The Bush administration has won a major price concession from the German drug company Bayer AG for its antibiotic ciprofloxacin (Cipro), after threatening to buy generic alternatives.
The Centers for Disease Control and Prevention (CDC) had recommended ciprofloxacin as the antibiotic of choice for both inhalation and cutaneous anthrax (MMWR Weekly 2001;50:917-8(tables 1 and 2)), although this week it changed its advice, and decided to recommend doxycycline.
Dr Bradley Perkins, an anthrax specialist at the CDC, was quoted in the New York Times (2001;Oct 30: B8) as saying that the centres were now recommending doxycycline because drug resistance was “less of an issue with doxycycline.”
Before the new advice was issued, however, Bayer agreed to sell 100 million tablets of ciprofloxacin to the government at 95 cents (66p) each—54% of its original wholesale price of $1.77. Three other drug manufacturers said that they would supply large quantities of their antibiotics free if the Food and Drug Administration approved their use for the treatment of anthrax.
The companies are Bristol Myers Squibb, offering gatifloxacin (Tequin), and Johnson and Johnson, offering levo-floxacin (Levaquin). GlaxoSmithKline is asking the FDA to approve for the treatment of anthrax two of its older drugs. It said that it would supply free all the medication the government needed to treat anthrax. Eli Lilly and Pfizer also offered to provide drugs at cost.
The anthrax outbreak might turn out to be a lifeline for Bayer after the company was forced to withdraw its cholesterol lowering drug, cerivastatin (Baycol in the United States; Lipobay in the United Kingdom) last August after 31 patients in the United States died from severe rhabdomyolysis (18 August, p 359; 25 August, p 415). The company's share price fell from more than $40 a share in August to $24 in September. It has now made a modest recovery to about $30.
With the Bayer deal, the National Pharmaceutical Stockpile (a programme run by the CDC) will have accumulated 120 million ciprofloxacin tablets by the end of the year. That would be adequate to treat 12 million Americans, but only for five days. Under the latest MMWR guidelines for treating pulmonary and cutaneous anthrax for 60 days, the ciprofloxacin would be adequate for only one million people.
“Bayer is fully committed to supporting America in its war on terrorism,” said Helge Wehmeier, president of the American subsidiary of Bayer AG. “The men and women of Bayer are 100% committed to delivering this vital antibiotic to the US government on schedule.”
Doctors and scientists are beginning to worry that the widespread use of ciprofloxacin could lead to the development of antibiotic resistance. Dr Ken Alibek, president of Hadron Advanced Biosystems, a private research company that is trying to develop broad respiratory resistance to the full range of evolving biological weapons, warned about the dangers recently in the New York Times (2001;Oct 28:B3).
“If this craziness with Cipro continues, in about two years we're going to have a huge number of new bacteria with powerful resistance to antibiotics,” he said. “Antibiotics should be the last resort.”
Dr Alibek, author of the book Biohazard (Hutchinson, 1999), which exposed the former Soviet Union's biological warfare establishment, added: “It's part of the panic, chasing each new immediate threat but never thinking several steps ahead.”
More details about the CDC's recommendations on anthrax are accessible at www.cdc.gov
(see editorial by Hart, p 1017)