Published November 27, 2006
Antibiotic linked to human resistance
WASHINGTON, D.C. xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x82xacxc2x9d The U.S. Food and Drug Administration (FDA) is being urged to follow the recommendation of its scientific advisory committee to reject the use of cefquinome for treating respiratory disease in cattle linked to antibiotic resistance in human medicine.
No withdrawal. Despite this negative recommendation, the drugxc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s manufacturer, Intervet, has not withdrawn its application xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x82xacxc2x9d as is common practice after advisory committee rejections.
In fact, according to a news release, the company says it is convinced that cefquinome use in livestock will not create public health concerns and Intervet will continue to pursue approval activities.
Cefquinome is a fourth generation cephalosporin, a class of drugs that is highly valued in human medicine as treatment for serious and life-threatening infections.
Drug resistance. Growing scientific evidence shows that when used in poultry, swine and beef cattle, antibiotics that are identical or similar to important antibiotics used in human medicine promote development and spread of antibiotic-resistant bacteria that can be transferred to people via air, food, soil and water, making it harder to treat infections in humans.
xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3x85xe2x80x9cThe FDAxc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s handling of scientific advice is under increasing public scrutiny, with critics alleging the agency sometimes gives industry or ideological interests priority over science and public health,xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xafxc2xbfxc2xbd wrote Richard Wood, steering committee chair of the Keep Antibiotics Working coalition, in a letter to the FDAxc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s acting commissioner Dr. Andrew C. von Eschenbach.
xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3x85xe2x80x9cAn FDA decision to disregard its own scientific advisory committeexc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s recommendation on fourth generation cephalosporins would fuel those concerns. Such an approval would be a big step backward for the public health.xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xafxc2xbfxc2xbd
Claim rejected. The FDAxc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s Veterinary Medicine Advisory Committee voted Sept. 25 to reject the claim of cefquinomexc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s manufacturer, Intervet, that the new cattle drug could be considered safe for human health.
At that meeting, the American Medical Association and Infectious Disease Society of America joined the coalition in testifying that use of cefquinome in cattle could increase cephalosporin-resistant E. coli and Salmonella bacteria, two major causes of food poisoning in humans.
Precedence. The coalition has reason to be concerned that the FDA may reject the advisory committeexc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s advice. Two years ago, in a vote on another cattle drug, Tulathromycin, the meeting summary of the committeexc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s recommendation on the drugxc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s extra-label use (use not indicated on the label) did not clearly reflect the opposition of the committee.
xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3x85xe2x80x9cThe public expects, and the law requires, that advisory committee records accurately reflect the events of the day and the substance of the committeexc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xa2xe2x80x9exc2xa2s deliberations,xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xafxc2xbfxc2xbd the coalition letter concluded.
xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3x85xe2x80x9cThe arguments [against approving Cefquinome for use in cattle] are even stronger in light of the likelihood that the drug would be approved without strong prohibitions on extra-label use and thus would be used in other food animals, including swine and poultry.xc3x83xc2xa2xc3xa2xe2x80x9axc2xacxc3xafxc2xbfxc2xbd
Findings. In Europe, where Cefquinome has already been approved and used in livestock under the brand name Cobactin, E. coli and Salmonella bacteria isolated from animals have already been found to carry resistance to this and other cephalosporins...
Farm and Dairy