Rejecting Schering's Sugammadex
Pre-Election FDA On Lockdown
Mark Mansour of the Bryan Cave law firm says the FDA is on hold while America selects a president.
"Contagion" is one of the top films in America just now. It has been bested only by two movies at the box office—one about cartoon lions and another about a maid and her boss. "Contagion" is scary. It's a phlegm-filled tale about an Asian virus that infects the globe in a few days. School's cancelled, millions die. Yes, the National Guard takes over the country, but basically everything turns out fine. Matt Damon and his daughter survive to watch everything on TV. The last thirty minutes of "Contagion" are a sugary, Disney-worthy ending in contrast to this over-the-top British movie about an epidemic. Gwyneth Paltrow's character, a corporate executive, perishes in the first moments of "Contagion." Kate Winslet, playing an epidemiologist, lasts a bit longer. For inexplicable reasons, the movie's biggest male stars are immune to the deadly pig virus. One actor, secure in this gender-based immunity, gives precious, lottery-assigned medicine…more...
History records that after her husband was assassinated, someone asked Mrs. Abraham Lincoln about the theatrical production she had just seen. With all deference to Mrs. Lincoln, we are in a…more...
Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to…more...
If pharmacovigilance were a movie, it would be Groundhog Day, except as a tragedy. Here's the plot. Reports of adverse events (AE) pop up and take years to be evaluated. The…more...
So much for multimodal pain therapy. A leading proponent, anesthesiologist Scott Reuben, is watching his abruptly damaged reputation. The fraud continued for twelve years, from 1996-2008. More than twenty of Reuben's thirty peer-reviewed articles have been retracted or are being reassessed. It's a black day for peer review. The honor system. And anesthesiology. What industry critics will…more...
We’ve been sad lately. Once again, without explanation, our invitation to a presidential inauguration has been lost in the U.S. mail. We know that when the tears stop, as they eventually must, the emotional corner will have been turned. It’s not that Barack Obama is merely charisma—or some sort of electoral fluke. No. He’s a genuine visionary.…more...
As many readers know, the Supreme Court is considering the case of a Vermont musician, Diana Levine, who lost an arm when a physician assistant didn’t fully consider the label on a Wyeth anti-nausea drug. The legal debate is stark: can the FDA’s approval take precedence, or “preempt,” state courts hearing liability cases? Earlier this year, we…more...
Sydney “Syd” Wolfe, director of Public Citizen’s health research group, is scratching his head. Tequin (gatifloxacin)—an antibiotic that Public Citizen had campaigned against—was pulled from the market by its manufacturer, Bristol-Meyers Squibb (BMS). But BMS said that was because of lagging sales. That was two years ago. In September of this year, the FDA formally announced that…more...
Mark Mansour of the Bryan Cave law firm says the FDA is on hold while America selects a president.
The industry’s image takes another hit in Britain. Unsolicited advice on avoiding similar encounters.
Joseph Camardo spoke at the Post-Approval Summit at Harvard, and was wicked smart. Even so, what he didn’t say perturbed us.
A lawyer says litigation illuminates how the pharmaceutical industry thinks and conducts itself. A few forward-looking statements.
Reflections on the power of narrative and the industry’s wobbly reputation.
The first class action settlement for Vioxx is good news for Merck but will play out differently for industry.
Why the pharmaceutical industry’s ill-advised reliance on lobbyists will hamper its efforts to rehabilitate its reputation.
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