Ethics
In this section you can read about ethical issues surrounding pharmacogenetics.
1. Confidentiality
2. Exclusion from research
3. Accessibility to treatment
4. Ethnic profiling
5. Protection of children
6. Other links on ethical issues in pharmacogenetics
As with any medical intervention, breaching confidentiality with respect to pharmacogenetic test results could lead to discrimination by third parties, such as insurance providers and employers.
Moreover, pharmacogenetic research requires large genetic databases, which could be vulnerable to breaches of confidentiality. In several countries, it is necessary to store samples in a coded form to obtain approval for clinical trials and market placement.
One concern around pharmacogenetics is orphan disease groups. An orphan disease group is a minority group in which patients have a genetic profile that is different from the majority of the population. These individuals could be excluded from research developing treatments that would be only be effective for the majority population.
Setting a medication for a small number of patients to market might not generate significant economic returns to pay back research and development. This could work against the development of medications for orphan disease groups. This problem is not unique to pharmacogenetics, but the issue is relevant to pharmacogenetics.
Another concern is the impact of expensive pharmacogenetic treatments on universal health care coverage programmes. There is concern that the elevated sales price of pharmacogenetic medications may occur.
Pharmacogenetics raises questions concerning the link between response to treatments, genetics and ethnicity. Ethnic differences are sometimes important with regard to response to drugs. Anti-hypertensive agents, for example, have different efficacy rates in different ethnic groups. For example, African-Americans respond better to diuretics than to beta blockers if monotherapy is given. In 2005, a medication for cardiac weakness in these African-American males was approved in the United States. The concern is whether this is scientifically valid or whether it constitutes unjust discrimination against other ethnic groups.
When pharmacogenetic research involves children, certain ethical issues must be underlined. Parental consent to pharmacogenetic research and children’s assent can be complicated due to the complexity of the information that needs to be transmitted. The complexity of this type of research can make explaining information to children difficult. Ultimately, this could affect their assent to participate in research.
Communicating results to children raises some questions such as: who should receive the results (the child, his/her legal representative, his/her doctor, or someone else?) and in what manner? These questions are particularly important because the information could have an impact on a child’s clinical care.
They could also have an impact on the family. Should the information be provided to the child’s parents? When a child is mature, should the results be communicated to them? This could lead to problems around communication of results because the child may have forgotten that he/she participated in the research or may no longer be a minor.
Pharmacogenetic research in children could lead to the formation of a new orphan disease group. This would occur where pharmaceutical companies fail to develop pharmacogenetic treatments for children because developing these treatments for only a small group would be an economic disincentive. As a result, children would not benefit from the promise of pharmacogenetic developments.
American and European legislation has put provisions in place in the hope of promoting treatment development for children and orphan disease groups.
6. Other links on ethical issues in pharmacogenetics
- Read more on pharmacogenetics on the HumGen website.
- The Nuffield Council on Bioethics has published an extensive report "Pharmacogenetics, ethical issues".
Source: modified from HumGen