief of Force Health Protection. PACOM is headquartered in Hawaii.

There is no direct publicly-accessible URL to see a listing of these reports (it appears to be only available to people in the .mil and .gov domains). Instead, if you have construct a Google search that will hit them. This search works pretty well.

In short, the reports offer an interesting view into Bird Flu According to The Pentagon. And they show just how closely the US (and Australian) military are following H5N1 issues. Here are some recent extracts:

31 October 2008:
CEO of Indonesia’s National Committee for Avian Influenza and Pandemic Control (KOMNAS), reportedly told French officials that the “successful” GOI-USG negotiations,” facilitated by Australia, could lead to an end of the sample-sharing impasse at December’s WHO Intergovernmental Meeting.

24 October 2008:
Indonesia: Legal proceedings against the USG and WHO brought in April 2008, alleging responsibility for the death of an Indonesian from H5N1 have again been postponed. As a result of internal debate, the court further postponed a decision regarding the proceedings until perhaps mid-December.

26 September 2008:
Indonesia: (1) NAMRU-2 laboratory will be temporarily shut down because it offers "little benefit" to Indonesia said the GOI’s MOH. Negotiations between the USG and GOI are ongoing. U.S. HHS Secretary said Indonesia's refusal to share its samples of the H5N1 virus with the rest of the world has spilled into the NAMRU talks. (2) USDEL in Manila reported in conference calls September 21 and 22 that the two delegations, in discussions facilitated by Australia, made progress in reviewing a U.S.-drafted notional materials transfer agreement (MTA) text, as well as a text on Terms of Reference (TORs) for the WHO influenza surveillance network provided by Indonesia

19 September 2008:
Indonesia: The next round of consultations involving Indonesia, the U.S., and the WHO Intergovernmental Meeting Chair (Australia) on sample and benefit sharing is scheduled for September 21-22 in Manila. USG will draft a human influenza virus model Materials Transfer Agreement for discussion in Manila.

12 September 2008:
(2) MOH recently claimed that developed countries are creating new viruses that are meant to infect people in poorer nations in order to help drug companies sell more vaccines.

...

WHO Assistant Director-General David Heymann spoke with Special Rep Lange today about the November Intergovernmental Meeting on Pandemic Influenza Preparedness. Based on his conversations, Heymann expects that developing countries will seek recognition of some kind of “viral sovereignty" and will agree to continue sharing human influenza virus samples only in return for “sustainable” benefits (i.e., some system by which developing country access to benefits, such as vaccine stockpiles, is guaranteed over the long term).

29 August 2008
India/Bangladesh: The bird flu virus, that caused India's worst AI outbreak, has been found to be "a lot similar" to the one in that cause havoc in Bangladesh. However, we can't say that Bangladesh was the cause of the outbreak. Sources said India complained to FAO and OIE about Bangladesh's slack handling to contain the virus, putting at risk India's internal security.

Indonesia: GOI authorities are now reporting possible human AI cases to the WHO within 24 hours in compliance with the International Health Regulations. WHO does not report Indonesian cases until the GOI MOH announces them, on a monthly basis. However, if there are international public health risks, WHO will report it with or without GOI permission.

18 July 2008:
Indonesia: A WHO official confirmed to Embassy Jakarta on 16 July that the GOI had reported a new, confirmed human AI fatality: a 38-year old male resident of Tangerang municipality died on 10 July. A WHO representative told Embassy Jakarta that Health Minister Supari had assured him that Indonesia would comply with the Health Regulations by notifying WHO of fatalities.

11 July 2008:
Indonesia:(1) MOA “temporarily”bans import of U.S. poultry. Poultry “treated to inactivate the avian influenza virus”is exempt, if it can pass a “risk analysis”and is approved by MOA. (2) Australian Authorities have sought clarification of Indonesia’s policy on reporting human cases of avian influenza to the WHO. A senior Australian official has said that Indonesia’s management of avian influenza is severely deficient.

3 July 2008
Indonesia: GOI and USG plan to meet in Australia, 25-28 July 08, to discuss next steps toward resolving sample sharing issue.

20 June 2008:
Reporting of these 2 cases demonstrates that Minister Supari is somewhat cooperate with WHO, but reporting not done within 24hr International Health Regulation requirement agreed to by the 193 member states of WHO.

