Chapter 2 - Stem cell research and human cloning: an overview of scientific aspects
Introduction
2.1
The fields of stem cell
research and cloning are complex and rapidly developing areas of scientific
endeavour.
2.2
There are a number of detailed
and accessible accounts available of the science involved in these fields. In
particular, the report of the Australian Parliament’s House of Representatives
Standing Committee on Legal and Constitutional Affairs, Human cloning: scientific, ethical and regulatory aspects of human
cloning and stem cell research, August 2001,[15] provides a comprehensive introduction
to human reproductive processes as well as to the specific technologies
involved in stem cell research and human cloning.
2.3
Other sources of information
for non-specialists are the National Health and Medical Research Council’s
(NHMRC) fact sheets,[16] and the
National Institutes of Health (NIH), Stem
Cells: Scientific Progress and Future Research Directions, June 2001.[17]
2.4
The Committee will not repeat
in detail the information available from these sources. It seeks in this
chapter to provide an overview of the technologies pertaining to stem cell
research and human cloning, before outlining a range of the scientific concerns
raised in evidence in relation to them.
Defining terms
2.5
In this section, the Committee
seeks to define the terms and to outline the main areas of possible future
scientific development in stem cell research and human cloning in such a way
that the provisions of the Bills before the Senate and the ethical issues
provoked by them can be properly considered.[18]
Stem cells
2.6
There are two types of cell
which form ‘the building blocks of the body’. They are called ‘germ’ cells and
‘somatic’ cells.
2.7
Germ cells are located in the
ovary and testis, and are the cells from which sperm and eggs arise. All other
cells types in the body are somatic cells. They are usually specialised for
their roles as, for example, muscle cells or nerve cells in particular tissues
or organs.[19]
2.8
The House of Representatives
Human cloning report explained that ‘all cells form initially from
unspecialised cells. In the embryo, stem cells form the early tissues and
organs. Under the influence of unknown genetic and chemical signals, cells
become specialised and differentiated. Some stem cells are retained in most
tissues or organs throughout life to participate in regeneration and repair’.[20]
Embryonic stem cells
2.9
After fertilisation of the
human egg by sperm, the process of cell division in the embryo commences. By
about the fourth day, the embryo consists of a ball of 32-64 cells, known as a
‘morula’.[21]
2.10
By day five or six, the morula
has developed into a ‘blastocyst’. The blastocyst consists of an outer casing
of cells and an inner cell mass.[22] The
cells of the ‘outer casing’ are already committed to becoming placental tissue
and have lost the ability to develop into other tissues and organs. The ‘inner
cell mass’, however, is composed of embryonic stem cells and they become many
or all of the specialised cells or tissues of the body.[23]
2.11
Embryonic stem cells can be
removed from the blastocyst with a thin glass needle, or by a biochemical
dissociation of the cells.[24] The
removal of the embryonic stem cells from the blastocyst entails the destruction
of the embryo.
2.12
The embryonic stem cells can be
placed into a culture medium, where they can replicate and remain
undifferentiated indefinitely. They can also be frozen and stored, or grown in
culture to differentiate into a wide range of specialised cell types or
‘lineages’.[25]
2.13
Stem cells that have
differentiated into specialised types, either spontaneously or in response to
specific culture conditions, are called ‘stem cell lines’. The Academy of
Science has noted that:
The research challenges are to identify and characterise the
factors and conditions that maintain, expand and direct the lineages of the
cell lines, to drive exclusive differentiation of cells into desired tissue
types.[26]
Adult stem cells
2.14
An adult stem cell is an
undifferentiated or unspecialised cell that occurs in differentiated tissue and
is responsible for normal repair and replacement of that tissue.[27] Adult stem cells have been found in
sources including bone marrow, blood, the brain, skeletal muscle, the pancreas,
fetal tissue and tissue from the umbilical cord.[28]
2.15
Adult stem cells are able to
make identical copies of themselves, or to ‘self-renew’, for the lifetime of
the organism.[29]
2.16
It has been difficult so far
routinely to identify adult stem cells from the majority of organs. They are
also not easy to grow or maintain in an undifferentiated state in culture,
because ‘they naturally incline to become one or other more specialised cell
type such as muscle, nerve or skin’.[30]
However, in the past three years, there has been a major expansion in research
on adult stem cells and there is a new understanding of their flexibility.[31] In particular, some evidence suggests
that, given the right environment, some adult stem cells are capable of being
‘genetically reprogrammed’ to generate specialised cells that are
characteristic of different tissues.[32]
Embryonic germ cells
2.17
An embryonic germ cell is
derived from fetal tissue. As noted earlier, germ cells are located in the
ovary and testis, and are the cells from which sperm and eggs arise. Embryonic
germ cells are isolated ‘from the primordial germ cells of the gonadal ridge of
the 5- to 10-week foetus’.[33]
2.18
Embryonic germ cells are like
embryonic stem cells in that they have the capacity to differentiate into many
or all of the tissues in the body. They are not, however, identical in their
properties and characteristics.[34]
Embryonic stem cells and germ cells
- The Trounson debate
2.19
The differentiation between
different cell types, their derivation and properties (including developmental
potential) is complex. That difficulties arise can be seen in the debate that
arose following Professor Alan Trounson’s presentation of the rat with a motor
neurone lesion.
2.20
In a presentation to the
Liberal/National parties that received widespread publicity, Professor Trounson
referred to experimentation on a paralysed rat as an example to demonstrate
that ‘embryonic stem cells have been used to derive tissue for transplantation
for the following major diseases/pathologies’:
Human ES cells directed into neural stem cells and motor neurone
cells - when injected into the spinal column of rats with a motor neurone
lesion (viral induced) - no muscle control at all below C6 (lower body) - were
completely reversed (animals walked again and had control of bowel and bladder
function) - potential application for human Motor Neurone Disease.[35]
A similar presentation was made in a Parliamentary briefing
for National Science Week on Thursday, 22 August 2002.
2.21
Subsequent to the presentation
it was established that the paralysed rat had been treated with ‘differentiated
germ cells from the early sex gland of a two month old aborted foetus’.[36] This led to much criticism of
Professor Trounson for misrepresenting the science involved and misleading the
politicians with the presentation. The Committee received many general comments
echoing these views. A number of witnesses did provide specific comments
relating to the Trounson presentation and the science involved.
