An Uncertain Call to Arms

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Science  16 Apr 2004:
Vol. 304, Issue 5669, pp. 359
DOI: 10.1126/science.304.5669.359

A recent special issue of Science described the scientific, economic, and political complexities of the drug discovery process (Science, 19 March 2004) that are driving pharmaceutical companies away from the development of antimicrobials and vaccines. Instead, the industry is focused on developing drugs for treating chronic diseases such as arthritis, Alzheimer's, and Parkinson's disease that now confront the increasing numbers of graying U.S. baby boomers. The decisions within the pharmaceutical industry to abandon infectious disease research programs, which reflect today's economic reality, are coming at a time when the specter of antibiotic-resistant organisms is growing ever larger. The number of reports of drug-resistant strains of bacteria that cause tuberculosis, syphilis, gonorrhea, hospital-acquired pneumonia, and skin and blood infections is rising, as is the number of patients who are dying from infectious disease. What makes the decisions of pharmaceutical companies to cut back or eliminate their anti-infectives research programs even more ironic is the fact that recent advances in microbial and host genomics have provided a wealth of potential new antimicrobial targets and vaccine candidates, as well as the possibility of changing the drug discovery paradigm from direct screening programs to more rationally based strategies.

In the aftermath of the anthrax letter attacks of 2001, President Bush announced Project Bioshield in his January 2003 State of the Union address, a $6 billion initiative to create a stockpile of medical countermeasures that would protect the U.S. public from any future bioterror attacks. At the heart of this plan was the government's promise to purchase new antibiotics and vaccines that are effective against the most serious threats, including smallpox, anthrax, and plague, from pharmaceutical and biotechnology companies. In the current economic climate, without such an incentive it is almost certain that no company would heed the government's call to arms and shift gears to focus on infectious disease research.


The announcement of Project Bioshield has met with mixed reviews within the pharmaceutical industry and Congress. For some companies such as Human Genome Sciences in Rockville, MD, the timing of this announcement came at an opportune time, because it was in the midst of developing Abthrax, an antibody-based treatment against anthrax. But 16 months after Project Bioshield was first unveiled, the legislation is now stalled in the Senate. And this delay has had a sobering effect within the industry, causing doubt that any investments made to develop new countermeasures against potential bioterror agents will ever pay off. At Human Genome Sciences, further work on Abthrax is on hold until such a commitment from the government to support the next stage of development is made. As Avinar Pharmaceuticals chief executive Gerald J. Yakatan said in an interview published in the Washington Post in December 2003, “Other than patriotism, there may not be any reason to continue to do this [develop biodefense drugs] any longer.”

The parallels between the need for new countermeasures against potential bioterror agents and the need for new countermeasures against more familiar but equally dangerous pathogens are strikingly obvious. Our arsenals against microbial foes are inadequately stocked, and we are vulnerable not only to deliberate attacks but to natural outbreaks of emerging and reemerging diseases. There are increasingly fewer people who remember the devastating effects of diseases such as smallpox, polio, scarlet fever, and whooping cough before the introduction of effective vaccines and antibiotics. It is essential that academia, industry, and government work together to support the research and development needed to create new drugs and vaccines against the world's most deadly diseases. Although the fate of the current Project Bioshield is uncertain, it is essential that in our robust response to bioterrorism here in the United States, we must not lose sight of the fact that what we really need is a more comprehensive Project Bioshield focused on the larger panoply of public health threats around the world.

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