Inadequate FDA Antibiotic Policy Spurs Criticism

Apr 27, 2012 | Katharina Schwan | Research & Policy

 

The U.S. Food and Drug Administration’s (FDA) recent recommendations on antimicrobials in animal food production gave rise to a myriad of opinions, ranging from biased opposition to candid claims of too little, too late.

 

The FDA’s Strategy

The FDA settled on a new collaborative strategy between pharmaceutical companies, veterinarians, and animal producers to promote the judicious use of antimicrobials in food producing animals. This plan hopes to address the growing concern over the increase in antibiotic resistant bacteria. The suggested framework, published as a voluntary guidance document, is based on two fundamental principles.

First, the use of medically important antimicrobial drugs (antibiotics that are also important for therapeutic use in humans) should be limited to what is necessary to preserve animal health. In other words, while the continued use of drugs to prevent, control, and treat illness in animals is approved, the use of drugs to promote growth is not.

Second, all use of medically important antimicrobial drugs should include veterinary oversight or consultation. This would promote the use of veterinarian-prescribed drugs based on diagnoses, rather than those sold over the counter. 

 

Critics

Robert Lawrence, professor at the Johns Hopkins Bloomberg School of Public Health, openly denounces the FDA’s new plan in his article published in The Atlantic. He claims that the agency “missed the point.” The FDA’s continued support for the use of drugs for therapeutic treatment does not address the issue of antibiotic resistance. Lawrence calls for a reform in production practices by improving living conditions and nutrition of animals. Such measures would eliminate the need for antimicrobials for disease prevention.

Caroline Smith DeWaal, the Food Safety Director for the Center for Science in the Public Interest, considers the FDA’s new policies “tragically flawed.” Animal agriculture and food production has contributed greatly to the problem of antimicrobial resistance. She believes that the FDA is not adequately addressing this issue nor protecting public health by promoting voluntary guidelines. “The time for half-measures and voluntary steps has passed,” says DeWaal.

The Animal Health Institute (AHI), on the other hand, supports the FDA’s strategic stakeholder approach; one that satisfies the most people involved in the conflict.  The AHI represents the interests of companies that manufacture animal health products, including medicines. In a statement released on April 11, the institute said it backs the responsible use of antibiotic medicines and supervision by a veterinarian. Nevertheless, the AHI maintains a certain degree of hesitation. In an interview with the Center for Infectious Disease Research and Policy (CIDRAP), Richard Carnevale, AHI’s vice president of regulatory, scientific, and international affairs, stated that the use of antibiotics to promote growth actually improves animal health. “We have evidence that the use of these at lower levels… actually serves to prevent subclinical infections,” Carnevale revealed.

Opposing Lawrence and Smith DeWaal, but equally against the FDA proposal, stands the National Pork Producers Council. The NPPC clearly supports the continued use of antibiotics to promote animal health. Chief veterinarian for the NPPC, Liz Wagstrom, cites evidence suggesting that antibiotic use yields health benefits for farm animals and without it, more animals will get sick and production costs will increase. This will ultimately result in higher meat prices, with no measurable public health impact. Another interesting point made by Wagstrom is that Denmark, which banned the use of antibiotics for production in 2000, has since seen an increase in the use of important medical antimicrobial drugs for therapeutic purposes. “Over time, the amount they've used for treatment or therapy has more than doubled, so that total use is almost back to the same level as before the ban,“ added Ron Phillips from AHI.

 

What will change?

The term “voluntary” keeps creeping up throughout the FDA’s proposal: “the voluntary adoption of practices,” “instituting voluntary measures,” and “phase-in the voluntary practice.” If this strategy is voluntary, is it likely that the various stakeholders will actually embrace it? Some say yes.

The FDA has not banned the use of all antibiotics in animal production because it would simply take far too long. Over decades, the FDA has approved the use of hundreds of different antibiotics, for both therapeutic and nontherapeutic purposes in farm animals. Revoking these approvals will be extremely difficult, because it can take years to navigate through the legal appeals. For example, in 1995 the FDA approved the use of fluoroquinolone in the poultry industry. However, when research showed that the use of these antibiotics in chickens and turkeys promoted the development of fluoroquinolone resistant Campylobacter, the FDA proposed to ban the two approved fluoroquinolone antibiotics. In response, Bayer Corporation, one of the manufacturers of the drugs, launched a near 5-year legal battle against the FDA. In 2005, the proposed ban finally went into effect. This marked the first time that the FDA withdrew an agricultural drug from the market because of concerns about antibiotic resistance and its effect on human health.

Despite this single victory, considering that in this case hundreds of drugs are involved, creating a collaborative strategy is likely the more effective and efficient method. As part of this collaborative strategy, Michael Taylor, the FDA’s deputy commissioner of food, asks pharmaceutical companies to voluntarily change drug labels to require prescription and prohibit production uses. If resistance is strong, a more forceful ban may be implemented.

Since the forced withdrawal of growth-promoting antibiotics looms on the horizon anyway, some drug companies may likely choose the voluntary route. According to federal officials, the majority of drug companies have already agreed to the label change. Furthermore, since the majority of profits drug companies earn are through their human consumers, it seems counterintuitive to support a plan that could hurt their most profitable clients.

 

Drug Resistance

The development of antibiotic resistance due to unsustainable food animal production has been a growing concern since the introduction of the “industrial model” in the 1940s. Small-scale farms were replaced by huge industrial operations. This caused a giant leap in the number of food animals produced, but a sharp decline in the number of production sites. This model of animal husbandry has evolved into large-scale, concentrated housing systems characterized by overcrowding and unsanitary conditions.

Thousands of poultry, cattle, and swine are crammed into their respective compounds, and facilities are only cleaned once a new shipment of animals arrives. In the poultry industry, for example, this is once every 45 days. The quantity of feces and waste that accumulates during this time is hazardous to animal health, and unsurprisingly, infectious diseases such as Salmonella and E. coli spread often and rapidly throughout these animal housings. In an effort to prevent infection, animal producers often administer antibiotics to the entire flock or herd via feed or water. This nontherapeutic administration of drugs may be continued throughout the animal’s lifetime. The Center for Science in the Public Interest estimates that food animals consume approximately 80% of antibiotics sold in the U.S., and 65% of these are similar or identical to drugs used in human medicine.

To farmers nontherapeutic use of antibiotics opened the gate to far more cost-effective and efficient methods of production of animals-for-food. Not only did antibiotics keep the animals from becoming sick, but it also promoted weight gain and improved feed efficiency. Yet, it has also lead to a dramatic increase in the number of drug resistant bacterial strains. Treated animals have become reservoirs for antimicrobial pathogens hazardous to both human and animal health. 

 

Final Remarks

Those critics who consider the FDA’s proposal “too little, too little” have an arguable point, as similar suggestions were made back in 1977 but were never implemented.  It seems as though the FDA has a clear intent, but refuses to assert its authority to propagate real change. At this stage in research, epidemiological evidence clearly shows that administering antibiotics to farm animals fosters resistance. Despite this, the issue of long-term antibiotic treatment is only minimally addressed within the guidelines. Further, the voluntary trait leaves many tentative. The stakeholder approach will likely pacify both sides of the conflict momentarily, but whether a measurable change in animal food production will follow, remains uncertain.

 

 

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