[UPDATED — 07.02.08 @ 10:00 PM EDT: A gent named Random John (who really isn’t — all that “random“, that is), at Realizations in Biostatistics, has also weighed in on this topic — the likely irrelevance of “blinding/unbliding” in non-inferiority studies, where non-inferiority does NOT result — and, he linked my post. Thanks!
07.01.08 @ 11:00 PM EDT: That gentleman across the pond, the Insider — at PharmaGossip, has linked this story, and featured its graphics! Thanks a ton!
Apparently, Dr. Peter Rost at The PharmaLaw Blog has also linked this, freely-liberating the graphics — COOL! (that’s what they are here for, folks!) — while adding significant additional detail about the possible origins of Sen. Grassley’s scientific understanding of “non-inferiority” studies — studies like ENHANCE. Did the Senator’s staffers “go to school” on all of this via The Insider and Dr. Rost? Read the above two links, and decide for yourself!]
I missed this earlier in June, but it would seem that the first case reciting Sen. Grassley’s theory of the irrelevance, from a scientific/statistical and legal point of view, of the blinded v. unblinded ENHANCE data-sets — has now been filed. This will likely become a central theory advanced in the yet-to-be amended securities fraud complaints, the shareholders’ derivative action, and all the others, due to be filed later this summer.
This particular case is a consumer fraud case, filed June 13, 2008, by a health-care plan in Minnesota, captioned Electrical Workers 242 Health and Welfare Fund, et al. v. Merck & Co., Inc, et al. (Case No. 2:08-cv-03025-DMC, Complaint filed June 13, 2008, US Dist. Ct. NJ).
This is the legal theory I think I was the first to really outline, and then amplify, back in early April 2008, after reading Sen. Grassley’s February letter, referenced in the below paragraph. As ever, click the image to enlarge it.
[Late-night edits: the original PDF of the complaint, as well as my original .jpg of this portion, above, contained a typo: “unblended” where “unblinded” was plainly intended — I’ve fixed it, in three places, just now. Also, “not” was used once where “no” was intended. Even though the original at the federal district courthouse in Newark still contains these typos — this one will be fully-correct. In this way, it will make a better model — for all of the other plaintiffs’ lawyers, likely to graft it into their respective complaints.]