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KEYCODE BAYER #200

Jul 28, 2005

FDA bans Bayer antibiotic for poultry use

The Food and Drug Administration on Thursday banned the use of a poultry antibiotic made by Bayer, an unprecedented action aimed at preventing the rise of drug-resistant germs that infect people.

The FDA, which first proposed the ban five years ago, said the use of the drug, Baytril, in chickens has made it difficult for doctors to treat human patients with food poisoning. The drug was sometimes used by farmers to treat entire poultry flocks when a few birds showed signs of respiratory disease. FDA Commissioner Lester Crawford said Baytril "has not been shown to be safe for use in poultry." The ruling, effective Sept. 12, does not affect other approved uses of the drug.

The Union of Concerned Scientists hailed the ruling as a "big victory for public health." Bayer said it was "surprised and disappointed" and mulling whether to appeal the decision in court.

Baytril is part of a family of potent antibiotics known as fluoroquinolones, which physicians consider valuable for treating serious infections in people. The class of drugs includes Cipro, a well-known human antibiotic. Health officials argue that the widespread use of the drug by livestock farmers was one reason that more germs were becoming resistant to other fluoroquinolones.

Bacteria learn to outsmart antibiotics when repeatedly exposed to the medicines. Humans then pick up drug-resistant bacteria when they eat or handle contaminated meat.

"We are surprised and disappointed with the commissioner's decision," said Bob Walker, spokesman for Bayer's U.S. animal health division. "We will soon make a determination on which course to take next." Baytril was used in the mid-1990s to treat about 1 percent of the U.S. chicken population, Walker said.

Consumer groups and health experts welcomed the ban. "It's a big victory for public health in that the FDA has acted to protect the efficacy of human drugs," said Margaret Mellon, food director at the Union of Concerned Scientists. The ban is the first time the FDA has withdrawn an antibiotic drug for animals because of a concern about its impact on human use, she said.

Mellon said she hoped this would be the first of many poultry drugs to be taken off the market because of concerns about antibiotic resistance.(By Randy Fabi)

July 28, 2005

Keep Antibiotics Working Praises FDA`s First Ever Ban of Agricultural Drug Due to Antibiotic-Resistance Effects in Humans

Ban on Cipro-like Drugs in Poultry Initiated During Clinton Administration

The Keep Antibiotics Working (KAW) coalition commended newly confirmed U.S. Food and Drug Administration (FDA) Commissioner Lester Crawford for today issuing a precedent-setting, final decision to withdraw approval for use of Cipro-like
antibiotics in poultry (see FDA decision at http://www.fda.gov/oc/antimicrobial/baytril.pdf).

This action is the first time that FDA has ever withdrawn an agricultural antibiotic from the market because of concerns about antibiotic resistance affecting human health. The ban was proposed in October 2000, but took nearly five years to finalize because of numerous procedural delays created by Bayer Corp., the only manufacturer of the drug, whose trade name is Baytril. Both Baytril and Cipro are members of the fluoroquinolone class of antibiotics.

FDA has shown that use of Baytril in poultry reduces the effectiveness of Cipro in treating Campylobacter, one of the most common causes of severe bacterial food poisoning. The most recent data from the Centers for Disease Control and Prevention show that resistance to Cipro in Campylobacter in humans has risen to 21 percent as of 2002; when Cipro-like drugs were first approved for use in poultry in 1995, such resistance was negligible. Although Bayer claims that Baytril is critical for poultry production, most top poultry producers have announced that they no longer use these drugs in chickens produced for human consumption, including Tyson, Gold Kist, Perdue, Foster Farms, and Claxton.

Major chicken purchasers, including McDonald`s, Wendy?s, Dairy Queen, Burger King, Domino`s, Hardee`s, Popeye`s,Subway and Bon Appetit, have instructed their suppliers to stop using fluoroquinolones in chickens they purchase.

“We applaud Commissioner Crawford and the FDA for acting decisively to protect the public`s health,” said David Wallinga, M.D., MPA, a senior scientist and director of the Antibiotic Resistance Project at the Institute for Agriculture and Trade Policy. “Cipro is an essential antibiotic and we cannot allow its
effectiveness to be compromised by squandering it on poultry.”

The decision takes effect September 12, 2005, but implementation could be delayed if Bayer requests a stay from FDA or from the courts. “This proceeding has dragged on for nearly five years, during which time resistance has continued to climb,” said Karen Florini, senior attorney with Environmental Defense. “It would be simply irresponsible for Bayer to seek a stay at this point, or for FDA to grant one pending judicial review.

“This is a very important decision because it is the first time FDA has cited antibiotic resistance as the reason for banning use of a drug,” said Margaret Mellon, Ph.D., J.D., Director of the Food and Environment Program at the Union of Concerned Scientists. “But FDA also needs to take additional steps to address inappropriate antibiotic use in agriculture, particularly use of medically important antibiotics as feed additive uses.”

