Global gene mining and the pharmaceutical industry

• Published in: Toxicology and Applied Pharmacology
• Main Author: Knudsen, Lisbeth E.
• Format: Article in Journal/Newspaper
• Language: English
• Published: 2005
• Subjects: Drug Industry; Ethics; Genetic Testing; Humans; Information Storage and Retrieval; Pharmacogenetics; Polymorphism; Single Nucleotide; Iceland
• Online Access: https://curis.ku.dk/portal/da/publications/global-gene-mining-and-the-pharmaceutical-industry(6dcf51c4-89d4-4426-a911-f929c2d8a264).html; https://doi.org/10.1016/j.taap.2004.11.031

Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society ...