FDA Crackdown on Antibiotics Relies on Unproven Steps

A delegation of public-health advocates filed into the suburban Chicago headquarters of McDonald (MCD)’s Corp. last January to deliver a tough message: A decade after the fast-food giant’s groundbreaking promise to reduce medically important antibiotics fed to the animals it buys, the policy had glaring loopholes and questionable impact.

Many farmers and food companies were using antibiotics not for their medicinal properties, but because they also make animals grow faster or become heavier. The company’s plan was supposed to address concerns that persistent use of such drugs on animals might increase the resistance of dangerous microbes to antibiotics. Such bugs could then be transmitted to humans who ate the meat. But the McDonald’s policy was easy to sidestep, the health advocates told company officials: Livestock producers or farmers could continue to give millions of healthy animals antibiotics for the purpose of preventing disease -- an exception the company’s program allowed.

“It’s time for McDonald’s to update their policy,” Steven Roach of the Keep Antibiotics Working coalition recalls telling company officials, Bloomberg Businessweek reports in its Jan. 6 issue.

So far, McDonald’s hasn’t announced any major changes to its animal antibiotics rules, but a much more important player in the food world has: the U.S. Food and Drug Administration. The agency in December announced its own industry guidance to combat the growing use of antibiotics in farm animals, and its plan strongly resembles the 2003 McDonald’s program.

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Photographer: David Paul Morris/Bloomberg

McDonald's Corp. chicken selects, a MCafe coffee and strawberry banana fruit smoothie are arranged for a photograph in San Francisco.

Speeding Growth

Both prohibit the drugs from being used to speed animals’ growth and call for veterinarians to oversee the dispensing of antibiotics for approved uses, such as disease prevention and treatment. And both would allow livestock raisers to continue giving antibiotics to healthy animals. That has critics worrying that the FDA’s new guidance will suffer from the same weaknesses as the restaurant company’s pledge.

“We are going to be able to continue the same practices and call them something different,” says Sasha Lyutse, a policy analyst at the Natural Resources Defense Council. “These routine prevention uses are where the rubber hits the road. Unless you close those loopholes, you are not going to see any material changes in practices.”

Several animal pharmaceutical companies say that they don’t anticipate much fallout from the FDA guidelines and that the volume of antibiotics affected will be relatively small. “Will it have an impact? Yes. It’s not a material or significant impact,” says Michael McCarty, a spokesman for Elanco, the animal health division of Eli Lilly (LLY) & Co.

Facing Skeptics

The FDA defends its approach, which urges pharmaceutical companies to voluntarily stop marketing the drugs’ ability to promote growth on labels and to require veterinary prescriptions.

“I don’t begrudge people who are skeptical,” says Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, citing decades of debate and inaction on the issue. Still, he says the agency’s efforts will get results. “We are going from a few companies doing things voluntarily to fundamentally shifting public policy so there will be fewer approved uses and much tighter control over the uses that remain.”

McDonald’s declined to discuss the effects of its antibiotics policy. Becca Hary, a McDonald’s spokeswoman, said in an e-mail, “We will continue to look to physicians, suppliers, animal welfare experts, veterinarians, and engage with various stakeholders on this topic. We also look to the FDA for guidance as this conversation evolves, and we will review our policy as necessary to remain consistent with available scientific information.”

Antibiotic Era

The antibiotic era in animal agriculture began in 1946, when researchers from the University of Wisconsin noted that chickens fed an antibiotic grew faster. Scientists still can’t agree why that happens. From 1960 to 1970, the use of antibiotics in animal feeds increased sixfold, according to the predecessor of today’s U.S. Government Accountability Office. In 1972 a task force for the FDA warned that feeding animals low doses of antibiotics could incubate antibiotic-resistant bacteria in their bodies -- and that the microbes could be passed along to humans.

During the next four decades, the livestock and pharmaceutical industries successfully opposed most efforts to regulate antibiotics in farm animals, arguing that little correlation could be drawn between antibiotics used in agriculture and resistant infections in humans.

23,000 Deaths

Experts from the World Health Organization and the U.S. Centers for Disease Control and Prevention say that routine feeding of antibiotics to healthy animals plays at least some unquantified role in causing resistant infections in humans. Two million people each year in the U.S. contract an antibiotic-resistant infection, and 23,000 of them die, according to the CDC.

