by Richard EganNews Weekly
Has the PM been misled on stem cell research?
, June 15, 2002
Richard Egan, WA Director of the Coalition for the Defence of Human Life, analyses the new federal cloning Bill and the Government's decision to put $46.5 million into the new Centre for Stem Cells and Tissue Repair.The Human Cloning and Research Involving Human Embryos Bill 2002 is now, in its draft form, being circulated for comment to selected interest groups by the National Health and Medical Research Council.
The bill, which gives effect to the decisions of the Council of Australian Governments to pursue national uniform legislation on human cloning and human embryo research is expected to be introduced in the House of Representatives by June 27 when Parliament rises for the winter recess. Debate on the bill could commence in the House soon after Parliament resumes on August 17th.
The first part of the draft bill makes it an offence to engage in any attempt to clone a human being regardless of the method used or the end in view. So-called "therapeutic" cloning (producing a human embryo clone as a source for stem cells) as well as "reproductive" cloning (producing a live born baby).Unacceptable
Other "unacceptable practices" such as human animal hybrids, human embryos with genetic material derived from more than two people and the intentional production of human embryos for any purpose other than implantation into a particular woman are also made offences under Commonwealth criminal law.
This part of the bill will be welcomed by those who have been concerned at the complete absence of regulation of human reproductive technology in states and territories other than Victoria, South Australia and Western Australia. It also remedies some defects in the existing prohibitions on cloning in the states with legislation.
The second part of the bill sets up a licensing regime to allow so-called "excess" human embryos to be used in scientific experiments.
Although the current debate has focussed on the use of human embryos as a source for stem cells it is clear that licences will also be given for other uses of human embryos in experiments involving fundamental research into embryonic development, researching new techniques for IVF and other artificial reproductive technologies and training personnel in microsurgical manipulation of human embryos. The use of human embryos for toxicity testing of drugs and cosmetics is not ruled out.
The bill initially limits access to "excess" embryos to those created before April 5, 2002. This limit will automatically expire on April 5, 2005 giving scientists access to all "excess" embryos whenever they were created.
The bill also provides for an earlier lifting of this restriction if the Council of Australian Governments so determines in writing. This is an unusual provision to have the terms of a criminal offence in Commonwealth law variable by diktat from a meeting of Prime Minister and Premiers without reference back to the Federal Parliament.
Federal MPs opposing embryo experimentation are expected to move amendments to the bill during debate in the House of Representatives (and later in the Senate) to replace the licensing regime with a national prohibition on any destructive research involving human embryos.
A national campaign in support of such an amendment has been launched by Do No Harm - Australians for Ethical Medical Research. The campaign will focus on informing the public of the alternative to embryo stem cell research using the more effective, safer and ethical approach of utilising adult stem cells.$46 million grant
Meanwhile the Federal Government has given concrete expression to its enthusiastic acceptance of the embryo research lobby's claims by granting $46.5 million over five years to the new Centre for Stem Cells and Tissue Repair. This Centre, whose Chief Executive Officer will be Professor Alan Trounson, was the successful applicant for this funding for a "Biotechnology Centre for Excellence".
A summary of the Centre's application for the grant states that the new Centre
"[C]onsolidates the national expertise and international leadership in stem cell biology and medicine and provides the vehicle for Australia to successfully compete in the rapidly growing area of tissue regeneration and cell therapies.
"This new area of medicine has expanded rapidly with the discovery of pluripotential human embryonic stem cells, with their unlimited plasticity to develop into any tissue of the body. The ability to produce large quantities of these specific cell lineages opens the possibility of cell therapies for a variety of degenerative disorders that can affect the nervous system, the heart and blood vessels and bone and joints.
"The applications extend to juvenile diabetes, bone marrow transplants and the expansion of skin for burns patients. While some of these applications may take some time to reach clinics, the identification of the pathways that control these cells opens the way for new drug development and new avenues of basic research.
