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2007/06 Should the Australian Parliament have approved therapeutic cloning? <BR>

2007/06 Should the Australian Parliament have approved therapeutic cloning?


What they said ...
'That some in the community believe embryos deserve as much protection as adults does not mean the force of law should compel this view'
Associate Professor Ian Kerridge, Professor Peter Schofield and Professor Loane Skene were members of the Lockhart committee

'Creating human beings as tiny stem cell generators, only to destroy them once their utility has been served, tramples on the critical ethical principle that human beings should never be treated as a means to an end'
Kevin Dillon, a British spokesperson for the Movement Against Cloning

The issue at a glance
On December 6, 2006, the federal House of Representatives passed the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. In doing so it lifted a four-year ban on cloning human embryos for stem cell research.
The decision is contentious. The Prime Minister, John Howard, his two deputies and the leader of the Labor Party, Kevin Rudd, all argued that the sanctity of human life must take precedence over potential cures for conditions that include Parkinson's disease, spinal cord injuries and arthritis.
All parliamentarians were allowed a conscience vote (that is, they were not directed by their parties) and after considerable debate the House of Representatives voted 82 to 62 to scrap the ban. The bill was passed by the Senate in November by the narrowest of margins - 34 to 32.
The new law allows therapeutic cloning, the splicing of DNA from skin cells into eggs to produce embryos from which stem cells can then be harvested. Stem cells, also known as master cells, are capable of forming all the tissues of the human body. The cloned embryos cannot be implanted in a womb and must be destroyed within 14 days.
The senator who drafted the private members bill, former Health Minister Kay Patterson, has claimed it should reduce the number of scientists going from Australia to other nations that allow therapeutic cloning. She also argued that it would enable Australian medical researchers to work with peers in countries where therapeutic cloning is permitted, including the United States, Britain and Singapore.

Background
Some key terms

a) A clone
A clone is an exact copy of an organism.

i) Cloning occurs in nature, without human intervention in a variety of ways. For example, after conception (the fusing of sperm and ovum) the fertilized egg, now called a zygote divides one time, resulting in two cells. By approximately four days after fertilization, the zygote has about 100 cells and is called a blastocyst. If at some point soon after this the blastocyst splits, each half may embed separately in the wall of the womb and two identical offspring will result. This is how identical twins occur.

ii) Cloning can also be induced artificially in the laboratory.
This process is referred to as Somatic Cell Nuclear Transfer (SCNT). The nucleus is removed from an egg cell and then replaced with the nucleus from a somatic cell (a cell of the body which is not a sperm or egg cell) taken from another animal of the same species. The resulting fused cell has the potential to develop into an entire animal which is a virtual replica of the animal from which the somatic cell was taken, that is it has the same genotype as the donor of the somatic cell. The clone develops to form a blastocyst from which embryonic stem cells can be harvested.
This method of creating stem cells has been suggested as a way of overcoming the problems of tissue rejection. If the stem cells were used to treat the animal or human from which the somatic cell had been taken there should be no rejection of the transplanted cells as they would have the same genotype.

b) Therapeutic cloning.
Therapeutic cloning is the creation of a clone for treatment purposes, where there is no intention that the clone will ever reach maturity. This is different from reproductive cloning where a clone is produced and allowed to survive to maturity.

c) Stem cells
Most human cells are differentiated. This means they are of a specific type and have a specific function. What makes stem cells so important is that they are either undifferentiated or are far less differentiated than the majority of cells. This means, that depending on the type of stem cell they are, they can either develop into one of many types of cell or, if more restricted, into a narrower variety of cells. Stem cells that have the potential to develop into one of many cells are called pluripotent. Those that can develop into one of a narrower variety of cells are called multipotent.

What makes stem cells potentially important in the treatment of disease and injury?
i) Probably the most far-reaching potential application of human pluripotent stem cells is the generation of cells and tissue that could be used for so-called 'cell therapies'.
Many diseases and disorders result from disruption of cellular function or destruction of tissues of the body. Today, donated organs and tissues are often used to replace ailing or destroyed tissue. Unfortunately, the number of people suffering from these disorders far outstrips the number of organs available for transplantation.
Pluripotent stem cells, stimulated to develop into specialised cells, offer the possibility of a renewable source of replacement cells and tissue to treat many diseases and disabilities, including Parkinson's and Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis. (Please note: the effectiveness of stems cells as a means of treating some of these diseases has been disputed.)

ii) Pluripotent stem cells could also help scientists understand the complex events that occur during human development. A major goal of this work would be to study the cellular decision-making process that results in cell specialisation. Turning genes on and off is central to this process, but not much is known about these 'decision-making' genes or what turns them on or off.
Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell specialisation and cell division. A better understanding of normal cell processes could allow medical scientists to better understand the fundamental errors that cause these often-deadly illnesses.

iii) Human pluripotent stem cell research could also change the way drugs are developed and tested. For example, new medications could be initially tested using human cell lines. This would not replace testing in whole animals and testing in human beings, but it would streamline the process of drug development. Only the drugs that are both safe and appear to have a beneficial effect in cell line testing would graduate to further testing in laboratory animals and human subjects.

