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Tuesday, 17 December 2013

Antibiotic soaps are getting a cleansing. Are they a victim? or the cause?

Those working in the field of antibiotic resistance have often aimed, and perhaps misdirected, their control efforts at use of antibiotics in the livestock industry and in handwashing.  The issues of general antimicrobial and superbugs have been touched on previously  Superbugs and Canadian response, Political expression of superbugs  plus mentioned many other times, and antimicrobial use in livestock industry at     AMR and livestock,  

Thus the Food and Drug Administration focus on antimicrobials in customer products is a refreshing look at an old problem.  As typical in health, the previous concerns have related to the negative impacts of such products.  The FDA focus introduces the question of whether such claims on protecting health are valid.
A nice FDA overview document not only lays out the evidence, regulatory action and recommendations, but links to key science analysis of the main product, triclosan which was undertaken by the EPA.  Such cross government collaborations are uncommon and speak to better regulatory practices in the US as well.   It is notable that the triclosan review was undertaken in 2008 and the FDA review was promised for the winter of 2012, so only five years in the making for a policy direction. 

Triclosan is unrelated to other human antibiotics, hence its role in facilitating antimicrobial resistant organisms in general has been challenging to extract.  The novel FDA asks the more fundamental question, is there evidence that triclosan containing products can care any health claim on preventing illness?   Handwashing is predominately a mechanical scrubbing process for cleansing.  Disinfectants like iodine, chloride and alcohol used in clean settings like operating rooms have proven beneficial in reducing contamination.  Hence the use of antibiotics in handwashing soaps was an extension of infection control practices.

Hence the proposed FDA rule does not negate addition of triclosan like products, but does limit health claims about using the word “antibiotic” in labelling as the public perceive such labels as being more protective.     A variety of other products have used antibiotic claims including toilet seats, however the proposed rule only addressing body applied products such as soaps and washes. There are numerous other agents other then triclosan which will be subject to scrutiny concurrently, but the public focus has and will be on the triclosan-like products.   The rule is now out for a 180 day comment period.

For those intrigued, a careful read of the proposed rule will raise a few eyebrows.  Well written from a regulatory perspective, its conclusions are based on shaky evidence and dismissal of the bulk of existing research as methodologically unsound.  Such comments should raise concerns from an industry that might just be interested in protecting its current practices, and who may be justifiable concerns at the potential implications of the ruling.  Given most mild illnesses are viral in nature, antibiotics are of no value compared with certain disinfectants.  Scientific studies where the outcome of interest is a only small contributor to the general outcomes of interest are methodologically very difficult. 

Given the limited value, it is likely a good thing to eliminate an unnecessary chemical exposure. However society works on a different principle, that of generally safe, it means demonstrating true harm is being caused by products rather than proving value.  The FDA is taking a bold step to question the generally safe current status. 

Two closing comments
1.        It requires at least twice as much evidence to take something out of common practice in comparison to what we accept before putting something into practice.

2.       Antimicrobial resistance (AMR) is driven predominately by prescribing of antibiotics for human illnesses.  Addressing minor issues like triclosan containing products or growth promotion use will do very little to alleviate AMR problems and more likely as this case shows, focuses attention away from the prime concern. 

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