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May 12, 2008

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.

Less Dictionary-Based Pain

Updated Phase Coding Tool

Updating Central Coding for InForm, Phase Forward tries to simplify the management of vital dictionaries like WHO Drug and MedDRA.

Fringe Movements

Ode To Abigail

With the Supreme Court putting a long-simmering case to rest, we take a look at the lessons of the Abigail Alliance.

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.

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Fringe Movements

Ode To Abigail

January 22, 2008

Last week, the U.S. Supreme Court declined to hear an appeal of another court’s rejection of the suit brought by The Abigail Alliance for Better Access to Developmental Drugs. We hope that legal defeat allows Abigail to rest. With any luck, the Supreme Court has slowed a quixotic and ill-informed… more...

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The V-Word

Merck’s Win, Industry’s Loss

November 26, 2007

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 approve the deal. But it appears to be a… more...

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Three Ticking Clocks

Bayer Halts Trasylol Sales

November 07, 2007

In another significant win for medical journal editors in their new role as regulators, Bayer suspended sales of anti-clotting drug Trasylol (aprotinin), which had been implicated in kidney failure, cardiovascular problems and mortality risk. The drug had approximately $135 million in 2007 sales. We have no special knowledge of Trasylol.… more...

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The Case For Outreach

Stopping Drug Safety Spin Cycle

October 12, 2007

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 resolved to outgrow that outlook. Then, as luck would… more...

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Quintiles Safety Spinoff

iGuard Post-Marketing Database

September 26, 2007

When something goes awry with a particular vehicle and it’s recalled, every consumer who bought one gets a notice in the mail. The way Hugo Stephenson sees it, prescription drugs should work much the same way. But they don’t. That’s why Stephenson, a drug safety expert, and Quintiles Transnational, where… more...

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A Chance To Give Back

Toward A Global Safety Network

September 10, 2007

There is an article in the British Medical Journal related to international aspects of drug safety in the developing world. ”Pharmacovigilance in the Developing World,” written by researchers in England and Ghana (Munir Pirmohamed, Kwame Atuah, Alex Dodoo and Peter Winstanley), points out the inadequacies of the networks for drug… more...

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New Diabetes Endpoints?

NEJM Hits Post-Approval Trials

September 05, 2007

Concerns about diabetes blockbuster Avandia have been addressed by the mass media, by FDA statements—and by the August 30, 2007, New England Journal of Medicine (NEJM). It’s not a surprise that the journal would have a negative view of the saga: its editors have recounted their perception of being mislead… more...

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New (Free) U.S. Guide To Phase IV

Outcome: Why Good Registries Matter

June 15, 2007

With Congress poised to legislate new mandates for post-approval studies, it seemed like a good time to talk to Richard Gliklich, the president of Outcome and a professor of surgery at Harvard Medical School. We covered his company’s substantive conference on what happens after drugs are approved here. Gliklich’s take-away… more...

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Gottlieb on FDA, Safety

Poking The Politicians

May 25, 2007

Former deputy FDA commissioner Scott Gottlieb left the agency not long ago, returning to the American Enterprise Institute (AEI). Since leaving FDA, the prolific Gottlieb has written a large number of essays and articles for a variety of publications. We’ve got one of them in PDF format below. ClinPage heard… more...

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FDA, Vertex CEO

News from BIO 2007

May 16, 2007

The 2007 BIO conference finished up last week in Boston. It was not our favorite conference, if only because of the unfocused nature of the agenda and the badly signed architectural failure (also called a convention center) in which the event took place. Perhaps next year, in San Diego, will… more...

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