Category Archives: Vytorin SEAS statin/ezetimibe v. placebo trial FDA proc

Of the "Generally-Goofy" Thoughts of Tim Anderson on SEAS. . . .

As I first hinted here, yesterday afternoon, with my first link, some analysts — Tim Anderson at Sanford Bernstein, most notably — are suggesting that a small study due out in the Fall of 2008, called SEAS, will provide some vindication for Schering’s Vytorin.

I. think. not. Here’s why:

SEAS is a study not at all designed to measure Vytorin v. statins, or other actual therapies. No, it is a superiority non-inferiority study [Thanks go to commenter Marilyn, below!].

In fact, all SEAS “measures” is the effectiveness of the combo-pill, Vytorin, against a placebo. In other words, it seeks to provide the data that Vytorin should have shown, in order to be approved by the FDA, in the first place, as to effectiveness [but that, lax FDA approval processes, 2001-2004, is a topic for another day].

So, when all is said and done — if SEAS returns a “positive” — all we will know is that Schering’s Vytorin does better than nothin’ at all.

There will be no statistical way to tease out how much of the effect was due to the statin portion of the pill, and how much was due to the ezetimibe portion. [This point was very-cogently first made by one Marilyn Mann at Pharmalot’s joint, yesterday.]

In fact, it might be fairly argued — if we accept Tim Anderson’s rather non-lucid analysis, and original premise — that a “win” on SEAS simply declares that a statin — the portion of the pill-combo that has been around forever, and been proven to work in improving outcomes — was responsible.

So, IMO, this line of analysis is really clutching at straws.

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Confidential Sidebar: Isn’t it possible that Schering has (once again!) acheived a “functional unblinding,” (this is a superiority non-inferiority study, after-all) and “pre-“determined that Vytorin will show a positive outcome? I think so. Why else are we hearing about this, now?

Note — IF Vytorin shows anything less than a VERY STRONG improvement over the PLACEBO — it has NO BUSINESS being an approved drug — none. It should be pulled by FDA, if it can’t beat a placebo. This is especially true, if one considers that such a failure would mean that ezetimibe somehow dampens the known-effectiveness of statins. Wow.

To be clear — I think Vytorin will show an improvement over nothin’ at all — but that is very cold comfort, for such a pricey drug.