Pharma on Trial
There are a lot of prominent trials (or trials to be) involving Pharmaceutical companies right now, so here are two that have caught my eye over the past week (well, one of them was just pounded into my head over and over by the media).
From the TortsPorf Blog, Wyeth lost in a lawsuit against them in the Vermont Supreme Court in which a woman got gangrene from an accidental injection of a drug (”Phenergan”, a.k.a. promethazine) into her artery. Thing is, the drug’s label (approved by the FDA) “repeatedly and prominently warned” that gangrene is a risk if the drug is accidentally injected into an artery as opposed to a vein (alternatively, a doctor could choose to administer the drug, say, orally, which apparently works slower). A woman lost her arm because of a mistake, and so Wyeth lost the lawsuit. As Ben says, “If that’s the case, why don’t we sue gun manufacturers for every accidental death that guns cause?” I’d like to add, why don’t we sue car manufacturers for every injury sustained from not using seat belts?
Steve Nissen’s Meta-analysis of Avandia (a.k.a. rosiglitazone) is all over the news. Unfortunately, it’s being blown up to be a much bigger deal than it should be. In the Pipeline has a good overview about the caveats on the paper, from Steve Nissen himself as well as a good description about what meta-analyses are, and their inherent problems. Meanwhile, (from Pharmalot), lawyers are already holding conferences on how to sue GlaxoSmithKline. Pharmalot has a good post on the reactions to the NEJM article and the editorial that came with it, including a response editorial from the Lancet (PDF), and the various company affiliations that commenters have (e.g. Steve Haffner, who has been critical of the media frenzy, has gotten speaking fees from pharma companies in the past, and the NEJM editorialists have been paid as expert witnesses by plaintiffs’ lawyers in pharmaceutical trials). Orac has a set of links to good blog post articles on the article. The Examining Room of Dr. Charles has a good post on some unanswered questions about the methodology of the study.
