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22 January 2009

The dilemma on the t­ip of a needle

Stem cell research may hold the key to future wonder cures. It is predicted that the market for stem

By John Cornwell

In a biotech laboratory close to the National Hospital for Neurology and Neurosurgery in Bloomsbury, London, Professor Geoffrey Raisman, is researching a treatment for spinal cord injury using adult stem cells. This week, with no brief for Republicans or Democrats, he has been pondering the presidential inauguration celebrations with serious misgivings. He believes that the new president’s pledge to fund human embryonic stem cell ­research could have a detrimental effect on the future of his work.

Ten years ago in a tiny, underequipped laboratory in the University of Wisconsin, Madison, Professor James “Jamie” Thomson, an embryologist, extracted the first human embryonic stem cells from an embryo. Thomson was part of a community of scientists who had been pursuing the “philosopher’s stone” of embryonic stem cells with slender resources and huge determination for a decade. Last year, at a conference in New York City calling itself the World Stem Cell Summit, it was projected that the market for stem cell clinical products could reach $8.5bn within a decade.

Stem cells have potential to be coaxed into different tissue, blood and cell types, in the body. In the human embryo they are “totipotent”, that is, in a state of greatest potential to become any blood or cell type. But stem cells, albeit with more restricted potential, also exist in adults: in the gut, high in the nose, in blood, in the ­umbilical cord, and in bone marrow. While stem cell research has been hailed for its prospects for future wonder cures, scientists are divided over the merits of the two basic cell strategies: adult and embryonic. Some, such as Raisman, believe that adult cells are yielding the fastest and safest ­clinical results; others insist that embryonic cells ­offer the best prospects. Thus the question arises: where do governments and investors put their money?

Professor Raisman charges that the media hype over embryonic research as a coming miracle cure has put his adult stem cell research programme in the shade

Scientists on the Raisman wing believe that human embryonic research holds back medical progress by attracting funds that might otherwise go to adult stem cell work. Raisman, who is not against embryonic stem cell research on ­ethical grounds, has been funded by the Medical Research Council, and by private donations, but in common with many similar research programmes he is underfunded. If President Barack Obama makes good his promise to support funding for human embryonic research, Raisman predicts that there will be a rush to “invest” in embryonic strategy.

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Information on the actual sums invested by private industry and governments into the many hundreds of stem cell research programmes worldwide are impossible to calculate because of secrecy. In the meantime, however, adult stem cell therapies have been achieving notable successes. The Stem Cell Summit in New York cited the use of a breast cancer patient’s own stem cells in breast reconstruction, and a heart patient whose bone marrow stem cells mended a severe lesion. In Bristol, last November, the first tissue-engineered trachea (windpipe), using the pat­ient’s own stem cells, were transplanted into a young woman with a failing airway, saving her life. No such tangible successes can yet be produced based on human embryonic stem cells.

Under George W Bush, federal funding of ­human embryonic stem cell work was banned in the United States for religious reasons. Bush’s scruples were prompted by the stock objections of the American religious right, which regards human embryos as persons with full human rights. The Catholic Church also bans research that threatens the life of the human embryo for, according to papal teaching reiterated frequently by the late John Paul II, human individuality, or ensoulment, commences from the moment of conception. Research involving embryos has, for two decades, riven churches and religious groups within and outside America, as well as national governmental policies and research communities throughout the west. During his election campaign Obama repeatedly claimed, however, that he would overturn George W Bush’s policy on the issue in the interests of its future benefits for a wide range of illnesses.

Under Tony Blair, Britain adopted a go-ahead policy on human embryonic stem cell research during a period (ending three years back) when the European Union declined to fund such programmes. Last year Britain went beyond the ­ethical limits of most countries in the west by sanctioning the creation of hybrid animal/ ­human embryos. After a heated nationwide ­debate, the Human Fertilisation and Embryology Authority (HFEA) licensed three British research laboratories, in Newcastle, London and Warwick, to create embryos in which the ovum comes from an animal (typically a cow or rabbit) and the nuclear DNA from a human being.

The scientific and political arguments in Brit­ain in favour of hybrid embryos focused on the scarcity of donated human embryos available for research, and the claim that such research transgressed moral norms was rejected by parliament. Professor Raisman argues, however, that the ethical debate over both human and hybrid stem cells ignores the issue of intellectual property rights and patenting: in other words, the profit motive. “Adult stem cells are much more promising therapeutically; they are already in use for such things as skin grafting, but they attract less funding and much less interest because they can’t be patented.” As the adult cells come from the patient’s own body, the cells are not amenable to the imposition of intellectual property rights. On the other hand, exploitation of embryonic stem cells for therapy requires many complex laboratory processes from the out­set, and is consequently more amenable to patenting. Both governments and industry the pharmaceutical industry) are loath to invest or fund unless they can see the prospect of intellectual property rights – in other words, ownership.

