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US says nudging Bayer on anthrax drug patent on Cipro
Bayer triples production of antibiotic
By Charles Sheehan, Associated Press, 10/17/01
PITTSBURGH - After anthrax was found at NBC, Tom Brokaw held up a prescription bottle during a newscast and declared: "In Cipro we trust." On Capitol Hill, politicians lined up for the small white pills after a scare there. The word on everyone's lips: Cipro.
Few people had even heard of Cipro a month ago. Now, Bayer Corp. is more than tripling its production of the drug, the only form of the powerful antibiotic ciprofloxacin approved by the Food and Drug Administration to fight anthrax.
Even with production running 24 hours a day, seven days a week at its West Haven, Conn. plant, Sen. Charles Schumer, D-N.Y., said he is worried about a shortage.
The government is talking to German drug maker Bayer AG about relaxing its patent on Cipro, which has become the drug of choice for those worried about anthrax, Health and Human Services Secretary Tommy Thompson said Wednesday.
Asked on NBC's "Today" show whether he had nudged Bayer to "turn the other way in terms of their patent and allow other countries to produce Cipro," Thompson replied: "There's no question that discussions like that have been going on and will be going on."
The company's U.S. subsidiary declined to comment on talks with the U.S. government. Spokesmen for Thompson and for the Food and Drug Administration also declined to elaborate on the discussions.
At issue is a long-running controversy with implications for both intellectual property rights and for poor countries who want cheaper drugs for their epidemics of AIDS, malaria, tuberculosis and other diseases.
Bayer said Tuesday it planned to more than triple production of Cipro, an antibiotic in the fluoroquinolone class, over the next three months to meet soaring public demand fanned by a spate of anthrax cases since the Sept. 11 attacks on the United States.
Meanwhile, in Bombay, India, a generic drug manufacturer offered to supply the United States with 20 million tablets a month of ciprofloxacin, the generic name for Cipro.
Brian Tempest, president of Ranbaxy Laboratories Ltd, said Wednesday he was ready to start shipping in December at an "attractive" but unspecified price. Two months' supply of Cipro equivalents cost just $20 in India -- about one-thirtieth of the U.S. price.
Indian drug makers have been on the forefront of providing cheaper versions of important drugs and have given governments a strong financial incentive to sidestep patents and international property law.
BACKBONE OF U.S. TRADE POLICY
Strong intellectual property protections for pharmaceuticals have been at the backbone of U.S. trade policy for years. The United States argues that respect for patents preserves the incentive to develop new drugs.
"No one benefits if research on such products is discouraged because companies cannot protect their patent," U.S. Trade Representative Robert Zoellick's office said in an April 30 report. At the same time, Washington has shown a willingness to compromise for countries facing a major health crisis, such as the HIV/AIDS epidemic in sub-Sahara Africa.
Thirty-one members of Senate Majority Leader Tom Daschle's staff tested positive for exposure to anthrax apparently sent by mail, congressional leaders said Wednesday as they moved to shut down much of the U.S. Capitol temporarily as a precaution.
In congressional testimony, Thompson said the administration was seeking an extra $1.5 billion to combat bioterrorism, including $643 million to expand the national pharmaceutical stockpile and $509 million to speed up the development and purchase of a smallpox vaccine.
The administration is seeking to boost its anthrax antibiotics stockpile -- including Cipro, penicillin and doxycycline -- to treat 12 million people for anthrax for 60 days. The current stockpile is enough for about 2 million.
Sen. Charles Schumer, a New York Democrat, proposed Tuesday that the government buy generic versions, both to reduce reliance on a sole supplier and to cut costs.
Thompson said the government was considering the legal implications of Schumer's suggestion.
But FDA lawyers "indicate that we do not have the authority to purchase any place but Bayer at this point in time," he said on CNN. He did not elaborate and Larry Bachorik, the FDA's associate commissioner for public affairs, declined further comment.
PENICILLIN ALSO EFFECTIVE
Thompson said Cipro was not the only antibiotic being used to treat anthrax. Penicillin, he said, was cheaper and had been effective.
U.S. officials from President Bush down have said they suspect but have no firm evidence the anthrax scare could be linked to Saudi-born Osama bin Laden, accused of masterminding the attacks that killed nearly 5,400 people in New York, Washington and Pennsylvania.
In announcing plans to boost its Cipro production, Bayer said it would stick to pre-Sept. 11 price levels. The company charges the U.S. government about $1.89 a tablet.
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