FDA's wasting time while continuing to put antibiotics at risk

Instead of actually dealing with the problem of routine and widespread misuse and overuse of antibiotics in livestock, the Food and Drug Administration (FDA) yesterday came out with an attack on a recent piece from the Environmental Working Group (EWG), which raises concerns about the presence of antibiotic resistant bacteria on meat on supermarket shelves and makes recommendations about what consumers should do to avoid buying and supporting meat raised with the routine use of antibiotics. Such use (along with human use) is jeopardizing the effectiveness of essential medicines we all rely on by breeding antibiotic resistant bacteria.

The FDA accuses the EWG analysis of not looking at the “proper context,” and implies that the analysis did not have “a good understanding of the microbiology, epidemiology and genetics of antibiotic-resistant foodborne pathogens and their clinical management.”

This is ironic coming from an agency whose actions run counter to the advice of just about every leading medical and scientific group imaginable. Conversely, EWG’s concern about the public health implications of antibiotic-resistant bacteria showing up in meat production and on meat is squarely in line with the vast mainstream of scientific opinion. Here is just a short highlights list of groups that have urged action to control the routine use of antibiotics to speed up animal growth and to prevent diseases associated with crowded, unsanitary conditions, uses that could be avoided with better management practices:

• American Academy of Pediatrics (AAP)
• American Medical Association (AMA)
• American Society of Microbiology  (ASM)
• American Public Health Association (APHA)
• Infectious Diseases Society of America (IDSA)
• Pediatric Infectious Disease Society (PIDS)
• The World Health Organization (WHO)

These groups are experts in microbiology and genetics, epidemiology and foodborne pathogens, and illnesses and their clinical management. As the World Health Organization has noted here (see Chapter 4) and here, there is concern about antibiotic-resistant bacteria showing up in meat because resistant bacteria can exchange genetic material with each other and even harmless bacteria can share their resistance with harmful ones. (These bacteria can also travel off of livestock facilities that routinely use antibiotics via air, water, and soil, and on workers.) But has FDA listened to these organizations? I’m afraid not.

In fact, FDA appears to have paid heed to no one except industry in developing the voluntary approach it keeps touting.

First, FDA says that it is dealing with the problem by creating a voluntary program to deal with uses of antibiotics to speed up animal growth.

But, there’s a sleight of hand here.  FDA identifies one use as inappropriate—using antibiotics to speed up animal growth (growth promotion). But it says another very similar use is OK—using antibiotics to compensate for crowded, unsanitary conditions (aka “disease prevention”)—without any justification. The only rationale FDA has articulated for not targeting disease prevention uses is that they are “necessary.” But there is no real difference from a resistance perspective. Both uses rely on low doses of antibiotics in animal feed day after day at herd-wide and flock-wide levels, just the kind of use that favors the emergence of antibiotic resistant bacteria. In fact, many of the approved dosage and durations for both uses overlap. So, what’s the microbiological, epidemiological, and genetic basis for FDA’s decision to discourage the use of antibiotics for growth promotion but not “disease prevention”? There is none. Because based on the microbiological, epidemiological, and genetic evidence, FDA simply cannot justify the different treatment of the two kinds of antibiotic uses in livestock. Even its own analysis from 2003 (Guidance 152) acknowledges this, indicating that herd-wide or flock-wide uses of antibiotics for extended periods of time should be avoided for drugs that are of importance to human medicine –without distinguishing the purpose of the use.

Second, we haven’t yet talked about the fact that FDA’s touted solution is voluntary—as in, the industry gets to do what it wants even on growth promotion uses. So far, all FDA has done is offer recommendations on eliminating  growth promotion uses.  In other words, FDA is giving industry even longer than the 35+ years that it has already wasted in dealing with this pressing public health concern. And even that voluntary guidance isn’t final, and there is no indication when it will be. So, FDA has actually done less than nothing. As a reminder, FDA first formally acknowledged the risks of using low doses of antibiotics in animal feed back in 1977, the year I was born. At this rate, FDA won’t take any meaningful action at all until after I’m retired.

What makes FDA’s stance especially egregious is the success it has achieved in reducing antibiotic resistance as a result of its very limited attempts to address the problem in a meaningful way. In 2005, FDA banned the use of a class of antibiotics called fluoroquinolones in poultry because of concerns that its use was rapidly leading to an increase in bacteria resistant to this important class of antibiotics. Here are the results in FDA’s own words:

• “In the critically important class of antimicrobials, the 2011 data showed no fluoroquinolone resistance in Salmonella from any source. This is the drug of choice for treating adults with Salmonella.”
• “Fluoroquinolone resistance in Campylobacter has stopped increasing and remained essentially unchanged since the FDA withdrew the use of this drug class in poultry in 2005.”

So, is FDA proposing to replicate this success by further regulating the use of antibiotics in livestock? Again, I’m afraid the answer is no.

FDA also points to its regulation of many non-approved uses of cephalosporins in livestock as evidence of its good work. FDA says it did this because resistance to the drug had increased in meat from chickens and poultry. This is a good reason for FDA to act, and a small but good step in the right direction—small because it constitutes a very tiny fraction of antibiotic use in livestock.  But it is not sufficient and does not solve the problem, because the use of penicillins, which FDA still allows to be used pretty much indiscriminately in livestock, can breed resistance to cephalosporins.

Much more needs to be done. Regulation of the type FDA has pursued for cephalosporins and fluoroquinolones (two very small categories of use in livestock) is required to stop the misuse and overuse of antibiotics in animal agriculture and the dangers they pose. FDA would make better use of its time pursuing that goal and trying to make real progress on the issue then attacking a report that is informing consumers about the extent of the problem.