Where are stem cells found in human development?
i) Embryonic stem cells
Human development begins when a sperm fertilises an egg and creates a single cell that has the potential to form an entire organism. This fertilized egg is totipotent, meaning that its potential is total.
Approximately four days after fertilization and after several cycles of cell division, these totipotent cells begin to specialize, forming a hollow sphere of cells, called a blastocyst. The blastocyst has an outer layer of cells and inside the hollow sphere there is a cluster of cells called the inner cell mass.
The outer layer of cells will go on to form the placenta and other supporting tissues needed for foetal development in the uterus. The inner cell mass cells will go on to form virtually all of the tissues of the human body. Although the inner cell mass cells can form virtually every type of cell found in the human body, they cannot form an organism because they are unable to give rise to the placenta and supporting tissues necessary for development in the human uterus.
These inner cell mass cells are pluripotent embryonic stem cells, that is, they can give rise to many types of cells but not all types of cells necessary for foetal development.
The pluripotent stem cells undergo further specialization into stem cells that are committed to give rise to cells that have a particular function. Examples of this include blood stem cells that give rise to red blood cells, white blood cells and platelets; and skin stem cells that give rise to the various types of skin cells. These more specialised stem cells are called multipotent embryonic stem cells.

ii) Adult stem cells
While stem cells are formed during early human development, multipotent stem cells are also found in children and adults, for example, the blood stem cell. Blood stem cells reside in the bone marrow of every child and adult, and in fact, they can be found in very small numbers circulating in the blood stream. Blood stem cells perform the critical role of continually replenishing our supply of blood cells - red blood cells, white blood cells, and platelets - throughout life. A person cannot survive without blood stem cells.
Multipotent stem cells have not been found for all types of adult tissue, but discoveries in this area of research are increasing. For example, until recently, it was thought that stem cells were not present in the adult nervous system, but, in recent years, neuronal stem cells have been isolated from the rat and mouse nervous systems. The experience in humans is more limited. In humans, neuronal stem cells have been isolated from foetal tissue and a kind of cell that may be a neuronal stem cell has been isolated from adult brain tissue that was surgically removed for the treatment of epilepsy.
Until recently, there was little evidence in mammals that multipotent cells such as blood stem cells could change course and produce skin cells, liver cells or any cell other than a specific type of blood cell; however, research has lead scientists to question this view.
It has been shown that some adult stem cells previously thought to be committed to the development of one line of specialised cells are able to develop into other types of specialised cells. For example, recent experiments in mice suggest that when neural stem cells were placed into the bone marrow, they appeared to produce a variety of blood cell types.

The status of cloning around the world
In South Africa currently, the Human Tissue Act prohibits both therapeutic and reproductive cloning of humans. This situation will change when chapters 6 and 8 of the National Health Act are promulgated - and therapeutic cloning will then be allowed under strict conditions, requiring Ministerial permission, but reproductive cloning on humans will remain strictly prohibited.
In China, there are no laws against cloning either. However, with the huge population problem and the policy of only one child per family, there is no interest in reproductive cloning. On the other hand, there is huge interest in therapeutic cloning and, as a result, there is a lot of it on the go in China. Some Chinese cultures believe that humans only become people when they participate in society - so, according to these cultures, embryos and foetuses are not considered to be human beings, thereby eliminating any ethical problems surrounding the creation and destruction of embryos to get the required stem cells.
The Chinese government is funding extensive research and drawing back many Chinese scientists from overseas, to undertake work they would not be allowed to do elsewhere. With easy access and no limits on obtaining the embryonic material they require, it is expected that Chinese scientists will race ahead of the rest of the world in therapeutic cloning technologies.
South Korea and Singapore are other nations where therapeutic cloning is permissible and where substantial research has taken place. South Korea's reputation in this area has recently been damaged by revelations that its principal research scientist falsified his results and used eggs donated by female research staff. This is unethical and there were concerns that these women make have been pressured to donate their eggs.
In the UK there are clear rules banning reproductive cloning, but scientists in both the UK and Israel are allowed to generate new embryonic cell lines for therapeutic research. The law in Germany bans the extraction of stem cells from human embryos for research within the country, but in 2002 a new law was passed allowing some human embryonic stem cells to be imported. This means that German scientists are allowed to undertake work on embryonic stem cells if they originate from outside Germany.
In the United States there is no public funding for research on embryonic stem cells. Therefore, although there is no law against therapeutic cloning in the United States, there is almost no public research happening due to the lack of money and access to the embryonic material. Simultaneously, an announcement was recently made stating that United States public funds (about US$1,4 million) will be provided for studies using adult stem cells instead of embryonic stem cells.
These different rules for different countries mean that if a scientist is banned from undertaking cloning in his/her home country, he/she can simply move to a country where it is allowed. To prevent this from happening, the United States and about 30 other countries want a global ban on all forms of cloning. However, many other countries do not agree and this ban has not been implemented.

