Jesus that's stupid. What needs to happen here -- some statute redefining the FDA's mission to include the public health implications of drug approval, rather than merely the effect on each individual using the drug?
Dr. Oops mentioned once that a possible, and IHO underused, technique for dealing with drug resistant infections in a hospital was to cycle through the drugs used. If you take drugs A, B, and C off the menu for a couple of years and use alternatives, the hospital bacteria get re-naive to those drugs (that is, the non-resistant bacteria repopulate). Then two years later, you put drugs D, E, and F on the bench, and break out A, B, and C again.
I think that this decision is a good test case for basic ethical, political, economic, legal, ideological, and philosophical principles. Based on what we know about medicine, bacteriology, epidemiology, veterinary medicine, and agriculture, this step is as wrong as wrong can be, and it also might be a very weighty misstep. So we can just argue back from here and find the philosophical principles (etc.) which say that this step was a good or even permissible thing, and conclude that these principles are wrong principles.
Of course, the people we're arguing with are virtuosos of argument, even if they're otherwise useless, so we can be confident they'll manage to weasel their way out one way or another. But at least we might be able to make them squirm a little.
Concept of fallow applied to medicine.
Antibiotic resistant beef bacteria: it's what's for dinner.
2: That's right. Reading the article, I find myself completely failing to understand why this step doesn't count as causing human mortality under the current rules, though. We know how antibiotic resistance works, we know that antibiotic resistant infections kill people, we particularly know that this is a class of drugs to which bacteria are not yet likely to be resistant, so if we lose these, we're losing an important weapon... what more did the FDA have to show?
There was Cidecin, which I think blew up in phase III trials, and there's an antibiotic in investigation called doripenem. This actually seems like just the sort of place where the prize model of scientific research would be useful; if no big pharma companies can be bothered to research this (which I don't think is entirely the case, but close enough), announce a $500 million prize for a novel antibiotic that works on drug-resistant TB or staph.
Draft version in 2002, so it's been kicking around for some time now.
I had an argument about this issue 25-30 year ago. The free-marketer I was talking to was adamant that it was no big deal. (He was going into medicine, too). He'd just finished an econ class where the teacher had "rationally" discussed the issue, and my friend was pumped for deregulation.
Economists have this cool, snotty way of arguing against what they think of as "the conventional wisdom". This case strikes me as an example of why it's important to be able not to think like an economist.
Surely getting this approval blocked can't be any harder than their stalling on Plan B for years, or our having gotten it approved, finally.
Yeah, except there are defined voting blocks of people who wanted to kill Plan B and people who wanted it to pass, both of which were willing to organize into pressure groups. What's the voting block to counter the pharmaceutical and cattle interests here? "Scientists Terrified of Drug-Resistant Staph"? "Historians of 19th-Century Health Care for Common Sense Medical Decisions"? "Americans Who Understand How Drug Resistance Works United"?
10: Point taken, but this also does sound like the kind of thing that Physicians for Social Responsibility would view as their bailiwick. I wonder if they're involved.
Tangentially, this is one other evil super-cheap corn has visited on us.
The irony is that if I went into the lab and intentionally ran experiments to create bacteria resistant to these drugs and released them into the wild, it would be a violation of NIH guidelines, and probably a crime. If you use a herd of cattle as your lab, though, it's just bidness.
Mike the Mad Biologist has been on this subject for a while.
The short version is still "this is dumb, six ways to Sunday". I think the scariest bit in all of his ranting on the subject was the discovery that somewhere around 5% of surveyed cattle ranchers has admitted to particular uses of antibiotics in their herds that turn out to be illegal
This is infuriating. I don't know enough about FDA procedures... can one lobby Congress to do something?
Ted Kennedy is chair of the relevant committee. Any Mass. voters here who would like to write/call?
based on this (pdf), the rule seems to have been published in 2000 or 2001.
Surprise.
I scanned the rule, and don't understand it well enough to see how it compels the bad result, still. Can anyone walk me through it?
I don't understand why anyone would think a 4th generation cephalosporin for animal use is a good idea. One would want to look at the EU data more closely to understand the magnitude of the danger, but it seems like a needless resistance risk. It would be interesting to hear from the 4 members of the advisory committee who backed approval. (one Intervet presentation to FDA can be found here, and includes data on resistance in the EU setting. The counter-claim, as I understand it, is that this analysis does not cover all relevent pathogens.)
If it's any consolation, the notion that industrial drug development has abandoned antibacterials is (fortunately) mistaken. There are 3 novel lipopeptides in late stage development, and a number of anti-MRSA cephalosporins are following close behind. Pfizer made a huge splash in 2005 with the $1.9B acquisition of Vicuron, a biotech focused on anti-infectives. And a number of other major antibiotic acquisitions by large pharma since have created a strong funding environment for early stage drug discovery in the area.
19: From page 19 of the PDF I mentioned before, it looks like the probability of a resistant strain appearing AND the probability of human exposure to that strain defines the danger. So, if one appeared in the teeth of the animals and no teeth are processed, the danger would be rated low. Of course, they're going to be optimistic about nasties getting loose 'cause everyone is super-careful. Eat your spinach and lettuce.