23 January 2009

Well, this is bad news.

Hi again, constant readers - yes, eye-deep again in a chapter, and sinking. About which: Is there anyone there who remembers staph 80/81 and would like to talk about it? Email me, address in the right-hand bar.

And now to the bad news. I am coming to this story late, but truthfully I am not even sure how late, as it seems to have trickled out without fanfare, and different media have covered it at different times over the past month. At any rate: The FDA has quietly reversed a decision it took last summer, and will allow cephalosporins, a human medicine, to be used without restriction in food animals.

What's a cephalosporin? The best-known one is the very commonly used drug Keflex (cephalexin), which you might take for tonsillitis or bronchitis - not a drug that you want to stop working because bacteria have developed resistance to it. (Yes, MRSA already has.)

Supporting material, tracking backward: A notice from the National Academies of Science news office from two days ago is here. An NPR story from Dec. 29 is here. A lengthy essay hosted by food-safety expert/attorney Bill Marler is here. A statement from the Pew Charitable Trusts' Campaign on Human Health and Industrial Farming, dated Dec. 12, is here. A short story from the Wall Street Journal, dated Dec. 9, is here.

Here's where I think this all ends up: On Nov. 25, the FDA put a note in the Federal Register announcing that it was reversing its earlier, July 3 decision to put curbs on the "extra-label" — anything not specifically allowed by the label — use of cephalosporins in animals. (Here's a July 16 Q and A explaining what it was prohibiting.)

The reason for the revocation of the ban/permission to use without restrictions, the FDA said in the Nov. 25 notice, was that it had gotten so many public comments on the ban — which was supposed to take effect Nov. 30 — that it decided the only appropriate action was to lift the ban until it could fully consider whether to reimpose it. And, because it was a revocation of a previous order and not a new order, it did not have to give advance notice.

As to what this means, consider this stinging op-ed from John Carling, former governor of the very agricultural state of Kansas, and chairman of the Pew Commission, which produced a mammoth report last year on industrial-scale agriculture:
The rest of the world has leapt ahead of us on this issue. In Europe, antibiotics have long been eliminated from food production. South Korea followed suit this summer. Our refusal to turn away from this practice could cost us markets for our food products overseas and, by extension, precious jobs here at home.
The Pew Commission was composed of farmers, doctors, veterinarians, economists and other talented professionals who took on the challenge of finding a model that would allow U.S. farmers and ranchers the freedom to pursue their livelihoods in a way that does not adversely impact public health, the environment and the economies of their communities.
We believe we found such a model, and it included phasing out the indiscriminate overuse of antibiotics.
Changing the way agriculture works in this country will likely prove challenging, and involve many difficult decisions.
It's a tragedy that on this occasion the FDA took the easy — and more dangerous — way out.


Anonymous said...

You are mixing up 'extra-label' use with 'sub-therapeutic' use. Most drugs in veterinary medicine are used 'extra-label' because drug companies do not find it economically viable to submit for FDA approval for each and every use, dose, etc., for veterinary patients.

Sub-therapeutic use is when food animals are supplemented with antimicrobials for such purposes as growth promotion. There are arguments associated with the term 'sub-therapeutic' also. If I give cattle antimicrobials for growth promotion, but it also decreases the incidence of damaging liver flukes in the animal, is it still 'sub-therapeutic'.

The bottom line is that you've mixed up what the proposed 'ban' entailed. It would have acted to limit the use of cephalosporins for 'sub-therapeutic' uses, but it could still be used for treatment of sick animals - some of which would be 'extra-label' use.

Here's a link to the American College of Veterinary Internal Medicine's Consensus Statement on 'Antimicrobial Drug Use in Veterinary Medicine'. The profession is working to police itself and its use of antimicrobials. http://www3.interscience.wiley.com/journal/119821304/abstract

It is dangerous to discuss bans on 'extra-label' use of antimicrobials in veterinary medicine (or any extra-label drug use for that matter) - this has come up in the past. As much of the drug prescription in vet med is 'extra-label' (as explained earlier), this would effectively hamstring the veterinary medical field, thereby impacting animal welfare, food safety, and direct human public health.

Maryn McKenna said...

I don't see anywhere in that post where I discuss sub-therapeutic use, so I don't see how I can be accused of conflating the two. The point here is that the FDA was set to impose some controls on the use in animals of an antibiotic also valuable in human medicine, and chose not to.

I'm glad to know about the ACVIM statement, though, I'll look it up.

Anonymous said...

The article you reference discusses 'sub-therapeutic' use, not 'extra-label' use.