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!
An antibacterial is an agent that inhibits bacterial growth or kills bacteria.The term is often used synonymously with the term antibiotic(s).Today, however, with increased knowledge of the causative agents of various infectious diseases, antibiotic(s) has come to denote a broader range of antimicrobial compounds, including anti-fungal and other compounds.
ReplyDeleteAmoxicillin is used to treat various different types of bacterial infections such as tonsillitis, pneumonia, ear infections, bronchitis, UTIs, gonorrhea, & skin infections.
Antibiotics