The lead-up to the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006
* In 1998 scientific advances in cloning prompted legislatures around the world to consider the ramifications of this work.
* In 2001 the House of Representatives Standing Committee on Legal and Constitutional Affairs released it report Human cloning: scientific, ethical and regulatory aspects of human cloning and stem cell research. It recommended
legislation to regulate human cloning and stem cell research;
that such legislation should include a ban on cloning for reproductive purposes combined with criminal penalties and loss of an individual's research licence; and
the establishment of a national licensing body empowered to issue licences for research involving the isolation, creating and use of embryonic stem cells. It also recommended 'there should be a moratorium on the creation of embryos by means of somatic cell nuclear transfer techniques for three years, at which point the issue should be re-examined.'
* In 2002 the Australian Parliament passed the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002. These Acts allowed the use of 'spare' embryos produced for IFV procedures to be used for stem cell research but prohibited cloning embryos for either reproductive or research purposes.
* In December 2005 a government-appointed committee, the Lockhart committee, released its review and recommendations relating to the Prohibition of Human Cloning Act and the Research Involving Human Embryos Act. On of the recommendations of the committee was to support Somatic Cell Nuclear Transfer (SCNT), sometimes known as therapeutic cloning.

Internet information
The Internet technical information site, Howstuffworks, has two clear and straightforward accounts of cloning. One deals with cloning as applied to animals and plants and the other looks at how human cloning will work. The two treatments can be found at http://science.howstuffworks.com/cloning.htm and http://science.howstuffworks.com/cloning.htmhttp://science.howstuffworks.com/human-cloning.htm

On November 2, 2006, the ABC's science information program, Catalyst, presented a segment titled, 'The A to Z of therapeutic cloning'. The program raised many of the issues associated with therapeutic cloning and presented views from most of the major perspectives in the debate.'
A full transcript of the program can be found at http://www.abc.net.au/catalyst/stories/s1778636.htm

The ABC also invited viewers to present their questions about therapeutic cloning. Ten of these questions were then passed on to a panel of experts whose responses were then put on line. Questions and answers can be found at http://www.abc.net.au/science/expert/realexpert/cloning/
The full text of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 can be found at http://www.comlaw.gov.au/ComLaw/Legislation/Act1.nsf/0/71AC9EAE45677788CA2572440012F18A/$file/1722006.pdf
Please note, this is an adobe acrobat file and will require Adobe Acrobat Reader which can be downloaded at no charge from the Internet.

The Lockhart Report which formed the basis of the new legislation allowing therapeutic cloning can be found at http://www.lockhartreview.com.au/_files/Legislation%20Review%20Reports%20Full%20Doc-19Dec05.pdf
Please note, this is a very long document (284 pages) and it is recommended you make careful use of its contents pages. This is an adobe acrobat file and will require Adobe Acrobat Reader which can be downloaded at no charge from the Internet.

The University of Wollongong has a section on its Internet site titled 'Big-Picture Bioethics'. One of the bioethical issues it treats is therapeutic cloning. It supplies an index which will allow the reader to go to a wide range of news media and other treatments of the issue in the lead-up to and immediately after the passing of the current act allowing therapeutic cloning. This index can be found at http://www.uow.edu.au/arts/research/bigpicturebioethics/issues.html

On November 27, 2006, The Sydney Morning Herald printed an opinion piece written by Professors Ian Kerridge, Peter Schofield and Loane Skene, all members of the Lockhart Committee and supporters of therapeutic cloning. The piece is titled, 'Five myths of therapeutic cloning' and is an attempt to answer five common concerns put about therapeutic cloning. It can be found at http://www.uow.edu.au/arts/research/bigpicturebioethics/issues/five-myths.pdf

On January 13, 2006, Professor Alan Trounson, a leading researcher in the field of stem cells, presented a defence of therapeutic cloning which was published in On Line Opinion. This can be found at http://www.onlineopinion.com.au/view.asp?article=4051

On January 16, 2006, Dr David van Gend, a family doctor in Toowoomba and the Queensland Secretary for the World Foundation of Doctors who Respect Human Life had published in On Line Opinion a comment presenting a range of objections to therapeutic cloning. These can be found at http://www.onlineopinion.com.au/view.asp?article=4033

On November 8, 2006, On January 16, 2006, Dr David van Gend, a family doctor in Toowoomba and the Queensland Secretary for the World Foundation of Doctors who Respect Human Life had published in On Line Opinion a second comment outlining his objections to therapeutic cloning. This can be found at http://www.onlineopinion.com.au/view.asp?article=5128

Do No Harm; The Coalition of Americans for Research Ethics is a national coalition of researchers, health care professionals, bioethicists, legal professionals, and others dedicated to the promotion of scientific research and health care that does no harm to human life. The Coalition has a section of its website that presents articles either arguing against the use of embryonic stem cells or arguing in favour of the use of adult stem cells. An index of these articles can be found at http://www.stemcellresearch.org/

