IS THE CURE worse than the condition? U.S. postal workers and others being treated with Cipro for exposure to anthrax—along with the average Seattleite who>"/>
IS THE CURE worse than the condition? U.S. postal workers and others being treated with Cipro for exposure to anthrax—along with the average Seattleite who might be ill-advisedly stockpiling or using the drug without approval—are likely unaware they're, in effect, guinea pigs for a pill that has been shown to be dangerous, failed to live up to its billing, and been harmful even when properly used.
Most importantly, Cipro, the Viagra of antiterrorism, is untested on humans in a biological epidemic. While the federal government announced last week it is buying 100 million Cipro tabs, officials didn't mention that the drug's safety and effectiveness is based on the study of lab animals.
The pill may arguably be the best we have to initially counter the effects of known and unknown strains of anthrax, say experts such as Dr. Jeff Duchin, the chief of communicable diseases for Public Health-Seattle & King County. But its use is purposely limited when possible, and we have safe and cheaper alternatives for additional treatment—drugs such as penicillin and doxycycline, which doctors prefer for extended use.
"Cipro," Duchin says, "has been used many years for other reasons, and there's every indication it would be effective against anthrax. It is a safe drug in the context of how it has been used." But, he adds, Cipro "has not been in use as an antibiotic for anthrax."
Like all drugs, Cipro—Bayer AG's marketing name for ciprofloxacin, one of the world's top-selling drugs—carries warnings that may be as little known publicly as the drug itself was to most Americans until recently. But thousands may now be taking or hoarding Cipro, a fluroquinolone generally used to combat sexually transmitted disease and skin and internal infections. Quinolones are considered the last effective treatment for some infections.
"The reason Cipro has been recommended as the drug to at least start with," says Duchin, "is because there is some concern that some bad guys could have bioengineered a strain of anthrax that might be resistant to the [alternative drugs]."
King County and other government and private medical providers are following the treatment guidelines of the Centers for Disease Control and a civilian biodefense study that recommended Cipro be used on anthrax victims who have inhaled spores.
"Yes, it is one of the drugs we recommend," CDC Director Dr. Jeffrey Koplan said in a media teleconference call Saturday after the CDC suddenly modified its preference for Cipro, "and we [now] recommend it in the same breath as doxycycline, which would be just as good. They both have adverse reactions associated with them. They are a little different. And for someone who has to take it for a prolonged period of time, they can be significant. We have already had several severe adverse reactions in just the groups who have started taking it already, including some of our own staff who, after exposure, went on these medications, namely Cipro."
The 1999 biodefense study concluded that "animal models suggest" Cipro is an effective anthrax treatment, but "treatment of anthrax infection with ciprofloxacin has not been studied in humans."
Even years of laboratory and animal testing failed to turn up side effects discovered only after the drug was introduced to humans 14 years ago as a broad-spectrum antibiotic.
Cipro use has been linked, for example, to tremors, hallucinations, and convulsive seizures that can be fatal, particularly in those patients with known or suspected central nervous system disorders.
The drug was lab tested on 2,799 people, about 7 percent of whom developed complications. Those early, nonanthrax studies concluded that the drug shouldn't be used, period, on pregnant women, children under 16, and the elderly since it can cause such side effects as painful joint deterioration.
Bayer has steadily had to add or clarify warnings in its Cipro packaging inserts, pointing out newfound risks for toxic psychosis, nightmares, paranoia, musculoskeletal complications, and shock.
Author Stephen Fried, whose 1998 book Bitter Pills chronicled the complications of Cipro and other quinolones, says pharmaceutical companies do their best to downplay initial reports of adverse reactions and deaths and are usually required only to amend their inserts. He points out that drug warnings are favorably formulated by the companies, not the government.
Bayer and many medical experts note that's the situation with any drug: They're produced, they have complications, they evolve. Yet in the meantime, people are harmed or die. Many don't read packaging inserts or aren't told of complications by their doctors. Those are among the reasons that adverse reactions to legal drugs kill more consumers annually than all illegal drug use combined.
Dr. Duchin of Public Health isn't arguing for or against Cipro. He says it's simply the recommended tool under the right conditions.
"It's the first line of defense," says Duchin. But "as soon as you know what the bug is sensitive to, the recommendation is to switch to the most widely available, economic alternative. Cipro isn't the one you would continue to use if you had a choice."