FDA Archives - Page 2 of 4 - Maryn McKenna

Getting More Farm Antibiotics Data: What Will It Take?

March 5, 2013 By Maryn Leave a Comment

Sorry for the radio silence, constant readers: I’m preparing for the big annual conference of the Association of Health Care Journalists, where I am on the board, and the tasks are piling up. Here’s one of the things that happened last week, while I was off getting ready: The Senate committee charged with oversight of agricultural antibiotic use took up re-authorization of the regulation that delivers data on ag drugs, without allowing any testimony about the negative, unintended consequences of misusing and overusing those drugs.

Fortunately, the House of Representatives provided a partial corrective: Members there introduced a bill that would require better data collection. Unfortunately, that bill is a long way from law — and the re-approval of the FDA regulation is close.

"Sh*t, Just Ship It": Felony Prosecution for Salmonella-Peanut Executives

February 24, 2013 By Maryn Leave a Comment

A pretty extraordinary thing happened Thursday, here in Georgia: A district court in the middle part of the state unsealed a 76-count, 52-page indictment of former officials of the Peanut Corporation of America (PCA), charging them with fraud and conspiracy for knowingly distributing peanut products contaminated with Salmonella.

The 2009 outbreak caused by the contaminated peanuts reached, literally, nationwide. Hundreds of products were recalled; 714 people were known to have been made sick by it in 46 states, one-fourth of them were hospitalized, and nine died, according to the Centers for Disease Control and Prevention. (As with other foodborne outbreaks, in which only a fraction of cases are confirmed by lab analysis, the actual number of victims may be much larger.) While that is not the largest outbreak recorded in the United States — the Salmonella in eggs scandal of 2010 sickened almost 2,000 people — it is definitely large: Most of the multi-state foodborne outbreaks analyzed by the CDC involve fewer than 100 known victims.

The PCA outbreak’s size makes it unusual, but so does the decision to press for prosecution: That happens in very few foodborne-illness cases. But if you read the indictment (which I extracted from the federal PACER system and put up at my Scribd account), you’ll see why the Department of Justice decided to prosecute this time. It alleges a trail of not only negligence — unrepaired roof leaks, ignored rodent infestations — but also deliberate deception which ranged from faked origin labeling to falsified lab results.

Antibiotics and Antibiotic-Resistant Bacteria in Meat: Not Getting Better

February 9, 2013 By Maryn Leave a Comment

A few days ago, the Food and Drug Administration released two important documents related to antibiotic use in livestock raising, and what the results of that antibiotic use are. I’d say that they released them quietly, except, when it comes to this issue, every release seems to be quiet, never accompanied by the press releases or briefings that other divisions of the FDA use to publicize their news.

The two documents are the 2011 Retail Meat Report from the National Antimicrobial Resistance Monitoring System, or NARMS, and the 2011 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, which is known for short as ADUFA, after the 2008 Animal Drug User Fee Act that mandated the data be collected.

These two reports capture almost all the data we receive from the federal government about antibiotic use in livestock production (which is not the same thing as “all the data the federal government possesses” — there is evidence they receive more than they release). So their annual release is an important indicator for whether antibiotic use in meat production, and antibiotic resistance in meat, are trending up or down.

The news does not appear to be good.

2012 In The Rear-View Mirror: What You Liked

January 1, 2013 By Maryn Leave a Comment

Happy New Year, constant readers. For the second year in a row, here’s my list of which of my posts (91 in 2012!) most moved you to react. Last year (find that list here), I counted down based on which posts provoked the most comments. This year, Wired installed a tweet-counter — which registers only if someone clicks through from Twitter, but not if the post’s URL is mentioned or RT’d — so I thought it would be amusing to score posts that way this year.

And the verdict is: You care enormously about food policy, but you continue to be fascinated by the emergence of scary diseases — and, to my surprise and pleasure, you care about public understanding of science as well.

One Family's Journey From Foodborne-Illness Victim to "Food Patriots"

December 19, 2012 By Maryn Leave a Comment

A quick post today, because I have deadlines, and because this Kickstarter closes tomorrow and you should take a look at it while you can.

