Additional Comments - Family First
Inquiry into the Legislative responses to
Recommendations of the Lockhart Review
We all want cures to
debilitating diseases
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FAMILY FIRST wants
cures as much as anyone else. FAMILY FIRST wants scientists to find cures to
all manner of debilitating diseases. However, the evidence presented to the Committee
has reinforced FAMILY FIRST's concerns about the Lockhart Committee's report
and reinforced our view that cloning human embryos will not produce the cures
we all desire.
Promising cures from
such research is simply peddling false hope to some of the most vulnerable
members of our community.
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Embryonic stem cells
from cloned embryos cannot be used for cures
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The scientific facts
must be considered. A number of scientists gave credible evidence that
embryonic stem cells from cloned embryos will not be able to be used for cell
therapies. Why then would we pursue this path, which is also fraught with
ethical problems? Only adult stem cells can repair adult tissue.
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Parliament should
set ethical boundaries
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Focussing on the
ethics, it is appropriate that the Parliament set ethical boundaries around
science to reflect medical ethics and community concern about cloning human
embryos for research.
FAMILY FIRST's comments
focus on the Lockhart recommendations about cloning human embryos.
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Three reasons to
oppose cloning human embryos
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While FAMILY FIRST
wants cures, we strongly oppose cloning human embryos for research for three
reasons:
- The science tells us this will not produce cures;
- Concerns about sourcing human eggs from women for
cloning; and,
- We would be crossing a major ethical line, because
for the first time we would be deliberately creating a human being with the
intention of then destroying it.
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The Science
Evidence to the Committee
challenges the prevailing view that cloning embryos is necessary to find cures
to diseases.
Emeritus Professor John Martin from
the University of Melbourne submitted that
There is no evidence from animal experimentation, in Australia
or elsewhere, that animal ES cells can be used as treatment for any disease in
a manner that is effective, and is safe in the long term. Of course there have
been no trials of human ES cells in man. Animal models of several of the
relevant diseases exist, which provide this as an open and obvious way to
search for evidence to support the credibility of therapeutic cloning. There
could be no possible purpose in therapeutic cloning unless it is established
that ES cell therapy can be applied effectively and with long term safety.[1]
Professor
Martin argued that
We need to do a lot more work in animals and a lot more work on
the properties of human embryonic stem cells, which is already permitted under
the legislation. Until we have all that information, what could be the specific
reason for trying to make an embryonic stem cell line that is specific to an
individual? If this legislation were to go through, what would be the first
question to be asked? It would be difficult to justify anything.[2]
Professor James Sherley from the
Massachusetts Institute of Technology testified that
... embryonic stem cells cannot be used to develop new adult
therapies ... based on the fact that the only way it is possible to do it is to
take the embryonic stem cells and turn them into adult stem cells. If we were
to go to that path, then all of these problems that are being presented to us
in adult stem cells would also exist on that path as well, and in addition to
those problems would be all the problems that embryonic stem cells bring along
with them, and that is the tumour information and the problems with gene
expression.[3]
Professor
Sherley explained that
... embryonic stem cells cannot fulfil the job of adult stem cells
and mature tissues because they were designed by Mother Nature to work in the embryo
and not in the adult. Effective repair and regeneration of mature tissues can
only be done by adult stem cells ... The corollary to this failing of embryonic
stem cells is that continued advances in research on adult stem cells, which
are the natural cells for repair and regeneration of mature adult tissues, hold
promise for continuing advances in medicine for currently incurable diseases in
children and adults.[4]
Professor Peter Silburn from Griffith University asked the rhetorical question: "do we need to
clone to get adult cells to try and treat disease? No, we do not."[5]
"From my point of view as a scientist, I do not think that we need to go
and use somatic cell nuclear transfer to generate cells to study disease or
treat patients."[6]
Dr Renate Klein, former associate professor at Deakin University,
explained how cloning damages the embryo and the embryonic stem cells extracted
from the cloned embryo:
The difference with embryonic stem cells derived from a clone is
that they are even less useful than embryonic stem cells from an IVF embryo.
