Sunday, November 22, 2009

A near conspiracy of hype

Nov 21, 2009

By Andy Ho, Senior Writer

Ten years into the stem-cell story, we must confront its real heart: Clearly, advances in embryonic stem-cell research have not translated into therapies for patients with intractable conditions.

THE Government is convening a blue-ribbon committee to review its investments in scientific research. So this would be a good time to revisit the stem-cell story.

Initially, our national discourse on stem cells was focused on the science per se and also the ethical questions concerning the status of the research embryo, which scientists cull to derive stem cells for their work.

Later, we debated the ethics of procuring eggs from young women and then using the eggs to make embryonic clones from which new stem cells can be extracted. We also considered the morality of creating hybrid embryos using a mix of animal and human genomes.

But 10 years into the stem-cell story, we must confront its real heart: Clearly, advances in embryonic stem-cell research have not translated into therapies for patients with intractable conditions.

To put it bluntly: The tantalising promises of stem-cell research bandied about in 2000 when we began on this journey have not been substantiated.

Clinical trials may be many years and millions of dollars away. While stem-cell research may yet shape medical practice, some experts now say there has been almost 'a conspiracy of hype' in this field.

In September, The Times of London revealed how hundreds of British parents, taken in by the hype, have squandered huge sums of money in China where they had taken their sick children for unproven stem-cell therapies.

In August, The New Scientist magazine exposed scientific misconduct at the University of Minnesota Stem Cell Institute - again. The institute had previously been found complicit in falsifying data as well as manipulating and duplicating photo evidence. Two previous inquiries had led to three papers from the institute being corrected and one retracted.

Then there was that South Korean shyster Hwang Woo-suk who faked data to claim he had successfully cloned human embryos from which he supposedly derived patient-specific stem-cell lines. Exposed in 2006, he was handed a two-year suspended jail term just last month for embezzling research funds and coercing his female co-workers to 'donate' their eggs.

Anecdotally, the field of embryonic stem-cell research seems to have more than a sprinkling of scammers and scallywags.

It may be that the field is fraught with unusually intense competitive pressures that tempt many of those involved to fudge and finagle. The pressures are generated by patients and patient interest groups, politicians, and the scientists themselves fighting for research funding and responding to a mass media eager for new breakthroughs to report.

In the nature of things, there cannot be groundbreaking news every other week. But scientists - or university corporate communications - may feel compelled to talk up even the smallest discovery. In this connection, cautionary lessons may be drawn from the disastrous failures involving gene therapy.

In the 1990s, gene therapy was embroiled in the same kind of hype that has accompanied stem cells in this decade. In an infamous case, the first known death from a form of gene therapy, 18-year-old Jesse Gelsinger suffered multiple organ failure after he was given adenoviruses. These bugs were supposed to carry a gene into his DNA to cure an inborn genetic defect in his liver enzymes.

Jesse had only a mild form of the illness, so he grew up normally on a restricted diet and some medication. The therapy being tested at the University of Pennsylvania was meant to treat the severe form of the defect in infants who die from it. Thus, Jesse had enrolled in the trial altruistically, only to perish.

Dr James Wilson, the lead investigator whom university corporate communications had called the 'Michael Jordan of Gene Therapy', did not inform Jesse that some monkeys had died after being given the bugs experimentally.

He also concealed his 30 per cent interest in the biotech firm that made the therapy he was testing on Jesse. Later, he would earn US$13.5 million (S$18.7 million) from the sale of that firm to a larger corporate entity that, in 2007, was linked to the death of a woman under eeriely similar circumstances in another gene therapy trial.

As part of a settlement with US government prosecutors over his role in the Jesse Gelsinger affair, Dr Wilson gave interviews to both Nature and Science in May, warning everyone that the same kind of hype which surrounded gene therapy then colours stem cell research now.

Dr Wilson recounted how gene therapy was rushed to bedside because of various factors including: a simplistic belief that it 'ought to work'; many patients and patient interest groups were urging that trials take place sooner rather than later; the 'unbridled enthusiasm of some scientists'; an uncritical media; and biotechs firms that promised the sky - with or without results.

The same factors are operative in stem-cell research today, he said. However, Dr Wilson is a Johnny-come-lately. A realisation that stem cells have been overhyped seems quite widespread already.

In the 2004 US presidential elections, actor Michael J. Fox, afflicted with Parkinson's, emerged as a poster boy for the campaign to get funding for stem-cell research, then still a hot button issue. But by the time of the US congressional polls of 2006, it had become a marginal concern.

In the 2008 presidential campaign, stem cells were no longer a focus. Admitting that stem-cell therapy is no longer 'a near-term hope', the Michael J. Fox Foundation for Parkinson's Research now backs the development of conventional drugs instead.

The hype seems to have died. Perhaps scientists can now plod on with less media glare. And who knows, they might even come up with something useful.

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