Taken for a Ride

Taken for a Ride

I just read a news article about the FDA that is so completely ridiculous I had to read it twice to make sure I wasn’t missing something.

I wasn’t. It’s insanely ridiculous. And the subject of this recent Washington Post (WP) article would be hilarious if only it didn’t have the potential to negatively impact the health of nearly every U.S. citizen.

Who let these guys in?

There’s a public health issue in this country that borders on scandal: The overuse of antibiotics – among humans and animals – is creating greater and greater antibiotic resistance. You, me, your family, your neighbors – all of us, little by little, are developing resistance to the best antibiotics out there.

For instance: About 10 years ago, an FDA-approved animal antibiotic known as Baytril (made by Bayer Corp.) was linked to microbial resistance in humans. When the FDA tried to ban Baytril, Bayer put up a fight that lasted years.

To avoid further problems like this, the FDA brought together representatives of the public health community to establish guidelines for evaluating new animal drugs and the potential impact on humans. The result was an official checklist called Guidance for Industry #152. But according to the WP article, drug companies pressed hard to influence the checklist, and the final guidelines tilt in favor of – guess who? – the drug companies!

Now let’s watch Guidance #152 in action

Authority figure

The FDA is currently considering the approval of cefquinome, a powerful animal antibiotic that happens to be in the same class of drugs that provide humans with what’s known as a “medicine of last resort.” One of the medicines in this class is effective against several human infections that are otherwise nearly impossible to treat. It’s also the only drug that effectively treats the most severe infections among cancer patients.

How great is the fear that cefquinome use might lead to the loss of this last resort? This past September, the American Medical Association lobbied against cefquinome’s approval, and the advisory board convened by the FDA voted to reject approval, largely based on two factors: 1) The likelihood that human microbial resistance may develop, and 2) The fact that there are already more than a dozen effective medications that address the cattle respiratory disease that cefquinome is designed to treat.

After the advisory board’s vote, Stephen Sundlof, head of the FDA’s Center for Veterinary Medicine, dismissed it, describing it as “non binding.” He added that Guidance #152 would provide the basis for safety decisions. So the FDA is expected to approve cefquinome this spring, thanks to G #152, which places the bar very high for proving the dangers of a new drug.

Meanwhile, the advisory board also suggested that if cefquinome was approved, the FDA should require InterVet Inc. (the maker of the drug) to supply details about the distribution of cefquinome so that patterns of human resistance could be compared to patterns of the drug’s use.

You know – for SAFETY. General Welfare. That sort of thing.

Here’s the exact wording from the Washington Post: “But Sundlof offered little hope for that outcome. ‘That is information that would be useful to have,’ he said. But the agency does not have the authority to demand it.”

In my entire life I’ve never read a statement more stupefying than that one!

The agency doesn’t have the authority? The agency IS the authority! Well, that’s the way it’s supposed to work. Maybe Mr. Sundlof assumes we’ll read between the lines and understand that drug companies keep the agency’s “authority” on a very short leash.