Maryn McKenna

Journalist and Author

More MRSA Found In U.S. Retail Meat (Turkey, Too)

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There are two new studies out that confirm, once again, that drug-resistant staph or MRSA — normally thought of as a problem in hospitals and out in everyday life, in schoolkids, sports teams, jails and gyms — is showing up in animals and in the meat those animals become.

The strain of staph that shows up in farm animals, known as “livestock-associated” MRSA or MRSA ST398, first emerged in pigs in the Netherlands, and has been widely identified in retail meat in Europe. (You can find a long archive of posts on ST398 here, and more here.) But that same strain has been difficult to identify in the United States. That may be due in part to the U.S. having a uniquely massive epidemic of community-associated MRSA, far larger than in any other country, which likely both obscures any animal epidemic from detection, and possibly also fills the ecological niche that livestock-associated staph might otherwise occupy. But, it must be said, there’s also remarkably little political will to look for livestock-associated MRSA (though the U.S. Department of Agriculture has now funded a study).

Nevertheless, individual investigators keep trying, and when they look for the pathogen, they find it, such as in these studies from May and this one from April. Now, two other teams have as well.

[Read more…]

25 Dead From Melons: FDA Points to Packing Facility

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Federal health authorities have determined responsibility for the vast 26-state outbreak of Listeria in cantaloupes, almost three months  — and 123 illnesses, 25 deaths and one miscarriage —  since it began.

In a long report released this week, they say they found Listeria not in the fields where the melons were grown, but in the packing and cold storage facilities on the single large farm where they all came from; and, in addition, they identified some practices on the farm that may have caused Listeria contamination or allowed it to multiply.

Just as a reminder of what was at stake here since we last talked about it: This is the first time that Listeria was found on cantaloupe in the United States, meaning there wasn’t a lot of past science to draw on. And this was a huge outbreak: The farm had 480 acres in cantaloupe, and shipped more than 300,000 cases of it. The number of fruit involved, according to MSNBC.com, may have been as high as 4 million.

[Read more…]

Cantaloupe Outbreak: 13 Dead, 18 States, More To Come

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I’ve been away at a couple of very interesting conferences — more on those soon — so I’m late to this story; on the other hand, the story hasn’t even peaked yet, and thus there’s plenty of time for us to catch up.

So: An outbreak of foodborne illness that appears to be spread by fresh cantaloupes has sickened 72 people so far, in 18 states, and 13 have died. According to investigators, the source of the contamination has not yet been found. And also, according to a media briefing today, the contaminated cantaloupes were also shipped overseas, to countries that investigators would not identify. And, as an extra bonus, the tally of cases and deaths is likely to keep rising, because the particular illness in this outbreak has an incubation period of up to two months.

[Read more…]

Big News But: USDA Bans "Other" E. coli Strains

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Good news, but not excellent news, today from the US Department of Agriculture: It has agreed that, starting in March 2012, six more strains of E. coli will be considered “adulterants,” putting them in the same regulatory category as the much-feared E. coli O157:H7.

It is a big step, to do this. Those six bacterial bad actors — technically, E. coli O26, O45, O103, O111, O121, and O145 — are now responsible for the majority of foodborne illness caused by E.coli in the United States, causing almost twice as much illness each year as O157 does.

[Read more…]

Tick-Borne Infections Infiltrate U.S. Blood Supply

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Allow me a tiny I Told You So. In February, I wrote a story for SELF Magazine about the rising incidence of diseases other than Lyme that are caused by tick bites. (And told you about it here, of course.) The story highlighted one particular tick-borne parasite, Babesia, and a serious problem with the infection it causes, babesiosis: that it was moving into the blood supply. We dug through FDA transcripts and CDC field reports in order to reveal that federal health authorities were very concerned about this prospect, and that more than 100 babesiosis infections caused by transfusions had already occurred — not just in the few states  where the tick species carrying Babesia are found, but throughout the United States because blood products are shipped nationwide.

Ours was the first reporting we could find about babesiosis in the blood supply, and it didn’t get the attention it should have, probably because women’s magazines tend to be dismissed as not-serious — even though SELF’s health and medical reporting has won prizes and been turned into books. But based on research released this morning, our story at SELF wasn’t hyping the problem. If anything, we understated it.

OK, enough infomercial. Here’s the news: In a paper released ahead-of-print by the Annals of Internal Medicine, researchers from the Centers for Disease Control and Prevention, Rhode Island and New York State report that 159 cases of babesiosis were caused by transfusions in the past 30 years  and “the risk may be increasing.” Twenty-seven of the patients died.

[Read more…]

Drug Shortages: Endangering Human Lives and Pets, Too

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198.

That’s how many critically needed antibiotics, cancer drugs, diuretics, sedatives, stimulants and vaccines — among other drug categories — currently are in short supply in the United States. If you print out the list, which is maintained by the American Society of Health System Pharmacists, it runs to seven pages.

