It would be hard to find a firm handling more electrocardiogram (ECG) data than ERT. The company handles 9 million ECG data points annually. Not long ago, the firm decided to do something about industry-standard ECG data error rates in the neighborhood of 80-90 percent. That's no typo. The typical error rates reflect the difficulties that all life science companies encounter—grossly antiquated methods of hand transcribing heart data to a piece of paper or an electronic system. New Process The resolution of even minor gaffes is costly, running perhaps $10 to $35 per error. On a human level, the correction can involve a few emails, phone calls or even a personal visit to a clinical site. ERT wondered if the ECG error rate could be slashed by 85 percent. To find out, the Philadelphia-based firm (with 650 employees and $141 million in 2010 revenues) sat down and tried to rethink everything.…more...
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…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 the industry, we banged out an email to Scott Evans. He’s a senior research scientist in Harvard University’s School of Public Health. He teaches biostatistics 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...
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...
The FDA’s Sandra Kweder talks about Vioxx, a consultant’s study of its process, and how that process is about to be standardized across all sections of CDER. A report from the 2007 RAPS conference for regulatory affairs pros.
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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