Proof the FDA is a Revolving Door for Big Pharma: Approves HIGH RISK DRUG

[The Cleaner]

When considering issues such as Gardasil and its safety, consider this.

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.

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 like cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.

http://www.washingtonpost.com/wp-dyn/content/article/2007/03/03/AR2007030301311.html?referrer=email

[itsmesgd]

1. good for cows, bad for humans

I guess it'll be ok as long as nobody eats the cows or their milk. Oh wait, that might suck if a superbug is developed in a moo-cow and somebody eats a funky burger and then gets the bug and passes it on to everybody else. But the USDA has such strict regualtions, what are the odds that somebody would get sick from cow meat?


ummm microbe-burgers

[havocmom]

3. Super bug doesn't have to emerge in the cattle to be a problem

The fact that humans will be sucking down the drug themselves in meat and milk means trouble. One of the lasts drugs against super-bugs and it's going into our food. Hmm, bugs will keep evolving. REALLY bad bugs will be the result of widespread use of this strong bug juice and those really bad bugs will be just about everywhere.

Problem is not getting the bugs from the food, but getting so much drugs from the food that we end up speeding up the evolution of things which make us sick. We end up building a better bug which we will have nothing to kill.

Infections once limited to places like hospitals are now becoming more common all over. We are in trouble and the FDA is sinking us deeper.

[Kagemusha]

2. (angry face) You realize other health agencies spoke out on Gardasil.

I'm sure you do. If it was the FDA alone, as it is in this case with this antibiotic, that's one thing. But don't drag this into the vaccine mess because it's not just the FDA vouching for it. Surely you're not arguing that Merck has the regulatory agencies of "socialist" countries in the bag too. Well, if you are, make that argument separately please - this one doesn't apply to both cases.

It's just very enraging to read your implication that if the FDA speaks out on one thing, all things said in agreement with the FDA by foreign regulatory agencies must be tainted because no one can believe the FDA. Is that logical?

[rinsd]

4. So what? The WHO has recommended Gardisil as well.

And I thought the issue was the mandating not the safety of the vaccine itself.

Or is your slip showing.