Arguments against therapeutic cloning
1. Therapeutic cloning involves the commodification and destruction of human life
Those who hold this position argue that no human life should be treated as an exploitable property.
Dr David van Gend, a family doctor in Toowoomba and the Queensland Secretary for the World Foundation of Doctors who Respect Human Life stated in an opinion piece published in On Line Opinion on January 16, 2006, 'Here is the dual desecration of cloning not just that a human life is wrongfully killed for the benefit of others, but that a human life is wrongfully created out of any normal human setting.
According to this line of argument, each human life has unique, individual value and no human life should be created as a means to another end. That is, human beings are not commodities, or resources, to be created and used for purposes that ignore their fundamental rights to life, identity and autonomy.
Dr Joe Santamaria (a consultant physician, with postgraduate experience in haematology, public health and epidemiology and founding chairman of St. Vincent's Bioethics Centre, Melbourne) stated in an opinion piece published in On Line Opinion on January 12, 2006, 'The diversion of enormous amounts of public funds into research on human embryos is being justified on ... a claim that the technology and its products will generate economic wealth for our nation. This is otherwise accurately known as the "commodification" of the human embryo and its cell lines and there is nothing to suggest that human cloning will not become the standard method of creating human embryos for commercial exploitation.'
Dr Santamaria further noted, 'Surely the virtue of justice [should] extend to the human embryo, to a more fundamental right for it to exist and to grow and not to be treated as a material commodity for the good of others.'
On August 21, 2006, the federal health minister, Tony Abbott, similarly stated, 'Even potential human life needs to be treated with great respect and we shouldn't be willy-nilly creating potential human life just to satisfy the urges of the scientific community.'
This position has been summed up by Kevin Dillon, a British spokesperson for the Movement Against Cloning. Mr Dillon has stated, 'Creating human beings as tiny stem cell generators, only to destroy them once their utility has been served, tramples on the critical ethical principle that human beings should never be treated as a means to an end.'

2. Therapeutic cloning challenges the reproductive autonomy of women
It has further been claimed that therapeutic cloning would result in the exploitation of women's egg production capacity in a way which is likely to reduce women's control of this aspect of the reproductive process.
'Hands off our ovaries', is an international coalition of women's groups including Women's Forum Australia and FINRRAGE who are opposed to egg extraction for research. On November 7, 2006, 'Hands off our ovaries' issued a media release stating, 'Cloning is impossible without a continuous - and large - supply of eggs from women. This carries the risk of ovarian hyper stimulation syndrome including organ failure, respiratory distress, stroke, infertility and even death.
Throughout the debate cloning advocates have ducked and weaved one fundamental problem: where will all the eggs come from? They have failed to identify a viable source of eggs that is safe for women. Yet the Senate has rushed to cross the ethical Rubicon which will have a profound impact on Australian women.'
Bob Phelps, the executive director of GeneEthics, a secular network of Australians with concerns about all genetic manipulation, has stated, 'If human embryo cloning is allowed, women will be used as egg-producing machines: asked, induced or coerced to each give dozens of eggs for cloning, despite the risks to their lives and health from invasive surgical and hormone treatments. In the Lockhart inquiry, harvesting eggs from dead women and aborted female foetuses was also proposed.
Eggs and embryos are seen by gene-manipulation and drug industries as mere raw material. Women egg and embryo producers would also be required to surrender control and connection with their eggs, embryos and resulting tissues. The companies and researchers would reap the rewards of patents.'
There have been early instances of women being coerced to donate eggs.

3. There are already enough stem cells available for experimentation
It has been claimed there are already sufficient embryos available for stem cell research without the need to produce more via cloning.
This position has been put by Monique Baldwin (a neuroscientist, and an Australian representative of Hands Off Our Ovaries, an international coalition of women seeking a moratorium on egg extraction for research), 'As a scientist, I believe the provisions that allow stem cell research in Australia are already very generous. The existing legislation allows research on human embryonic stem cells using excess embryos from IVF programs. Scientists here have used only 179 excess IVF embryos from more than 104,000 embryos in storage, yet they are asking for more embryos, deliberately cloned to be destroyed.

4. There are significant risks associated with embryonic stem cell therapy
It is claimed that there are risks associated with embryonic stem cells being used to develop replacement tissue to treat a range of diseases. It has further been claimed that the extent of these risks has been minimised by some of those scientists promoting therapeutic cloning.
James Sherley, Associate Professor of Biological Engineering at Massachusetts Institute of Technology in Boston, has stated, 'Some scientists have not revealed the problems with embryonic stem cells that prevent them being used to treat diseases.
For example, in terms of fundamental biology, embryonic stem cells are not able to be used to treat adult tissue. One major barrier to using embryonic stem cells in therapy is that tumours could form when they were put into adult tissue.
Also, cloned cells have inherent defects in their genetic material that would make any cells derived from them ineffective. That is why cloned animals such as Dolly the sheep die prematurely.'
A similar point has been made by Bob Phelps, the executive director of GeneEthics, a secular network of Australians with concerns about all genetic manipulation who has also noted, 'Dolly and other animal clones born since have died prematurely or been put down. They suffered various systemic disorders, the inherent results of destructive and poorly understood cloning processes.'
Finally, bioethicist, Nicholas Tonti-Filippini, has stated, 'Cultured stem cells (whether taken from the body or embryonic) have the capacity for enormous benefit if their growth and differentiation can be controlled, but they also have significant capacity for harm if that growth and differentiation is not controlled and they then cause disease.
Embryonic stem cells are less controllable. There have already been some deaths of people who received stem cells that then proliferated in an uncontrolled way.'

