Drugs

New England Journal Under Attack

The New England Journal of Medicine, considered by many to be the best known and most venerated such journal in the world, is now the subject of concerns that it is slipping in relevancy and reputation, according to a ProPublica report co-published with the Boston Globe The report discusses a number of well-publicized feuds with prominent medical researchers and former Journal editors over whether the publication and its current leadership have resisted correcting errors and lag behind others in an industry-wide push for more openness in medical research. Critics also say that dissent has been dismissed with a paternalistic arrogance.

NEJM editor-in-chief Jeffrey Drazen told ProPublica that the criticisms are misguided. He said the goal is always for the research that the Journal publishes to be accurate, while its editorials are designed to be “controversial” as a means of inciting discussion.

“If there’s anything that I have a passion for, it’s getting it right,” Drazen said. “We work very hard at that. We’re not arrogant. We’re not dismissive.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome