Since 2007, the blockbuster cholesterol pills Zetia and Vytorin have been under a cloud as many doctors questioned their effectiveness at preventing heart attacks – and those questions have caused prescriptions of the pills to fall by more than 50%. Today, that cloud lifts.
An 18,000-patient trial shows that Vytorin, which combines Zetia and the older drug simvastatin, prevented more heart attacks, strokes, and other heart problems than simvastatin alone, exonerating the drugs. Merck revealed that the study succeeded in a press release this morning.
The release reads, in full:
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that IMPROVE-IT met its primary endpoint. The results are scheduled to be presented at the American Heart Association Scientific Sessions later today. The data are embargoed by the American Heart Association until the start of the late-breaking clinical trials session at 10:45 a.m. CT today.
I’ve seen the full results, but, under an agreement between reporters and the AHA, I can’t reveal them until the embargo lifts.
But just knowing that the study succeeded is enough to say the following: this is good for Merck. It means that the company will avoid yet another controversy about its past behavior and ethics. It also could mean a bump in sales.
The result is good for the drug industry as a whole. The backlash against Vytorin was part of a distrust of drug companies that started with another Merck medicine, the painkiller Vioxx, which caused heart attacks and was withdrawn from the market. It was driven by things that Merck and Schering-Plough did: trying to avoid bad data, marketing both medicines to too broad a population, faking meeting minutes and paying doctors large sums to talk up drugs. And it poisoned the industry’s relationship with consumers and the FDA.
That will benefit other companies developing cholesterol drugs, because it could mean faster approvals of those medicines by the Food and Drug Administration and more rapid sales uptake when and if the the medicines hit the market.
Investors should expect the stocks of Amgen, Regeneron, Sanofi, and Esperion to most directly benefit from this news.
At the heart of the Vytorin story is a big scientific question: how much can we trust that lowering the bad cholesterol, known as low-density lipoprotein, or LDL, means preventing heart attacks. This study won’t completely settle this issue, but it does mean that scientists and doctors will assume that cutting LDL means preventing heart attacks and strokes.
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