In a stern editorial, the editors of the Journal of the American Medical Association write that industry-sponsored research should be analyzed by researchers without ties to the drugmaker that is developing the medicine being studied. And they argue at least one study author must indicate that she or he "had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis."
The missive was prompted by the recent US Senate Finance Committee report, which concluded that GlaxoSmithKline tried to undermine the scientific steering committtee on its own study of its Avandia diabetes pill and failed to acknowledge the drug increased the risk of heart problems. The editorial also pointed to commentary in the same JAMA issue by Steve Nissen, the Cleveland Clinic cardiologist, whose meta-analysis three years ago suggested problems with Avandia. In his JAMA piece, Nissen offers his take on the chain of events surrounding his original publication, including his interactions with Glaxo officials and their handling of their own RECORD trial, which Nissen claims raised questions about its integrity.
For its part, Glaxo has maintained Avandia was studied thoroughly and correctly, and its handling of the RECORD trial was appropriate. But the JAMA editors cite the RECORD trial as a "disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of (Avandia) reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm. Analyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first."
"It is now time for all editors to require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance,” wrote JAMA editorsl Catherine DeAngelis and Phil Fontanarosa wrote in the editorial. “This approach would add powerful support to the fundamental principle that physicians must first do no harm.” What do you think? Perhaps there is an argument to be made that this approach may raise unforeseen consequences? Share your thoughts...
Should industry-sponsored trials include independent statistical analysis
- Yes (84%, 82 Votes)
- No (16%, 16 Votes)
Total Voters: 98