Drugs

‘Alarming’ Trend in Schizophrenia Drug Trials

Retired CDER Division of Psychiatric Products director Thomas Laughren says a trend of increasing placebo response in trials of schizophrenia drugs should be “alarming not only to pharmaceutical companies and regulators but also to clinicians, the academic community, and of course patients and their families.” In a commentary on an article in the Journal of Clinical Psychiatry, Laughren says there are several aspects of drug study conduct that need to be explored in general as an approach to improving study outcomes.

He suggests that of the various potential factors to examine, patient selection may be the most important for the placebo response findings revealed in the article showing that the problem is primarily with North American trial sites.

According to Laughren, patient selection for North American sites could be an issue because sites are incentivized to recruit patients, but not for getting the “right” patient. He says that payment is generally for randomized patients and not for the quality of each patient selection. And he says the same is largely true for contract research organizations.

“There is no reason why incentives for improved quality in patient selection couldn’t be included in contracts,” Laughren says. “One would hope that oversight by companies and regulators would help to ensure quality over quantity in this process, but pharmaceutical company staff also face recruitment pressures that may outweigh the incentive to get the right patients. Regulators are too far removed from the actual process to have any meaningful impact.”

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