Pharma to farms, cultivating the germs that won’t die

In 1982, my father, the late toxicologist and medical ethicist Dr. Marc Lappé, published “Germs That Won’t Die,” raising the alarm about the overuse of antibiotics and the rise of antibiotic-resistant bacteria. He would have no idea that nearly four decades later, the crisis has only gotten worse. Two million people are now infected every year with bacteria that are resistant to antibiotics, and at least 23,000 people die annually as a direct result of these infections, according to the Centers for Disease Control. Today as many people die in the United States from the drug-resistant bacterium MRSA as from complications from HIV/AIDS.

At a time of rising concern among public-health officials about an epidemic of antibiotic-resistant bacteria, the Food and Drug Administration released a new policy on Dec. 11, restricting the use of antibiotics in industrial livestock operations, also known as factory farms. The policy asks drug companies to phase out, over three years, the use of antibiotics on factory farms to “enhance growth or improve feed efficiency.” The drugs can still be used to prevent and treat disease. Some observers call the policy, Guidance for Industry #213, a step in the right direction. It is certainly the first to address the abuse of antibiotics in factory farms, but it does not go nearly far enough. 

For decades, livestock operators have been administering antibiotics through animals’ feed and water, often as a way to enhance growth. In fact, an estimated 80 percent of all antibiotics used in the U.S. are being used not to protect human health but to promote growth or prevent disease in cramped and inhumane factory farms. And we know — indeed, we have known for a long time — that this medically unnecessary use of antibiotics creates the perfect environment for drug-resistant bacteria to thrive. This constant, low-level use of antibiotics has spurred an increase in antibiotic-resistant bacteria, with serious public-health implications.

As far back as the 1970s, government officials have been concerned about antibiotic abuse on factory farms. And in 1977, the FDA first proposed putting limits on the use of antibiotics for growth promotion. Those restrictions never passed.

Now we know the consequences. A recent and alarming report from the CDC states, “Because of the link between antibiotic use in food-producing animals and the occurrence of antibiotic-resistant infections in humans, antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases, not to promote growth.” Other countries have taken note. As journalist Maryn McKenna, who is an expert on superbugs, has noted, European countries, understanding these risks, barred the use of growth-promoting antibiotics back in 2006.

So it is with no small bit of anticipation that those of us following the debate about antibiotic use in livestock production wondered what position the FDA would take. The answer, according to many who have been fighting for more-cautious use of antibiotics, is not much. In response to Guidance for Industry #213, Congresswoman Louise M. Slaughter, the only microbiologist in Congress, summed it up clearly, describing the policy as “an inadequate response to the growing antibiotic-resistant crisis caused by overuse of antibiotics on the farm.”

The new regulation got a positive response from one group, at least: the Animal Health Institute, a trade association for the companies that produce antibiotics. In its statement, the Animal Health Institute said, “Animal health companies have supported this policy since it was announced in 2012 and will continue to work with FDA on its implementation.” Tellingly, as the Natural Resources Defense Council (NRDC) observed, the trade group sent out this statement before the FDA’s public announcement, indicating that the group knew details about the final guidance beforehand.

Agribusiness and pharmaceutical companies have spent millions lobbying against any restrictions on antibiotic use in animal production. The Center for Responsive Politics noted that in just the first three quarters of 2013, the American Farm Bureau, a farm industry trade group, spent more than $3.3 million on lobbying, an effort that partly focused on antibiotics. The Farm Bureau’s lobbying disclosure documents state the group is fighting “an effort both through legislation and regulation to limit the use of animal antibiotics based on emotion and no credible peer reviewed science.” The industry has spent big on lobbying too. This year Merck, a major supplier of antibiotics to the meat industry, spent $6.8 million on lobbying, including on the issue of antibiotics in animal production. Eli Lilly, another big supplier, has shelled out more than $8 million in 2013. 

So what do the advocates who have been calling for government oversight of the pharmaceutical industry’s big business of antibiotics in livestock production think about the FDA’s move? They point to real limitations in this new policy.

First, it is entirely voluntary. That’s right: totally optional. It simply asks drug companies to stop approving the use of drugs for growth promotion on factory farms. The Center for a Livable Future at Johns Hopkins University, which has been a strong supporter of action on antibiotic abuse, wrote in response that the “FDA does not need to rely on voluntary guidelines; it already has the regulatory authority to withdraw approvals to use antibiotics for growth promotion and disease prevention. FDA should use this authority to protect public health by withdrawing all growth promotion and disease prevention approvals.”

Second, the policy focuses on the use of antibiotics for growth promotion and continues to allow use for disease prevention. But as the Center for a Livable Future and others note, many of the same antibiotics are used for both growth promotion and disease prevention. And in both cases, they are administered to livestock in low doses for long periods. So it is entirely possible that a drug company could simply continue business as usual by stating that the drugs now being used for growth promotion will be used for disease prevention. As Avinash Kar at the NRDC wrote, the policy could amount to “a change in label but not in practice.”

Third, many in the advocacy community are concerned that this weak policy and its three-year phaseout of growth-promotion uses of antibiotics could delay more meaningful action, possibly by presenting the public and elected officials with the illusion that real action has been taken.

The Consumers Union’s director of food policy initiatives, Jean Halloran, suggested that it is at least a “good first step down the path towards ending antibiotic overuse in animal agriculture and more than any administration has done in 37 years, but much more needs to be done to address disease prevention, track and report on antibiotic use.”

A decade after my father published “Germs That Won’t Die,” he wrote a follow-up book, “When Antibiotics Fail.” Having been among the first in the medical profession to sound the alarm about the consequences of antibiotic resistance, he made it clear, yet again, that we fail to stop the abuse of antibiotics at our own peril. It is now more than 30 years since my father published his first book on antibiotics and over 35 years since the FDA first proposed restricting antibiotic abuse on factory farms — and the problem has only gotten worse. The difference is that today we can no longer plead ignorance. We know the consequences of bowing to the lobbying power of big pharma. We pay with our health; we pay with our lives.