UPDATED — FDA’s letter re Vytorin is now online!
I’ll have much more on all of this in the coming days, but the after-the-fact creation of highly-defensive, lawyerly, written minutes — for a meeting (a meeting at which, at least one doctor was told, there would be “no recorded minutes” — ostensibly to improve the freedom of debate) of the lately-appointed, but finally-independent science panel on the ENHANCE study — just looks pretty bad, pretty-desperate, on its face.
Adding to the embarrassment for Schering and Merck, is the fact that the U.S. House Committee has ALSO released, to the public, the various doctors’ specifically-marked proposed revisions (in bubble-commented Word-versions) of those draft minutes.
Many of the comments made by the doctors disagree vehemently with some of the re-characterizations of the tenor of the meeting. . . . They use phrases like “overstates“, “misleads“, “is contradicted by” and “mischaracterizes” — and, well — NOW, I just have to say it — you’ve got a brand new public relations crisis on your hands, at Schering-Plough. I’ll have some of those other snippets up, later. [But even that doesn’t seem to be the worst of it.]
No, I’ve chosen to first put up the portion of the comments that suggest it was highly likely that — as Senator Grassley suggested — even the “blinded data” would have revealed the study’s failure, at least to a sophisticated set of medical eyes. Click to enlarge — I will have more; this is but one page from the Stupak-Dingell document dump (of more than 60 pages!), tonight:
The highlighting on the above is original [not so, on the below]. As if all of this were not tough-enough sledding for Schering, Chairman Dingell also released a letter from the FDA, dated January 23, 2008, that called Vytorin advertising “misleading“, in view of the ENHANCE results. Ouch — that will leave a mark. Now the Committee wants a bevy of answers, and additional documents, from both Schering-Plough and Merck & Co., all within two weeks’ time — that’s April 25, 2008. Take a look — again, click to enlarge — but I highlighted it, to make it easier to read:
The most important question for the moment is to figure out when Schering knew about the FDA’s concerns — as Dingell and Stupak specifically ask, above. But it may turn out, that these Congressional committees are, day-by-day, proving the cases of the 33 consumer fraud complaints, consolidated and transferred, earlier this week, to Judge Cavanaugh in New Jersey.
Wow — just when I think I won’t be terribly-surprised to learn anything more about this whole mess — I see new, and difficult, issues surface. It just keeps on churning, here. It is hard to imagine how Schering put itself this awkwardly behind the Eight-ball.