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"Peggy" Hamburg Officially Launches FDA Transparency Initiative


FDA has launched its new transparency initiative, promoting it in this just-released video with Commissioner "Peggy" Hamburg. Perhaps using her familiar name, rather than Margaret, is Hamburg's small way of letting the transparency begin.

--Paul Thomas

 


Could Pharma Use a Dose of Paranoid Leadership?


I took time this morning to listen to a podcast interview with MIT Sloan professor Steven Spear on what characterizes “high velocity” organizations. (Spear is the author of “Chasing the Rabbit: How Market Leaders Outdistance the Competition,” and a new book called "The High-Velocity Edge".) Such organizations, Spear says, are able to effect dramatic improvements within extremely short windows of time.


GSK Whistleblower to 60 Minutes: The "Decline and Cancer" Had to Be Stopped


The 60 Minutes interview with GSK whistleblower Cheryl Eckard is now available online here, after airing on CBS last night. Eckard primarily discusses the mixup of drugs at the Cidra, Puerto Rico facility and her efforts to not only stop outgoing shipments but to have the plant shut down.


Come On Now, Cellulose and Iron Are Good for You


The public and drug regulators have misunderstood J&J's helpful attempts to include supplemental dietary ingredients in its products, forcing the company to recall Rolaids in the U.S. and Canada.

I need my Rolaids. What's wrong with iron filings? The human body needs iron. And there's a helluva lot of fiber in wood, too. Isn't fiber good for you? As to the crystallized sugar, don't it help the medicine go down?


Deadly Medicine: A Look at Clinical Trials Overseas


A thought-provoking (if not unbiased) article from an unexpected source, Vanity Fair.


Merck's Frazier: Joining the Ranks of the "Scientifically Illiterate"?


Fewer and fewer of the men (and occasionally women) that are chosen to head up drug companies come from a scientific background. Most are businesspeople by trade, or perhaps accountants and economists. Merck's incoming CEO Ken Frazier, who takes over for Richard Clark upon his forced retirement at 65, is a lawyer. This expertise has come in handy in helping the company navigate the Vioxx crisis.


Harris Poll: Pharma a Bit More Trustworthy, But in Need of More Regulation?


Harris Interactive has just come out with results of its annual poll of which industries are the most trusted in the eyes of the public. Pharma, once high on the list, took a deep dive over the past decade (languishing in near-Tobacco territory), but has in the past few years bounced back in public perception.


Are More Pharma cGMP Whistleblower Cases on the Way? Experts Think So.


Most of the U.S. Department of Justice’s major pharma-related decisions invoking the False Claims Act recently have involved illegal marketing and sales. So far, GSK’s is the only one to deal with current good manufacturing practices (cGMP’s).  Read on for a roundup of the top 20 recent cases from Taxpayers Against Fraud (TAF).


Lady Gaga and Beyonce's GSK Song


Uberblogger Pharmagossip and the expert satirist Pharmagiles recently posted riffs inspired by the GSK whistleblower case, with Pharmagiles setting the lyrics to Harry Belafonte's famous Banana Boat Song. Click here for a view.


The Lean Novel: Free Audiobook Chapter from "The Gold Mine"


A novel about Lean Manufacturing?  Not as strange as it may sound. After all, Lean visionary Frank Gilbreth, who, together with his wife Lillian, and Frederick Taylor, is credited with inventing time motion studies, wrote the somewhat fictionalized memoir "Cheaper by the Dozen." It was nothing like the recent movies....
A few years ago, we heard of a science fiction novel on Lean and ISO.