22 May 2008:
Indonesia:(1) Virus sequence (genome) sharing with pubic database but no actual virus isolate sharing & proposed pay-for-virus system unacceptable to WHO.

29 February 2008:
Indonesia:Clarification on last week’s sample shipping report: US CDC confirms 15 samples, all came from 2 cases, a mother/daughtboth still alive; samples received without MTA or other restriction

18 January 2008:
GoI has reached tentative deal with Iran to co-produce bird flu vaccines, MoH says Iran has an advanced pharmaceutical industry, capable of producing bird flu vaccines using Indonesian virus.

US, EU on the Revised IHR: "Yes, we have no bananas."

perezoso — Thu, 18 Sep 2008 10:29:07 -0500

This is a short paper that I wrote late last year on the contradictory and self-destructive US and EU positions on influenza virus sharing and the Revised International Health Regulations. It was originally distributed at a meeting of the Pugwash Study Group on the Chemical and Biological Weapons Conventions and is thus written from a security perspective, and uses terms like "biosecurity".

I generally think that security language is essentially useless and even counterproductive for talking about flu, particularly the ill-defined term "biosecurity" which is dangerous (I try to always put it in quotes). I use it nonetheless because it is (hopefully temporarily) part of the lingua franca of security types (but never public health, I hope!).

Discussion Paper for the 27th Pugwash CBW Workshop, Geneva, Switzerland, 8-9 December 2007
(Edited for distribution on 18 September 2008.)

International “Biosecurity” Cooperation Placed at Risk

US and EU Attempts to Reinterpret the Revised International Health Regulations (2005) related to the Issues of Influenza Virus Sharing and Transparency and the Fair and Equitable Sharing of Benefits of Arising from Influenza Research

1. International sharing of influenza viruses is important for the development of effective diagnostics and vaccines against influenza viruses and is thus important for pandemic preparedness (herein considered an aspect of “biosecurity”).

2. Governments have sovereignty over the biodiversity, including the microbial biodiversity, found within their borders. This sovereignty is most importantly, but by not exclusively, reflected in the Convention on Biological Diversity, which includes influenza and other viruses and bacteria within its scope.

3. Regrettably, many scientists and scientific institutions are not aware of national sovereignty, choose to ignore it, or cling to antiquated notions that genetic resources are the “common heritage of mankind”. Paradoxically, some of the same scientists and the institutions they work for will readily assert their own property rights over viruses and their parts. Confusion about these issues has negatively impacted public discussion of virus sharing.

4. The WHO Global Influenza Surveillance Network (GISN) has, in its 60 years of operation to date, received millions of viruses from across the world. It has distributed these viruses, as well as candidate vaccine seed strains and sequence data, to third parties, including the vaccine industry.

5. The sharing of these viruses has enabled the development of seasonal influenza vaccines, however, in general, only the vaccines for the Northern Hemisphere have resulted in major public health benefit because demand for seasonal influenza vaccine in the Southern Hemisphere is severely limited by socioeconomic factors.

6. The WHO has endorsed a plan to expand seasonal influenza vaccine manufacturing in less developed countries in order to improve pandemic preparedness (herein considered an aspect of “biosecurity”), yet this plan to increase global production is patently preposterous because there is no market for these vaccines. That is, the poor generally cannot afford and have greater priorities than buying an annual flu shot.

7. The details of virus distribution by the GISN are not known to governments and have not been systematically recorded. Only in response to recent concerns raised about virus sharing has the GISN made an effort to track virus sharing. This effort remains interim and may or may ultimately prove to be effective.

8. Indonesia’s decision to reduce sharing of H5N1 influenza viruses infecting humans has resulted in allegations that this situation impacts the pandemic preparedness (herein considered an aspect of “biosecurity”) of other Member States and initially caused criticism from the WHO Director-General and other officials, many of whom began their careers with or are seconded from the US Centers for Disease Control or Health Canada.

9. Among the reasons cited by Indonesia for its decision are the lack of transparency of the GISN, failure of the GISN to provide for fair and equitable sharing of benefits arising from influenza research, and intellectual property claims lodged on viruses and virus parts (RNA, cDNA, etc) by recipients of virus from the GISN system, giving rise to biopiracy.

10. The criticisms of Indonesia and governments supporting its position have extended to attempts by the United States and the European Union to engineer WHO statements and resolutions that imply that by not sharing H5N1 samples, Indonesia stands in violation of its obligations under the International Health Regulations (2005).

