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November 09, 2004

Patent for Race Specific Drug

In the latest issue of the New England Journal of Medicine Dr. M. Gregg Bloche notes in an editorial entitled Race-Based Therapeutics that:

Two years ago, NitroMed obtained a second patent, this one based on the use of the formulation in blacks. This patent, the first ever granted to a preexisting drug for a new, race-specific use, pushes back potential market entry by generic sellers of the fixed-dose combination from 2007 to 2020. Less than a month later, NitroMed went public, raising $66 million (even though isosorbide dinitrate and hydralazine are available separately in generic formulations, making it possible to closely approximate Nitro-Med’s combination at a cost of about 44 cents per dose).

Thus, the emergence of the combination treatment as a race-specific drug was driven in large measure by regulatory and market incentives. It remains unknown whether these two drugs in combination with an ACE inhibitor improve survival among patients with heart failure in general (or among patients in other racial groups) beyond the improvement achieved by ACE inhibition alone. But a treatment for all patients with heart failure, regardless of race, could not have extended NitroMed’s intellectual property protection by 13 years.

What's interesting here is that a similar treatment can be achieved by combining two generic drugs, but formulating those drugs into one pill would be a violation of intellectual property rights. I think that this IP issue is as newsworthy as the race-specificity of the drug treatment.

Dr. Bloche also goes into the issue of race-based medicine and references the squid ink rationalization that race-based medicine is just a placeholder until to personalized pharmacotherapy becomes mainstream. However, Dr. Bloche makes the economic case that personalized pharmacotherapy will suffer from diminished market share:

First, as A-HeFT illustrates, market and regulatory incentives shape research agendas. The ease with which race can be used as a crude marker for clinically relevant biologic difference makes it attractive as a basis for bringing pharmaceutical products to market. But once a pharmaceutical firm has obtained patent protection and regulatory approval, it has little incentive to sponsor research aimed at elucidating the relevant genetic variations and their physiological manifestations. Indeed, such research risks shrinking the demand for a drug, by subtracting patients who lack the genetic markers that predict a good response. Such research is a classic “public good” in the economic sense: absent government support (or state-imposed obligation), it will tend to be undersupplied by market actors. And without the needed follow-up science, racial categories are at heightened risk of being reified as biologic.

Second, race is a very crude marker — ill-defined, indeed undefined. Again, A-HeFT is illustrative. Its investigators included patients who were self-identified as black. They thus delimited “blackness” in social and cultural fashion, poorly connected to underlying population genetics.

Clearly, the pharmaceutical company is benefiting from patients within the racial group whose individual genetic composition is an outlier in the standard distribution of genetic composition of race that was used in the clinical trials and while these patients do broaden the market for the drug and enable more research to take place Dr. Bloche goes on to warn of the pitfalls that may result from such reification.

I'm sure that this news is giving the "Race Doesn't Exist" crowd severe indigestion.

Posted by TangoMan at 03:21 PM