FDA Panel’s Crestor Vote is More About CRP

Yesterday afternoon, Dec. 15, an FDA advisory panel voted 12-4 in favor of AstraZeneca’s application to broaden its labeling for rosuvastatin (Crestor) to include patients who meet enrollment criteria from the company’s large JUPITER study.
In short, the new indication would approve use of rosuvastatin for patients who have “normal” blood levels of LDL cholesterol (less than 130 mg/dL), but [...]

Pulling Back The Curtain on the FDA

From the FDA’s Public Meeting on Transparency at the National Transportation Safety Board Conference Center, Washington, DC
Outside of the C.I.A., the Food and Drug Administration (FDA) has been one of the most enigmatic federal agencies, inscrutable to the industries it regulates, a mystery to the public, and feared by executives at small publicly traded companies [...]

A Faustian Bargain?

From the FDA’s Psychopharmacologic Drugs Advisory Committee meeting, Silver Spring, MD
To strike a Faustian bargain is to trade your soul to the devil in exchange for limitless knowledge or power.  Some might say the FDA skirts the edges of such a trade-off with many of the decisions it makes on whether to approve a drug or [...]

Splashy Statisticians in Spotlight at ACC ‘09

 
From the annual scientific assembly of the American College of Cardiology, Orlando
Many of the biggest ooh’s and ah’s at this meeting were directed not at new blockbuster megatrial findings–those were in limited supply–but rather at groundbreaking study methodologies so dazzling even nonstatisticians were awed. It’s been a rare chance for the statisticians to take center stage and accept [...]

Safety and Efficacy First

From the meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee, Adelphi, Md. 
Like cost-effectiveness, convenience is on the list of topics that cannot be taken into account when a Food and Drug Administration advisory panel decides whether or not to recommend approval of a drug. But for the oral anticoagulant rivaroxaban, under review for the prevention of deep [...]

Drug Makers Tweeting About Their Tweatments?

From the Waggener Edstrom Worldwide webinar on the pharmaceutical industry’s hopes for, and fears about, tapping into social media in Washington, D.C.
The pharmaceutical industry, like many other sectors seeking a way to stay viable in a world where customers are becoming ever more elusive (um, like maybe journalism?), is dipping its toes into the brave [...]

Stemming the Diabetes Tide

from the American Diabetes Association’s annual advanced post-graduate course, New York
It’s pretty routine for a medical-meeting speaker–especially when starting the leisurely and lengthy type of lecture they gave at this meeting–to begin  by placing the disease in question in some sort of introductory context. The demographics of type 2 diabetes, mentioned several times during 2 days of talks here, are [...]

von Eschenbach: Regrets, I’ve Had a Few

FDA White Oak Campus, Silver Spring, Maryland.
In Food and Drug Administration Commissioner Andrew von Eschenbach’s final briefing with reporters, coming just one day after President George W. Bush’s final press conference, the Commissioner was asked if he, too, had any regrets about his three-year tenure.  “I regret I didn’t get here earlier,” the oncologist informed the ten [...]

Waiting for Febuxostat

The annual meeting of the American College of Rheumatology, San Francisco
Here at the annual meeting of the American College of Rheumatology, the talk between investigators is about how the Food and Drug Administration has stopped approving new drugs. This case of regulatory paralysis makes no sense, according to people who talked to me on the [...]