Here's a dated AP article that suggests that it was the federal government
that motivated the anthrax indication for Cipro.
FDA may approve anthrax treatment drug
July 28, 2000
By PAUL RECER -- Associated Press Science Writer
ROCKVILLE, Md. -- An advisory committee recommended approval
of an antibiotic for treatment of people exposed to inhaled anthrax,
an action designed to help prepare the nation for a possible biological
terrorist attack.
A Food and Drug Administration advisory committee voted unanimously
Friday to recommend that the agency select ciprofloxacin as the first
antibiotic formally approved for treating people who may have inhaled
spores of anthrax.
Ciprofloxacin has been marketed for 13 years by Bayer Corp. of West
Haven, Conn. under the brand name Cipro. The drug already is
approved for a wide variety of infections and has been used by about
250 million patients worldwide. But there currently is no drug formally
approved for preventing infection in people exposed to inhaled
anthrax.
Committee chairman Dr. L. Barth Reller of Duke University said the
unanimous vote of the committee "is clearly linked" to the unusual
circumstances of preparing for a possible terrorist attack.
The FDA is not required to follow the committee recommendation, but
approval is considered by insiders as almost certain. The FDA had
requested that Bayer apply for the formal approval and some federal
agencies had already recommended Cipro as the prophylactic drug of
choice for people exposed to inhaled anthrax.
To be effective, experts said, Cipro would have to be taken by
exposed patients before symptoms appear. Once the fever, chills, rash
and respiratory congestion start, there is little than can be done,
researchers said. This means that once it is known there has been a
release of anthrax spores, people will, within hours, have to take an
antibiotic, the experts said.
The FDA action is part of an organized effort by federal agencies to
prepare the nation to respond to biological attack. A Presidential
directive two years ago called on federal agencies to coordinate efforts
to protect against such attacks.
Cipro already has been identified by the Army and by the Centers for
Disease Prevention and Control as the recommended antibiotic for
post-exposure treatment of inhaled anthrax. The military stockpiled the
drug during the Persian Gulf War, where there was a threat of
biological weapons use.
The CDC also is poised to stockpile the drug, if it is approved. A plan
calls for the agency to be prepared to distribute the stockpiled drug
within hours after any biological terrorist attack.
The military also launched a program to vaccinate all of its personnel
against anthrax, but a shortage of the vaccine has slowed the effort. A
Michigan plant that was making the vaccine has been closed and will
require FDA approval before it can reopen.
Experts say anthrax is a biological agent that could be used both by
terrorists and as a military weapon because it can be easily distributed
and is highly effective. Spores of the bacteria can be sprayed and
allowed to drift with the wind, covering a wide area.
When inhaled, anthrax rapidly produces toxins that cause severe
damage to the respiratory system and brain. Untreated patients
usually die within days.
"Its whole purpose is to kill, as quickly as possible, and then to make
spores," Dr. Martin Hugh-Jones, an anthrax researcher at Louisiana
State University, told the advisory committee.
Other researchers on Friday presented data from monkey studies that
showed that Cipro and some other antibiotics could prevent infection
from developing after inhaled anthrax exposure. The data, from an
Army study, however, showed that inhaled anthrax spores in the lungs
can remain dangerous and infectious for weeks.
No human studies have been conducted with inhaled anthrax and the
advisory committee was asked to evaluate the use of Cipro against
anthrax based only on the animal studies. Members of the committee
noted, however, that Cipro has a long record of safety.
Some human data was collected, researchers said, from an anthrax
accident at a biological weapons plant in Russia in 1979 that killed
about 90 people.
The proposed indication for Cipro calls for adults to take 500
milligrams every 12 hours for 60 days after a possible exposure to
inhaled anthrax. Children would take smaller doses for the same
period.
Anthrax bacteria has been manufactured as a biological weapon by at
least three nations, Russia, Iraq and Iran. At least 14 other nations,
according to a federal study, have biological weapons programs, but it
is not known how many are using anthrax.
The deadliness of a spray of anthrax spores has been widely
recognized. A Congressional study concluded spraying just 200
pounds of anthrax spore over Washington, D.C. could killed up to
three million people.
In 1979, workers at an anthrax plant in Sverdlovsk, Russia, operated a
spore drying machine without replacing a filter. This allowed spores of
the bacteria to drift downwind. About 400 people, some up to three
miles away were sickened and about 90 died before effective
treatment could be started. A flock of sheep 30 miles away was killed
by the disease. |