5. The prospect of imminent cures for serious diseases and disabilities using embryonic stem cells has been exaggerated
It has been claimed that the promises of probable cures for a range of diseases as a result of stem cell research have been either fraudulent or exaggerated. Bob Phelps, the executive director of GeneEthics, a secular network of Australians with concerns about all genetic manipulation, has stated, 'The likelihood of successful therapies from embryonic stem cell research has declined since 2002. Claims of therapeutic breakthroughs were mainly based on South Korean research but the results were fraudulent and the research has been discredited.'
James Sherley, Associate Professor of Biological Engineering at Massachusetts Institute of Technology in Boston, has stated, 'As a scientist who has specialised in cancer research, I want a cure for this devastating disease as much as anyone else. That is what I am working towards... what I cannot do is peddle false hope that a cure is imminent.
It disturbs me that others are doing so. The idea that research on human embryos will yield an amazing medicine chest of new cures for debilitating diseases of children and adults is a myth.
Nothing could be further from the truth. Yet this promise of miracle cures is at the centre of the Australian debate about whether we should allow human embryos to be produced for research purposes.'
Professor Sherley has explained this claim by stating, 'Embryonic cells simply cannot be used to restore adult tissues.
Adult stem cells are responsible for the continuous renewal and repair of adult tissues and organs but embryonic stem cells cannot replicate in this fashion and are not sufficiently long-lived to allow effective cures for diseases and injuries.'
Professor Sherley has concluded, 'It is important for parliamentarians to know that stopping the production of cloned embryos for research will not deny Australians the opportunity for benefits in the form of new cures.'
It has further been noted that a number of the diseases which supporters of therapeutic cloning claim would be assisted by such cloning either do not require nit or would not be helped by it.
Scottish cloning expert Professor Ian Wilmut has stated, 'In any treatment regime we must avoid immunological rejection of the transferred cells, but the immune response is likely to vary from one disease to another... [I]n the treatment of diseases within the central nervous system cells from cloned embryos seem likely to offer less advantage as foetal cells in the central nervous system appear not to be subject to rejection. Finally, several of the conditions that are mentioned as candidates for cell therapy are autoimmune diseases, including type 1 diabetes. In such cases transfer of immunologically identical cells to a patient is expected to induce the same rejection.'

6. Adult stem cells may be superior to embryonic stem cells
There are those who claim that adult stem cells offer the same research prospects as embryonic stem cells without the ethical complications. It has also been claimed that adult stem cells may have superior research potential.
Bob Phelps, the executive director of GeneEthics, a secular network of Australians with concerns about all genetic manipulation, has stated, 'In contrast to failed embryo cloning, adult stem cell research does not involve harvesting eggs or creating embryos and shows good prospects of successful therapies. For instance, a report released last week said stem cells from umbilical cords, not embryos, were used to fabricate the beginnings of a human kidney.'
Proponents of the use of adult stem cells note the advantages they have over embryonic stem cells. They are not prone to tumours and other forms of genetic malfunction and, unlike embryonic stem cells, they are not inherently short-lived. It has further been claimed that adult stem cell's relatively low profile in the stem cell debate is because embryonic stem cells supporters have either made false claims about their own preferred stem cell source or have misrepresented the potential usefulness of adult stem cells.
James Sherley, Associate Professor of Biological Engineering at Massachusetts Institute of Technology in Boston, has stated, has stated, 'Despite the misinformation adult stem cell research is a viable and vibrant path to new medical therapies.'
It has been claimed that advances in adult stem cell science may make therapeutic cloning redundant.
Leading stem cell scientist Professor Alan Mackay-Sim, of Griffith University, has over 40 disease-specific lines of adult stem cells (sampled from the noses of sufferers of Parkinson's, motor neurone disease, schizophrenia and so on) which they have transformed into the relevant cell type for genetic study and drug testing.
The Griffith team has also used these adult stem cells successfully as direct cell therapy in Parkinson's disease (in tests with rats), and is conducting trials for human spinal cord injury. There are now 65 human diseases treated with adult stem cells, while [their critics note] embryo stem cells remain both useless and dangerous and, as the Lockhart Committee concedes, have not had a single successful human application.

7. Therapeutic cloning is likely to lead to other more ethically dubious applications of cloning
It has been argued that approving the deliberate creation of cloned embryos to them be killed so that their stem cells make be harvested is the start of an ethical progress which could see us approving cloned embryos being grown to a point where there organs, not merely their stem cells, could be harvested for transplantation.
Those who hold this view refer to what is referred to as the 'slippery slope' principle. According to this line of argument, once a certain action has been taken and as a consequence a certain moral principle has been violated, it then becomes progressively easier to take more and more morally suspect actions.
Dr David van Gend, a family doctor in Toowoomba and the Queensland Secretary for the World Foundation of Doctors who Respect Human Life stated in an opinion piece published in On Line Opinion on November 8, 2006, 'Cloning human embryos for research will perfect the technique needed for cloning babies and for growing cloned foetuses for their organs.
Both of these unthinkable acts are being promoted in major journals, and while they will remain illegal in Australia for the time being, they will no longer remain impossible, since the Senate chose to take the first step in human cloning.'
Dr van Gend went on to note, 'much worse than live-birth cloning, there are scientists and ethicists defending "foetus farming" - the plan to grow cloned embryos to the foetal stage where we can extract their organs for transplant.
In an article in the Journal of Medical Ethics entitled "Cloning as a source of tissue for transplantation", Melbourne ethicist Professor Julian Savulescu argues that we must clone and kill unborn babies to solve the organ transplant shortage: "Indeed, it is not merely morally permissible but morally required that we employ cloning to produce embryos or foetuses for the sake of providing cells, tissues or even organs for therapy, followed by abortion of the embryo or foetus."'
Dr van Gend has further noted, 'And practical experiments to harvest tissues or organs from the cloned foetus are being done in animal models - not out of tender concern for the animal's wellbeing, but as a model for human cloned foetus farming.'

