"The FDA's review today of BiDil could make it the first drug approved specifically for African Americans and marks the end of 'one-size-fits-all' medicine," said Dr. Jane L. Delgado, President and CEO of the National Alliance for Hispanic Health (the Alliance), the nation's leading Hispanic health advocacy group.
The Food and Drug Administration's review of BiDil comes after a November 11, 2004 study published in the New England Journal of Medicine. That study showed that adding BiDil to standard heart failure therapy provided a 43% improvement in survival compared to taking standard therapy plus placebo for patients in the African American Heart Failure Clinical Trial.
"The success of BiDil for African American patients demonstrates that there can be significant therapeutic differences for subgroups of the population that may not show up in clinical trials that only produce 'general population' results," said Adolph P. Falcon, co-author of the Alliance report Genes, Culture, and Medicines. (The full study is available online at http://www.hispanichealth.org/)
That report brought together for the first time emerging research demonstrating that genetic and environmental factors have a significant impact on the effectiveness of medicines for Hispanic patients.
Among the report's findings: