Drugs

Many Journal Articles Not Reproducible, Transparent: Researchers

Some seven academic and government researchers in the U.S. say that despite a growing movement to encourage reproducibility and transparency practices in the scientific community, including public access to raw data and protocols, the conduct of replication studies, systematic integration of evidence in systematic reviews, and documentation of funding and potential conflicts of interest, most studies they reviewed failed to meet these criteria. Writing in the open-access journal PLOS Biology, the authors say they reviewed a random sample of 441 biomedical journal articles published in 2000-2014.

“Only one study provided a full protocol and none made all raw data directly available,” they report. “Replication studies were rare (just 4) and only 16 studies had their data included in a subsequent systematic review or meta-analysis. The majority of studies did not mention anything about funding or conflicts of interest…. Articles published in journals in the clinical medicine category versus other fields were almost twice as likely to not include any information on funding and to have private funding.”

The article expresses the hope that the survey will further sensitize scientists, funders, journals, and other stakeholders in science to the need to improve the indicators. “There are several efforts to improve reproducibility,” the authors conclude. “By continuing to monitor these indicators in the future, it is possible to track any evidence of improvement in the design, conduct, analysis, funding, and independence of biomedical research over time.”

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