Back in February, I wrote in the Annals of Emergency Medicine, and also here at this blog, about ongoing shortages of critical drugs, and how physicians were beginning to worry about them. At the time, the list of drugs in short supply was up to about 140. [Read more…]

MRSA in meat: How much? Which? And more bad news.

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(Sorry for the radio silence, constant listeners. It’s been a challenging few weeks at Casa Superbug, with a death in the family and the chaos afterward of catching up to the rest of life. But back now, with some interesting stuff planned for later this week.)

Last week was the General Meeting of the American Society for Microbiology (ASM). This is the conference at which, several years ago, Tara Smith’s team at the University of Iowa first announced they had found MRSA ST398 in pigs in the United States, so it always bears watching for new MRSA news, and this year it didn’t disappoint.

First: I’ve complained persistently because the federal system that monitors antibiotic-resistant bacteria in animals and food, NARMS (National Antimicrobial Resistance Monitoring System) doesn’t include MRSA among the pathogens that it tracks. It is possible that might be changing — because at ASM, a team from the Food and Drug Administration reported the results of a pilot study that looked for MRSA in retail meat in the US and found it.

[Read more…]

Growth Promoters: If You Can't Convince Them, Sue Them

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A little less than a year ago, the Food and Drug Administration took a step that, depending on your point of view, was either far too activist or nowhere-near-enough-but-good-try: It proposed, in a draft document, that the agricultural industry voluntarily restrict its use of growth-promoting micro-doses of antibiotics.

It was a significant step. The FDA has been trying to restrict subtherapeutic use of antibiotics in livestock since the 1970s because of the practice’s clear contribution to the development of antibiotic resistance, and had always been defeated. At the same time, it was far from bold: The proposal was made in a draft document that would be made final at some unspecified future date, and that when it became final would have behind it no force of regulation or law. (Here’s my long discussion from last year of the context and history of FDA’s move.)

And there things rested, while the FDA’s docket reportedly filled up with thousands of comments from both sides of the issue. The document — formally, Draft Guidance #209, Judicious Use of Antimicrobial Drugs in Food-Producing Animals — is scheduled to be finalized sometime before the end of this year. But in its draft form, it excited abundant opposition, and the administration official who seemed to be leading the charge on it, memorably suggesting, “We have the regulatory mechanisms and the industry knows that,” has left the FDA for a state-government job.

Clearly, things aren’t moving very fast. So today, a coalition of nonprofit groups attempted to get the issue jump-started: They sued.

[Read more…]

The biggest foodborne-disease threat may not be addressed by the new food-safety law

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So if we wanted to reduce the danger of pathogens passing to people via food — not just drug-resistant bacteria, which are an increasingly significant problem, but all disease-causing ones — where to start?

Formulating a strategy is more difficult than it seems. In the US, policing food safety is divided among several federal agencies: the FDA, USDA and CDC. The FDA has responsibility for most of the food supply, including seafood, produce, processed food and fresh eggs. The USDA’s Food Safety and Inspection Service (FSIS) regulates fresh meat and poultry and egg products. The CDC surveys the illnesses that result from any of them, estimating most recently that one in six US residents, or about 48 million people, get sick each year, 128,000 are hospitalized and 3,000 die.

But most of those illnesses are never investigated, because a substantial portion of them occur individually or in small clusters, not in major outbreaks. Many of them have long-term consequences that are never recorded by any federal counting mechanism. And there’s currently no surveillance system that links pathogens and food — which means there’s no way to target which foods, or food-raising practices, pose the greatest risks.

The new food-safety bill, signed in January, addresses at least some of those barriers, by requiring a risk-based approach to foodborne illness — meaning, you look at what is causing the greatest problem, and aim your efforts and funding in that direction. But the bill — which certain Congressmen have threatened to starve of funding — covers primarily the FDA. And a new analysis suggests that’s not where the greatest problems lie. [Read more…]

World Health Day update: Use an antibiotic, pay a fee?

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So if we agree that the untrammeled rise in antibiotic resistance is a bad thing — and given the unexpected World Health Day news that an incredibly resistant bacterium is in New Delhi’s water supply, I think many do agree — what do we do next?

How about charging everyone who buys an antibiotic a user fee?

That’s one of the surprisingly nervy proposals that surfaced Thursday during World Health Day, a refreshing change from the somber but predictable rhetoric put forward by the WHO and CDC. It comes from a comprehensive set of policy recommendations released Thursday by the Infectious Diseases Society of America in the journal Clinical Infectious Diseases and at a press event in Washington DC.

