 |
 |
The Age Company Ltd 2001 COMMENT Danger! Rogue scientists at work By NICHOLAS TONTI-FILIPPINI Monday 14 May 2001 In recent times we have witnessed an enormous growth in biotechnology. Investment in the burgeoning biotechnology industries is expected to reap huge rewards. There is a rush to the goldfields of the human genome. Daily we hear of new finds: the cloning of yet another species; children from genetically modified human eggs or embryos; human embryos formed by placing the human genome into a pig or cow egg; brain cells turned to bone cells; blood cells turned to liver cells; embryonic stem cells turned to nerve cells. We also hear many false claims and exaggerations, such as growing a human heart in a pig, or growing a whole organ from a stem cell (as the Australian Academy of Science claimed could occur), or growing a human ear on the back of a mouse. The latter turned out to be skin grown over a frame to resemble a human ear, but that did not stop the media declaring it to be a human ear. Flush with new money, biotechnology has seen the development of what might be called rogue science. This is science that seeks to apply new technologies without adhering to established ethical guidelines. The process that resulted in children born from embryos with added mitochondria, including additional DNA, is an example of rogue science. Powerlessly, responsible scientists have condemned these experiments, and other possibilities such as trying to clone human beings by the Dolly process. But what protections are there against rogue scientists? In 1992 Federal Parliament established the National Health and Medical Research Council as an independent statutory authority answerable not to the government but to the parliament. Within the NHMRC, the parliament established the Australian Health Ethics Committee, with a membership broadly representative of the community. The council is required to promulgate the ethical guidelines of the committee. The existing AHEC guidelines prohibit forming human embryos for research purposes, including all forms of producing human embryos asexually (cloning) and germ cell gene therapy such as the mitochondrial experiments that resulted in experimental children. Except in those few areas in which some states have legislated, the AHEC and a system of ethics committees in government-funded research facilities have been all that has stood formally in the way of rogue science. But that system of control has only ever been a control over the allocation of Commonwealth funding to medical research. The Commonwealth has no control over research in the private sector, nor in state-funded research, which together account for 75 per cent of Australian medical research. The Commonwealth recently passed the Gene Technology Act 2000. Like the NHMRC, the act has no jurisdiction over individuals. The constitutional powers used have very limited scope. The act established an elaborate licensing system, but rather than link it to the NHMRC review system, the government established an alternative system of committees and incorporated a complex set of poorly drafted, misfitting definitions and exclusions that make it unclear what is the scope of the authority of the Gene Technology Regulator and what is or is not permitted. For instance, there are varied legal opinions as to whether the children from the germ cell mitochondrial modification project are or are not genetically modified organisms within the scope of the act. That that question exists shows the inadequate nature of the act in regulating the genetic modification and release of new organisms when the sub-ject of those processes is a human being. Medical research should have been treated separately from agriculture. The NHMRC has been effectively sidelined. The Gene Technology Act, insofar as it applies to medical research, is a vote of no confidence by the parliament in the NHMRC. A simple solution was available to the Commonwealth. It could have required all those undertaking human genetic research to be licensed, and for licence holders to abide by the NHMRC guidelines and other licence restrictions as the parliament saw fit to enact. The constitutional matter of applying that form of regulation to individuals could be resolved by having the states legislate to require individuals undertaking research involving the human genome to be licensed under the Commonwealth act. Until some such measure is adopted, 75per cent or more of Australian biotechnology will remain unregulated, and the spoils will go to the swelling ranks of rogue scientists who are leading the rush to patent and market with scant regard for human or bio-safety, or the concerns of the community. Nicholas Tonti-Filippini is a consultant ethicist. E-mail: [log in to unmask] http://www.theage.com.au/news/2001/05/14/FFXZCRUONMC.html ********** ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn