BRUSSELS, Belgium - EuropaBio, the European biotechnology industry association, is trying to persuade the European public of the merits of gene therapy - and at the same time trying to disentangle the subject from European fears of eugenics.
"Gene therapy does not imply the permanent modification of the inheritable genome of a patient, but only a permanent or transient modification of the genetic information of specific, somatic cells," it stresses, in a just-released paper prepared by its working group on gene therapy over recent weeks, which deals with the ethical, social and public awareness issues that gene therapy raises, and which also has been reviewed by EuropaBio's independent external advisory group on ethics.
By contrast, EuropaBio points out, "germ line (sperm or ovary) cell modification to permanently alter the genetic blueprint of a human being and its progeny is not supported by industry and is additionally prohibited by law in some European countries." The association says that its own core ethical values - a document adopted last year - preclude any EuropaBio support for human germ cell gene therapy and human in utero gene transfer experiments.
The industry body argues strongly for development of gene therapy, on the grounds that "most human diseases do not have a cure yet." Gene therapy, it says, may provide a curative rather than only a symptomatic approach to a number of diseases, for example by treating directly the genetic defect through the transfer of new genetic information into the affected cells or organs. It is too early to draw significant conclusions from the 400 clinical trials started to date (in the treatment of severe immunodeficiencies, cystic fibrosis, hypercholesterolemia, hemophilia, muscular dystrophy, AIDS, cardiovascular disorders, and tumors including melanoma, prostate, ovarian and lung cancer, the group admits, but "lessons learned from these trials have enabled the European bioindustry to work under a balanced and realistic view of the potential risks and benefits of the technology, which is making slow but continuous progress."
If the 10 years of trials to date have not provided conclusive evidence of benefit, the trials - involving 3,278 patients worldwide - have not shown up serious risks either. "EuropaBio takes the issue of safety very seriously and member companies conform to the best practices in designing supervision and reporting procedures as required by the authorities. We should emphasize that for life-threatening disorders, gene therapy so far has proved safe," it says.