Healthy Skepticism Library item: 12620
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Schering-Plough denies Vytorin study cover-up
CNN Money.com 2008 Jan 28
http://money.cnn.com/2008/01/28/news/companies/schering_rise.ap/?postversion=2008012815
Abstract:
Pharmaceutical company says senior executives only knew about discouraging cholesterol trial results days before public release.
Full text:
Battered shares of Schering-Plough Corp. rose 3 percent Monday, after the company said on its Web site that senior executives had only known about Vytorin study results for mere days before they were publicly released, implying that no cover-up had taken place.
On Jan. 14, Schering-Plough (SGP, Fortune 500) and Merck & Co (MRK, Fortune 500). said data from the 2002-2006 ENHANCE clinical trial showed their combination cholesterol drug Vytorin didn’t reduce plaque buildup any more than one of its components, Zocor, available as a generic for about a third the cost.
Wall Street had been anxiously awaiting details on the results and a congressional committee had begun probing the data’s delay, with some critics accusing the companies of trying to alter findings. The news has sent Schering-Plough’s stock down 34 percent in two weeks and Merck’s tumbling 21 percent. Prescription-tracking firm ImpactRx reported new Vytorin prescriptions dropped by two-thirds last week.
Furthermore, the study’s findings have triggered potential class-action lawsuits in several states, alleging the companies mislead consumers.
Merck and Schering-Plough on Friday defended their actions, saying they acted “with integrity and good faith.” Schering-Plough posted additional information on its Web site, noting that Chief Executive Fred Hassan learned of the top-line results on Jan. 10, just 5 days before the data was released to the public, and Executive Vice President Tom Koestler was informed only a few days earlier, on Jan. 7.
The company also said Hassan hasn’t sold any company stock since 2003, implying he didn’t use his knowledge to sell positions before the stock plunge.
Shares rose 45 cents, or 2.4 percent, to $19.47 in afternoon trading, having climbed to $19.88 earlier in the session.
In an official statement Friday, Food and Drug Administration officials said the study’s finding was unexpected, but noted that sometimes even drugs known to work don’t show an effect in a study. Additional analysis will be needed, the agency said.
Lehman Brothers analyst Charles Butler said the FDA appeared to be “neutral to slightly positive” on the companies, with their actions seemingly designed to prevent a public safety concern should patients decide to discontinue therapy based on the study’s results.
Lehman’s Butler said official statements from the American College of Cardiology and the American Heart Association also have been neutral and only recommend discussing data with a healthcare provider before making any changes to their medical regime.
