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

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