Cipro Isn't the Only Drug That Can Be Prescribed, Anthrax Experts Say [NY Times]
(I think The Times said earlier that sending anthrax letters to the media guaranteed that it would be a huge story, and they are proving their point.)
nytimes.com
October 17, 2001
OTHER MEDICATIONS
By GINA KOLATA
Though the antibiotic Cipro has become the drug of choice among people worried about anthrax, several other widely available and less expensive antibiotics are very likely to work as well.
Cipro was approved last year in the United States specifically to prevent the inhaled form of anthrax, the most lethal form of the disease, which can be contracted by people who inhale anthrax spores deep into their lungs. The sole death in the current outbreak of bioterrorism was caused by inhaled anthrax.
But two other classes of antibiotics, penicillins and tetracyclines, had already been approved to treat anthrax generally, including cutaneous anthrax, a less deadly disease that can be caused when the spores contact a break in the skin, and gastrointestinal anthrax, which is contracted from eating infected meat.
All three forms are caused by the same microbe, Bacillus anthracis, and scientists say they believe that all the drugs could work equally well. They are best used before symptoms occur.
"Everyone is focusing on Cipro, and that is giving the false impression that it is the only drug that would work against anthrax," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.
Dr. Fauci said Cipro, or ciprofloxacin, is one of a class of antibiotics known as fluoroquinolones.
"There are other fluoroquinolones, and if you look at their spectrum of activity against microbes, they are essentially identical," he said. "There are at least four and maybe five fluoroquinolones, and although they are not explicitly recommended, in a pinch they certainly are drugs that one would be able to use."
The Food and Drug Administration has also approved two other types of drugs against anthrax, tetracyclines, including doxycycline, and penicillins. Originally, they were meant to prevent and treat cutaneous anthrax. But both drugs are also generally expected to work against infections caused by anthrax spores.
"There are other drugs that are strikingly similar to doxycycline," Dr. Fauci said. One is erythromycin. There is also a wide array of penicillinlike drugs on the market. Like most anthrax strains, the anthrax bacteria that infected two people in Florida and two in New York are said to be sensitive to penicillin.
"What happens if it is a microbe like the one we are seeing now that is in fact sensitive to penicillin?" Dr. Fauci asked. "Then you have a whole host of drugs that can be used," including amoxicillin and erythromycin.
Experts said Cipro was approved for use for inhalation anthrax because it is the drug for which scientists had the best data when the government was looking for something to recommend against terrorist attacks.
In a small study of monkeys by the Defense Department, Cipro had been shown to prevent inhalation anthrax at doses comparable to what people would take. Though animal data would not normally be enough to warrant the approval of a new use of a drug, there are little data on drugs for use in anthrax because it would be unethical to expose people to them in tests.
Dr. Michael Osterholm, who directs the Center for Infectious Disease Research at the University of Minnesota, was on a committee at Johns Hopkins that recommended Cipro because, he said, "as a fluoroquinoline, it was the drug we have the best data for."
But, like Dr. Fauci, he expected that other drugs in the class could be about equally effective.
The Johns Hopkins group wrote in its report that still other antibiotics were effective against anthrax bacteria in the laboratory, including "chloramphenicol, erythromycin, clindamycin, extended-spectrum penicillins, macrolides, aminoglycosides, vancomycin hydrochloride, cefazolin and other first-generation cephalosporins."
Dr. Osterholm worried, however, about encouraging the public to seek out the other drugs. "If we talk about this in public, we'll just see runs on other antibiotics," he said. "You just give the public the sense that, `Hey, if I can't get Cipro I'll get doxy, and if I can't get doxy, I'll get penicillin.' "
Warning of side effects, doctors stress that people should not take antibiotics unless they are genuinely needed. Cipro and drugs in its class can cause nausea and diarrhea and, rarely, allergic reactions, serious skin rashes, tremors, hallucinations, abnormal heartbeats and liver damage.
Surgeon General David Satcher said he worried that if people started taking antibiotics "just in case" that they could do themselves more harm than good, encouraging the growth of bacterial strains that are resistant to the drugs. "We do not want to lose this weapon," he said.
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U.S. Weighs the Hidden Cost of Its Pharmacy Bill [NY Times]
nytimes.com
October 17, 2001
NEWS ANALYSIS
By DONALD G. McNEIL Jr.
