Controversial, Ill-Fated Obesity Drug Trial Published In JAMA

The final– but now largely useless– results of the cardiovascular safety trial of the obesity drug Contrave have now been published in JAMA, one year after the trial’s dramatic and scandalous crash and burn. By way of background: Contrave is a combination of naltrexone and bupropion marketed as a weight loss drug by Orexigen and…

Click here to continue reading…

Third Strike For CETP Inhibitors: Lilly Halts Big Evacetrapib Trial

For the third time a large trial testing a CETP inhibitor drug has gone down the tubes. On Monday morning Eli Lilly announced that it had terminated ACCELERATE, its large phase 3 trial of the drug evacetrapib. The company said the trial was stopped “due to insufficient efficacy” and that the company planned to discontinue…

Click here to continue reading…

Califf, Nissen, And Others Agree And Disagree About Regulatory Standards

Everyone agrees. A panel of US and European cardiologists, regulators, and industry executives agreed broadly that regulatory standards for drugs and devices need to be rigorous enough to prevent harm to patients. And, they also agreed, the standards shouldn’t be so strict that they stifle innovation. The problem, of course, is how to find the right…

Click here to continue reading…

Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs

(Updated) Does Steve Nissen, an outspoken critic of inappropriate industry influence in medicine, have his own conflict of interest problem? This week Nissen, the chief of cardiology at the Cleveland Clinic, was widely quoted in news reports about the FDA advisory panels evaluating two new highly promising cholesterol drugs from Amgen and Sanofi/Regeneron. Nissen was broadly supportive of the drugs….

Click here to continue reading…

Takeda Disagrees With Orexigen Over Data Disclosure

(Updated) On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does not support the release of the interim data. Here is the Takeda statement: “Pursuant to the Collaboration Agreement between…

Click here to continue reading…

Orexigen Released Interim Data Without Approval Of Trial Leaders

Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. (You can read a good summary of the findings by Adam Feuerstein on TheStreet.) The surprising thing about the Orexigen disclosure, which was contained in a Form…

Click here to continue reading…

Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone

An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary two-day FDA advisory committee meeting next…

Click here to continue reading…

Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at…

Click here to continue reading…

Controversial NIH Chelation Trial Published In JAMA

Final results of the troubled NIH-sponsored TACT trial testing chelation therapy for coronary disease have now been published in JAMA. Last November, when the preliminary results were presented at the American Heart Association meeting, the positive finding in favor of chelation therapy surprised many observers, though the investigators and senior AHA representatives expressed considerable caution  about the proper…

Click here to continue reading…