A new lawsuit has been filed tonight, April 18, 2008, against Schering and Merck, alleging RICO pattern-activity violations, various state Consumer Anti-Fraud violations, Unjust Enrichment and common-law fraud. The most note-worthy feature of this suit, though, is that it picks up, almost word for word, much of what is written below, and adds it to the factual allegations already made in other suits -- to establish civil RICO enterprise racketeering pattern activities. This new federal suit is captioned "Plumbers and Pipefitters Local 572 Heatlh and Welfare Fund v. Merck & Co., Inc., Schering-Plough Corporation, and Merck/Schering-Plough Pharmaceuticals, et al." (Case No. 2:08-cv-01894, Complaint filed April 17, 2008, US Dist. Ct. NJ).
END, UPDATED PORTION
The more I look through the 70-plus pages of the document dump from Chairman Dingell, and Subcommittee-Chairman Stupak, tonight, the more convinced I become that several of the medical professionals associated with the ENHANCE study were wondering (aloud, at times) whether much of the "re-reading", "querying of outlier data" and "potentially choosing new primary endpoints" was simply a delay tactic, given that it looked very likely, even in the "blinded" data (see this prior post), that there would be no statistically significant "non-inferiority" of the treatment arm, over the control arm.
But we start with an alleged attempt to document (and/or overstate) the few scientific conclusions reached by the independent ENHANCE science panel, at a meeting held in November 2007. The "draft minutes" were circulated not long after Schering Plough and Merck learned that a congressional inquiry was afoot. In one document, company executives assure a science panel member that the minutes will not be a public document, but will be used solely internally, and/or with the FDA. Oops. And with Committees of Congress. And with anyone who has an internet connection. Or buys a newspaper. Or watches television. But I digress -- first, the "really overstates" snippet; then the overall e-mailed summary of this independent cardiologist's problems with the "minutes" as drafted (some of which remained, apparently, in the final document used by Schering with the FDA, and others). In each case, click to enlarge: