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IN DECIDING whether to approve new pharmaceuticals, the federal Food and Drug Administration must often weigh risks versus benefits, depending on test results that contain varying levels of uncertainty.
For drugs that could treat human diseases, these decisions can sometimes be exceedingly difficult. If the FDA errs in approving a product that hasn’t been fully tested, it can sicken or even kill people the drug was intended to help. Yet if the agency is overly cautious, it can reject a promising medication that potentially could save lives.
The risk-benefit equation is less challenging, however, when the FDA evaluates medications aimed at increasing production of cattle and other livestock. If the FDA errs in rejecting one of these drugs, certain industries and farmers may lose potential profits, but no one is directly harmed. Yet if it errs in approving a drug that could find its way into the food chain, the consequences to consumers could be staggering.
By all indications, the FDA isn’t sufficiently weighing these consequences as it prepares to approve a highly potent cattle antibiotic called cefquinome. As the Washington Post reported Sunday, the American Medical Association and about a dozen other health groups have warned that cefquinome could speed the emergence of cattle microbes resistant to certain antibiotics. If consumers were to ingest the microbes in large quantities while eating meat, it could increase their resistance to commonly prescribed antibiotics used to treat diseases and infections.
Despite the warnings, the FDA appears to be close to approving cefquinome, which is made by a Delaware company called InterVet Inc. to treat cattle lung infections. According to the Post, an internal policy document called Guidance Document 152 makes it difficult for the FDA to say no to cefquinome, even though the FDA’s advisory board recommended rejecting the drug last fall.
The agency’s march toward approval is doubly troubling, because the federal government has a mixed history of keeping potentially dangerous antibiotics out of the food supply. In the mid-1990s, the FDA allowed poultry to be treated with two antibiotics containing a class of drugs called flouroroquinolones. Only after bacteria resistant to flourorquinolones started showing up in patients with severe diarrhea did the agency pull the antibiotics from the market.
While bovine respiratory disease is highly common and extremely expensive for the cattle industry, experts say effective medicines are already on the market to treat this disease. Moreover, indications are the industry could reduce the spread of this disease by not packing cattle so closely into feedlots and train cars.
Clearly, the risks of celquinome outlined by the FDA’s advisory board outweigh the benefits. Until InterVet can demonstrate otherwise, the federal government should keep this drug off the market.