Drugs

DTC Research Supports Disclosures on Endpoint Differentiation

New FDA research on direct-to-consumer (DTC) television ads found that study subjects have trouble differentiating progression-free survival and overall response rate from overall survival. The agency says research has suggested that disclosures can help consumers stop conflating overall survival with other endpoints. Such disclosures specifically state that the drug has not yet been shown to increase survival.

An FDA Web post highlighting the study results says that in the open-ended responses, “participants correctly described (and differentiated among) the three endpoints. However, when researchers asked participants whether the drug can help people live longer, subjects did not differentiate progression-free survival and overall response rate from overall survival when there was no disclosure.”

For example, FDA says that in a lung cancer DTC study, 90% of participants who viewed the ad with an overall response rate claim without a disclosure believed the drug would help people live longer, compared with 30% who watched the ad that contained a disclosure. Also, in a progression-free survival ad group without a disclosure, 93% of viewers said the drug would help people live longer; among the group with a disclosure, this number fell to 51%.

The agency concluded from its research that while participants in the different groups “understood the three endpoints and could differentiate among them, people still made inaccurate inferences. The findings show that people may be overly optimistic when they see ads with claims about overall response rate and progression-free survival without a disclosure stating that the drug has not yet been shown to extend life.” It further found that like previous studies “disclosures may convey important information, help correct potential misunderstandings and manage expectations about a drug’s benefits.”

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