The direct language in the recommendations’ introduction indicates their tone:

The availability of effective antibiotics is not a ‘‘lifestyle’’ issue, and the lack of availability of these agents is not theoretical. Society worldwide is facing a public health crisis due to stagnation in the antibiotic drug pipeline combined with rapidly spreading, deadly antibiotic-resistant pathogens. The lack of effective antibiotics already is resulting in deaths and maiming of patients and the problem will only continue to worsen until Congress and the Administration act. The time for debate about the problem has passed. Immediate action is critically needed now.

[Read more…]

Food safety: Needs speed, technology — and funds

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Perhaps you remember the Great Tomato Scare of 2008.

It started in mid-May, when the New Mexico Department of Health told the Centers for Disease Control and Prevention that it had identified a  Salmonella cluster: four people who were infected with an identical, uncommon strain called Salmonella Saintpaul, and another 15 who seemed to be part of the same outbreak but whose infections hadn’t been characterized enough for authorities to be certain. Then there were cases in Texas, and then more cases in the Navaho Nation. By June 9, 2008, there were at least 150 cases nationwide; by July 1, the count was 869. By the time the outbreak ended in late August, there would be 1,499 victims — almost certainly an undercount — in 43 states. Two people died.

The outbreak was chaotic. On June 3, based on some early studies, the Food and Drug Administration warned people in New Mexico and Texas against eating certain types of raw tomatoes; on June 7, the FDA expanded the warning to nationwide. Investigators were puzzled by tomatoes causing an outbreak so early in the season, and hypothesized that they must have been grown in a warm climate area — maybe California, Florida or Mexico. Then they were troubled by how widely the outbreak spread. Because tomatoes can come from so many different places, they wondered whether the source of the contamination wasn’t the growing fields, but rather a packing house or a wholesaler where fruit from many different farms came together.

Consumers were just as confused. The FDA said raw red plum, red Roma and red round tomatoes were no-gos, but cherry tomatoes, grape tomatoes and tomatoes sold on the vine were OK. People were unsure what was safe to eat and from where it was safe to buy. The entire enormous tomato industry — 8 billion pounds per year in the US — ground to a halt.

There was just one problem: The cause of the outbreak wasn’t tomatoes at all. [Read more…]

News break: Slaughter will reintroduce PAMTA (and cites data from this blog)

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Rep. Louise Slaughter (D-NY), Congress’s only microbiologist, said late today that she plans shortly to reintroduce PAMTA, the Preservation of Antibiotics for Medical Treatment Act, a timely move given the collapsing antibiotic market (see this morning’s post) and continuing reports of resistance moving off farms (as in this post).

PAMTA would direct the FDA to re-examine its approvals of veterinary antibiotics that are close analogs of ones used in humans, because they can stimulate the development of resistant organisms. When those organisms move off the farm, as research shows they do, they then cause illnesses that cannot be treated by the functionally identical human drugs.

The Union of Concerned Scientists said in 2008 about an earlier version of the bill:

The FDA is aware of the problem of antibiotic resistance due to overuse in animal agriculture, but the agency’s process for reviewing and withdrawing drugs from the market is far too slow and cumbersome. A recent effort to withdraw an antibiotic from use by poultry producers due to concerns about human antibiotic resistance lasted for more than five years, costing millions of taxpayer dollars. And while the judicial proceedings dragged on, disease-causing bacteria continued to outwit antibiotics.

While some producers and retailers of meat products have announced policies that take steps to curb antibiotic use, private-sector initiatives to reduce antibiotic use in animal agriculture are relatively rare, limited in scope, and difficult to verify. Federal action is needed to achieve comprehensive reductions and create a level playing field for all producers and retailers.

Passage of PAMTA is critical to keep antibiotics working for human health. In addition to averting the harmful effects of antibiotic overuse on human health, curtailing animal use of antibiotics will encourage producers to raise animals in better living conditions that are less conducive to disease.

Parenthetically, it is flattering to see Slaughter reference new data on the amount of antibiotics used in animals in the United States — almost 29 million pounds — and the percentage of the total market antibiotic market that represents: 80 percent. Those pieces of news were broken over the Congressional break by myself, here at SUPERBUG, and by Ralph Loglisci at the blog of the Center for a Livable Future.

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Running out of antibiotics — and other drugs too

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Last night, the Journal of the American Medical Association posted ahead of print an editorial by Dr. James Hughes, former director of the National Center for Infectious Diseases at the CDC and now a professor of medicine and global health at Emory University. It’s a blunt and eloquent plea for attention to a problem that many people haven’t yet faced up to: We’re running out of antibiotics.

