Industry representatives say they trust Guidance #152's calculation that cefquinome should be approved. "There is reasonable certainty of no harm to public health," Carl Johnson, InterVet's director of product development, told the FDA last fall. ... "The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."Let me get this straight. Thanks to Guidance #152, the FDA has limited power to disapprove drugs that cannot currently be shown to have a risk to humans? This guidance appears to not account for the effects of evolution at all. Evolving resistance evolves. The fact that resistant organisms don't exist at the Time A doesn't negate the fact that resistance is highly likely to evolve when conditions (like indiscriminant use of the antibiotics or their use in densely packed livestock) are optimal for the evolution of resistance at Time B. After resistance has evolved to broad-spectrum antibiotics is not the time to prevent the evolution of resistance. The article goes on to explain how the drug would have been denied approval had it led to the evolution of resistance in food-bourne illness. Since fourth-generation cephalosporins treat diseases other than food-bourne illnesses, the FDA is limited in its power to disapprove it due to the specific language of Guidance #152. The restriction that the FDA can only deny antibiotic approval in those agents likely to impact only food-bourne illnesses is arbitrary and indefensible. Finally, the article discusses indirectly the phenomenon of multidrug resistance traits, which can get passed to other bacteria. Briefly, if a bacterium evolves resistance to fourth-generation cephalosporins, they can often resist third-generation cephalosporins as well. Guys, this is concerning stuff. Creationists hem and haw about this or that aspect of evolution, but the evolution of bacterial resistance is life-and-death stuff. When your kid has meningitis and 48 hours after starting a third-generation cephalosporin there's no improvement, that is not the time to be wondering whether steps should have been taken to limit the evolution of resistance to antibiotics. When your ailing mother has a pneumonia involving an organism that ought to be susceptible to fourth-generation cephalosporins but isn't, that is not the time to wonder whether a guidance document that permits the exclusion of drugs that could lead to resistance in food-bourne illness but not for others might unduly restrict the FDA's oversight power. Write your congressperson and senator and demand that Guidance #152 be revised to reflect resistance to antibiotics in any disease, not just food-bourne illnesses. The FDA needs to have the power to regulate all antibiotics and to disapprove of any drug to which such broad opposition exists. Edit: Mike the Mad Biologist has already covered this, it seems. (Check out his letter to the FDA written ages ago.)
Why You Should Care if Cattle Get Fourth-Generation Cephalosporins
It would come as no surprise to us here at the Thumb that our readers would accept a physician not giving antibiotics for an ailment unless that physician felt that the infection was bacterial, that the therapy was warranted, and that the selection of antibiotics was appropriate for the suspected organism. Doctors restrict their antibiotic use because of evolution: indiscriminate use of antibiotics leads to the evolution of resistance to those antibiotics in those bacteria that survive the infection. I suspect many of our readers also know that antibiotics are given to livestock routinely to help them grow bigger, faster. Our friends at ScienceBlogs are all over this topic and the problems it presents. By way of summary, if you give animals an antibiotic that looks and acts like one you give humans, resistance will also evolve there, just as surely as it will from a doctor who reaches for his prescription pad before he's taken an adequate history or completed an adequate exam.
This morning's Washington Post has a disturbing article on the approval of cefquinome for use in cattle. It's disturbing for a number of reasons, and we'll discuss them on the flipside.
First, cefquinome is a fourth-generation cephalosporin, a class of antibiotics that have extremely broad spectra of activity against bacteria. From my experience as a physician, I can tell you that when someone is extremely sick in the ICU, fourth-generation cephalosporins like cefepime are often the first drugs we reach for, especially if the patient has a penicillin allergy.
Now we don't give cefepime to everyone with a bacterial infection for the same reason we don't give every person with a cough or cold an antibiotic: setting aside the fact that antibiotics can lead to life threatening infections, indiscriminant use of fourth-generation cephalosporins would increase the risk of bacteria evolving resistance to those antibiotics.
So approving the use of fourth-generation cephalosporins in cattle is a healthcare version of being penny-wise and pound-foolish: what good does it do to have discerning physicians who limit their use of fourth-generation cephalosporins when bugs can just evolve resistance to them when they're given to cattle indiscriminately?
