David's New Book

Wednesday, May 1, 2013

Antimicrobial Resistance - the FDA Has Your Back!


I know you all will be excited to hear that the FDA has just added an informational release for consumers on “Fighting the Impact ofAntimicrobial Resistance.”  The best part of the piece is the photos of key FDA personalities.  The FDA explains how antibiotics transformed the health of Americans starting in 1940 (actually the revolution started with the sulfonamides in the mid-late 30s).  They then point out that some organisms have developed resistance to these important drugs.  They even point out that some organisms came already packaged with “intrinsic” resistance – presumably before the advent of antibiotics – but this is rather glossed over in this consumer info piece.


The message comes from both Ed Cox (above) of the office of antimicrobial products (human health) and David White (right) of the office for food and veterinary medicine.  Ed points out that the FDA is doing two main things to address antibiotic resistance. (1)  They are “facilitating” the development of new antibiotics with new recommendations providing for both practical and scientifically sound development pathways.  (2) They want to help assure the appropriate use of the agents we already have.  This is fascinating since all the guidance documents produced since 2006 with one exception specifically call for infeasible clinical trial designs for the development of new antibiotics. It is true that the FDA has been softening their approach within the last year and essentially are no longer following their own guidance documents – but all this is secret and behind closed doors.  Only those who actually speak to the FDA in confidence about specific products know that they no longer strictly follow their own guidance. But the message to consumers is a little misleading in that you get the impression that the FDA is a facilitator when for the last decade they have been quite the opposite. Europe has been leading the way here and it seems like the FDA is trying to follow – but its all still a secret.

On the veterinary side, David White (who should know better!), says that the FDA is approaching antibiotic use in animals using “voluntary” guidance.  That is, its OK for food producers in the US to continue to use low doses of antibiotics as food supplements to get their food animals to grow faster and therefore get to market faster.  They are encouraged to stop this practice in a voluntary way.  Right! That will work!  It is abundantly clear in study after study that antibiotic resistance is selected by these practices in food animals and that resistant organisms and the resistance genes they contain can be transmitted directly to humans or the resistance genes to human pathogens and that resistant human infections result from this process.  They do reassure us that most isolates from food-borne outbreaks are still susceptible to the first line drugs used to treat them – but what does that mean exactly?  I looked up the NARMS data for 2010 myself. There is extensive resistance to tetracycline, amoxicillin and augmentin but little resistance to Bactrim and ciprofloxacin among human, food and animal isolates of Salmonella. The FDA’s approach, in addition to “voluntary” guidance is to tell consumers to wash their food, their hands and their cooking surfaces and to cook the meat well – all good advice – but really!


On the basis of many years of evidence culminating with the superbug vancomycin-resistant Enterococcus (VRE), Europe banned the practice of using low dose antibiotics in food animals as growth promotants. Once again, the European regulators are leading the way while the FDA lags well behind.  Personally, I find it inexcusable that the FDA permits this practice to continue knowing the risk this poses to human health here in the US.  This is especially frustrating since the same FDA has obstructed new antibiotic development for years (although they have started to try and turn themselves around in the last year).

So – for you consumers out there – don’t worry – the FDA has your back!