As noted earlier this week, Merck said it made a mistake when it described the type of method of analysis used in the study released in 2004. The reference to treatment by-log-time interaction in the article should have referred to treatment by-linear-time-interaction, according to Merck representatives.
What does this mean for attorneys? Below you will see comments by attorneys already, but the new information needs to be fully assessed, documents reviewed and experts consulted. Several people much smarter than I are already weighing in. Steven Nissan, M.D., of the Cleveland clinic has again said that the initial studies were flawed and that with the correction in the data and conclusions of the study the misleading assumption of no risk inside of eighteen months has been exposed for what it was - an effort to to limit the claims of people alleging an injury caused by Vioxx.
According to the NEJM and to other reports on the web, an editor with the NEJM has said in looking at the 100-page data analysis plan there was no reference to using a linear method. The editor has suggested that one cannnot look at the data and then decide how to analyze it. By doing so, Merck would be suggesting that is permissible to change the data plan, which cannot be done. (See AP and Yahoo for sources).
The VIOXX cardiovascular data analysis plan called for numerous statistical and graphical methods to be used to assess whether the relative risk of VIOXX compared to placebo was constant over time or if it changed over time. The use of the variable, logarithm of time, was an element in the primary method specified. The reference to logarithm of time in the description of methods published in the NEJM was in error. The reference to treatment-by-log (time) interaction should have referred to treatment-by-linear-time interaction. The reported p-value = 0.01 came from that test using linear time, not logarithm of time. Recent tests show that the result using logarithm of time based on the final dataset has a p-value = 0.07. Results of diagnostic analyses indicate that a model using linear time is more representative of the data than one using logarithm of time. Thus, the linear time analysis is an appropriate method to assess the changes in relative risk over time.
As specified in the analysis plan, Merck used additional analytical and graphical methods to evaluate whether the relative risk changed over time. These methods included a Kaplan-Meier plot that showed similar curves for placebo and VIOXX during the first 18 months, which then began to separate at approximately 18 months. Relative risks were also calculated over successive six-month intervals in the study. Over the 36-month period of the study, the relative risk was lowest in the first three sets of six-month intervals and highest in the last three sets of six-month intervals, again demonstrating changing relative risk over time. The results of the linear time analysis, the Kaplan-Meier plot, and the interval relative risks together confirm that the relative risk changes over time. In the APPROVe base study, the increased relative risk was observed beginning after 18 months.
Chris Seeger, the attorney who lost the first NJ Trial didn't mince words, saying that Merck had been "lying" about the data it had. An attorney with Beasely Allen will now file a Motion in Judge Fallan's Court claiming a Fraud upon the Court.