11. In fact, the International Health Regulations (2005) do not require sharing of viruses or any other causative agents of outbreaks of disease of international public health concern.

12. Although the International Health Regulations (2005) do not require sharing of viruses or any other causative agents of disease, in diplomatic correspondence senior WHO officials have asserted that they do, in contradiction to legal advice WHO has received and calling into question the independence of the WHO Secretariat in this matter.

13. When asked if the US interprets the IHR to require virus sharing, US officials stumble and vacillate and will not give a clear answer, despite their efforts to get WHO officials to state that the IHR requires virus sharing.

14. When asked about the applicability of international law to influenza virus sharing, the EU has stated that it believes that there are international legal virus sharing requirements that outweigh national legislation.

15. Paradoxically, when Indonesia has requested return of samples of its own viruses from WHO Collaborating Centres in the US (and, apparently, the UK), it has been told that national legislation (export controls) impedes transfer of H5N1 viruses to Indonesia. The EU, and apparently the US, thus argue that the same international regulations that they allege to preempt Indonesian national legislation do not preempt European and US legislation.

16. Although both talk about “collective action”, the policies of the US and EU with respect to the IHR and influenza virus sharing thus reflect arbitrary and contradictory interpretations of international law and ex post facto attempts to modify it.

17. In general, the response of the US and EU to the concerns about virus sharing raised by many developing countries has been to maintain the GISN status quo that those countries find unacceptable. Neither the US nor the EU has brought a significant new idea to the table for how to bring about reforms to that system so as to reflect the concerns about its lack of fairness.

18. Particularly in view of disparities in resources available to respond to a flu pandemic, the naked self-interest and cynical machinations of the US and EU on the IHR virus sharing, as well as apparent attempts to manipulate the WHO Secretariat for the same ends, is alienating many developing countries, large and small.

19. The mistrust created by the GISN’s lack of equity and US and EU policies is so great that the Indonesian Minister of Health has gone so far as to suggest that viruses given to the GISN may be being used to create biological weapons.

20. To date, developing countries of Asia and Africa provide most new H5N1 isolates.

21. Safe handling of H5N1 requires high containment facilities and expertise in infectious disease agents.

22. The organizations, labs, and scientists that collect and handle new H5N1 samples in developing countries are thus frequently precisely the institutions of interest to international “biosecurity” efforts to promote the integrity of research institutions and to ensure that potential biological weapons agents are properly handled and safely stored.

24. These same organizations, labs, and scientists are those that are most likely to be impacted and alienated by short-sighted US and EU policy on virus sharing.

25. Thus, what goodwill has been earned in recent years through US and EU “biosecurity” programs in developing countries is being placed at considerable risk, and the possibility exists for rifts to emerge between infectious disease research institutions.

26. If the US and EU seek a binding international agreement requiring influenza virus sharing and/or sharing of other causative agents of infectious disease, then they should not do so in such a dangerous and fractious manner that builds tensions between countries and may even come to threaten the revised IHR itself.

27. It thus may be concluded that it is not in the interest of the US and EU to continue to construe that the IHR mandates virus sharing, particularly in the absence of making any meaningful proposals to address the concerns of developing countries.

28. An international agreement requiring influenza virus sharing and, eventually, sharing of other causative agents of infectious disease might be achieved as a result of reforming the GISN. Rather than resisting reform, the US and EU should advance their desire to ensure the transfer of these agents by recognizing the double standards and backlash potential of their current policies, and to seriously address the concerns that have been raised by developing countries, rather than defending the unjust GISN status quo.

Are CDC's PR Hacks Lying about Patent Claims?

perezoso — Wed, 27 Aug 2008 07:45:35 -0500

If secondary sources are to be believed, such as this one, then CDC's PR hacks have sallied forth with a pack of lies about their patent claims on Indonesian, Thai, and other H5N1 genes, which were first brought into the public eye by this blog.

There are two main arguments that CDC has been quoted to me as making with respect to my article and related items that have come out in the press. I will refute both of CDC's claims.

