Gene Squatters Claim the Next Pandemic

perezoso — Tue, 19 Aug 2008 13:15:46 -0500

If you think oil speculators are an ethically-challenged crowd, consider pandemic squatters. There are many examples. For one of the ugliest and most audacious, we turn to Finland.

Finns are usually an inoffensive lot, but it seems that a few of their number are hoping for the big one to come. A big pandemic, that is. And they're putting their money on H5N2. Helsinki-based Remedal, a tiny company with no apparent independent R&D capacity, has filed for patent on basically all injected or intranasal human vaccines containing an H5 and an N2 antigen (i.e. against H5N1 recombined with 'normal' human H3N2).

For good measure, Remedal further specifically claims such a vaccine using three HA genes that are WHO GISN materials: A/Hong Kong/213/2003, A/Vietnam/1194/2004, and A/Vietnam/1203/2004.

So, Remedal hopes, if an H5N2 recombinant goes pandemic (or seriously threatens to), it will own rights to the vaccine - and make a fortune. Some might vainly hope that we can have confidence that the patent authorities weed out this kind of application, but that would be an unfounded hope, because lousy patent applications issue all the time.

It's clear that the company has no ability to develop and market a flu vaccine. It's only announced compound is a "dietary supplement" that it says aids alcohol metabolism, reducing hangovers and liver damage. Even there it is looking for somebody to buy and commercialize the compound. Remedal of Helsinki is not about to provide the world with pandemic flu vaccine, although it is ready to claim a royalty on every shot if its gamble on H5N2 pans out. (And probably file a patent infringement lawsuit against anyone selling an H5N2 vaccine, driving up the price for everyone.) Worse than Roche and Tamiflu. At least Roche makes something. (No comment here on the perverse incentives to crime that issuing such patents might generate.)

Part of what's going on with this kind of patent squatting is an intellectual property system in dire need of reform, which goes well-beyond the H5N1 issue. But WHO's blind eye cast on pandemic influenza vaccine patents is a big problem too. When pressed to acknowledge intellectual property issues at all, WHO usually apologizes for whatever is the status quo. Its stockpile effort to date is a good example. WHO should be out there drawing a public health line around claims on pandemic vaccines and, in particular, patent claims on WHO GISN materials. If that were the case, then the GISN's crisis wouldn't be nearly as severe, and attempts at unethical pandemic squatting would be reduced.

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.

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... 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.

Immunocompetent

Gene Squatters Claim the Next Pandemic

Richard Holbrooke and Laurie Garrett are Full of Sh*t