Thursday, July 31, 2008

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.


cpo said...

Late "News"

Politicians are now trying to take over the job of the FDA. The idea that Vytorin might be causing cancer, at least on the basis of the SEAS study is ridiculous. Statistically it is a non event, yet they are trying their best to make SGP go under. I have never seen so much furor over so little for so long. They would serve this country better if they addressed the problems of the economy and the shenanigans within wall street.

Condor said...

cpo -- I think many serious scientists are simply asking how the cancer incidence (not morbidity; just incidence) can be dismissed as an "anomaly" in the data -- if Schering won't show the data -- to the public.

Those scientists have apparently found friends, in Chairmen Stupak and Dingell -- and we all will, within two weeks' time, likely see the data Dr. Peto claims allowed him to effectively "dismiss" the cancer finding, as an anomaly.

The point is that such a dismissal seems premature -- until independent scientists review, critically assess, and ultimately sign off (or, don't sign-off) on the conclusions offered by Dr. Peto earlier this week.

This process is called "peer review" -- Mmmmmmm! -- Tastes good! Do try some!

munichjustin said...

As a "serious scientist" I can tell you that I trust the statistical analysis of a scientist over some idiot politician.

There is no conspiracy here.

Data analysis was done by a third party at Oxford.

Waste of time and money.

Condor said...

Then I am sure you'll have no problem, munichjustin, if some more scientists take a look -- that is what the process of "peer review" is all about. Dr. Peto's analysis has not been peer reviewed, has it?


So, as a "serious" scientist, I am sure you prefer to read peer reviewed journals, rather than company press releases, right?

There should be no fuss about this issue -- IF one actually sees the value of the peer review process. . . .