Antimicrobial agents have saved millions of lives and improved the outcomes for countless patients since these drugs were introduced in the early 1930s. However, the effectiveness of these lifesaving resources is at risk. Many medical advances that physicians and patients take for granted—including cancer treatment, surgery, transplantation, and neonatal care—are endangered by increasing antibiotic resistance and a distressing decline in the antibiotic research and development pipeline. (JAMA Hughes)

Drug resistance is a biologic inevitability — but in the 83-year history of the antibiotic miracle, starting from Fleming’s first recognition of natural penicillin, whenever resistance made one drug useless, another drug came along to save us. Those days are over. [Read more…]

The dangers of ticks: Not just Lyme disease

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I have a story in the forthcoming March issue of SELF Magazine that has just been put up online: The Rising Dangers of Ticks. It’s a long look at the under-appreciated other diseases that can be transmitted by tick bites — that is, not the Lyme disease that most people associate with ticks, but babesiosis, erlichiosis, anaplasmosis, and others. From the story:

“We’ve seen pretty dramatic increases,” says Jennifer McQuiston, an epidemiology team leader in the vector-borne disease division of the Centers for Disease Control and Prevention in Atlanta. “We’re told to get out and exercise and enjoy nature, so we need to be aware.” Most people have heard of Lyme disease, which appeared among residents of that town in Connecticut in the mid-1970s and now affects more than 35,000 Americans per year. Most Lyme cases occur in the Northeast and upper Midwest; if you don’t live there, you might be safe from Lyme but still at risk for other diseases. Cases of a tickborne illness known as ehrlichiosis grew from 200 to 957 nationwide—a 378 percent jump—between 2000 and 2008, according to the CDC. The infection anaplasmosis nearly tripled in the same period, and Rocky Mountain spotted fever quintupled. The new disease STARI (southern tick-associated rash illness) has spread across the South, and strains of an infection called rickettsiosis have hit the Gulf and Pacific coasts.

All of these non-Lyme tick diseases attack victims in a similar way, bringing on fever, headache, and muscle and joint pain—making it easy to misdiagnose them as anything from flu to meningitis, says [Gary P. Wormser, M.D., the chief of infectious diseases at Westchester Medical Center and New York Medical College and head of a team researching tick diseases]. If the patient remembers finding a tick, or develops a rash, that’s a big clue. If not, “it is somewhat common for these to be missed. The symptoms resemble so many other common viral infections,” says Gregory A. Storch, M.D., a pediatric infectious-disease specialist at Washington University in St. Louis, which created a multidisciplinary tickborne-disease research team because cases have surged there.

…[B]ecause medical awareness has not kept up, patients have been overlooked, undertreated and taken by surprise when their enjoyment of the outdoors—a hike, a run, a round of golf, their own backyard—turns into a life-altering threat.

Sometimes these infections can be transmitted by a tick bite at the same time as Lyme, making them what physicians and Lyme patients call “co-infections.” Sometimes they are mistaken for Lyme. Some of them require different drugs to treat, so if they are not diagnosed correctly, people will not be treated properly and the diseases can linger.

That’s especially important for one of them, babesiosis, because it is caused not by a bacterium but by a parasite that lives in red blood cells much as malaria does — in fact, one researcher described it to me as “American malaria.” Because many people don’t show obvious symptoms, babesiosis isn’t always detected and treated. As a result, it is spreading, both from women to their children prenatally, and also, troublingly, through the blood supply. Babesiosis is currently the No. 1 cause of infections transmitted through blood transfusion in the United States. Unlike other infections that are potentially passed by blood, such as HIV and West Nile virus, there is no test for babesiosis that blood banks can use.

In 2007, in a case that rang alarm bells, a cancer patient in California arrived at the hospital weak and throwing up blood. Tests revealed babesiosis: He had been infected by blood from a man who had donated in Maine, say Van P. Ngo and Rachel Civen, M.D., epidemiologists at the Los Angeles County Department of Health who investigated the case. The FDA has since reported that over the past 10 years, babesiosis has infected more than 100 Americans via transfusions—and 11 of them have died.

These are tiny numbers compared with the more than 5 million people who receive transfusions in the United States each year. But there are almost certainly more cases than there would be if blood banks could effectively check for the parasite. Right now, donors merely complete a questionnaire that asks whether they have had babesiosis or unexplained fever. In one study in Connecticut, 1 out of every 100 donors who passed that screening was shown to be potentially infectious.

These infections aren’t often deadly, but sometimes “deadly” isn’t the point: For many of the women (and men) who have had them, they are life-interrupting and sometimes life-changing, requiring tough drug treatment and long recovery times. A number of women who suffered from babesiosis and erlichiosis generously shared their stories with me, and two are featured in SELF. I hope you’ll take a look.

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Superbugs in Canadian chicken? Yes, and US too

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CBC News, the Canadian national TV network, has caused a stir in the food-blog world with the results of a nationwide investigation that found antibiotic-resistant bacteria contaminating supermarket chicken. In its words:

Chicken bought at major supermarkets across Canada is frequently contaminated with superbugs — bacteria that many antibiotics cannot kill — an investigation by CBC TV’s Marketplace has found.

