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July 22, 2002
More on Drug Prices
I can strongly recommend this piece from Robert Bartley in the Wall Street Journal today. It's a clear-eyed look at the issues involved.
There are a couple of misconceptions in it, though. He mentions an "acquisition" of Imclone by Bristol-Meyers Squibb, but their deal was always about clinical candidates, not acquisition. BMS did make a large equity investment in Imclone (well, at the time it was large,) but not enough to have control of the company. That was left in the strong, capable hands of the Waksals.
Bartley also proposes that some drugs be allowed onto the market after Phase II trials are complete, but before the larger (and longer) Phase IIIs. It's easy to see why proposals like this come up, since that's one of the few places in the whole drug business where you can push costs down.
Bartley states that Phase I and II trials "establish safety and offer some evidence of efficacy" as opposed to Phase IIIs. Unfortunately, it's often the other way around. Getting through Phase I does indeed show that there aren't any immediate toxicological issues. And Phase II trials, if well-run, can be enough to establish efficacy. Phase IIIs, though, can be just as much about safety as they are about efficacy. As you expand the patient population and the length of the study, problems that never even broke the surface during the earlier trials can surface.
So, I'm afraid that putting drugs on the market after Phase II would require some sort of tort reform. The sorts of unpleasant surprises that show up in Phase III would be now be showing up in your patient population. And then the liability lawyers would swoop down with eager squawks, pick us clean, and leave our bones bleaching in the sun.
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