Maryn McKenna

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Antibiotic use in animals: The feds move, a little

July 7, 2010 By Maryn Leave a Comment

This is an addition for archival purposes of a post that originally appeared at Scienceblogs.

(You leave the country for a few days — I spoke at a conference in Brussels, which was was lovely, thanks for asking — and all kinds of news breaks out. So, sorry to be late on this, but it’s an important issue.)

Last week, the Food and Drug Adminstration took the first (baby, mincing, tentative) steps to address the problem of antibiotics being used in animal agriculture, not to treat disease, but to make animals grow up to market weight faster. This practice — variously called subtherapeutic dosing, growth promotion, and “for production purposes” in the FDA’s exceedingly careful language — has been fully banned in the European Union for 4 years, and some aspects of the practice have been banned longer.

The simple reason for the ban: There’s decades of good science and real-world experience showing that it contributes to the development of drug-resistant organisms in farm animals and the farm environment, organisms that leave farms in the animals and in their manure, and also contaminate the environment beyond farm borders via leakage into groundwater and dust blowing off manure lagoons.That movement off the farm is critical because many of the drugs used in agriculture are the same, or close analogs, of drugs used in human medicine; so resistance that develops on the farm endangers human health as well. (MRSA ST398, livestock-associated MRSA, is the latest example of this. Find a long archive of posts on ST398 here.)

Just to be clear, growth-promoters don’t treat disease; they’re given to healthy animals solely for the purpose of getting them up to sale weight and to market faster. The ways in which antibiotics are given to livestock to treat or prevent disease have their own issues, but those are not part of the FDA effort. (Historical note: The growth-promoting effect of trace amounts of antibiotics was first recognized in 1947, when scientists at Lederle were looking for something to do with the leftover fermentation mash from the manufacture of chlortetracycline, fed it to chickens, and discovered they thrived on it. Stuart Levy’s The Antibiotic Paradox tells this story in detail.)

In human medicine, when we give antibiotics to people who are not sick with a bacterial illness, we call it inappropriate use — and aim massive education campaigns at the practice in an attempt to dial it down. In contract, the animal side has had a free pass for a long time, to the extent that it remains unclear how many antibiotics are used in farming in the US (best estimate: about 70% of all antibiotic use in the US per year), and there is no organized surveillance that would look at what organisms are emerging in animals from that use.

The FDA has been trying to put curbs on growth promoters since the 1970s, always without success; the lobbying against it, by agriculture and also by pharmaceutical interests, is reliably intense. There’s been a parallel effort in Congress to limit the use in animals of drugs that have close analogs in human medicine, via the Preservation of Antibiotics for Medical Treatment Act, or PAMTA, authored by Rep. Louise Slaughter (D-NY), Congress’s only microbiologist. PAMTA has been introduced in several Congresses but this year finally gained some traction. Last year, the Obama administration signaled, in testimony by then-new assistant FDA commissioner Joshua Sharfstein, that it might be friendly to the idea of dialing back on growth-promoter antibiotic use, and it looked as though the long logjam might finally be broken.

Well, OK: Not broken, exactly. Just shifted a little, and maybe showing a tiny bit of light.

On Tuesday, the FDA released a “draft guidance” that proposes animal ag do two things: stop using growth-promoting subtherapeutic dosing, and administer antibiotics to animals under the supervision of a veterinarian. That’s the good news.

The bad news: It’s only a guidance, not a regulation. In other words, it has no force in law. It’s more like a request — though in a press conference last week, Sharfstein suggested it might also be a shot across agriculture’s collective bow:

We have the regulatory mechanisms and the industry knows that. But we are also interested in what things can be done just voluntarily that they would do them. And I think it’ll be interesting to see how the industry responds to this and how – what direction their comments take. …We’re not handcuffed to the steering wheel of a particular strategy at this point. We really want to understand what people think. And but we’re also – I’m not ruling out anything that we could do to accomplish these important public health goals. (Transcript)

Reactions to the FDA announcement were predictable — effectively “No science, more research needed”: Here’s the National Cattlemen’s Beef Association, the National Pork Producers Council, and a standing statement by the Animal Health Institute. (Supporting the FDA move: the Pew Charitable Trusts, the New York Times.)

The draft guidance stays open for public comment for 60 days, until Aug. 30. The required Federal Register posting is here, with the mailing address. Electronic comments can be left at Regulations.gov; the docket number for the guidance is FDA-2010-D-0094; 33 comments have been posted already.

Filed Under: animals, FDA, food, legislation, ST 398

Catching up to MRSA news (not about me)

April 21, 2010 By Maryn Leave a Comment

Constant readers: I’m looking forward to having the breathing space to get back to in-depth blogging. Meanwhile, though, news is zipping by — so here’s a quick list of recent things worth reading.

“Cows on Drugs” — a superb history of the 30-year-old fight to get unnecessary antibiotics out of food animals. Note, written by a former commissioner of the Food and Drug Administration, not exactly a wild-eyed radical:

More than 30 years ago, when I was commissioner of the United States Food and Drug Administration, we proposed eliminating the use of penicillin and two other antibiotics to promote growth in animals raised for food. When agribusiness interests persuaded Congress not to approve that regulation, we saw firsthand how strong politics can trump wise policy and good science.Even back then, this nontherapeutic use of antibiotics was being linked to the evolution of antibiotic resistance in bacteria that infect humans. To the leading microbiologists on the F.D.A.’s advisory committee, it was clearly a very bad idea to fatten animals with the same antibiotics used to treat people. But the American Meat Institute and its lobbyists in Washington blocked the F.D.A. proposal.

