Drugs

Use Data-Driven Approach to Drug Analysis: Researchers

Researchers from the University of Chicago Booth School of Business say if FDA were to use a more data-driven approach in its postmarket drug analysis, there would be fewer cases in which safe drugs are wrongly penalized. To make their point, the researchers used different data to reanalyze the risk of heart problems with GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone).

The study reports that FDA relied in 2007 on a meta-analysis to determine that Avandia could increase the risk of heart problems. After FDA described its findings, the use of the drug dropped by 78% over 15 months. “Had FDA used a more-data driven approach to the postmarket drug surveillance,” the researchers say, “they would have found a different verdict on this drug.”

For their review of Avandia, the researchers compiled Veterans Administration data for more than 320,000 diabetes patients over eight years. They found that Avandia was not associated with major coronary events, and when patients taking Avandia were matched exactly with patients not on the drug, Avandia was associated with fewer deaths and lower mortality, and not associated with any kind of adverse coronary events.

Lead researcher John Birge says FDA is “somewhat passive” in how it collects adverse drug event data. He says that much of the adverse event information the agency receives is submitted voluntarily and cites studies indicating that 94% of adverse events are not reported.

“So, if we see maybe a few rare events that are reported,” Birge says, “FDA may think that those are more common than they actually are and may react to them more severely than they would otherwise.”

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