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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Monday, September 18, 2006

Bioterror Protection Setbacks

With everything going so well on the health front, i.e., the increased number of uninsured, the e-coli outbreak, the re-defining of torture, and more, who would have thought that our efforts to improve our stockpiles of bioterror drugs would be problematic. . . .  The New York Times reports today that there are been some difficulties, political ones, which have caused delays and well, things aren't progressing like people had hoped.  The Times states,

The last of the anthrax-laced letters was still making its way through the mail in late 2001 when top Bush administration officials reached an obvious conclusion: the nation desperately needed to expand its medical stockpile to prepare for another biological attack.

The result was Project BioShield, a $5.6 billion effort to exploit the country’s top medical and scientific brains and fill an emergency medical cabinet with new drugs and vaccines for a host of threats. “We will rally the great promise of American science and innovation to confront the greatest danger of our time,” President Bush said in starting the program.

But the project, critics say, has largely failed to deliver.

So far, only a small fraction of the anticipated remedies are available. Drug companies have waited months, if not years, for government agencies to decide which treatments they want and in what quantities. Unable to attract large pharmaceutical corporations to join the endeavor, the government is instead relying on small start-up companies that often have no proven track record.

The troubles have been most acute with the highest priority of all: a $900 million push to add a new anthrax vaccine to the stockpile. What had begun as an effort to test and manufacture a safer, faster-acting vaccine has turned into an ugly battle between two biotech businesses.

Each has hired Washington lobbyists to attack its rival’s product and try to win over lawmakers and administration officials. Delivery of the new vaccine is far behind schedule, and a dispute between the Department of Health and Human Services and VaxGen, the company chosen to make the vaccine, could even end the deal. The only doses that have been added to the stockpile are of a decades-old vaccine that has generated complaints of serious side effects. . . .

“The inept implementation of the program has led the best brains and the best scientists to give up, to look elsewhere or devote their resources to medical initiatives that are not focused on biodefense,” said Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland. . . .

From the start, officials in Washington knew that Project BioShield would be a risky venture — for the government, the companies involved and even ordinary Americans, who might be asked to take relatively untested treatments in an emergency.

Officials hoped $5.6 billion in federal money would entice companies to develop new drugs and vaccines for anthrax, smallpox, botulism, Ebola and other deadly diseases.

Because of the perceived urgency of the threat, the project suspends some traditional standards. It allows new vaccines or drugs to be used in emergencies before completing the lengthy Food and Drug Administration approval process. Full testing on humans is also not required because it is too dangerous, even though that means no one will know with certainty whether the vaccines will work until used in a crisis.

For their part, the companies have to take all the risks of developing and manufacturing new products; they get paid only upon delivery.

The article ends on a slightly upbeat note - people have recognized that there is a problem and will be meeting to solve some of the issues raised in the article so there may be some hope for the future.

http://lawprofessors.typepad.com/healthlawprof_blog/2006/09/bioterror_prote.html

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