ADA's Ratner: We Expect Patient Level Data From All Drugmakers

Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs called GLP-1 inhibitors and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that generated considerable controversy. The outcome was inconclusive, but the FDA may want further studies. Meanwhile, the American Diabetes Association called for drugmakers that sell these meds to release patient-level data that can be used for an independent review (back stories here, here and here). Whether the drugmakers - Merck, Bristol-Myers Squibb, AstraZeneca, Eli Lilly, Novo Nordisk and Boehringer Ingelheim – will comply remains to be seen. With the exception of GlaxoSmithKline, the pharmaceutical industry has resisted releasing such data over concerns that proprietary information will be compromised. But ADA chief medical officer and chief scientific officer Robert Ratner believes they are now on the spot. We spoke with him about this decision… Pharmalot: Three months ago, when one study was first released, the ADA issued a statement that played down or at least sought to allay concerns. Now you want patient-level data. I don’t know if you would consider this an about face, but it’s certainly a change in tone. What happened? Ratner: Science is an iterative process and the way science unfolds, observations are made and hypotheses are tested and then it goes through peer reviews and is challenged. It takes a l...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs