Drugs

Probe Leqembi, Kisunla Trials: Public Citizen

Citing New York Times 10/23 reporting that participants in two Alzheimer’s drug trials were not told if their genetic profiles indicated a higher risk of brain injuries from the drug, Public Citizen is calling on FDA and the HHS Office for Human Research Protection (OHRP) to look into how Eisai conducted the Leqembi (lecanemab) trial and how Lilly conducted the Kisunla (donanemab-azbt) trial. “The requirement under federal regulations to obtain informed consent before involving individuals in research is a fundamental protection for research subjects,” said Public Citizen Health Research Group director Robert Steinbrook. “The revelations about the secrecy provisions in the Alzheimer’s disease trials suggest that the principles of informed consent were undermined. If subjects had known that they were at higher risk of brain injuries, they might have decided not to participate in the trials.”

The Times reported that trial participants had to sign consent forms that said that people with certain genetic profiles faced higher risks. They were told they would be tested for the genetic markers, but would not be given the results. The article described adverse events experienced by some participants, including death.

Steinbrook said FDA and OHRP should formally investigate the conduct of the two trials and the actions of the institutional review boards with oversight over the studies. He said both drugs were approved with “very modest” clinical benefits that do not outweigh their substantial safety risks, including brain swelling and bleeding. “FDA should not have approved either drug,” he declared.

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