FDA Races in Wrong Direction

Despite recent genetic evidence and the promise of individualized medicine, there is a continuing interest in using self-identified categories of race and ethnicity as variables in scientific and medical research. The U.S. Food and Drug Administration recently proposed a standardized approach for the collection of race and ethnicity data in clinical trials. We believe that this move fails to acknowledge new scientific data and recommend that relevant data from individuals be collected and used rather than broad group statistics. We also encourage that increased funding be committed to this important issue.

[1]  R. Cooper,et al.  Race and genomics. , 2003, The New England journal of medicine.

[2]  N. Risch,et al.  The importance of race and ethnic background in biomedical research and clinical practice. , 2003, The New England journal of medicine.

[3]  R. Kim,et al.  Molecular basis of ethnic differences in drug disposition and response. , 2001, Annual review of pharmacology and toxicology.

[4]  D. Carvalho-Silva,et al.  The phylogeography of Brazilian Y-chromosome lineages. , 2001, American journal of human genetics.

[5]  D. Goldstein,et al.  Human migrations and population structure: what we know and why it matters. , 2002, Annual review of genomics and human genetics.

[6]  R. Bhopal,et al.  Current census categories are not a good match for identity , 1999, BMJ.

[7]  David L Veenstra,et al.  Association between CYP2C9 genetic variants and anticoagulation-related outcomes during warfarin therapy. , 2002, JAMA.

[8]  M. Nobles,et al.  History counts: a comparative analysis of racial/color categorization in US and Brazilian censuses. , 2000, American journal of public health.

[9]  Hua Tang,et al.  Categorization of humans in biomedical research: genes, race and disease , 2002, Genome Biology.

[10]  Ching-Hon Pui,et al.  Molecular Diagnosis of Thiopurine S-Methyltransferase Deficiency: Genetic Basis for Azathioprine and Mercaptopurine Intolerance , 1997, Annals of Internal Medicine.

[11]  M. Relling,et al.  Mercaptopurine therapy intolerance and heterozygosity at the thiopurine S-methyltransferase gene locus. , 1999, Journal of the National Cancer Institute.

[12]  W. Evans,et al.  Pharmacogenetics as a Molecular Basis for Individualized Drug Therapy: The Thiopurine S-methyltransferase Paradigm , 1999, Pharmaceutical Research.

[13]  L. Jin,et al.  Ethnic-affiliation estimation by use of population-specific DNA markers. , 1997, American journal of human genetics.

[14]  M. Feldman,et al.  Genetic Structure of Human Populations , 2002, Science.

[15]  David B. Goldstein,et al.  Population genetic structure of variable drug response , 2001, Nature Genetics.

[16]  Michael J Bamshad,et al.  Human population genetic structure and inference of group membership. , 2003, American journal of human genetics.

[17]  R. Bhopal,et al.  Ethnicity as a variable in epidemiological research , 1994, BMJ.

[18]  B. Truman,et al.  Identifying Ancestry: The Reliability of Ancestral Identification in the United States by Self, Proxy, Interviewer, and Funeral Director , 1996, Epidemiology.

[19]  W S Watkins,et al.  Population genomics: a bridge from evolutionary history to genetic medicine. , 2001, Human molecular genetics.