In February of 2006, when he was 16 years old, Sam Spitz went out for lunch with his high school pals. They were athletes, and looking for a big meal, so they went to a pizza-pasta place. Sam, though, had an inkling of healthy eating from his mother, Jennifer Amdur Spitz, who liked to shop at farmers’ markets. He chose a chicken Caesar salad instead.

By the end of the school day, it seemed like a bad choice. He developed diarrhea so severe that Jennifer and his dad, Jeff Spitz, had to tape an adult diaper on him to get him to the emergency room. The ER staff assumed it was a foodborne illness, took a culture, and sent them home with a broad-spectrum antibiotic.

It had no effect. It took weeks, along with visits to specialists and more tests and more drugs and eventually a colonoscopy, before the family discovered that what had felled the strapping young athlete was an antibiotic-resistant foodborne illness: Campylobacter, a bug that frequently travels on chicken.

Sam Spitz was seriously sick for a month and recovering for many more. He was a pitcher, but missed his entire baseball season, along with the chance to be inspected by college recruiters. He was still on restricted activity when the football recruiters came around the following fall. He eventually recovered (and played football for University of Wisconsin) — but his family’s attitude toward food and food safety was forever changed.

The Spitzes, who are award-winning filmmakers, have documented their journey to a better understanding of our food system in a new film that they are now polishing, called “Food Patriots.” In it, they talk not only about their own dawning understanding of how our food is produced, but also about many other people who are trying to get food grown and distributed in a healthier, more equitable way.

“We were really insulated, as a family, from knowing where our food comes from, and from having the awareness that allows you to make healthy choices,” Jennifer told me. “But this film has a much bigger footprint than just our journey. We’re in it to provide a narrative, and some humor — but what we do is look at people who are inspiring us to think about, buy and eat food differently.”

The Spitzes are in their last 24 hours on their Kickstarter. They have made their initial goal, which was to fund post-production — but in the last day, they’ve been offered a match by a major donor. Anything they receive today will be doubled by the donor, and those funds will be spent getting the film out to communities for screenings.

Jennifer described the film to me as “zero-depth” — like the kind of public pool where you can stand at the end with just your toes wet, and move deeper at your own pace. “There have been a lot of scary, hit-you-over-the-head food films already, and people have already responded to that approach,” she said. “We don’t preach. We want to get people into conversation.”

Take a look.

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Footnote: If antibiotic-resistant Campylobacter sounds at all familiar, it may be because I wrote about it in my two-year investigation of foodborne illness for SELF Magazine last summer. Here’s that story and my post about it.

Flickr/mollyeh11/CC

The FDA Is Holding Back Data on Farm Antibiotics Use — And Plans to Keep Doing So

December 17, 2012 By Maryn Leave a Comment

Tomorrow morning, the US Food and Drug Administration will consider whether to accept reauthorization of legislation that allows us to know a few details about how many antibiotics are sold each year for agricultural use.

The agency probably will accept the reauthorization, and you would think that would be a good thing. But the untold story of the legislation — known as ADUFA for the Animal Drug User Fee Act — is that the FDA is forgoing opportunities to compel companies to disclose data that it would be in the public’s interest to know.

Antiseptics Used to Prevent Health Care Infections Might Cause Them. Oops.

December 7, 2012 By Maryn Leave a Comment

Well, this is ironic. The Food and Drug Administration is warning the country of the possibility of health care infections caused by the antiseptics used to disinfect skin before health care procedures — that is, to prevent infections. They consider it a serious enough problem that they have scheduled a hearing about it next week.

Advice for the Annual Observance of Food-Poisoning, Umm, Thanksgiving Day

November 20, 2012 By Maryn Leave a Comment

My grandparents — children of Irish and Scottish immigrants, for whom calories per penny was a much more important food value than fine cuisine — had a little mnemonic for Thanksgiving. It went like this:

Turkey, tetrazzini, ptomaine.

Perhaps that requires a little explanation.