Arguments in favour of therapeutic cloning
1. Embryonic stems cells offer hope for disease cures
Supporters of the use of stem cells, especially embryonic stem cells as a means of curing a wide range of diseases stress their potential rather than any cures that have already been achieved. This was the position adopted by the Lockhart Committee and reiterated by Associate Professor Ian Kerridge, Professor Peter Schofield and Professor Loane Skene who were members of the Lockhart committee. The Sydney Morning Herald published the professors' response to a number of supposed myths about therapeutic cloning. The professors stated, 'There is no disputing that embryonic stem-cell research and therapeutic cloning has been insufficiently tested and has not, as yet, led to cures. But it is an irrational misrepresentation to suggest it has no proof and no potential and should be banned.
There have been great advances since 2002 and good evidence exists in animal models to warrant the pursuit of both embryonic and adult stem-cell research to better understand reproduction, normal development and disease, and to examine the possibility of human therapies. The House of Lords, a majority of the US Senate, the
American and Canadian medical associations, 80 Nobel laureates, the Australian Academy of Science and past and present Australians of the year have all supported the potential of embryonic stem-cell research and therapeutic cloning.'
However, supporters of therapeutic cloning claim there are some areas where cures might be more rapid. Australian of the Year, Professor Frazer has suggested diabetes as one disease that might benefit more quickly from the patient-specific cloning technique, also known as somatic cell nuclear transfer (SCNT).
A team from Monash University has already pioneered a way to induce mouse stem cells to become insulin-secreting pancreas cells. Professor Alan Trounson, who led the research has claimed his team was ready to begin similar trials in people with juvenile, or type 1, diabetes.
'The anticipation is that we should be able to start making stem cell lines from cells donated by these patients by next year,' Professor Trounson has said. 'The other areas in which we have some expertise are motor neurone disease and multiple sclerosis. Those will be the three targets that we'll adopt in the first phase.'
Professor Stephen Livesey, the chief executive of the Australian Stem Cell Centre, said the main focus of early research would be on modelling the progression of disease. Using the DNA of a patient with Alzheimer's, for instance, scientists would then create an embryo and direct it to grow only nerve cells, which are targeted by the disease.
'If you've got a cell line that carries the Alzheimer's trait ... you potentially have a way of looking at the onset and the progression of that disease,' Professor Livesey has claimed. 'That's a really fundamental tool to be able to develop treatment.'

2. Women will not be subjected to unethical egg collection procedures
Supporters of therapeutic cloning argue that it is not necessary to ban the procedure in order to stop inappropriate and exploitative harvesting of women's eggs. Rather, they argue, educations and protocols should be put in place to ensure that women are able to make free and informed decisions about how their eggs might be collected and used.
Associate Professor Ian Kerridge, Professor Peter Schofield and Professor Loane Skene were members of the Lockhart committee. The Sydney Morning Herald published the professors' response to a number of supposed myths about therapeutic cloning.
The professors stated, 'There are risks associated with egg donation and care needs to be taken to exclude the possibility of coercion or exploitation. But it does not follow that this requires therapeutic cloning to be banned.
Women, and men, make informed decisions regarding organ and tissue donation and participation in research daily. To suggest that women are unable to weigh the risks of egg donation for themselves, and are incapable of making decisions based on consideration of these risks, is not a feminist argument, but a deeply paternalistic one. Similar pseudo-feminist arguments have been used in relation to many issues related to reproduction. They have been rejected in these situations and should be rejected here.
Instead of a ban on therapeutic cloning, what is required is the development of processes that ensure women are able to make informed decisions and research into
alternative strategies that may reduce the number of eggs required.'
This point has also been made by Leslie Cannold, , in an opinion piece first published in The Herald Sun on November 7 and reprinted in On Line Opinion on November 24. Ms Cannold states, 'Is stem cell science anti-woman? The clear answer is "no". Researchers and scientists believe that as long as relevant legal rulings and ethical guidelines are followed, women have the same ability to give - or withhold - informed consent to being involved as men.' She believes that any group which holds that women are unable to give informed consent on the question of egg donation is infantilising, under-estimating both their independence and their intellectual objectivity.
Ms Cannold further notes that Australia's new therapeutic cloning legislation specifically prohibits the purchasing of eggs. This is intended to insure that poor women cannot be induced to sell their eggs in a manner that runs counter to their physical and emotional best interests.

