>From The Washington Post,
http://www.washingtonpost.com/wp-dyn/articles/A32486-2001Nov2.html
-
Prescribing Cipro Is 'Uncontrolled Experiment'
Health Officials Worry That Taking Drug for Anthrax May Have Serious
Side Effects
By Shankar Vedantam
Washington Post Staff Writer
Saturday, November 3, 2001; Page A15
Fifteen months ago, spurred by fears that bioterrorists armed with
lethal strains of bacteria could launch an attack on the United States
and kill millions of people, the federal government took the unusual
step of pressuring Bayer Corp. to rush a medicine called Cipro through
the approval process for the treatment of anthrax.
The older antibiotics penicillin and doxycycline were known to be
effective against the disease, but there were fears that Russian
scientists had engineered a strain of anthrax resistant to those
drugs. Due to the rarity of the disease, Cipro had never been tested
against anthrax in people. But based on its effectiveness against
other bacteria and an animal study from 1993, regulators at the Food
and Drug Administration designated Cipro the only medicine officially
approved for inhalation anthrax.
What regulators could not have known then -- and what has come true in
the last three weeks -- is that the bioterrorist scare would unfold so
differently from the worst-case scenario they had envisioned. The
attack involved a strain of anthrax that was not bioengineered to be
impervious to the other drugs, which are safer and cheaper. And the
number of people exposed and sickened was far fewer than planners had
feared.
But when the public discovered that Cipro was the only approved
medicine for inhalational anthrax, demand soared. Little attention was
paid to the fact that the current strain of anthrax had not been
bioengineered. And the 60-day course was accepted as proven even
though no studies had demonstrated that was necessary for the kind of
attack that actually occurred.
The disparity between the imagined attack and the real one underscores
the difficulty of formulating public health measures against
little-known bioweapons, and the very real danger that some cures can
cause more harm than the bioweapons themselves. For while the anthrax
attack that has unfolded over the last three weeks has so far been
much milder than the worst-case scenario, the consequences of
over-aggressive treatment may not be mild at all.
The full impact of large numbers of people being put on Cipro by
doctors -- and even larger numbers taking the medicine on their own --
will not be known for weeks or months. But already, patients with
other illnesses who desperately need Cipro have been deprived of the
medicine, and patients around the country taking the drug have begun
reporting such side effects as dizziness, headaches, nausea and achy
joints. Concerns are mounting that overusing Cipro will spawn the
growth of resistant microbes, rendering ineffective a drug considered
to be a last resort when no other antibiotics work.
"We have never faced the mass use of an antibiotic for 60 days;
there's no precedent for that in medicine," said William Hall,
president of the American College of Physicians and the American
Society of Internal Medicine.
"We are conducting the world's largest uncontrolled experiment,
including all these people and TV personalities," said Stephen Porter,
a Tennessee pharmacologist who runs Virtual Drug Development Inc., a
company that is trying to make an alternative medicine to Cipro.
The studies that originally established the safety of Cipro involved
regimens of seven to 10 days, according to Philip Hanna, an anthrax
expert at the University of Michigan at Ann Arbor. "When you start
giving it for two months, that's a whole level of usage that hasn't
been proven to be safe," he said.
Leigh Thompson, a South Carolina physician, took Cipro for 21 days
when he came down with an infection in Cambodia that he couldn't
diagnose with certainty. He took 500-mg tablets, occasionally twice a
day, for 21 days. His Achilles tendon became painfully inflamed --
damage to weight-bearing joints and tendons is a known side effect of
Cipro's class of drugs. In clinical trials, the medicine has caused
young dogs to become lame.
"I personally wouldn't take it prophylactically unless I knew I had
big-time exposure, not if I had walked through a building where
someone saw a white powder," said Thompson. About putting people
prophylactically on 500-mg tablets of Cipro, twice a day for 60 days,
he said, "God, that would be insane."
The 60-day recommendation, which was made at the FDA meeting in July
last year, was among the measures designed for a worst-case scenario,
where public health officials feared they would confront the specter
of tens of thousands of deaths.
Since no one had a good idea how long anthrax spores could incubate
within the body before turning lethal -- the last known outbreak
occurred in a remote part of Russia in 1979, where people continued to
fall sick weeks after billions of anthrax spores leaked from a Soviet
bioweapons facility -- regulators suggested the 60-day regimen.
"The question was, if you've inhaled spores, how long will it be
before you can be safely off antibiotics?" asked Janet Woodcock,
director of the FDA's Center for Drug Evaluation and Research. "People
could develop cases weeks away from their exposure. We felt it was
important to put out a definite recommendation. . . . That's where the
60-day course came from. It was a conservative recommendation -- it
was intended for the worst-case scenario."
People found to have inhaled a lethal amount of spores should be
aggressively treated, said Woodcock: "The problem with the public is
they think that if they were nearby, they were exposed."
This week, the agency formally approved the use of penicillin and
doxycycline against inhalation anthrax.
Much of the worst-case scenario was laid out in a paper that was
published in the Journal of the American Medical Association in 1999,
authored by a working group of 21 leading government, military and
university scientists.
The authors wrote that "between 130,000 and 3 million deaths would
follow the aerosolized release of 100 kg of anthrax spores upwind of
the Washington, D.C. area -- lethality matching or exceeding that of a
hydrogen bomb."
The scientists recommended starting victims on Cipro because of the
reports that Russian scientists had engineered a strain of the anthrax
bacterium "to resist the tetracycline (doxycycline) and penicillin
classes of antibiotics."
At least one scientist questioned the group's recommendation: In 1992,
the man who had been the Soviet Union's top bioweapons scientist
defected to the United States and brought with him news that the
Russians had strains of anthrax resistant to penicillin, doxycycline
-- and Cipro. Even if U.S. doctors feared that America would be
attacked by a virulent Russian strain, Cipro might not worked any
better than penicillin or doxycycline.
If proof was needed that making Cipro-resistant anthrax was possible,
scientists said that last year an American lab developed such a strain
to find a cure.
"It was considered a pretty big deal to develop antibiotic-resistant
strains of anthrax," said Ken Alibek, a former Soviet bioweapons
scientist who now runs Hadron Inc., an Alexandria company trying to
find cures for anthrax. "We developed resistant strains to penicillin,
streptomycin, doxycycline and ciprofloxacin [Cipro] by the late '80s
or early '90s."
� 2001 The Washington Post Company
--
Dan S
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