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Analysis: More scrutiny for vet drugs?

By STEVE MITCHELL, UPI Senior Medical Correspondent

WASHINGTON, May 25 (UPI) -- Antibiotics used in animals that are important to human medicine could face increased scrutiny if legislation working its way through Congress gets passed.

The U.S. House of Representatives this week passed a bill that would allocate $1 million to the Food and Drug Administration's Center for Veterinary Medicine for reviewing the safety of the drugs when used in animals, in light of the increasing problem of antibiotic resistance.

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In addition, the Preservation of Antibiotics for Medical Treatment Act, which would phase out certain uses of antibiotics in food animals, has been introduced in both chambers and has the support of major medical organizations, including the American Medical Association.

Watchdog and public-health groups applauded the $1 million amendment to the appropriations bill. The measure, which was an amendment attached to the fiscal year 2007 Agriculture-Food and Drug Administration appropriations bill, would authorize $1 million for application-review activities to determine if drugs used in animals pose a risk of generating antimicrobial resistance.

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"We're very excited about it," Susan Prolman of the Union of Concerned Scientists told United Press International. "For the Center for Veterinary Medicine budget, $1 million is very significant," she added.

The appropriations bill has moved to the Senate, and it remains to be seen if a similar amendment will be introduced there.

"Similar legislation has passed before in the Senate ... so we're hoping that this will come to fruition this year as well," Prolman said.

Bob Guidos, director of public policy and government relations at the Infectious Diseases Society of America, told UPI his organization supported the amendment.

"We think it's a great idea," Guidos said. Noting that it took the FDA five years to get Bayer's Baytril off the market, he said, "Without additional resources, there's no way for the FDA to go back on its own and do risk assessment on antibiotics that have already been approved."

In addition to treating illness, antibiotics are also used in agriculture to promote growth. The possible risk the practice poses to human health has received increased attention in recent years. In a particularly noteworthy case, Bayer withdrew its drug Baytril last September after a five-year battle with the FDA. The agency wanted Baytril, which is similar to the human drug Cipro, taken off the market because it was concerned it was creating resistant strains of Campylobacter, an intestinal bacteria that infects people and can be fatal.

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The Pharmaceutical Research and Manufacturers of America referred UPI's request for comment to the Animal Health Institute. The AHI, which represents manufacturers of animal medicines, said antibiotic use in animals is safe and necessary.

"There are several published studies that demonstrate that antibiotic use is important in keeping animals healthy and producing safe food for humans, and we're confident further study will show the same results," AHI spokesman Ron Phillips told UPI.

Phillips said the use of antibiotics for growth enhancement is an approved use by the FDA, and about 5 percent of all animal antibiotics are used for this purpose.

According to the Union of Concerned Scientists, about 70 percent of the antibiotics and related medications used in the United States are routinely administered to food animals, and more than half of these drugs are also important in human medicine.

Prolman said the inappropriate use of antibiotics in agriculture can have significant implications for both human health and the economy.

"For every year that antibiotics are being used in animal agriculture, we know they are generating more and more resistance that affects the human population," she said. The practice costs the economy $4 billion to 5 billion every year, she added.

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The Preservation of Antibiotics for Medical Treatment Act has encountered resistance, and it may not get passed this session of Congress.

"It's an uphill battle," Prolman said. "We have some very strong sponsors, but it's tough because it deals with animal agriculture and pharmaceuticals," she said.

"There are some in the animal agriculture industry and the pharmaceutical industry who have a philosophy that no regulation is good regulation, and their voices are heard very loudly in the halls of Congress," she added.

IDSA's Guidos said he thought Congress, not the pharmaceutical industry, bore responsibility for tackling this issue.

"IDSA's position is that although many factors contribute to antibiotic-resistant infections, there's a growing body of evidence that antibiotics used in livestock contributes to the spread of resistant bacteria in humans," he said.

However, he noted, "We do not have concerns about antibiotics used appropriately in animals to treat illness. We're just concerned about them being used in ways that are detrimental."

The FDA did not respond to UPI's request for comment by press time.

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