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US Government Needs to Improve Countermeasure Development

Drug and Vaccine Development Process Too Long and Too Expensive

JULY 13, 2005 -- Baltimore, MD -- Since the anthrax attacks of 2001, the U.S. government has taken steps to stockpile medicines and vaccines that could be used in the event of another bioterror attack. But have these steps been effective? Do we have sufficient protection from the most likely bioweapons?

In an article published in the current issue of Biosecurity and Bioterrorism titled "Anthrax Countermeasures: Current Status and Future Needs," authors Luciana Borio, MD, and Gigi Kwik Gronvall, PhD, argue that the government has made a start at stockpiling countermeasures, but much remains to be done.

The current Strategic National Stockpile includes enough smallpox vaccine for everyone in the U.S., and it also contains antibiotics used to treat anthrax, plague, and tularemia. But licensed drugs and vaccines are lacking for many potential bioweapons -- in part, the authors say, because of the difficult and lengthy process of developing and bringing drugs and vaccines to market. The process includes what has been called the "valley of death" -- the gap between academic basic research and the development of a viable product by private industry.

Borio and Gronvall, who are with the Center for Biosecurity of the University of Pittsburgh Medical Center, selected the development of anthrax countermeasures as illustrative of the difficulties of the process. They discuss the current status of both antibiotics and vaccines for anthrax and trace the medical countermeasure development process as it now exists. Typically, it can take from 5 to 15 years and cost over $800 million to successfully bring a drug to market -- and comparatively few drugs make it through the process.

The U.S. government has responded to these concerns by increasing funding to NIH and NIAID for basic research and by funding drug and vaccine development through BioShield, but problems remain, including bridging the gap between these two funding mechanisms.

The authors offer several suggestions for ways to improve the process, including more guidance from the federal government to manufacturers with respect to the government's priorities, a more transparent selection process of pharmaceutical candidates, and additional funding for countermeasure procurement. "It's not rocket science -- it's harder. But there are steps we can take to get the vaccines and therapies we need," says Gronvall.

"Anthrax Countermeasures: Current Status and Future Needs" by Luciana Borio, MD, and Gigi Kwik Gronvall, PhD, appears in Biosecurity and Bioterrorism and is available at The journal is published for the Center for Biosecurity of UPMC by Mary Ann Liebert, Inc.

The Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) works to affect policy and practice in ways that lessen the illness, death, and civil disruption that would follow large-scale epidemics, whether they occur naturally or result from the use of a biological weapon.



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