January 2002

Rebuttal to Bayer's False Claims regarding FDA's Proposed Ban on Fluoroquinolones

Since October 30, 6,100 Keep Antibiotics Working activists have emailed letters to Bayer’s CEO Helge Wehmeier, urging the company to comply with the Food and Drug Administration’s proposed ban on use in poultry of Baytril, a Cipro-like antibiotic. The FDA proposed the ban based on evidence that such use is spurring Campylobacter, the leading bacterial cause of severe food poisoning, to become increasingly resistant to Cipro.

In response to the 6,100-plus messages from concerned members of the public about this issue, Bayer has distributed materials arguing that FDA’s proposal is unjustified. This memo outlines why Bayer’s assertions are wrong or misleading.

Bayer assertion: “Data for the past five years shows that the rate of Campylobacter infections in humans is markedly decreasing (15% from 1996-2000) while at the same time chicken consumption is increasing.”
Response: The decreasing rate of Campylobacter infections is good news. However, the bad news is that approximately one in every six Campylobacter infections, or nearly 18%, is now resistant to fluoroquinolones (the class of antibiotics that includes both Cipro and Baytril). Poultry is the major source of Campylobacter infections in humans in the United States. In recent years, consumers have become increasingly aware that they must carefully handle uncooked meat and poultry to avoid this and other food-borne infections. Even so, there are still almost two million cases of Campylobacter infections in the United States each year. Fortunately, most cases do not require antibiotic treatment. However, patients with severe infections and/or those with weakened immune systems - including the elderly as well as chemotherapy, transplant, and HIV/AIDS patients - depend on antibiotics to recover. Bayer Corporation should live up to its slogan, "Expertise with responsibility," and protect the effectiveness of antibiotic treatments for Campylobacter by withdrawing Baytril from the market.

Bayer assertion: “The rate of infections with fluoroquinolone-resistant Campylobacter has not increased since the introduction of Baytril for poultry.”
Response: Bayer provides no factual basis for this statement, and the company ignores data to the contrary in the scientific literature and from federal agencies. Although fluoroquinolones (the class of antibiotics that includes Baytril) were approved for use in humans in 1986, resistance to them remained quite low until shortly after these drugs were approved for use in poultry in 1995. By 1997, 13% of Campylobacter infections were resistant, a figure that rose to 18% in 1999.

Bayer assertion: “Centers for Disease Control and Prevention (CDC) data from 1998-1999 point to other more significant causes for human Campylobacter infections than poultry consumption, primarily infections acquired during foreign travel, such as to Latin America.”
Response: The Food and Drug Administration (FDA) took such infections into account when the agency proposed to ban Baytril use in poultry. Specifically, FDA estimates that 9,261 people in 1999 who needed antibiotic treatment for severe Campylobacter infections had fluoroquinolone-resistant infections as a result of Baytril use in U.S. chicken production. The fact that even more people may have been infected by resistant Campylobacter from foreign travel is no reason to ignore those sickened by resistant Campylobacter from contaminated chickens.

Bayer assertion: “The theoretical human illness rate that the FDA’s Center for Veterinary Medicine attributes to fluoroquinolone resistant Campylobacter is greatly overestimated. Even if its exaggerated assumptions were correct, the risk the FDA accepts for bottled drinking water is greater than that estimated for Baytril.”
Response: Again, Bayer provides no factual basis for its contention that the FDA estimate is incorrect. Indeed, the incidence of food-borne illness in this country, including from Campylobacter, is almost certainly underestimated. Many people with "food-poisoning" do not seek treatment and, even if they seek treatment, may be given an antibiotic without being tested for the cause of their illness.
With regard to FDA's standards for bacteria in bottled water, those standards should be made more stringent to be consistent with EPA's tougher standards for bacteria in tap water. However, this is not a reason for Bayer to jeopardize public health by keeping Baytril on the market.

Bayer assertion: “A recent assessment of FDA’s position on Baytril for poultry by the European Agency for the evaluation of Medicinal Products (EMEA), the European equivalent of the FDA, supports Bayer’s conclusions that the use of Baytril in poultry poses no public health threat.”
Response: The assessment in question was actually prepared by EMEA’s Committee on Veterinary Medicinal Products, which is comprised of veterinarians and animal scientists rather than medical or public-health experts. By contrast, major U.S. health care professionals are very concerned about the threat to public health from the use of Baytril in poultry. Over 180 U.S. health care professionals and organizations, including the American Medical Association and the American Public Health Association, have written Bayer Corporation asking the company to withdraw Baytril.
Moreover, Bayer misrepresents EMEA's assessment, which agrees with most of FDA’s analysis concerning the use of fluoroquinolones in chickens. EMEA's assessment refutes many of Bayer’s claims, including items (2) and (3) above. However, EMEA's assessment downplays the threat of fluoroquinolone-resistant Campylobacter to humans, stating that most Campylobacter infections in humans do not require antibiotic treatment and that alternative antibiotics are available. This portion of EMEA's conclusions is partially contradicted later in EMEA assessment, which notes that early treatment with fluoroquinolones can be critical to prevent complications in patients at particular risk for severe Campylobacter infections (such as the elderly and those with less-effective immune systems due to chemotherapy, HIV/AIDS, transplant-related immunosuppression, or other factors).

Bayer assertion: “Baytril is used sparingly and for therapeutic purposes only, that is, only to treat disease. In 2001, less than 1 percent of U.S. broiler flocks will be treated with Baytril. It is used only when prescribed by a veterinarian for specific life-threatening poultry diseases. Baytril is never used in the feed of animals, and it is not a growth promoter.”
Response: About 80 million broiler chickens -- 1 percent of the more than 8 billion broiler chickens processed annually in the United States -- are treated with Baytril each year. In 1999, industry estimated that around 38,000 pounds of Baytril were given to poultry. Although Baytril is only prescribed by veterinarians for treatment of illness, individual sick birds are not treated. Rather, Baytril is administered to an entire poultry flock (which may consist of more than 30,000 birds), via the facility’s drinking water system – even if only a portion of the flock is sick. Such treatment of healthy as well as sick birds, each receiving levels of antibiotic that vary with their water consumption, is a recipe for the proliferation of antibiotic-resistant Campylobacter.

Bayer assertion: “Beyond its use to treat disease in poultry, many veterinarians consider Baytril essential for the treatment of many types of serious infections in cats and dogs.”
Response: No one has suggested limiting Baytril use in cats and dogs. FDA’s proposed ban explicitly addresses use of Baytril in poultry, and only in poultry.

Bayer assertion: “Scientific data clearly show that the judicious use of Baytril on the farm, under the supervision of veterinarians, contributes to the wholesomeness of our food while preserving the effectiveness of fluoroquinolones as powerful antimicrobial agents.”
Response: We are not aware of data showing that the use of Baytril in poultry contributes to the wholesomeness of foods. However, as discussed above, this use of Baytril is compromising the effectiveness of fluoroquinolones to treat human illness.

Keep Antibiotics Working: The Campaign to End Antibiotic Overuse