Wednesday, November 12, 2008

A Lively "To and 'Fro" on SEAS, and cancer, at AHA, This Afternoon. . . .

UPDATED -- 11.13.08 @ 7:30 AM EST

Mike Huckman's story on this, from yesterday afternoon, is plainly in need of updating -- why should we listen to stock analysts, over actual physicians, as to what SEAS means? True enough, the "expectations" were very low, at AHA, for Schering -- but SEAS is about whether a very-expensive drug might be linked to various types of cancer. That makes this a "doctors' debate" -- not a stock analysts' debate.

Later -- 3 PM: Now The Wall Street Journal Health Blog is on the below story. It comes out at about the same bottom line, as I did, yesterday.


At the panel discussion, Dr. Allen Taylor, quite sensibly, I think, took the position that we don't know enough to decide whether Vytorin and/or Zetia are entirely safe. Rather predictably, the people hired by Schering and Merck (to conduct other cholesterol trials, including the IMPROVE-It trial, running through 2012) took the other side of the argument -- chiefly, Dr. Rory Collins. Quoth Reuters reportage, tonight:

. . . .The panel discussion here on Wednesday brought the Vytorin cancer debate to a major U.S. medical forum. . . .

Still, the Zetia cancer discussion at the heart meeting stood in stark contrast with data presented three days earlier that demonstrated AstraZeneca Plc cholesterol fighter Crestor dramatically cut the risk of death, heart attack and stroke in a clinical trial, without serious safety issues.

"I think it is impossible to be completely certain, based upon what we currently know, that there isn't a cancer signal" with Vytorin and Zetia, said Allen Taylor, a cardiologist with Washington Hospital Center Walter Reed Hospital [Cogent RE-edit, from the pen of one Marilyn Mann, below, in comments] in Washington, D.C., who joined Collins in the panel discussion.

Taylor said until ongoing large trials definitely prove the safety and effectiveness of the Zetia component of Vytorin, doctors should avoid prescribing the drugs, except for patients who cannot tolerate other treatments.

"That's not many of your patients, but it may be some," Taylor added.

Rory Collins [an Oxford University researcher who is helping lead a large ongoing Vytorin study called Improve-It], took exception with Taylor's conclusion . . . .

Well, this would all be rather droll, if it weren't already established that we -- as a matter of pure investigational science -- cannot be sure that Vytorin, and/or Zetia work. at. all. -- to reduce heart attacks. That, my dear readers, is the object lesson of the ENHANCE trial, as Dr. Taylor taught us.

So -- does it really matter (all that much) to the fortunes of Schering -- given that Vytorin/Zetia started the day, just this morning, as a consensus third- or fourth-line of therapy?

Now, these two may be "re-elevated" to a third-line form of therapy -- where all other hope is lost (and an ambigous signal on cancer is a tolerable risk -- for someone very likely to die, if his or her cholesterol doesn't come down, and he or she cannot tolerate statins). Gee, that's reassuring. Or. not. so. much.


Marilyn Mann said...

Dr. Taylor is with Walter Reed Army Medical Center, not Washington Hospital Center.

Condor said...

Marilyn -- of course you are right, and I should have noticed Reuters' error.

Thanks -- corrected it, just now!


Marilyn Mann said...

Oops! Turns out he moved to the Washington Hospital Center a month ago. I wasn't aware of that, sorry for the confusion.

Condor said...

He-he! Wild -- I'll fix it later. Gotta' jet now.