ALERT FDA says to heck with public health approves potentially dangerous drug in cattle

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Permission to CROSS POST!!! fda says to heck with public health approves potentially dangerous drug in cattleMon, 5 Mar 2007 10:30:53 -0600"Johnson, Carol" carol.johnson "Linda Furness \(E-mail 2\)" linda.furness1, "Jason Williams \(E-mail\)" bananakaboom, "Joan Devagno \(E-mail\)" JDevagn, "Joanie Stambaugh \(E-mail 3\)" the_hardluck_hounds, "Denise Wilson \(E-mail\)" DeniseWilson, "ANITA WILLIAMS

\(E-mail\)" WILLIAMS, "Roie \(E-mail\)" roieg, "Jennifer Brown \(E-mail\)" JBrown FDA poised to approve cattle antibiotic despite warningsAgency likely will approve antibiotic despite fears it could harm people By RICK WEISSWashington Post 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 is all but required by a recently implemented "guidance document" codifying how to weigh threats to

human health posed by proposed animal drugs. The wording of "Guidance for Industry 152" was crafted within the FDA after a long struggle. Some say it 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 Marshfield (Wis.) Clinic Research Foundation. "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, it approved the marketing of Baytril and SaraFlox for use in poultry. Both are

fluoroquinolones, drugs important for their ability to fight the bacterium that causes anthrax and the food-borne bacterium campylobacter, which causes a 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. Abbott Laboratories pulled Saraflox, but Baytril's manufacturer, Bayer, pushed back. Late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread fu ://www.chron.com/disp/story.mpl/nation/4600179.html http://politics.slashdot.org/article.pl?sid=07/03/04/1836223 anonymous reader writes

"The Washington post reports that the FDA is expected to approve the marketing of the new antibiotic called Cefquinome for use in cattle. This is over objections of the American medical association, the FDA advisory board and the World Health Organization. Cefquinome is from a class of highly potent 'last line of defense' antibiotics for several serious human infections. It is feared that large scale use in cattle will allow bacteria to develop a resistance to these drugs <http://www.washingtonpost.com/wp-dyn/content/article/2007/03/03/AR2007030301311.html>. This news follows complaints from the FDA that it is no longer getting the funds needed to do the research required for the desired level of food safety." http://www.reuters.com/article/healthNews/idUSN0421639920070305 Report faults FDA drug-safety tracking system: WSJ Mon Mar 5, 2007 10:14AM EST < NEW YORK (Reuters) - The U.S. Food and Drug Administration is relying on a "dysfunctional" computer system for tracking drug safety as it struggles to upgrade its technology, The Wall Street Journal reported on Saturday, citing a report commissioned by the FDA. According to the Journal, the report prepared by the Breckenridge Institute consulting firm found that a new system is unlikely to be up and running until 2009 at the earliest, and that the FDA has wasted an estimated $25 million on its efforts. The report, which has not been made public, says the FDA could have had a new system working in 2005 if it had relied on off-the-shelf software, the Journal said. FDA safety experts waste an average of 45 minutes per day dealing with inefficiencies and snags caused by the current software, the Journal said, citing the report. The Journal said a document prepared by FDA officials in response to the report, which is marked as a draft, said it is "riddled with editorial conclusions based on misleading or incorrect

facts." FDA spokesman Doug Arbesfeld said the agency is seeking to upgrade, but that the current system works well. "This is a viable system today and ... we are looking to move to a second system," Arbesfeld said. © Reuters 2007. All rights reserved.

 

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