nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
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Tuesday, July 27, 2010

Can Drugs Work On Patients In One Country But Not In Another?

The FDA will be considering approval of a new blood thinner (Brilinta).  The research suggests that it doesn't work as well on US patients.  Could that be true?

The Wall Street Journal lays the groundwork for this curious finding (July 27).  A review of the analysis submitted by the researchers to the FDA doesn't come up with a final answer, just some suggestions.
"In a review posted to the FDA’s website yesterday, the agency noted that the drug didn’t fare favorably against the market leader, Plavix, in North American studies. Across the entire population of patients studied, however, it reduced the incidence of heart attacks, strokes and deaths related to cardiovascular causes by 16% compared to the other drug."
The casual observer might speculate that humans in the US are different from humans in other countries.

But there are other (less dramatic) reasons that might explain this effect.  In the US we are more likely to use aggressive aspirin strategies to reduce risk of clotting.  We also use the cholesterol-lowering "statins" more often; some of the statins can reduce the effectiveness of blood thinners.

So there are reasons why the new drug might not work as well  here, based on outcomes driven by other treatments US patients receive.

The bigger question is, do you approve a drug--for use in this country--if it has a measurable impact only in other countries?

Probably yes, because individuals are not statistics, and some may benefit...if not enough to make the statistics significant.

And we are sure the new drug doesn't introduce new risks other blood thinners don't have.

Doc D

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