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Executive Summary
- Unregulated Hazards ‘Naked’ and ‘Free’ Nucleic Acids

Unregulated Hazards ‘Naked’ and ‘Free’ Nucleic Acids

Mae-Wan Ho, Angela Ryan
Biology Department, Open University Walton Hall, Milton Keynes MK7 6AA, UK J. Cummins
Department of Plant Sciences, University of Western Ontario Ontario, Canada T. Traavik
Dept. of Virology, Institute of Medical Biology, MH-Breivika and Norwegian Institute of Gene Ecology, N-9037 Tromso, Norway

An article from The Institute of Science in Society


Executive Summary

A huge variety of naked/free nucleic acids are being produced in the laboratory and released unregulated into the environment. They are used as research tools, in industrial productions and in medical applications such as gene therapy and vaccines. These nucleic acids range from oligonucleotides consisting of less than 20 nucleotides to artificial constructs thousands or millions of basepairs in length, typically containing a heterogeneous collection of genes from pathogenic bacteria, viruses and other genetic parasites belonging to practically every kingdom of living organisms. Most of the nucleic acids and constructs have either never existed in nature, or if they have, not in such large amounts. They are, by definition, xenobiotics -- substances foreign to nature -- with the potential to cause harm. Some, such as gene therapy vectors and vaccines, have already been shown to elicit toxic and other harmful reactions in preclinical trials.

Nucleic acids are now known to persist in all environments, including the digestive system of animals. Transformation by the uptake of DNA is recognized to be a significant route of horizontal gene transfer among bacteria, and there is overwhelming evidence that horizontal gene transfer and recombination have been responsible for the recent resurgence of drug and antibiotic resistant infectious diseases.

Recent investigations associated with gene therapy and vaccines leave little doubt that naked and free nucleic acids are readily taken up by the cells of all species including human beings, and may become integrated into the cell’s genetic material. There is also abundant evidence that the extraneous nucleic acids taken up can have significant and harmful biological effects including cancers in mammals.

The need to establish regulatory oversight of naked/free nucleic acids at both national and international levels is long overdue. It is irresponsible to continue to exclude them from the scope of the International Biosafety Protocol.

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