Key Meeting Next Week Offers Federal Experts New Chance to Curb Antibiotics in Livestock

Note: this blog was previously published on the Medium website, before the March meeting of the President’s Advisory Council on Combating Antibiotic Resistant Bacteria. The next meeting of the Council is June 21-22, 2016. 

How many of us have sisters, uncles, cousins, or friends whose lives one day were turned upside down by a fight with a deadly bacterial infection? Mostly, they are happy endings — the crucial corner turned with the help of the “right” antibiotic. We shudder to think what life without these miracle drugs would look like.

But that may soon be our future, our new reality. Bacteria are becoming increasingly resistant to life-saving antibiotics in large part because of their overuse. What many people don’t realize is that livestock production is a major driver of that problem. At last count, around 70% of all antibiotics of human importance sold in the U.S. are for use in food animals; much of that use is to promote growth and prevent disease in animals that are not sick — essentially to compensate for poor conditions and diets.

In March 2015, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council) was established to review, evaluate and implement the President’s response to the public health crisis of antibiotic resistance. It meets again next week, and is expected to deliver a one-year progress report. When it comes to the overuse of human antibiotics in livestock, I’m afraid the news will be disappointing. Despite growing public concern and attention from policymakers, sales of these same essential drugs for use in food animals continue to rise — up 23% from 2009 to 2014.

The Advisory Council should use this opportunity to look at how to fix some fundamental flaws in the federal efforts to-date to try and reverse this troubling trend. The flaws include:

• Almost no follow through on even voluntary requirements: In December 2013, the FDA launched a program (“Guidance 213”) that asked drug companies owning nearly 300 affected antibiotics to volunteer by the end of 2016 to stop selling them for use as growth promoters in animal feed. FDA assured the public all the companies had agreed. (In a separate directive, FDA moved to require that remaining uses of these antibiotics take place only with a veterinarian’s order.) With only nine months left in FDA’s three-year time frame, the voluntary plan is nowhere near those goals. FDA’s most recent update reveals that only one product is no longer being sold for use in growth promotion, and veterinary oversight has been added to the labels for only three of them.
• Failure to address antibiotic use for routine disease prevention in animals that are not sick: Even if the FDA were to meet its commitment to curb antibiotics used for growth promotion, it is rather unclear this will significantly reduce overall antibiotic use. That’s because the FDA left a major loophole unaddressed: the continued use of many of the same antibiotics for routine disease prevention, another common driver behind agricultural overuse. NRDC’s fact sheet lays out the loophole in detail. Perhaps that loophole also explains how the CEO of drug maker, Zoetis can, in the Wall Street Journal, both endorse FDA’s approach and predict that approach will little have little impact on his company’s revenue, or presumably its hefty sales of antibiotics for livestock.
• Similar approaches have failed in other countries: FDA’s general approach — even when required by law and not voluntary — has been tried elsewhere, and failed. The Netherlands phased-out of the use of antibiotics for growth-promotion in 2006, but antibiotic use continued to rise even after the ban took effect. Only after the government and industry launched a new, much more aggressive effort to reduce use of ALL antibiotics in feed — by setting a reduction target and banning use for disease prevention — did the country see significant reduction in antibiotic use. Within just four years, sales of veterinary drugs were cut by more than half. The successful 45% reduction in livestock antibiotic use in Denmark also followed a ban on use for both growth promotion and disease prevention.
• Lack of targets for reducing antibiotics sales in livestock: Last December, an important report commissioned by UK Prime Minister David Cameron made a compelling case that for there to be essential reductions in agricultural use of antibiotics globally over the next 10 years, individual countries have to set ambitious, hard targets for themselves. The Netherlands has successfully done so. The report states: “We think this would be more effective than a ban on growth promotion because, whilst welcome, it is very difficult to define and enforce by type of use, and might well lead to either individuals or systems redefining use that is growth promoting as prophylactic, or even therapeutic.” As we noted earlier, this precisely the loophole created by the FDA’s current approach. To its credit, the President’s Action Plan sets a hard target for human medicine of reducing inappropriate antibiotic use by 50% in outpatient settings and by 20% in inpatient settings by 2020. So far, no numeric targets have been set however for reducing antibiotic overuse in agriculture, where 70% of all medically important antibiotics are sold. The Action Plan should either set a target as the UK commission recommends or end the use of antibiotics for both growth promotion and disease prevention to close the loophole the UK commission identified.

So, the outlook is not good if the FDA continues with business as usual. But how soon will FDA, and by the extension the public, even know if the agency’s plan to reduce antibiotic use in agriculture has had any impact at all?

At the earliest, the data FDA collects on 2017 sales of livestock antibiotics after the end of growth promotion won’t be publicly reported until the end of 2018. Only then will we know if FDA’s plan defies the predictions of the pharmaceutical industry itself, or whether the sales of feed antibiotics continue to rise, as they first did in the Netherlands.

Of course, sales data also are an imperfect proxy for understanding exactly how antibiotics are used, and why they are used, on farms. For years, most experts writing about this issue have acknowledged the need for the latter. But neither the FDA nor the USDA has ever collected such data. A recent update from FDA states that the agency is working with the Center for Disease Control and the U.S. Department of Agriculture “to develop and implement a plan to collect additional data [from farms] on estimated antibiotic use in food-producing animals.” FDA promises that plan will be finalized in 2016. Of course, a promise is not a plan; and a plan still falls short of a working system that is collecting data.

When the President’s experts meet next week, they will do us all a tremendous disservice if they issue nothing more than a ‘progress’ report on plans that are themselves fundamentally flawed. Instead, the Advisory Council should take a step back. Evaluate what’s not working for the U.S. to reach its ultimate goal of reducing widespread overuse of antibiotics. And issue a Plan B, one that recommends meaningful targets for reducing of antibiotic use in livestock, or alternatively recommends an end to the use of antibiotics in livestock for both growth promotion and disease prevention.

What’s at stake is a future where antibiotics may still work when we, or our loved ones, most need them.