Yesterday, five world-renowned centres of biomedical excellence teamed up with 10 multinational drug companies to form an unprecedented alliance. The aim of the consortium is to discover the genetic "signposts" that could be used by doctors of the 21st century to predict a patient's future susceptibility to disease. Not only that, the signposts could be used to treat patients with tailor-made drugs, specifically designed to combat the disease in question and to prevent side-effects in those with a certain genetic constitution.
The signposts in question are technically known as SNPs, or single nucleotide polymorphisms. They represent the smallest change possible in a gene and, as such, the genetic difference between one person and another is effectively the result of the differences in their SNPs. For every 1,000 "letters" in the genetic alphabet or code of a human gene, there is typically one SNP. This means that two unrelated people have roughly a million SNPs to distinguish between them.
The SNPs are known as signposts because they can be strongly associated with a specific disease. They can indicate the inheritance of a conventional genetic disorder, such as cystic fibrosis or haemophilia, and more importantly they can act as a marker or test for other genes that confer a predisposition for more common illnesses, such as cancer, asthma and diabetes. If heart problems run in your family, there is almost certainly a group of as-yet- undiscovered SNPs that could be used to estimate your risk of suffering a heart attack.
In other words, a database of SNPs - a map of the genetic signposts - could tell doctors of the future what a person is likely to die of and what must be done to avert the disaster. All that is needed is to compare a patient's genetic profile against a set of known genetic signposts, and, hey presto, get a read-out to reveal not only what a person is likely to die of, but at what age the disease will present itself.
This is not so futuristic as it may seem. Already there is a little-known genetic test that can predict whether a person is likely to develop Alzheimer's disease, and at what age this will most probably occur. Drug companies have an obvious vested interest in the results of such research. But what makes the 15-strong consortium so unusual is that all parties have vowed that, whatever information they gather about these all-important signposts, it will be published straightaway and will be freely available to anyone who wants it. Because the data will be in the public domain, no one will be able to patent the genetic material and so there will be no restrictions on who can take advantage of the information.
Why is this so important for the rest of us? One clue comes from the fact that drug companies, which are notoriously secretive about research, seem prepared to join forces and publish information openly. It is a mark of the importance they have attached to the huge potential benefits emanating from the international initiative to unravel the entire genetic map of man - the Human Genome Project. If drug companies are prepared to sacrifice their exclusive rights, it must mean something pretty earth-shattering is going on.
An immediate worry of the drug firms is that several smaller companies, which were specifically set up to be the first to discover the genetic signposts for disease, are going to find and patent the material, and so restrict their commercial exploitation. Several outfits, in the US and Europe, are known to be unravelling the genetic sequence of human genes as fast as they can in order to patent the information before anyone else. One such company, Genset, in Paris, is said to have found and applied for patents on two genetic traits that indicate a predisposition to prostate cancer. It is offering intellectual rights on the patents for a sum said to lie somewhere between pounds 30m and pounds 60m.
The consortium, led by the Wellcome Trust, Britain's largest medical research charity, says it wants to identify about 300,000 genetic signposts, and to map the precise whereabouts of about half of these on each of the 23 pairs of human chromosomes, over the next two years. This may seem a bold objective, but it in fact represents only 10 per cent of the total number of signposts that are believed to exist. It is, nevertheless, a far bolder attempt to unravel the genetic indicators of disease than anything else going on in the world.
The 10 drug companies have therefore deftly carried out a nice piece of anti-competitive work aimed at frustrating those smaller gene-sequencing operations, while basking in the glory of making everything they discover open and therefore unpatentable. They have realised that there is strong opposition to patenting human genes and have assumed, probably quite rightly, that the effort to place everything in the public domain will be applauded.
Indeed, one vociferous opponent of gene patenting - the Genetic Interest Group, representing families affected by inherited disorders - believes that any form of patenting on parts of the human body, including genes, will discourage rather than encourage research and development. "There are serious ethical and moral objections to the notion that part of the human body could be patentable. Genes and DNA are natural parts of the human body," the group has ruled.
In fact, the "genes" that form part of a patent are not physically part of a body. They are merely bits of information that can be written down on paper. If someone can use this to invent something - a genetic test, say - then surely they must have the right to protect that invention against plagiarism? The problem, as I see it, comes when the patent is so broad that it stifles research by dissuading others from engaging in work which they think is likely to end up being the subject of a lengthy and costly lawsuit for patent infringement.
This is what lies behind the action of the drug companies which yesterday formed the consortium with five biomedical centres, including Cold Spring Harbor Laboratory, where one of the founding fathers of modern genetics, Jim Watson, holds court. Getting into bed with academics such as Watson - who has always argued for open access to information regarding human genes - was a smart move because it meant that the drug monoliths could argue that they have the saints on their side.
Yesterday's announcement, made in the dying embers of the 20th century, has set the scene for what we are to expect in the years to come. When asked where the technology is likely to end up, Michael Morgan, the head of the Wellcome Trust's initiative to unravel the human genome, gave this honest assessment of the future: "I think the way it will end up is like pregnancy testing. It will first of all be done only in research clinics. It'll then come into a doctor's office, and it'll then become a dipstick in the chemist's."
In the longer term, the use to which the genetic signposts will be put raises far more serious ethical concerns than anything related to the question of patents. For instance, what will it mean for people to be told they are likely to develop an illness for which there is no cure? Some ethicists argue that this sort of information is too dangerous for people to know, but what about third parties, such as insurance companies? You may not want to know you have a 91 per cent chance of developing Alzheimer's disease by the age of 68, but I bet the insurance company offering to take out a post-retirement policy against long-term care would like to know.Reuse content