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Wednesday, November 10, 2004

New Uses for Old Drugs

Political Animal Kevin Drum reports that
A new heart drug that targets African Americans reduced deaths from advanced heart failure by 43% and reduced hospitalizations by a third, setting the stage for it to become the first drug approved for only one racial group. [from an LA Times article by Thomas Maugh]
An old study, when re-analyzed, found that a combination of two generic drugs was superior to the usual treatment for Blacks but not for Whites. A few years later, clinical trials enrolling only African Americans found that the two drugs, in combination with a third, were better than the third alone. It's quite possible that the 3-drug combination is effective for people of all races, but this hasn't been tested. One reason for running the clinical trials with Blacks only was U.S. patent law:
[Nitromed] holds a patent on using the combination to treat all races, but that patent expires in 2007. NitroMed has a patent on using it to treat blacks, and that patent is good until 2020, preventing anyone from bringing out a generic version of the combination pill before then. Physicians could, however, prescribe the two drugs individually to either blacks or whites. A dose of the generic drugs costs about 44 cents.
Drum focusses on the racial angle ("Racist Drugs?" he asks) but also says:
Isn't that lovely? Maybe it works for whites too, but there's no money in it so no one's going to bother finding out. For blacks, there is enough money in it to make testing worthwhile, but in the end it turns out that BiDil [the generic combination] is mostly a marketing gimmick that provides a way for NitroMed to charge them more for drugs that already exist. It's almost like the worst of both worlds, isn't it?
I don't think this is fair to Nitromed, and I think this criticism is contradictory. Nitromed says that will probably spend $39 million [p. 45 of the pdf] on the clinical trial. This estimate doesn't seem to include adminstrative overhead, or the opportunity cost of the funds. The treatment probably won't make it to market until 6 years after the start of the trial. Nitromed's money could have been earning interest during those years instead of being spent on study expenses. At a guess, the total expense of the trial could easily be double the direct costs, say $80 million. And, of course, the drug combo might not have panned out.

So Nitromed better be able to "charge them more for drugs that already exist" if we want them to have an incentive to take the risk and invest in the research in the first place. Kevin would like the research to be done to see if the treatment works for other races. If we want the private sector to do it, we'd better insure that there's some money to be made. (The alternative is a bigger public sector role, which I really ought to blog about one of these days).

Really, I think this is a pretty happy outcome, not the "worst of both worlds." There's probably not enough research done to find new uses for old drugs. So I'm glad that you can get a patent for finding a new use for an old drug, or even just packaging two drugs into one pill. It sounds to me like this -- frequently criticized -- aspect of the patent system has worked well in this case.

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