Maryn McKenna

Journalist and Author

Farm-Drug Companies Agree to Antibiotics Ban. More of the Same, or Fresh Start?

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USDA Photos by Lance Cheung/Flickr

Big news in the realm of agricultural antibiotics: For the first time in almost 37 years of trying, the US Food and Drug Administration has achieved some control over the meat-industry practice of routinely giving antibiotics to livestock. The drawback: The control comes in the form of a voluntary commitment by veterinary drug manufacturers — and while the FDA maintains the voluntary program will work, there is widespread skepticism that the agency may be optimistic.

Here is what has happened; it takes a few steps to lay out. The FDA has been putting this voluntary program together for several years now, via two “Guidances” (numbered 209 and 213), which are nonbinding agency recommendations without the legal force of regulations, plus a Directive, which fills in the details. The three documents set forth what the agency wants to see happen: for meat production to stop using the routine micro-doses (“growth promoters” or “subtherapeutic antibiotics”) that fatten animals, but create antibiotic resistance; for farmers to stop administering antibiotics to entire herds or flocks via their feed and water; and for antibiotics to be used on farms only with the oversight of a licensed veterinarian. They accomplish that by asking veterinary antibiotics manufacturers to change the labeling on the drugs, so that they can no longer legally be sold over-the-counter to be used for growth promotion. The first Guidance, 209, was made final a year ago, and sets out the rationale for making this change. The second, 213, was made final last December; at that time, the FDA gave veterinary drug manufacturers  three months to say whether they were going to comply.

Which brings us to the new news: On Wednesday afternoon, the FDA’s Center for Veterinary Medicine published the list of veterinary drug manufacturers who have agreed to comply with the voluntary label change. Out of 26 manufacturers in that market, 25 agreed to cooperate. The FDA says this represents “99.6 percent of the applications,” that is, drugs and the ways they are administered.

So: Is the long battle over growth-promoter antibiotics, banned in Europe for 8 years now, over just like that? Or is there more to do?

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Serious Resistant Infections Increasingly Found in Children

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Photo: Ishai Parasol/Flickr

Photo: Ishai Parasol/Flickr

Here’s some disturbing news published late last week in the Journal of the Pediatric Infectious Diseases Society by a team of researchers from two Chicago medical institutions plus an expert analyst of antibiotic resistance: Serious drug-resistant infections in children are rising across the United States. While the rate of their occurrence remains low overall, they nonetheless increased two- to three-fold over 10 years.
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CDC: Some Hospitals Need Assistance Using Antibiotics Properly (And the New Federal Budget May Help)

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Image: Zach Bulick/Flickr

Image: Zach Bulick/Flickr

Double-barreled news today from the US Centers for Disease Control and Prevention. In an analysis of several sets of hospital data, gathered by the agency and also purchased from independent databases, the CDC said it found that more than 37 percent of prescriptions written in hospitals involved some sort of error or poor practice, increasing the risk of serious infections or antibiotic resistance. And in a surprise announcement timed to the release of the federal draft budget, the agency said it is in line to receive $30 million to enhance its work combating antibiotic resistance in the US.

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Fecal Transplants: Treat Them Like Tissue, Not Like Drugs

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Messtiza (CC), Flickr

Messtiza (CC), Flickr

It’s been a little more than a year since the first-ever clinical trial of fecal transplants — the practice of infusing diluted donor stool into the colon of someone suffering from Clostridium difficile infection — demonstrated that the low-tech process not only works to overcome the disease’s painful, life-disrupting diarrhea, but works better than the standard treatment of antibiotics.

That finding confirmed what gastroenterologists had known for a while — not to mention what patients who had sought out the procedure, in the United States or in other countries, could confirm from their own experience of being rapidly and, for the most part, permanently cured.

Despite that result, and despite significant pent-up demand from patients and physicians both, fecal transplants’ status in US medicine has barely budged in the ensuing year. The procedure is caught in a bind at the Food and Drug Administration, which has struggled to define under which of its regulatory authorities the transplants fall. Last May, the agency proposed forcing physicians who wanted to perform the procedure — many of whom were already doing so — to obtain a cumbersome Investigational New Drug application beforehand. After an outcry, the agency backed off, but many practitioners had been spooked, and many patients (judging by my email at least) returned to seeking out the procedure in a semi-underground manner.

