Ancillary risk information and pharmacogenetic tests: social and policy implications

Abstract

Some pharmacogenetic tests may provide ancillary disease risk information. To evaluate evidence and assess the social and policy implications of ancillary disease risk information associated with candidate pharmacogenetic variants, We conducted a literature search and abstract review of disease susceptibility studies for each of 42 gene variants potentially associated with drug response. Twenty-two variants (53%) had suggested association with disease risk in at least two studies, and sixteen (38%) were for diseases other than the pharmacogenetic indication. Seven variants (16%) were associated with risk for at least two different diseases. Pharmacogenetic tests have the potential to provide ancillary disease risk information, and this potential should be considered as pharmacogenetic tests are brought into clinical use. Implications will vary with each test but tests should be evaluated individually within a framework that outlines the potential implications of ancillary information.

Researchers’ Perceptions of the Ethical Implications of Pharmacogenomics Research with Children

“…Other emerging issues which are not mentioned by the respondents0 but are a source of ethical debate in the literature and the guidelines include compensation of the participants [16, 17], storage and destruction of data after completion of the study [43], future research use of the collected samples, policy on the communication of research results [19, 44], identification of sources of funding, and the possibility of commercialization of the results [16, 17]. From an ethical point of view, there is a need to think about these issues when addressing the informed consent [45].…”

Pharmacogenomics – how close/far are we to practising individualized medicine for children?

“…In addition, pharmacogenomic testing may provide ancillary disease risk information, which might affect the ability of patients to obtain secure life insurance/protection [55]. The psychological burden to both children and parents should also be considered, because ancillary disease risk information implies the potential development of one or more diseases.…”

Pharmacogenetic testing: not as simple as it seems

“…However, one study reported more than a third of the 42 inherited pharmacogenetic variants reviewed were associated with a disease unrelated to the pharmacogenetic indication. 30 The greatest risk of ancillary information will likely occur with a prospective pharmacogenetic profile. This testing approach involves measurement of many gene variants to inform future treatment decisions, amplifying the potential for ancillary risk information.…”