Vytorin Study Fallout

Vytorin a Schering Plough prescription drugs which combines the now generic Zocor with Schering Plough's Zetia, has come under fire this week following the release of a study at the American College of Cariology's annual conference this week concluding that Vytorin is no more effective in reducing plaque in neck arteries than Zocor alone. Indeed the Wall Street Journal reports today that "Schering-Plough Corp. announced a plan to cut costs by $1.5 billion by 2012, after a panel of cardiologists called for doctors to limit use of the company's blockbuster cholesterol drugs and sent its stock down nearly 29%."

The New Jersey Star Ledger reports that an FDA medical policy official warns that patients on cholesterol medication should be wary about abandoning treatment.

"(A)n aspect of the current discussion that troubles me greatly is the implication in some stories that we're not so sure anymore that even lowering cholesterol with statins is all that clearly beneficial," Robert Temple, medical policy director for the FDA's Center for Drug Evaluation and Research, told the web site. [That's what I took away from reading a recent BusinessWeek article on statins, but I'm not an MD.] "As the recent Crestor story reminds us (for people without known cardiac disease, by the way) we sure do know it is beneficial and people who need that treatment will pay with their lives if they're encouraged to avoid treatment."

Temple also said he hasn't drawn any conclusions about the purported ineffectiveness of Vytorin, also known as ezetimibe, and said the agency will likely take six months to review new data about the drug.

The New York Times reports that UnitedHealth Group is recommending -- in line with the FDA official's comments -- that its members who have Vytorin prescriptions remain on the drug because it presents no safety issues. CNNMoney reports that Cigna adjusted its drug coverage in response to the study. "The Philadelphia health insurer said it was immediately suspending part of a program that notified members using certain other cholesterol drugs that Vytorin was an effective and less costly alternative. The program, known as 'step therapy,' is an effort to help health plans control drug costs." Similar to UnitedHealthcare, "Cigna will continue to pay for Vytorin prescriptions, and the insurer stressed that no one should discontinue any therapy without first talking to a doctor."