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【drug-news】福布斯杂志载文分析先灵CEO, Fred Has
Fred Hassan is pharma's best trauma surgeon. But sutures are popping on his latest patient.
Until a few weeks ago Fred Hassan was God's gift to the pharmaceutical industry. In his career he'd made a decades-old drug invulnerable to generic rivals, made Pharmacia so desirable Pfizer (nyse: PFE - news - people ) had to buy it and had turned Schering-Plough (nyse: SGP - news - people ) from a cash-hemorrhaging criminal into a jewel of a stock.
Then he botched the handling of a study of his most important product, the Schering-invented cholesterol drug Zetia that is also the basis for the combo pill Vytorin. The two generate $5 billion a year (profits are split 50-50 with Merck (nyse: MRK - news - people )) and are prescribed 100,000 times a day. Until recently Merck and Schering were saying the franchise would add $1 billion in sales this year and $1 billion next. Not likely.
As FORBES was first to report in November, Schering has been futzing for 18 months with this comparison study, which ended up showing that these expensive pills were no better at clearing out artery gunk than a generic statin. The study is not definitive, but it raises doubts about Zetia's effectiveness. "I took my mother off it," says David Brown, head of cardiology at SUNY Stony Brook Medical Center. The long delay has sparked a Congressional investigation into Schering's scientific conduct, the stock sales of its executives and its $150-million-a-year Vytorin ad campaigns.
Hassan's defense? Schering didn't mean to do anything wrong, and he doesn't know exactly what went wrong. "I'm quite sure nobody had bad intentions," says Hassan, 62. "Why didn't it happen on time as it should have? I don't have the answers."
The excuses are thin. Either Schering deliberately delayed a result it suspected would be bad or Hassan's team incompetently failed to realize that they were sitting on a time bomb. Since FORBES' first report on Nov. 19, Schering shares have given up 12 months of gains.
Schering's case reveals the ugly reality of the pharma business. Lacking genuinely new medicines or definitive proof that their costly, patented drugs work better than cheap ones, producers are forced to turn minor marketing advantages into billion-dollar opportunities. Hassan's great at this. At Pharmacia he made the urinary-incontinence pill Detrol a bestseller. At Schering it was Nasonex, a me-too allergy nose spray that had been ignored under his predecessor.
"You can always wish you had the next big thing," he says. "But if you approach it in the right manner, you can get a lot of traction with what you have."
Zetia was, in fact, a breakthrough for patients who can't get their cholesterol low enough with other drugs. But Schering pushed far beyond that use without proving that the drug prevented heart attacks, strokes and deaths--the cardiologist's gold standard that statins such as Pfizer's Lipitor have passed. Now this delayed study shows that even pharma's Mr. Fix-It can't run a straightforward operation.
Hassan will have to defend himself from now on against the same accusations that have crushed pharmaceutical companies since Merck's Vioxx was yanked from the market in 2004. Doctors and politicians want more transparency, meaning no sweeping of disappointing trials under rugs. They don't trust pharma anymore. Merck hadn't disclosed key results or started a big study to prove Vioxx's safety. GlaxoSmithkline's Avandia, for diabetes, was torched after buried studies pointed to an increased risk of heart attacks. Glaxo threatened one of its academic critics with a lawsuit. A recent issue of the New England Journal of Medicine says that, when unpublished studies are included in the statistics, it turns out that certain mainstream antidepressants are not as effective as they seemed.
"What's very important to us is our integrity, our reputation and the robustness of what we do," says Hassan. "It's not the actual trial. This thing runs on trust, and we'd like to say Schering-Plough is a very improved company since 2003."
Schering says there were problems with the way the data from the study were collected and analyzed, and that it needed all this time to fix those problems. Susan Wood, a professor at George Washington University and former Food & Drug Administration official, doesn't buy that. "You can't just say, 'Wait, we'll fix it,'" she says. "You have to get it out and let people decide." Says Representative Bart Stupak (D--Mich.), who is leading the House investigation: "Somewhere in here these companies have ethical and moral obligations to cardiologists and patients."
Schering was calling in outsiders to look at the artery images and trial data starting in the spring of 2006, and a year later the lead investigator complained to colleagues that the situation with the study was "a mess." Robert Califf of Duke University, who is conducting a larger study for Schering and takes Zetia, calls it "a Bill Buckner type of study," after the hapless Boston Red Sox first baseman.
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作者:admin@医学,生命科学 2011-04-07 18:34
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