Face it, nobody knows if ezetimibe does anything other than lowering LDL. And nobody knows if it works with or against the beneficial event effects of a statin. And we won’t know for at least 4-5 years. Close just doesn’t count in evidenced-based medicine and extrapolation is for fools!

“. . .Food, Drug & Cosmetics Act § 201:

. . . .(m) The term “labeling” means all labels and other written, printed, or GRAPHIC matters (1) upon any article or any of its containers or wrappers, or (2) ACCOMPANYING such article.

(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations MADE or SUGGESTED by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising FAILS to REVEAL FACTS material in the light of such representations or MATERIAL with respect to CONSEQUENCES which may result from the use of the article to which the labeling or advertising relates. . . .”

Okay — didja’ catch that? Does Vytorin reduce heart attacks? Or doesn’t it? Is heart attack risk “material” — if one is taking a drug to lower cholesterol? That is the issue, for me.

Now, look closely at this one and a half minute video I made:

http://blip.tv/play/AbjLe4eodQ

Now, the object lesson, here: “omissions” can be the basis for civil and criminal liability. In fact, the Chairmen of two Congressional Committees believe the ommissions in Vytorin’s ads. . . . were “material”. Each has said, and written, as much. In any event. . . .

Namaste

Said another way - Schering didn’t have to TELL US that “Vytorin had not been shown to reduce heart attacks or strokes more than Zocor alone”, for the same reason that Crestor has never had to tell us that (even though it would apply)- because it is completely irrelevant to the approval and assumed use of the drug.

I bet you still don’t get it Condor, so how’s this sound: Lipitor was approved based on its ability to lower LDL. Later, Zetia was approved based on its ability to lower LDL. Then, Lipitor was shown to reduce the odds of a heart attack for every 1 out of 30 over a five year period. That was added to Lipitor label. The 4S trial had already shown a CV risk reduction for Zocor, which had been applied to its label. No such trial has yet to apply to Zetia, or Crestor for that matter (although Crestor has been shown to regress plaque). Thus, Zetia’s label has not been UPDATED to show CV risk reduction and Vytorin’s label had not been UPDATED to show CV risk reduction beyond that of Zocor. That’s how drug labels work. They include what has been proven.

So let’s try this again Condor. What’s on a drug label? A drug’s proven benefits. What’s not on a drug label? A long list of benefits the drug does not provide (example: prozac has not been proven to clear skin, increase intelligence, or augment muscle tone). Most drugs haven’t been proven to do a lot of things, that’s why their labels only include what they HAVE been proven to do.

Please explain for me — as I apparently lack common sense — why it would be that the FDA would REQUIRE Schering to put this bold black warning on Vytorin (and a similar one — for Zetia, too). . . . ONLY AFTER “ENHANCE” was disclosed:

“VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone.”

That was new, at the demand of the FDA, post-ENHANCE — LINK:

http://www.vytorin.com/ezetimibe_simvastatin/vytorin/consumer/index.jsp

So — if you are right about the above, WHY on EARTH would FDA EVER NEED toorder this change?

Said another way — why didn’t Schering TELL US all this — right along — ever since FDA approval in 2002?

Why? — I’d tell you why, but I don’t need to — Suffolk County, NY governmental officials already have. [Hint: It's the oldest reason in the world.]

Cheers!