U.S. Wants To Draft Antibiotic Against Anthrax

by Rita Rubin

USA Today

July 20, 2000

At the government's urging, the maker of one of the world's top-selling antibiotics is seeking Food and Drug Administration approval of a new use for the drug: preventing illness after inhaling anthrax bacteria in a bioterrorism attack.

The FDA, the Centers for Disease Control and Prevention, and the Department of Defense have asked Bayer Pharmaceuticals to apply for the new use of Cipro, says Larry Posner, Bayer's global head of regulatory affairs.

An FDA advisory committee is scheduled to discuss the new use July 28. In total sales of antibiotics, Cipro ranks highest or second-highest in every country in which it is sold, Posner says. It has been on the U.S. market since 1988 and is approved for 17 ailments, including respiratory and urinary tract infections.

But unlike private physicians, the U.S. government is not allowed to use any approved drug "off label" - that is, for a non-approved use.

The CDC wants to include Cipro, the trade name for ciprofloxacin, in its National Pharmaceutical Stockpile program, agency spokeswoman Barbara Reynolds says. The program, which began last year, was created to ensure that drugs and other critical medical supplies can be shipped quickly to the site of any biological or chemical terrorist attack in the USA, she says.

The CDC manages the program, and the Department of Veterans Affairs - experienced in buying large amounts of medications on behalf of the U.S. government - is in charge of purchasing. Some of the stockpiles are being housed at VA medical centers, Reynolds says.

Besides the stockpiled supplies, which can be shipped anywhere in the USA within 12 hours, the CDC is asking manufacturers to keep a "bubble" of extra inventory on hand, she says.

Anthrax has been given a high priority by the stockpile program because it can be effectively treated with antibiotics, according to the CDC. Two other antibiotics, penicillin and doxycycline, are approved to treat anthrax, but there are strains of anthrax that are resistant to both of those drugs.

Animal studies suggest that Cipro would be highly effective against anthrax, and there have been no reports of Cipro-resistant anthrax strains, according to a May 1999 consensus statement published in the Journal of the American Medical Association by the Working Group on Civilian Biodefense.

The Department of Defense has been vaccinating military personnel against anthrax, but last week questions arose about the accuracy of tests used to make sure the vaccine is safe and effective. As a result, spokesman Jim Turner says, the department has initiated an anthrax vaccine "slowdown."

Previously, anyone who was going to be on the ground for even a day in the Persian Gulf or Korea - considered high-risk areas - was vaccinated. Now, only those who are scheduled to be on the ground in those areas for at least 30 days will receive the vaccine, Turner says.

Cipro can help fill the gap for people who have not been vaccinated, he says.

"If you know you've been attacked, and you haven't shown the symptoms, you can take it, and it will keep you alive until you can get the vaccine," Turner says.