September 3, 2010demonization

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Compliance? Huh?

Are Academics Competent?

August 05, 2010

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 similarly stunned state of mind after talking to Kit Howard, principal of Kestrel Consultants. Based in Michigan, with a Canadian's calm demeanor, Howard speaks in methodical, reasonable cadences. There's no rancor. But oh, my—it's a hot topic. Howard's career includes working at and consulting for some of the largest firms in the industry. Lately, she's been helping academic medical centers. And she's been surprised, to say the least, by what the bow-tied physician-experts at medical schools actually know about, um, well, clinical trials and GCP. 21 CFR Part 11. Minor stuff. Details. Seeking Rigor If Howard is right, major medical schools, by relying on self-reinforcing reputations of high rectitude, have been held to a far lower standard of clinical research…more...

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Pfizer's Michael Ibara

Toward A Neutral AE Facilitator

April 23, 2010

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...

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Pfizer's Warning

Starting Over On Safety

April 22, 2010

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...

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Reuben, Baystate, Pfizer

Exclusive: Fraud Postmortem

March 20, 2009

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…more...

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Rx For 2009

Obama’s Biggest Problem

January 15, 2009

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...

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Frustrated Justices

Supreme Court Mulls Drug Labels

November 20, 2008

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...

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Public Citizen Gadfly

Wolfe on FDA, Tequin

November 04, 2008

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...

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Rejecting Schering's Sugammadex

Pre-Election FDA On Lockdown

August 06, 2008

A while back, we checked in with someone who makes a living suing the pharmaceutical industry. This week, we worked the other side of the street, chatting with Mark Mansour of Bryan Cave, where he runs the FDA practice group in the firm’s Washington, D.C. office. Mansour has been perplexed, he reports, at the non-approvable letter that…more...

Rocket Man

On NASA, BBC and GSK

The industry’s image takes another hit in Britain. Unsolicited advice on avoiding similar encounters.

Business As Usual

Wyeth on FDAAA

Joseph Camardo spoke at the Post-Approval Summit at Harvard, and was wicked smart. Even so, what he didn’t say perturbed us.

Litigation Into Perpetuity?

Drug Safety: A Lawyer’s View

A lawyer says litigation illuminates how the pharmaceutical industry thinks and conducts itself. A few forward-looking statements.

Trasylol, Bayer & Three Mile Island

Drug Safety Story Time

Reflections on the power of narrative and the industry’s wobbly reputation.

The V-Word

Merck’s Win, Industry’s Loss

The first class action settlement for Vioxx is good news for Merck but will play out differently for industry.

The Case For Outreach

Stopping Drug Safety Spin Cycle

Why the pharmaceutical industry’s ill-advised reliance on lobbyists will hamper its efforts to rehabilitate its reputation.

Post-Approval Summit

Politician, Serono Speak at Meeting

Two divergent presentations at the Post-Approval Summit at the Harvard conference this week in Boston.


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