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KEYCODE BAYER #207

Washington Post, September 9, 2005

Ending Battle With FDA, Bayer Withdraws Poultry Antibiotic

By Marc Kaufman

For the first time, the Food and Drug Administration has succeeded in forcing off the market an antibiotic used to treat animals because of concerns that it will make similar antibiotics less effective in treating people. After a five-year battle, Bayer Corp. said yesterday that it would immediately stop selling its poultry antibiotic, Baytril, a close relative to its widely used human antibiotic, Cipro. The company could have appealed the FDA ban on the drug to a federal court but instead decided to comply.

"We disagree with the FDA's conclusion about our drug," said Bayer spokesman Robert Walker. "But we understand they made a scientific decision, and courts tend to defer back to the agency. . . . It seemed like the chances that we would be successful in court were small."

The resolution of the Baytril case opens the door to FDA action against other animal antibiotics. The agency has already told the makers of at least three types of penicillin used on farm animals that their products might raise similar concerns, and regulatory action might be needed.
Yesterday, public health advocates hailed Bayer's decision and the FDA actions that precipitated it. "We applaud Commissioner Lester M. Crawford for defending the public's health and Bayer for finally recognizing the need to comply with the FDA's ruling," said Karen Florini, senior lawyer at Environmental Defense and chairwoman of the Keep Antibiotics Working coalition. "Cipro is a critical antibiotic for treating human illness. It simply makes no sense to allow its effectiveness to be squandered by continued use of near-identical drugs in poultry flocks."

All antibiotics grow less effective over time as bacteria evolve to become resistant to the drugs' effects. Experts say wider use of an antibiotic -- by either animals or people -- leads to a speedier development of resistance. In its battle to continue marketing Baytril for use in poultry flocks, Bayer was joined by the Animal Health Institute, which represents drug makers, and four poultry trade associations. The company and the groups argued that no proof existed that Baytril was making drugs such as Cipro less effective, and that the drug's benefits were not properly considered. "It's disappointing to us that the case played out this way," said Ron Phillips, spokesman for the Institute. "While we disagreed with the FDA's methodologies and conclusions, consumers should be comforted by the fact that the agency does have sufficient authority to act when it thinks there's a threat to public health."

Antibiotics are used on American farms to treat sick animals and promote faster growth. Makers of animal drugs do not have to report how much animal antibiotic they sell, and no firm statistics exist. The Union of Concerned Scientists has estimated that 24.6 million pounds of antibiotics are used on American farms yearly, about 75 percent of the nation's antibiotic consumption. The animal drug industry says most of the antibiotics on farms are used to treat disease, but UCS scientists, who oppose the widespread use of antibiotics for livestock, say most is to promote growth.

The FDA and critics of widespread antibiotic use on farms have argued that the use of Baytril to treat chickens and turkeys was especially worrisome because the drug is a fluoroquinolone, in the same family of antibiotics as Cipro (ciprofloxacin hydrochloride). The agency also said during a long administrative hearing that poultry farmers have alternatives that are as effective as Baytril but pose less of a threat to the human antibiotic supply. In 2003, the World Health Organization urged that the use of antibiotics as animal growth promoters be stopped worldwide to preserve the effectiveness of important human drugs.

When the FDA first ordered Bayer to stop producing Baytril in 2000, it also told Abbott Labs to take its similar fluoroquinolone for poultry off the market. Abbott voluntarily withdrew the product, but Bayer appealed. An administrative law judge upheld the FDA position in March 2004, and Crawford affirmed the decision in July. Last week, Bayer, the AHI and poultry associations made an eleventh-hour request to delay the ban, but Crawford rejected that petition on Friday.

Baytril, which was approved for sale in 1996, quickly became a popular treatment for respiratory diseases in chickens and turkeys. Because farm birds cannot be treated individually, entire flocks are regularly given the drug in their feed to treat those that are sick and to protect others. The FDA concluded that this kind of broad use led to increased antibiotic resistance. The ban affects only the use of Baytril in poultry; the drug can still be given to pets and other farm animals that can be treated individually.

The withdrawal of Baytril is encouraging, Florini said, but she called on the FDA to go further. "We certainly hope that Crawford's rock-solid analysis of this issue is an indication he will take the bull by the horns in dealing with the much bigger quantities of medical antibiotics that are used as feed additives," she said. "These are too valuable to be used to just make animals on big industrial farms grow faster."

Newsinferno.com, September 3, 2005

Bayer Accused of Endangering Public Health by Attempting to Stay the September 12 FDA Ban on Agricultural Antibiotic Baytril

On July 28, the FDA announced the first-ever ban on an agricultural antibiotic as a result of a growing concern that the use of such drugs could lead to antibiotic-resistant pathogens in humans.The ban is scheduled to go into effect on September 12. At that time, the drug Baytril (manufactured by pharmaceutical giant Bayer Corp.) will no longer be permitted to be distributed or used for the purpose of treating bacterial infections in poultry.

Although the move has been praised by many experts as well as by leading consumer groups as unquestionably the right thing to do, it appears that there have been two requests for a stay; one by the Animal Health Institute, an agricultural drug trade group, and the other by poultry-veterinarian groups. Each petition requests the FDA to allow Baytril to remain on the market for an indefinite period while Bayer seeks judicial review of the Commissioner's decision.

