FDA approves race-tested drug

The US Food and Drug Administration yesterday (December 17) linkurl:approved;http://www.fda.gov/bbs/topics/NEWS/2007/NEW01757.html a beta blocker that I wrote about last month in an linkurl:article;http://www.the-scientist.com/news/display/53869 about the value of race-based medicine. The FDA's approval notice did not mention any particular race or ethnicity, and a linkurl:press release;http://www.frx.com/news/PressRelease.aspx?ID=1088188 from the drug's manufacturer noted that the drug, nebiv

By | December 18, 2007

The US Food and Drug Administration yesterday (December 17) linkurl:approved;http://www.fda.gov/bbs/topics/NEWS/2007/NEW01757.html a beta blocker that I wrote about last month in an linkurl:article;http://www.the-scientist.com/news/display/53869 about the value of race-based medicine. The FDA's approval notice did not mention any particular race or ethnicity, and a linkurl:press release;http://www.frx.com/news/PressRelease.aspx?ID=1088188 from the drug's manufacturer noted that the drug, nebivolol, is effective in a broad range of patients. But the drug had been tested in a trial of African American patients only, because that group typically has a lower response to beta blockers than white patients. Nebivolol was effective in lowering blood pressure among the trial participants, but the researchers did not compare it to other treatments for hypertension. Nebivolol also underwent clinical trials that were not race-specific, and was effective in other groups that present challenges for treating hypertension, such as elderly and obese patients, Keith Ferdinand, the chief science officer at the Association of Black Cardiologists, told __The Scientist__. Ferdinand was an investigator in trials of BiDil, a heart medication that earned its reputation as a "race drug" when the FDA - linkurl:not without controversy;http://www.the-scientist.com/article/display/15896 - approved it specifically for African American patients. "Whether that should be a specific marketing plan [for nebivolol] is difficult to say," Ferdinand said. In a previous interview, Ferdinand said that while race can be valuable as a metric in studies, it can mask underlying causes of differences in how patients respond to a treatment. He also said then that he did not view nebivolol as the "black beta blocker."

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