"From a commercial returns perspective the Research and Development proposed has the strong prospect of both early, to mid and long-term returns. In the early phase there is clear prospect of licensing cell lines, and research reagents in cell biology; subsequently developing cell lineages in sufficient quantity and purity for various diagnostic or drug discovery purposes, to the longer term challenge of therapeutic cell lines, tissue and organ repair - the full realisation of regenerative medicine".
The Centre is in commercial partnership with both BresaGen, a public company, and ES Cell International, an international consortium of which Alan Trounson is a shareholder. The Centre's plans for commercial returns closely follow the business model of ES Cell International.
This consortium owns six of the 78 stem cell lines listed by the National Institutes of Health (US) as eligible for funding under President Bush's decision of August 2001.
These six stem cell lines were derived from six human embryos destroyed in Singapore, two in September 1997 and two in September 2000. Three were Caucasian and three Chinese; three were girls and one a boy (the sex of the other two is not identified). ES Cell International profits from their ownership of these cell lines by lucrative contracts with NIH-funded researchers who want to use the cell lines for research. The contracts give ES Cell International intellectual property rights in any discoveries made using the cell lines.
The early and mid-term returns promised by the Centre and by ES Cell International bear no direct relationship to the much-touted cures for diabetes and other diseases. Rather they relate to such things as the sale of differentiated cells, such as cardiac, renal or liver cells, derived from the embryonic stem cell lines, to pharmaceutical companies for use in toxicity testing for drugs.
ES Cell International claims that, while there is virtually endless work to be done using their existing stem cell lines, they will soon need between 20 and 100 embryos from which to derive new stem cell lines. The reason cited is that the Federal Drug Administration requires that therapeutic products derived from stem cell lines have not been in contact with animal cells. All the existing stem cell lines at ES Cell have been cultured on animal feeder cells.
ES Cell International disclaims any interest in cloning. However, they acknowledge that without using cloning as a source for embryonic stem cells any therapeutic application using cell lines derived from human embryos will need to involve the use of immunosuppressant drugs, such as are used for organ transplant recipients.
The other commercial partner of the Centre for Stem Cells and Tissue Repair is BresaGen, a public company listed on the Australian and New York stock exchanges. BresaGen's estimate of the potential market for therapies derived from human embryonic stem cells of $70 billion by 2010 was echoed by Professor Alan Trounson in his comments on the new Centre's commercial promise.
BresaGen is focussing its embryonic stem cell research on a therapeutic package for Parkinson's disease ready for marketing to neurosurgeons worldwide.
The package would include BresaGen-licensed neural cell lines, derived from embryonic stem cells, specific catheter technology for delivering cells into the affected area of the brain without damaging other tissue and application-specific imaging technology for monitoring the effect of the cell transplant. BresaGen is enticing its shareholders with the lucrative profits to be made if they can be the first on the market with such a package, locking neurosurgeons into the use of this proprietary technology.
BresaGen and ES Cell International would both be pleased with the outcome of the grant process for the Biotechnology Centre for Excellence. Not only did their Centre for Stem Cells and Tissue Repair secure the $46.5 million but rival applicant Australian Biotechnology Centre of Excellence for Therapeutics Development, in which the Peter McCallum Cancer Institute was a participant, missed out.Adult stem cell success
The McCallum Institute has recently announced that it is close to significant breakthroughs in treatments for both Parkinson's disease and cancer. The new treatments rely on the use of adult stem cells.
The Institute is a non-profit health care organisation dependent on public and philanthropic funding for its clinical, teaching and research activities. Some of the funding for Associate Professor Paul Simmons' research into adult stem cell therapy for Parkinson's disease came, for example, from the sale of Lions' Christmas cakes.
Australia is at a crossroads. It can choose to invest financially and legislatively in backing multinational corporations seeking lucrative profits from the exploitation of human embryos as a readily available laboratory material or it could choose to prohibit destructive research on human embryos and make the less commercially profitable, but more promising (and certainly more ethical) research into adult stem cell therapies by groups such as the Peter McCallum Institute a national priority.