Pharmaceutical News

“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:

A study of the cardiovascular drug Nifedipine found blood levels of the drug for Mexicans was three times higher than for the U.S. general population.
Mexican Americans metabolize drugs regulated by the CYP2D6 gene faster than whites, impacting 30 percent of therapeutically important medications, including many cardiovascular drugs.

Some Hispanic groups may require lower doses of antidepressants and some antipsychotic medications and may be more prone to increased side effects at normal doses of these medicines.

“Eventually advances in genetics will allow us to tailor pharmaceutical therapy to individual needs. FDA’s review of BiDil for African Americans is putting our drug review process in step with the 21st century science of medicine,” concluded Falcon.

The National Alliance for Hispanic Health is the nation’s oldest and largest network of Hispanic health professionals. The nation’s action forum for Hispanic health, Alliance members deliver services to over 12 million persons every year making a daily difference in the lives of Hispanic communities. For more information, visit the Alliance’s website at http://www.hispanichealth.org or call 1-866-SU-FAMILIA (1-866-783-2645).