When you clone, the process of cloning so damages the software in that embryo
that you get epigenetic damage to the point that cloned embryonic stem cells
can be rejected as foreign even by the animal that was cloned because of the
genetic damage that accumulates.[7]
There is
also dispute over whether conditions like Alzheimer’s can be treated by
embryonic stem cells from cloned embryos.
Professor Colin Masters, Australia’s leading authority on
degenerative diseases of the brain, dismissed as “beyond our imagination” any
proposal for stem cell therapy in Alzheimer’s. Adelaide embryo researcher, Professor
Peter Rathjen, put it more bluntly in the Australian newspaper as “bloody
nonsense”. No serious medical expert, here or overseas, will dispute that
judgment.[8]
In contrast to the difficulties
of using embryonic stem cells from cloned embryos, “adult stem cells are the
only type of stem cells for which there are current clinical treatments.
Transplantation of bone marrow, which contains adult blood stem cells, to
restore blood cell production is a well-known adult stem cell therapy.”[9]
Professor Silburn explained the usefulness of adult stem cells:
... adult stem cells exist and from a single person can be turned
into multiple different cell types in animals as well as humans (Murrell et al
2005). Importantly disease specific and patient specific adult stem cells have
already been generated in Australia from patients with different diseases. Each
disease type attempted has resulted in stem cells being obtained and cells have
been generated which involve the disease cell type as well as others.[10]
Professor Alan Mackay-Sim from Griffith University spoke about the advantages of adult stem cells:
I can tell you now that we have over 50 cell lines from people
with disease, and they are much easier to make than somatic cell nuclear
transfer therapeutically cloned cells, which cannot be made currently in
humans. You could take them from people with a range of diseases, for some of
whom you know the genetic cause and for some of whom you do not, but they have
the same clinical symptoms, and you could compare the cell biology of tho se
and find out what is commonly going wrong. That is unlikely to happen with
somatic cell nuclear transfer or therapeutically cloned cells because of the
difficulty.[11]
There was also evidence that
the Lockhart Committee's proposal that animal eggs be used to clone
human/animal hybrid embryos for research be rejected:
Both the Stem Cell Sciences submission and mine quite
independently make the point that in relation to research [use of animal eggs]
would be uninterpretable, in relation to training it is unnecessary and in
relation to therapy it would be totally unacceptable by any regulatory body.[12]
Professor Sherley questioned
the logic of funding research into embryonic stem cells from cloned embryos
which would not produce cures.
Opportunity costs are often overlooked. The cost of taking money
that is available now for conventional disease research and money that could be
dedicated to increasing the amount of support for adult stem cell research and
shifting it to embryonic stem cell research would be okay if there were going
to be the benefits from embryonic stem cell research that have been promised.
My main message both before and now is that the money that goes into cloned
embryos and the stem cells derived from that may very well give information
about the science of human embryos, but it will not lead us to new therapies
for adults and children. If the goal is to improve the health and the welfare
of the Australian people, this is not the way to do it.[13]
Professor Martin stressed that Australia
would not lose if Parliament did not approve cloning human embryos:
We have waited over the last four years and nothing of any
substance has happened to advance the case towards a compelling argument for
the very specific step of SCNT, or therapeutic cloning. When you say that Australia
will suffer from this, I cannot actually see how Australian science will suffer
from it. The first step that would need to be taken is a major effort to
successfully undertake human SCNT. No-one in the world has ever done it.[14]
This was backed by the report
of mpconsulting, which told Cabinet there had been no scientific developments to
justify lifting the ban on cloning embryos:
On the basis of advice from the NHMRC it would not appear that
there have been any other scientific developments relevant to the question of
whether the ban on the creation of embryos by SCNT should be lifted.[15]
Several submissions noted that
the Lockhart Committee had been unable to point to scientific advances to
justify changing the law:
The only peer-reviewed papers reporting successful human cloning
to blastocyst stage in the Lockhart Report were those by Hwang et al. This work
has since been discredited. ... In view of the original brief to the Committee,
since there has been no scientific progress to justify a change in the law, we
suggest that all forms of human cloning should continue to be prohibited.[16]
The failure [of the Lockhart Committee] to address whether there
was an established necessity to create human embryos for research purposes was
an instance of a failure to address the facts. In fact the animal studies so
far have not established proof of concept for stem cell therapies derived from
SCNT embryos.[17]
... the Lockhart Report was unable to report any clinical advances
to justify a change in the law. Even if human embryonic stem cells were
produced from human clones tomorrow, it would not be possible to use them on
human subjects and we are concerned that this problem is not sufficiently
addressed in the report.[18]
FAMILY FIRST concludes there are
no strong scientific reasons to change the law to allow cloning of human
embryos.