2.22
Professor Peter Silburn, a
clinical neurologist, told the Committee:
The issue was used, and it was portrayed that this was an
embryonic stem cell line from a human that was used to treat and cure-the word
‘cure’ was used-an animal with motor neurone disease. We have subsequently
learnt that when you actually look at that evidence, look at that statement,
indeed they were not human embryonic stem cell lines. We also found out that
these in fact were not published...We also found out that in fact it was not
motor neurone disease and that the animal was not cured.[37]
2.23
The point of difference between
a germ cell and an embryonic stem cell was commented upon by Dr Amin Abboud, a
lecturer in medical ethics and health law:
Listening to [Professor Trounson’s] explanation of the
differentiation between germ cells and embryonic stem cells reminded me-and I
am not trying to be cynical-of what medieval theologians are often accused of:
questioning how many angels can dance on a pinhead. There is a fundamental
difference between a differentiated germ cell-it was a gonadal germ cell-and an
embryonic stem cell, and I feel his explanation is wanting scientifically.[38]
2.24
Professor Trounson provided an
explanation at the hearing of the terminology used in the presentation and the
provenance of the research he quoted. He disputed that there is a ‘fundamental
difference’ between the two types of cell:
I use the term embryonic stem cells to describe embryonic germ
cells. In doing so, I did not mislead members of parliament because the terms
‘embryonic stem cells’ and ‘embryonic germ cells’ are often used
interchangeably...
Embryonic stem cells from embryos are functionally
indistinguishable from embryonic germ cells and will do everything that
embryonic germ cells can do in terms of differentiation and tissue
colonisation. Both represent human pluripotential stem cells derived from
embryos and are quite distinct from adult tissue stem cells.
Given the time available and the need to make several points
about the potential benefits of embryonic stem cells, rather than give an
extended lesson in cell biology, I used the term ‘human embryonic stem cells’
in a generic sense. This is not incorrect. It is perfectly reasonable to use a
study on embryonic germ cells to support the argument for further research
using embryonic stem cell lines derived from IVF embryos for treatment of some
motor neurone disorders...
I do not believe that I had any intention to mislead you or any
other members of the parliament during that period of time. If I did, I
apologise; it was certainly not my intention. I was trying to make an argument
that this was the first time I had ever seen ‘human embryonic stem cells’
generically used in an animal in that way.[39]
2.25
Senator Jacinta Collins did not
accept Professor Trounson’s explanation:
The public record shows quite clearly that in the question I
asked you...I sought to understand the distinction between embryonic stem cells
and those used in the particular case. Your response reiterated three times:
‘No, they were embryonic stem cells.’ This is what has given the media and
others cause to believe that perhaps they were deliberately misled.[40]
2.26
Professor Trounson did however
receive international support for his view. Professor Marilyn Monk, from the
Institute of Child Health in London, submitted:
His “error” was that he was not exact in that he did not make
clear the derivation of the stem cell. The stem cells originally came from the
gonads of an aborted post-implantation fetus rather than from the
sub-population of cells of the pre-implantation embryo mentioned above. The
point is that they are the same lineage of cells - the embryonic stem cells -
just further ‘down the line’. Both types of cells behave in similar ways in
terms of their developmental potential.[41]
Properties of cells
2.27
For the purposes of this
inquiry, the properties of cells that are of interest are those related to
their capacity to ‘differentiate’ or ‘specialise’ into particular kinds of
tissue.
2.28
‘Differentiation’ is the
process by which an unspecialised cell, such as a stem cell, becomes
specialised into one of the cells that make up the body. During
differentiation, certain genes become activated and other genes become inactivated,
meaning that the cell develops specific structures and performs specific
functions.[42] For example, a mature,
differentiated nerve cell has thin, fibre-like projections that send and
receive the electrochemical signals that permit the nerve cell to communicate
with other nerve cells.
2.29
In the laboratory, stem cells
can be manipulated to become specialised or partially specialised cells and
this is known as directed differentiation.[43]
However, most of the cellular triggers and signals that determine how cells are
differentiated to become, say, muscle, nerve or skin cells, are not understood.[44] Much of the research in this area is
directed towards understanding how to control and direct cell differentiation
or to identify the factors responsible for doing so.[45]
2.30
The kind of capacity that cells
possess to differentiate into different kinds of cell is described by the
concept of ‘potency’ or potential.
2.31
Totipotent cells can develop
into a whole individual. The cells that possess this capacity are fertilised
eggs and the individual cells of the embryo up to the 16-32 cell stage.[46]
2.32
Pluripotent cells have the
capacity to develop into many or all the cells of the body, but cannot develop
into whole individuals. The only known sources of human pluripotent cells are
embryonic stem cells and embryonic germ cells.[47]
2.33
Recent research on adult stem
cells indicates that they have the capacity to generate not only the tissue in
which they are found, but to generate the specialised cell type of another
tissue.[48] It is thought, however, that
adult stem cells can differentiate into a more restricted range of tissues or
organs than embryonic stem cells. They are thus described as ‘multipotent’
rather than ‘pluripotent’.[49]
Cloning technologies
2.34
The Australian Academy of
Science has defined ‘cloning’ as:
the production of a cell or organism with the same nuclear
genome as another cell or organism.[50]
2.35
As this definition makes plain
and as the report into human cloning of the House of Representatives Standing
Committee on Legal and Constitutional Affairs emphasised, cloning does not
necessarily mean the replication of an entire individual.[51] It can mean simply the replication of
a cell or group of cells.
2.36
Cloning occurs naturally in the
‘asexual reproduction of plants, the budding of yeast in beer, the formation of
identical twins and the multiplication of cells to repair damaged tissue in the
normal process of healing’.[52] Cloning
may also be achieved artificially.[53]
At present, there are two artificial cloning technologies: embryo splitting;
and nuclear transplantation, also known as ‘somatic cell nuclear transfer’.[54]
Embryo splitting
2.37
The technology of embryo
splitting involves fertilising an egg with sperm, and dividing the newly formed
embryo into two or more individuals. In cases of identical twins this is the
mechanism that occurs naturally, but it can also be performed in the
laboratory. The individuals that result from this process, which is also known
as ‘fission’, will be genetically identical to one another but not a clone of
either parent.[55]
Somatic cell nuclear transfer
2.38
This technique was used to
create ‘Dolly’ the sheep, and may be a technique used in developing stem cell
therapies.[56] It involves removing the
nucleus of an egg cell, which contains almost all of the genetic material in
the cell, and replacing it with another cell nucleus. This second nucleus may
be taken from any somatic cell, such as a skin cell or liver cell. In the case
of Dolly, the cell was taken from the sheep’s mammary gland.[57]
2.39
The enucleated egg and its new
nucleus are fused using an electric current, and it forms a new embryo which is
‘substantially’ genetically identical to the organism from which the somatic
cell was taken. In addition to the DNA from the somatic cell, this ‘cloned’
embryo would also possess very small amount of DNA attributable to the
mitochondria in the egg cell.[58]
2.40
In theory, the cloned embryo
may either be transplanted into a gestational mother and allowed to develop
until birth, or it may be allowed to develop to the blastocyst stage when the
inner cell mass or embryonic stem cells could be harvested, resulting in the
destruction of the cloned embryo. In practice:
the success of the somatic cell nuclear transfer procedure to
form a viable blastocyst is approximately 1-2% of attempts made. The success of
cloned embryos transferred to the uterus [of non-human mammals] resulting in
live births is also of this order. The reasons for the many failures have yet
to be fully defined. The efficiency of the procedure must be improved greatly
before it becomes a viable technique, either for animal husbandry or for cell
manipulation.[59]
2.41
Where the new embryo produced
by a cloning technology is allowed to develop until birth, the term
‘reproductive cloning’ applies.