In Nature last week, a team of researchers (including gastroenterologist Colleen Kelly, MD, who heads a US clinical trial that is still underway) argued for a way out of the paralysis. They propose that the FDA evaluate stool infusions not under the rules for drugs, with all the clinical trial requirements that implies, but rather under the rules for tissues such as blood, cartilage, skin and bone.

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From Bird Flu to Big Farms: The Rise of China's Agriculture

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Image: Willem vdh/Flickr

Image: Willem vdh/Flickr

In my last post, I talked about the unnerving increase in avian flu H7N9 in China. The novel flu strain, now in its second year, appears to be spreading more rapidly than it did in its first appearance, and also more rapidly than H5N1, the avian flu strain that has caused the most worry internationally.

You can’t have avian flu — or at least, not this avian flu — without birds; most of the people who have been diagnosed with H7N9 had contact with live chickens or visited a market that sold live poultry for slaughter. H7N9 is continuing to spread in China; and so it’s a lucky coincidence that a nonprofit with deep knowledge of Chinese agriculture has just published a series of reports exploring the vast expansion of Chinese production of meat animals, including chickens.

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H7N9 Flu, Year Two: What Is Going On?

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Live-poultry market, Shandong, China, 2009. Jonas_in-China (CC), Flickr

Live-poultry market, Shandong, China, 2009. Jonas_in-China, Flickr

Cast your mind back to about this time a year ago. A novel strain of flu, influenza A (H7N9), had emerged in China, in the provinces around Shanghai. International health authorities were deeply concerned, because any new strain of flu bears careful watching — and also because, on the 10th anniversary of the SARS epidemic, no one knew how candid China would be about its cases.

By the time peak season for flu ended in China, there had been 132 cases and 37 deaths from that newest flu strain. But, confounding expectations, the Chinese government was notably open about the new disease’s occurrence, and scientists worldwide were able to ramp up to study it. Still, no one could say whether that flu would be the one to make the always-feared leap to a pandemic strain that might sweep the globe. As with other, earlier, worrisome strains of flu, science could only wait and see whether it might return.

And now it has.
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Report: FDA Documents Show Decade of Unsuccessful Attempts to Control Farm Antibiotics

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Image: gina pina/Flickr

Image: gina pina/Flickr

A nonprofit group that has been using the courts to pressure the Food and Drug Administration into exerting more control over farm antibiotic overuse has done a deep review of FDA documents prised loose through Freedom of Information Act requests — and concludes that by allowing the drugs to remain on the market as formulated, the agency isn’t meeting its own internal safety standards.

Instead of only making that assertion, the Natural Resources Defense Council took the unusual step of showing its evidence in detail. NRDC published its analysis, Playing Chicken with Antibiotics, alongside a selection of the raw documents it received from the FDA. You’ll have to be a document-obsessive to take it on: The file (cached in a Dropbox and requiring download to view) is 306 mb and 971 pages. But even without considering its content, the file’s heft makes clear how much discussion there has been at the FDA over this issue, and suggests how much evidence has been accumulating over the problem of antibiotic resistance emerging from livestock production. Also telling: The FDA has been attempting to put some controls on livestock production since 1977; these documents cover only reviews of antibiotic feed additives that were conducted between 2001 and 2010.

NRDC’s conclusion, in its report:

FDA’s scientific reviewers’ findings show that none of these products would likely be approvable as new additives for nontherapeutic livestock use if submitted today, under current FDA guidelines. Eighteen of the 30 reviewed feed additives were deemed to pose a “high risk” of exposing humans to antibiotic-resistant bacteria through the food supply, based on the information available. The remainder lacked adequate data for the reviewers to make any determination and their safety remains unproven. In addition, FDA concluded in their review that at least 26 of the reviewed feed additives do not satisfy even the safety standards set by FDA in 1973.

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Almost Three Times the Risk of Carrying MRSA from Living Near a Mega-Farm

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Pig farms from the air. Image: Maryn McKenna

Pig farms from the air. Image: Maryn McKenna

In the long fight over antibiotic use in agriculture, one of the most contentious points is whether the resistant bacteria that inevitably arise can move off the farm to affect humans. Most of the illnesses that have been associated with farm antibiotic use — resistant foodborne illness, for example — occur so far from farms that opponents of antibiotic control find them easy to dismiss. So whenever a research team can link resistant bacteria found in humans with farms that are close to those humans, it is an important contribution to the debate.