Hard data on antibiotic use in livestock is scarce, but the numbers that are available, though imprecise, suggest the sales are going up. The Johns Hopkins Center for a Livable Future estimates that antibiotics in livestock account for 80 percent of all such drugs sold. The FDA and animal-pharmaceutical industry groups disagree with that figure but can’t provide a better one. The FDA, which only recently began compiling sales data for antimicrobials, which include antibiotics, found that U.S. sales of food-animal antimicrobials climbed 4 percent from 2009 to 2011, to 29.9 million pounds.

Human Infections

Sales to livestock and poultry producers of tetracyclines, a class of antibiotics important for treating infections in humans, grew 22 percent during that period. At the same time, annual American production of cattle and swine remained unchanged, at about 72 billion pounds, and poultry production rose 4 percent, according to the U.S. Department of Agriculture.

The Animal Health Institute, which represents animal pharmaceutical companies, tracked sales data prior to the FDA’s data gathering efforts, reporting antibiotics sales of 17.8 million pounds in 1998, 23.7 million pounds in 2000, and 27.8 million pounds in 2007. The institute now disavows its 1998 numbers, which were reported in academic papers, saying they can’t locate data prior to 2000.

Regardless of the numbers, the issue has resonated with many consumers. In 2003, McDonald’s vowed to lean on suppliers to reduce the amount of antibiotics fed to their animals. The company would require most of its chicken suppliers to eliminate antibiotics used for growth promotion and give preference to pork and beef suppliers that did the same. While McDonald’s requires its vendors to keep track of antibiotic use, the company declined to disclose that data.

‘High Standards’

Several McDonald’s competitors, including Burger King Worldwide Inc. and Yum! Brands (YUM) Inc., operator of the Taco Bell and KFC chains, established similar policies. “We have very high standards and strict guidelines for our suppliers, and they must comply with all relevant FDA and USDA regulations,” says Virginia Ferguson, a Yum! Brands spokeswoman who wouldn’t comment on the impact of the company’s antibiotics policy. Burger King didn’t respond to inquiries about its program.

Smithfield Foods, the nation’s largest hog producer, also vowed in 2002 to prohibit use of medically important antibiotics solely for growth promotion. Yet in 2013 its use of the drugs per pound of pork produced reached a four-year high, according to data the company publishes. Smithfield, which was acquired in September by China’s largest pork producer, Shuanghui International Holdings, is “refreshing” its antibiotics policy and says its usage varies each year based on weather, illnesses, and other factors, says spokeswoman Keira Lombardo.

Hatching Dispute

Tyson Foods (TSN) announced in 2007 that it would sell fresh chicken from birds raised without using antibiotics. The pledge was backed with a marketing campaign featuring the tag line “Chicken your family deserves, raised without antibiotics.” But U.S. regulators withdrew their approval for the claim a few months later because Tyson continued to list ionophores, classified as an antibiotic by the FDA, as a feed ingredient. The company disputed that ionophores were antibiotics and noted that they weren’t used in human medicine anyway.

Meanwhile, Tyson was also injecting eggs with a vaccine that contained an antibiotic. The company argued that this didn’t count, because “raised without antibiotics” didn’t include the days before a chick hatches. “Our ‘raised without antibiotics’ initiative, which was suspended in 2008, was ahead of its time,” says Gary Mickelson, a Tyson spokesman, who blamed government confusion over labeling requirements for the flap. “It essentially provided what FDA is requesting today.”

Representative Louise Slaughter, a Democrat from New York, has introduced legislation that would prohibit the use of antibiotics in livestock, except to treat sick animals. Slaughter says the FDA’s voluntary guidance has no enforcement mechanism and no way to keep tabs on progress. “It’s based on hope,” she says. “And we don’t have any evidence to support that wish.”

To contact the reporters on this story: Ben Elgin in San Francisco at belgin@bloomberg.net; Andrew Martin in New York at amartin146@bloomberg.net

To contact the editor responsible for this story: Flynn McRoberts at fmcroberts1@bloomberg.net

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