The FDA apparently thinks that physicians should continue to prescribe Avandia. Which in a regulatory sense may make a difference, but practically will any clinician still prescribe Avandia?
Key sentence from the article: "Avandia global sales last year were $3.4 billion, but they have plunged since May."
Look, Avandia may or may not significantly increase heart attacks or deaths from cardiovascular deaths. The main Nissen and Wolski article shows increased odds risks for both:
In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06).
But as we've already seen, odds ratios less than 3 may not be so clinically relevant and the second confidence interval crosses 1, rendering it statistically insignificant.
Nonetheless, what can be shown from the study is that while Avandia may only possibly increase harm, Avandia for sure does not decrease myocardial infarcts or deaths. From an outcome standpoint, then, it may not benefit diabetics. Meaning, even if the blood sugars of diabetics are better controlled by Avandia, that may not decrease a patient's chance of a cardiovascular death while using the drug.
Couple that with clinicians' fear that they might eventually get sued for prescribing Avandia, and it now becomes radioactive.
(Though I do predict that we'll see a hell of a lot more Avandia pens, paper-pads, mouse-pads, and other goodies as the GlaxoSmithKline drug reps ramp up the "Avandia is still a good drug" bit.)