September 6th, 2011
FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)
Larry Husten, PHD
FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers […]
September 5th, 2011
Base-Rate Neglect: A Common Clinical Fallacy
John E Brush, MD
Estimating probabilities subjectively can lead to indiscriminate testing.
September 4th, 2011
Montreal Heart Institute Researcher Fired After Investigation of Retracted Papers
Larry Husten, PHD
Zhiguo Wang, a researcher at the Montreal Heart Institute (MHI), has been fired less than a month after wide publicity over the retraction of two papers that he had coauthored, Retraction Watch reports. MHI director Jean-Claude Tardif said at a press conference that a hospital investigation had resulted in a recommendation that three more of Wang’s articles […]
September 2nd, 2011
Rosuvastatin Fails to Best Atorvastatin in IVUS Study of Atherosclerosis Progression
Larry Husten, PHD
AstraZeneca announced today that its lipid-lowering agent rosuvastatin (Crestor) was not superior to atorvastatin (Lipitor, Pfizer) in reducing the progression of atherosclerosis, as assessed by IVUS. The company announced the top-line results of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN), which is scheduled to be presented at the American Heart Association meeting in November. […]
September 2nd, 2011
When Patients Can’t Afford a Medication
Beth Waldron, MA
Editor’s Note: The following guest post by Beth Waldron is reprinted with permission from ClotConnect, a valuable resource for patients about blood clots and clotting disorders. Waldron is the program director of the UNC-Chapel Hill Blood Clot Outreach Program. Prescription Assistance: When Patients Can’t Afford a Medication Beth Waldron, Program Director of the Clot Connect project, writes…. Approximately 1 […]
September 1st, 2011
How Is TAVI Like a European Toaster?
Richard A. Lange, MD, MBA and L. David Hillis, MD
Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the “CE mark” — a mandatory conformity stamp for products placed on the market in the European Economic Area. Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the […]
September 1st, 2011
Paris or Orlando? A Tale of Two Cities
Larry Husten, PHD
‘ Paris, where the European Society of Cardiology is currently holding its annual meeting, is one of the world’s great cities. Orlando is the world capitol of medical meetings. Here are just a few of the differences. (Thanks as indicated for the suggestions.) Paris has a bewildering variety of long-distance trains, commuter trains, and subways. […]