Cow Drug? What About Us?

Hey folks,

In what is becoming a continuing series "Health and Science," along with the "here we go again" category, here comes more untested tampering by science to our health. What am I talking about? This new drug for cattle.

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 defenses against several serious human infections. No drug from that class has 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 antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA's advisory board last fall voted 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 the threats to human health posed by proposed new animal drugs.

So they know that this is a danger, but yet, because of certain rules they are going to allow it?

Most glaring, they say, is that the guidance makes it almost impossible to say no to a new animal drug unless it is likely to threaten the effectiveness of an antibiotic that is a critical player against food-borne illnesses. By contrast, the World Health Organization recommends saying no if approval would spur resistance to any antibiotic that is important for fighting "serious human disease" -- not just food-borne illnesses.

Cefquinome's primary threat is that it may undermine the usefulness of the closely related human drug, cefepime. But as it turns out, the FDA does not consider cefepime a front-line drug against food-borne infections. So although it is a highly important drug in human medicine generally -- and although the Infectious Diseases Society of America even recommends it against some food-borne bacteria -- that risk does not count under the terms of Guidance #152.

So how great is the risk to us?

An analysis of E. coli bacteria in pigs and other animals in Spain, published in December, found high levels of the resistance that renders fourth-generation cephalosporins useless. A January report from Britain documented similar resistance patterns emerging at 10 farms.

Microbes resistant to fourth-generation cephalosporins have also begun to pop up in European patients. Such resistance is virtually unknown in the United States, where fourth-generation cefepime has been used in patients since 1997. That suggests that the resistance emerging in Europe is a result of veterinary use, said Steve Roach of the Food Animal Concerns Trust, a Chicago public interest group.

Roach says he is concerned that history is about to repeat itself. U.S. cattle were free of bacteria resistant to third-generation cephalosporins in 1997, but by 2003 one of every five samples was resistant. "This is exactly what should be avoided with cefquinome," he said.

Even some top Politicians are getting into the mess. I agree, yes. I said I agree with Rep. Louise M. Slaughter (D-N.Y.), who chairs the House Rules Committee.

In January, New York Democratic Rep. Louise Slaughter, a Democrat who chairs the U.S. House of Representatives Rules Committee, sent the FDA a letter asking it not to approve the drug. She is a microbiologist.

"Over the past several years, the integrity of the FDA's drug review process has been called into question amid allegations that your agency has put the interests of industry and politics above science," Slaughter wrote at the time.

"Given the recent outbreaks of E. coli and other food borne illnesses across the nation, it is hardly the time to ignore the advice of scientists, and potentially impair our ability to treat deadly infections," she wrote.

Absolutely! We are going to be told that it’s OK to use this drug in animals, yet there is a risk to human health. This is just another Big Drug Company looking to make even more money, at the risk to YOUR health, with the Federal Government assisting them to do it. Well, more profit for the drug company, more taxes to the Government. It is ALWAYS about the money.
Peter

Sources:
Washington Post- FDA Rules Override Warnings About Drug
Reuters-FDA set to approve controversial cow drug: report