A team from the University of Iowa, Iowa City Veterans Affairs, and Kent State University have done just that. In next month’s Infection Control and Hospital Epidemiology, they survey 1,036 VA patients who lived in rural Iowa and were admitted to the Iowa City facility in 2010 and 2011. Overall, among those patients, 6.8 percent were carrying MRSA, drug-resistant staph, in their nostrils. But the patients’ likelihood of carrying MRSA was 2.76 times higher if they lived within one mile of a farm housing 2,500 or more pigs.
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Former New York Times Editor, Wife Publicly Tag-Team Criticism of Cancer Patient. Ugh.

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image; Rebecca Barray (CC), Flickr

Back in 2011, I was researching a story about the under-appreciated toll of foodborne illness. Through social media, I met Lisa Bonchek Adams, a mom of three in Connecticut who had suffered an extended, bad bout with antibiotic-resistant Campylobacter. She was a great interview — thoughtful, funny, frank — and she had an extraordinary story: She was a survivor of breast cancer and aggressive treatment for it — double mastectomy, preventative removal of her ovaries and chemotherapy — but, she said candidly, foodborne illness had made her sicker than her cancer treatment ever did.

After confirming her story via physicians and factcheckers, I used it as the opening of a long investigative piece that was published in June 2012. After that, we stayed in touch on Facebook and Twitter, and I watched as her already substantial following expanded, responding to that same forthright voice that I had found so compelling. Within a few months, though, her fortunes changed — and subsequently, so did her online circle. In October 2012, Adams learned that her cancer had returned and metastasized elsewhere in her body. It was judged Stage IV, incurable. She wrote:

I am at the beginning of what treatments are available for me.

Don’t you count me out yet. Far from it.

Just because this disease can’t be cured doesn’t mean there isn’t a lot of life left in me; there is still so much for me to do.

In the 2 years since, I’ve watched in admiration as Adams has spoken directly and realistically about her treatments, family relationships, symptoms, hopes and fears. She is uniquely not a treat-at-all-costs cancer warrior, not a Pinktober booster, not a believer in miracle cures. Carefully and patiently, even when in pain (she has been in the hospital since Christmas for pain management), she commiserates with other patients and their families, urges people via her #mondaypleads hashtag to get regular checkups, and starts every day on Twitter with this mantra: “Find a bit of beauty in the world today. Share it. If you can’t find it, create it. Some days this may be hard to do. Persevere.”

So you’ll understand why I, and numerous other bloggers and tweeters, object to two first-person essays about Adams, published over the past few days by a New York Times editor and his wife, and consider them gratuitous, mean-spirited attacks. (A sample of reaction: Xeni Jardin, on Twitter (Storified); Megan Garber, The Atlantic; Greg Mitchell, The Nation; Cecily Kellogg, Babble; Adam Weinstein on Gawker.)

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Can Antibiotics User Fees Force Down Drug Mis-Use and Overuse?

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image: NeilT (CC), Flickr

Happy new year, constant readers. Here’s the most urgent thing I have to say today: Stop reading and go set your DVRs for 8pm ET tonight. The fantastic The Poisoner’s Handbook, written by Wired colleague and dear friend Deborah Blum, has been adapted by PBS and airs tonight on The American Experience. It’s going to be superb.

Back? OK, on to business. Just before the holidays, the Food and Drug Administration finalized its long-aborning plan to ask the meat-production industry to reduce its use of routinely administered antibiotics. (My posts on the move here and here.) The FDA’s guidance to industry, as it is called, is not a regulation but rather a request for voluntary action on the part of veterinary-drug companies. It has met with skepticism and concerns that manufacturers will redefine the uses of their drugs in such a way that nothing will change.

The FDA action is aimed at the routine use of antibiotics for what is called growth promotion — causing animals to gain muscle faster than they would without the drugs being used — and is modeled on a ban on growth promoters enacted by the European Union in 2005. The goal, as in the EU, is to reduce the drugs’ use, and therefore the antibiotic-resistant bacteria that use stimulates.

In a recent New England Journal of Medicine, University of Calgary economist Aidan Hollis suggests though that a ban may not be the most useful or practical approach to the problem of drug overuse. In its place, he suggests the pocketbook persuasion of having to pay a fee.

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