2.42
Where the new embryo is allowed
to develop only so that its embryonic stem cells may be extracted, the term
‘therapeutic cloning’ has been applied. There is some dispute over the
application of this term.
2.43
The term ‘therapeutic cloning’
derives from the potential application of the technology to the development of
therapies. For example, through somatic cell nuclear transfer it is at least
theoretically possible to create an embryo using the nucleus of a somatic cell
from a patient. The stem cells that are subsequently extracted from that embryo
are clones of the patient’s own cells, and thus have the potential to grow into
‘matching’ or compatible tissue for the treatment of particular diseases. In
other words, the purpose for which the cloned embryo is created is
‘therapeutic’ rather than ‘reproductive’.
2.44
However, some have objected to
the term ‘therapeutic cloning’ on the grounds that the relevant contrasting
term should not be ‘reproductive’ but ‘non-therapeutic’.[60]
2.45
The distinction between
‘therapeutic’ and ‘non-therapeutic’ scientific or medical research was made in
the 1964 Declaration of Helsinki, and revised in Tokyo in 1975. This
declaration was confirmed by the World Health Organisation and the Council for
International Organisations of Medical Sciences as the basis for international
guidelines for biomedical research involving human subjects.[61]
2.46
According to that distinction,
‘therapeutic’ research is research or practice carried out where the procedure
is or is expected to be of benefit to the subject of the research.
‘Non-therapeutic’ research does not directly benefit the subject of the
research, although it may be of benefit to others or to scientific
understanding in general.[62]
2.47
The distinction was more
recently affirmed by the Australian Health Ethics Committee in a statement by
the Committee’s chair, Dr Kerry Breen:
Therapeutic interventions are interventions directed towards the
wellbeing of the individual embryo involved and non-therapeutic interventions
are interventions that are not directed towards the benefit of the individual
embryo but rather towards improving scientific knowledge or technical
application. Non-therapeutic experimentation includes both non-destructive
procedures (which include observation) and destructive procedures...
The more-recently-coined term `therapeutic cloning' collapses both
(a) the distinction between therapeutic and non-therapeutic research on embryos
and (b) the distinction between destructive and non-destructive experimentation
on embryos. The creation of embryos specifically for research purposes,
experimentation on those embryos and their subsequent destruction, etc. all
fall under this term. It was because of the lack of transparency of the term
`therapeutic cloning', because the term concealed rather than revealed these
ethically-significant differences, that AHEC rejected its use.[63]
2.48
The cloning of an embryo in
order to extract its stem cells for therapeutic application to others does not
constitute a procedure ‘of benefit’ to the embryo.
2.49
The Reverend Professor Michael
Tate, former Chair of the Senate Select Committee on Human Embryo
Experimentation, observed:
Language has now changed, and in a dangerous way that confuses
the permissible ways in which to advance science in this area. Recently,
‘therapeutic’ has been simply opposed to ‘reproductive’. This is because the question
of cloning has become significant, and ‘therapeutic’, said to be advancing some
knowledge that can have clinical or medical benefits immediately on the subject
or, prospectively, on other embryos or human lives, is said to be undeniably
good, whilst ‘reproductive’ experimentation is said to be still the subject of
debate.
I believe we need to emphasize again that the term ‘therapeutic’
is misused if applied to the intentional and deliberate destruction of the
subject of the experiment. However, if this definitional argument has been lost
by the media’s contrasting of therapeutic with reproductive, nevertheless,
within ‘therapeutic’, distinctions clearly need to be made.[64]
2.50
The Academy of Science supports
therapeutic cloning as ‘a possible way ahead for the production of appropriate
stem cell lines if that turns out to be what is needed to produce them’. The
Academy also supports a moratorium on therapeutic cloning advising that ‘at the
moment the position of the Academy is that it is unwise to close [therapeutic
cloning] off as a possibility in the future’.[65]
Professor Robert Jansen indicated that he was not opposed to what he described
as ‘somatic cell nuclear transfer, sometimes referred to as therapeutic
cloning’ saying ‘no, not as a matter of principle. I accept that, because of
perhaps incomplete understanding of the issues, a suspension of activity in
that area for three years might be reasonable. I do not have strong views.’[66] The Juvenile Diabetes Research
Foundation was opposed to a permanent ban on the practice, recognising ‘that
there is quite a considerable amount of research that has to be done before we
get to the stage where therapeutic cloning may or may not be useful’.[67]
Potential applications of stem cell research
2.51
There are two broad two areas
of research with possible clinical applications enabled by stem cell
technologies. They are:
-
research into cell therapies; and
-
‘spin-offs’ from that research including
research into early embryo development.
Stem cell therapies
2.52
The potential applications of
stem cell therapies, whose development may or may not make use of cloning
technologies, are said to be wide-ranging and revolutionary. The House of
Representatives Human cloning report stated that:
The ability to control and direct cell differentiation or to
identify the factors responsible for doing so, has enormous potential for new
therapies in medicine and for new biomedical industries...The potential benefits
include a complete revolution in the ability to treat acute and chronic
diseases, including Alzheimer’s, Parkinson’s, diabetes and many others.[68]
2.53
There are two main types of
cell therapy currently envisaged as potentially arising from stem cell
research. The first involves replacing or transplanting damaged or diseased
cells by tissue developed either from embryonic stem cells or from adult stem
cells. The second involves developing drugs or other therapies that may trigger
tissue to repair itself or prevent tissue degeneration.