The Union of Concerned Scientists estimates 70 percent of all antibiotics used in the U.S. (about 25 million pounds annually) are routinely fed to poultry, swine, and beef cattle not to treat illness but rather to promote slightly faster growth and to compensate for overcrowded and unhealthy conditions in concentrated animal feeding operations. More than half of these drugs are identical or similar to antibiotics that are important in human medicine. Use of antibiotic feed additives spurs the development and spread of antibiotic resistant bacteria in our food supply and the environment.

In April, KAW members Environmental Defense, Food Animals Concerns Trust, and the Union of Concerned Scientists, along with the American Academy of Pediatrics and the American Public Health Association, petitioned FDA to ban the use of medically important antibiotics as feed additives for chickens, hogs, and beef cattle. The petition is based on a detailed analysis showing that such use violates the specific safety criteria in FDA's official Guidance on agricultural antibiotics (see FDA guidance at http://www.fda.gov/cvm/guidance/fguide152.pdf and see petition at
http://www.keepantibioticsworking.org/new/resources_library.cfm?RefID=36302). The American Medical Association and nearly 300 other groups have joined in supporting the bipartisan “Preservation of Antibiotics for Medical Treatment Act,” legislation that would end the use of medically important antibiotics as feed additives unless FDA finds that they are safe.


Salt Lake Tribune, August 07, 2005

Chickening out: Medicating livestock only threatens humans

Why did the chicken take the antibiotic?
Not because she was sick, necessarily, but because some other birds in her beak-by-giblet poultry barn were sick. Which isn't surprising, considering their less-than-sanitary living conditions.

Whenever a few birds show symptoms of respiratory infections, which they often do, it has long been common practice to just medicate the lot of them by putting an antibiotic such as Bayer's Baytril into their water.

Except that, come Sept. 12, it will be illegal to give Baytril to chickens and turkeys raised in the United States. And not a moment too soon. Because of the new ruling by the Food and Drug Administration, it will be less likely that you will get sick and, if you do get sick, the Baytril-like drugs that are given to people in your circumstance will stand a better chance of actually working.

It took five years for the FDA to act on the recommendation of its own animal health office. McDonald's already told its suppliers to stop using the stuff. But finally the evidence that the overuse of Baytril in poultry was giving rise to a drug-resistant form of a particularly nasty bacteria was too great to ignore.

Here's the Darwinian process that the FDA hopes to end: Sick chickens, along with hundreds or thousands of healthy ones, are given Baytril. That kills most of the germs, particularly a nasty one called Campylobacter. Except some of the stronger Campylobacters survive and, having the field to themselves, thrive and reproduce prodigiously.

Some people who eat the chicken pick up the super Campylobacter and might get sick, sometimes very sick, with symptoms including nasty stomach problems, arthritis and bloodstream infections. The normal medicine for that, Cipro, is so chemically similar to Baytril that chances are high the Campylobacter in your system, or your child's system, is immune.

So Baytril is out.
What's disheartening about this ruling is that, while the FDA has removed from legal use a drug that really is used to cure sick animals, it still allows all kinds of healthy livestock to be given some other antibiotics in small, "sub-therapeutic" doses just because it supposedly makes them grow faster.

Maybe. But it makes certain kinds of bacteria grow faster, too. It is time to end the practice of flooding livestock with antibiotics. We don't need the meat that badly.

Washington Post, September 2, 2005

Bayer Seeks Reprieve For Animal Antibiotic

By Marc Kaufman

Bayer Corp. has asked the Food and Drug Administration to allow it to keep selling its controversial animal antibiotic, Baytril, while it fights an agency ban on the drug in federal court.
Almost five years after the FDA first moved to ban the drug -- which the agency had concluded was contributing to a decrease in the effectiveness of closely related human antibiotics -- FDA Commissioner Lester M. Crawford issued a final rule in July ordering the drug off the market as of Sept. 12.
Bayer, a number of veterinarian organizations and the trade association that represents animal-drug makers filed their petition last week, asking for a permanent delay or a temporary one that would allow them to argue the timing of the ban in court.
The petition argues that the poultry industry needs the drug on the market now because the type of respiratory illness treated by Baytril poses the greatest risk to birds in the autumn.
All antibiotics gradually become less effective as bacteria adapt to them, and the speed of the adaptation is to some extent determined by how much of the medication is used. Because a substantial percentage of the antibiotics used domestically go to treat farm animals or to speed their growth, the FDA and many medical researchers have sought to limit their use on farms to ensure that the antibiotics used to treat humans do not become ineffective.
The agency considers Baytril an especially troublesome animal drug because it is very similar to the important human antibiotic ciprofloxacin.
As the FDA considered proposals to ban Baytril, Bayer sought the help of numerous members of Congress to stop the process. That effort failed, but supporters of the ban worry that the agency will now respond to pressure and allow the drug to stay on the market during a legal appeal, which could take years.
"If the agency decides to leave Baytril on the market, it will add to the growing evidence that FDA's agenda is being driven by politics, not science," said Margaret Mellon of the Union of Concerned Scientists, an advocacy group that supports the ban. "The petition for a stay submitted by Bayer and its allies is based on arguments that the FDA has already considered and soundly rejected."

background: Keep Antibiotics Working