Marketplace researchers — along with their colleagues at Radio-Canada’s food show L’Epicerie — bought 100 samples of chicken from major grocery chains in Vancouver, Toronto and Montreal… The 100 samples were sent to a lab for analysis. Two-thirds of the chicken samples had bacteria. That in itself is not unusual — E. coli, Salmonella and Campylobacter are often present in raw chicken.

What was surprising was that all of the bacteria uncovered during the Marketplace sampling were resistant to at least one antibiotic. Some of the bacteria found were resistant to six, seven or even eight different types of antibiotics.

“This is the most worrisome study I’ve seen of its kind,” said Rick Smith, the head of Environmental Defence, a consumer advocacy group.

I haven’t had time to watch the full program, but no question I think this kind of reporting is worth doing. Nothing brings the threat of agricultural antibiotic use home to people like showing them that resistant bacteria are living on the meat they might have brought home last night.

One important point, though: Don’t think for a moment this is just a Canadian problem.

Last month, a team from the University of Ioannina in Greece analyzed in Foodborne Pathogens and Disease 428 samples of various retail meats they bought in northwest Greece over three years:

E. coli from chicken exhibited high rates of resistance to ciprofloxacin (62.5%) followed by lamb/goat (10.9%), pork (15.7%), and beef (27.9%) meat. Resistance to nitrofurantoin dominated in the lamb/goat isolates (60%). Resistance to tetracycline predominated in pork (68.2%) and chicken (62.5%), and resistance to aminoglycosides dominated in lamb/goat meat isolates. S. aureus resistance to clindamycin predominated in lamb/goat isolates (50%), whereas resistance to ciprofloxacin predominated in the pork strains, but no resistance to methicillin was observed. Of the enterococci isolates 21.1% were resistant to vancomycin. High resistance to ampicillin (96%) was observed in Y. enterocolitica and all of the C. jejuni isolates were resistant to ampicillin, cephalothin, and cefuroxime. These results indicate that meat can be a source of resistant bacteria, which could potentially be spread to the community through the food chain.

Last year, a team from the University of Iceland found fluoroquinolone-resistant E. coli passing from chickens to humans there (the drug Cipro is a fluoroquinolone, and the human isolates were Cipro-resistant), a multi-institution team from Canada found resistance to third-generation cephalosporins in Salmonella enterica spreading from chicken meat to humans, and the Irish quasi-governmental group SafeFood released a long report (and hosted a conference) on “The Problem of Antimicrobial Resistance in the Food Chain.” And of course MRSA ST398, the strain of drug-resistant staph that arose in food animals, has now been found in retails meats across the EU.

Oh, but none of those countries are the United States, you say. Then take a look at these:

Those graphics come from a little-read report put out every year by the US Food and Drug Administration as part of its participation in NARMS, the National Antimicrobial Resistance Monitoring System that’s shared by the FDA, USDA and CDC. The FDA handles the part of NARMS that looks for resistant bacteria in meat (CDC does human illnesses, USDA does live animals), and the figures above show the percentages of Salmonella and enterococci that were found in retail chicken breasts between 2002 and 2008 (the most recent report) and were resistant to various drugs. The bar along the bottom of each figure shows the major drug classes. So in 2008: 45% of Salmonella on chicken were resistant to tetracycline and 30% to penicillins; among enterococci (common gut bacteria, and therefore common contaminants of meat during slaughtering), 65% resistant to tetracycline and more than 90% to lincosamides, which include the everyday drug clindamycin.

In the narrative portion of the report, the FDA said:

38.2% of chicken breast Salmonella isolates were resistant to ≥ 3 antimicrobial classes in 2008 compared to 51% in ground turkey, an increase in both from previous years. From 2002–2007, multidrug resistance to ≥ 3 antimicrobial classes ranged from 20–34.4% among chicken breast and 20.3–42.6% for ground turkey. More than 15% of chicken breast and ground turkey isolates showed resistance to ≥ 4 classes in 2008.

So, just to underline: Multi-drug resistant superbugs aren’t only on chicken in Canada; if you buy chicken in the United States, they are more than likely on your chicken too.

And whatever country they are occurring in, the solution is the same. Drug-resistant bacteria in food won’t diminish until we reduce the amount of drugs that food animals receive while they are raised.

