The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks.
Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”
Here are some “talking points” from the editorial:
- at a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
- such findings damage all who are involved in clinical research, and will likely make funding, ethical approval, and recruitment more onerous for future studies
- trust between doctor and patient, researcher and participant, or author and editor is undermined when the foundations on which evidence is built are treated with such casual contempt
- nothing can completely protect against scientific misconduct
The Lancet reported that it has strived to encourage and use better and more transparent protocols, but that a recent audit of those protocols found that “adherence to protocols was ambiguous and selective.” Like a Tiger Woods apology (or a Jesse James apology, or a Michael Richardson apology, insert your celebrity here), they have vowed to do better, and have spent the past three years working with others on Standard Protocol Items for Randomized Trials (SPIRIT). Heck, just having an acronym makes me feel better.
But seriously—The Lancet is a good publication, and its heart is in the right place, I think. Hopefully they can turn this around and restore confidence in scientific studies and pharmaceuticals.