Mr. Herper offers a very tightly-knit narrative, tonight, to explain what he feels Chairman Waxman was driving at, with his latest document-demand letter (of last Thursday). For Herper, it all boils down to a central question -- that is, "Why did it take six months for Schering to make first mention of the SEAS cancer signal?"
Mr. Herper's is excellent, so do go read it all, and to entice, here's a juicy snippet:
. . . .The three-person DSMB for Pedersen's [SEAS] study began worrying about the increased rate of cancer among Vytorin patients in June 2007. The panel met twice more that year. When the panel met in January 2008 and saw no signs that the risk had abated, the chair of Pedersen's DSMB contacted the chairs of the two other ongoing Vytorin studies. . . .
. . . .[W]hy, Congressional investigators want to know, did Vytorin's maker. . . Schering-Plough, tell the House Committee on Energy and Commerce that safety committees overseeing the analysis had started looking into a cancer signal a full six months earlier -- in January 2008?
Because that's what happened.
In January 2008, Merck and Schering were already being enveloped in a firestorm of controversy for delaying the results of a preliminary study where Vytorin had failed to best a cheap generic. The story of how the results from Pedersen's study, known as SEAS, were handled shows medical researchers basically doing things right, but it also reveals weaknesses in the way medical studies are monitored -- an issue that threatens to become more prevalent as industry and government do more to uncover drug side effects. . . .
Indeed. This one is going to keep on making headlines -- even if Schering-Plough performs absolutely admirably, from here on out.
2 comments:
Did you see the Yahoo business article on exchange rates?
"U.S. companies with significant European operations benefit when the U.S. dollar weakens. A stronger Euro or British Pound means more U.S. dollars when European currency denominated revenues are repatriated to the U.S. and converted to dollars. The opposite is true when the U.S. dollar strengthens.
Schering-Plough (NYSE: SGP - News) and Pfizer (NYSE: PFE - News) with 70% and 58% of total 2008 sales, respectively, coming from outside the U.S. were among the largest beneficiaries of a weaker U.S. dollar in the large-cap pharmaceutical space.
Schering's revenue benefited by about 6% through the first 9 months of 2008 (3% for the full-year), while Pfizer's revenue benefitted by about 4% over the same period (3% for the full-year).
Bristol-Myers (NYSE: BMY - News) is one of the least-exposed large-cap pharma companies to currency volatility with only 41% of revenues coming from overseas.
London, England-based GlaxoSmithKline (NYSE: GSK - News), which uses the British Pound as its domestic currency, has 60% of sales coming from outside of England and saw revenue benefit by 10% in 2008 and 19% in the 4th quarter due to currency translation.
The U.S. dollar continues to make gains against both the Euro and British Pound and is currently trading higher against both versus the levels at the end of 2008. If the trend continues, we would expect those U.S. companies that benefited the most from currency translation in 2008 to experience the biggest foreign exchange headwind in 2009."
Congratulations~~~on the observation and prior reporting!
Fabulous!
No, I actually missed it. Good to see that Fred's standard "bob and weave" is NOT "fooling all of the people, all of the time. . . ."
Thanks! And do stop back.
Namaste
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