The Lancet Oncology
Volume 4, Number 2
01 February 2003

A legislative minefield

In November 2002, Severino Antinori, an Italian embryologist,
announced that three women in the late stages of pregnancy were
carrying cloned human foetuses. Antinori, who runs a fertility clinic
in Rome, has previously supported the notion of human cloning and has
suggested that the approach used to create Dolly the sheep (somatic-
cell nuclear transfer) could be easily applicable to humans. In an
unrelated but similar disclosure, Clonaid, an associate group of the
Raelian religious cult, added further fuel to the public debate by
claiming that that two baby girls, born on 26 December 2002 and 3
January 2003, were the world's first human clones. These two events
have lead to widespread calls for stringent legislation. Many
researchers fear that an ill-informed backlash against all types of
cloning would jeopardise research in to novel ways of tackling
serious diseases such as heart disease, diabetes, Alzheimer's and
Parkinson's disease, and cancer.

There is a danger that the current media circus surrounding these
stories and the amount of overt publicity gained by both Antinori and
Clonaid may overshadow a crucial distinction between reproductive
cloning and therapeutic cloning. There is a possibility that this may
cause a knee-jerk reaction, lead by public pressure, outlawing all
forms of cloning. Such an eventuality must be avoided if potential
advances in medical research are not to be substantially harmed.

The disclosures by Antinori and Clonaid relate to reproductive
cloning, ie, the replication of identical animals or humans by
implantation of a somatic cell nucleus from one individual into an
enucleated oocyte and the subsequent full-term gestation of the
oocyte in a host. It is entirely right that reproductive cloning
should be banned. Notwithstanding the far-reaching ethical, moral,
and religious arguments, there are also a many biological questions.
Animal research has shown that cloned organisms are at greater risk
of gross abnormalities. These include developmental delays,
respiratory deformities, malformed foetuses, and oversized young. In
addition, there are unknown long-term complications such as the
effect on natural evolution and the loss of genetic variation, the
accumulation of genetic deflects by successive cloning, and the age
of cloned cells and their influence on life span. Some researchers
have suggested that cloned cells are older than normal foetal cells
and this can contribute to premature ageing of the animal. Aged
cells, with their inherent increased level of DNA mutation, are
susceptible to loss of regulation and neoplasia. Thus, one could also
speculate that cloned animals might carry a greater predisposition
for cancer.

Therapeutic cloning, however, is entirely different ethically and
essential for medical progress. This type of cloning can provide
material for replacement tissues and organs, facilitate successful
organ transplantation, enhance immunological surveillance, or correct
genetic defects via the introduction of functional genes. All of
these applications have potential clinical utility in the treatment
of cancer and other major diseases.

A clear distinction between therapeutic and reproductive cloning is
recognised by the legal situation in some countries, indeed, human
reproductive cloning is banned in the UK and Australia. Other
countries, however, have yet to follow suit and many have deferred
making a decision by adopting moratoria. A lack of clear legislation
can lead to many problems. The situation in the United States is a
good example. In 1997, the Clinton administration implemented a 5-
year moratorium on human reproductive cloning, which has now expired.
During the intervening 5-year period, the House of Representatives
voted to ban human cloning but draft legislation did not permit
embryonic stem-cell research (ie, therapeutic cloning). An amendment
to allow this application was subsequently rejected and a suitable
bill has yet to be ratified. Confusingly, a separate piece of active
US legislation bans federal funding for human embryo research but not
human embryonic stem-cell research. Thus, although some precedence
exists, the situation is very unclear and US pharmaceutical companies
are worried that recent events may lead to a blanket ban on all forms
of cloning.

The legal situation in many countries needs to be clarified quickly,
but this will only occur in a rational and sensible way if evidence-
based conclusions are used to formulate new legislation. Medical
research and its potential to find cures for major diseases such as
cancer should not be influenced by legal solutions designed to
address similar, but essentially different, issues.

The myriad of nationally administered laws and unclear legislation
are patently insufficient to prevent human reproductive cloning and,
taken together, potentially endanger clinical research. A worldwide
commitment to legal harmonisation, uninfluenced by propaganda or
public pressure, is urgently needed to resolve the current situation.

SOURCE: The Lancet Oncology
http://oncology.thelancet.com/journal/vol4/iss2/full/lonc.4.2.the_lead
ing_edge.24214.1


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