Far be it from me — to suggest these two are related — BUT. . . .

. . . .I could not help noticing that, as of this morning (filed July 10, 2008), in a consent dated yesterday, July 9, 2008 by Defendants’ counsels — Lowenstein, Sandler has taken the reins from Arent Fox, in US v. Organon, Inc. (Case No. 07-2690, US Dist. Ct. NJ), the <a href =”http://shearlingsplowed.blogspot.com/2008/04/it-seems-pre-acquisition-organon-matter.html
“>Organon Qui Tam/False Claims litigation matter.

Click it — to enlarge (and, in such a pretty color, too)!

It is unclear why this “mid-stream horse-switch” was undertaken, but I would not be terribly surprised to learn that it had something to do with the throw-away due diligence argument Arent Fox offered, and I highlighted in a discussion, toward the end of last month.

A bit of a pickle that one created, no?

Of course, it could be completely unrelated — and it could be as simple as “it makes sense to keep all our defense counsel well-coordinated, so why not consolidate at one firm?”

Which, of course, is to admit that I was (mostly) right — as “better coordination” could have avoided that particular gaffe.

I’m jes’ sayin, that’s all. . . .

Vytorin/Zetia Marketing, Sales Practices, and Products Liability case hearing in Newark — July 18, 2008

Udating an earlier item, here — the previously-scheduled judicially-supervised teleconference has just been ordered to be handled as an “in person” hearing on the record, in open court — the court rooms open to the public, at large. That is a very good thing, for this blog, and perhaps, for Pharmalot (hint-hint), too.

Re: In Re Vytorin/Zetia Marketing,
Sales Practices, and Products
Liability Litigation, Civil
Action No. 08-285 (DMC); MDL No. 1938

Dear Counsel:

Kindly be advised that the telephone conference scheduled for Thursday, July 17, 2008 at 10:00 a.m. has been converted into an in-person conference on Friday, July 18, 2008 at 10:00 a.m. Should this change present an unavoidable conflict for counsel involved, the Court will be amenable to further rescheduling.

SO ORDERED.

/s/ Mark Falk
United States
Magistrate Judge

Well, this could be a very entertaining day in the federal District Courthouse — in Newark, New Jersey.

Maybe I’ll pop-in. We’ll see.

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.

~~~~~~~~~~~~~~~~

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.