Update: At Grist’s Meat Wagon, Tom Philpott very kindly points out that I actually broke the news of the latest NARMS report, which I didn’t realize (it was a busy day; see my next post for why). Apparently the report was posted to the FDA web site on Dec. 17, but neither of us can find any evidence that it was publicized, such as a press release on the FDA’s press site. His larger point is important:

We find out from the report that the FDA has been monitoring the situation since 2002 — and finding plenty of antibiotic-resistant strains on meat sold directly to consumers. And they’ve been sharing the information with other leading regulatory/public health agencies — but not so much to the people they’re supposed to be protecting and informing: i.e., us. … six weeks since the FDA report and a year since Sharfstein’s testimony [in 2010, promising scrutiny by the Obama adminsitration – m.], policy hasn’t moved at all. Where are the loud public statements from the FDA trumpeting the fact that our factory farms are cooking up superbugs that make their way to our meat? Where’s the USDA on this topic, which is supposed to protect the public from tainted meat? Where’s CDC?

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New antibiotics: Not many and fewer all the time

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The New England Journal of Medicine last week published the results of a Phase 3 trial of a new antibiotic called fidaxomicin, made by a company called Optimer Pharmacuticals. Fidaxomicin is the first of a new class of antibiotics called macrocycles; it’s a narrow-spectrum drug aimed specifically at Clostridium difficile, the bacterial, toxin-producing, potentially fatal infection of the gut that occurs when broad-spectrum antibiotics have killed off the other populations of bacteria that normally live in the intestines.

Fidaxomicin’s existing competition is vancomycin, the 50-year-old broad-spectrum big gun used for MRSA and many other serious bacterial infections. As compared against vancomycin, fidaxomicin was “noninferior,” in industry jargon; its selling point was a lower rate of recurrence of C. diff among patients who received it compared to those getting the older drug. From the paper:

A total of 629 patients were enrolled, of whom 548 (87.1%) could be evaluated for the per-protocol analysis. The rates of clinical cure with fidaxomicin were noninferior to those with vancomycin in both the modified intention-to-treat analysis (88.2% with fidaxomicin and 85.8% with vancomycin) and the per-protocol analysis (92.1% and 89.8%, respectively). Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of the infection, in both the modified intention-to-treat analysis (15.4% vs. 25.3%, P = 0.005) and the per-protocol analysis (13.3% vs. 24.0%, P=0.004). The lower rate of recurrence was seen in patients with non–North American Pulsed Field type 1 strains. The adverse-event profile was similar for the two therapies. (NEJM Louie et al.)

Fidaxomicin has been in the works for a while — it was given Fast Track status by the Food and Drug Administration back in 2003 — and it has faced some criticism for not being different enough from vanco to justify the price that a new drug can charge. Nevertheless, on the basis of this and other trials, Optimer has completed its New Drug Application, and the FDA’s Anti-Infective Drugs Advisory Committee will review it at a meeting in April.

[Read more…]

Update: Farm Animals Get 80 Percent of Antibiotics Sold in U.S.

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Two weeks ago, I broke the news of a new FDA report that estimated for the first time the amount of antibiotics sold in the United States every year for use in agriculture: 28.8 million pounds.

That long-awaited report didn’t answer a crucial question: What volume of antibiotics are sold in the United States each year for human use. It’s a crucial question because, in answer to concerns about antibiotic resistance arising on farms, the answer has always been that human medicine is equally culpable because it uses similar volumes of antibiotics.

The only research that has attempted to answer that question is contained in a decade-old report by the Union of Concerned Scientists that put the proportion of antibiotics going to animals at 70 percent of the U.S. total.

That UCS report and estimate are a decade old not because no one has cared about the topic, but because accurate updated figures have been so hard to get. So we owe a special holiday thank-you to the researchers at the Center for a Livable Future, who decided the release of the FDA report justified another attempt to get the numbers straight. They succeeded.

The proportion of antibiotics sold in the United States each year that go to animals turns out to be not 70 percent, but rather 80 percent. Here’s CLF’s Ralph Loglisci, who got the confirmatory numbers from the FDA:

In accordance with a 2008 amendment to the Animal Drug User Fee Act, for the first time the FDA released last week an annual amount of antimicrobial drugs sold and distributed for use in food animals. The grand total for 2009 is 13.1 million kilograms or 28.8 million pounds. I … contacted the FDA for an estimate of the volume of antibiotics sold for human use in 2009. This is what a spokesperson told me:

“Our Office of Surveillance and Epidemiology just finished an analysis based on IMS Health data. Sales data in kilograms sold for selected antibacterial drugs were obtained as a surrogate of human antibacterial drug use in the U.S. market. Approximately 3.3 million kilograms of antibacterial drugs were sold in year 2009. OSE states that all data in this analysis have been cleared for public use by IMS Health, IMS National Sales Perspectives™.”

3.3 million kilograms is a little over 7 million pounds. As far as I can determine, this is the first time the FDA has made data on estimates of human usage public.

At its blog, CLF lays out the math for each major drug class as sold for animal use and human use, with a long discussion of the significance of the different drug classes. Here’s the CLF table summing up the math, but please go over to CLF’s blog for its discussion.

