While pharmacogenomics holds promise for increasing drug effectiveness and reducing drug-related adverse events, there is a risk of “racialization” of medicine. It`s easy to rely on race as a surrogate for genotype, but the social cost of doing so can be high. “By carelessly equating race with genetic variation and genetic variation with genotype-based drugs, we risk developing an oversimplified view of race-specific drugs and a misleading view of the scientific importance of race” (Rothstein 2003, p. 330). The controversy surrounding the FDA`s approval of the drug BiDil in 2005 for self-identified African Americans shows the timeliness of the problem (Saul 2005). See Box 11-3. Consider approaches to harmonize standards for de-identification and informed consent and authorization under the Federal Rule for the Protection of Research Subjects (Common Rule) and the HIPAA Privacy Rule to minimize unnecessary barriers to research while continuing to protect the privacy and well-being of individuals. Researchers and practitioners in the field of health behaviours and health education can play a critical role in integrating toxicogenomics into practice to improve public health (e.g., Sorenson & Cheuvront, 1993; C. Wang et al., 2005). Priority areas ripe for further research, understanding, and applications include: (1) public and provider education on genetic information, (2) risk communication and behavior change interventions, (3) sociological consequences of genetic testing, and (4) public health insurance and advocacy.
An environmental perspective should be considered when considering education and communication issues associated with the application of toxicogenomics to reduce health risks. Many types of stakeholders and practitioners should be considered and, therefore, many levels of intervention and analysis should be sought. The identification of genetic sensitivities to chemicals, consumer products, pharmaceuticals and other materials raises a number of regulatory issues. One of the topics discussed is the question of the feasibility of protecting genetically sensitive individuals. On the one hand, protecting the most vulnerable individuals in society can be extremely costly and perhaps even impossible without major and massive changes in our industrial society. On the other hand, the concept that government regulators leave the health of some people born through no fault of their own with susceptibility to a particular product or chemical also seems politically and ethically unworkable (Cranor 1997). As more and more information about individual genetic susceptibility becomes available, regulators and society at large will face difficult challenges in deciding whether and how to protect the most genetically vulnerable citizens among us (Grodsky 2005). 1. Develop strategies and provide professional development at school or classroom to teach social, ethical and legal issues and the responsible use of technology. The common rule is intended to protect the welfare of human research subjects and, therefore, the definition of “research” is an important preliminary issue. The Common Rule defines it as “a systematic investigation, including research, development, testing, and evaluation, aimed at developing or contributing to generalizable knowledge” (45 C.F.R. § 102(d)).
Research also includes the creation of repositories for future research (DHHS, 1997). Address privacy, confidentiality and security issues that affect the use of toxicogenomic data and the collection of data and samples required for toxicogenomic research. Technological advances are increasingly undermining privacy. Protecting our privacy is therefore an important issue that requires a thorough understanding of who stores data for what purpose and how personal data is collected without our consent. The computer is invaluable for the management and distribution of information. However, it is up to those who have access to this information to use it legally, judiciously and ethically. There is an urgent need to improve monitoring and enforce existing laws more strictly. To ensure that legal protections are not ignored, a public research center, the Electronic Privacy Information Center (EPIC), has set up a www.epic.org website to disseminate information on emerging civil liberties issues, including privacy and the First Amendment.
Confidentiality refers to a situation where information received or disclosed in a confidential relationship (e.g., physician-patient) is generally not re-disclosed without the individual`s permission (Rothstein, 1997). In terms of toxicogenomics, the most important relationship is the doctor-patient relationship. Republication restrictions are an important ethical imperative for health professionals, and maintaining the confidentiality of health information is important to prevent intrinsic and indirect harm to individuals (Orentlicher, 1997). Although toxicogenomic and pharmacogenomic information falls under “genetic privacy” laws passed by several states (NCSL 2005a), these laws provide limited and inconsistent protection. Toxic tort litigation involves judgments about an actor`s duty of care that creates risks for those who may be harmed by those risks. Toxicogenomic data could influence or modify these due diligence judgments in a number of contexts. For example, finding that certain members of the population may have a genetic susceptibility that makes them particularly sensitive to a product may impose new obligations on the manufacturer of the product with respect to testing, labelling and selling that product. Some people claiming to have been harmed by the Lyme disease vaccine Lymerix have sued, claiming that the vaccine manufacturer was required by law to warn vaccine users to obtain genetic testing for polymorphism, which would have affected the user`s propensity to develop serious side effects of the vaccine (Noble 2000).