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October 10, 2008
Database Finds 150K Patients
In Silico Studies By i3 Innovus
The health outcomes division of the i3 brand discusses trials that are professionally designed and run on the computer.
IND Ethics Loophole
Circare: Academic Patient Advocate
University of Maryland physicist Adil Shamoo, founder of CIRCARE, says there are gaps in existing law that leave patients exposed.
Shark Repellent
Empirica From Phase Forward
A new name for the safety products from Phase Forward, plus insights into faster responses to safety crises.
A-List Of Speakers At Harvard
Post-Approval? Or Pre-Apocalypse?
With Mark McClellan and Janet Woodcock on the agenda, the Outcome meeting will be another illuminating event this year.
Strategies from Wyeth, Actelion & Pfizer
CTC 2008: Proactive Risk Abatement
A report from the Clinical Trials Congress about risk. One message: start a regulatory conversation early. And consult your preclinical team.
Maybe it’s the medical school ambiance. Or the end of a long Boston winter. But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings. It’s a little cozier. More intimate. The conference is held in the spring in an auditorium at Harvard Medical… more...
Talk about a rock and a hard place. Once drugs reach the market, or as a condition prior to approval, the industry’s handling of risk is caught between the needs of regulators, shareholders and public. At the 2008 Clinical Trials Congress, held in Orlando, there were signs that the burdens… more...
When will the drug safety wars end? How will they end? A new president? A Supreme Court decision? We thought Tom Lamb might know. He’s an attorney based in Wilmington, North Carolina. Like it or not, lawyers like Lamb are shaping the perceptions of the pharmaceutical industry and clinical trials.… more...
With the Oscars upon us, it’s time to reflect on something simple. Our brains store information and make sense of the world in stories. This is true in all cultures, all individuals. “She saved my career.” “They worked it out.” Homo sapiens specialize in stories. Stories are a more basic… more...
There has never been a time in the pharmaceutical industry when the coding of adverse events was more pivotal. The industry is not quite to the point of knowing that three identical events will trigger a product withdrawal. But it’s close. In that context, Phase Forward last week updated its… more...
Last week, the U.S. Supreme Court declined to hear an appeal of another court’s rejection of the suit brought by The Abigail Alliance for Better Access to Developmental Drugs. We hope that legal defeat allows Abigail to rest. With any luck, the Supreme Court has slowed a quixotic and ill-informed… 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… more...
In another significant win for medical journal editors in their new role as regulators, Bayer suspended sales of anti-clotting drug Trasylol (aprotinin), which had been implicated in kidney failure, cardiovascular problems and mortality risk. The drug had approximately $135 million in 2007 sales. We have no special knowledge of Trasylol.… more...
A few years ago, thinking the way all journalists think, we had an epiphany. The reportorial brain is the one we’re happily stuck with. But it often adopts a harshly negative, critical outlook that transcends age, geography and political affiliation. We resolved to outgrow that outlook. Then, as luck would… more...
When something goes awry with a particular vehicle and it’s recalled, every consumer who bought one gets a notice in the mail. The way Hugo Stephenson sees it, prescription drugs should work much the same way. But they don’t. That’s why Stephenson, a drug safety expert, and Quintiles Transnational, where… more...
