Pradaxa and Drug Safety: Product Liability Played a Role

This week’s post is about the problem of product liability in pharmaceutical policy, an issue that I have not discussed since my first posts on this blog in February.  Boerhinger-Ingelheim’s drug Pradaxa (dabigatran) is a “thrombin inhibitor,” an anticoagulant drug used to prevent strokes and embolisms in patients with atrial fibrillation or other conditions that put them at high risk for stroke. One of the principal selling points of Pradaxa and other direct thrombin inhibitors is that their recommended use does not monitoring patient’s blood levels of the drug, unlike the much older drug Coumadin (warfarin) which is used for the same purpose but has a different mechanism of action and requires individual dosing and monitoring. Pradaxa has been the subject of very interesting news this past week, initiated by an article by Deborah Cohen, M.D. in the British Medical Journal (BMJ) entitled: Concerns over data in key dabigatran trial.  Accompanying the article was a feature editorial with the even more attention-grabbing title: Dabigatran: how the drug company withheld important analyses Continue reading

Pharmaceutical Pricing– The Story That Just Keeps Going

After last week’s foray into patents and pharmaceutical policy, which is perhaps the most technical and specialized area of pharmaceutical policy, I will return to the never-ending story of pharmaceutical prices and the controversy over Sovaldi, Gilead’s break-through Hepatitis C drug. Sovaldi has a “sticker price” of $84,000 for a 12-week course of treatment, at the end of which 90% or more of patients would be expected to be cured. Since Sovaldi is a pill that is given once a day, the 12-weeks of treatment means that there are 84 daily doses. The math is easy, even if the price, unlike the pill, is hard to swallow–$1,000 per pill. The drug has been a huge financial success for Gilead, which reported $2.274 billion in sales in just the first quarter of 2014. However, the backlash has been equally huge. In a rare display of bipartisanship in Washington, Senator Ron Wyden (D.-Ore), the Chair of the Senate Finance Committee and Senator Chuck Grassley (R.-Iowa), the Ranking Member of the Finance Committee, sent a demand for information concerning the development costs of Sovaldi and Gilead’s pricing decision. However, even more than the investigation by two senior senators, the impetus for today’s post came from the blog RxObserver, which featured a post entitled Sovaldi: A Poster Child for Predatory Pricing sic Before discussing the epithet “predatory pricing,” the perspective of RxObserver requires a bit of explanation. RxObserver is a site that primarily provides the views of pharmaceutical benefit managers (PBMs), or as the blog itself states its purpose: “the Clearinghouse of the Future for Pharmacy Benefits.” It is, in general, a very high-quality blog, with an editorial staff composed primarily of well-recognized academic and government experts in health care policy. I regularly read it and find it useful, although I was taken aback by that “predatory” epithet.
Continue reading