Wagging the Dog: FDA Restricts Certain Antibiotics In Animals

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Photo by Tech109/Flickr

In the waning days of 2011, the Food and Drug Administration (“FDA”) posted a notice in the Federal Register announcing its withdrawal of a 34 year attempt to regulate routine uses of penicillin and tetracycline in animal feed. Tom Philpott over at MotherJones called out the agency for having “snuck a holiday gift to the meat industry.”

Sometime in the 1940′s, the meat industry discovered that it can add drugs to water and animal feed to boost growth and counter the ill effects of overcrowding and poor sanitation, otherwise known as animal abuse. Today, factory animals are drugged to the tune of 28.8 million pounds of antibiotics a year or nearly 80% of all antibiotics sold in United States.  All of this is done without a prescription.

But the concern of overuse of antibiotics in farm animals, which the agency has publicly wrestled with since 1970′s without much success, has continued to intensify as antibiotic resistant illnesses became more prevalent. Despite loud noises to the contrary from the meat industry, a “definitive” link between the uses of antibiotics in food animal production and the crisis of antibiotic resistance in humans has long been established. “[M]any medical organizations including the American Medical Association, the American Academy of Pediatrics and the World Health Organization warn that this practice is putting human health at risk,” noted The Pew Campaign on Human Health and Industrial Farming.  And on its consumer information page, the FDA admits that antibiotic resistance is a serious problem worldwide:

Today, almost all important bacterial infections in the United States and throughout the world are becoming resistant to antibiotics. Antibiotic resistance has been called one of the world’s most pressing public health problems.

Last July, Joshua M. Sharfstein, M.D., the Principal Deputy Commissioner Food and Drug Administration at the Department of Health and Human Services, testified before the Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives that “[a]bout two million people acquire bacterial infections in U.S. hospitals each year, and 90,000 die as a result.  About 70 percent of those infections are resistant to at least one drug.”

In its withdrawal notice, the FDA did say that it remains concerned about the issue of antimicrobial resistance and that its “action should not be interpreted as a sign that FDA no longer has safety concerns.”

But don’t look at the FDA’s recent decision to restrict cephalosporin to be a demonstration of that concern.

On January 4, 2012, the FDA issued an order (“Order”) prohibiting certain extralabel, or unapproved uses of the cephalosporin class of antimicrobial drugs (e.g., Cefzil and Keflex) in cattle, swine, chickens and turkeys effective April 5, 2012. These antibiotics are commonly used in humans to treat pneumonia as well as skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections. The New York Times reports that “surgeons also often use them before surgery, and they are particularly popular among pediatricians.” In a mellow sounding press release the agency informed us that “[i]f cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects.”

When the FDA figures for antibiotic use are analyzed, however, it is evident that the agency’s move to prohibit the cephalosporin class of antibiotics is little more than window dressing. Tom Philpott reported that:

the industry’s already-modest use of cephalosporin plunged 41 percent between 2009 and 2010. Meanwhile, overall antibiotic use held steady (rising 1 percent), tetracycline use jumped 21 percent, and consumption of penicillin — another important human-health medicine you may have heard of — soared 43 percent to 1.9 million pound.

In other words, the very same antibiotics for which the FDA quietly decided to forgo regulating, tetracycline and penicillin, are the ones whose use has skyrocketed.

Mark Bittman, the New York Times food opinionator, called the agency’s decision  “a pathetic, token, and infuriating effort” and added:

To recap, the F.D.A. will partially ban a disappearing family of antibiotics that is relatively non-existent in animal agriculture and that the meat industry does not rely upon. Not exactly a bold move. Kind of like protecting less than 1 percent of the acreage in the rainforest or 1 percent of the fish in the sea while allowing producers to devastate the rest, and patting yourself on the back to boot.

That’s score 1 for industry and 0 for the rest of us. But who is keeping score when the agency spent the last three and a half decades sitting on the fence. And last year’s soft-handed, industry friendly draft guidance, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, further underscores the agency’s commitment to speak softly and carry no stick on this issue. Not only did the guidance lack explicit prohibitions on the routine use of antibiotics in healthy farm animals, it was only and merely a “recommendation” and not a a regulation with the force of law. And to add insult to injury, to this day, the draft guidance remains just that, a draft.

Michael R. Taylor, the Deputy Commissioner for Foods at the FDA, a controversial figure whose ties to Monsanto are rarely forgotten, had this to say about the FDA’s recent cephalosporin restrictions , “[w]e believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals.” Others, however, would argue that the FDA has to take many more steps before it reaches the realistic level of protection that is needed to preserve the effectiveness of antibiotics.