First, CDC is said to have rather remarkably claimed that they aren't part of the patent application. This is patent bullshit, as I will show. Secondly, and somewhat contradictorily, CDC's hacks are said to claim that the patent application is (to paraphrase), "for a vaccine and not a virus, so the Indonesian and other strains aren't claimed." This too is wrong. To demonstrate that, I will walk readers through the text of one of the (many) claims, so you can read it for yourself. The claims analysis is a bit tedious; but it's not rocket science. Wade through it, and you will be rewarded with a clear explanation of why CDC is wrong. We'll deal with the CDC arguments one by one:

First, CDC is said to have bizarrely claimed that they aren't part of the patent application. This would be a remarkable thing for the CDC hack to say, because CDC is indicated as a patent applicant on the first page of patent application (quoting directly):

APPLICANTS: THE GOVERMENT OF THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES [US/US]; National Institutes of Health,, Office of Technology Transfer, 6011 Executive Blvd., Suite 325, Rockvillle, Maryland 20852-3804 (US) (All Except US).

THE GOVERMENT OF THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES [US/US]; Centers for Disease Control and Prevention, 4770 Biford Hwy (K79), Atlanta, Georgia 30333 (US) (All Except US).

Clear as can be. Is there really a need to say more? There shouldn't be; but I'm afraid there is.

That's because an ancillary argument that the CDC hacks are said to be advancing is that the US National Institutes of Health (NIH) is really responsible for this and CDC should not be held accountable for its name on the patent.

Off the top, I find it very hard to believe that a patent application can be submitted in CDC's name without CDC knowing about it. But more importantly, this CDC red herring needs to be put into context. Both CDC and NIH are part of the US Department of Health and Human Services (i.e. the health ministry). CDC hosts the WHO Collaborating Centre, and both it and NIH conduct flu research. And while it is true that most of the inventors listed in the application are from NIH, it's more than slightly disingenuous for CDC to try to beg off by foisting the blame on its HHS sister institute. In the international context, it's simply not credible to have one half of the health ministry (CDC) saying "no patents", while it is passing the material to the other half of the health ministry which is patenting away. So, in many senses, whether it is CDC or NIH or both is immaterial, because they are ultimately part of the same organzation (HHS) that has a WHO Collaborating Centre.

Turning to the claims analysis: CDC's hacks are said to have claimed that the patent application is (to paraphrase), "for a vaccine and not a virus, so the Indonesian and other strains aren't claimed."

The government spokesman bullshit detector of anyone with a whit of common sense would start ringing loudly just looking at the cover page of the patent (click it), which has an illustration of a genetic construct, claimed in the patent, that incorporates the "codon optimized" HA gene of A/Indonesia/5/05. It even says so right on the picture.

Could it be any clearer? Not really; but just be sure, we can turn to the most important part of patent, the claims, where the applicants specifically articulate the alleged invention that they are seeking patent for. Typically (but not always), the first claims are the most important in a patent. Let's turn to Claim 1 of the CDC/NIH application:

	WHAT IS CLAIMED IS:

		1. A nucleic acid molecule comprising a polynucleotide encoding an influenza
	protein selected from the group consisting of hemagglutinin A (HA),
	neuraminidase (NA), M2 Protein, and nucleoprotein (NP), wherein said
	polynucleotide comprises
			 
	(a) a plasmid taken from Table 1 (or its insert), or
			 
	(b) an analog of said plasmid or insert having at least 95% identity thereto.
	 
	
The first thing to note about this claim is that it is a claim on matter. That is, it is not merely a claim on the use of a particular type of matter (not that that would make it innocuous), it is a claim to the thing itself, full stop. Specifically this claim is for any polynucleotide (i.e. DNA or RNA) that encodes specific polypeptides (i.e. proteins), including some specific HA, NA, M2, and NP genes from influenza. And for good measure, anything 95% or more like them.

But which specific DNA or RNA is claimed, it's not spelled out explicitly in the quote above? Good question.

And what does that phrase "or its insert" mean? Another good question.

If you read the claim again, you will see that determining what specific DNA / RNA is claimed requires referring to "Table 1", and looking at the patent text in order to establish what "insert" means in the context of this patent application.

The meaning of insert can be quickly clarified. It is this: The plasmids refered to in Claim 1 are longer DNA constructs designed as vaccines, and which are pieced together with genes from multiple organisms. The picture on the cover page (click above) is one of these plasmids. The "insert" is/are the influenza pieces that are placed into the longer plasmid. Mostly "codon optimized" HA genes that have been copied into DNA from the viral RNA.