3. The early stage embryos are not currently given the same legal protection as fully developed human life
Supporters of therapeutic cloning argue that it is inappropriate to give excessive legal protection to early stage embryos. They argue either that the prospect of curing diseases currently being suffered by patients is of greater significance than the claims to protection of a potential human life. They further argue that our current laws governing abortion, IFV procedures and the use of surplus embryos from this process indicate that the rights of early stage embryos are limited.
Associate Professor Ian Kerridge, Professor Peter Schofield and Professor Loane Skene were members of the Lockhart committee. The Sydney Morning Herald published the professors' response to a number of supposed myths about therapeutic cloning.
The professors stated, 'While there is a range of views regarding the moral status of the embryo and the degree of protection that should be extended to the embryo, most people would agree that human life, in and of itself, is deserving of respect. But it does not logically follow from this that embryo research and cloning should be banned. That some in the community believe embryos deserve as much protection
as adults does not mean the force of law should compel this view.
That Australians support assisted reproductive technology and donation of excess embryos from assisted reproductive technology for research; the law mandates destruction of excess embryos from assisted reproductive technology; we do not mourn miscarriages in the same way we do the death of children; we tolerate abortion (legally and sociopolitically) without prosecution in certain situations; and the churches' positions on the moral status of the embryo, assisted reproductive technology and destructive embryo research is neither historically static nor homogeneous suggests a ban on embryo research and cloning cannot be justified.'

4. Current embryo stem cell sources are not adequate
It has been claimed that the embryonic stems cells that the 2002 legislation made available for Australian researchers were not sufficient. This is not simply a matter of the number of cells that can be made available. What appears to be more important is the type of cell that can be made available. One of the areas of potential within this area of research is that it enables researchers to study the apparent genesis of a particular disease. For example if stem cells taken from the embryonic clone of someone with Parkinson's disease were grown in culture into nerve cells researchers may be able to track the early development and progress of the disease at a cellular level. Such research has the potential to assist in the development of treatments and a possible cure or means of prevention.
Associate Professor Ian Kerridge, Professor Peter Schofield and Professor Loane Skene were members of the Lockhart committee. The Sydney Morning Herald published the professors' response to a number of supposed myths about therapeutic cloning.
The professors stated, '...research on excess normal embryos ... does not
allow the study of diseases through research into "abnormal" embryos or the creation of disease models for research or, potentially, for development of "patient-specific" therapies that may repair or regenerate diseased tissue. These require therapeutic cloning."

5. Embryonic stem cells have advantages over adult stem cells
Supporters of the use of stem cells, especially embryonic stem cells as a means of curing a wide range of diseases have argued that this area of research complements adult stem cell research and that one should not be developed at the expense of the other.
They further note that embryonic stem cells from specifically created embryos offer a range of research options that adult stem cells do not. One of these is the ability to clone tissue from human beings known to carry a certain disease. They claim that watched the gradual development of this tissue could allow them to search for the particular markers that indicate the initial presence of a disease and perhaps prompt its development. This research could lead to either cure or earlier diagnosis and thus possibly better cure.
Associate Professor Ian Kerridge, Professor Peter Schofield and Professor Loane Skene were members of the Lockhart committee. The Sydney Morning Herald published the professors' response to a number of supposed myths about therapeutic cloning.
The professors stated, 'The fact that researchers can use adult stem cells does not reduce the potential for scientific and medical advances from research involving embryonic stem cells. These are complementary and not competing fields of research.
Existing law allows research on excess normal embryos but does not allow the study of diseases through research into 'abnormal' embryos or the creation of disease
models for research or, potentially, for development of 'patient-specific' therapies that may repair or regenerate diseased tissue. These require therapeutic cloning.'

6. The only means of overcoming the risks associated with therapeutic cloning is to allow research to continue
Supporters of therapeutic cloning generally acknowledge that there are risks associated with any treatment that may be developed using tissue grown from the stem cells of cloned embryo, however, they argue that only through research using such embryo can these risks be overcome. Australian researchers further argue that while the ban on cloning embryos exists in Australia, they will be prevented from working collaboratively with researchers in the some twenty other nations where such cloning is allowed.
Megan Munsie, Scientific Development Manager at Stem Cell Sciences, a private laboratory in Melbourne, has noted 'it would be a blow' if the laws were not changed. 'It wouldn't preclude advances in the field but would leave Australian researchers lagging behind their overseas colleagues. The current laws mean that really we're precluded from collaborating with people who are doing this [SCNT] work,' she has claimed.
Australian researchers in this field hope that an SCNT-friendly environment will enable them to strengthen ties to overseas facilities such as the California Institute of Regenerative Medicine, which attracts funding of $US3 billion ($A3.9 billion), and the new Centre for Stem Cell Biology (CSCB) at the University of Texas in Houston, which is attached to the world's largest hospital.
CSCB's Australian director Paul Simmons hopes to combine forces to make the
dream of embryonic stem cell therapy real as soon as possible.
Simmons has been reported as being excited by the opportunities a hospital and research facility with multinational partners can bring in the complex process of turning laboratory research into new or improved therapies for conditions as diverse as motor neurone and Parkinson's diseases and spinal-cord injury. Such research would also obviously need to overcome any of the risks associated with such treatment.

