Catchup from last week: Dartmouth’s Steve Woloshin and Lisa Schwartz had a New York Times op-ed piece last week, “Think Inside the Box,” promoting their terrific idea of “a simple model” for conveying “independent, plain-English facts” about prescription drugs. They write: “The government should follow through on proposals to require fact boxes, similar to those [...]
Dr. Len Lichtenfeld of the American Cancer Society, who drew raves on Twitter today for tweeting from the FDA meeting about whether Avastin should be allowed for the treatment of metastatic breast cancer, also blogged about his day’s experience. “As one might expect, the experience ran the gamut from deeply felt emotions to cold hard [...]
On Maggie Mahar’s Health Beat Blog, see Naomi Freundlich’s piece, “New Health Indicators Site is a ‘Treasure Trove’ of Valuable Data.” On the Dose of Digital blog, see Jonathan Richman’s excellent analysis, “Lies, Damn Lies, and Pharma Social Media Statistics.” The FDA has announced a webinar for next Thursday (April 28) on its “Bad Ads [...]
Alicia Mundy of the Wall Street Journal reports: “Federal officials Tuesday questioned companies that make six cancer drugs about their failure to complete follow-up studies they promised to conduct in exchange for accelerated approval.” The story reminds readers why these promised follow-up studies are essential: “The meeting took place in the shadow of a recent [...]
Journalists Shannon Brownlee and Jeanne Lenzer published an important article in the BMJ entitled, “Why the FDA can’t protect the public.” Much of their emphasis was on medical device makers failing to properly conduct safety studies before or after marketing approval. On the local level, another fine example of TV reporting came from Jeff Baillon [...]
That’s the way Merrill Goozner analyzes the Avandia story – a terrific analysis focusing on the fact that “The Food and Drug Administration today slapped new restrictions on GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone), while the European Union suspended its marketing entirely.” Read the entire column – a GoozNews gem.
Only so much to say about this story. It’s about Senator David Vitter of Louisana. He says that an FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer is “essentially government rationing.” The WSJ reports: New studies presented to the panel showed more side effects among women being treated [...]
The New York Times had an important story that “highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices. …Those with the most to lose are the hundreds [...]
While we recover from the news that flibanserin was unanimously rejected by a vote of an FDA advisory panel because the data didn’t match some of the hyped claims, let’s catch up on some stuff the FDA caught about the marketing of drugs it had already approved. The Dow Jones Newswire reports: “The U.S. Food [...]
The AP reports: “…members of the Food and Drug Administration’s reproductive drugs panel voted 11-0 that the drug’s benefits did not outweigh side effects, including fatigue, depression and fainting spells. Flibanserin failed to increase sexual desire, as recorded by women in daily journals, in two company studies. The FDA will make its own decision on [...]
This story focuses on a family that may have a rare genetic mutation that increases their risk of heart disease. Unfortunately, the “rare” part wasn’t mentioned until 1,600 words into this 2,100 word story.
While this story adequately addressed 7 of our 10 criteria, the 3 on which it missed were significant omissions, yet could have been easily addressed.
Solid medical conference reporting, with many expert interviews and good context provided. Goes far beyond the conference presentation itself.
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