A proposed fairer method for conducting rofecoxib trials.
In this communication, a new plan will be proposed for the conductance of rofecoxib [Vioxx] trials because the current system of individual trials is considered to be irretrievably flawed and grossly unfair. The ideas about rofecoxib trials stem from a different paradigm to explain COX-2 inhibitor (coxib)-induced myocardial infarctions. This model for coxibs is based on the position that coxib-induced infarctions basically are "regular" infarctions, and thus differs from the apparent current position that coxib-induced infarctions are a "special" type of infarction. Three major problems with the current system of rofecoxib trials are proposed: presently used methods of separating out rofecoxib-induced infarctions are invalid, it is difficult to separate out with surety the half of rofecoxib-related infarctions which are rofecoxib-induced, and determining together at rofecoxib trials the two issues of whether an infarction is rofecoxib-induced and whether Merck handled rofecoxib properly leads to unfairness. The new plan bypasses these problems by bypassing the issue of determining at trial whether individual infarctions are rofecoxib-induced. In essence, the plan is a voluntary process designed to result in a class settlement. Plaintiffs are benefited mainly because they do not have to establish individually whether their infarctions are rofecoxib. Merck would benefit because its voluntary acceptance of the plan would be in accord with Merck's position it acted ethically with rofecoxib, and the plan has several factors to reduce significantly the overall level of recompense.
Hellstrom
H R
HR
5035 Bridlepath Road, Fayetteville, NY 13066, USA. hellstro@twcny.rr.com <hellstro@twcny.rr.com>
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000517:prevention & control; D002986:Clinical Trials as Topic; D051546:Cyclooxygenase 2 / Q000378:metabolism; D016861:Cyclooxygenase Inhibitors / Q000494:pharmacology; D004992:Ethics, Medical; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008962:Models, Theoretical; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D013450:Sulfones / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D051546:Cyclooxygenase 2