Cell division

With technology and interest growing steadily, will embryonic stem cell research head a medical revolution?

With technology and interest growing steadily, will embryonic stem cell research head a medical revolution?

Embryonic stem cell research has divided the world. For some, it represents the future of medical science, for others, the end of human dignity. Whatever the ethical concerns, it represents a massive commercial opportunity for biotech companies. And for countries that come down on the right side of the divide, a big boost to the economy.

The UK biotech industry is growing. Though it still lags some way behind its American competitors, it is enjoying better health today than it has ever sustained before. Last year, biotech investment in the UK and Europe rose by 20 percent to 1.4bn, reflecting a new era of stability for the industry.

Barring the mini-boom of investment some five years ago, fuelled partly by the hype surrounding the human genome project, the pioneering days of the industry saw very little investment, and when the bubble burst on the overvalued science of the HGP, the biotech start-ups were once again painfully short of money, leaving some of the industry’s most talented scientists out of jobs.

As low-tech manufacturing drifted east, the UK government focussed more and more on the ‘knowledge economy’ and the manufacture of high-tech and scientific products. Extra government spending and increased investment helped nurture biotechnology through a long and tentative recovery period. Investor confidence has now finally returned, largely in response to biotechs taking better account of commercial demands and focussing on projects with shorter lead times. But it is partly this commercial maturity – and scientific conservatism – that has left potentially vast wells of investment into controversial embryonic stem cell research untapped. The research promises to test the parameters of bio-medical ethics, and most of the newly commercialised biotechs have been unable to steel themselves to enter this dangerous and confusing moral landscape before legal, regulatory and intellectual property issues have been resolved.

Dr Cathy Prescott of Avlar BioVentures, talking at the White Rose Bioscience Forum in York last October, highlighted the difficulties faced by biotechs brave enough to take the journey alone, in the face of an almost total lack of support for cell-based product development from the pharmaceutical industries. She said: “If that crucial support is not there from the pharma industry, young companies need to think very hard about whether they realistically have the expertise to take a product to market on their own… Of the money invested, the majority of it is used to continue to support the more mature biotech companies… The most pragmatic advice I can give to young companies is to show venture capitalists that they have anticipated, understood and determined a route forward to resolve key hurdles facing them. This will underpin the success of UK biotech companies whose technology expertise lies in stem cell therapeutics.”

Divide and conquer
There’s little doubt that unrestricted stem cell research would be the catalyst for a full-scale medical revolution – something any biotech would want to be involved in. The cells of a human embryo are essentially units of human potential. After conception, the first two cells grow and divide to create four cells, which grow and divide again. Before long they multiply into a ball of many cells, eventually transforming into all of the more than 200 kinds of cell that constitute a human body. Each cell has the power to divide and conquer a problem that has long been the holy grail of biology; creating complex organisms from simple building blocks. Scientists have long dreamed of taking those cells from a new human embryo and coaxing them to perform, in the laboratory, the miraculous feat they perform in the wombs of hundreds of women every day around the world. The cells could then be used to repair damaged tissues or replace diseased organs with living, purpose-grown replacements, rather than the crude mechanical devices currently at the disposal of the medical industry. That dream could now be a reality.

The great debate
In November 1998, James Thomson, a scientist at the University of Wisconsin in Madison, announced that he had succeeded in removing cells from the unused embryos routinely stored in fertility clinics across the country, and using them to establish the world’s first human embryonic stem cell line.

The potential impact of his findings could hardly be exaggerated. It was a discovery that in any other field would have resulted in a major federal research project. Instead, it sparked a violent dispute about human life and human progress that spread around the world. The big decisions over stem cell research have since been wrestled from the hands of scientists. The progress made is no longer to be decided by dithering biotech companies or their reluctant investors. The decision belongs to the policymakers and governments of the world. It is for them to draw the line, to mark the limits of progress and of moral behaviour, and many have already made their decisions.

Thomson’s announcement dragged biotechnology into a maelstrom of religious and political arguments. Religious leaders, congressmen, and finally the Oval Office wanted to know where the needed embryos would come from and how many would be consumed by the demand of the world’s sick. Many in the US insisted that embryos are just as fully members of society as adult humans, and that their vulnerability demands they be protected more than most. Some compared the harvesting of embryonic cells to cannibalism and hyperbolic phrases like ’embryo farms’ and ‘cloning mills’ became commonplace. The same reaction was repeated in many other countries, as religious and moral anger raged across the globe.

The attitudes of those opposed to the research were summed up by a Greenpeace protest against human embryo patents outside the Reichstag in Germany. Protesters carrying placards with the uncompromising slogan ‘Stoppt Patente Auf leben’ marched around hundreds of frozen blocks of ice, each one with a plastic baby doll inside. The Greenpeace representatives were probably aware (unlike many of those who saw their protest) that the embryos being discussed were no bigger than the full point at the end of this sentence. They have no identifying features, and not even the merest hint of a nervous system. But shock tactics are from rare when discussing issues as important and emotive as this.