So, what's specified in Table 1? I have extracted Table 1 from the patent application, and you can click here to read it yourself (PDF format). It is 6 pages long, and includes no fewer than ~~151~~ 150 separate genetic constructs claimed by NIH/CDC, most of which are either "plasmids" or "inserts". (Remember that the plasmids are claimed in their entirety, including the inserts... which are also claimed apart from the rest of the plasmid.)

If it's a plasmid or an insert in Table 1, then it is claimed. On the first of the 6 pages of Table 1, there are 8 different constructs incorporating Thai H5N1 genetic material and one plasmid incorporating (i.e. with an "insert") of Indonesian genetic material. On the second page, there are 4 more constructs with Thai material. On the third page, there are 6 plasmids with Chinese (Hong Kong) genetic material, 2 with sequences from South Korea, and another Thai one. On the fourth and fifth pages there are 8 more with Thai genenic material. On the sixth page, there are 2 constructs with Thai genetic material, 6 with Hong Kong genetic material, and 2 with South Korean genetic materials.

The Indonesian construct ("VRC 9123") is the first listed and is the exemplary construct of the invention. Also, because the Indonesian HA gene is an "insert", it is claimed both as part of the VRC 9123 plasmid and by itself, alone. The same holds true for the other H5N1 inserts in Table 1.

Then NIH/CDC goes a step further, and says anything 95% or more like those genes is also claimed.

I hope that clarifies the nature and scope of CDC's patent claims. If CDC representatives have been accurately quoted as saying that they are not part of the patent application and that the application in any event does not claim Indonesian (and other) H5N1 materials, then the CDC representatives are spreading clearly false information, and the leadership of CDC should be reprimanded for permitting them to do so.

[Edited for clarity - 27 Aug PM]

Richard Holbrooke and Laurie Garrett are Full of Sh*t

perezoso — Tue, 12 Aug 2008 21:17:46 -0500

Update: 6 September 2008

An Important Note About This Blog Entry

The short essay below was originally written as a Letter to the Editor of the Washington Post, because I believed that it was very important to publicly correct the numerous errors and misperceptions contained in the Holbrooke / Garrett editorial.

When the Washington Post did not publish the letter, I sent it to a number people and urgently asked them if they would be so kind as to put forward the ideas contained in the letter, given the important international humanitarian interest in reforming the GISN.

I was therefore very grateful when Ambassador Wibisono of Indonesia adapted the essay below and was able to have it published in the Jakarta Post on my behalf. An utmost priority in the debate over influenza virus sharing is widely circulating the powerful arguments for changing the current system, therefore, I again thank Ambassador Wibisono for his willingness to carry this message to a broader public.

------

... and it's time for America to wake up to that fact.

In their badly informed Washington Post op-ed "'Sovereignty' That Risks Global Health" (10 August), Richard Holbrooke and Laurie Garrett make a number of factual mistakes and misleading statements, some of which I will enumerate here.

The existing World Health Organization (WHO) system of sharing influenza viruses, called the Global Influenza Surveillance Network, is radically unjust in that it takes resources from developing countries and provides little in return, and leaves us all more vulnerable to an influenza pandemic. Indonesia and other countries that have taken the initiative to reform the WHO system are taking a laudable and overdue step to improve public health for all.

There is no constituency seeking to create "viral sovereignty". De facto, such sovereignty already exists in international law. Inexplicably, the authors mislead by simply ignoring that fact and, in particular, 20 years of development of the Convention on Biological Diversity which, among other international instruments, recognizes national sovereignty over genetic resources, including microbes. Viruses are, unequivocally, genetic resources subject to national sovereignty, whether Holbrooke and Garrett want to admit it or not.

Holbrooke and Garrett claim that it is "ludicrous" to apply sovereignty to genetic resources that easily cross borders. Their position belies ignorance of both biodiversity and related law and policy. As any farmer, biologist, or duck hunter can tell you, most genetic resources cross borders: birds, plants, insects, microbes, crops, and practically everything else made of DNA (or, as in the case of flu, RNA). This simple biological truth has not stopped sovereignty or international cooperation in biodiversity use and protection. Transboundary biodiversity issues have been discussed and addressed for over two decades by the UN. Holbrooke and Garrett have no apparently clue about this, otherwise they would not have made such an off-base assertion.