A drug safety consumer group, however, Keep Antibiotics Working coalition, opposes the stay and has filed its own comments with the FDA stating the ban should go into effect as ordered. The coalition maintains such a review could take several months, or even years, to complete. According to an attorney for Environmental Defense: "This proceeding has already dragged on for nearly five years, during which time a growing number of people have suffered from Cipro-resistant food poisoning associated with poultry." Moreover, Bayer and its allies are simply rehashing the same unpersuasive arguments expressly rejected by both an FDA administrative law judge and the Commissioner himself." As previously reported by newsinferno.com, the antimicrobial drug enrofloxacin (Baytril) belongs to a class of drugs known as fluoroquinolones and is marketed under the name Baytril by Bayer Corporation. The drug is in the same "family" as Cipro, the widely used human antibiotic.

The FDA finally made a decision which many infectious disease experts had been calling for and directed its Center for Veterinary Medicine (CVM) to begin proceedings to withdraw use of this animal drug in poultry. The FDA now acknowledges scientific data shows that the use of enrofloxacin in poultry caused resistance to emerge in Campylobacter, a bacterium that causes foodborne illness. Chickens and turkeys normally harbor Campylobacter in their digestive tracts without causing poultry to become ill.

Enrofloxacin does not completely eliminate Campylobacter from the birds' intestinal tracts, and those Campylobacter bacteria that survive are resistant to fluoroquinolone drugs. These resistant bacteria multiply in the digestive tracts of poultry and persist and spread through transportation and slaughter, and are found on chicken carcasses in slaughter plants and retail poultry meats.

Campylobacter bacteria are a significant cause of foodborne illness in the U.S. Antimicrobial treatment is recommended for people with severe illness as well as the very young, the elderly, and people with certain medical conditions. Complications of such infections can include reactive arthritis and, more rarely, blood stream infections. Early treatment can mitigate symptoms and may decrease the risk of complications. Fluoroquinolones used in humans are ineffective if used to treat Campylobacter infections that are resistant to them. This failure can significantly prolong the duration of the infections and may increase the risk of complications. The proportion of Campylobacter infections that are resistant to fluoroquinolones has increased significantly since the use of enrofloxacin in poultry was approved in the U.S.

The Final Decision can be found at http://www.fda.gov/oc/antimicrobial/baytril.pdf. This ruling is seen as a step forward in the battle to stem the tide of antibiotic-resistant bacteria that are rapidly becoming a public health crisis. Critics of the FDA's inactivity on the matter have praised this first, decisive measure to deal with the problem.

Sept. 2, 2005 /U.S. Newswire

Bayer Threatens Human Health by Seeking Stay of FDA's 1st Ever Banof Agricultural Drug Due to Human Antibiotic-Resistance Concerns,Group Says

The Bayer Corp. is endangering public health by seeking to stay the Sept. 12 effective date of the first-ever ban for an agricultural antibiotic by the U.S. Food and Drug Administration (FDA) because of concerns about antibiotic resistance affecting human health. "That's the conclusion of comments filed today with the FDA by the Keep Antibiotics Working coalition regarding Bayer's attempt to delay the effective date for FDA Commissioner Lester Crawford's July 28 decision to withdraw approval for use of Cipro-like antibiotics in poultry (see Keep Antibiotics Working coalition comments on Bayer's appeal at http://www.keepantibioticsworking.com/new/resources_library.cfm?refID=76521 and news release about FDA decision at http://www.fda.gov/bbs/topics/news/2005/new01212.html)." Two similar requests for a stay were filed, one by Animal Health Institute (an agricultural drug trade group), and the other by the poultry-veterinarian groups. Each petition asks that FDA allow the drugs to remain on the market for an indefinite period while Bayer seeks judicial review of the Commissioner's decision. Such a review would take many months, and possibly several years, to complete. Many major medical groups, including the American Medical Association and the Infectious Disease Society of America, have publicly supported banning fluoroquinolone use in poultry.
"This proceeding has already dragged on for nearly five years, during which time a growing number of people have suffered from Cipro-resistant food poisoning associated with poultry," said Karen Florini, senior attorney with Environmental Defense. "It's just appalling that Bayer is pushing to leave these Cipro-like poultry drugs on the market for several more months or years, condemning more people to hard-to-treat illnesses. In their motion for a stay, Bayer and its allies are simply rehashing the same unpersuasive arguments expressly rejected by both an FDA administrative law judge and the Commissioner himself."
Commissioner Crawford, who holds a Doctor of Veterinary Medicine degree as well as a Ph.D. in pharmacology, issued a 126- page final decision banning use of Cipro-like antibiotics in chickens and turkeys because of concerns about antibiotic resistance affecting human health (the entire 126-page decision is available at http://www.fda.gov/oc/antimicrobial/baytril.pdf. The FDA first proposed the ban in October 2000, but took nearly five years to finalize it because of numerous procedural delays created by Bayer, the only manufacturer of the drug, whose trade name is Baytril. Both Baytril and Cipro are members of the fluoroquinolone class of antibiotics.
The FDA concluded that using Baytril in poultry reduces the effectiveness of Cipro in treating people who have severe food poisoning caused by 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 fluoroquinolones 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.