Sunday, March 04, 2007

What the FDA is doing now!

The more I read of what is being allowed to happen, the more I worry about the future. The people that are running our Government don't seem to care about anything except money and power. Whoever is running the FDA these days is right there with "Brownie" in the incompetece department.

From Reuters and the Washington Post:
The Food and Drug Administration may be poised to approve a controversial antibiotic for cattle despite fears it could hurt human health, The Washington Post reported in Sunday's edition.

The drug, called cefquinome, is a fourth-generation cephalosporin, a class of antibiotics used for a range of human diseases including serious gastrointestinal diseases in children and meningitis.

The fear is that using such drugs in animals can lead to the emergence of new drug-resistant "superbugs" which will be immune to similar drugs when used in people.

The overuse of antibiotics in both humans and animals has already helped such bacteria evolve, and infectious disease experts have been warning doctors to use them more judiciously.

The FDA's own advisors, the Veterinary Medical Advisory Committee, voiced such concerns when they voted in September to reject approval of cefquinome by InterVet Inc. of Millsboro, Del., which makes it.

Yet the Post quoted experts as saying the FDA was moving toward approval anyway, overriding the advice of the panel, the American Medical Association and other health groups.

The Post said the FDA was being pressured to approve the drug because of an internal guidance document called "Guidance for Industry #152" on how to weigh threats to human health from by proposed new animal drugs.

It quoted experts saying the rule makes it difficult for the FDA to deny a new animal drug unless it is likely to threaten the effectiveness of an antibiotic critical in treating food-borne illness.


The problem with over-using anibiotics is that they become resistent:
Microbes are constantly mutating, and some of those mutations happen to confer immunity to one drug or another. Exacerbating the problem, bacteria constantly exchange bits of DNA with each other, spreading that resistance.

Given those realities, experts agree that all antibiotics should be used judiciously.

"If a drug is used less, then less resistance emerges," said Patricia Griffin, chief of the CDC's enteric disease epidemiology branch.

Prudence is especially important for medicines of last resort, which is why the cefquinome application stirred such a storm.

Cefquinome is a fourth-generation cephalosporin, the most recent of several steadily improving versions of the cephalosporin family of antibiotics. Only one medicine from that family has been approved in the United States - a powerful human drug called cefepime (brand name Maxipime), which is the only effective treatment for serious infections in cancer patients and a reliable life-saver against several other nearly invincible infections.


We need a whole new crew at the FDA. Someone with intelegence that will weigh the options and test more before something is allowed to be marketed. What kind of world are we leaving our children and grand children? What kind of monsters are running our government?

1 comment:

Jenise said...

just thought i'd mention, tonid, that yours is the first blog i look at in the morning. and when i start getting overwhelmed with work, it's a god-send. thank you.

oh, and james is right - you are a dudette :)