December 17, 2009


Amidst all of the debate about the cost of healthcare, the concept of generics comes up a lot. What most people don't realize is that drug research companies actually have to do massive clinical trials involving thousands and thousands of people spending nearly a billion dollars in the process. With a price tag like that, there is obviously some vested interest in getting your formulation right. Self interest ain't a bad thing. Generic manufacturers do not have to do that. They just have to do a very small trial in a handful of people where the drug is given once and then blood levels are drawn. That's it. From what I've heard of other docs, generics tend to be ok for things where if the dose is off a bit, it won't matter much. Say you're taking an antiobiotic. The thing has been on the market for years, the synthesis is usually pretty straight forward, and there isn't much to the delivery. You're taking 500 mg of the stuff, sometimes twice a day. If the company is sloppy and only gets it partially right, it's not going to matter much if there is actually only 450 mg of the active compound in the pill. It'll still work. But for other drugs, say coumadin, the difference between the efficacious and lethal dose ain't that wide. There, it's not worth it to play around. Well, some new research from consumerlabs that just came out seems to expands that list. It seems that Teva had come under fire for their generic Wellbutrin, a common antidepressant and smoking cessation drug (and possibly weight loss when combined with another old drug, we'll see how the trials pan out). Well, their product is a slow release and so the synthesis gets a bit trickier. Patients started complaining and one site run by pharmacists ( started to pick up on the signal. They passed on the information to the FDA and it prompted the FDA to require some more trials from Teva. When that'll get completed is anyone's guess and I suspect that the Teva probably knows it cut some corners and will quickly clean those up for the trial. didn't wait. They tested it on their own and it turns out there more than just price differences between the brand and generic. The generic had vastly different kinetics of release which could explain the complaints of patients (wellbutrin without the slow release would need to be taken 3 times a day). So to recap, private citizens complained and a private website picked up on it. Then a private company addressed the complaints. Now consumers should be free to chose. But that's not the way it'll work. We'll need to wait on the ridiculously slow FDA. I think that this is a very salient point when debating a centralized healthcare system where bureaucrats in some far off distant land dictate what works instead of you and your doc deciding together what works best for you. Generics not working? It wouldn't be considered at all by that monolith when the cost savings are blinding them.

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