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.