 Antibiotic resistance in your kitchen, playroom, car... — After years of begging from health advocates, the FDA and EPA are taking a second look at the chemical compound triclosan, an antibacterial that is put into, well, almost anything you can name: soaps, hand sanitizers, cutting boards, toys. Triclosan is suspected of interfering with hormone regulation in the body, and also increases resistance in organisms in our environment. (When I ask you to use hand sanitizers that contain only alcohol or salts, not antibacterials, triclosan is one of the things I’m thinking of.) The FDA will report its findings in a year. I’d rather see it happen sooner, but it’s a great move.

No progress on hospital-acquired infections — The Agency for Healthcare Research and Quality, part of the Department of Health and Human Services, has published its 2009 National Healthcare Quality Report. The news is not good. To quote the agency’s own language: “Very little progress has been made on eliminating health care-associated infections.” This is all hospital-acquired infections, not just MRSA, but MRSA is a leading organism. The ugly details:

  • Post-operative bloodstream infections up 8%
  • Post-operative catheter-associated urinary-tract infections up 3.6%
  • “Selected infections due to medical care” up by 1.6%
  • Bloodstream infections as a result of central lines unchanged.

(NB, three professional organizations — the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, and the Association for Professionals in Infection Control — put out a statement in response to this report saying it “presents an outdated and incomplete picture on healthcare-associated infections (HAIs) in our healthcare system.” The gist of the statement seems to be that they’ve got better numbers coming… soon. When there’s actual data, I’ll let you know.)

Filed Under: animals, antibacterial, FDA, food, hospitals, nosocomial, ST 398

Well, this is bad news.

January 23, 2009 By Maryn Leave a Comment

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.

Filed Under: animals, antibiotics, FDA, Keflex, politics

Even more bad news on new drugs

December 10, 2008 By Maryn Leave a Comment

Via Forbes.com comes news that the Food and Drug Administration has turned back Targanta Therapeutics‘ application for its new antibiotic oritavancin, which was designed specifically to target drug-resistant staph, and has asked for additional trials. This is a follow-on to a decision by an FDA advisory panel last month that also expressed doubt about the drug.

This comes on the heels of last month‘s withdrawal of dalbavancin and delay in approval of ceftobiprole.

The long, thin pipeline of new drugs for MRSA just got longer and thinner.

Filed Under: antibiotics, drug development, FDA

More bad news on new drugs

December 1, 2008 By Maryn Leave a Comment

The Infectious Diseases Society of America (IDSA) has published a new report that fills in the background on last week’s news below, and confirms: The landscape for new drugs against MRSA and other multi-drug resistant organisms is bleak. (The organisms, summarized in the acronym ESKAPE, are: E. faecium, MRSA, Klebsiella, Acinetobacter, Pseudomonas aeruginosa and Enterobacter.)

The report, published in the journal Clinical Infectious Diseases, is both an update of surveys of the new-drug landscape done in 2004 and 2006, and also a call to action that asks for broad federal effort to encourage pharma companies to produce new drugs.

Here are the highlights:

  • Since the last iteration of the survey in 2006, only one new antimicrobial, doripenem — a very broad-spectrum injectable that is most active against the Gram-negative bacterium P. aeruginosa — has been approved.
  • Only three new compounds — ceftobiprole, dalbavancin and Paratek Pharmaceutical’s PTK-0796 — are in their final rounds of trials. (The report was obviously written before the latest news about ceftobiprole and dalbavancin.)
  • Four of seven efforts to achieve a staph vaccine have been terminated.
  • Though the pharma industry, through its lobbying arm PhRMA, claims “388 infectious diseases medicines and vaccines and 83 antibacterial drugs in development“, that number is misleading:

Careful review of these data reveals that most are preclinical and phase 1 compounds. Also included are topical and nonabsorbable antimicrobials, which we do not consider here, and several compounds for which development has been terminated. Finally, … many of the listed drugs are previously approved agents that are being studied for new indications.

Just to make sure no one misses the big picture, the authors emphasize:

…The number of new antibacterials that make it through the complete development process and ultimately receive FDA approval has precipitously decreased over the past 25 years. Indeed, we found a 75% decrease in systemic antibacterials approved by the FDA from 1983 through 2007, with evidence of continued decrease in approvals, even during the most recent 5-year period.

What are the answers? IDSA is candid, as in its earlier reports, that it believes incentives for drug companies are the only way to improve the situation: financial boosts, patent extensions and changes in trial requirements. Two things are critical, the group says:

  • Novel intravenous and oral drugs to treat both hospitalized and community-based patients are needed, as opposed to “me too” drugs that provide minimal improvement over existing therapies.
  • Priority should be given to antimicrobials with the potential to treat serious infections that are resistant to current antibacterial agents.

Filed Under: antibiotics, drug development, FDA

Bad news on the new-drugs front

November 26, 2008 By Maryn Leave a Comment

Via the very robust pharma blogosphere, reports that two much-anticipated new antibiotics will be remaining in the pipeline a while longer:

Fierce Biotech says that Pfizer has withdrawn its US and European applications for dalbavancin, a much-awaited new MRSA drug, and will conduct another Phase III trial.

Pharmalot reports (via Reuters) that the Food and Drug Administration has asked for additional trials for ceftobiprole, another much-anticipated new drug for MRSA, coming from Johnson & Johnson. Shearlings Got Plowed has more detail, speculates that a “new game face” is emerging at the FDA, and notes that J&J’s partner in ceftobiprole, Basilea, acknowledged that the FDA raises “issues of data integrity” regarding the current application. J&J’s press release is here.

So it’s back to vancomycin, again, for now.

Filed Under: antibiotics, drug development, FDA

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