They further state that "The WHO has elicited pledges from the world's major drug companies not to exploit international repositories of genetic data for commercial benefit". Such pledges, even if they existed in the form claimed, are contradicted by fact. First of all, a number of companies have lodged US and international patent claims over hundreds of H5N1 genetic sequences - resources that were freely given to WHO by Indonesia and other countries. These resources come from the gene repositories.

Secondly, major pharmaceutical companies have advanced clinical trials underway utilizing Indonesian, Vietnamese, and other viruses in vaccines. One vaccine using a Vietnamese strain is licensed. The companies intend to profit from sales of these vaccines, and Indonesia (and other countries) will receive nothing of the proceeds. The fact of the matter is that industry - large and small - massively benefits from resources of the WHO system, and no commeasurate benefit accrues to Indonesia and other countries who, ironically, are facing the gravest immediate threat from H5N1.

Further, contrary to Holbrooke and Garrett's erroneous suggestion, the revised International Health Regulations do not require viruses to be sent to WHO, and Indonesia has not defied them. The revised regulations mandate sharing of information on disease outbreaks of international importance, and such information continues to be shared. The authors further - and unaccountably - allege that Indonesia has violated "a host of other WHO agreements". What agreements? I have participated in the WHO negotiations on influenza virus sharing, where I have not seen either Holbrooke or Garrett, and I am unaware of any such allegations.

In reality, Indonesia has repeatedly offered to provide more viruses to WHO. Neither Indonesia, nor its Health Minister, are intrinsically opposed to providing viruses. Rather, the stumbling block is an unwillingness of some countries to implement a just Material Transfer Agreement (MTA) to define the rights of parties when viruses are transferred.

The underlying proposition that Garrett and Holbrooke rail against in their callous editorial is that Indonesia and other countries are asking for a reasonable MTA for influenza viruses - one that doesn't rob them - and for an unbiased WHO. The hypocrisy of the US and some other countries is especially palpable when one looks at the typical agreements signed by US institutions for transfer of viruses between themselves. Those agreements are far more restrictive than anything that Indonesia or its allies have proposed for sharing their viruses.

The move to reform the WHO Global Influenza Surveillance Network is neither self-destructive nor anti-Western. Holbrooke and Garrett's lashing out against Indonesia is uninformed about the pertinent policy and law related to genes and sovereignty, and callous toward the concerns of developing countries trying to better protect their own citizens from a pandemic. In their blindness to the obvious injustices of the WHO system, Garrett and Holbrooke recklessly dismiss a very important, and potentially very positive - but delicate - negotiation underway to make the multilateral system more fair and equitable.

It's time for the US and its allies to stop hurling abuse at Indonesia and to acknowledge the need to reform the virus sharing system so that developing countries receive tangible benefits for their participation. Indonesia and other developing countries have put concrete and detailed proposals on the table for negotiation in Geneva. The real danger to public health is not sovereignty that is already a reality; but that these proposals are not discussed and implemented, leaving us with a dysfunctional global influenza surveillance system.

CDC lays claim to Indonesian (and other) Flu Genes

perezoso — Tue, 12 Aug 2008 15:04:36 -0500

It would be hard to be more "in your face" than what the US National Institutes of Health and Centers for Disease Control are doing with patent claims to their new H5N1 DNA vaccine.

But right there on the front page it's laid out in black and white:

US GOVERNMENT SAYS INDONESIAN H5N1
VIRUS IS NOW THE PROPERTY OF UNCLE SAM.

Well, it doesn't literally say that; but this graphic appears:

The vaccine that is the exemplary embodiment of the invention contains the HA gene of A/Indonesia/05/05 and/or the NA, M2, and MP genes from the same strain.

How the CDC, which is a WHO Collaborating Centre, can simultaneously:

a) Claim it is not patenting WHO materials; and,
b) Blast Indonesia for "harming global public health [security]"; and,
c) Patent Indonesian viruses,

is one the miracles of modern scientific doublespeak. Talk about two-faced! No wonder Jakarta is hopping mad. But it gets even worse...

Get this: Adding insult to injury, the patent application designates Indonesia as a country where the US intends to pursue the patent. The CDC - a WHO Collaborting Centre - patenting an Indonesian virus in Indonesia. (As a practical matter, patent applicants dont always follow through on these country designations, but one never knows...)

And: The patent application claims similar DNA vaccines built around Thai, Chinese, and Korean H5N1 strains.

