issue 60

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Science, ideology and profit - The stem-cell research controversy

    Controlling the lines
    High risk
    Box: What is stem cell research?
    Box: How are stem cells obtained?

Until the attacks on the World Trade Center and the Pentagon, one of the most hotly-debated issues of George Bush's presidency had been federal government funding into stem cell research, the New York Herald describing it as 'the most politically charged decision of his administration'. DR JON DALE explains what lies behind the controversy.

SCIENTISTS, RELIGIOUS LEADERS, business interests and patients' groups have been intensively lobbying the Bush administration over federal government funding of stem cell research. The paralysed star of 'Superman', Christopher Reeve, threatened to sue the government if funding was not approved. Nancy Reagan spoke out in favour. Her husband, the former Republican president, has Alzheimer's disease. Companies involved in this research threatened to move abroad.

On the other side, three Republican Party leaders described stem cell research as an 'industry of death'. The Pope said it was 'gravely immoral'. Bush himself had opposed federal funding during last year's election campaign, when he wanted the votes of the religious right.

In August he eventually made his first presidential TV broadcast - on stem cell research. He partly backtracked from his election stance, proposing a compromise. Limited government funds would be spent supporting research on existing stem cell lines but would not be used to develop any new lines. (When a stem cell has been made to reproduce itself in controlled laboratory conditions, each cell is identical and the resulting cell culture is called a stem cell line.)

In Britain this research was given a limited go-ahead last year. Other countries, including Australia, Israel, France and Canada, are also involved.

Religious and anti-abortion groups argue that using embryonic or foetal cells is destroying life. The British anti-abortion group, Life, said: 'It exploits human beings at the most vulnerable stage of their lives - it is neo-cannibalism'. Ken Connor, president of the conservative Family Research Council in America, said that federal funding of embryonic stem cell research 'would provide financial incentives for researchers to destroy human beings'. Tory MP Edward Leigh described the research as 'the killing of innocents... The Nazis surely were saying that some humans are sub-human, therefore they are expendable... it is the same argument. People are arguing that these embryos are sub-human'.

But an embryo a few days old, without a nervous system, has no sensation. It cannot be considered as human or sub-human. Given the right conditions in a mother's womb, it might develop into a human. In life many embryos naturally perish. Surplus embryos produced by IVF treatment have no possibility of developing a life.

The 'pro-life' arguments of extreme right-wing Tories and American Christian fundamentalists never cover capital punishment. The 'sanctity of life' suddenly no longer applies. Bush sent over 150 people to execution when governor of Texas. Two-thirds of those executed in the USA may have flawed convictions. Many in the 'pro-life' lobby have not opposed arms exports to murderous dictatorships. They have supported globalisation that has increased disease and starvation in underdeveloped countries.

Despite the anti-abortionist views of many of those opposed to stem cell research, however, not all anti-abortionists have taken this stance. A number of prominent right-wing Republicans have argued that 'the most pro-life position' is stem cell research because of its goal of saving millions of lives. US health secretary, Tommy G Thompson, an anti-abortion Catholic, has supported advocates of embryonic stem cell research. National polls conducted by ABC News and the Wall Street Journal found overwhelming support for the research, even among a majority of Catholics.

    Controlling the lines

THIS IS A field of biotechnology that could develop into a massive industry worth billions of dollars. Restrictive government regulations and finance could lead to research being undertaken in other countries, with loss of market share and profits for US companies.

There had been a ban on public funding of stem cell research in the USA from 1996 to 2000, when the position was partially reversed. Former president, Bill Clinton, described this change as having 'potentially staggering benefits'. Bush opposed funding 'research when it involves destroying a living, human embryo'.

The hugely profitable pharmaceutical industry is unwilling to risk spending the enormous sums of money required to research this unproved field. Public money to fund research in universities is needed for the work to go forward. US universities typically receive less than $1 from private sources for every $10 obtained from the government. So Bush was under pressure from big business to back down from his pre-election stance. But he was reluctant to offend the religious groups, not just because of votes. He wants them to take on more welfare provision so that government funding can be cut back further. This releases more money for tax cuts to bolster the falling profit rates of big business.

Bush's compromise has been to allow federal funding for research into 64 existing stem cell lines but not the development of new ones. Ten organisations control these lines, mostly universities but also private companies and research foundations. Since his speech, it has emerged that there may be no more than 25 usable lines around the world. Capitalism turns everything into a commodity that can be bought and sold. These 64 lines could earn their owners a lot of money. 'I would think the cost of accessing these lines will go through the roof', said Alan Walton, a biotechnology investment analyst. 'I think the cell lines themselves will be commoditised', said Albert Rauch, another investment analyst. 'The value-added will be how to take these cell lines and commercialise them'.

Others predict that the cost will be kept low so that access will be broad and cheap rather than narrow and expensive. A Wisconsin University research foundation, which holds the rights to five lines, is charging $5,000 for a license to use its cells. However, they have already sold six existing cell lines to Geron Corporation, a biotechnology company (taken over last year by Celera Genomics, the private company involved in human genome research). BresaGen Ltd of Australia also owns lines.

According to Geron, in exchange for millions of dollars in funding, the company received an exclusive license to six types of cells - liver, muscle, nerve, pancreas, blood and bone - as well as the option to exclusively license an additional 12 cell types. In a sign of things to come, Wisconsin University has sued Geron over the rights to these 12 lines.

Scientists are already working on the approved stem cells. They are free to research and publish anything they find. But if one of them discovers an effective treatment and wants to market it, Geron and the University of Wisconsin has a say over who profits. 'That's the way the system in the US works in any area of biomedical research', said one commentator.