Some of the protestations of the so-called ‘pro-life’ movement and the wider religious right in the US rested on ground already lost. They argued that embryos should not be created ‘unnaturally’ (outside the womb) at all, and that all embryos should be allowed to fulfil the potential to grow into adult humans. But many thousands of unwanted embryos legally created in just such a way are lying in the freezers of fertility clinics around the world waiting to be destroyed. Proponents of stem cell research argue that, as long as parents agree to donate them, it would be positively unethical not to use them in the pursuit of overcoming disease, rather than destroy them. The debate goes on.

Profit from progress
Not all stem cell research is surrounded by such controversy. It is possible to take stem cells from adults. But although early research indicates these are useful for some diseases, they cannot produce the range of cell types possible with embryonic cells. The umbilical cords and placental blood of newborn babies are also rich in stem cells, and although some balk at the idea of purpose-grown tissue in any form, fearing it will lead to human cloning, these cells at least do not have possess potential to naturally develop into human beings.

Richard Branson has just launched a much-publicised Virgin-branded cold-storage operation where parents can store their newborn’s umbilical cord and placental blood for use in later life. The stem cells thereby retained could be used to grow tissue or organs much less likely to be rejected by the body than cells imported from another donor, and the project might prove to have huge medical potential. But research carried out on pigs and mice suggests these types of stem cell could not match the versatility of embryonic stem cells, which have already been used to replace injured or dead cells in these animals to cure heart disease, diabetes, spinal cord injuries and many more afflictions. Research on human embryonic stem cells could yet prove to be modern medical science’s biggest discovery.

Clearly, this area could be a potential goldmine for biotechnology, and crucially – given the massive polarity of views globally – a chance for biotechnology to find strongholds in the scientifically liberal countries willing to embrace, promote and invest in the resulting technologies. Branson’s step is a brave one. Private storage, of the type he is offering, is opposed by the EC’s European Group on Ethics in Science and New Technologies and is now unlawful in France and Italy. But Branson’s courtship of controversy might be just what biotechnology needs. Much of the discussion and legislation surrounding stem cell research so far has been squeamish of commercialism to say the very least. Of course Branson has tried to show that his motivation in this venture, as with the research he is privately funding into biofuels, is born of corporate conscience – half of the donated blood will be stored in a national bank for research purposes – but the company will be run for profit. And biotechs can’t afford to be afraid of turning profit from progress.

Pharmaceutical industry executives at the World Economic Forum in Davos at the beginning of this year suggested Branson could be in a position to set up a fully-fledged biotech company if he invested in the medicines associated with stem cells.

Biotech’s new stronghold
The likely locations of biotechnology’s new strongholds are already emerging as countries come down on one side or the other of the great cell division. Germany has already prohibited some types of stem cell research, France and Italy have outlawed private stem cell storage, and the US has imposed severe limits on government funding. But the UK, along with China, Korea and others, has offered funding and bio-ethical guidance to research projects in a bid to establish itself as an epicentre for the potentially huge stem cell industry.

Boundaries, of course, have been drawn, but the UK is keen to achieve the best results possible within the parameters of public approval. To that end, Science and Innovation Minister Malcolm Wicks has announced that the UK’s two major public funders of stem cell research, the Biotechnology and Biological Sciences Research Council and the Medical Research Council (MRC), will run a national public discussion on the issue funded by the Sciencewise unit of the DTI. The dialogue programme will aim to bring scientists and the public together to identify public expectations, aspirations and concerns about stem cell research, and will be paid for by a £300,000 government grant. When the announcement was made at a meeting of leading experts in the field in London recently MRC Chief Executive, Colin Blakemore, made it clear that the dialogue was as much about moving forward as gauging opinion. He said: “Discussion will help to make scientists understand the potential of their work and policymakers aware of the public’s views. In turn, this might lead to laboratory discoveries being applied more quickly in the clinic.”

As the world’s governments mark their moral cards, scientists around the globe are racing to see which techniques will produce treatments soonest. Many will migrate to the countries where research is most easily and freely carried out, in turn boosting the intellectual resources of those countries, and the level of investment they enjoy. If the UK continues to do all it can to count itself among them, its biotech industry is set to become one of the strongest in the world.

Virgin stem cell storage
Richard Branson has announced the launch of a Virgin-branded cold-storage operation where parents can store their newborn’s umbilical cord and placental blood for use in later life. The storage facility, which opened in February, will charge parents £1,500 to put their child’s cord blood into storage. The controversial private cord storage industry is growing quickly, with more than 11,000 families in the UK currently paying an average £100 per month to use the facilities, despite the odds of an individual using their personal cord blood before the age of 20 being estimated by the Royal College of Obstetricians and Gynaecologists (RCOG) at 1/2700. The RCOG maintains it “remains unconvinced of the benefit of personal commercial banking for low-risk families.”
Related topics: