By Marc Kaufman, Washington Post Staff Writer / Friday, October 27, 2000
The Food and Drug Administration announced plans yesterday to ban the use of two antibiotics used by poultry farmers to keep chickens and turkeys healthy, saying the practice increases the danger that humans will become infected with germs that resist treatment.
The removal would mark the first time the government has pulled any drug to combat infections that have grown resistant to antibiotics, a rising problem that public health officials have been warning for years could return the world to the days before penicillin and other infection-killers.
The action would also be the first specifically aimed at reducing the use of any specific antibiotics by livestock farmers, a practice that has increasingly raised alarms that it may boost the transmission of resistant microbes from animals to people.
Public health organizations, including the federal Centers for Disease Control and Prevention and the World Health Organization, have strongly advocated such a ban for years. But agriculture and pharmaceutical interests have successfully held them off until now.
Abbott Laboratories of North Chicago, Ill., maker of one of the drugs, will withdraw its antibiotic immediately, according to the FDA.
But Bayer Corp. Animal Division, of Shawnee Mission, Kan., which dominates the market, said it will consider whether to request a hearing to contest the proposed ban.
"We want to take a look at the basis of the [FDA's] decision," said Senior Vice President John Payne. "We have always said if we thought our product is causing harm, we would do the right thing."
The antibiotics in question are in the class known as fluoroquinolones, which have been available for human use since 1986 and are commonly prescribed to treat serious gastrointestinal illness, including from the common campylobacter bacteria. The FDA action would not affect the availability of the drugs for humans.
The drugs were approved for chickens, turkeys and cattle in the mid-1990s, and since then the incidence of resistance to fluoroquinolones in people has increased dramatically. After years of testing and construction of an elaborate risk assessment, the FDA concluded earlier this year that the health of at least 5,000 Americans is affected each year by the use of these drugs in chickens.
These people eat animals that are carrying resistant campylobacter bacteria because the animals were treated with fluoroquinolones. If the bacteria make people sick and they seek treatment, fluoroquinolones will be far less effective than normal. This could be life-threatening to the elderly, to children and to people with depressed immune systems.
While the consequences of fluoroquinolone resistance may not be grave to most people, public health officials call it the tip of an iceberg of rising resistance to dozens of other life-saving antibiotics. Resistance develops when antibiotics are overused, both by doctors treating people and by farmers treating animals. An estimated 40 percent of the nation's antibiotic use is in livestock.
The FDA selected fluoroquinolones to study because they are so commonly used and because the agency was able to collect the necessary data to directly link the drugs' use in chickens with a specific problem in people.
The drugs, Baytril from Bayer and SaraFlox from Abbott, are used to treat respiratory problems in chickens and turkeys.
Because the birds are raised in large flocks, it is impossible to treat the birds individually, and so the drugs are used in the flocks' drinking water. About 1.5 percent of chickens are treated with the antibiotics, according to industry sources. Without the drugs, farmers would be forced to find other ways to protect their flocks from illness.
The FDA is reviewing the use of fluoroquinolones in cattle as part of a comprehensive examination of all agricultural antibiotic use.
If Bayer challenges the ban for poultry, either in court or through an administrative appeal, it could take months for the issue to be resolved.
Reflecting the worries of Bayer and the animal pharmaceutical industry, several members of Congress wrote to Health and Human Services Secretary Donna E. Shalala on Wednesday, voicing concern about the FDA's impending action.
"The FDA's decision regarding fluoroquinolone use will set a precedent for all future activity regarding antibiotic resistance and will have a significant impact on the livelihood of hard-working poultry growers and on food safety," wrote Rep. Calvin M. Dooley (D-Calif.). "Given these implications, FDA must make the process more transparent and must render a decision based on fact rather than fear." But advocates of a more restrained use of antibiotics hailed yesterday's action.
Rep. Sherrod Brown (D-Ohio) said that the issue of antibiotic resistance has become increasingly important to scientists, regulators and the public. He said the Center for Veterinary Medicine, an arm of the FDA, has just been allocated $3 million to study the problem, the first appropriation of its kind.
"This has never happened before, and it's quite exciting," said Fred Angulo, who follows antibiotic resistance for the CDC. "The agency recognizes there is a problem that has to be corrected, and consumers will be the beneficiaries."
"There was tremendous opposition to the use of fluoroquinolones when FDA first approved them for treating flocks of poultry, and I suppose you can say the chickens have now come home to roost," said Michael Jacobson, director of the Center for Science in the Public Interest, a consumer group. "This action will reduce the spread of bacteria that are not sensitive to a very powerful antibiotic, and that is good for public health."
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