Bird Flu Won't Wait

By Kendall Hoyt, an assistant professor at Dartmouth Medical School and an associate with the New England Center for Emergency Preparedness (THE NEW YORK TIMES, 03/03/06):

As avian flu makes its way from Asia across Europe, the United States has yet to meet the challenges that this potential epidemic and other biological threats pose to our health and security. One challenge in particular needs attention: the shortfall in countermeasures like vaccines.

Most biological threats are likely to be unannounced and unfamiliar (like the outbreak of SARS in 2002 and 2003), so rapid drug development is critical. With few exceptions, the United States lacks the ability to develop, manufacture and administer vaccines in response to specific threats as they arise. That ability is within reach, but only if we invest wisely.

Congress recently appropriated $1.8 billion to develop and purchase a pandemic flu vaccine. Any vaccine we develop now, however, may not work against a human-to-human transmissible strain that could emerge later. The problem is that the government has been focused on a prognostic model of developing and stockpiling countermeasures aimed at specific pathogens. This "one bug, one drug" strategy makes sense for a small number of biological threats that are highly communicable, lethal or easily weaponized, like smallpox and anthrax.

It is less sensible, however, for many other threats, for two reasons. First, the number of pathogenic threats far outstrips our drug development resources. Second, epidemiological forecasting and intelligence about such threats are unreliable: witness the vaccination campaigns against botulinum toxin in World War II, swine flu in 1976, anthrax in the 1991 gulf war and smallpox before the Iraq war, which all addressed threats that failed to materialize. Creating stockpiles of vaccines for high-consequence pathogens is important. Beyond those, however, it's wiser to build a system that will allow us to react quickly to rapidly evolving or unexpected biological threats.

Agencies like the National Institutes of Health and Department of Defense have spent a lot of money on building early-stage research and development programs and laboratories for combating biological threats. But there have been no commensurate investments in late-stage research and surge manufacturing. Without that, the value of early-stage research is greatly diminished.

These capabilities can and should be developed, starting now. It now takes 8 to 10 years on average to develop one vaccine. As the Defense Advanced Research Projects Agency has been urging, it may be technologically feasible to build a "bug to drug" program that yields a countermeasure within months, rather than years, of identifying a novel pathogen.

A "bug to drug" program would accelerate the translation of early-stage research into new countermeasures. Such a program would make broad investments in technologies to speed development (for example, microarray diagnostics, computerized model immune systems, DNA vaccines and animal models for diseases of particular concern). In some cases, it could build a library of clinical-grade vaccine seed strains to allow the rapid production of vaccine. In other cases, it could establish manufacturing protocols, as well as emergency administration and distribution procedures.

Besides investing in rapid response mechanisms, such a program would also support research projects. These projects could include the development of production methods to reduce the time and cost of vaccine manufacturing, ways to boost an immune response after a single dose and thermostability innovations and "no needle" vaccinations to make it easier to distribute vaccines in an emergency.

Unless we act now, we will have to rely on primitive and probably ineffective methods, like quarantine, when a new pathogen arrives. Such methods will take an unnecessary and unprecedented human, economic and political toll on the United States and on all nations that do not prepare.