Is the biotech revolution a myth?
One of the main selling points of stem cell research has been its dramatic potential to revolutionize public health. The message is that it will turn medicine on its head and it will rain money upon investors and governments. American Senator Orin Hatch summed up the hopes of many when he described stem cell research as "the most promising research in healthcare perhaps in this history of the world".
The upshot of this is that governments everywhere are doling out stem cell dollars. Californians have approved US$3 billion in funding over the next 10 years and UK Prime Minister Tony Blair recently announced that it was to be a key element in his science policy. Even developing countries like Singapore, South Korea and Israel have jumped onto the bandwagon.
What are the odds in favour of a quick return on taxpayers' money?
Very long indeed, according to a study commissioned by the British government. "Many expectations are wildly optimistic and over-estimate the speed and extent of the impact of biotechnology," concluded Paul Nightingale, of the University of Sussex, and Paul Martin, of the Institute for the Study of Biorisks and Society. (1)
This doesn't mean that stem cells won't work. Researchers everywhere agree that when the science is mastered, stem cells could provide therapies for a range of diseases either by rejuvenating decrepit and sick tissue or as a tool for drug development. But, as with all biotech advances, the question is when.
Setting a timetable
In an email interview, Dr Nightingale, an expert on technology development, argued that turning laboratory science into new products is far more difficult, costly and time-consuming than most policy-makers are willing to admit. "I doubt very much that we will see major clinical benefits from stem cells for a long, long time. Technologies typically take 50 to 80 years to produce economic effects. Given that US life expectancy (which is very low) is mainly influenced by poverty -- hence the very poor figures on infant mortality -- if the Californians wanted to improve their health there are much better ways of spending the money. But stem cells seem to fit in nicely with a myth that science is going to make people live forever. It's not, it's simply going to make the last 10 years of their lives a little more comfortable if they are prepared to pay huge amounts of money."
Contrary to what most non-medicos think, we are not living in revolutionary times for biomedical advances. Last year the late David Horrobin, a well-known British scientist and biotech entrepreneur, wrote starkly in a professional journal that "pharmaceutical research is failing in its ability to deliver new drugs".(2) In fact, faced with an alarming decline in the number of new drugs in the research pipeline, the pharmaceutical industry is reassessing how it discovers and develops new products. Nightingale and Martin point out that roughly the same number of new drugs were approved in 2002 as 20 years before - despite a substantial increase in R&D. Productivity in the drug industry is decreasing, not increasing.
The future looked more promising in the early 1990s when the drug industry was picking the low-hanging fruit - but further progress has proved elusive. Only a handful of successful new biologic drugs have been developed since recombinant DNA techniques were developed in the 1980s. And despite a ten-fold increase in spending world-wide, the total number of drugs has remained steady. Despite the promise of gene therapy, it has yet to produce a single cure. Why, then, has there been such a hullabaloo about miracle cures?
The hope and the hype
Dr Nightingale put forward an uncomfortable explanation in our interview. "The reason there is so much hype about biotechnology is not because it is a revolutionary technology. If it was revolutionary you wouldn't need hype because people would be too busy making drugs and making money. Instead, it is precisely because biotechnology is not a revolutionary technology and takes a lot of time and effort to get to work that you need to create hype. Unfortunately, this opens the door to consultants and academic charlatans who can get away with giving extremely poor advice because they are promising results in the future when they will be long gone with a lot of public money."
Evidence that he is on the right track can be found in an odd place: the economic impact analysis used by the backers of California's Proposition 71. According to figures cobbled together by Stanford professor Laurence Baker, California would make a 120 percent to 236 percent return on its investment. Dangling before voters, too, was the tantalising possibility of "continuing to generate billions of dollars in revenues and savings for the State of California for decades after that".(3)
However, Baker was cautious enough to preface his analysis with several caveats which ought to have given supporters of Proposition 71 serious misgivings. "Despite uncertainties about whether or when the promise of stem cell research will be realized, our conversations with a variety of experts have led us to the conclusion that the potential for successful therapies is strong enough to warrant analysis of the type we undertake here. With that in mind, we also believe it prudent to keep in mind the difficulties and challenges associated with the research."
The enthusiasm of experts is one reason why so many people have unrealistic expectations. "Management consultants, financial analysts and venture capitalists all clearly have a vested interest in hyping new technologies," Nightingale writes in his study. "Similarly, the promise of a biotechnology revolution provides government policy makers with simple, but ... probably ineffective ways of promoting regional development, improved healthcare delivery and economic growth."
Is all disease genetic?
An even more fundamental reason for the long road ahead is that biotech is a very, very tough game. As Horrobin points out, "there is no doubt about the cascade of new information. The fundamental issue, however, is whether that new information is in any way congruent with the real world of medical illness."
Some of biotech's heady initial successes were due to the discovery that a disease was related to a single gene. But nearly all the major killers, such as cancer or heart disease, are the result of the interaction of many genes with the environment, society and lifestyle. Obesity and depression will be amongst the leading diseases of the 21st century - and biotech products may not do much to stop their advance.
Eventually scientists may come to regret inflating the promise of stem cell research, especially in California. Already some have warned that too much money may be sloshing about in the public trough. Each year, the Californian budget for stem cell research will be more than 10 times what the whole US Federal Government currently spends on embryonic stem cell research. Greg Linden, an economist at the University of California at Berkeley, says "As the pot [of money] gets bigger, you extend out to projects that are more and more questionable." (4)
And failure could make Proposition 71 a public relations nightmare. Important advances in basic science will undoubtedly emerge from research labs -- but it is possible that major products will not. Taxpayers may end up feeling swindled. As Horrobin warned, "the research enterprise will fall into such disrepute that there could be a dramatic loss of public support for biomedical and pharmaceutical research."
Michael Cook is the editor of MercatorNet.
(1) Paul Nightingale and Paul Martin, "The myth of the biotech revolution", Trends in Biotechnology, November 2004.
(2) David F. Horrobin. "Modern biomedical research: an internally self-consistent universe with little contact with medical reality?". Nature Reviews Drug discovery. February 2003.
(3) Laurence Baker and Bruce Deal. "Economic Impact Analysis: Proposition 71 California Stem Cell Research and Cures Initiative". Sept 14, 2004.
(4) "Scientists already lining up for Prop. 71 stem cell funds". Sacramento Bee, Nov 8, 2004.
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