Pharmacogenomics and Data Protection

Introduction That the genes are responsible for disease susceptibility, differential drug response and drug toxicity was always suspected; post-genome developments, pharmacogenetics and pharmacogenomics have proven that beyond doubt. The trials of AstraZeneca drug, IRESSA, an EGFR kinase inhibitor approved for non-small lung cancer have clearly shown the consequences of exposing the non-responders to such drugs. It has also initiated an intense debate within the regulatory set up to seek genomic solutions to drug variability during development, clinical testing and their approvals. The strong drug lobby that is used to “one drug for all”, pushing their products across continents to re-coup the heavy ivestments made in R&D and currently fighting for “TRIPS plus” rights over ”Data Protection” may not like the population dynamics. However, one wonders the worth of such clinical data if the drug fails or induces adverse reactions in a different set of population with variation in crucial set of genes that the drug intends to target!