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Vytorin Update: Big Pharma Strikes Back

The saga over Vytorin, the expensive cholesterol pill that may be no better than older, cheaper "statin" drugs, has come to a familiar pass: The manufacturer backlash.

vytorin-logo.gifMerck and Schering-Plough, the makers of Vytorin, saw their stocks crushed the day after cardiologists trashed the multi-billion-dollar drug at a high-profile medical meeting and recommended doctors downgrade it to a treatment of last resort. So the pharmas are now spinning for all they're worth, sending their CEOs on the interview circuit to argue against a rush to judgment and to implicitly trash Vytorin's critics -- a difficult proposition, given that their ranks now include the New England Journal of Medicine.

The companies also struck back -- sort of -- against John Kastelein, the Dutch heart specialist who found little evidence that Vytorin could help prevent heart problems and strokes in a recent trial. In internal emails, Kastelein had railed against the companies' heavy-handed management of that trial, which among other things delayed release of the results for a year or more.

In response to snippets of those messages released by the Senate Finance Committee, Merck and Schering gave the WSJ Health Blog the full text of the correspondence in question (PDF link), apparently hoping it would put Kastelein's statements in "context" by making him out to be something of a nut. That was a questionable strategy in the first place -- Kastelein was the lead investigator for the company-sponsored study, after all. And while one excerpt does reveal Kastelein referring to his outbursts as "[t]he raging part of my former emails," ultimately the string just strengthens the independent researcher's case that the trial in question was at best really badly managed, and at worst manipulated in an attempt to delay release and even perhaps to produce results more to Merck's and Schering's liking.

Insurers are starting to balk at Vytorin as well. Cigna, for instance, said it will suspend a program that recommended Vytorin to certain patients, and others are reviewing their prescription policies as well.

The drugmakers still have some heavy weaponry to deploy in the form of their massive sales forces, which are already fanning out to doctors across the country with their preferred interpretation of the trial results. Yet the ability of sales reps to blunt PR damage of this magnitude is probably limited, and it certainly doesn't help that there are fewer of them all the time, given a wave of pharma layoffs over the past several months. Schering, in fact, just announced it would cut 5,500 jobs as part of plans to trim $1.5 billion over the next four years.

UPDATE: And now, the backlash to the backlash, as Yale professor and Vytorin critic Harlan Krumholz ably defends himself against snide remarks from Schering CEO Fred Hassan at Pharmalot.