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Published online 4 June 2008 | Nature 453, 710 (2008) | doi:10.1038/453710b
News in Brief
Merck scores victory in three Vioxx appeals
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Please note this is News in Brief, and so will be a short article.
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The following excerpts from a most recently published book review (STATISTICS AND SOCIETY: Signifying Little. Theodore M. Porter, Science 6 June 2008: Vol. 320. no. 5881, p. 1292, DOI: 10.1126/science.1160305) is illuminating: ....."In a clinical trial of Vioxx in 2000, five experimental patients suffered heart attacks, compared to only one in the control group. The different did not rise to statistical significance at the 5% level, and on that basis the researchers declared there was no danger. Is this dubious reasoning to be blamed on the Fisherian statisticians? Not really. The sins of pharmaceutical trials are legion, as is now amply documented, and in this case the work was done and the paper written by Merck, which subsequently recruited phantom authors at universities willing to attach their names to the publication. Ziliak and McCloskey point out that Merck had already suppressed other data implying the riskiness of Vioxx. Most of the really harmful abuses chronicled in the rather overblown first 40 pages of this book involve statistical maneuvers that are illegitimate even by the standards of Fisher's program. We can better explain the Vioxx episode in terms of a corrupt research program than of flawed statistical tools.".....
In my opinion, the relation between Vioxx (rofecoxib) and CAD deaths has to be analized from an original, scientific viewpoint, overloked until now. In fact, firstly we have to ask ourselves why not all patients, who were been treated with rofecoxib died from CAD? Secondly, we must solve the following question:why not all individuals with high blood level of glucose, cholesterol-LDL, omocysteine, blood pressure, a.s.o., are suffering from CAD, while young subjects (among them some professional athletes!)apparently in good healthy condition, suddenly die fron Acute Myocardial Infarkt? In other words, with the aid of Biophysical Semeiotics, I demonstrated the existence of CAD Inherited Real Risk, based on coronary congenital microcirculatory remodelling, characterized by newborn-pathological, type I, subtype b) aspecific, Endoarteriolar Blocking Devices in small artery, according to Hammersen. This predisposition to acute myocardial events can be recognized at the bedside wit a simple stethoscope, as I illustrated ALSO in a Lecture in 2007 at V International Congress of Cardiology, organized by FAC (Argentin Federation of Cardiology): Role of Coronary Endoarterial Blocking Devices in Myocardial Preconditioning - c007i. Lecture, V Virtual International Congress of Cardiology. 2007. http://www.fac.org.ar/qcvc/llave/c007i/stagnaros.php As a consequence, before administering such as drug, physicians has to exclude the presence of Biophysical-Semeiotic Inherited Real Risk of CAD.