Second, the Washington Post article talks about the conditions under which those cattle are raised. This is not a situation where Bessie the family cow is sick and needs antibiotics to continue making milk for Farmer Jim and his wife; this is not a case of isolated antibiotic use. This is a situation where cattle are kept in such high density that disease transmissibility goes up and immune strength goes down. It makes sense that it is easier and cheaper to simply give those closely-packed cattle fourth-generation cephalosporins than it is to take steps to prevent disease virulence in the first place. It also makes sense that these analyses probably didn't put as much weight on the risk of evolving resistance to fourth-generation cephalosporins as would, say, people worried about dying from it. (Unfortunately, we can't know the answer to that question because the Washington Post tried to interview InterVet representative several times, probably to ask them how strongly they weighed the risks of increased human morbidity or mortality if their drug were approved. InterVet declined several requests for interviews communicating to the Post only via statements which included such facile boilerplate as the company "fully supports the prudent use of antibiotics in animals.")
Recognizing the risks of antibiotic reistance evolution, the AMA, along with several other concerned groups, warned the FDA that the approval of the drug might lead to the evolution of resistance. They cited much evidence in support of their concerns, including the fact that the approval of fourth-generation cephalosporin use in Europe led to increased fourth-generation cephalosporin resistance in bacteria there. Recognizing this, the FDA's own advisory board voted to not approve the drug. Everyone and their dog, it seems, want the FDA to not approve the drug, but the FDA will probably have to approve it thanks to a "recently implemented 'guidance document' that codifies how to weigh the threats to human health posed by proposed new animal drugs" known as Guidance #152.
57 Comments
Gary Hurd · 4 March 2007
Very good post Burt. Thanks for the information.
Katarina · 4 March 2007
When are we going to get our heads out of our fat butts and realize that beef from factory farms is neither necessary, nor the most sustainable source of food? Has it occured to anyone here how many problems we could avoid by eating less steaks and hamburgers, including antibiotic resistance? Think of all the water that is used for the crops cows eat. Think of all the land. What about the runoff from factory farms?
Sorry, I couldn't help myself. Seriously, though, everyone bitches and is depressed about being overweight. There is a solution: stop eating burgers!!!
I'll stop.
Katarina · 4 March 2007
I meant, I'll stop foaming at the mouth.
The burger part is already taken care of.
David B. Benson · 4 March 2007
Katarina --- Foam away!
Burt Humburg · 4 March 2007
Katarina, it doesn't help if you drop hamburgers only to move to cheese and other fats. Healthy eating goes far beyond whether you eat red meat or not. But your larger point, that ultra-concentrated beef production has costs not necessarily seen at checkout is well-taken.
Rage mightily against meat, girl, but I still enjoy a good burger! :)
BCH
Engineer-Poet · 4 March 2007
It doesn't matter if you boycott burgers; the resistant bugs from the factory farm can wind up on your spinach salad anyway.
Factory farming ought to be restricted as a threat to public health. Approval of this drug isn't merely reckless, it's downright insane.
Sir_Toejam · 4 March 2007
yeah, but that burger can be made of any of a different number of meats, as well.
seriously, cattle farming has done tremendous damage historically to just about any environment you can think of; and still continues to do so, especially in Africa and South America.
why not have a turkey, chicken, or vege burger?
heck, even pork would be better.
hiero5ant · 4 March 2007
But evolution is incapable of generating "new information", so if thousands of people get sick and die it's because God designed the germs to murder more people. In fact, if this does occur, it is proof positive of the miraculous!
Flint · 4 March 2007
entlord · 4 March 2007
As in so many other areas of our lives, we have allowed factory methods to be adapted where they do not fit. Animals raised on a factory farm are kept in highly concentrated groups with very high stress for each individual, reducing that animal's immune system.
Some years ago, concerned about the damage that can be done by feral hogs, I questioned a neighbor regarding what would happen if one or a dozen of his 5000 hog herd were to escape.
He replied that the factory rep had assured him the animal would be incapable of surviving, being white, it was susceptible to sunburn; it had been bred for generations to lessen its "rooting" instinct, which is how most wild hogs hustle a meal, and its foraging instincts; its tail and ears had been cropped (due to stressed out hogs biting off each other's tails), making it less immune to insects; and finally, loaded up as it was on antibiotics (and high salt levels to keep it thirsty), any hog that did escape, would soon contract a bug and die.
Finally, he said that the individuality had been bred out of them so that anyone that did stray from the herd would return on its own, being uncomfortable alone.
I can believe it as the brains have been bred out of beef cattle to the extent they are barely more sentient than an oak tree.
steve s · 4 March 2007
steve s · 4 March 2007
Engineer-Poet · 4 March 2007
It's only stupid if you don't react positively. Tried a squirtgun?
Katarina · 4 March 2007
It's very well and good that we're all willing to write letters to our representatives and raise awareness about the environmental effects, including health hazards to humans (oh no, not humans!!), of factory farming in general.
