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March 16, 2010

Reuben, Baystate, Pfizer

Exclusive: Fraud Postmortem

A research scandal at a Tufts facility shows that peer review cannot identify scientific fraud quickly.

Rx For 2009

Obama’s Biggest Problem

Reflections on the new year and what pharma should do to avoid a pounding from politicians.

Frustrated Justices

Supreme Court Mulls Drug Labels

A recent Supreme Court discussion suggests the high court can’t get its head around current label regulations.

Public Citizen Gadfly

Wolfe on FDA, Tequin

Public Citizen’s health research advocate Sydney Wolfe talks turkey on the antibiotic Tequin and the possibility of change at the FDA.

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Reuben, Baystate, Pfizer

Exclusive: Fraud Postmortem

March 20, 2009

By Mark Uehling

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 More than twenty of Reuben's thirty peer-reviewed articles have been retracted or are being reassessed.…

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Rx For 2009

Obama’s Biggest Problem

January 15, 2009

By Mark Uehling

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…

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Frustrated Justices

Supreme Court Mulls Drug Labels

November 20, 2008

By Mark Uehling

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…

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Public Citizen Gadfly

Wolfe on FDA, Tequin

November 04, 2008

By SuzR

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…

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Rejecting Schering's Sugammadex

Pre-Election FDA On Lockdown

August 06, 2008

By Mark Uehling

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…

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Rocket Man

On NASA, BBC and GSK

June 03, 2008

By Mark Uehling

Is there a more wasteful federal program than NASA? Does it matter if a robot can land on some planet and take a picture of itself digging a small hole? It’s clear that NASA is both useless and popular. Which is…

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Business As Usual

Wyeth on FDAAA

May 20, 2008

By Mark Uehling

Because of the random sighting of Ira Spector at one conference or another, we’ve always had a soft spot for Wyeth. We don’t know Spector—no need to fret he has been consorting with the news media. But from remarks by Spector…

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Litigation Into Perpetuity?

Drug Safety: A Lawyer’s View

March 05, 2008

By Mark Uehling

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 Carolina. Like it or not, lawyers like Lamb are shaping…

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Trasylol, Bayer & Three Mile Island

Drug Safety Story Time

February 22, 2008

By Mark Uehling

With the Oscars upon us, it’s time to reflect on something simple. Our brains store information and make sense of the world in stories. This is true in all cultures, all individuals. “She saved my career.” “They worked it out.” Homo…

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The V-Word

Merck’s Win, Industry’s Loss

November 26, 2007

By Mark Uehling

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…

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The Case For Outreach

Stopping Drug Safety Spin Cycle

October 12, 2007

By Mark Uehling

A few years ago, thinking the way all journalists think, we had an epiphany. The reportorial brain is the one we’re happily stuck with. But it often adopts a harshly negative, critical outlook that transcends age, geography and political affiliation. We…

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Post-Approval Summit

Politician, Serono Speak at Meeting

May 02, 2007

By Mark Uehling

The Post-Approval Summit at Harvard, now in its third year, is the most cerebral conference on our calendar. It is also the meeting most larded with VIP speakers, including a preponderance of physicians who run a) large swaths of international companies…

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Nonsense About Ketek

Ex-PPD Employee Testifies

February 14, 2007

By Mark Uehling

There’s another wrinkle in the Ketek story. The Wall Street Journal reports on the Congressional testimony of Ann Marie Cisneros. She’s a former employee of Pharmaceutical Product Development (PPD), a leading contract research organization with $1.26 billion in revenues in 2006.…

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Themes For 2007

The Demonization of Pharma

January 02, 2007

By Mark Uehling

In the aftermath of 9/11, Newsweek did a cover story on the roots of Islamic hostility to the U.S. That story was titled “Why They Hate Us.” As 2007 begins, the same unsettling question can be asked of the life sciences.…