Needless to say, Uncle Sam will not be sharing patent rights and writing royalty checks to Indonesia if this works, nor will Indonesia have a say in where and how and at what cost the company that actually produces this (if it works) sells the vaccine.

It's difficult to imagine that a company would want to sell the vaccine to poor Indonesians when it can extract top dollar from rich Americans and Europeans if a pandemic comes.

Bottom Line: Indonesia gave WHO the virus, the CDC and NIH are patenting the virus, and Indonesia is S.O.L. when it comes to benefits.

Here's the full front page:

Say you're the Indonesian Health Minister. Do you think you're getting a fair shake?

Material Transfer Agreement Hypocrisy

perezoso — Mon, 11 Aug 2008 17:41:42 -0500

One of the things that's got a lot of the Cro-Mag Indonesia bashers up in arms is that Jakarta is asking the US (and other countries) to sign reasonable Material Transfer Agreements for influenza viruses, in the context of an unbiased WHO system.

Wow, how radical and anti-American. Not.

The hypocrisy of the Bush administration's resistance to a decent MTA for flu virus transfers is especially palpable when one looks at the typical MTAs signed by US institutions for transfer of flu viruses and flu-related genetic materials between themselves.

To show that hypocrisy, I chased down some actual MTAs signed by US institutions for transfer of research materials containing flu strains and genes originally from the WHO GISN. Here is a brief introduction to those MTAs, written with TWN, and a link to PDFs of actual influenza Material Transfer Agreements that you can see for yourself.

Third World Network
The Sunshine Project

November 2007

INFORMATIONAL HANDOUT

Intergovernmental Meeting on Pandemic Influenza Preparedness: Sharing of influenza viruses and access to vaccines and other benefits

Material Transfer Agreements for Influenza Viruses and Genes Some Examples of Recent Standard Practice in the United States

Since the May 2007 World Health Assembly, which prompted international discussion of sharing of influenza viruses, some developed countries have been reluctant to discuss development of Material Transfer Agreements (MTAs) applicable to the provision of influenza viruses and clinical specimens to WHO Collaborating Centres, as well as for international agreement on MTA terms for transfers from the WHO Centres to third parties. Some have even objected to use of the term MTA at all. Perhaps developed countries hope that providers of H5N1 genetic resources will continue to transfer their viruses with no strings attached, which has led to a wave of patent claims on viruses and their parts.

Contrary to the suggestion of the some North countries, detailed MTAs for the transfer of influenza viruses and their pieces are, in fact, standard practice in the United States and other developed countries. Some standard MTAs are extremely restrictive with respect to the uses permitted to the virus recipient, for example, banning transfers to third parties and granting no rights to the recipient apart from those expressly authorized in the document.

Behind this cover sheet are six recent Material Transfer Agreements between US influenza research centers. They illustrate the kinds of terms and conditions that are already typically placed upon virus transfer.They are:

• MTAs between the US Centers for Disease Control, AstraZeneca (MedImmune), University of Wisconsin, and the University of Texas at Austin, for influenza materials and reverse genetics systems, November 2004 and January 2005;

• MTA between St. Jude Children’s Research Hospital and the University of Texas Medical Branch, also protecting interests of AstraZeneca (MedImmune), for plasmids encoding Chinese and Vietnamese H5N1 strains, November 2006.

• MTA and Letter of Transfer Agreement between the University of Georgia and BEI Resources, a US government contractor that manages microbial collections, for proteins produced by Thai and Vietnamese influenza isolates, September 2006.

It is not necessary delve into the fine detail of the attached documents to understand our point. In fact, these MTAs treat intellectual property in ways that make these agreements inappropriate to consider for use in a WHO system. It is sufficient to review the paperwork and identify the severity and types of stipulations, and the conditions and procedures used.

If it is standard practice in a country like the US for influenza viruses to be transferred under such heavily elaborated and frequently very restrictive terms, why have developed countries claimed that it is too onerous to develop material transfer agreements to govern the exchange of influenza viruses between donor countries and a WHO network?

Is it because a well-designed MTA would be too difficult to develop, or is it because rich countries want to continue to get viruses with no strings attached so that they may be freely appropriated?

LINK TO DONWLOAD THE MTAS: http://www.sunshine-project.org/flu/MTA_Handout.pdf

A Glance at Current H5N1 Vaccine Trials

perezoso — Mon, 11 Aug 2008 16:06:14 -0500

More than five dozen clinical trials for H5N1 vaccines have been registered in the US in recent years. A listing of trials (which includes many taking place outside the US) is available here.