Most important to note: Most of the drugs used in animal agriculture and in human medicine are functionally identical. That’s one reason why the overuse of antibiotics in animals is such a concern: When organisms become resistant on the farm to drugs used on livestock, they are becoming resistant to the exact same drugs used in humans. (One major drug category used in animals, ionophores, do not have a direct human analog. But use of them on farms is still a concern, because resistance factors can move freely between species of bacteria. That’s a discussion for another day.)

Loglisci’s conclusion is also worth underlining:

The next battle, which industry has already begun, is defining what non-therapeutic use will constitute. Producers are already claiming that the use of antibiotics for growth promotion has decreased, maintaining current low-dose usage is aimed at disease prevention. Regardless, all low-dose usage of antibiotics can lead to a significant increase in antibiotic resistance.

Image: Flickr/Epsos

The food safety bill and the long cost of foodborne illness

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In a nailbiter ending tonight, the US House of Representatives passed the long-stalled, almost-lost, back-from-the-dead FDA Food Safety Modernization Act, a decades-overdue piece of legislation that will equip the US Food and Drug Administration with enforcement tools to help it prevent and track foodborne illness outbreaks.

For people who don’t know the regulatory landscape of food in the United States, it comes as a shock that FDA (which regulates both drugs used in food production and much of the food produced in the US, except for meat and poultry which are under USDA) has so little power. Until now, the FDA could not compel a food recall; it could only ask for a problematic or dangerous food to be recalled, and the food producer could demur. That was, if the FDA even associated a particular food with a foodborne outbreak, which was unlikely given its lack of surveillance resources or inspectors. (A remarkable number of foodborne outbreaks are solved not by the feds but by the Minnesota Department of Public Health, which is well-funded by the state it represents.) The last time food-safety legislation was updated in the US was 1938. [Read more…]

News break: FDA estimates US livestock get 29 million pounds of antibiotics per year

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This afternoon, the Food and Drug Administration posted without fanfare a report that many people have been waiting a long time for: Its first-ever estimate of the amount of antibiotics sold for use in food animals in the United States.

And the number is: almost 29 million pounds in 2009.

That’s a lot.

Is it more or less than was expected? It’s almost impossible to say. Estimates of the amount of antibiotics given to food animals in the United States are ferociously contested and plagued by squishy definitions and category creep. In 2000, the Animal Health Institute, which represents veterinary drug manufacturers, put total use at 17.8 million pounds. In 2001, the Union of Concerned Scientists, which campaigns (among other issues) to dial back use of agricultural antibiotics, estimated that 24.6 million pounds per year are used only for “non-therapeutic purposes” — that is, to make animals grow to market weight faster and to prevent them catching diseases in the close quarters of confinement agriculture.

The reason why antibiotic use on farms is a concern, of course, is because such use stimulates the emergence of drug-resistant organisms that move off the farm in animals, in groundwater, in dust, on the wind and in the systems and on the clothes of those who work there, and makes new resistance factors available to be swapped among bacteria. (For much more about that, see these three posts and this long archive at my former blog.)

The FDA’s estimate comes as the agency has been moving to curb agricultural antibiotic use after years of non-action. Today’s report, which is very short — basically a table and a bunch of footnotes — is the direct result of a 2008 amendment to the Animal Drug User Fee Act of 2003, which required manufacturers to report yearly on sales of agricultural antimicrobials. (Here’s an FDA Q&A on the report background.)

More important, though, today’s report dovetails with the FDA’s new effort to curb antibiotic use in agriculture, which Commissioner Dr. Margaret Hamburg said in October would involve “very serious scrutiny.” (Video here.) The main instrument of that effort is a “draft guidance” that the FDA opened for public comment over the summer, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” (pdf here). The point of that guidance is to ask agriculture to voluntarily withdraw from use the ag drugs that are functionally identical to drugs that are important in human medicine — because if bacteria become resistant to those drugs when they are used in animals, that newly derived resistance will also affect humans, making common diseases difficult or impossible to treat.

In addition to the volume figure, the real value of today’s brief report may be simply to make clear just what antibiotics are used in agriculture. Take a look at the report table at right, which lists the animal drugs used by amount sold within drug classes. (Note that the amounts are given in kilograms.) It lists:

Aminoglycosides: Human versions include streptomycin and amikacin.

Cephalosporins:  Human versions include Keflex and Rocephin.

Lincosamides: Human versions include clindamycin.

Macrolides: Human versions include erythromycin.

Sulfas: Human versions include half of the very common drug combos Bactrim and Septra.

Penicillins and tetracyclines: Yup, just what they sound like.

“NIR”: That’s FDA shorthand for “not independently reported” because they have few manufacturers or make up a small portion of the market. Among them are fluoroquinolones. Human versions: Cipro and Levaquin.