PARIS, Oct. 16 — America's demand for Cipro, an antibiotic for treating anthrax, could raise serious questions for the United States government, and poor countries seeking cheaper drugs to treat their own epidemics of AIDS and other diseases will be looking closely at the way they are answered.
Bayer, the German drug company that makes Cipro, said today that it was tripling production of the antibiotic in the face of growing public fears about anthrax. Bayer did not say how much of its increased production would come to the United States, and it was not clear exactly how much Cipro might be needed. [Page B7.]
Although a government official said doctors had assured him that patients exposed to anthrax can be treated with other antibiotics after an initial course of Cipro, it is not clear that the public will accept such assurances in what it perceives as a health emergency.
Shortages of Cipro — whether caused by a genuine anthrax emergency or by panic buying — may convince Bush administration health officials that they want the generic version, ciprofloxacin, more than Bush administration trade officials want Bayer's patent protected.
American budget officials could also decide to buy cheaper generic drugs.
Alternatively, American consumers might become outraged to learn that while Cipro has cost nearly $350 a month in the United States, a generic drug from reputable suppliers costs only $10 a month in India.
Senator Charles E. Schumer, Democrat of New York, proposed today that the government buy generic versions for its emergency stockpile, noting that such a step would reduce dependence on a single supplier and could significantly reduce the costs of getting the amount of ciprofloxacin needed.
If the United States were to purchase large amounts of cheaper generic drugs, it could open the floodgates for poor countries who want cheaper versions for their epidemics of AIDS, malaria, tuberculosis and other diseases.
The pharmaceutical companies — often backed by Western governments — have long defended the patent system as the only one that allows them to protect their products and recover the high costs of developing drugs.
But experts say that if the United States wants to purchase generic drugs to meet the sudden demand for ciprofloxacin, that presents no legal problem.
American law is very clear: when the United States government needs a patented product, any official authorized to make purchases can ignore the patent and license someone else to make it.
"Any employee of the United States government can authorize a compulsory license for the product without even holding a hearing," said James P. Love, director of the Consumer Project on Technology, part of Ralph Nader's organization pushing for lower drug prices. "The company can't even sue to enjoin the government from doing it. All they can do is sue for compensation."
That compensation, Mr. Love said, is based on eminent domain, the principle used when the government seizes land for a highway or military base. A judge picks an amount based on lost value, but not necessarily the highest price that could have been charged.
The government uses the law fairly frequently, Mr. Love said. In the 1960's, it used the law to buy a drug, and the reason was simply that the patent holder charged too much.
The United States Army wanted supplies of a tranquilizer, meprobamate, known by the brand name Miltown. Carter-Wallace, the American patent holder, sold it for $34.25 for 500 capsules, while a Danish supplier sold the same amount for $1.55 — or one-twentieth the Carter-Wallace price.
The United States bought it from Denmark and paid Carter-Wallace a modest royalty.
Bayer's American patents on its most common forms of ciprofloxacin expire on Dec. 9, 2003. More than 80 companies in India and elsewhere make generic versions, but only a few have been deemed to meet standards set by the Food and Drug Administration.
Five or six generic companies are already qualified to sell Cipro when its patent expires, and getting supplies from them now is possible, according to William F. Haddad, an American generic-drug manufacturer who helped write the 1984 Hatch- Waxman act that encouraged generic production.
In any case, the outcome of any American battle over ciprofloxacin will have broad ramifications for poor countries desperate for affordable drugs. While it is not an anti- retroviral that suppresses the AIDS virus, ciprofloxacin is often a crucial drug for AIDS patients because it cures secondary brain infections that can kill quickly.
Bayer has the drug under patent in some African countries, including South Africa and Kenya, which both have serious AIDS epidemics and nascent generic-drug industries. Like many major drug companies, Bayer gives some medicine away free in Africa — helping to build good will — but resists letting in generic competitors who would force prices down.
African countries generally do not have laws as aggressive as those in the United States, and in the past some of those nations have come under heavy pressure from the United States trade representative's office and pharmaceutical companies to honor patents in all cases.
The Clinton administration eventually reversed itself and said it would not punish African countries that sought cheap AIDS drugs even if they broke American patent law.
The Bush administration initially said it would continue that policy. Recently, however, it has backed American pharmaceutical manufacturers against African countries that are trying to meet World Trade Organization rules so they can import drugs from the cheapest sources for public health reasons. |