Ethical limits to science
There was
concern about ensuring appropriate ethical limits to science. Dr Megan Best argued
"there are some things which we have to accept we will never know because
the method by which we can discover them is unacceptable on ethical grounds."[19]
There
were particular concerns about the Lockhart Report's approach to ethics:
... a basic concern of the SIE is that the notion of ‘what can be
done must be done’ pervades the Lockhart review, with the accompanying ethos
that if any scientific advantage can be had, however theoretical, then any
ethical concerns are immediately outweighed. Yet ethical boundaries in medical
research have not caused medical research to stop progressing, but instead have
moved it forward by promoting creative solutions ...[20]
There was also a warning that, should
Parliament allow the cloning of human embryos for research, we would be looking
next to reproductive cloning, or cloning to produce a live baby.
My concern is that there is no way once technology is developed
that we can restrain its applications. I know that we have safeguards in the
bill and I think, as I said in my submission, it is very touching that we have
such faith in human nature, but our history as human beings has shown that once
technology is developed we cannot restrain its application for bad purposes as
well as good. I think we all accept that our community is opposed to
reproductive cloning and the only way we can ensure that it will not go ahead
is to stop the development of cloning technology.[21]
Professor Mackay-Sim said technology
had not always been used in ways originally intended:
But I do not see a distinction in the technology between making
a blastocyst one way going to therapeutic cloning and one way going to cloning
human beings. I think that process is the same, and I think that is the ethical
decision that is being made. If you go by the history of technology, that
technology will be used for purposes for which it was not intended in the
particular jurisdiction—that is, to do therapeutic cloning.[22]
Professor Mackay-Sim pointed to a practical example:
I remember hearing Professor Wilmut being interviewed on the
radio when Dolly the sheep was cloned—and he, of course, led that group. He was
asked about human cloning and he said, ‘Why would anybody want to clone human
beings?’ He is now the second person in the UK who has applied for a licence to
do therapeutic cloning. Views change; science changes. Once one can see the
potential, people will change their views.[23]
In fact, Professor Wilmut has
gone even further and now advocates reproductive cloning as the GeneEthics
Network documents:
In 1997, when Ian Wilmut announced Dolly the sheep had been
cloned, the almost universal response from all section of society was that this
technology must never be used on human beings. But within a short time
advocates began to propose a variety of possible justifications for cloning in
human research and for human reproduction. Wilmut has shifted from his 2002
position that, "nobody should be attempting to clone a child" to now advocating
cloning and germline gene manipulation, to produce children.[24]
FAMILY FIRST believes there
must be appropriate limits on science and the Lockhart Report goes too far by
advocating embryo cloning.
Definition of an embryo
Definitions of human embryos
have become central to the debate because: (1) the two embryo cloning bills
have adopted a new definition, (2) it has been claimed that an embryo cloned by
somatic cell nuclear transfer is not really an embryo or not if it is not implanted
in a uterus, and (3) it is also claimed that cloned embryos do not have the
same moral status as conventionally produced embryos.
