thank you for stopping by Having invited you to mediate I don t want to be tendentious but I will attempt a single cycle of checking to make sure you understood my concerns The conclusion that Only 31 of men prescribed finasteride met the eligiblity criteria for the pivotal trials required two logical steps 1 The authors reviewed the eligibility criteria for the pivotal pre approval clinical trials and 2 They aggregated and interpreted previously unpublished data about men prescribed the drug from the Northwestern University Enterprise Data Warehouse Specifically they set criteria for choosing a comparison population those administered 1 25 mg or less per day and analyzed the characteristics of this population to determine the frequency of men having conditions that they believed would have excluded them from the aforementioned trials This gathering and interpreting of unpublished data to my mind represents pretty much the definition of primary research The latter step involved a number of judgement calls that require review by a secondary source 1 The authors determined eligibility by matching the ICD 9 codes of patients from the Northwestern database to relatively vague statements of exclusionary criteria such as A history of any illness or condition that might confer additional risk or confound the results For example the authors stated that 4 5 of their patients would be ineligible due to obesity but obesity is not explicitly stated to be an exclusionary criteria for any pre approval trial They presumably decided on their own that obesity might confer additional risk 2 A secondary source is needed to assess whether the population that these authors analyzed is representative enough to make the study itself significant According to Table 2 of the source document 8 5 of the patients prescribed propecia at Northwestern would have been ineligible for the pivotal trials because they had cancer 7 1 were ineligible because of substance abuse issues 27 were ineligible due to heart disease or hypertension and nearly 17 had disorders of the male genital organs I personally find it it difficult to believe that nearly 10 of those prescribed propecia nationally have cancer This seems to me to be primary research in every sense of the word and in need of a secondary source for interpretation All these things being said I invited you to mediate and will not pursue this issue further should you still disagree with me after reviewing these comments