lpioch
Sun, Mar-04-07, 19:22
WASHINGTON (Reuters) - The Food and Drug Administration may be poised to approve a controversial antibiotic for cattle despite fears it could hurt human health, The Washington Post reported in Sunday's edition.
The drug, called cefquinome, is a fourth-generation cephalosporin, a class of antibiotics used for a range of human diseases including serious gastrointestinal diseases in children and meningitis.
The fear is that using such drugs in animals can lead to the emergence of new drug-resistant "superbugs" which will be immune to similar drugs when used in people.
The overuse of antibiotics in both humans and animals has already helped such bacteria evolve, and infectious disease experts have been warning doctors to use them more judiciously.
The FDA's own advisors, the Veterinary Medical Advisory Committee, voiced such concerns when they voted in September to reject approval of cefquinome by InterVet Inc. of Millsboro, Del., which makes it.
Yet the Post quoted experts as saying the FDA was moving toward approval anyway, overriding the advice of the panel, the American Medical Association and other health groups.
The Post said the FDA was being pressured to approve the drug because of an internal guidance document called "Guidance for Industry #152" on how to weigh threats to human health from by proposed new animal drugs.
It quoted experts saying the rule makes it difficult for the FDA to deny a new animal drug unless it is likely to threaten the effectiveness of an antibiotic critical in treating food-borne illness.
Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin, said that made it difficult for the FDA to say no to some drugs, according to the newspaper.
"The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,"' it quoted Belongia as saying.
"But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open," he was quoted as saying.
InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. But more than a dozen antibiotics are on the market for the respiratory syndrome, and all are still effective.
The disease becomes a problem for cattle raised on intensive farms, and when they are packed into trains for shipment.
In January, New York Democratic Rep. Louise Slaughter, a Democrat who chairs the U.S. House of Representatives Rules Committee, sent the FDA a letter asking it not to approve the drug. She is a microbiologist.
"Over the past several years, the integrity of the FDA's drug review process has been called into question amid allegations that your agency has put the interests of industry and politics above science," Slaughter wrote at the time.
"Given the recent outbreaks of E. coli and other food borne illnesses across the nation, it is hardly the time to ignore the advice of scientists, and potentially impair our ability to treat deadly infections," she wrote.
Article from Scientific American:
http://www.sciam.com/article.cfm?chanID=sa003&articleID=8DB966959676F75BD2BA06C4A2EA266A
The drug, called cefquinome, is a fourth-generation cephalosporin, a class of antibiotics used for a range of human diseases including serious gastrointestinal diseases in children and meningitis.
The fear is that using such drugs in animals can lead to the emergence of new drug-resistant "superbugs" which will be immune to similar drugs when used in people.
The overuse of antibiotics in both humans and animals has already helped such bacteria evolve, and infectious disease experts have been warning doctors to use them more judiciously.
The FDA's own advisors, the Veterinary Medical Advisory Committee, voiced such concerns when they voted in September to reject approval of cefquinome by InterVet Inc. of Millsboro, Del., which makes it.
Yet the Post quoted experts as saying the FDA was moving toward approval anyway, overriding the advice of the panel, the American Medical Association and other health groups.
The Post said the FDA was being pressured to approve the drug because of an internal guidance document called "Guidance for Industry #152" on how to weigh threats to human health from by proposed new animal drugs.
It quoted experts saying the rule makes it difficult for the FDA to deny a new animal drug unless it is likely to threaten the effectiveness of an antibiotic critical in treating food-borne illness.
Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin, said that made it difficult for the FDA to say no to some drugs, according to the newspaper.
"The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,"' it quoted Belongia as saying.
"But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open," he was quoted as saying.
InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. But more than a dozen antibiotics are on the market for the respiratory syndrome, and all are still effective.
The disease becomes a problem for cattle raised on intensive farms, and when they are packed into trains for shipment.
In January, New York Democratic Rep. Louise Slaughter, a Democrat who chairs the U.S. House of Representatives Rules Committee, sent the FDA a letter asking it not to approve the drug. She is a microbiologist.
"Over the past several years, the integrity of the FDA's drug review process has been called into question amid allegations that your agency has put the interests of industry and politics above science," Slaughter wrote at the time.
"Given the recent outbreaks of E. coli and other food borne illnesses across the nation, it is hardly the time to ignore the advice of scientists, and potentially impair our ability to treat deadly infections," she wrote.
Article from Scientific American:
http://www.sciam.com/article.cfm?chanID=sa003&articleID=8DB966959676F75BD2BA06C4A2EA266A