Well there are several points to consider regarding dabigatran and FDA's recent NEJM publication. First, the authors of that paper do not and have not practiced medicine or seen patients in many years, if at all--they are in fact bystanders.  Second, when the FD&C Act was amended in the early 1960's Congress prohibited FDA itself from the "practice" of medicine.  In other words, it was not FDA's mandate to tell physicians "what" drug to prescribe and to whom. Third, FDA has always maintained that dose response is very valuable evidence and perhaps the most compelling evidence of a drug effectiveness for condition or disease.  A dose response for effectiveness parameters and safety parameters is the most desired statistic of all.  In dabigatran, a dose response was evident for effectiveness and safety.  Instead of elaborating on this compelling finding in the product label and allowing physicians to decide which dose to use, FDA made a decision for every practicing physician and withheld approval of an effective dose.  In doing this, FDA ignored the variance around mean or average data and "lumped" all patients into 2 groups:  one dose dose for those with renal impairment and one dose for those without.   In the practice of medicine, the "one size fits all approach" has failed despite Pharma's best marketing efforts. But in this case, no one will know how badly "one dose fits all" will fail.   FDA has set a very dangerous precedent and ignored its own approval standards and scientific disclosure policy in the product label.  FDA has now distinguished itself from every other Western Civilized Country which has approved the 110 mg dose by withholding approval of the 110 mg dose because statistical reasons.   FDA's decision was made without transparent consultation from the practicing physicians.  The publication was just too late and for most part inadequate to justify the "one size fits all" decision. Expect more of this in the future.