Most of the ClinPage podcasts are done in a pretty typical Q&A format. Today, however, we're posting a different type of audio: some snippets from the 2009 Clinical Trials Congress, held earlier this year. We thank the Institute for International Research (IIR), which organizes a fabulous conference every year, for their permission to do this. The speaker who made the deepest impression was Roy Vagelos, the former president and CEO of Merck. We've been thinking about his remarks for several months. His presentation hit two remarkable notes that remained with us. One in a major key. One in a minor key. Vagelos didn't mention any of the mega mergers affecting both Schering-Plough, which Merck is acquiring, or Wyeth, which is being swallowed by Pfizer. Big Shoes Instead, he told war stories. Some very good ones. Although his tendency is to downplay his own role and showcase the scientists who worked for…more...
Is this the year for mega-mergers? Merck will buy Schering-Plough for $41 billion in cash and stock. Merck had perennially insisted it would never merge or acquire rivals. But evidently the…more...
The most notable nugget from the Center for Business Intelligence’s (CBI) Arlington, Virginia meeting on patient-reported outcome (PRO) research late last month was not so much from the podium, though there…more...
Earlier this month, after months of negotiations, Merck announced a large but manageable $4.85 billion settlement of an unknown number of Vioxx plaintiffs who can prove they took the drug and suffered strokes or heart attacks. Those plaintiffs still have to approve the deal. But it appears to be a watershed win for Merck, which had tenaciously…more...
The math of adaptive trials is hairy. But the appeal is simple. Adaptive trials can reveal the optimal dose in a single trial—not six. They can identify dud drugs early. The approach can require significantly smaller sample sizes and save big companies billions of dollars. There’s just one mathematical fly in the clinical ointment. Adaptive trials will,…more...
Wondering whether to hire an MBA or an MD to head up global clinical development for your contract research organization (CRO)? You can always do what MDS Pharma Services did: get both—in one guy. He’s London native James Pusey, and he recently joined the King of Prussia, Pa.-based company as vice president and general manager of global…more...
We’ve been as surprised as anyone by the Wall Street Journal’s running baseball-style scorecards showing how many lawsuits Merck has won, lost and tied. It’s notable. Merck is using a starkly different strategy than the one that was popular not that long ago. Remember the Fen-Phen mess? That saga is about to have its 10th anniversary. It’s…more...
Our sense is that ordinary Americans could still be persuaded that the drug industry serves an important role in taking basic scientific research and delivering it to a local pharmacy or loved one. But the industry needs to produce its scientists and specify how its products improve life, save money and prevent surgery.
The Vioxx debacle continues.
Jury: “Wanton and willful disregard”
Dr. David Graham of the FDA once publicly estimated that Merck’s painkiller Vioxx had caused 160,000 heart attacks and strokes.
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