FDA concludes that drug's use in poultry impairs antibiotics effectiveness for treating humans

WASHINGTON — In a letter released today, more than 150 health professionals and organizations, including the American Medical Association, urged the Bayer Corporation to comply voluntarily with the Food and Drug Administration’s recent proposal to ban the use of certain antibiotics in chickens and turkeys. The antibiotics in question, known as fluoroquinolones, are also the best drug for treating severe food poisoning in humans. Bayer, which is the only remaining manufacturer of these antibiotics for use in poultry, also produces Bayer Aspirin, Flintstones vitamins, and numerous other consumer products.

     In proposing the ban, FDA cited sharply rising rates of resistance to fluoroquinolones by Campylobacter bacteria, which are the leading cause of foodborne illness in the U.S. Absent a ban, FDA concluded that “more people will be unable to be effectively treated with fluoroquinolones when those drugs are needed for foodborne illness.” Such illnesses can be life-threatening for the elderly, and people with weakened immune systems such as chemotherapy patients, transplant patients, and AIDS patients.

     Bayer has until November 30 to decide whether to consent to FDA’s proposed ban or to request a formal hearing on the proposal — a process that could take many months or even years.

     Last week, the American Public Health Association adopted a policy urging that Bayer comply voluntarily, saying that doing so constitutes the “quickest, most responsible way to address the public health threat” posed by fluoroquinolone use in poultry.

     Physicians have used fluoroquinolones as an essential treatment for foodborne disease since 1986. Very little resistance occurred until shortly after its use in poultry began in 1995. By 1998, the Centers for Disease Control found that over 13 percent of foodborne Campylobacter were resistant to fluoroquinolones. Last year resistance rose to nearly 18%.

     “It is irresponsible and shortsighted to continue to allow this drug to be used in poultry. The health of Americans must come before profit margins and market shares,” said Mohammad N. Akhter, MD, MPH, executive director of the American Public Health Association. “We hope that Bayer will show their commitment to safeguarding and improving the public’s health by heeding the FDA’s proposal and stopping the production of this drug for use in poultry.”

     “FDA has done the right thing by proposing to ban use of fluoroquinolones for poultry, in order to help preserve this invaluable antibiotic as a treatment for human illnesses. Bayer also should do the right thing by voluntarily withdrawing its drug from the market,” said Tamar Barlam, MD, an infectious-disease specialist with the Center for Science in the Public Interest. “The letter released today should ensure Bayer understands that the medical community regards Bayer’s upcoming decision on whether to comply with the proposed ban as extremely important.”

     “Rather than playing chicken with public health, Bayer should comply voluntarily with FDA’s proposed ban,” said Environmental Defense senior scientist Rebecca Goldburg, Ph.D.

     “FDA’s proposed ban is based on years of scientific study, and is critical for protecting public health,” said David Wallinga, a physician with the Minnesota-based Institute for Agriculture and Trade Policy.

     The other manufacturer of fluoroquinolones for poultry, Abbott Laboratories, voluntarily withdrew its product upon when FDA informed them that a ban was about to be proposed. Public-interest groups have previously applauded Abbott’s leadership.

EDITORS/REPORTERS NOTE: In addition to the signatories to the letter and those quoted above, groups supporting FDA’s action and calling for the Bayer withdrawal include:

Union of Concerned Scientists, Margaret Mellon, (202) 223-6133

Physicians for Social Responsibility, Sharon Newsome,(202) 898-0150, ext. 230

National Catholic Rural Life Conference, Brother David Andrews,(515) 270-2634

Humane Society of the United States, Suzanne Millman,(301) 258-3114

Global Resources Action Center for the Environment, Alice Slater,(212) 726-9161

Food Animal Concerns Trust, Richard Wood, (312) 860-3930

Delmarva Poultry Justice Alliance, The Rev. Jim Lewis,(302) 537-5318