MANAGED CARE November 2001. ©MediMedia USA
PUBLIC POLICY
Federal health officials were slow to get out the word that doxycycline and penicillin are also approved for use against anthrax.
Information seems to have been one of the first casualties in medicine's participation in the battle against terrorism. Robert Stevens, photo editor of the Sun tabloid, died from anthrax inhalation on Oct. 5. Almost immediately, sales of Cipro skyrocketed.
It took another 12 days — days filled with growing hysteria surrounding more confirmed incidences of exposure as well as hundreds of false alarms and reports of doctors being besieged by demands for ciprofloxacin — before the mainstream news media started focusing beyond Bayer's product. The New York Times on Oct. 17 ran a story that informed the public that there are other drugs that can be used against anthrax, including doxycycline.
"Everyone is focusing on Cipro, and that is giving the false impression that it is the only drug that would work against anthrax," Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told the Times. One industry insider mused that perhaps the media's overfocus had to do with the fact that Cipro had only recently (August 2000) been approved by the FDA to specifically treat anthrax.
The Times article stressed that two other classes of antibiotics — penicillins and tetra-cyclines — had already been approved to "treat anthrax generally." That same day, during testimony before Congress, Health and Human Services Secretary Tommy Thompson said that the Food and Drug Administration was approving new labeling for the use of several antibiotics to treat anthrax. The next day, Oct. 18, the FDA issued a statement saying that doxycycline "is approved for the treatment of anthrax in all its forms."
This may have been a case of too little information being disseminated too late. Until that point, the public had assumed that there was a limited amount of anti-anthrax antibiotic.
"We currently have enough antibiotics to prevent the disease in 2 million persons exposed to anthrax...," said Jeffrey P. Koplan, MD, MPH, director of the Centers for Disease Control and Prevention, in a letter sent to local health departments on Oct. 2.
Who's reassured?
Some quick math — a supply of antibiotics for 2 million in a country of about 280 million — probably didn't go far in alleviating fear, as evidenced in reports of Americans crossing into Mexico to buy Cipro.
Janet Woodcock, director of the center for drugs at the Food and Drug Administration, said the dosage picture looks considerably better when you factor in doxycycline and penicillin, although she could not estimate how much better when Managed Care contacted her on Oct. 17.
"There are a number generic manufacturers of both penicillin and doxycycline," Woodcock said. "There are many additional doses of those products available."
These disclosures beg the question: Who dropped the ball here? Before that question is addressed, however, it should be noted that everybody, since Sept. 11, has been dealing with unprecedented events unfolding in a tense environment. It should also be noted that evoking fear is a goal of terrorists, and the widespread assumption that Cipro, and only Cipro, could treat anthrax didn't help.
Kathy Harben, a CDC spokeswoman, was careful to distance her organization from the hype. "You're absolutely right: From the beginning, everyone has heard 'Cipro,' and that suggests that that's simply an antibiotic that a lot of people have been prescribed." She then steered further inquiries to FDA officials, who pointed to the medical community.
"Retrospectively, perhaps we could have done more," admitted Woodcock. "I guess we were not as attentive to the public, but certainly the medical community was well aware of this."
Added FDA spokesman Jason Brodsky, "Treatment for this kind of infection would be done in close consultation with a physician." Brodsky also said efforts had been made to inform the public. "FDA and HHS have information posted on our Web sites that lists all the approved products."
Woodcock: "The CDC has a number of treatment recommendations of different antibiotics for anthrax, and most of the infectious disease community knows that very well — and certainly the medical community knows."
When challenged to admit that the focus had been too much on Cipro in the wake of Stevens's death, Brodsky responded, "Yeah, right I agree. That's why we're happy to talk to you today, to get that word out further that other antibiotics are available."
Probably by the time this appears, that word will have been well circulated — one would hope, anyway. Yet, as an article in the New Republic recently pointed out, public trust in Thompson is being sorely tested.
In trying to strike a balance between informing and alarming citizens, "Thompson has chosen to treat Americans like a parent trying to shield a helpless child from some frightening truth," wrote Michael Crowley. "The problem is that it's getting hard to believe anything daddy says anymore."
Woodcock said that Cipro's label had much to do with the media's fixation. "The media basically focused on Cipro because it had the specific indication in its label. It was the only drug that was specifically approved to fight anthrax."
Still, as Woodcock noted, the medical community knew better. A 1999 study published in the Journal of the American Medical Association titled "Anthrax as a Biological Weapon" said this: "Most naturally occurring anthrax strains are sensitive to penicillin, and penicillin historically has been the preferred therapy for the treatment of anthrax. Penicillin is approved by the FDA for this indication, as is doxycycline."
Penicillin is also much cheaper. A cursory search of an online pharmacy shows Cipro at $4.30 a pill (500 mg); doxycycline at 41 cents a pill (100 mg), and penicillin for 16 cents a pill (500 mg).
Some online sites have reportedly been selling Cipro for as much as $7 a pill. Somebody, obviously, is profiting from the public's overreaction.
As Time magazine put it (about a week and a half after Stevens's death), unless "you are exposed to one of the strains genetically engineered to be resistant to other antibiotics, you don't need Cipro."
Cipro surge
The power of first impressions will soon be tested as news spreads that Cipro is not the only treatment. Meanwhile, the Cipro surge was still going strong at press time.
Kinray, one of the largest drug distributors in the country, had been selling about 300 to 400 bottles of the antibiotic a day before the scare.
"On the day the first incident was reported, we jumped to about 1,000 bottles a day, and since the incident in New York, we are selling 1,500 to 2,000 bottles a day," Stewart Rahr, Kinray's CEO, told the Philadelphia Inquirer. Bayer was planning to triple production over the next three months.