Or. . . . Your 90 days are. . . . over!
Well, in the last few days, the Schering/Merck website has begun to implement the FDA January 23, 2008 mandates (click on the small FDA letter image, below right, to read those mandates) — The quote below is from the last line, on the first page, of the NEWLY-REVISED Vytorin web-advertising; the second paragraph (in blue, below) is from the Zetia page, on that same site [Emphasis below, is as it appears in the original]:
“. . . .VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet. VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone. . . .
[Ed. Note — And, from the new Zetia page:]
The most common cholesterol-lowering medicines, known as statins, work mainly with the liver. ZETIA works in the digestive tract, as do some other cholesterol-lowering medicines. Statins are a good option. As you can see in the animation above, ZETIA works differently. Now there are some other medicines, such as fibrates, bile acid sequestrants, and niacin, that work in the digestive tract to help lower cholesterol, but ZETIA is unique in the way it helps block the absorption of cholesterol that comes from food. Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks. . . .“
Wow. I’m going to pay up to four-times more, at least here, in the U.S. (where about 80 percent of the sales of Vytorin/Zetia were generated, last year), for Vytorin/Zetia, but Schering’s website tells me that, unlike statins, it “has NOT been shown to prevent heart disease.” Note particularly this sentence, as well:
“Statins are a good option.” Wow.
Then, on the Vytorin page aimed at “people already taking Zocor”, we read this, right near the top of the very first page:
“VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet. VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone. . . .“
[The same language (immediately above, with the same emphasis) appears on the page aimed at people taking Lipitor or Crestor — and it even still refers to “Zocor” — hmmm — that seems like a typo, no?]
These revisions are almost word-for-word, what FDA earlier wrote it would expect Schering/Merck to say, in order to avoid “misleading” the public, post ENHANCE. And now — the object-lesson, here? When the regulator holds your license-to-sell in its hands — it has quite a bit of negotiating ju-ju, no?
I am, quite frankly, uncertain as to how a salesperson for the Joint Venture product(s) would go about handling any doctor who, during a sales-call, took even one moment to point these web-pages out, to that sales representative [shivers!]. Said another way, it would seem a very tall-order to “talk around” these recitations, in one’s own marketing materials — especially that the competitors’ products (at a fraction of the price!) are a “good option.”
And, of course, it remains a largely-open question as to whether, and for what purposes, these now very-public changes and revisions will be admissable as evidence in the various RICO/consumer fraud lawsuits now pending against Schering, and Merck, and the joint venture each helps operate.