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Editorial Board

FDA drug approval would make humans more vulnerable.

Wisconsin dairy farmer John Vrieze wants FDA permission to give his cows a powerful antibiotic, cefquinome, that is now the drug of choice and last resort for several difficult-to-treat human conditions. He shouldn't get that permission. That would be, as the Gold'n Plump billboards say about antibiotics and animals, a "cock-a-doodle-don't."
By all accounts, Vrieze is a very good dairy farmer who embraces advanced techniques for keeping his cows happy, healthy and producing. So when one of his cows comes down with bovine respiratory disease, he'd like to treat the animal with a powerful drug, cefquinome. The manufacturer of cefquinome has petitioned the Food and Drug Administration for permission to begin selling the drug for use in animal husbandry.

That has set up a tug of war between those opposed to wider use of antibiotics in animals and those who favor it. In this battle, the opponents are the good guys; they include the American Medical Association, other health groups and the FDA's own advisory panel.

The problem is that the disease-causing microbes which antibiotics attack constantly mutate. The wider the use of an antibiotic, the sooner one of those mutations will defeat the drug.

Widespread use of antibiotics in animals accelerates this process tremendously, leaving humans more vulnerable to diseases once controllable. That's what is behind a movement to reduce the use of antibiotics in animals, and why the Gold'n Plump billboard is an effective marketing device.

Enter cefquinome. A close cousin, cefepime, is the only effective treatment available for some serious infections. Worried that using cefquinome in animals puts the efficacy of cefepime at risk, the advisory board at the FDA's Center for Veterinary Medicine recommended against approving animal use.

The panel had two other reasons for voting the way it did: A dozen other, effective treatments already are on the market for bovine respiratory disease, and the incidence of that disease can be significantly reduced if the animals are treated right -- i.e., not frequently moved long distances and not packed tightly together.

Notwithstanding the common-sense judgment that drugs from the cephalosporin family should be reserved for humans, the FDA may still approve it for animals. The reason is one that has become common under the Bush administration: deference to industry.

FDA guidelines have been rewritten so that approval in a case like this is pretty much guaranteed unless opponents can prove a risk to a drug used in humans to fight a food-borne illness. Since that is not the case for cefquinome, dairy farmer Vrieze may get his wish and be allowed to use its close cousin on his sick dairy cows. His "Bossy" may be better off, but someone's very sick Aunt Millie eventually is going to pay the price. Something's wrong with that outcome.Minneapolis Star Tribune