Drugs

Medical Journals Need Better Conflict Disclosures: Article

Medical journals should beef up their transparency efforts regarding disclosures about the “relationships of authors to companies with financial interests related to topics they write about,” according to Public Citizen’s Health Research Group founder and senior advisor Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro. The two penned an article on STAT News that criticized the New England Journal of Medicine (NEJM) for publishing 11/2021 a commentary that strongly backed the drug industry’s position on drug pricing because it was authored by economists with drug company ties that were not adequately disclosed.

The NEJM article, “Drug-Pricing Debate Redux — Should Cost-Effectiveness Analysis Be Used Now to Price Pharmaceuticals?” contended that the appropriate price “is a drug’s value-based price, measured appropriately.” Wolfe and Shapiro complain that the commentary “echoes the views of pharmaceutical manufacturers, whose price increases regularly exceed the inflation rate and the actual rise in production and distribution costs. This argument gives pharmaceutical companies license to charge as much as they can extract, rather that something in reasonable relationship to what it costs them to produce the product.”

Wolfe and Shapiro say that the NEJM “failed to make clear to readers that the authors had profound conflicts of interest directly relevant to the content of the piece, involving corporations advocating for and benefitting financially from the point of view it expressed.”

They contend that journals should not be giving drug companies free advertising by publishing opinion pieces that promote the industry’s “socially regressive business strategy.”

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