ACC panel unleashes Vytorin whirlwind

If Merck and Schering-Plough really expected their Enhance presentation to turn the tide on Vytorin and Zetia, then they were sorely disappointed this weekend. At the American College of Cardiology confab, a panel of heart docs said the Enhance data offered little redemption for Zetia and its cousin Vytorin, a Zetia-and-Zocor combo med. The media coverage today is extensive. Here's a representative sampling:

• Enhance data showed no benefit to treatment with Vytorin, the study's lead investigator said. "Zilch." John Kastelein told the WSJ Health Blog that Enhance was a "trial out of hell" and that he'll never conduct research in the same way again.
• Before a panel of experts spoke to the ACC, they reached consensus on the two meds and issued a press release urging docs to back away from the drugs. The cardiologists recommended a return to tried-and-true cholesterol treatments such as Merck's Zocor--which recently went generic--Pfizer's Lipitor, and AstraZeneca's Crestor. These meds have been shown to not only lower bad cholesterol, but also have effects on heart disease, the docs said.
• Wall Street analysts, stunned by the negativity of the ACC discussion on Vytorin and Zetia, lowered their sales estimates for the meds and downgraded Schering-Plough's stock.
• The New England Journal of Medicine said Vytorin and Zetia may not work and should only be used as last-resort alternatives if other cholesterol treatments--diet, exercise, statins, niacin, fibrates, and resins included--either fail to work or can't be tolerated by a patient. There's no evidence that the drugs help patients, a Yale cardiologist told the ACC meeting, and may even be harmful.
• Researchers found that the U.S. spent billions more on Vytorin [1] and Zetia than Canada did, positing that the lack of DTC advertising in Canada may account for the difference.
• Schering-Plough stock dropped 17 percent before the bell this morning and Merck fell 10 percent.
• Amid the firestorm of bad publicity, Merck and Schering-Plough stood behind their products, citing various reasons why Enhance failed to prove Vytorin's superiority; for one thing, patients in the study had been treated already with statins, and so it would be more difficult to show a benefit. The companies said the meds remain good first-line treatment options for cholesterol.

No doubt the data will continue to get sifted and hashed over in coming days. But until outcomes data for Vytorin are available--now unlikely until at least 2012--any new, concrete info will be hard to come by.

- here's the release [2] from Merck
- read the Associated Press story on the retreat [3] to older meds
- see Kastelein's comments [4] in the Health Blog
- check out what analysts are telling [5] the WSJ
- find the NYT's coverage [6] of the meeting
- read New Scientist's story [7] about Canadian ezetimibe spending
- see the stock performance news [8] at MarketWatch

Related Articles:
Companies saw Vytorin threat in 2005. Report [9]
Congress: Were Enhance results secret? Report [10]
FDA to review Enhance study. Report [11]
Congress promises Vytorin hearings. Report [12]
Merck, Schering defend embattled Vytorin. Report [13]
Merck, Schering's Vytorin fails trial. Report [14]