Drugs

Study on Physician Use of Off-label ‘Unsupportive Data’

Just published data from a study on the influence of data disclosures on physician decisions about off-label uses suggest that there is limited awareness of, and exposure to, unsupportive data about off-label uses among physicians. Writing in the journal BMC Primary Care, CDER Office of Prescription Drug Promotion research analyst Katherine Aikin and researchers at Westat write that it is “unclear whether this is due to a lack of published studies containing unsupportive data, a lack of information seeking, or other reasons. Regardless of the reason, it appears that the information physicians receive about off-label use tends to support that use, so finding ways to increase awareness of existing unsupportive data may be beneficial.”

The researchers note that the study examined one option, a short disclosure statement that provided brief information about the existence of unsupportive data, and tested three versions of that statement, each with varying amounts of information. “Although more research is needed, particularly regarding the ideal amount of information to provide, our study suggests that even a brief statement about unsupportive data may influence prescribing decisions,” they write. “Using the information we gathered in this qualitative study, we will continue to explore this topic in a subsequent experimental study that will test the impact of disclosure statements with a larger sample of physicians.

Additionally, the researchers say further studies could also “examine nuances within the safety and efficacy of the unsupportive data or different levels of evidence supporting that data. Although some research shows physicians can correctly identify low methodological study rigor, other research suggests that they are not good at determining if data are of high enough quality to support a clinical decision. It would be useful to explore physicians’ ability to identify and understand poor quality unsupportive data, and the influence these factors have on their prescribing behaviors. More research is also needed to better understand the ideal amount of detail to provide, and reasons why physicians are not typically aware of unsupportive data.”

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