FDA approves first race-specific medication
Studies found drug benefited blacks, not general population
•FDA Recommends Approval of BiDil for CHF in African-Americans
An FDA advisory panel recommended today that BiDil, a new heart failure drug, should be approved for African Americans.
Physicians
Updated: 8:28 p.m. ET June 23, 2005
WASHINGTON - The heart failure drug BiDil was approved Thursday by government regulators for use by blacks. It will be the first medication marketed for a specific racial group.
The Food and Drug Administration called the approval a step toward “the promise of personalized medicine.”
But some medical experts say there could be a downside to approving medicine for specific races of people.
“There are many, many who claim these use of (racial) categories may not have any biological meaning, only social meaning, and basing medical decisions on them may be problematic,” said David Magnus, director of the Stanford Medical Center for Biomedical Ethics.
For example, Magnus said, researchers could also look at whether a particular drug worked more effectively on Catholics than Protestants. The more categories explored, the more likely one can find data showing that one category of people is helped more than the others when it comes to a particular medicine, he said.
“But the more we know genetically, the more we know these social categories don’t correspond to genetic groups,” Magnus said.
http://www.msnbc.msn.com/id/8336206/
Studies found drug benefited blacks, not general population
•FDA Recommends Approval of BiDil for CHF in African-Americans
An FDA advisory panel recommended today that BiDil, a new heart failure drug, should be approved for African Americans.
Physicians
Updated: 8:28 p.m. ET June 23, 2005
WASHINGTON - The heart failure drug BiDil was approved Thursday by government regulators for use by blacks. It will be the first medication marketed for a specific racial group.
The Food and Drug Administration called the approval a step toward “the promise of personalized medicine.”
But some medical experts say there could be a downside to approving medicine for specific races of people.
“There are many, many who claim these use of (racial) categories may not have any biological meaning, only social meaning, and basing medical decisions on them may be problematic,” said David Magnus, director of the Stanford Medical Center for Biomedical Ethics.
For example, Magnus said, researchers could also look at whether a particular drug worked more effectively on Catholics than Protestants. The more categories explored, the more likely one can find data showing that one category of people is helped more than the others when it comes to a particular medicine, he said.
“But the more we know genetically, the more we know these social categories don’t correspond to genetic groups,” Magnus said.
http://www.msnbc.msn.com/id/8336206/