2.54
Professor Alan Trounson, Monash
Institute of Reproduction and Development and CEO (Designate), National Stem
Cell Centre, told the Committee that:
Future research with embryonic stem cells will allow us,
firstly, to discover factors that influence and regulate tissue formation. This
knowledge may be used to develop pharmaceuticals for tissue repair in the
future. Secondly, it will help us understand the role of genes in development
and tissue function and why some of those genes lose their regulators and are
associated with cancer later in life. Thirdly, research will help us produce
cells in abundance that may be used to regain tissue function in people
suffering from diseases such as diabetes, Parkinson’s disease, cardiovascular
disease and cystic fibrosis. Fourthly, research will help us develop new drugs
using some specific cell types such as hepatocytes in the liver.[69]
2.55
Professor Trounson spoke of
these developments as contributing to ‘a new era of medicine’, with a
combination of cell therapies and conventional medicine available to treat
disease.[70] Mr Robert Moses, Chairman
of the Board, National Stem Cell Centre, spoke on the potential of stem cell
research as ‘identified throughout the world as one of the three or four new
bioscience endeavours most likely to yield major advances in the development of
medicines during the next 10 to 15 years’.[71]
2.56
Other evidence to the inquiry,
however, seriously questioned these claims, saying that they were overblown and
premature.[72] Professor Colin Masters,
Professor of Pathology at the University of Melbourne with expertise in the
study of brain diseases, Alzheimer's and other neurodegenerative disorders,
questioned claims made about the potential of research with embryos to create
therapies:
My observations on the current stem cell debate relate to the
misrepresentation which has occurred over the potential therapeutic benefits of
stem cell therapies, especially in the areas of Alzheimer's disease,
Parkinson's disease, motor neurone diseases and other causes (traumatic and
non-traumatic) of spinal cord paralysis.
I have been concerned that advocates of embryonic stem cells as
a therapy have created false expectations in the mind of the general community.
The difficulties in developing these cells for therapeutic purposes in the
brain pose immense scientific difficulties which require much more
developmental research. The real value of stem cells for drug discovery has
been almost overlooked in the public debate.[73]
2.57
Dr Peter McCullagh advised the
Committee that his career was spent studying immunological tolerance in the
area of experimental transplantation. He said:
I am appalled at the meretricious arguments and claims that have
been presented for what can be done in relation to transplantation if this bill
goes through and if the research that is foreshadowed by people appearing in
favour of the bill proceeds...In fact, when one looks at the claims made for
transplantation based on embryonic stem cell research, I suspect that you will
not find a single published paper on transplantation by any of the main
protagonists.[74]
2.58
Dr David van Gend, a general
practitioner and the Queensland spokesperson for Do No Harm, expressed the view
that proponents of embryonic stem cell research in particular have
misrepresented both the prospects of that research and the proven therapeutic
success of adult cells.[75]
2.59
Professor Peter Rowe, Director,
Children’s Medical Research Institute, Westmead, Sydney, stated that he had
been interested for the past 38 years in the prospects of genetic or cell
therapy, particularly for the treatment of childhood inherited disease and developmental
abnormalities. Nevertheless, he considered that ‘at this stage, human embryonic
stem cells have very little to offer’. Professor Rowe said that:
I think the public...has been grossly misinformed as to the
potential...I feel that there is a lot of work that could be done on human
embryonic stem cells, but to what end? Because I do not think we are ever going
to use them in any form of treatment, not in the next foreseeable 20 or 30
years, if even then.[76]
2.60
Professor Michael Good, an
immunologist and Director, Queensland Institute of Medical Research, argued
that there will be major difficulties with the therapeutic application of
tissue grown from embryonic stem cells because of the problems of immunological
rejection. He also claimed that there is no established ‘proof of concept’ or
‘proof of principle’ that human embryonic stem cells can be used clinically,
and that successful therapies derived from adult stem cells are being
overlooked in the ‘hype’ about embryonic stem cells.[77]
2.61
Professor Good agreed that
embryonic stem cell research should go ahead in animals, in order to establish
any ‘proof of principle’, but that in the meantime:
when there is a limited amount of money for research in this
country...why would we waste it on putting something into human embryonic stem
cell research that, in my estimation, will never make it into a therapy.[78]
2.62
The Committee asked the
proponents of embryonic stem cell research to respond to these criticisms. In
general terms, the proponents agreed that it is unrealistic to expect
‘overnight’ or ‘miracle’ cures from either embryonic or adult stem cell
research, but disputed the claim that there is insufficient ‘proof of
principle’ to justify undertaking research into human embryonic stem cells.
2.63
For example, Professor John Shine,
Secretary, Biological Sciences, Australian Academy of Science, stated that:
we all realise that, in this particular area, the goal at the
end of the day is to take one of our own cells, a skin cell or a blood cell,
put it into culture, multiply it up, add the appropriate growth factors and
transfer it or reprogram it into a nerve cell to treat Parkinson’s or a
pancreatic cell to treat diabetes. That is the goal at the end of the day.[79]
2.64
‘To get there’, he
acknowledged:
the academy, and all of us as scientists, recognise that we have
an enormous amount of information that we have yet to gain - a lot of knowledge
we have to learn - about what triggers cells and how they reprogram themselves
in this situation...[80]
2.65
Professor John Hearn, a
developmental biologist and Deputy Vice-Chancellor, Research, ANU, supported
research in human embryonic stem cells, but agreed that ‘embryonic stem cells
are still a very long way off application to therapy’. He said that:
it is unhelpful to have unqualified statements and sometimes
emotional statements about the promise of this field, where we are at a very
early stage ...It is quite wrong to expect...that in the next five to 10 years, in
the normal course of science and the normal progress of clinical trials, there
is going to be anything that resolves those problems.[81]
2.66
Nevertheless, Professor Hearn
submitted that the study of human embryonic stem cells will be important for
understanding how cells ‘choose’ to develop into different types of lineage and
that this understanding will have the potential to underpin major new therapies
and possibly major new drugs.[82]
Professor Hearn also disputed the claim that proof of principle sufficient to
justify proceeding had not yet been established in relation to this research.[83]
2.67
Associate Professor Martin
Pera, Co-Director, Centre for Early Human Development, Monash Institute of
Reproduction and Development, similarly agreed that this is a rapidly evolving
area of research and that ‘it would be very wrong for anyone in the scientific
community to promise cures in a certain time frame’.[84]
2.68
He also, however, disputed the
claim that there is no proof of principle underpinning the research. He said:
In recent years we have seen proof of concept of treatment in
animal models, using mouse embryonic stem cells in Parkinson’s disease,
diabetes, stroke, demyelination, severe combined immune deficiency and
myocardial infarcation.[85]
2.69
Proof of concept studies using
human embryonic stem cells or embryonic germ cells transplanted into mouse
models are, according to Professor Pera, ‘probably taking place in labs around
the world now. It will certainly be taking place in ours within the coming
year’.[86]
2.70
Dr Andrew Elefanty, Senior
Research Fellow and Laboratory Head, Centre for Early Human Development, Monash
Institute of Reproduction and Development, argued that, in any case, there are
limitations on the extent to which proof of concept studies in animal models
can validate human stem cell research. He stated:
Whilst human and mouse embryonic stem cells do have many similarities,
there are many differences in the growth and differentiation of these two
species of cells. Although we strongly believe in the use of mouse embryonic
stem cells as a complementary system...it is evident that the differences between
the biology of mouse and human embryonic stem cells will limit the degree to
which results in the mouse system can be extrapolated to humans.[87]
2.71
Very similar points were made
by Dr Edouard Stanley, joint head of the embryonic stem cell differentiation
laboratory at the Centre for Early Human Development, Monash Institute of
Reproduction and Development.[88] In
view of this argument, Dr Stanley concluded that ‘there is no valid scientific
justification for restrictions to be placed on the work using or generating
human ES cell lines’.[89]
2.72
However, in addition to their
general concerns about allegedly exaggerated claims and about the lack of proof
of principle, critics raised a number of more specific questions about the
likely feasibility and effectiveness of potential therapies deriving from human
embryonic stem cell research.
