Vytorin - a drug that dodged scrutiny

The Ledger writes:

The study that sent Merck and Schering-Plough stock plung ing and put doctors in a tizzy this week did not find any harm from taking the drug Vytorin -- except to pocketbooks.

The problem was that while there was no harm, there was not much benefit either. Vytorin, which combines Merck's drug Zocor and Schering-Plough's Zetia, does not seem to clear arteries any better than taking Zocor alone -- and generic Zocor sells for a mere one-fifth of Vytorin's price.

The other problem for the pharmaceutical giants is that some members of Congress are investigating whether the companies delayed the release of the study's not-so-good news to protect profits for as long as possible.

If so, they did it at the expense of stockholders as well as consumers and insurance programs, including Medicaid and Medicare, which paid for Vytorin when cheaper Zocor would have done. Was the combined drug about science or a market device to up the price of one old drug by dressing it up as something new?

There are still unanswered scientific questions. Merck and Schering-Plough chose to study Vytorin in patients with an elevated genetic predisposition for very high cholesterol. Vytorin reduced the so-called bad cholesterol levels although not as low as target levels set by experts.

Reducing the buildup of plaque on artery walls is the business end of cholesterol control, and Vytorin did not perform any better than plain old, cheap Zocor. Why not? Might the results be different in a more typical population? In a larger study?

Those are important questions. So is this one, for Congress and the Food and Drug Administration: Why is it that Vytorin has been on the market for years, has saturated consumer and medical minds with $140 million a year in advertising and raked in more than $5 billion in sales -- yet we're just getting around to finding out if it works?

Insider's view: Hear hear!

The FDA should, and will, be more cautious when approving NCE's like ezetemibe based only on weak surrogate endpoints.

Pargluva was stopped with a request for harder data.

I wonder which drugs in development will now have the bar raised for them!?