ROCKVILLE, Maryland -- A U.S. advisory panel Friday endorsed making a widely
used antibiotic the first government-approved drug for fighting infection from
the deadly biological agent anthrax in the wake of a future terrorist attack.
A Food and Drug Administration (FDA) advisory panel unanimously said Cipro, a top-selling antibiotic made by Bayer Corp., appeared safe and effective for preventing disease from an aerosol attack with anthrax, one of the most feared biological agents.
The FDA and other agencies working to prepare the United States to respond to bioterrorism took the unusual step of urging Bayer to seek the approval. It is the first time the FDA has considered clearing an antibiotic specifically for use in response to a bioterrorist attack.
Bayer Corp. is a division of German chemical group Bayer AG.
The U.S. government already keeps a stockpile of medications and other supplies on hand to dispatch in case a biological weapon is unleashed. Officials said making Cipro FDA-approved as an anti-anthrax agent would make it easier for agencies to stock and ship the drug in times of emergency.
"We want to make sure people would have access to the therapies they would need," said Dr. Diane Murphy, head of one of the FDA's drug evaluation offices.
Experts warn that groups in several countries have the means to launch an attack with biological weapons. The Department of Defense has charged that Iraq and North Korea have supplies of an infectious anthrax agent.
If anthrax were released in a large metropolitan area, scientists project millions of people could die in a matter of days if they do not get treatment. Anthrax almost always is fatal without treatment, but many lives could be saved if antibiotics were given early after exposure.
"The response is extremely (good) to early treatment. Late - you can't save people," said Martin Hugh-Jones, a veterinarian from Louisiana State University who has studied anthrax exposure in animals.
Two antibiotics, penicillin and doxycycline, already are approved for treating anthrax, but scientists have seen evidence of strains engineered to resist those drugs, leading health officials to examine other alternatives.
Cipro, known generically as ciprofloxacin, has been on the market since 1987. It already has approval for treating 17 types of infections.
To test its effectiveness against anthrax, the Department of Defense, which ordered reserves of Cipro during the 1991 Gulf War, treated monkeys with various antibiotics. Exposing humans to anthrax for testing would have been unethical.
In the tests, nine of 10 monkeys who received a placebo died, but nine of the 10 monkeys treated with Cipro for 30 days survived.
"It appeared the antibiotics totally suppressed the infection," said Dr. Arthur Friedlander of the U.S. Army Medical Research Institute of Infectious Diseases.
Because spores from anthrax bacteria can live for long periods of time, the
panel recommended that patients receive treatment with Cipro for 60 days.
Copyright © 2000 Reuters Limited.
FAIR USE NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of criminal justice, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner.