Drugs

Many Advertised Drugs Have Low Therapeutic Value: Study

Researchers at Harvard, Yale, and Dartmouth say their analysis of the therapeutic value (whether they represent advances over existing treatments) of drugs subject to the most direct-to-consumer advertising from 2015 to 2021 found that fewer than one-third of the most common drugs featured in DTC ads were rated as having high therapeutic value. “We used the most favorable therapeutic value rating at any point since approval,” the researchers say in a JAMA Network research letter, “which may overestimate the proportion of higher-benefit drugs.”

Therapeutic value ratings were obtained from independent health technology assessment agencies of Canada, France, and Germany, the article says, and defined ratings of moderate or greater therapeutic value as high therapeutic value. The ratings consider drugs’ added benefit, safety, and strength of evidence, as compared with existing therapies.

They write that one explanation may be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have greater incentives to promote drugs of lesser value.

“Policy makers and regulators could consider limiting DTC advertising to drugs with high therapeutic or public health value or requiring standardized disclosure of comparative effectiveness and safety data, but policy changes would likely require industry cooperation or face constitutional challenge,” the authors conclude.

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