In a sense, companies that are trying to develop personalized medicine face the same problem as the National Security Council does in trying to analyze electronic intercepts culled from satellites or email: the flood of "noise" (innocuous communications) overwhelms their ability to detect real signals (terrorist communications). In the sphere of medicine, companies are similarly overwhelmed with information and are having a very hard time finding the real correlations between genetic variation and the risk of developing a disease or having an adverse reaction from drug treatment (biomarkers).
Forbes reports that Novartis and other companies are borrowing a tactic from software developers and dumping more "code" (genetic information) into the public domain so that researchers from public and private institutions can all work the problem simultaneously, increasing their chances of finding and validating new biomarkers.
Some of the world's biggest drug companies are finding that their genetic research is worth more to them if they give it away.
Novartis, the Basel, Switzerland, drug giant, has helped uncover which of the 20,000 genes identified by the Human Genome Project are likely to be associated with diabetes. But rather than hoard this information, as drug firms have traditionally done, it is making it available for free on the World Wide Web.
"It will take the entire world to interpret these data," says Novartis research head Mark Fishman. "We figure we will benefit more by having a lot of companies look at these data than by holding it secret."
Researchers at Novartis partnered with Sweden's Lund University and the Cambridge, Mass.based Broad Institute, a joint venture between the Massachusetts Institute of Technology and Harvard that is funded by billionaire Eli Broad. This international team compared the genomes of 1,500 people who had diabetes with 1,500 who were diseasefree. All the patients were from Sweden. To do this quickly, the scientists used gene chips from biotech Affymetrix that allowed them to track 500,000 places in the genetic code where past experience has shown that there are likely to be differences.
The result: a library of genetic differences that are likely to increase a patient's risk of diabetes. Researchers don't know what most of these errant genes do, or exactly why diabetics are more likely to have these genes. That is exactly the puzzle a world's worth of scientists are needed to unravel. But Fishman says 12 genetic differences turned up by the work are promising enough to pursue further. More leads are expected to emerge.
There was a time when drug giants tried to keep leads like that to themselves in an attempt to gain an advantage over their competitors. They paid lots of money for the privilege, too. In 1993, GlaxoSmithKline tied up with Human Genome Sciences to develop drugs based on genome data. Five years later, Bayer spent $465 million to get access to the genetic library being assembled by Millennium Pharmaceuticals. Neither collaboration has led to a marketed drug.
Harvard geneticist David Altshuler, who worked with Novartis on the diabetes study, says that genetic research is only now progressing to the point where large numbers of human genes can be linked to common diseases like heart disease, diabetes or depression. Also, too much of the previous research has been done on single cells or in other species, such as mice or rats.
"How can we say we understand these diseases when we can't say why people pass them on to their children?" asks Altshuler. "That's why it's so hard to develop drugs."
But another requirement of making the leap from genes to drugs is making the research publica step that will make it difficult for researchers elsewhere to patent any of this raw genetic information.
Novartis isn't the only drug firm embracing this "give it away for free" mentality. Pfizer has promised to make available for free a swath of genetic information emerging from a threeyear collaboration with the National Institutes of Health.