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Context of 'July 27, 2000: FDA Endorses Anthrax Antibiotic Cipro, Despite Conflict of Interest and Health Concerns'

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The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. (US Food and Drug Administration 2005)

The Sunday Times reports that an inquiry has been launched into the behavior of Bayer, after revelations in a British trial regarding the anthrax antibiotic drug Cipro. The drug has been tested on hundreds despite the company having conducted studies which showed it reacted badly with other drugs, seriously impairing its ability to kill bacteria. These results are kept secret. Nearly half of those on whom the drug was tested at one test center develop a variety of potentially life-threatening infections, while data at other test centers is unknown. (Sunday Times (London) 5/14/2000)

The FDA endorses the use of Bayer’s Cipro drug to prevent inhalation anthrax. (Reuters 7/28/2000) An official recommendation like this is highly unusual for the FDA. A 1997 Pentagon study of anthrax in rhesus monkeys showed that several other drugs were as effective as Cipro. The reason given for only recommending Cipro is the government wants a weapon against anthrax should it come up against a strain resistant to drugs in the penicillin and tetracycline families of antibiotics. (Bumiller 10/21/2001) The pharmaceutical industry spent $177 million on lobbying in 1999 and 2000—more money than any other industry. The FDA has been accused of conflicts of interest with companies including Bayer. (Wayne and Petersen 11/4/2001)

The Canadian government overrides Bayer’s patent for the anthrax antibiotic Cipro and orders a million tablets of a generic version from another company. The US government says it is not considering a similar move. Patent lawyers and politicians state that adjusting Bayer’s patent to allow other companies to produce Cipro is perfectly legal and necessary. (Harmon and Pear 10/19/2001) The New York Times notes that the White House seems “so avidly to be siding with the rights of drug companies to make profits rather than with consumers worried about their access to the antibiotic Cipro,” and points out huge recent contributions by Bayer to Republicans. (Bumiller 10/21/2001)

The Bayer Corporation, holders of the US patent on the anthrax antibiotic Cipro, agrees with the US to reduce the price of Cipro in the US from $1.83 to 95 cents. Analysts say the price reduction will reduce Bayer’s profit margin from 95% to 65%. This reduction applies only to sales to the US government, not sales to the public. (Wayne and Petersen 11/4/2001) Bayer has allowed no other companies to produce or import Cipro into the US. Other countries with less stringent patent laws sell Cipro for 1/30th the US price, and have offered to import large quantities into the US. (Bradsher 10/21/2001) Nevertheless, a class action suit by over one million Americans has been filed against Bayer and two other companies, alleging that Bayer has paid $200 million to two competitors to not make generic versions of Cipro. (Lieff Cabraser Heimann & Bernstein 10/25/2001) The profits from Cipro are considered a “lifesaver” for Bayer, which had been considering pulling out of pharmaceuticals altogether. (Kelso et al. 10/31/2001)

The New York Times reports that health officials and experts believe numerous other drugs are as effective as the antibiotic Cipro in combating anthrax. “Several generic antibiotics, including doxycycline, a kind of tetracycline, and various penicillins, are also effective against the disease,” and they all are in plentiful supply. (Abelson and Pollack 10/23/2001) A 1997 Pentagon study of anthrax in rhesus monkeys showed the other drugs to be equally effective. But Cipro remains the only drug officially recommended by the FDA (see July 27, 2000). (Bumiller 10/21/2001)


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