7. The use of embryos created for therapeutic purposes will be regulated
Those who support therapeutic cloning typically stress that its use will be strictly regulated. Reproductive cloning and 'foetus farming' for spare parts for transplantation will not, they claim, be allowed.
On January 3, 2006, Professor Bob Williamson, chairman of the National Committee for Medicine, Australian Academy of Science, had an opinion piece published in The Sydney Morning Herald in which he expressed both his support for the recommendations of the Lockhart committee and his recognition of the need for strict regulation of therapeutic cloning.
Professor Williamson wrote, 'The Lockhart committee says these new research approaches will only be permitted in the laboratory, in the context of a prohibition on cloning for reproduction, subject to strict legal regulation by law, overseen by national and local ethics committees. Indeed, it proposes a stricter set of definitions to ensure that cloning is banned, and they also recommend the continuing of the ban on making embryos for research purposes.'
The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Act lists 23 practices which are prohibited under the Act and the penalty each offence would attract. In most cases this is a maximum of 15 years imprisonment. One of the practices which is prohibited is reproductive cloning. The Act explicitly makes it an offence to place a human embryo in a human body of the body of an animal. Under the new legislation it is also an offence to develop an embryo outside a human body for more than 14 days. This restriction effectively prohibits 'foetus farming' as it prevents researchers developing embryos beyond the earliest stages of life in a way that could allow their more developed organs to be used for treatment or research purposes.

Further implications
The further implications of this legislation are enormous both from an ethical and a pragmatically medical perspective. From the later position there is clearly the potential for medical advances which at this stage it is possible only to speculate about. Supporters of therapeutic cloning acknowledge that the scope to develop cures and diagnostic procedures for a vast array of currently intractable diseases is at present only a potential, however, that potential is enormous. It will take a significant number of years before Australia and indeed the rest of the world knows if that promise will be met.
In the short term, the legalising of therapeutic cloning within this country will allow for three developments. It will prevent a number of prominent Australian researchers in this field moving to other countries where they could pursue their research unimpeded. It will allow for collaboration between Australian researchers and peers in other countries conducting similar research. It will attract significant investment to medical research in this country.
From an ethical perspective the consequences of this new legislation are more uncertain. Many have argued that this legislation could represent the beginning of a disturbing trend in Australian medical research - the deliberate creation of a human life to be used solely for research purposes. The authors of the Lockhart Report argued that the ethical/religious view that early stage embryonic human life deserves protection was not a view that had to be endorsed by law. That is obviously true. What the Report writers did not acknowledge is that the opposite situation now applies. The view that early stage embryonic human life is not to be protected has now been endorsed by law. Critics of this Act are concerned that it will be a precursor to other laws which allow other more developed forms of human life to be produced and exploited for medical research and disease treatment. There are those who consider that however desirable the prospect of cures for currently untreatable conditions, Australia and other countries may now have crossed a very significant ethical divide.

Newspaper items used in the compilation of this issue outline (NOTE that all items are from 2006 newspapers)
The Age: October 21, page 6, news item by Annabel Stafford, `Church to urge faithful to reject stem cell cures'.
The Age: October 20, page 13, comment by Frank Brennan, `Stem cell bill takes us down a slippery slope'.
The Age: November 7, page 5, news item by Annabel Stafford and Michelle Grattan, `Clone bill emotions intensify'.
The Age: November 4, page 12, news item (ref to paraplegic Joanna Knott) by A Stafford, `Therapeutic cloning advocate claims the right to hope'. The Age: November 11, page 11, analysis / explanatory diagram, photos and information on medical researchers, `Stem cells the new frontier'.
The Age: December 8, page 14, editorial, `A clear conscience on therapeutic cloning'.
The Age: December 7, page 1, news item by K Murphy, `Finally, Parliament approves therapeutic cloning'.

The Australian: December 7, page 4, news item by Matthew Franklin, `MPs give all-clear to clone embryos'.
The Australian: October 26, page 5, news item by Matthew Franklin, `MPs swamped with anti-cloning emails'.
The Australian: November 7, page 10, comment by Bob Phelps, `Embryo research a Pandora's box'.
The Australian: November 7, page 10, comment by Joanna Knott, Bob Turner, `Saving lives, not playing with life'.
The Australian: November 8, page 11, editorial, `A vote for science over irrationality'.
The Australian: November 9, page 13, analysis by Leigh Dayton, `Sweating on a hard sell'.
The Australian: November 20, page 3, news item by K Lyall, `Investors shun cell research'.
The Australian: November 23, page 5, news item by Leigh Dayton, `Clone pioneer plans hybrid eggs'.
The Australian: November 28, page 16, comment by Monique Baldwin, `Pro-cloning activists shroud the truth'.
The Australian: November 28, page 3, news item by Jill Rowbotham, `Clones marked for death, warns Pell'.
The Australian: December 8, page 15, editorial, `Right life decision'.

The Herald-Sun: October 21, page 4, news item, `Catholics to ban stem cell benefit'.
The Herald-Sun: October 25, page 22, comment by Sir Gustav Nossal, `Leave all cell doors open'.
The Herald-Sun: November 6, page 20, comment by Leslie Cannold, `Women can still say no'.
The Herald-Sun: December 7, page 2, news item by Michael Harvey, `Ban on cloning toppled'.
The Herald-Sun: December 8, page 30, editorial, `A vote for the living'.
The Herald-Sun: December 8, page 11, news item by K Jones, `Fatal disease hit list'.
The Herald-Sun: November 8, page 11, news items by Fiona Hudson, `Mum may say moo'.
The Herald-Sun: December 11, page 19, comment by Paul Gray, `Cloning a nightmare from the past'.


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