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May
10, 2004
Dr. Attila Molnar, President and CEO
Bayer Corporation
100 Bayer Road
Pittsburgh, PA 15205-9741
Dear
Dr. Molnar:
The
undersigned organizations strongly urge you to comply
immediately with the Food and Drug Administration's
proposal to ban Baytril, a fluoroquinolone antibiotic
used in poultry. Such a decision would accord with the
recent determination by an Administrative Law Judge
that FDA's proposed ban of Baytril is supported by a
"substantial body of evidence" (Decision of March 16,
2004, p. 64).
The
Judge's opinion makes clear that the decision to ban
Baytril is not even remotely a close call. In addition
to concluding that substantial evidence links use of
Baytril in poultry to increased fluoroquinolone
resistance in Campylobacter, the Judge determined that
the credibility of one of Bayer's key witnesses was so
"severely compromised" that "his testimony cannot be
relied upon" in light of his repeated mis-quotation of
the scientific literature in his sworn testimony (p.
15). The Judge also characterized this same witness
as using "faulty" and "unsubstantiated" methods (p.
62) and found that some of Bayer's arguments were "not
relevant" (p. 32), while others were "inconsistent"
(p. 63). Bayer has already dragged this proceeding out
for three and a half years following FDA's October
2000 proposal.
The
Judge's 68-page decision is based on a formal
evidentiary record that included 388 bound volumes
containing more than 1,100 documents, and on
cross-examination of experts lasting for more than a
week. Enough is enough. Though not a focus of the
Judge's decision, it is also worth noting that several
major poultry corporations in the US have stated they
are no longer using fluoroquinolones to produce
chicken for human consumption. Similarly, many leading
food-service companies - including McDonald's, Dairy
Queen, Burger King, Domino's, Hardee's, Wendy's,
Popeye's, Subway, and BonAppetit - have stated that
they do not purchase chicken raised with these drugs.
In addition, pending legislation would ban the
national school lunch program from serving chicken
that was produced with the use of fluoroquinolones.
While
FDA regulations provide Bayer with a 60-day period in
which to appeal the ruling to the FDA Commissioner, we
strongly encourage Bayer not to do so, and instead to
comply immediately with the Judge's decision that
Baytril should be withdrawn from the market. Bayer is
now the only manufacturer of fluoroquinolones for
poultry, as the only other manufacturer of
fluoroquinolones for poultry (Abbott Laboratories)
voluntarily stopped marketing its version of the
product when FDA first moved to ban it.
Baytril is virtually identical to Cipro, which is a
key drug in treating severe food-borne illness in
humans such as that caused by Campylobacter -
particularly in people with weakened immune systems,
such as cancer patients, transplant recipients, and
persons with HIV/AIDS. In light of Bayer's motto,
"Expertise with Responsibility," the responsible
action now is to discontinue the manufacture of Cipro-like
drugs for poultry without further procedural delays.
Sincerely,
ACCORD Ag, Inc.
Action for a Clean Environment
Adrian Dominican Sisters
Alliance for Sustainable Communities
American Academy of Neurology
American College of Preventive Medicine
American Holistic Nurses Association
American Medical Student Association
American Society for Clinical Laboratory Science
American Society of Plastic Surgical Nurses, Inc.
Amigos Bravos
Animal Welfare Institute
Arkansas Nurses Association
Audubon International/Audubon Society of
New York
State
Blue Heron Environmental Network, Inc.
Border Ecology Project
Breast Cancer Fund
Center for Food Safety
Center for Science in the Public Interest
Children's Health Environmental Coalition
Citizens for Humane and Wholesome Food
Citizens for Pennsylvania's Future (PennFuture)
Citizens for Sludge-Free Land
Citizens of Putnam County for Clean Air and Water
Clean Water Action Alliance of Minnesota
Clean Water for North Carolina Coalition for a Clean
Minnesota River Coast Action Group Community Alliance
with Family Farmers Concerned Citizens of Hidden
Meadows Consumer Federation of America Department of
the Planet Earth Des Moines Water Works Earth Day
Coalition Ecology Center Edison Wetlands Association
Endangered Habitats League Environment Colorado
Environmental Defense Episcopal Diocese of Rhode
Island, Environment Committee Family Farms for the
Future Farm Sanctuary F.H. King: Students of
Sustainable Agriculture Florida Medical Association
Florida Nurses Association Food Animal Concerns Trust
Friends of Alum Creek and Tributaries Friends of
Arizona Rivers Friends of the Nanticoke River
Generation Green Glenview Prairie Preservation Project
Global Resource Action Center for the Environment
Public Fund Grass-roots Halifax River Audubon Hardy
Groves, Inc. Health and Medicine Policy Research Group
Hoosier Environmental Council Humane Education Network
Humane Farming Association Humane Society of the
United States Huntington Breast Cancer Action
Coalition Illinois Stewardship Alliance IHM Justice
and Peace Office: Working for a Sustainable World
Institute for a Sustainable Future Institute for
Agriculture and Trade Policy Iowa Association of Water
Agencies Iowa Children's Water Festival Iowa Citizens
for Community Improvement Iowa Environmental Council
Kettle Range Conservation Group Lake Superior Greens
Land Stewardship Project Leukemia and Lymphoma Society
LIVING Upstream Lymphoma Foundation of America Maine
Chapter of the American Academy of Pediatrics Maine
Medical Association Maine People's Alliance McCook
Lake Chapter of the Izaak Walton League of America
Medical Society of New Jersey Mercy Investment Program
Michigan Environmental Council Michigan Nature
Association Minnesota Catholic Conference Minnesota
Project My Mother's Garden, Inc. National Catholic
Rural Life Conference National Environmental Trust
Natural Resources Defense Council Neponset River
Watershed Association Nevada State Medical Association
New Jersey Environmental Lobby New Mexico Medical
Society North Carolina Association of Black Lawyers'
Land Loss Prevention Project Northeast Center for
Social Issue Studies Northeast Organic Farming
Association of Massachusetts Northeast Organic Farming
Association of New Jersey Northeast Organic Farming
Association of New York Northeast Organic Farming
Association of Vermont Northland Health and Wellness
Northwest Environmental Defense Center NY/NJ
Environmental Watch Ohio Division, Izaak Walton League
of America Ohio Public Health Association Ohio Valley
Environmental Coalition Oregon State Public Interest
Research Group Organic Consumers Association Organic
Independents Organic Trade Association Park County
Environmental Council PCC Farmland Fund PCC Natural
Markets Physicians for Social Responsibility Preserve
Wild Santee Prevention Is The Cure, Inc. Protect Our
Earth's Treasures Protecting Animals USA Rahway River
Association Regional Farm & Food Project Rivers
Foundation of the Americas San Francisco Medical
Society Science and Environmental Health Network
Sierra Club Society for Animal Protective Legislation
South Carolina Coastal Conservation League Southern
Streams Stonyfield Farm, Inc. (& O'Naturals) Stream
Team 714 Sustain Sustainable Earth Tear of the Clouds
LLC/Keeper Springs Tri-County Conservation League
Union of Concerned Scientists United Anglers of
California Ursulines of Tildonk for Justice and Peace
U.S. PIRG Vermont Public Interest Research Group
Virginia Forest Watch Waterkeeper Alliance Western
Nebraska Resources Council West Virginia Rivers
Coalition Women, Food and Agriculture Network Wyoming
Outdoor Council
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