Whatever Happened To The ADA Request For Data From Pharma?

Last spring, the American Diabetes Association attempted to resolve a burning debate about the safety of various diabetes drugs called GLP-1 inhibitors by asking several drugmakers to release patient-level data that could be used for an independent review. At issue was whether a definitive link exists to developing acute pancreatitis and pancreatic cancer. The questions were raised after a pair of studies caused a stir. One study indicated that two widely used drugs – Merck’s (MRK) Januvia and Bristol-Myers Squibb’s Byetta – can double the risk of developing pancreatitis, which is an inflammation of the pancreas that is linked to cancer and kidney failure, an issue that has plagued both drugs over the past few years (more here). The other study found that in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. The findings were sufficiently concerning to prompt the FDA to begin an evaluation and for the National Institutes of Health to hold a two-day workshop to examine safety issues, although the outcome was inconclusive. Meanwhile, a watchdog group compared the drugs with a control group consisting of older treatments, such as metformin, and found the odds were roughly 25 times higher of developing either pancreatitis or pancreatic cancer. The Institute for Safe Medicine Practices examined 1,723 serious adverse events reported to the FDA between July 2011, and June 2012 for all GLP-1 ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs