Next steps for embryonic stem cell research

While many people's abiding image of the Lockhart Review debate in Australia last year was a certain senator's ludicrous claims about animal-human hybrids being unleashed upon an unsuspecting public, the whole experience was a rather sobering one for the scientific community.

That such wild claims had the effect of clouding the serious philosophical concepts at the heart of the debate was unfortunate, but it did illustrate just how deeply felt the issue had become.

Watching, and participating fully, in the debate was Dr Megan Munsie, at the time the scientific development manager of biotechnology company Stem Cell Sciences (SCS). It taught her a lot about what she might face in her new position with the ASCC as director of scientific affairs, ethics and policy.

"You hear a lot of politicians talk about how this whole process has been an enormous education in stem cell biology - this has been an enormous education for me on government, policy and legislation," Munsie says.

"When I first heard of the Lockhart Review I was very keen, when I was working for Stem Cell Sciences, to put in a submission on their behalf and to talk about how legislation could be modified to provide a reasonable framework [for researchers] but also to give the community the appropriate safeguards."

Munsie did just that, writing a submission on behalf of SCS for the Lockhart committee in September 2005. She was interviewed in November and then attended a number of public consultation sessions, "which was very interesting", she says.

"There were a lot of people that were opposed ... and it was quite personal and aggressive. I suppose I was a little naive - I knew it was a contentious issue, I'd worked in IVF for years, but I suppose I was a little surprised as I thought we were there to discuss the alteration of the current legislation but what we ended up discussing was the merit of doing embryonic stem cell research in the first place."

Munsie was appointed to her new position in January this year. Internationally respected in the stem cell community, she was the first person in the world to demonstrate proof-of-principle for therapeutic cloning in an animal model, publishing her groundbreaking paper, "Isolation of pluripotent embryonic stem cells from reprogrammed adult somatic cell nuclei", in Current Biology in 2000, when she was a PhD student at Monash University.

She was also part of the SCS team that has derived the MEL series of human embryonic stem cell lines in association with Melbourne IVF and the ASCC. Added to 12 years as an embryologist in IVF practices, she certainly knows what she's talking about. That doesn't mean that swaying the public is an easy matter, however.

"Fundamentally, most people who were there who were opposed [to SCNT] didn't support the creation of human embryos for infertility treatment as well, so they couldn't come to terms with the fact that we have these excess human embryos. So leaving aside the whole SCNT issue, which is a separate one, we spent much time arguing this point."

One disturbing experience occurred at a public forum attended by patients suffering from diseases that in future may be assisted by stem cell research. What was disturbing was that scientists were accused by some attendees of dragging the patients along, exploiting their hopes for an advancement that may improve their lives.

"I think fundamentally medical researchers are interested and hopeful of alleviating suffering," she says. "I think we are realistic that what we do may not, but it is the hope that drives us. I was very keen to engage in the discussion as I had a background in IVF with an understanding of a patients' perspective.

"Then having done nuclear transfer in an animal model I see an embryo created through SCNT as very distinct from an embryo created from a sperm and egg.

"When you are using the egg cytoplasm to copy a patient's cell, a patient who has consented to that kind of research and an egg donor who has consent to the donation of their egg for research, I feel very comfortable about that. We as a community have safeguards in place via legislation and regulations, ensuring researchers act responsibly."

Regulatory issues

Ethical guidelines are the next step in the process. While the Patterson bill amending the two previous acts - the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning Act 2002 - was passed last year, it does not come into effect until June 12.

In addition, the 1999 national statement on the use of human materials in research, which provides the guidelines to ethics committees considering this research, must be amended to take into account the new act.

The situation should become clear shortly, with the National Health and Medical Research Council (NHMRC) announcing in mid-March that it has approved a new national statement on ethical conduct in human research, which will be tabled in Parliament in the next month or two. Guidelines for the use of embryos are in draft stage and should be available for consultation this month as well.

NHMRC spokesman Nigel Harding says this document will incorporate guidelines on oocyte donation, another contentious issue that has recently been debated vigorously in the UK.

"Prior to the 12th of June, when the legislation comes into force, we have to try to amend those guidelines so that they accord with the new act," Harding says. "The new act will permit SCNT, which weren't allowed before. The Australian Health Ethics Committee is going to make every endeavour to have those guidelines revised and out for public consultation and finalised in time."

Harding says there will be a "very quick" public consultation period, mainly with a view to making the changes align with the legislation to avoid inconsistency.

"Then we have to do mechanical things like the application form and the licences themselves," he says. "They have to account for a wider range of expertise than before. There are two other things as well: the Patterson bill asks us to investigate the feasibility or the desirability of setting up a stem cell bank and an excess embryo register. So between [the NHMRC] and the Department of Health we will look at that. It doesn't mean they will be set up but we have to look into it."

At present, there have been nine licences issued involving using human embryos in research, four for stem cell derivation and five for improvements in IVF. All except one of those licences expire this year.

"I think it's fair to say that we are anticipating that because of the broader spread of activities that will be permitted there will be an increased number of licences," Harding says. "Given there are only nine at the moment we are expecting a lot more."

Consistency

Another concern is that due to Australia's decision in 1901 on becoming a federation, all of the states and territories must amend their existing legislation - or introduce new bills - to ensure consistency with the federal legislation which, under the constitution, will prevail.

Victoria is the first off the block in introducing its own legislation, with the government tabling amendments to its Infertility Treatment Act in March.

Victoria, which is hugely proud of its history in world-class medical research and now biotechnology, aims to become the first state to allow SCNT for medical research, Premier Steve Bracks says.

Bracks' health minister, Bronwyn Pike, says adopting the proposed changes would bring Victorian legislation into line with the Commonwealth and enable local scientists to apply for licences. The other states, all of a similar political hue, are expected to follow suit.

For Megan Munsie, it should be an interesting year. Her major focus in her new position at the ASCC will involve interaction with research programs, advice on strategy, oversight of ethics procedures and policy, facilitating new collaborative ventures and providing scientific liaison within and external to the centre. She will also continue to talk to community groups, politicians and regulators.

"I've been doing it for a couple of years now and I actually really like it, I don't find it hard at all," she says. "And it is necessary so it's not really a choice - it has become part and parcel of working in the field."

She will also be closely watching developments overseas, particularly in the US and the UK. "There is a perception that in the US they are against stem cell [research] but it differs state by state.

"In California, legislation is permissive, supporting human embryonic stem cell research and SCNT. In the UK, they have a licensing system very similar to what we have now. As in Australia, UK scientists must apply to an independent body for a licence, justifying the use of human embryos in research."

Munsie believes that underlying the whole discussion of SCNT is a lack of understanding of the basic scientific concepts involved in the work.

"What we are really trying to do is to reprogram cells, or create disease-specific stem cell lines. If we could find the factors in the egg that do the reprogramming, we won't need to use human embryos, we could add factors to somatic adult cells, ending with stem cells lines.

"You have to be prepared to have a different opinion to others and you have to accept their opinion and not be confrontational. I don't get angry [with emotive statements] but I do get concerned because people get confused.

"What I try to do is cut to the chase and be frank and try to be honest about where we are at. At the end of the day it is the public, via the parliament, that will decide, and scientists will continue to work within the parameters decided."