PMP Profile

Pharmacogenomics & Minority Populations

Abstract (September, 2003 Update)

The overall objective of the proposed research is to study the ethical, legal, and social implications of drug responsive genetic variations, especially where significant differences have been found based upon race, ethnicity, and gender.

The research will focus on four elements:

• the current and potential future use of pharmacogenomics to establish the safety and efficacy of certain drugs;
• the impact of pharmacogenomics on the legal standards applicable to the recruitment and use of human subjects in drug trials, including issues of diversity, informed consent, and confidentiality;
• the role of pharmacogenomics in providing access to appropriate health care for certain groups and the anticipated response of managed care organizations to pharmacogenomic-prescribed drugs, including issues related to the experimental nature of pharmacogenomic-based drugs, coverage mandates, and cost savings; and
• the impact of pharmacogenomics on the legal and ethical standards of care applicable to physicians and pharmacists in advising patients about genetic intolerance to or compatibility with certain drug therapies.

The research design will consist of tradition legal, medical science, social science and bioethics research and analysis.

The results of the research will be used to:

• conduct a survey to determine how various racial and ethnic groups view pharmacogenomics and what they would need to know before submitting to a diagnostic test or agreeing to take drugs based upon drug responsive genetic variation;
• host a conference that brings together the key players to examine and discuss the ethical, legal and social implications of pharmacogenomics;
• the role of pharmacogenomics in providing access to appropriate health care for certain groups and the anticipated response of managed care organizations to pharmacogenomic-prescribed drugs, including issues related to the experimental nature of pharmacogenomic-based drugs, coverage mandates, and cost savings; and
• publish two papers, one on the future of the science and one on the survey results.

PMPTeam