Wednesday, April 16, 2008

In answer to a reader, over at CafePharma. . . .


These questions deserve more-complete answers -- and so, I'll return later today, to provide 'em, but this is the thumbnail version I gave, just now, on CafePharma's boards:

From: Anonymous -- Today, 08:39 AM

"....thank you for your fine work...I'm a big fan of yours from the Yahoo! board.

What I can't figure is how you know so much about SP...did you work there? Or are you a journalist?

What do you make of Bots' report dated Jan 2007 which said that the data were 'fine'? Why did it take 10 months to convene the infamous end-point changing advisory board after that? Does that sound like a delay to you? But what is the problem, since delaying the data isn't illegal?

Thanks"

My answers, for now, are below, in green -- other duties call me, at the moment -- but, I will return to more fully flesh these answers out, with links (and some editorial asides):
Smile -- I've NEVER worked for Schering-Plough; I am NO journalist. Did you ever see "Three Days of the Condor"?



I am a. . . . reader, I guess. I just read. . . everything. I've spent some time really "reading up" on SGP, over the past three months.

Now, your questions do deserve answers, and I do have my opinions(!), but I want to be careful not to libel/defame any private person. I do think Dr. Bots was right. I think the data were "fine." I think it likely that Schering and Merck just didn't "like" what the data pretty-plainly implied. Note that I've echoed, and amplified, Sen. Grassley's publicly-aired concerns that the very-likely outcomes from even the "blinded" data, were discernible to a medically-trained eye, long-before the data were actually, formally, unblinded.

So, I think -- emphasis on "think", here -- Schering and Merck asked to have the data "refined" -- to try and tease some statistically-significant outcome, from it. But even the expert panelists then later agreed, on November 16, 2007, that it was likely that any variance in the "blinded data" could be the result of pure chance, not treatment/control arm outcomes. In a word -- the study had utterly failed to show any benefit -- in my humble opinion, of course(!).

I'vell likely posted answers to your specific questions on my blog, where I can links to each piece of authority, for each statement, above.

Now, I will say that -- as a matter of law -- even innocently delaying such data, and then selling stock to the public at $27.50 (near the high-price for the year!), is generally-frowned upon, over at the SEC.

Note that Schering sold $3.8 billion of equity, and another ~$4 billion of debt -- right in the middle of this "entirely innocent delay" on a project that impacted (or should I say sustained) 60-plus percent of Schering's 2007 profitability. That much is entirely undisputed -- and fascinating, no?. . . .

Hopefully, I'll be back soon, to add to this.

No comments: