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Problems with Pandemic Monitoring

THE DEADLY H5N1 strain of avian influenza could at any moment evolve a mutated strain capable of being transmitted from human to human, creating the potential for a pandemic. That potential has spurred an unprecedented global effort to track and study the virus. But in the countries where the virus is most prevalent, government leaders have hindered the healthcare community’s work.

For example, more than one-third of the 400-plus human cases of H5N1 documented since 1997 occurred in Indonesia. While Indonesia has been willing to share genetic typing of its H5N1 strains, it has refused to provide international public health authorities with live H5N1 samples. The live samples, according to the World Health Organization (WHO), are necessary for conducting a risk assessment of the strain’s potential for mutation.

Indonesian Health Minister Siti Fadilla Supari has said publicly that her government will not turn over samples because foreign pharmaceutical companies will develop vaccines based on strains that originated in Indonesia, then profit from selling them to countries around the world, including her own.

Indonesia is not alone in its argument. China, Thailand, and Vietnam each resisted sharing samples for the same reason; those three countries have, however, relented.

Experts agree that Indonesia’s boycott greatly handicaps epidemiologists’ ability to detect whether new H5N1 cases bear an elevated threat of producing a pandemic strain. But the experts also acknowledge that these countries have a point about their populations not benefiting from the research.

Price and profit are not the only considerations. Countries where most H5N1 cases have originated might not get any pandemic vaccine after a global outbreak, says David Curry, executive director of the University of Pennsylvania Center for Bioethics’ Ethics of Vaccines Program.

The vast majority of vaccine production capacity is located in Western countries. And that capacity is either already legally obligated to home nations in the event of a pandemic, or it might be commandeered during a global outbreak by those nations’ governments, experts say.

Indonesia is among the nearly 200 countries that signed the 1992 Convention on Biodiversity under which any genetic material originating in a given country is that country’s intellectual property, Curry notes. One of the treaty’s primary goals is the “fair and equitable sharing of the benefits arising out of the utilization of genetic resources.” Most developed Western nations have signed and ratified the treaty, but the United States has not.

In 2007, Indonesia appeared to have reached an agreement with one major pharmaceutical company, Deerfield, Illinois-based Baxter International, offering to share viruses in exchange for guidance on vaccine production. By 2008, however, Indonesia had backed out of the deal.

Supari complained that Baxter was not communicating with her and was overdue delivering vaccines based on Indonesian strains. Baxter disputed Supari’s contentions, stating that the company had not formalized an agreement with Indonesia and that the vaccines it had developed to date were based on samples provided by the WHO, not Indonesia, according to an Associated Press report.

Around the same time, Supari announced that her office would only release aggregated H5N1 infection statistics once every six months, rather than on a case-by-case basis as do other governments. Later, Supari accused wealthy Western nations of actually creating disease viruses for profit, according to Agence France-Presse.

Jennifer Nuzzo, an associate with the University of Pittsburgh Medical Center’s Center for Biosecurity, who consulted the U.S. Agency for International Development (USAID) on its efforts to bolster foreign countries’ disease surveillance efforts, noted that USAID directly assisted Indonesia in establishing a program to detect disease outbreaks. The USAID effort, as well as other international assistance, stands to undermine Supari’s contention that the West seeks solely to exploit Indonesia. That contradiction, and Supari’s fickle behavior and rhetoric, suggest the impasse may have as much to do with Supari’s personality as it does with her stated principles, Nuzzo says.

Despite repeated claims that it would cooperate, Indonesia remains recalcitrant as it conducts closed door talks between the country’s Ministry of Health, the WHO, and the International Federation of Pharmaceutical Manufacturers and Associations, which represents drug companies worldwide.