March 6, 2007 The Pump Handle 0Comment

by Revere, cross-posted from Effect Measure

While finishing drafting a series of posts on how Tamiflu resistant virus might spread as a result of intense use for influenza control, Melanie at Just a Bump in the Beltway posted this to remind us that drug resistant organisms spread for reasons much less useful than trying to stop people from dying. Like treating cows so they can be killed later and we can eat them and make money for agribusiness:

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. (WaPo)

Let me get the FDA argument straight. Yes, this is a bad idea, but the FDA has no choice? It is “all but required” (does that mean it isn’t really required?) because of a guidance document? A guidance document?

You probably think that guidance documents are for guidance, right? In actual fact, they are statements that “explain how an existing regulation will be interpreted, implemented and enforced” and Bush has been issuing Executive Orders that allow the Office of Management and Budget (OMB) to review regulations — and now guidance documents — before they reach the public, rewriting them if they wish. The clear implication here is that OMB has construed, if not rewritten, the FDA guidance document that tells the agency how to weigh threats to people from drugs given to animals.

Who do you think has the most pull with OMB, agribusiness lobbyists or public health specialists and doctors? I’ll give you a nanosecond to consider your answer.

Time’s up. (Take that any way you wish.)

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