The turkey part should be self-evident. Tetrazzini — a cream-sauce casserole based on spaghetti, one of those early 20th-century dishes invented to honor Italian opera stars — was what they did the second day with the turkey leftovers. Ptomaine (the “p” is silent) was what they worried lay in wait for them on the third. A late 19th-century term that has passed out of use, it derived from the notion that poisonous compounds lurked in rotting food.

For people who grew up before the antibiotic era — and who learned to cook when refrigerators were literal ice chests that kept things cool at best — “food poisoning” was a reasonable fear, and a risk they refused to take. On the Saturday after Thanksgiving, no matter how delicious it appeared, whatever remained of the turkey went into the trash.

People Want to Eat Meat Raised Without Excessive Antibiotics. Wouldn't You?

June 20, 2012 By Maryn Leave a Comment

This news is going to be everywhere today, but it’s solidly in the topics I care about (and you readers care about — at least I think you do), so I’m going to cover it regardless.

The magazine Consumer Reports is publishing a report and poll on US consumers’ attitudes toward the overuse of antibiotics in agriculture. From everyone’s reactions when I write about this, I thought people cared about this issue, but the numbers are a little surprising even to me: 86 percent of shoppers in a nationally representative sample of 1,000 adults said they wanted meat raised without antibiotics to be available in their local supermarkets. [Read more…]

The Superbugs In Your Dinner: A Storify

June 7, 2012 By Maryn Leave a Comment

As I said Wednesday would happen, I participated in a Twitterchat today about antibiotic-resistant foodborne illnesses arising as a result of agricultural antibiotic use. This is the subject of my investigative piece in the June issue of SELF Magazine. Chat participants were me and blogger and cancer survivor Lisa Bonchek Adams, with many constant readers checking in. And because I’m sure you were all busy, but I want you to know what we talked about, I made a Storify for you. You’re welcome.

The Superbugs in Your Dinner (Bonus: Twitterchat!)

June 6, 2012 By Maryn Leave a Comment

I have a new story up at SELF Magazine, where I’m privileged to do a long and often investigative piece about once a year. This one is close to my heart: It took two years to complete, and in that time I conducted 37 interviews and reviewed several hundred scientific papers.

Here’s what it says: The misuse of antibiotics in agriculture, particularly in livestock-raising, is creating antibiotic-resistant foodborne illnesses that are taking victims and their doctors by surprise.

We talk pretty often here about drug-resistant bacteria arising as a result of farm antibiotic use, and moving off the farm in a variety of ways. There is a lot of dispute, of course, about whether farm-caused antibiotic resistance has much effect on human health, or whether the various resistant illnesses that people contract arise instead from antibiotic misuse in daily life or in hospitals and health care.

But in this case, the illnesses are being caused specifically by classic foodborne bugs that have become resistant and are making people sick when the food is handled or eaten. The evidence is not 100 percent — no evidence ever is — but to me, these illnesses demonstrate the most direct link yet between antibiotic use on farms, and human illness far away from farm areas.

Court Scolds FDA Over Ag Antibiotic Use

June 5, 2012 By Maryn Leave a Comment

There’s been another development in the continuing court battle to get the US Food and Drug Administration to exert some control over agricultural use of growth-promoter antibiotics — and it arrives accompanied by some remarkably direct language from the US magistrate judge hearing the case.

In a Memorandum of Opinion and Order that was filed last Friday afternoon — which I extracted from the PACER system and stashed in my Scribd account — Judge Theodore Katz addresses the FDA’s denial of two citizens’ petitions regarding ag antibiotic use. I’ll explain the details below, but here is the key language:

… the Court finds the Agency’s denial of the Petitions to be arbitrary and capricious. For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread sub-therapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks.

Whew. OK, the details:

More On Court Ordering FDA Hearings on Farm Antibiotics

March 23, 2012 By Maryn Leave a Comment

Since I posted last night on the judge’s order that the Food and Drug Administration examine the safety of farm antibiotics — via hearings that the Food and Drug Administration scheduled, but never held, back in 1977 — a lot has happened. Here’s a round-up.

