Several bloggers have been following the saga of Ezetimibe (Zetia, Vytorin), the hidden data, and the threats to science which have resulted from the way in which Merck and Schering-Plough have thrown the usual safeguards of science into the gutter.
Earlier this week Schering-Plough CEO Fred Hassan spoke for 45 minutes at Morgan Stanley’s "Pharmaceutical CEOs Unplugged" conference. He tried to assert that the ENHANCE trial was unimportant anyway as it wasn't being counted on for anything. Also, it was a study conducted in a very rare population of patients and has no implications for the general population of patients with hypercholesterolemia.
Obviously, ENHANCE was THE study designed to demonstrate that ezetimibe has an impact on atherosclerosis. Any impact at all would be nice, since no clinically relevant benefit of Ezetimibe was demonstrated prior to licensing of the agent.
Scientific malfunction is fine when studies can be deemed (in retrospect) by important CEOs to "not matter anyway".
When individual scientists conduct themselves in such a way as to cause our understanding of science to be disturbed, then (unless they are very important people) they get thrown out of science, imprisoned, and their future "findings" are not believed. The rules of participation and believability are different for corporate "science".
Schering-Plough is of course the company that writes £10,000 checks to doctors in exchange for prescribing their drugs.
Schering-Plough clearly has a record, as does Merck. The examples are many. In 1999 it was reported that deaths in clinical trials involving gene therapy were being hidden on demand from companies who were worried that it would "have an impact on their business". The Washington post reported in that "Scientists and drug companies have failed to notify the National Institutes of Health about six deaths that occurred in gene therapy experiments in the past 19 months". Researcher Ronald Crystal "cited concerns about the impact on his business if the death were made public". "Schering-Plough also had demanded confidentiality for three recently filed reports of serious patient illness during gene therapy trials. The lead scientists in two of those studies determined that the complications "probably" were caused by the gene therapy; Schering-Plough officials had downgraded those assessments." It was then reported that Schering-Plough Corporation and the University of California had done preliminary trials in dying cancer patients, but "lowered the dose when two early participants experienced serious drops in blood pressure" (Nelson, Deborah, and Weiss, Rick. Hasty Decisions in the Race to a Cure? Gene Therapy Study Proceeded Despite Safety, Ethics Concerns. Washington Post November 21, 1999: A1, A26-A27 [Link]). These were not reported, and later trial participants were not informed.
Actual people died.
Wilson (the researcher) said: "If a mistake was made, we've got to own up to it and learn from it. Ultimately, the tragedy of Jesse's death would be if we don't learn anything."
What have we learned over 8 years Dr Hassan?
As Ben Goldacre writes in Bad Science, "the data belongs to the patients who gave it to you". Our patients deserve better Dr Hassan. Science deserves better.