2.73
In what follows the Committee
outlines the scientific issues that arise from three key questions:
-
feasibility of tissue transplantation;
-
the relative therapeutic effectiveness of adult
compared to embryonic stem cells; and
-
the relationship between cell therapies and
disease processes.
Feasibility of tissue
transplantation
2.74
The House of Representatives
report on human cloning discussed two hypothetical cases designed to illustrate
tissue transplantation therapies that might arise from stem cell research.
2.75
The first involved the
treatment of Type 1 diabetes:
Using somatic cell nuclear transfer, the nucleus of a somatic
cell from a patient with the disease could be fused with an enucleated donor
egg. The cell would develop into a blastocyst from which inner cell mass cells
could be isolated and grown in culture with growth factors, as yet unknown, to
develop into pancreatic islet cells that produce insulin. Because these cells
came from and are genetically identical to the patient...they would not be
rejected when transplanted back into the patient. There would be little or no
need for immune-suppressing drugs, with their often unpleasant and serious side
effects.[90]
2.76
The second envisaged that it
may be possible to identify and isolate adult stem cells from a particular
tissue or organ type, multiply and grow them in culture, manipulate them to
repair any genetic or metabolic deficiency, and then transplant them back into
the damaged organ with a view to its repair.[91]
2.77
The great advantage of the
hypothetical cell therapies outlined above is that they seem to overcome the
problems of immune rejection which are currently associated with the
transplantation of donated organs. New tissue is grown either from an embryo
created by somatic cell nuclear transfer using the patient’s own somatic cell,
or directly from the patient’s adult stem cells. It thus already matches the
tissue of the patient for whom it is intended.
2.78
In practice, however, there are
a significant number of difficulties to be overcome before these hypothetical
therapies can become a reality.
2.79
First, if the tissue is grown
from embryonic stem cells, then it is only directly compatible with the
patient’s own tissue if the embryo is the product of a somatic nuclear cell transfer
in which a somatic cell from the prospective patient is fused with an
enucleated egg. Even leaving aside the fact that this technique is prohibited
by the current Bill, it is unclear that it would be viable in any case.
2.80
As noted earlier, the rate of success
in forming viable blastocysts from somatic cell nuclear transfer is in the
range of 1-2% of attempts made. The inefficiency of this procedure would mean
that a very large number of human eggs would need to be available for every
treatment.
2.81
One concern raised in relation
to this technology was that, because of the number of eggs required, any
clinical application of this practice would necessarily be exploitative of
women, for example that women may possibly be coerced in some way into
providing their eggs for such purposes.[92]
2.82
A second concern focused on the
impracticality of the therapeutic application of the technology. For example,
the Caroline Chisholm Centre for Health Ethics submitted that:
A large supply of human eggs will be required as this procedure
is very inefficient; and, unlike preimplantation embryos, eggs are in very
short supply...Treatments involving therapeutic cloning therefore, will not be
readily available, will be very time consuming, labor intensive and, as are
result, expensive. Thus, apart from ethical considerations, therapeutic cloning
is, and will remain, problematic.[93]
2.83
The leader of the scientific
team that first isolated embryonic stem cells at the University of
Wisconsin-Madison has been reported as saying that therapeutic cloning would be
‘astronomically expensive’.[94]
Likewise, Dr Christopher Juttner, Medical and Executive Director, BresaGen Ltd,[95] told the Committee that his company:
felt from the beginning that therapeutic cloning using human
eggs as the recipients of an adult nucleus was never going to be possible
because the success rates are so low that you would have to hyperovulate 10
women to get enough cells - say 100 eggs - to have a chance of getting one
matching cell line. So that was practically impossible. We felt it was
ethically unacceptable because these would be egg donors and it would not be
reasonable to ask anyone to do that.[96]
2.84
If the problem of rejection of
tissue grown from embryonic stem cells cannot be overcome by the method of
somatic cell nuclear transfer, then other options need to be investigated.
2.85
One such option involves the
creation of a multitude of stem cell lines, from which tissue can be derived.
However, there are significant differences in scientific opinion about how many
such stem cell lines would be required in order to ‘match’ the needs of all
possible patients.
2.86
BresaGen Ltd informed the
Committee that, in its view, ‘600-1000 such therapeutic ESC [embryonic stem
cell] lines will provide adequate immunological tissue matching for 90-95% of
humanity across racial/ethnic groups’.[97]
Professor Michael Good, by contrast, estimated that ‘millions’ of stem cell
lines would be required for such matching. According to Professor Good:
This is because we all possess near-unique tissue types and it
is extremely rare to find stem cells with the identical tissue type to
ourselves. In humans, the tissue typing molecules are encoded by ‘HLA’ genes
and there are 5 main types...Each gene has multiple ‘alleles’ or
variants...The number of different HLA alleles in a population, however, is
thought now to be about 500 and the different alleles can be found in different
permutations and combinations. There are literally millions of ways to mix and
match the different genes. Collectively, these different ‘HLA’ genes determine
our ‘tissue type’.[98]
2.87
A second potential solution to
the problem of immune rejection was also proposed in evidence by BresaGen Ltd.
Dr Juttner told the Committee that BresaGen had been experimenting with the
somatic cell nuclear transfer technique. Rather than putting an adult somatic
cell into an enucleated egg, they had tried ‘putting adult cells into an
embryonic stem cell that had had its nucleus removed’. He said:
It is not easy. We have worked on that for three years in mice.