The Private Members Bills of Senators
Patterson and Stott Despoja both use a definition contained in a discussion
paper by a National Health and Medical Research Council (NHMRC) Working
Party. The NHMRC actually confirmed in the hearings that "this does not
represent council's definition of an embryo."[25]
A number of submissions and
witnesses expressed concern at this definition, as it omits stages of embryonic
development covered by the current definition and could be used by scientists
to escape regulation.
The new definition enables destructive research on whole classes
of embryos either presently protected, or whose generation is prohibited by the
2002 legislation. [26]
There was discussion about the failures
of the new definition:
Part (a) arbitrarily makes the beginning [of the human embryo]
not when the first cell is formed, but at a point sixteen hours later when the
first cell begins to divide to form two cells. The new entity exists when the
first cell is formed by the fusion of the two cells ... The effect would thus be
to remove the embryo for the first sixteen hours of development from the scope
of regulation, either ethical or legal.[27]
... the second part of the definition would allow an
interpretation that a cloned embryo was only an embryo if it is to be
implanted. Thus it would be permissible, using this definition, to form embryos
by cloning, as long as they were not to be transferred into an environment
where it would be possible for implantation to occur and development to the
stage of the formation of a primitive streak. Those unimplanted, cloned embryos
would then be completely outside the regulatory framework established by the
guidelines and by the proposed legislation.[28]
It is inappropriate to use a
draft definition in such a technical area in important legislation.
Some people have also claimed
that human embryos cloned by somatic cell nuclear transfer are not really
embryos, because they are not created in the usual way by the union of ova and
sperm.[29]
This
position was refuted by the current legislation banning cloning, by the
Lockhart Committee and by numerous witnesses.
The
Lockhart Committee found:
... human embryo clones are human embryos and that, given the
right environment for development, could develop into a human being.
Furthermore, if such an embryo were implanted into the body of a woman to
achieve a pregnancy, this entity would certainly have the same status as any
other human embryo, and were this pregnancy to result in a live birth, that
child would enjoy the same rights and protection as any other child.[30]
But the Lockhart Committee did
regard cloned embryos "as having a
different moral status from the embryos that are created in fertility programs."[31]
The
Social Issues Executive of the Anglican Church explained:
The Lockhart Committee denied the moral significance of a cloned
human embryo on the grounds that it was indeed created for destruction; but the
nature of a human embryo does not alter because of others’ plans for it. It
remains a human being and dismissing it as ‘a cellular extension of the
original subject’ (p.xvii) is a mere semantic claim that changes neither the
biology of this kind of embryo nor the moral concerns inherent in its use.[32]
Professor James Sherley stated
that “It is the cellular make-up of an embryo that makes it an embryo. Not its
location.”[33]
... the embryo is defined by its cellular properties. It is a fact
that we have a complete human genome – that is in the cytoplasm of the milieu
of an egg, which has been reprogrammed by that egg to start the developmental
process. It does not really matter whether you have it in a dish or in the
uterus of a woman; it is an embryo.[34]
Do No Harm said claiming a
cloned embryo was not a real embryo was "biological nonsense".
An embryo is an embryo no matter how it is made. Cloning is
simply one way of making an embryo; uniting egg and sperm is another. Dolly the
sheep, formerly Dolly the embryo, did not result from the union of egg and
sperm, but was clearly no different to any other embryo in that she was able to
be born as a lamb. In the Prohibition of Human Cloning Act 2002 the
definition of embryo clearly includes those made “by any means other than by
the fertilisation of a human egg by human sperm”, specifying cloning techniques
(SCNT) as one such means. [35]
Dr David van Gend referred to an editorial in the journal Nature
which
...condemned the International Society for Stem Cell Research in a
very short editorial called ‘Playing the name game’. It said:
‘Stem-cell biologists should not try
to change the definition of the word ‘embryo’.’
