Friday, January 18, 2008

J&J - Risperdal: a "must read" post on Health Care Renewal

So, here is the litany of sly tactics used by Janssen with the willing cooperation of KOLs like Nemeroff , Rapaport and Keller. Remember, these KOLs are paid directly or indirectly by Janssen for their association with the marketing campaign:

design a clinical trial in which unblinding is guaranteed and ignore this confound which favors the drug;

secure high profile product placement in a journal like NPP, with the cooperation of the editor;

make false claims of efficacy in a negative trial report; when challenged, lamely try to pass off this compound misrepresentation as an “error” for which nobody accepts responsibility;

take self-serving liberties with the results of statistical analyses so as to claim efficacy where none exists;

suppress inconvenient statistical analyses of toxicity; manipulate the apparent risk-benefit profile of the drug;

constructively plead nolo contendere to the charge of manipulating key data analyses;

focus on the statistical significance of psychometric outcome measures while ignoring clinimetric measures of usefulness like NNT;

bias the analysis of efficacy by using completer data;

bias the analysis of toxicity by using ITT data;

and ignore existing data that suggest the corporation’s drug is inferior to established alternatives.

Health Care Renewal

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