Germany has been reluctant to allow stem cell research in the light of its Nazi history

In Britain, consciousness of the urgent requirement to pay heed to patents in medical science gathered impetus when Margaret Thatcher came to power in 1979. She argued that Britain had lost billions of pounds in revenue through a single failure in the mid-1970s to patent an important discovery. The episode, ­notorious in the annals of British science, involved the development in Cambridge of monoclonal antibodies (crucial to diagnostic testing) by César Millstein’s molecular biology team. The discovery was not patented, but a member of the team patented a further development of the process in America, thus earning billions of dollars for biotech research in the United States. During the Thatcher years, the promotion and protection of intellectual property rights in British research became an absolute priority.

Individual European countries have pursued their own national funding policies on embryonic stem cell research, reflecting traditional ethical attitudes, in some cases to the detriment of commercial advantages. While Italy has banned funding because of the influence of the Catholic Church, Germany has been equally reluctant as a consequence of its sensitivity to human ­ex­experiments in the light of its Nazi history. Japan has adopted similar policies, for the same reasons. Both Germany and Japan invoke the “slippery slope” argument. In other words, they are less preoccupied with doctrinal issues due to their caution based on national historical experience. Britain’s more liberal ethical attitudes are largely based on classic utilitarian principles. The ideas of John Stuart Mill and Jeremy Bentham – the greatest good for the greatest number – hold more sway than arguments about ensouled embryos. When I served on an HFEA ­inquiry panel two years ago, exploring public attitudes towards ­hybrid embryos, it was noticeable that the majority of the participants, which included an ­ordained Church of England ethicist, emphasised the consequentialist clinical benefits – finding cures for Alzheimer’s disease, multiple sclerosis, and cancer.

In the United States, the administration’s views on stem cell research have been largely shaped by a combination of Evangelical and Catholic attitudes. While Catholics traditionally voted for the Democrats during and after the John F Kennedy era, the Republicans under George W Bush’s leadership won over a sizeable proportion of the massive Catholic vote. Rights to life, abortion, and embryonic stem cell issues loomed large. A mailshot of four million letters was despatched to Catholics in advance of the 2000 election, claiming that the Republican Party endorsed John Paul II’s views on family and life issues. Meanwhile John Kerry, the Democratic candidate, and a Catholic, appeared at odds with his own church on abortion.

During the 2008 election campaign, the Republicans were no less energetic in seeking the Catholic vote, and the Catholic bishops were ­vociferous in condemning Obama’s human ­embryonic stem cell policies. In 2000 and 2004, half of America’s Catholics voted for Bush. In 2008, however, there was a noticeable swing towards Obama of one crucial segment of the Catholic vote. Catholics, numbering 65 million, form the largest single denomination in the US, making up 27 per cent of the entire electorate. Some 52 per cent of white Catholic regular church-goers voted for McCain, and 47 per cent for Obama. But non-church-going Catholics voted 61 per cent for Obama and 37 per cent for McCain. The swing is probably a reflection of the increase in Hispanic voters, who opted for Obama on account of the economic downturn. The total Catholic vote was 54 per cent for Obama and 45 per cent for McCain, a five-point swing for the Democratic candidate on 2004.

Professor Raisman is typical of scientists who are agnostic on questions over the status of the human embryo; his jaundiced view of embryonic stem cell research is scientific, he insists. Using rat models, he has been grafting adult stem cells (known as olfactory ensheathing cells) from the upper region of a rat’s nose to create pathways across spinal cord lesions. The strategy has been amazingly successful in rats. Animals that had been paralysed in a front limb have completely regained movement. In the near future, Raisman hopes to apply the treatment to human beings, starting with victims of accidents (typically motorbike riders) who have lost the use of an arm as a result of trauma at a site of the spinal cord known as the brachial plexus (where the shoulder meets the spinal cord). The olfactory human cells will be taken from the patient’s own nose, thus reducing the possibility of immunity problems. This is just a prelude to tackling major spinal cord injury.