We have had the beginnings of some success.[99]
2.88
Dr Juttner noted that this
technique produced cloned embryonic stem cells, but not cloned embryos. For
that reason, he believed that it would not be prohibited by the current Bill
and that ‘it is likely, I think, that the Biotechnology Centre of Excellence
will take up and expand this if it does indeed go ahead’.[100]
2.89
In terms of the feasibility of
tissue transplantation, tissue cultivated directly from adult stem cells does
not present problems of immune system rejection. Many submissions to the
inquiry thus argued that research should focus on adult stem cells, because of
the ready therapeutic applicability of tissue so derived.[101] However, other evidence indicated
that the cultivation of tissue from adult stem cells presents its own difficulties.
Therapeutic effectiveness of adult
compared to embryonic stem cells
2.90
Adult and embryonic stem cells
have different properties. These affect both their presumed effectiveness in
different situations, and the ease with which they can be studied and used.
2.91
There was extensive debate in
evidence about the relative therapeutic prospects of research into embryonic
and adult stem cells. A number of submissions provided extensive bibliographies
of research published in scientific and medical journals supporting the use of
either adult or embryonic stem cells.
2.92
Proponents of adult stem cell
research referred to their successful use in therapies including using brain
precursor cells to treat stroke, the patient’s own stem cells to treat cancer
and to treat bone defects, and bone marrow cells to treat muscle, gut and
retina. Experiments with animal models have led to published accounts of adult
stem cell success in the treatment of conditions such as Diabetes, Parkinson’s
and spinal injury.[102] Proponents of
embryonic stem cell research noted studies indicating their potential for
treatment of a range of diseases including neurological, cardiac, cancer and
other conditions.[103] Embryonic stem
cell research is still in its infancy, whereas adult stem cell research has
been performed for a number of years.
2.93
Professor Martin Pera told the
Committee that:
The excitement over the potential for human embryonic stem cell
research relates to the unique properties of stem cells...These [embryonic] cells
may be grown in the laboratory indefinitely in the primitive embryonic state,
and they retain the key property of embryo cells from which they originate -
pluripotentiality or the ability to give rise to any type of adult body cell.
This combination of properties has not been documented in any type of adult
tissue stem cell isolated to date.[104]
2.94
According to Professor Pera,
these two properties mean that embryonic stem cells ‘in principle represent a
potentially indefinite renewable source of human tissue for use in research or
in transplantation therapy to correct a range of debilitating and currently
intractable medical conditions’.[105]
2.95
By contrast, adult stem cells
are generally rare in the tissues in which they have been discovered, and they
have not been discovered to exist in all tissue types. They are difficult to
isolate and extract.[106] Finally,
while some types of adult stem cell can be grown successfully in culture, there
are others that cannot be. Associate Professor Paul Simmons, head of the stem
cell program, Peter MacCallum Cancer Institute, told the Committee that, for
example, haemotopoietic stem cells cannot be grown in culture. He said:
When one attempts to grow haematopoietic stem cells in culture,
they actually lose their stem cell properties - they differentiate. Try as we
might, we have not - and I have been actively engaged in this form of research
for at least 10 years - found ways to retain their stem cell properties. They
differentiate.[107]
2.96
Although, Dr Simmons said, he
is ‘a passionate, fervent believer in the use of adult stem cells’:
[t]here are limited numbers, and we cannot grow all the adult
stem cell populations we would like. These I think are two important
limitations of adult stem cells which, in fairness, the committee needs to take
on board if it is to engage in a rational debate on the relative merits of
embryonic and adult.[108]
2.97
Arguments raised in opposition
to research on embryonic stem cells include that embryonic stem cells are not
the only stem cell alternative, that they are undesirable from the point of
view of therapeutic application, and that adult stem cells have already been
used in a large number of successful therapies while embryonic stem cells have
not - although embryonic stem cells have not yet been the subject of the same
level of extensive research.
2.98
In support of the view that the
identified properties are undesirable in the clinical setting, Dr Peter
McCullagh observed that the judgement that a cell’s capacity to differentiate
into a wide range of tissue is advantageous ‘is completely context-dependent’:
When one is contemplating the use of cells from any source for
the purpose of clinical transplantation, it is essential that their capacity
for differentiation after their introduction into a recipient patient has been
reliably defined and that this capacity is confined to cells of a type which
are normally present in the anatomical location into which it is proposed that
they be introduced...The moral is that toenails are fine, in their place, but are
not an asset in one’s brain. If the end use of cells is to be transplantation
to a sensitive location, an unrestrained capacity for differentiation is not an
advantage.[109]
2.99
Evidence given to the Committee
by Professor Good also suggested that pluripotency may not be an advantage:
The embryonic
stem cells are all called totipotent. They have enormous proliferative
potential and they can differentiate into every single cell of 200-odd tissues
of the body. That is not an advantage; it is a disadvantage. Why would you want
to put cells into a person which have the potential to change into other cell
types that are not required? Those particular cells, due to their
totipotential, can give rise to teratomas; that is, tumours formed by cells
which can give rise to multiple tissues.[110]
2.100
Similarly, Dr Megan Best,
representing the Archbishop’s Social Executive Committee, Sydney Diocese,
Anglican Church, described embryonic stem cells as ‘wild stallions and adult
stem cells as more like domestic horses’.[111]
She spoke of experiments with embryonic stem cells showing that they have ‘a
very disconcerting tendency...to form tumours, which has not been seen to the
same degree in adult stem cells’. She noted:
that, even though stallions may be able to run faster, it was
easier to bridle a horse; and that, even if adult stem cells were not shown to
be quite as plastic as the embryonic stem cells, this may in fact be an
advantage.[112]
2.101
In support of the argument that
embryonic stem cells may not really be unique in terms of their
pluripotentiality, witnesses cited two developments in recent research into
adult stem cells.
2.102
The first of these involves the
observation ‘made in many laboratories’ of the ‘plasticity’ of adult stem
cells.[113] The term ‘plasticity’
refers to the previously unsuspected capacity of adult stem cells to give rise,
not just to their tissues of origin, but to ‘completely unrelated cell types
and tissues’.[114] For example, it has
apparently been shown that stem cells from neural tissue can differentiate into
bone or muscle tissue, that stem cells from bone marrow can differentiate into
neural, liver, or epithelial tissues, and into skeletal muscle and myocardium,
and that skeletal muscle tissue can differentiate into bone marrow.[115]
2.103
The second research development
used to support the argument that embryonic stem cells may not really be unique
in terms of their pluripotentiality is found in the work of Professor Catherine
Verfaillie, University of Minnesota.[116]
This research was paraphrased for the Committee in the following terms by Dr
Simmons:
It demonstrated the presence in adult human bone marrow of what
appeared to be a population of adult pluripotent stem cells. They are cells
that ostensibly have characteristics very similar to embryonic stem cells. That
is, they could give rise to cells of all three germ lands - endoderm, mesoderm
and ectoderm. They had the apparent advantage over embryonic stem cells in that
they did not form tumours in the animal models these investigators were using.[117]
2.104
A number of submissions to the
Committee referred to these recent research findings to justify the claim that
research using embryonic stem cells is unnecessary, and that any therapeutic
applications needed can be derived from adult stem cells.[118]
2.105
However, Dr Simmons expressed
serious reservations about that line of argument. He noted, first, that many of
the experiments purporting to demonstrate adult stem cell plasticity had not
been able to be replicated by reputable researchers, and that the results of
the studies have come to be challenged on scientific grounds.
