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Wall St. J.: FDA on SEAS Cancer concerns for Vytorin — Rep. Dingell’s Latest Letter to FDA

More in a tick, but the Wall Street Journal is moving an important update on the two Congressional Committees investigating Schering’s Vytorin, generally, and now, the SEAS study — rather specifically — and pointedly. Do go read it.

It seems Chairman Dingell and Chairman Stupak want Dr. (Sir) Richard Peto’s work — now in FDA hands, but not available to the public — regarding his analysis of the cancer incidence data in SEAS. Some, including Dr. Harlan Krumholz, have wondered about the conclusions reached thus far largely dismissing the cancer incidence data seen in SEAS — at least, insofar as the public documents are — at the moment — not complete enough to reach the conclusions mentioned by Dr. Peto, with adequate certainty, where something as momentous as a potentially-elevated risk of cancer is suspected.

All of this means FDA will need to turn over all of Schering’s Vytorin/SEAS documents that mention the cancer incidence data — in under two weeks’ time. There is no doubt that these Committees have jurisdiction over FDA, in this matter. Take a look — as ever, click it to enlarge:

Quoth the Journal:

. . . .A report called the SEAS study stunned investors and the medical community in late July, because researchers looking at Vytorin’s efficacy in reducing cholesterol had unexpectedly found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo.

Vytorin is made by a joint venture of Merck & Co. and Schering-Plough Inc. The companies delayed their earnings announcement on July 22 to inform investors about the SEAS findings. . . .

It seems all those people in the blogosphere, rightly complaining about the incomplete — and thus potentially confusing — disclosures of only selected SEAS study papers have found a friendly ear — and so, it seems, we will all soon see most of those documents, right here.

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