Raisman complains, however, that he has had scant fund­ing over the years because he cannot promise patents that will make profits. He charges moreover that the media hype for embryonic research as a coming miracle cure, including for spinal cord injury, has put his kind of research programme in the shade. A new surge in gov­ernment-funded human embryonic research in the United States, he believes, is likely to make things worse, as grant bodies in Britain and ­elsewhere will seek to compete. “The scramble to fund human embryonic stem cell experiments looks like the scientific equivalent of sub-prime mortgages,” says Raisman. “One wonders how long the large sums of money and hype can go on chasing such a distant goal before the bubble bursts.”

Many clinicians agree with Raisman that actual therapies using embryonic stem cells are far off. Professor Keith Peters, until recently president of the Academy of Medical Sciences, puts it as distant as two, even three decades. Yet by no means all supporters of embryonic research base their enthusiasm on early delivery of therapies, or on the prospect of financial returns. There are many potential problems with all stem cell therapies, including adult stem cells, as scientists such as Raisman agree. Scientists still do not know how to make embryonic stem cells proliferate reliably, or indeed switch off once they do proliferate; hence there is anxiety that cancers could develop in treated patients.

All the more reason, according to one constit­uency of the research lobby, for studying human stem cells from their very earliest stage: the embryo. Most persuasive on this score is Professor James Pedersen of Cambridge University (who came to Britain from San Francisco to escape Bush’s ban on federal funding in 2004). He ­argues that ­reliable stem cell therapies must go hand in hand with fundamental research on the process of ­development from conception to birth to understand in depth how stem cells work, and hence how to avoid mistakes in therapies. Pedersen’s largely academic, non-clinical developmental work, however, does not involve the scramble for patenting rights described by Professor ­Raisman.

While the scientific row over funding and patenting heats up against the background of the new American president’s science policies, the ethical arguments are likely to be revived in a population where 57 per cent believe in creationism: the literal belief in the Genesis creation story. But as the economic downturn bites, there will be greater scrutiny of the returns on embryonic research funding – whether in terms of profits to be made on intellectual property rights, or actual delivery of successful therapies to the clinic. A 20- to 30-year delay for dividends in the current economic climate is a long time to wait. In the meantime, Professor Raisman makes an interesting link between regulation in medical science and regulation in banking and the economy: “The creditworthiness of scientific claims,” he says, “has no better system of regulation than other derivatives and instruments beloved of financiers, attracting huge bonuses by moving other people’s money about.”

It is a salutary reminder that the widespread adoption of entrepreneurial and monetarist models from the 1980s onwards for the conduct of medical research is as much due for scrutiny as other failing economic institutions.

John Cornwell is director of the Science and Human Dimension Project at Jesus College,

Hybrid embryos: a short history

The controversy over stem cell research revolves around the use of human embryonic cells, since extracting the cells destroys the embryo they are taken from. In December 2000, the UK parliament voted to permit the research under guidelines that, by European standards, were liberal. The Human Fertilisation and Embryology Authority (HFEA) was charged with granting licences for research on embryos discarded as part of the IVF process. Opposition from anti-abortion groups and senior Catholics was intense. Tory MP Edward Leigh described the research as “the killing of the innocents”, comparing its supporters to Nazis.

“Therapeutic cloning”, or the creation of human embryos for the purpose of growing stem cells, raised controversy on a second front. The lab-created embryos typically only exist for a few days, and are little more than a ball of cells; nevertheless, opponents such as Peter Garrett, research director for the pro-choice group Life, warned, also in 2000: “We are only a couple of years away from cloning human beings.” In 2004, the UK became the second country in the world to permit the procedure.

By 2006, British scientists were seeking permission to create hybrid embryos by injecting human nuclei into the shells of rabbit eggs. The resulting embryos would contain just 0.1 per cent animal DNA – but this was enough to raise the question as to whether the embryos were human. In late 2006, faced with furious opposition, the government proposed legislation banning the creation of hybrid embryos; but in September 2007, the HFEA decided that there was no fundamental reason to prevent cytoplasmic hybrid research.

A revised Human Fertilisation and Embryology Bill was drafted.

In January last year, the first licences were granted to carry out projects involving hybrids; but within days, 16 MPs had rebelled, calling for a free vote. The Catholic Church also vocally opposed the proposed bill – among them Cardinal Keith O’Brien, who claimed that the bill endorsed “experiments of Frankenstein proportion”. Nevertheless, in April, the first human-animal embryos were created in the UK, and in October, despite a further attempt by Edward Leigh to have the technique banned, the Human Fertilisation and Embryology Bill was passed in October 2008, on its third reading.

Alyssa McDonald

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