Manufacturers' conduct casts doubt on drug and industry.
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?
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