September 16, 2013
The Centers for Disease Control and Prevention (CDC) today released a report outlining the dire consequences of antibiotic resistance for public health and the economy. The agency now reports that antibiotic-resistant bacteria cause more than two million serious infections and 23,000 deaths in the United States annually. Notably, these are conservative estimates: the actual numbers likely are higher. The report also highlights a previously published estimate of the annual cost of antibiotic resistance: $16.6 to 26 billion to the health care system and up to $35 billion with societal costs included. These are costs shared by everyone, from taxpayers who foot the Medicare bill to people who pay higher premiums for private insurance. Everyone is affected, and everyone should be concerned.
The CDC pinpoints the main factor driving the rise of resistance: the misuse of antibiotics in humans and food animal production: “Perhaps the single most important action needed to greatly slow down the development and spread of antibiotic-resistant infections is to change the way antibiotics are used. …[M]uch of antibiotic use in animals is unnecessary and inappropriate and makes everyone less safe.”
As regular readers of LivableFuture blog know, 80 percent of antibiotics sold in the U.S. are approved for use in food animals, not humans. Ninety percent of antibiotics approved for use in food animals are made for use in feed and water, suggesting they are administered to speed animal growth (a practice known as ‘growth promotion’) or to compensate for the overcrowded and unsanitary conditions in which most food animals are produced (a practice known euphemistically as ‘disease prevention’). In both cases, low doses of antibiotics are fed to groups of healthy animals for extended durations. This promotes the development and spread of antibiotic resistance, placing public health at risk.
The Food and Drug Administration (FDA) has developed voluntary guidelines asking drug companies to withdraw approvals to use antibiotics for growth promotion while endorsing their continued use for disease prevention. Even if drug companies follow these guidelines, antibiotic use in food animal production is unlikely to change meaningfully. Most antibiotics are approved for growth promotion and disease prevention at similarly low doses and for long durations (sometimes, no duration is specified, meaning the drug may be used continuously). If drug companies voluntarily withdraw all growth promotion approvals, antibiotics will remain approved for use in similar and sometimes identical ways. The companies and the food animal industry will call it ‘disease prevention’ instead.
The Animal Health Institute (AHI), which represents major drug companies, has announced its support for a draft of the voluntary guidelines, known as Guidance for Industry #213. This is no surprise: AHI member companies can maintain their sales while renaming ‘growth promotion’ so it sounds more palatable: who would argue with ‘disease prevention’? The FDA is expected to finalize these guidelines soon. A number of advocacy organizations have urged the agency to revise the guidelines so they address disease prevention as well as growth promotion. But if the FDA does so in a meaningful way, drug companies will have no incentive to follow the guidelines, as doing so would reduce their sales.
If the FDA guidelines do not address disease prevention, we can expect drug companies to follow it; if they do address disease prevention, we can expect companies to pay them lip service, at best. Either way, they will fail to change antibiotic use in food animal production and, therefore, will fail to protect public health. Rather than voluntary guidelines, the FDA needs to take regulatory action. It already has the authority to withdraw animal drug approvals that threaten public health and it does not need permission from the industry it regulates to do so. The CDC’s report makes the problem clear. When will the FDA do something about it?