Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.
No question, statins are the big gorilla of the cholesterol-fighting drug market. And as Forbes reports today, that drug class is marking out an even bigger territory as time goes by. Over the past 5 years, statin prescriptions have grown by 17% to 214 million a year, while other cholesterol remedies lost 28% of their scripts. Now, those other drugs only account for 50 million prescriptions a year.
Merck will soon launch a new cholesterol combo that melds its Zetia drug with generic Lipitor. The Zetia-plus-statin approach isn't new, of course; Merck already sells Vytorin, a combination of Zetia and its own off-patent statin Zocor, known generically as Simvastatin.
The Vytorin outcomes trial will go on. That's all the information we're getting out of the enormous Improve-It study for now. An independent data monitoring board looked at the trial's results so far and recommended that it continue.
Merck agreed to pay $688 million to resolve two securities-fraud lawsuits filed by irate shareholders. Pension funds and other institutional investors alleged that Merck--and Schering-Plough, which Merck bought in 2009--held back key information about the Enhance trial, which tested the combination drug Vytorin against one of its constituent parts, the statin drug Zocor.
In an ongoing prioritization of its drug pipeline, drug giant Merck put on hold development of a combo pill for raising HDL or "good" cholesterol and lowering blood fat. The Whitehouse Station, NJ-based company revealed the decision from July on Wednesday among other updates to its closely watched drug candidates.
The Vytorin outcomes study is going ahead without a hint about how things are faring. The safety monitors of Improve-It, which is testing Merck's ($MRK) cholesterol-fighting drug Vytorin, say no new dangers have cropped up among the 18,000 patients enrolled.
The FDA's cautionary word on statin use has stirred up a back-and-forth risk-benefits debate. When the agency announced last week that it would highlight the risk of Type 2 diabetes on the cholesterol drugs' labels, some prominent heart doctors issued their own warnings: Don't worry too much about that risk. For most patients, the heart benefits of statins outweigh the "small" risk of developing diabetes.
The DTC juggernaut is weakening. As The New York Times reports, industry spending on TV ads fell by 2% in 2011, the fourth consecutive year of decline. Altogether, TV spending is down 20% from 2007...
The FDA approved a label change that recognizes how Vytorin can prevent heart problems among chronic kidney disease patients, butdidn't specifically give it an approval for that indication. Now Merck