2.106
In particular, he wrote:
Some reported phenomena have been shown to be artifacts due to
contamination of transplanted cells while other examples of conversion to other
cell types appear to be due to fusion
of different adult stem cell types leading to the generation of potentially
unstable hybrid cells with shared properties of each founder cell type.[119]
2.107
According to Dr Simmons, then,
‘it is to my mind not appropriate to use stem cell plasticity as an argument to
not study embryonic stem cells. It is looking very much like adult stem cells
are not as plastic in their developmental properties as was initially suggested
by publications’.[120]
2.108
Similarly, while Dr Simmons
agreed that Professor Verfaillie’s research involved ‘a very amazing
observation’, it has yet to be reproduced by any other laboratory. In any case,
he said that he did not accept that it made research into embryonic stem cells
redundant, and he noted that Professor Verfaillie herself had urged that
research into embryonic stem cells needed to continue.[121]
2.109
In an interview in Melbourne on
28 August 2002, Professor Verfaillie reiterated that point, saying that:
My message has always been, even though we’re excited about the
adult cells, that it’s too early to say that they will replace embryonic stem
cells to the point that our institution, the Stem Cell Institute, we actually
recruited and investigated who has extensive experience in human embryonic stem
cell work, so we’re now in a position to do exactly what you mentioned, which
is to parallel research and comparing and contrasting the two cell types.[122]
2.110
As intimated by Professor
Verfaillie’s remarks, there are two main reasons given by scientists for the
need to continue research into both adult and embryonic stem cells.
2.111
First, it is too early to
determine fully just what the potential applications of the two sets of stem
cells are. Professor John Hearn emphasised that the focus on embryonic stem
cells in humans is only four years old, and on adult stem cells even less than
that.
So our knowledge of whether adult stem cells or embryonic stem
cells are going to deliver the best benefit, either in advancing knowledge or
in advancing potential therapies, is still open to major question.[123]
2.112
In a similar vein, Professor
Sue Serjeantson, Executive Secretary, Australian Academy of Science, stated
that the Academy:
considers that research is warranted across a range of sources
of stem cells in the hope of developing tissue for use in repair of damaged
tissues. We would all be very happy if we thought that scattered adult stem
cells could be used for tissue repair. The ethical dilemma would then go away,
with it being set aside. But we think, it is unlikely at this time that the
different types of stem cells - whether derived from germ cells, blood cells,
adult tissues or embryonic stem cells - will all have the same characteristics;
we think it is unlikely that they will all have the same potential to develop
into particular tissues.[124]
2.113
The second reason given in
support of continuing research into both adult and embryonic stem cells relates
to the possibility that advances in one field will spur advances in the other.
2.114
Dr Simmons, for example,
referred to recent research done in laboratories at Harvard and Princeton which
compares two adult stem cell populations with embryonic stem cells. The
comparisons show that there are ‘genes that are uniquely expressed in each stem
cell population and there are genes that are expressed in all three
populations’. Dr Simmons noted that this ‘commonality of gene expression’ may
imply that there are ‘fundamental aspects in terms of stem cell biology that we
could approach only through studying all three types of stem cell’.[125]
2.115
Given, he continued, that the
heart of the matter is ‘to understand and define pathways with differentiation
that are responsible for derivation of the matured cell types that stem cells
give rise to’, then the comparison of completely undifferentiated cells such as
embryonic stem cells with adult stem cells ‘will inevitably yield secrets as to
how adult stem cells work’.[126]
2.116
Another example of the possible
complementarity of work in adult and embryonic stem cells was provided by Dr
Andrew Elefanty. He noted that ‘the recent very rare bone marrow derived
multipotential adult stem cells’, isolated in the mouse, grow only in the
presence of ‘the growth factor lift’. This growth factor, however, ‘was
identified and isolated because it works on mouse embryonic stem cells’. Dr
Elefanty commented that:
there is, if you like, an example already of the
cross-fertilisation of those ideas, and that is part of the reason why we feel
so strongly that both lines of research have to proceed in parallel.[127]
2.117
Professor Bob Williamson,
Director, Murdoch Childrens Research Institute, and Professor of Medical
Genetics, University of Melbourne said that:
Many, including me, are primarily interested in ‘adult’ stem
cell research because for the diseases we hope to treat (such as cystic
fibrosis or thalassaemia), avoiding rejection is a very important issue.
However, we need to learn how to use adult stem cells, and to treat them so
that they become more ‘pluripotent’ and can grow more easily (that is, more
like embryonic stem cells). In a sense, we need to learn from embryonic stem
cells how to use adult stem cells better. There is also a chance that new
developments in immunology may make embryonic stem cells less likely to be
rejected, and if this is true, they may become more useful for childhood
diseases. What I believe to be absolutely certain is that there are real
benefits in allowing adult and embryonic stem cell research to proceed side by
side in the same laboratories, so the experiments cross-refer and so that
lessons can be learnt by comparing the two systems.[128]
2.118
This body of scientific opinion
was echoed by Ms Sheila Royles, Spokesperson, Coalition for Advancement of
Medical Research Australia and Chief Executive Officer, Juvenile Diabetes
Research Foundation. She asked the Committee ‘to support the pursuit of both
adult and embryonic stem cell research’, saying:
We are at the start of the marathon; we have two strong runners,
embryonic and adult stem cells. As yet we do not know which one is going to be
capable of finishing or whether in fact they will cross the line together.
Let’s not make the decision to eliminate one of our strongest runners before we
even start. There are many, many scientific questions yet to be answered. I
urge you to support legislation and give our researchers the opportunity to see
whether this area of research really can deliver the benefits that we hope...[129]
Relationship between cell therapies
and disease processes
2.119
A third set of questions
surrounding the clinical applicability of stem cell therapies raises the issue
of the relationship between cell damage and disease processes.
2.120
In crude terms, the problem is
that even if you were able to introduce compatible ‘new’ tissue to replace
degenerated or damaged cells, the disease processes which caused the damage to
the original cells might just turn on the ‘new’ tissue.
