Twenty six patients. Eleven patients. Three patients. Despite the billions spent on clinical research, regulatory decisions often boil down to adverse events in a handful of patients. There are widely divergent views on whether the small numbers are statistically sufficient. But no one would argue that casting a wider net could be good for science, industry and the public. So it was auspicious to see that Phase Forward‘s safety software group, formerly known as Lincoln Technologies, has begun working on a project with FDA and the Pentagon. The effort is using the Waltham, Mass., company’s Empirica software to dip into a dataset of 12 million-patients, those in the U.S. Army and their dependents. Big File “The program will be managed by the Pharmacovigilance Center of the Office of the Surgeon General of the Army, which oversees medical benefits programs for Army personnel,” the December, 2008, Phase Forward press release notes. Chan…more...
Next time you write an email at work, imagine an aggressive prosecutor looking over your shoulder, ready to take your words out of context. His main aim: To besmirch you and…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…more...
Not long ago, on a bleak winter morning when the U.S. Congress and the New York governor and the Connecticut attorney general and the second most important medical journal were trashing…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...
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. All we can say is that for…more...
At the annual conference of the Regulatory Affairs Professionals Society (RAPS), held in Boston last week, the FDA’s Sandra Kweder (deputy director of the Office of New Drugs in CDER) gave a well-attended talk packed with sugary rhetoric. Such statements could be taken as indicating that nothing will change in the agency’s stance toward the industry. But…more...
Sitting there at the 2007 Regulatory Affairs Professional Society (RAPS) conference in Boston, we had a premonition. It turned out to be Bob Dylan, circa 1965: “Something is happening here but you don’t know what it is.” We couldn’t tell if Sandra Kweder was trying to relieve some of the pharmaceutical industry’s fears about a newly harsh…more...
A Quintiles offshoot has created an online drug-safety hub which simultaneously offers nifty color-coded warnings to consumers about their prescriptions and a potentially valuable post-marketing research tool for the industry.
News for Tuesday, May 22.
A senior FDA official tells the Post-Approval Summit what the agency is going to do and would like to do in the post-Vioxx era.
An article in the Harvard Business Review in February 2007 outlines the mistakes of companies that do not engage the media, and offers a prescription for regaining a good public image.
A federal judge is irritated with the media and orders a lawyer and physician to return secret documents that have already been widely posted on the web.
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.
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