November 4, 2011

Framing the debate

As you may remember, there was a flurry of headlines recently in the Kiwi media about the new anti-clotting drug dabigatran(Pradaxa) — it’s not often than Pharmac is accused of pushing too hard for an expensive new substitute instead of  an old, cheap drug.  Now, in Australia, the reverse is happening: the Goverment has refused to list dabigatran for subsidy (going against its own experts), and the media is reporting this decision as a danger to Australian patients (with help from the manufacturer’s lobbyists).

Warfarin (yes, rat poison) is a very safe and effective anti-clotting drug if it’s given at exactly the right dose. Unfortunately, the right dose varies between people, and changes depending on almost anything else (food, medications, herbals, alcohol) you might consume.  Keeping the dose right requires frequent blood tests, which are inconvenient and expensive, and even then the dosing is often imperfect unless you and your physician are truly obsessive.  But there hasn’t been anything else that came close to the safety and efficacy of warfarin.

Now there is a rush of new medications coming out that selectively disrupt a very late stage in clot formation: as well as dabigatran there are apixaban, rivaroxaban, and betrixaban.  These don’t have the variable dosage of warfarin, so it should be possible to just prescribe them and stop worrying: a big improvement in convenience and saving in cost.  On the other hand, these drugs are new (and so less well understood), and unlike warfarin there is no antidote and no convenient lab test for overdose.  And they are quite  expensive, even with Pharmac’s well-known haggling powers.

In this case I think the evil multinational drug company is right and the Australian Health Minister is wrong: these new drugs really are safer and more effective — they were better than warfarin in a large randomized trial, where warfarin dosing is likely to be better than in free-range patients — and the reduced need for blood tests will pay for quite a bit of the increased cost.  Still, it’s hard to avoid the suspicion that the main urgency in this debate is to get dabigatran into widespread use before its competitors make it on to the market…

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Thomas Lumley (@tslumley) is Professor of Biostatistics at the University of Auckland. His research interests include semiparametric models, survey sampling, statistical computing, foundations of statistics, and whatever methodological problems his medical collaborators come up with. He also blogs at Biased and Inefficient See all posts by Thomas Lumley »