Perhaps due to the aggressive marketing, U.S. doctors wrote 34 million prescriptions for Vytorin in 2006. That's 34,000,000 scrips for a drug that was not tested, it's just a combination that sounded like a good idea. To the tune of billions of patient dollars. Docs like the idea because high doses of statins cause muscle aches, so they wanted to try a lower statin dose combined with another mechanism for lowering cholesterol.
Vytorin is marketed as INEGY outside the U.S.
A 2006 RCT double blind study ("ENHANCE", 2 yrs, n=720) showed no difference between Vytorin and Zocor in the neck artery plaques of people with family histories of high cholesterol. Schering Plough tried to bury that study. They changed the "end point" when the results were not what they wanted. Those results were released in January after a substantial delay. In the meantime, one Schering-Plough executive sold off 900,000 shares. He must have known what was coming.
Shares of Merck (nyse: MRK - news - people ) and Schering-Plough (nyse: SGP - news - people ) have dropped 25% and 40% since the report came out in January, including a big drop this week after additional data sparked new worries about sales. Together, the drugs generated $5 billion last year. So far it looks like the insurance companies are still going to cover the drug, though it now has a bad rap with the few people who bother to follow such things.
My LAST Edward Jones guy recommended investing in Shering Plough, last year. I read up on it and I am glad I didn't buy. Maybe NOW it would be a good buy. My dad made a buncha dough investing in Merck just after the Vioxx scandal.
The hype on the drug:
Schering-plough on the ENHANCE study:
Forbes on the whole situation and the market:
Where I found the editorial below:
Ads, research undermine Vytorin
McClatchy-Tribune News Service
Article Last Updated: 04/04/2008 09:08:18 PM MDT
The following editorial appeared in the Minneapolis Star Tribune on Thursday, April 3:
In the turmoil swirling around the cholesterol medication Vytorin this week, an important message has been lost: This is not a bad drug.
But its manufacturers - Schering-Plough and Merck - have handled its development badly, undermining confidence in the industry and a drug that could yet prove to be an important addition to doctors' heart disease arsenal.
It's hard to miss the clever Vytorin ad campaign about diet and family history influencing cholesterol levels. Vytorin's pitch is that it's two drugs in one pill and treats both. In 2006, U.S. doctors wrote 34 million prescriptions for it.
The trouble is, Vytorin isn't ready to be a blockbuster drug. While it makes sense that combining the statin drug Zocor with Zetia, which blocks intestinal cholesterol absorption, would fight heart disease better than statins alone, there's no proof. Until the release of a massive study in 2012, we simply won't know if Vytorin, which costs about twice that of plain Zocor, translates to more lives saved.
That uncertainty - along with the drug's $200 million ad campaign - is behind this week's controversy. A just-released study involving 720 people with a family history of extremely high cholesterol suggested Vytorin didn't perform any better than Zocor on one gauge of heart disease progression: neck artery plaque.
Vytorin's manufacturers have long known this; the study was completed in 2006. So why did they delay the results' release and continue marketing the drug so aggressively? And, why did the companies create the impression of data manipulation when they announced that they were changing the study's "primary endpoint" - what researchers had originally set out to look for?
A congressional inquiry is now looking into all of this and whether millions of extra Medicare dollars were spent fulfilling Vytorin prescriptions with no apparent benefit. Sen. Charles Grassley, R-Iowa, is also questioning whether Schering-Plough executives sold off large blocks of company stock - one exec jettisoned 900,000 shares - while the firm delayed the data. This week, the American College of Cardiology reasonably called for doctors to use Vytorin only if more established drugs don't achieve treatment goals. Somehow that resulted in doctors here and elsewhere getting panicked calls from patients fearing Vytorin could harm them.
That's unfortunate. The study released this week gave Vytorin a clean safety profile. While its effect on neck plaque is questionable, the study did show it was more effective than plain Zocor in lowering levels of two other cardiac risk factors: LDL ("bad") cholesterol and C-reactive protein. A bigger study may well prove Vytorin's value. The question is, will it matter if the public's confidence is permanently shaken by its manufacturers' conduct?