In this very powerful, brief editorial—I am sorry it is not in
your current collection, but I have tabled it—it said:
‘Whether taken from a fertility
clinic or made through cloning, a blastocyst embryo has the potential to become
a fully functional organism, and appearing to deny that fact will not fool
diehard opponents of the research. If anything, it will simply open up
scientists to the accusation that they are trying to distance themselves from
difficult moral issues by changing the terms of the debate.’[36]
The same Nature article
details the work of the International Society for Stem Cell Research in
deciding to use the term 'somatic cell nuclear transfer' instead of 'therapeutic
cloning' because "... the work 'cloning' was generating public
concern".[37]
Some people
have tried to portray cloning embryos for research as a different technique to
cloning embryos for reproduction. Professor Mackay-Sim explained:
The development of stem cells—the development of the technology
to make blastocysts to make therapeutically cloned cells—is, to my
interpretation of the science, no different. You do the somatic cell nuclear
transfer—you make your blastocyst—and, on the one hand, under some
jurisdictions, you put those into a dish and make embryonic stem cells;
however, in other jurisdictions, and in an international context, you could
clone human beings with that technology.[38]
FAMILY
FIRST believes it is important that people in the embryo cloning debate do not
use language designed to confuse people or hide the truth.
Source of eggs for cloning
Cloning embryos requires a
supply of eggs and the only source of human eggs is the ovaries of women. Given
the discredited Korean cloning research team used more than 2000 eggs for no
result, this is a real cause for concern. [39]
Professor Silburn explained
that "as cloning is extremely inefficient it has long been recognised that
there will not be enough eggs to permit the achievement of the goal of
obtaining disease specific or patient specific stem cells from human cloning by
Somatic Cell Nuclear Transfer (SCNT) and use of human eggs."[40]
Some groups fear the implications
of a demand for eggs if embryo cloning is permitted.
Women's Forum Australia
detailed dangers for women in their submission:
Cloning depends on a continuous supply of ova which can only be
achieved with high doses of ovulation stimulating agents. There is increasing
evidence that the super-ovulation process is associated with serious health
risks, including death. The long-term health impacts might include reproductive
cancers.[41]
FINRRAGE pointed out that:
These serious health risks are not surprising considering that
superovulation drugs can stimulate women’s ovaries to produce up to 30 eggs a
month instead of the usual one in a natural cycle.[42]
Dr Sheryl de Lacy said cloning
should be banned until such issues are resolved.
It is my view that we should not proceed further by expanding
regulatory policy to include SCNT research until we have fully considered the
implications to the community in sourcing material for this work. Specifically
we need to consider where the genetic material required for progress will be
sourced and under what conditions we are comfortable with it being obtained.[43]
WFA questioned the usefulness
of informed consent regimes when the full risks of the procedure for taking
eggs are not understood:
It is not meaningful to speak of ‘informed consent’ when there
is a lack of independent assessments about the long term health risks of egg
harvesting. ... consent must be viewed against the background of powerful social
and economic influences that can encourage researchers to downplay the risks of
egg harvesting. As Beeson and Lippman have noted, some physicians who extract
eggs are also involved in cloning research. ‘Seeking consent from women in
these circumstances is problematic when clinicians have an interest in
obtaining their eggs’.[44]
When
questioned about whether donating eggs for cloning was the same as extracting
eggs for IVF, Katrina George
explained that:
... every medical procedure, as you know, has risks and benefits.
It is always a matter of weighing the benefits against the risks. A woman who
undergoes egg extraction for IVF assumes same health risks, but the potential
benefits are entirely different. She has up to a 40 per cent chance of
producing a baby for herself. Where women undergo egg extraction for research,
there is absolutely no benefit to them and, indeed, no certain benefit to
anybody.[45]
The
proposed legislation would make selling eggs illegal, but expenses could be
reimbursed. FINRRAGE argued:
Reimbursement of women’s ‘expenses’ or ‘inconvenience’ for
‘donating’ ova may not seem profitable to the people considering this legislation,
but it can represent a substantial sum of money to poorer women, particularly
students and unskilled or unemployed women.[46]
Inducements did not have to be
money.