The Natural Resources Defense Council, lead plaintiffs in the suit (with the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists) has put up a press release/explainer, accompanied by a blog post written by ~~lead~~ attorney Avinash Kar. (Correction: The lead attorney is Jen Sorenson.) Key quote from Kar:

The judge’s opinion makes it clear that FDA’s voluntary approach—letting the industry police itself—does not satisfy its legal obligations. FDA must schedule hearings to let drug manufacturers make their case, and if the drug manufacturers cannot prove that the use of antibiotics in animal feed is safe, FDA must withdraw approval for those drug uses.

Kar’s comment to me: “We think this is a great step forward for public health. For 35 years, FDA has basically sat on the sidelines, mostly letting the industry police itself. In that time we have seen a massive rise in the occurrence of antibiotic-resistant bacteria. This means we now will ensure that we preserve these lifesaving medicines for those who need them most.”

I asked the press office this morning at the Center for Veterinary Medicine, the FDA division named in the order, if the agency has a response yet. They said: “We are studying the opinion and considering appropriate next steps.”

Breaking News: Judge Orders FDA to Examine Safety of Ag Drugs

March 22, 2012 By Maryn Leave a Comment

Here’s breaking news that I’ve learned about. The significance is going to unfold over the next 24 hours and more, and when it does, I will update. (Update: Overnight, a lot came out about this, so I’ve wrapped it all into a new post here.)

Here are the basics:

A district judge in New York has ruled in favor of a coalition that sued the Food and Drug Administration in order to compel the agency to follow through on its 35-year-old attempt to exert control over antibiotics in animal feed known as “growth promoters” — tiny doses of antibiotics delivered in feed and water that are believed to stimulate the evolution of antibiotic-resistant organisms.

Technically, Magistrate Judge Theodore H. Katz has granted the groups’ motion for summary judgement, and denied the FDA’s request that the suit be dismissed.

The decision, filed this afternoon, does not compel the FDA to ban growth-promoter (or “feed efficiency”) use of antibiotics. What it does appear to do, though, is require the FDA to follow through on a process that it began in 1977, when the agency was so concerned over the safety of using penicillin and tetracycline drugs in livestock feed that it called hearings to examine withdrawing its approval of using the drugs in animals.

Because of pressure, largely from certain Congressmen, those hearings were never held.

High Levels of Resistant Bacteria on Meat (Again)

March 3, 2012 By Maryn Leave a Comment

A new report is out from the federal collaboration that monitors antibiotic resistance in animals, retail meat and people, and the news is not good.

The full title is the 2010 Retail Meat Report from the National Antimicrobial Resistance Monitoring System. This report is issued by the Food and Drug Administration; the humans one comes from the Centers for Disease Control and Prevention and the animals one from the US Department of Agriculture. It reports the results of testing on 5,280 meat samples collected in 2010 in California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, Tennessee, and Pennsylvania. (Those are sites of state labs participating in a federal surveillance network, FoodNet, plus one volunteer lab, Maryland.)

The report — which is broken down first by foodborne organism and then by meat type — notes a number of instances where either the percentage of bacteria that are antibiotic resistant, or the complexity of the resistance, is rising. Quoting from the report:

Also Receiving Antibiotics on Factory Farms: Shrimp

February 24, 2012 By Maryn Leave a Comment

Tom Philpott of Mother Jones had a great post earlier this week looking at the vast environmental damage caused by shrimp farming in South and Southeast Asia. He takes off from a presentation at the annual meeting of the American Association for the Advancement of Science by J. Boone Kauffman of Oregon State University, which examined the destruction of coastal mangrove forests that allows shrimp farms to be established and found that shrimp’s carbon footprint is 10 times higher than that of beef cattle. Tom says:

More News: FDA Curbs One Class of Farm Drugs

January 4, 2012 By Maryn Leave a Comment

Here’s a bookend to the Food and Drug Administration’s disappointing Christmas Eve notice that it will cease trying to regulate the largest classes of growth-promoter antibiotics. Today, the agency announced that it is forbidding certain uses of a different class of drugs, cephalosporins.

