660
- Genetic information about the patient, confi ded only to the physician in tradi-
tional medicine, will be accessible to other healthcare personnel in clinical trials
of personalized medicine, e.g. pharmacists.
Social Issues in Personalized Medicine
Introduction of personalized medicine in healthcare systems of Western cultures
would need to fulfi ll requirements of basic social values. Pharmacogenomics with
genotype-based optimization of therapeutic interventions would need to demon-
strate the following:
- Individual’s freedom of choice is not restricted by information generated by
pharmacogenomics. - Access to novel medical applications stemming from pharmacogenomics is
granted to all social and ethnic segments of the society. - The patient has full control over all his/her individual data.
- Novel therapeutic approaches are in no way hazardous to the patient.
It is now well documented that substantial disparities exist in the quality and
quantity of medical care received by minority Americans, especially those of
African, Asian and Hispanic heritage. In addition, the special needs and responses
to pharmaceutical treatment of these groups have been undervalued or ignored.
Genetic factors underlie varying responses to medicines observed among different
ethnic and racial groups. Pharmacogenetic research in the past few decades has
uncovered signifi cant differences among racial and ethnic groups in the metabo-
lism, clinical effectiveness, and side-effect profi les of many clinically important
drugs. These differences must be taken into account in the design of cost manage-
ment policies such as formulary implementation, therapeutic substitution and step-
care protocols. These programs should be broad and fl exible enough to enable
rational choices and individualized treatment for all patients, regardless of race or
ethnic origin.
Race and Personalized Medicine
Pharmacogenetics is growing fast and has reopened the debate on the biological basis
of race and ethnicity. It is hoped that and it will lead to a more refi ned understanding
of ethnic and racial differences in drug response. In spite of the contentious nature of
discussions about human races, it is often assumed that racial categorization has clin-
ical relevance when it comes to the choice of drug therapy. Chinese patients require
lower dosages of heparin and warfarin than those usually recommended for Caucasian
patients. As mentioned in Chap. 7 , there are race-specifi c therapies for cardiovascular
disease. Randomized trials have been interpreted to show that a combination of
21 Ethical Aspects of Personalized Medicine