Here is a quick review of many of those that are either ongoing or preparing to recruit human subjects, emphasizing those that relate to new biologicals (and less on studies primarily concerned with adjuvants):

GLAXOSMITHKLINE

Efficacy studies in the US and Canada, involving more than 5000 adults, of an experimental split virion H5N1 vaccine denominated 1557484A. This is a monovalent A/Indonesia/5/05 based vaccine.

Efficacy studies in Spain, Taiwan, Italy, Belgium, Hong Kong, Singapore, and Thailand of another experimental split virion H5N1 vaccine denominated 1562902A. The composition of this H5N1 vaccine is not stated.

SANOFI

A US safety and efficacy study of experimental monovalent formulations of its H5N1 vaccine, with the goal of reducing the required dosage. The exact composition of the H5N1 vaccine is not stated, although Sanofi's licensed H5N1 vaccine uses A/Vietnam/1203/2004.

A safety and efficacy study in Belgium and Australia of an experimental split virion H5N1 vaccine. (Related studies in Belgium and the UK assess the efficacy of adjuvants used in the vaccine.)

Further testing an H5N1 vaccine in infants and children in Thailand.

SOLVAY

Trial involving 400 adults in Finland and Germany of various formulations of an egg-based H5N1 vaccine. The exact composition of the H5N1 vaccine is not stated.

BAXTER

Safety and efficacy trials underway of a cell culture-produced killed whole virion vaccine, using A/Vietnam/1203/2004. Some study participants receive a booster shot containing A/Indonesia/05/2005. The studies are taking place in Austria and Germany.

Safety and dosing trials underway in Hong Kong and Singapore of a double-dose cell culture-produced killed whole virion vaccine. The exact composition of the H5N1 vaccine is not stated.

Large study, in 9 European countries, of a cell culture-produced killed whole virion vaccine, using A/Vietnam/1203/2004.

NOVARTIS

Multiple safety and efficacy and dosing trials of H5N1 vaccines that use (or not use) its MF59 adjuvant. This set of trials are in Italy. Exact composition of the vaccine not stated.

Safety trial in Colombia of an H5N1 vaccine in combination with a Southern Hemisphere trivalent seasonal flu vaccine. The exact composition of the H5N1 vaccine is not stated.

Safety trial in Germany of a combination seasonal (presumably North) and H5N1 tetravalent vaccine (i.e. with a total of 4 antigens). The exact composition of the H5N1 component of the vaccine is not stated.

A safety and efficacy trial in the UK of multiple doses of an H5N1 vaccine in combination with/without various combinations of a seasonal (presumably Northern Hemisphere) vaccine and a proprietary adjuvant. The exact composition of the H5N1 vaccine is not stated.

Further testing an H5N1 vaccine in infants and children in Finland.

NOVAVAX

A US safety and efficacy trial underway of its virus-like particle vaccine. The viral source of the VLPs is not specified.

US CENTERS FOR DISEASE CONTROL

A safety and efficacy trial of H5N1 vaccine (exact composition undisclosed), in 100 adults at occupational risk of exposure to live H5N1 viruses. Location unstated.

US NATIONAL INSTITUTES OF HEALTH (HAS COLLABORATION WITH MEDIMMUNE / ASTRAZENECA)

A dose comparison trial of an A/H5N1/Indonesia/05/05-based vaccine in adults who were previously vaccinated with an A/H5N1/Vietnam/1203/2004-based vaccine.

A US dosing trial administering 9 different vaccine formulations using A/H5N1/Vietnam/1203/2004 and/or A/H5N1/Indonesia/05/05.

Plans to enroll 155 US adults in a study that will inject them with a high dosage of an (undescribed) H5N1 vaccine in order to stimulate the subjects to produce high levels of antibodies to the vaccine strain. These antibodies are then collected and used in efforts to produce an immune globulin flu treatment.

Plans to enroll 44 US adults in a safety and efficacy study of a DNA plasmid vaccine delivered in a needle-free transdermal system. The exact composition of the H5N1 vaccine is not stated, although other sources indicate this lab has prepared DNA vaccine plasmids bearing the HA gene of A/Indonesia/5/05. A related study is injecting a DNA vaccine into 45 US adults.