2.121
For example, Professor Bernard
Tuch, Director, Diabetes Transplant Unit, Prince of Wales Hospital, spoke of
the problems associated with the attempted transplantation of healthy
pancreatic tissue into diabetics. He told the Committee of an experimental
study involving twins:
This is not stem cell work, but perhaps it can be used to
explain. They did take half a pancreas from the twin that did not have diabetes
and transplanted it into the person with diabetes. And of course the person
with diabetes was no longer diabetic for two weeks, and then their diabetes
recurred because of the self-destruct mechanism which causes type 1 diabetes.[130]
2.122
Professor Michael Pender, a
neuroimmunologist, made a similar point in relation to Alzheimer’s disease,
saying that it ‘is a global disorder of the brain and is highly unlikely to be
amenable to any form of cell therapy at any time in the future’.[131]
2.123
Similarly, Professor Peter Rowe
argued that:
It is not even sure that Parkinson’s disease is primarily caused
by specific self-generated damage within the particular part of the brain which
is responsible for producing the symptoms. It may well arise from a systemic
disorder, and work has been done to suggest that that is the case. In which
case, you put cells in and you get the same process occurring again.[132]
2.124
Nevertheless, evidence
suggested that even if direct transplantation of new tissue is unlikely to cure
certain diseases or conditions, research into stem cells may lead to other
therapies. In other words, the concerns just outlined may constitute arguments
against the prospects of the successful transplantation of tissue derived from
stem cells, but not an argument against stem cell research per se.
2.125
For example, Professor Perry
Bartlett, Head, Development and Neurobiology Group, Walter and Eliza Hall
Institute of Medical Research, Melbourne, described research he has recently
undertaken to isolate and purify neural stem cells, which are adult stem cells,
in the adult brain. He then said:
The reason that we went on to purify and find these cells was
not to be able to transplant them but to be able to finally discover what molecules
regulate these stem cells in you and me to make nerve cells, because the $64
million question - and the $64 billion therapy - is to have a drug that is able
to stimulate those cells that reside in our own brains and that can make nerve
cells to replace those cells lost in stroke, Alzheimer’s disease, et cetera.[133]
2.126
Professor Tuch explained that
research into a promising approach to treating diabetes is currently being
undertaken on embryonic stem cell lines.[134]
It involves not tissue transplantation but learning how to direct the patient’s
own cells, by developing genes or other agents that might turn
non-insulin-producing pancreatic cells into insulin-producing cells.[135]
Other applications of stem cell
research
2.127
Although most of the evidence
to the Committee focused on the issue of cell therapies and tissue
transplantation, some witnesses drew attention to other applications of stem
cell research.
2.128
For example, Professor David de
Kretser, Director, Monash Institute of Reproduction and Development, noted that
significant advances in knowledge will necessarily arise from the process of
developing tissue for transplantation. He said:
Researchers seeking to define the conditions necessary to enable
an embryonic stem cell to proceed down a selected pathway of development will
identify numerous products with the capacity to create markets for new drugs or
specific fluids and substrates to enable these cell types to be grown. Each of
these has the potential to develop small but important industries to underpin
Australia’s future role in biotechnology.[136]
2.129
Professor de Kretser also
expressed the view that this research would also greatly expand knowledge of
the ‘normal development’ of a human embryo, and hence increase understanding of
developmental birth defects.[137]
2.130
A large number of submissions
to the inquiry expressed grave concern that ‘other research’ undertaken as a
result of the passage of the Bill would include other destructive research on
embryos, including the use of human embryos for drug or toxicology testing, and
even for the testing of cosmetics.[138]
2.131
The Southern Cross Bioethics
Institute detailed the possible range of embryo research and observed the
majority of the research would not be related to stem cells:
The broad range of uses to which
embryos will be subjected are described, in part, in the Explanatory Guide to the Human Cloning and Research Involving Embryos
Bill 2002...the following categories for the use of excess Assisted
Reproductive Technology (ART) embryos were identified:
-
for the derivation of stem cells;
-
for examining the effectiveness of new culture media
used in ART practice;
-
for better understanding embryonic development and
fertilisation;
-
to train clinicians in micro-surgical ART
techniques;
-
to examine gene expression patterns of developing
embryos; and
-
for improving ART techniques.
To this list may be added:
-
toxicology studies on live human embryos, and
-
testing new drugs on humans rather than animals.
Therefore, even within the context of the Bill it is recognised
that human embryos will be used for purposes other than ES cell extraction,
even though these uses have been largely ignored in the debate. The promotion
of ES cell research in the emotive context of human suffering is being used as
a beach-head to gain generalised access to human embryos, most of which will be
destroyed for purposes like ART research, toxicology and drug testing.[139]
2.132
Professor Bartlett commented on
the commercial motivation for some of the embryo research that would be allowed
by this Bill:
In fairness to companies like BresaGen, they are aware that
therapy is 10 to 20 years away. Stem Cell International’s CEO has said publicly
that therapy, in their eyes, is 10 to 20 years away. So they have to generate
some form of income along the way. To use stem cells for screening and diagnostic
purposes is a perfectly understandable use of such cells.[140]
2.133
The Committee notes that the
uses of embryos in ART practice and research which are allowed by the Bill are
not new uses. The Bill brings under a national regulatory system uses and
practices which are currently regulated under State legislation, in the case of
Victoria, South Australia and Western Australia, and by NHMRC/AHEC guidelines
and the requirements of the Reproductive Technology Accreditation Committee.[141]
2.134
In relation to the use of embryos
in toxicology or drug testing, the Committee notes that a distinction needs to
be drawn between testing on live embryos and testing on embryonic stem cells
which have been derived in the first instance from an embryo and then grown
into stem cells lines.
2.135
Dr Juttner, Medical and
Executive Director, BresaGen Ltd endorsed the use of embryonic stem cell lines
for that purpose, saying that ‘I think [it] is actually a proper activity if it
saves patients from being exposed to testing of new drugs’.[142] Dr Juttner noted, however, that he
‘absolutely rejected’ the concept of using embryos as such for drug testing.
2.136
The NHMRC advised that the Bill
does not prohibit the use of embryos or embryonic stem cells for toxicology
testing. In the case of testing on embryos, however, any such proposed use
would require a licence from the NHMRC Licensing Committee.[143]
Summary
2.137
Research involving stem cell
and cloning technologies is in its infancy.
2.138
Most scientists would agree
that there is as yet insufficient experimental data to be certain either just
how important research into stem cells is likely to be, or to be certain about
the relative value of embryonic and adult stem cells for that research.
2.139
However, many agree that
therapies derived from stem cell research have at least the potential to
ameliorate currently incurable conditions, ranging from diabetes to spinal cord
injuries to motor neurone, Parkinson’s and Alzheimer’s diseases.
2.140
In the next chapter, the
Committee considers the nature of the ethical issues that arise in relation to
this research.
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