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Health concerns cause antibiotic opposition

Econ101

Well-known member
Health concerns cause antibiotic opposition



By Jeff DeYoung, Iowa Farmer Today

April 11, 2007 2:49 PM CDT



The proposed approval of a new cattle vaccine could turn into a political football, says a Kansas veterinarian.



Cefquinome, an antibiotic manufactured by Intervet, did not receive approval this past fall from the Food and Drug Administration’s (FDA) Center for Veterinary Medicine Advisory Committee. However, the FDA is still considering approving the drug for use in cattle.



“FDA cannot refuse the product if the company meets all the requirements set forth for approval, and Intervet has done that,” says Larry Hollis, Extension beef veterinarian at Kansas State University. “The only way approval can be denied is if it’s stopped politically.”



Intervet says Cefquinome is the “active ingredient of various Cobactan formulations, which are licensed in Europe for the treatment of respiratory disease, mastitis, septicemia and foot rot in cattle and/or swine.”



These fourth-generation cephalosporins have been used in Europe for treating veterinary and human infectious diseases. Intervet says there have been no problems. However, several U.S. organizations, including the American Medical Association (AMA), are opposed to the approval of Cefquinome because of human health concerns.



“The AMA is concerned by data that have accumulated on the use of a third-generation cephalosporin in food animals,” said Michael Maves, CEO and executive vice president of the AMA in a letter mailed to the FDA committee this past fall.



“The only third-generation cephalosporin approved for use in these animals in the United States is ceftiofur, which is widely used in cattle, chickens, and turkeys, in part because there is no withdrawal time. With the unrestricted use of ceftiofur, data from the National Antimicrobial Resistance Monitoring System (NARMS) indicate that ceftriaxone-resistant Salmonella and E. coli have emerged and spread in the United States. Ceftriaxone is commonly used for the treatment of severe infections, and the spread of resistance to this agent is therefore of clinical concern. Given the current outbreak of E. coli O157:H7 in this country, this increase in resistance is particularly troubling.”



Hollis says there are other antibiotics on the market that can do the same things as Cefquinome.



“Do we need the product? My contention is we don’t,” he says.



But, Hollis is concerned about possible ramifications if the drug is not approved.



“Do we want to give politicians the chance to block it? If we do, then you can kiss the money all these companies are putting into research goodbye,” he says. “They aren’t going to be willing to take the chance.”



Hollis says if beef is properly prepared, there is little chance of picking up any form of resistant bacteria.



“Intervet is following the letter of the law here,” he says. “I would hate to see this become a political issue.”



iowafarmer.com
 

Econ101

Well-known member
FDA shouldn't approve cattle antibiotic



McClatchy-Tribune News Service (MCT)

Belleville News Democrat

March 8, 2007



The following editorial appeared in the Sacramento Bee on Wednesday, March 7:



In deciding whether to approve new pharmaceuticals, the federal Food and Drug Administration must often weigh risks versus benefits, depending on test results that contain varying levels of uncertainty.



For drugs that could treat human diseases, these decisions can sometimes be exceedingly difficult. If the FDA errs in approving a product that hasn't been fully tested, it can sicken or even kill people the drug was intended to help. Yet if the agency is overly cautious, it can reject a promising medication that potentially could save lives.



The risk-benefit equation is less challenging, however, when the FDA evaluates medications aimed at increasing production of cattle and other livestock. If the FDA errs in rejecting one of these drugs, certain industries and farmers may lose potential profits, but no one is directly harmed. Yet if it errs in approving a drug that could find its way into the food chain, the consequences to consumers could be staggering.



By all indications, the FDA isn't sufficiently weighing these consequences as it prepares to approve a highly potent cattle antibiotic called cefquinome. As the Washington Post reported Sunday, the American Medical Association and about a dozen other health groups have warned that cefquinome could speed the emergence of cattle microbes resistant to certain antibiotics. If consumers were to ingest the microbes in large quantities while eating meat, it could increase their resistance to commonly prescribed antibiotics used to treat diseases and infections.



Despite the warnings, the FDA appears to be close to approving cefquinome, which is made by a Delaware company called InterVet Inc. to treat cattle lung infections. According to the Post, an internal policy document called Guidance Document #152 makes it difficult for the FDA to say no to cefquinome, even though the FDA's advisory board recommended rejecting the drug last fall.



The agency's march toward approval is doubly troubling, because the federal government has a mixed history of keeping potentially dangerous antibiotics out of the food supply. In the mid-1990s, the FDA allowed poultry to be treated with two antibiotics containing a class of drugs called flouroroquinolones. Only after bacteria resistant to flourorquinolones started showing up in patients with severe diarrhea did the agency pull the antibiotics from the market.



While bovine respiratory disease is highly common and extremely expensive for the cattle industry, experts say effective medicines are already on the market to treat this disease. Moreover, indications are the industry could reduce the spread of this disease by not packing cattle so closely into feedlots and train cars.



Clearly, the risks of celquinome outlined by the FDA's advisory board outweigh the benefits. Until InterVet can demonstrate otherwise, the federal government should keep this drug off the market.



Source: Sacramento Bee

belleville.com



Highly potent antibiotic may soon be used in cattle

FDA set to approve it despite warnings of human danger



Rick Weiss, Washington Post

via San Francisco Chronicle

Sunday, March 4, 2007



The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous -- for people.



The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defense against several serious human infections. No drug from that class has ever been approved in the United States for use in animals.



The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotic, as has happened with other drugs. Those super-microbes could then spread to people.



Echoing those concerns, the FDA's advisory board voted last fall to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.



Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh threats to human health posed by proposed new animal drugs.



The wording of "Guidance for Industry 152" was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs such as cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.



Industry representatives say they trust Guidance 152's calculation that cefquinome should be approved. "There is reasonable certainty of no harm to public health," Carl Johnson, InterVet's director of product development, told the FDA last fall.



But others say Guidance 152 makes it too difficult for the FDA to say "no" to some drugs.



"The industry says that 'Until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Clinic Research Foundation in Marshfield, Wis. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."



The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts from the Centers for Disease Control and Prevention, the drug agency approved the marketing of two drugs, Baytril and SaraFlox, for use in poultry. Both are fluoroquinolones, a class of drugs important for their ability to fight the bioterror bacterium that causes anthrax and a food-borne bacterium called campylobacter, which causes a serious diarrheal disease in people.



Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. But while Abbott Laboratories, which made SaraFlox, pulled its product, Baytril's manufacturer, Bayer Corp., pushed back.



"They fought this tooth and nail. It took years," said Kirk Smith, an epidemiologist at the Minnesota Department of Health.



Finally, late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread even further.



At the FDA advisory meeting in September, the agency's experts defied Guidance 152 and voted 6-4 against approval of cefquinome. But that day, and in follow-up interviews, Stephen Sundlof, head of the agency's Veterinary Medicine Center, made it plain the vote was "not binding."



"I think we all agreed ... that Guidance for Industry 152 would be the criteria against which we would base our decisions on safety," Sundlof said at the meeting.



Source: San Francisco Chronicle

sfgate.com
 
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