There’s much more to be said about the issue of antibiotic use in agriculture, especially because the lone piece of legislation addressing it, the Preservation of Antibiotics for Medical Treatment Act, is currently in lame-duck limbo. This report is an important piece of data for the ongoing debate.

Update: I asked some experts in the field to comment on the release of this data. Dr. David Wallinga, director of the Food and Health program at the Institute for Agriculture and Trade Policy in Minneapolis (also William T. Grant Foundation Distinguished Fellow in Food Systems and Public Health at the University of Minnesota School of Public Health) replied:

Clearly, antibiotic use in animal agriculture is huge, and as the FDA and CDC and WHO all agree, much of it is unnecessary. Data collection is important. But, because resistant bugs quickly adapt, we can’t afford to wait for data to take action to reduce antibiotic use wherever possible. That includes routine uses of antibiotics for cattle developing liver abscesses because they’re force-fed grain rather than grass, as well as antibiotics used to make animals get fatter faster.

Update 2: A day after the release of this report, Rep. Louise Slaughter (D-NY), author of PAMTA and a public-health microbiologist, commented on the data — and also said she’ll be reintroducing the legislation again in the next Congress in January.

This report illustrates the overuse of antibiotics in food animal production and makes a strong case for some common-sense limits on antibiotic use. We are putting millions of pounds of antibiotics into the food supply unnecessarily every year. This cannot continue and it’s my hope that these new data from the FDA will encourage even more members of Congress to join me next year when I reintroduce this legislation.  Moreover, the FDA must move fast to issue strong regulations on antibiotic usage in agriculture.

Update 3: Tom Philpott, senior food and agriculture writer at Grist — and a farmer, so he knows the territory — covered the FDA report and this post in a very kind and typically forthright post of his own.

Update 4: Helena Botttemiller, ace food-policy reporter for Food Safety News, covers this as well, noting how little mainstream media interest there has been. Any opinions why?

Cite: 2009 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, FDA, Dec. 9, 2010

Image via Flickr user net_efekt under CC

News break: FDA head promises "very serious scrutiny" of farm antibiotics

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Since July, the Food and Drug Administration has been moving — quietly and cautiously, but moving — to raise the stakes in its long and so-far unsuccessful battle to rein in overuse of antibiotics in agriculture. For those new to the topic, this is the use of antibiotics not in treatment-sized doses, to cure disease in farm animals, but in smaller doses to prevent disease or simply to make the animals gain weight faster so they can raised more efficiently and sold off more quickly than they would have otherwise.

There are decades of research by now, demonstrating that this contributes to the development of antibiotic-resistant organisms on farms that then move off harms and threaten human health. It’s not really a scientific question any longer; it’s a question of economics and politics.

(For a long discussion of what the FDA is proposing — and how much force it will, or won’t, have — see this post — at SUPERBUG’s earlier location, because we haven’t yet moved over all the archives.)

Yesterday, FDA Commissioner Dr. Margaret Hamburg gave a speech at the National Press Club at which she raised this issue and made some intriguing remarks. The overall point of the speech (see this AP article) was to promise increased investment and modernization — but she raised both the problem of antibiotic resistance generally and, in answer to a question, the problem of antibiotic use in farming.

First, here’s what she said generally about resistance (my transcription from CSPAN’s video above, starting at about 7:00):

There is increasing alarm about the problem of antibiotic resistance, and we worry with good cause. Today, antibiotic resistance mechanisms have been reported for virtually all known antibacterial drugs currently available for clinical use, which affects everything from global infectious diseases to ear infections in school children to staph infections in locker rooms. People actually talk today about a potential return to the, quote, pre-antibiotic era, unquote, where we no longer have effective tools to treat serious infectious disease. Clearly we must encourage more judicious use of these important drugs through improved infection control,  rational prescribing and better patient compliance.

But even if we improve these practices, resistant bacteria will continue to develop no matter what. We need new and better drugs and we need them now. Yet the research and development pipeline is distressingly low. The number of newly approved antibiotics, not just new formulations of previously existing drugs, has fallen steadily since the 1980s, and the range of new antibiotics in distribution is limited in terms of the types of classes of new antibiotics available and the diseases they can treat.

And here’s what she said about farm use, in response to a question (starting at about 31:00):

There historically has been a very considerable use of antibiotics as part of animal husbandry and also agriculture. I think that for many years individuals and organizations in public health and medicine have raised those very concerns, about what is the impact of the use of antibiotics in animal populations on human health and the availability of effective antibiotics to treat disease. We are in the midst of very serious scrutiny of these issues and we have made recommendations in support of judicious use of antibiotics. Nobody wants to deny antibiotics to animals that need medical treatment. But the use in certain preventive contexts, where it is not clearly medically indicated, is of growing concern,. And it is an area that, working with our partners in government, both the CDC and the USDA and others, that we are taking a very serious look at. (Emphasis mine.)