I am reproducing our Letter to Editor sent to NEJM in response to a perspective article. This wasn't accepted by the journal for publication:-
Issues with accelerating the availability of medical therapies
In the perspective article Borio et al. (1) argue for scientifically sound and globally acceptable protocols expediting evaluation of investigational therapies during public health emergencies. We believe that such protocols should also address questions related to possible surge in demand for expanded-access of investigational therapies proved to be statistically more effective in accelerated trials. Will these investigational therapies found to be effective in such trials get the permission for mass production to make them available to the patients outside controlled trials? If yes, will the product developers be able to mass produce during the public health emergency? If no, how these protocols would be justified? Further the ramifications of inability to provide therapies proved to be effective in such trials to dying patients outside controlled trials need to be kept in mind. In addition, it is important to be extra cautious and vigilant in framing such protocols having potential of being misused to rapidly test & try multiple investigational therapies during public health emergencies and create more mistrust among already suffering population.
References- 1. Borio L, Cox E, Lurie N. Combating emerging threats - Accelerating the availability of medical therapies. N Engl J Med 2015;373:993-5.
Issues with accelerating the availability of medical therapies
In the perspective article Borio et al. (1) argue for scientifically sound and globally acceptable protocols expediting evaluation of investigational therapies during public health emergencies. We believe that such protocols should also address questions related to possible surge in demand for expanded-access of investigational therapies proved to be statistically more effective in accelerated trials. Will these investigational therapies found to be effective in such trials get the permission for mass production to make them available to the patients outside controlled trials? If yes, will the product developers be able to mass produce during the public health emergency? If no, how these protocols would be justified? Further the ramifications of inability to provide therapies proved to be effective in such trials to dying patients outside controlled trials need to be kept in mind. In addition, it is important to be extra cautious and vigilant in framing such protocols having potential of being misused to rapidly test & try multiple investigational therapies during public health emergencies and create more mistrust among already suffering population.
References- 1. Borio L, Cox E, Lurie N. Combating emerging threats - Accelerating the availability of medical therapies. N Engl J Med 2015;373:993-5.
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