Why FDA Action Won't Stem Antibiotic Resistance

Two events last year inched the United States closer to reducing the overuse of antibiotics in food animal production. But many worry that we need to do more to prevent a post-antibiotic era.

First, the Centers for Diseases Control and Prevention (CDC) released a report in September on drug-resistant health threats. The good news, if there can be any, is that the CDC is (finally!) lining up with mainstream scientists who identify antibiotic resistance on animal farms — CAFOs really — as a grave problem (even if, unlike CDC, other scientists are more urgent in their description of the problem). The CDC report notes that “[t]he use of antibiotics for promoting growth is not necessary,” it is “inappropriate” and recommends that “the practice should be phased out.”

The CDC report “makes some of its clearest statements linking antibiotic use in food animal production with resistant bacteria that infect people,” said Dr. Gail Hansen, a senior officer with the Pew Charitable Trusts, in a statement to GMO Journal.

While it is laudable that the agency whose mission is to “protect America from health, safety and security threats” publicly agreed that the use of antibiotics in animals for growth promotion leads to drug resistance, one has to wonder what took so long. For decades many doctors, scientists, health groups and health and science policy makers have been urgently warning that the increasing antibiotic resistance must be addressed now. Indeed, several Scandinavian countries banned the use of antibiotics for growth promotion years ago and, as a result, were successful in reducing antibiotic use and resistance.

The CDC report, however, remained silent on the association between two important types of resistant infections, Extended Spectrum Beta Lactamase (ESBL) and Methicillin-resistant Staphylococcus aureus (MRSA), and animal production. These bacteria colonize in food animals and can transfer to humans. Dr. Hansen noted that even though ESBLs and MRSA infections are partially associated with livestock production and foodborne transmission, “the CDC report does not make that connection.”

While “the CDC report does not associate MRSA with livestock,” said Dr. Hansen, “a number of studies link some disease-causing strains of MRSA with food animals.”

ESBLs, which occur mostly in drug resistant E. coli, is another public health threat that CDC was mum about.  The Food and Drug Administration’s (FDA) data from the 2011 National Antimicrobial Resistance Monitoring System (NARMS) report tells another story. The report found that 56% of retail meat tested was positive for E. coli and further identified the classes of antibiotics to which the bacteria was resistant. Dr. Hansen points out that “numerous studies have linked foodborne E. coli with urinary tract infections.”

Second, the FDA finalized its voluntary guidance to the industry aimed at voluntarily reducing the use of medically important antibiotics. Food & Water Watch summarizes FDA’s recommendations as follows:

[the] new guidance requests that pharmaceutical companies change the labels on medications used in feed. The medication label states how the medicine is legally allowed to be used, and the change FDA is requesting is that antibiotics important in human medicine no longer be labeled for growth promotion purposes.

The agency is also giving the industry three years to phase in the labeling change. More importantly, the FDA’s voluntary guidance specifically allows antibiotics for disease “prevention” (more on that below).

Far From A Solution

This CDC report and FDA guidance are a far cry from needed action.

For starters, FDA dragged its feet for nearly four decades before issuing any directive to the industry while knowing all along that the use of antibiotics in animals for growth promotion will lead to resistance. Yet, now that we are here, many public health advocates believe that the “guidelines will likely fail to change how these drugs are used in food animals and will not stem the public health crisis of increasing antibiotic resistance.”

Lest you forget that FDA’s guidance is strictly voluntary, at the top of every page in bold italicized letters the guidance announces that it “contains nonbinding recommendations” and again, in bold introductory paragraph, it says that it does “not establish legally enforceable responsibilities.” Got it! Thanks. 

The guidance also leaves untouched the use of antibiotics for disease prevention that many believe will perpetuate the problematic use of antibiotics. The use of antibiotics in growth promotion and disease prevention are similar in nature. “In both cases, antibiotics are fed to animals at low doses, often throughout their lives making bacteria resistant to drugs used to treat infections,” underscored the Center for Livable Future of the John Hopkins Bloomberg School of Public Health.

And that’s problematic. “The FDA may care whether companies call it growth promotion or disease prevention, but the bacteria do not,” explains Keeve Nachman, PhD, MHS, a CLF scientist with the Johns Hopkins Bloomberg School of Public Health’s Department’s of Environmental Health Sciences and Health Policy and Management. “If antibiotics are used in the same ways, they will have the same effects.”

How will the FDA know if guidance is working? Currently, the FDA does not collect data on whether antibiotics sold are used for growth promotion, disease prevention or treatment. “FDA must shed more light on antibiotic use in order to ensure its policies are actually eliminating inappropriate practices. It cannot measure progress in the dark,” says Laura Rogers, Director, Human Health and Industrial Farming at the Pew.

Ralph Loglisci at CivilEats was also wary that voluntary guidance alone won’t change chronic industry behavior. He noted that the same animal agricultural groups that for decades denied the connection between resistance and the use of drugs in CAFOs came out in support of the voluntary guidance. “Not surprisingly,” he writes, “the recommendations do little to address the reasons why industrial-scale farms rely so heavily on antibiotics. Instead, they’ve come up with a complicated voluntary process that may in the end do little to save the effectiveness of antibiotics for both people and animals.”

Less than two months before the publication of FDA’s voluntary guidance, Dr. Robert S. Lawrence, director of the Johns Hopkins Center for a Livable Future, was commenting on changes five years after the Pew Commission on Industrial Farm Animal Production released its groundbreaking report and recommendation to the problems caused by CAFOs. Dr. Robert S. Lawrence, had this to say:

There has been an appalling lack of progress. The failure to act by the USDA and FDA, the lack of action or concern by the Congress, and continued intransigence of the animal agriculture industry have made all of our problems worse.