To those who are concerned about antibiotic overuse in agriculture, though, this is good news — though it may be more good news-bad news-bad news-good news.

The dialectic looks like this:

FDA Documents Show Agency Once Strongly Opposed Farm Antibiotic Overuse

December 29, 2011 By Maryn Leave a Comment

The use of antibiotics and sulfonamide drugs, especially in growth promotant and subtherapeutic amounts, favors the selection and development of single and multiple antibiotic-resistant and R-plasmid-bearing bacteria.

Animals that have received either subtherapeutic and/or therapeutic amounts of antibiotic and sulfonamide drugs in feeds may serve as a reservoir of antibiotic resistant pathogens and non-pathogens. These reservoirs of pathogens can produce human infections.

The prevalence of multi-resistant R-plasmid-bearing pathogenic and nonpathogenic bacteria in animals has increased and has been related to the use of antibiotics and sulfonamide drugs.

Organisms resistant to antibacterial agents have been found on meat and meat products.

If you give the text above a close read, you might think it was written by Mark Bittman or Tom Philpott or Tom Laskawy, or me — or any of the small number of journalists who focus on the safety and policy perils of giving scarce antibiotics to confinement-raised farm animals. After all, what it says is what any of us would say: Routine administration of antibiotics to livestock spurs the emergence of drug-resistant bacteria that move through the food chain, threaten human health, and lend their DNA to yet other bacteria, increasing the reservoir of resistance in a dangerous and untracked manner.

As it happens, though, the text above wasn’t written by any of us. It was written by the Food and Drug Administration, the FDA.

Yes, the FDA — the federal agency that, as I wrote last Friday, has just backed off a 34-year attempt to assert regulatory control over “growth promoter” antibiotic use, opting instead for voluntary self-policing by the agricultural and pharmaceutical industries.

News: FDA Won't Act Against Ag Antibiotic Use

December 23, 2011 By Maryn Leave a Comment

With no notice other than a holiday-eve posting in the Federal Register, the US Food and Drug Administration has reneged on its long-stated intention to compel large-scale agriculture to curb over-use of agricultural antibiotics, which it had planned to do by reversing its approval for putting penicillin and tetracyclines in feed.

How long-stated? The FDA first announced its intention to withdraw those approvals in 1977.

From the official posting:

The Food and Drug Administration (FDA or the Agency) is withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns.¹ … (¹FDA’s approval to withdraw the approved uses of the drugs was based on three statutory grounds: (1) The drugs are not shown to be safe (21 U.S.C. 360b(e)(1)(B)); (2) lack of substantial evidence of effectiveness (21 U.S.C. 360b(e)(1)(C)); and (3) failure to submit required reports (21 U.S.C. 360b(e)(2)(A)).)

There is a lot of background to this, but here is the takeaway: For 34 years, the FDA has been contending that administering small doses of antibiotics to healthy animals is an inappropriate use of increasingly scarce drugs — a position in which it is supported by organizations as mainstream as the American Medical Association. With this withdrawal, it backs away from the actions it took to support that assertion — which may indicate there will be no further government action on the issue until after the 2012 election.

Fecal Transplants: They Work, the Regulations Don't

December 9, 2011 By Maryn Leave a Comment

Lara Thompson was 26 when her life fell apart.

She was living in Rhode Island and working in HIV prevention research when she unexpectedly developed nausea and diarrhea. It was early 2008, a few weeks after New Year’s, and she thought she might have picked up a stomach virus at a holiday gathering, or stressed her system with overindulgence. She expected the symptoms would pass after a few days. They didn’t.

“In three weeks, I dropped 15-20 pounds,” she says now. “I couldn’t keep anything in; I would have to run to the bathroom at a moment’s notice. I was so lethargic I had to stay home from work.”

When she consulted her doctor, she found out what was bothering her was more complex than a virus. Somehow, her intestinal lining had become infected with Clostridium difficile, or C. diff, a tough and persistent bacterium that has been rising in incidence and gaining antibiotic resistance, becoming increasingly difficult to treat.