Unfortunately, what it's really going to take to make a difference is an actual change in our living habits.
"Pshht. Who does she think she is, trying to tell me what to eat? Anyways."
Sir_Toejam · 4 March 2007
Dave Carlson · 4 March 2007
The Burger King mascot with a target painted on his chest?
Sir_Toejam · 4 March 2007
yes, but we'd have copyright infingement issues. Besides, I'm sure someone would see that and think it some clever new ad campaign for burger king.
Corbs · 4 March 2007
While doping up animals is bad, I suspect it is not the area of greatest concern.
I have a geologist friend who travels a lot to India, Iran and Pakistan (boy does he get hassled going through customs). Not so long ago he came down with a nasty flu like illness in India (which he suspects was probably viral). The hotel doctor told him to go around the corner to the pharmacy and buy some antibiotics anyway. No prescription necessary.
He went around the corner where a little man with a shop window was selling Cipro and Vancomycin by the individual tablet.
At least the cattle get continuous doses.
Dave Carlson · 4 March 2007
Sir_Toejam,
Good points. Hmm. . .well, I'm out of ideas.
Sir_Toejam · 4 March 2007
no worries, something appropriate will pop to someone's mind, I'm sure.
Engineer-Poet · 4 March 2007
My last 5 major meals were sushi, chicken, tilapia, catfish and turkey. I think it's been about a year since I had a hamburger, and that only because I was a guest.
I'd like to know what the GHG emissions of range-fed beef (and buffalo) are.
Sir_Toejam · 4 March 2007
here's a start:
http://cdiac.ornl.gov/trends/meth/ch4.htm
Popper's ghost · 4 March 2007
Popper's ghost · 4 March 2007
Katarina · 5 March 2007
You're right, Pops. But it's a start, it says we practice what we preach, to ourselves and others. I'm not saying stop the advocacy and political activism. But I would like more emphasis on the ultimate cause of factory farming: demand. What do you suggest?
Dizzy · 5 March 2007
fnxtr · 5 March 2007
My brother printed a message for Adbusters once: a cow standing in front of a rain forest. The caption: "I'm dying for a Whopper!"
David Utidjian · 5 March 2007
This low level dosing of cattle feed has been going on for at least a few decades. Back in the early 80's I visited a plant in Covina, California where they added tetracycline to animal feed. The plant, at that time was owned and run by American Cyanamid (now, what's left of it, American Home Products). American Cyanamid was the maker of many fine products from Centrum vitamins, to Formica, to solar cells, to Cyalume light sticks. They also produced many antibiotics. At the time my father was corporate medical director of the company. His main concern at the time at the Covina plant was the health of the workers that had to handle the mixing and packing and storing of the feed. They had to wear protective clothing otherwise they could develop a sensitivity to the tetracylcine. It was dusty work and you didn't want to breathe it for long periods.
We talked about this article this morning and he told me that it is not only cattle feed... chicken feed, turkey feed, pig feed... all of them get a low dose of antibiotics in their feed. I don't know about "farmed" fish. The Tulapia fish is farmed.
My (and his) guess is that the cephalosporins are now popular because the tetracyclines are no longer as effective as they used to be.
Good luck going up against the farm lobby.
Torbjörn Larsson · 5 March 2007
David Utidjian · 5 March 2007
Torbjörn,
Well just giving production herds of food animals low levels of antibiotics in the feed is an abuse of antibiotics. According to my father, American Cyanamid shipped ten times as much antibiotics, pound for pound, for (non-human) animal feed as they did for humans. Granted the stuff for the animals was of lower quality.
Back in the day... when I used to date teenage girls (sigh) every one of them had several bottles of tetracycline prescriptions in their medicine cabinets. These were given to them by their dermatologists for acne. Many people I know would (and still do) take antibiotics when they get a cold... they think it is a cure (or so they tell me). When I try to explain to them why it is not a good idea to self prescribe antibiotics for every sniffle they dismiss it with the excuse that "it works!" I am not sure how they end up with excess antibiotics prescriptions... unless they are either not following their physicians instructions or they are over prescribed. I suspect that many of these are just over prescribed in the case of teenaged girls anyhow. They often had the large 100 cap or 250 cap bottles.
I don't know if this is still the practice.
Not sure how to check but it seems to me that reports of E. coli incidents have been increasing over the years.
