January 2012, Week 2


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Sun, 8 Jan 2012 21:57:30 -0500
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More News: FDA Curbs One Class of Farm Drugs
By Maryn McKenna 
January 4, 2012  

Here's a bookend to the Food and Drug Administration's
disappointing Christmas Eve notice that it will cease
trying to regulate the largest classes of growth-
promoter antibiotics. Today, the agency announced that
it is forbidding certain uses of a different class of
drugs, cephalosporins.

To those who are concerned about antibiotic overuse in
agriculture, though, this is good news - though it may
be more good news-bad news-bad news-good news.

The dialectic looks like this:

Good: The FDA is taking regulatory action, a strong
contrast to the "voluntary reform" path it declared
itself in favor of last week.

Bad: The regulatory action is only partial - it covers
only some "extra-label" uses of cephalosporins, though
those are important - and is three years late. In 2008,
the FDA promulgated and then withdrew a ban on all
extra-label uses of cephalosporins; this replacement ban
comes with exceptions.

Bad: Cephalosporins are one of the least-used of the
agricultural antibiotics. According to the FDA's Summary
Report on Antimicrobials Sold or Distributed for Use in
Food-Producing Animals, there were only 24,588 kilograms
(54,207 pounds, or 27.1 tons) of cephalosporins used in
food-producing animals in the US in 2010, compared to
5.6 million kilograms (12.3 million pounds, or 6,164
tons) of tetracyclines.

Good: Cephalosporins are a critically important drug in
human medicine, especially for kids. (One common
cephalosporin is Keflex.) Because some classes of
antibiotics aren't approved for pediatric use, the
options for treating infections in children are more
limited, and thus protecting the remaining drugs'
usefulness is vital, as the American Academy of
Pediatrics warned the FDA in 2007.

In its Federal Register notice, the FDA said: "We are
issuing this order based on evidence that certain extra-
label uses of these drugs in these animals will likely
cause an adverse event in humans and, therefore, present
a risk to the public health."

"I think this signals the FDA is very serious about
antibiotic use in agriculture, since it started with one
of the most important tools in the medicine chests of
physicians," Laura Rogers, who is project director of
the Pew Charitable Trusts' Campaign on Human Health and
Industrial Farming, told me. She noted too that the FDA
listened to concerns from the agricultural side by
preserving some uses of cephalosporins, notably two
drugs within the class - ceftiofur and cephapirin - to
treat specific diseases including foot rot, metritis and
staph mastitis in cattle.

Just to be clear: Cephalosporins are not used as growth
promoters, via feed (unlike the penicillins and
tetracyclines in last week's notice). But they are used
prophylactically, for disease prevention. For instance:
The vast majority of the almost 9 billion broiler
chickens raised in the US each year get a shot of a
cephalosporin into their shells, to "reduce mortality"
of newly hatched chicks. Under this order, that is an
extra-label use and will be disallowed.

The concern underlying this order is that when
cephalosporins are used, they promote the emergence of
cephalosporin-resistant bacteria that then go on to
cause human disease. That was made very clear by very
solid research from Canada (here's the 2009 paper and my
post explaining it). When chickens in Quebec were raised
with the use of cephalosporins, cephalosporin-resistant
Salmonella emerged in chicken meat sold at retail, and
also in people in the province - note, not people who
had eaten the chicken that was tested. When Quebec
enacted a ban on hatchery use of the drug, the incidence
of resistant Salmonella crashed in both birds and
humans. When - in an unfortunate natural experiment -
the province reauthorized some uses, the rates in both
chicken meat and humans began creeping up again.

Campaigners against antibiotic overuse in agriculture
want to stress the point that the resistant organisms
didn't remain confined to the chickens. Once resistance
DNA debuts in bacteria, it can move around freely to
other foodstuffs, and even to other bacteria as well.
Thus, as the Center for Science in the Public Interest
pointed out today, there were five major outbreaks of
foodborne, cephalosporin-resistant Salmonella in the US
in the past decade, and none of them were caused by


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