... inducements are widely recognised as coming in many forms
other than money (Grady 2001). For example, it has recently been argued that
so-called informed decisions in medical care and participation in research can
sometimes involve simple deference to medical authority rather than
self-determination.[47]
Already international
restrictions on paying women for their eggs are under pressure because of the
demand for eggs:
It is irresponsible and premature to allow research cloning
without identifying a viable source of ova that is safe for women. ... Only a few
years after the legalisation of research cloning in the UK, the licensing
authority has begun to authorise commercial incentives for supplying ova for
research.[48]
Failures of the Lockhart Committee
The Lockhart Committee was set
up to review the scientific evidence to see if scientific developments justify
overturing the ban on cloning embryos and determine if community attitudes supported
a change.
Professor Sherley highlighted
some of the scientific weaknesses of the Committee:
The constitution of that [Lockhart] committee did not equip it
to consider the science adequately in my view. It could have used all the
people who were on it, but it needed a broader participation as well. It
especially needed an uninvolved, critical view of the science. It also needed
the participation of a few people in cell and molecular developmental biology
and somebody with experience and expertise in research in at least one of the
main diseases that is being talked about as being a therapeutic possibility. My
arguments have been based on the science, and I simply do not think the science
was adequately canvassed in the Lockhart committee’s report.[49]
The Do No Harm submission states
that at least three Committee members, including deputy chair Loane Skene, were on
the record as strong supporters of cloning embryos for research before they
were appointed to the Committee. [50]
They already had a predetermined position.
In addition, the Committee has
admitted helping to draft the two cloning bills before the Senate:
[Lockhart] Committee members have assisted both Senator Patterson
and Senator Stott Despoja in the preparation of their respective draft Bill and
Exposure Draft.[51]
Several submissions complained
about the inadequacy of the Committee's approach to determining community
attitudes.
... when it comes to the most crucial part of the Lockhart
committee report—which is assessing where the community is at—the report openly
makes it clear that it does not have an evidence based perspective. But given
that lack of an evidence based perspective, it makes a profound shift and
purports to then represent where the community is at. I find that quite
astounding ...[52]
Do No Harm asks the very
reasonable question:
... why did the [Lockhart] Committee ignore the one major piece of
published research, that of Swinburne University in 2004, which found a
substantial majority of us – 63% - did not feel comfortable with scientists
cloning embryos for stem cells? The Committee preferred to be guided by a
non-academic phone poll conducted by ... Biotechnology Australia.[53]
The Lockhart Committee did not
refer to opinion poll research by Swinburne University and the Sexton Marketing
Group for the Southern Cross Bioethics Institute, both of which showed
community opposition to embryo cloning.
Professor Martin notes the Lockhart Committee referred "... to a
2006 Morgan Poll as though it was the only community survey available." But
"the information given to respondents is false" in the Morgan poll.
"No scientist has yet made a human embryonic stem cell [from cloning]. It
also gives an entirely misleading description of cloning. Most lay people would
not understand from this description that this process would still form a
living human embryo which is then destroyed by the extraction of stem
cells."[54]
FAMILY FIRST condemns the Lockhart
Committee for failing to do a proper job in critically assessing the important
issue of cloning human embryos for research.
Conclusion
FAMILY
FIRST believes the Lockhart Committee and supporters of the embryo cloning
bills have not made a convincing case for overturing the ban on embryo cloning.
The Senate Committee heard from
a number of scientists that there are no strong scientific reasons to change
the law to allow cloning of human embryos.
FAMILY FIRST wants cures as
much as anyone else. FAMILY FIRST wants scientists to find cures to all manner
of debilitating diseases. However, the evidence presented to the Committee has
reinforced FAMILY FIRST's concerns about the Lockhart Committee's report and
reinforced our view that cloning human embryos will not produce the cures we
all desire.
Senator
Steve
Fielding
Leader of the Family First Party
Family First Senator for Victoria
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