-DU-
Antiquated Tory · 6 March 2007
It looks like we're touching on a whole perfect storm of typical human irresponsibility here. Antibiotic misuse in cattle feed is part of overall antibiotic misuse in animal feed, which is part of both irresponsibility by pharma corps, who sell a heck of a lot more antibiotic for vet use than for human, and the whole intensive industrial farming clusterf**k. Which started as a drive for cheap and abundant food (it was not that long ago that there were food crises in the West) and spiraled out of control. The treatment of animals is abysmal, but of course intensive crop raising, while not by definition 'cruel,' is not done anything like responsibly. (Oh, we might as well throw in commercial fishing while we are at it.) The whole of modern mass food production is a fun-house mirror distorted economy--it's so far away from basic market principles I don't know if anyone even knows what an actual market driven agriculture would look like. Probably something heavily vertically integrated and thus also distasteful--with levels of environmental irresponsibility that make Big Oil look like Greenpeace. And governmental interventions that, due to vested interests, keep doing exactly the opposite of what they were set up for (CAP and CFP anyone)?
Cheap food is just too damn important politically for anything real to be done until things get bad enough that the current system collapses.
paul flocken · 6 March 2007
Philip · 6 March 2007
Guys, this is concerning stuff. Creationists hem and haw about this or that aspect of evolution,
I believe in Intelligent Design and I Disagree,Especially about your assessment that bacterial resistance to antibiotic is "conclusive proof" of evolution because, Mutations occur in the DNA leading to bacterial proteins that cannot interact with the antibiotic and the bacteria survive. Although they survive well in this environment, it has come at a cost. The altered protein is less efficient in performing its normal function. In an environment without antibiotics, the non-mutant bacteria are more likely to survive because the mutant bacteria cannot compete as well. Thus the gain in genetic information claimed by evolutionist is absent. To conclusively prove evolution a net gain of Genetic information to the level of protein molecule would have to be demonstrated in the bacteria. Evolutionists have not done this nor is it likely that they will ever do it for it would violate entropy.
http://www.answersingenesis.org/docs2007/0131observation.asp
Philip · 6 March 2007
Contrary to what is commonly believed
Bacterial evolution is not conclusive proof for evolution because,
Mutations occur in the DNA leading to bacterial proteins that cannot interact with the antibiotic and the bacteria survive. Although they survive well in this environment, it has come at a cost. The altered protein is less efficient in performing its normal function. In an environment without antibiotics, the non-mutant bacteria are more likely to survive because the mutant bacteria cannot compete as well. To be conclusive proof for evolution a clear gain of genetic information to the level of the protein molecule would have to be demonstrated. This critical peice of evidence has not been established yet
GuyeFaux · 6 March 2007
Torbjörn Larsson · 6 March 2007
David B. Benson · 6 March 2007
Well, at least Philip is not realpc...
John Krehbiel · 6 March 2007
To seriously address the original issue, see this:
http://www.fda.gov/cvm/Documents/VMAC0906Cefquinome.pdf
The sixth page is the summary. It points out that common bacteria present in cattle are not susceptible to the antibiotic, specifically Campylobacter, Enteroccocus faecium, and E. faecalis. Transformation by taking up plasmids from other bacteria is a much more common way of acquiring resistance genes, although mutations have been shown to have happened as well.
On the issue (I know, it's really not an issue) of increase in "information" in acquiring resistance, there was a specific reference to a gene duplication in a mosquito with the copy mutating to cause the mosquito to become resistant to a pesticide. (Can't remember more detail than that, sorry)
Wayne Francis · 7 March 2007
Popper's Ghost · 7 March 2007
Sir_Toejam · 7 March 2007
Factory farming is not limited to beef.
you can show me a pig lagoon if i can show you some free range cattle damage.
Just be warned that I'd also be willing to wager my presentation will take a lot longer.
not to say that effluent from large animal farms can't cause it's own level of environmental contamination (localized and not, through groundwater and watersheds), but free-range cattle have been responsible historically for HUGE amounts of damage to very large scale environments.
It's all bad, but cattle is pretty much the worst, as you have both heavily farmed AND free-grazing versions.
Max · 24 May 2007
Hello boys:
Best regards, inf1903
google · 27 June 2007
h11n9B test google test
oberoi H Singh · 5 March 2008
Well, I just wished to know the latest name of fourth generation cephalosporins in cattle, rather, in veterinary industry
But, I couldn't find any
I hope I'm clear
Looking forward to hear from the authorised body
Thanx
Oberoi
Harjeet Singh · 5 March 2008
I feel that Animal Health is kept on the back seat ( WHY )
The real crux is the right diagnoses & then the treatment part. When the Antibiotics have reached the highest level in treatment of Human Health then what is the hitch in curing the animals !!!!
KJ · 9 November 2008
anyone of you who doesnt grow and/or produce everything you eat.....hush
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