Friday, June 01, 2007

Avandia and the drive-by media

As I experience the barrage of hype about the Avandia meta-analysis the term drive-by media comes to mind. According to the Urban Dictionary drive-by media means---

Rush Limbaugh's term for the sensational, scandal-seeking, and agenda-driven coverage that is typical of the national press corps in America. Limbaugh draws an analogy between the media who cover a story with a barrage of unfair cheap shots before moving on to the next flavor of the month and an inner city gang that drives by and sprays a target with gunfire and then moves on to their next target.

Media coverage of Avandia that’s fair, that has any depth at all, would have to include these little known facts:

1) The ADOPT and DREAM studies did not show increased macrovascular risk for rosiglitazone. The small increase in cardiac events was attributable to heart failure precipitated by renal and metabolic effects leading to fluid retention and not indicative of an adverse macrovascular effect. The risk of fluid retention was previously known and is adequately addressed in current product labeling.
2) According to a recent Heartwire piece an interim safety review of the ongoing RECORD study reveals no adverse safety signal for rosiglitazone.
3) The same Heartwire article also notes that the data safety monitoring boards of two other ongoing rosiglitazone studies (BARI 2D and ACCORD) have found no safety concerns.
4) The landmark UGDP study, a randomized prospective trial of cardiovascular outcomes associated with various treatments for type 2 diabetes, showed a highly statistically significant increase in cardiovascular death associated with the first generation sulfonylurea tolbutamide compared to placebo or insulin. This was (according to product labeling) a greater than two fold increase in cardiovascular death, mind you, a finding much more concerning than those of the Avandia meta-analysis which found no statistically significant increase in cardiovascular death. Whether the currently popular new generation sulfonylureas carry similar risk is controversial---head to head studies haven’t been done---but the newer sulfonylureas carry the boxed warning. Here is the one for glimepiride (Amaryl). (Why aren’t the media mentioning a possible two fold increase in risk of cardiovascular death? Shouldn’t they be advising patients taking sulfonylureas to ask their doctor?).

Not all newspaper reports were so distorted. One Wall Street Journal report apparently got some things right. And the drive-by label is not restricted to newspapers. It could apply to medical journals and blogs when the shoe fits.

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