UPDATED: 11.15.09 @ 9:30 AM EST – Merck’s Dr. Pasternak used to sing a very different tune, apparently, back when Merck was seeking approval of Cordaptive, a niacin-added cholesterol management combo pill — subsequently rejected by FDA. [Tremendous thanks go to an anonymous commenter, below.]
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With this extraordinary Saturday press release, and a “preprint” of a letter sent to The New York Times by Dr. Dick Pasternak, Vice President of Clinical Research (excerpted below), New Merck is trying to get out ahead of the likely avalanche of stories on Monday morning:
Letter to the Editor
The New York Times
620 Eighth Avenue
New York, NY 10018To the Editor:
The New York Times story today about a clinical study called ARBITER-6 misses two key points that we believe your readers should know.
First, the results of ARBITER-6 have been described by others as largely predictable, as an analyst quoted in your story notes. But that is not because one drug is necessarily better than the other. Patients in ARBITER-6 were extensively pre-treated with statins, and had well controlled LDL but relatively low HDL, which is a study design that strongly favors a drug with niacin’s effects on HDL over an LDL-focused medicine such as ezetimibe.
Second, because ARBITER-6 did not include a true control group, absolute benefit for either medicine in this study cannot be determined. The lack of a control arm, as well as the statin pre-treated patient population, should lead one to be extremely cautious in the interpretation of the results of this small study. . . .
What all of this — out of Whitehouse Station — fails to address, however, is that if Arbiter 6 (before it was stopped), in fact did show benefits of Niaspan over Zetia, that will be three straight studies in which no positive outcome was seen for employing Zetia or Vytorin.
And that “strike-out, on three consecutive pitched balls” will stand in stark contrast to the impressive outcome studies showing the benefits of Crestor (in JUPITER) specifically, and of statins generally — in literally dozens of studies going back more than a decade. Studies that show a reduction in risk of cardiovascular events from statins — and of course, diet and exercise, first.
The tempest of Arbiter 6 is not the crux of it — no, the crux of the story on Monday ought to be the dearth of data showing any benefit for Vytorin/Zetia — despite cumulative global sales of these two drugs since 2003 (through the first nine months of 2009) of over $20 billion (as calculated by tallying the companies’ SEC Form 10-K and 10-Q filings from 2003 through 2009).
$20 billion – and there is no proof that these drugs improve outcomes. I think I read that Old Schering-Plough/Merck joint venture spent about $470 million (per TNS Media Intelligence) on TV DTC and other direct advertising for Vytorin and Zetia from 2006 to 2008, alone. At a bare minimum, we ought to be disappointed in that waste of resources.
