[Sci-tech-public] STS Grad in NY Times Today

[David Mindell]

'Just thought I'd call your attention to Kendall Hoyt's Op-Ed in the 
New York Times Today. Kendall did her Ph.D. at MIT in Science, 
Technology, and Society in 2002, on the history and science policy of 
vaccine development and is now on the faculty at Dartmouth Medical 
School. When addressed to a broad audience and accessibly written, 
STS  makes a difference in public discourse and science policy.

dm


New York Times
March 3, 2006
Op-Ed Contributor

Bird Flu Won't Wait
By KENDALL HOYT


Hanover, N.H.

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.

Kendall Hoyt is an assistant professor at Dartmouth Medical School 
and an associate with the New England Center for Emergency 
Preparedness.
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