These companies are drawing up agreements with researchers that will ensure they retain future profits from the commercial products eventually developed. One Harvard University professor has denounced the proposed arrangements, saying he has no intention of becoming, in effect, an unpaid worker for companies such as Geron. 'This may foreshadow some intellectual property issues down the road', said Robert Hazlett, an analyst at Robertson Stephens. 'We've seen it with the land-grab around the human genome and I think we'll see more'.

    High risk

THE REQUIRED INVESTMENT will only be forthcoming from private companies if there is a pot of gold in reach. The suffering of millions of people does not show on their balance sheets. 'In order to make a profit from these cells, there are a number of factors involved, including intellectual property, cell quality and the ability of the owners to make a business out of them. Not all of these institutions have a history of making a profit', said the chief executive of one healthcare fund management company.

The stock market saw a rise from $12 billion invested in biotechnology in 1999 to $22 billion in the first half of 2000. However, the major pharmaceutical companies are not directly investing in this high-risk area. Viable treatments with commercial products could be ten or 20 years away. The big companies prefer to allow public funds and small companies to carry the risks, moving in when developments are nearer completion.

The risks involved were shown earlier this year, when an experimental treatment for Parkinson's disease went disastrously wrong. Foetal brain cells were injected into the brains of patients with the hope that these would produce dopamine, the chemical that they lacked. Although not quite the same as stem cell therapy, the principles are very similar. For the first year it seemed the experiment was successful in patients under 60 years old. Their tremor diminished. But then several of them went on to develop uncontrollable writhing movements as dopamine was overproduced and the injected cells could not be 'switched off'. The result was 'absolutely devastating' as the effects of the treatment became worse than the disease.

Nevertheless, stem cells could eventually revolutionise the way diseases are treated. But this research is at a very early stage and it could be many years before this becomes a reality. Under capitalism, research is distorted. The most expensive and high-risk research is paid for with public funds. Private investment goes into the areas that offer the lowest financial risk or which have the highest potential profits. Scientists working in different institutions are under pressure to be secretive about their work until ready to publish their results. Breakthroughs become proprietary products so that their employers can reap any profits and beat the competition. This leads to pressure to publish work early and, in some cases, prematurely. If and when the 'miracle' cures come, they will be available only at astronomical costs. The NHS and Medicare budgets will be further stretched.

Under socialism, research would be based on co-operation and the sharing of knowledge. The pharmaceutical and biotechnology industries would be publicly owned, run by groups of elected scientists, health workers, trade unionists and government representatives. Instead of aiming to maximise quick dividends to their shareholders, the sole aim would be to develop safe and effective treatments.

    Box: What is stem cell research?

WHEN AN egg cell is fertilised by a sperm, the genetic material (DNA) from both parents mix. Within hours the resulting cell divides into two identical cells, then four, eight and so on. These cells can develop into any type of cell in the body, so are called stem cells. Together, they are called an embryo.

When there are about 250 cells, they start to differentiate. Eventually some will become nerve cells, others become blood cells, muscle, bone, guts and all the other tissues present in the child at birth (about 200 different types in all). At this stage they become a foetus. The embryonic phase of development lasts about 14 days.

By taking stem cells and reproducing them in controlled laboratory conditions, scientists hope to be able to develop new types of medical treatment that could repair damaged or failing parts of the body. Treatments might become possible for diseases like Alzheimer's and Parkinson's, which involve degeneration of nerve cells within the brain, or diabetes where insulin-producing cells are malfunctioning. Heart muscle damaged after a heart attack might be repairable, as might spinal cord severed in an injury.

Blood cells and even replacement organs, such as hearts and kidneys, might eventually be produced in laboratory-like 'farms'. This could end the need for donor transfusions and the shortage of transplants. Arthritic joints might be repairable without the need for artificial replacements. Supporters of this research say the list is endless.

    Box: How are stem cells obtained?

THERE ARE different ways to isolate stem cells. In 1998 James Thomson at the University of Wisconsin was the first to grow stem cells, using embryos obtained from IVF (fertility) clinics.

When couples embark on fertility treatment by in vitro fertilisation (so-called test-tube babies) there are more embryos produced than needed. The excess is kept frozen. Eventually they are discarded. Between 100,000 and one million unwanted embryos are in deep-freezes around the world. Taking some cells from these five or six day-old embryos destroys the embryos but, in the right conditions, the cells continue to reproduce themselves. An alternative method of isolating stem cells is from foetal tissue, obtained from terminated pregnancies. Both methods produce cells with similar properties.

There are other methods. Umbilical-cord blood contains stem cells. Adults have stem cells that replace old cells in the body. These can be found in bone marrow and organs. However, they do not have the ability to develop into any other cell type. It is not yet clear what the potential for such cells is, but it seems that there are limitations. They are also difficult to isolate and purify. Adult stem cells have not yet been found for all cell and tissue types. Research is needed to find the best source of the specialised cells and tissues of the body for new treatments and even cures.

A related issue is cloning, the production of a genetically identical embryo. Theoretically, this could develop into an identical adult (as Dolly the sheep showed). There are still serious scientific and technical difficulties in achieving this, as well as questions about its desirability.

'Therapeutic' cloning, however, could mean the production of an embryo from a patients' own cells. It might become possible to use the embryo stem cells as a source of repair tissue. A heart 'grown' from the patients' cells would not be rejected - one of the main problems with current transplant surgery.