WRONG MAP


Why public science can really be public!

 

By: Siddhartha Mukherjee



IN EARLY APRIL, 2000, a private corporation named Celera announced it was about to pull off the most important scientific breakthrough in a decade: a detailed map of the human genome.


But not everyone was happy about this news. Celera had been locked in a race with the Human Genome Project, a government initiative that soaked up almost $1 billion in public money trying to do the same thing. Now the project’s backers in Congress want to know why it’s finishing second.


 The simple answer is that the project lost one of its best scientists to the private sector. In 1995, a man named J. Craig Venter developed a new technique for gene sequencing called the “shotgun” method. Folks at the genome project were skeptical of his technique, which they considered less precise, so Venter left to start a nonprofit corporation.


After a blitzkrieg of scientific publications proved that Venter’s technique worked, he merged his nonprofit with a for-profit giant, Perkin-Elmer Corporation, and thus created Celera. Its mandate: Beat the feds, sequence the entire human genome, secure patents for genes with commercial applications, and reap massive profits —all of which it is about to do.


Members of Congress are vowing not to let this happen again. And one idea is gaining particular currency: abolishing gene patenting altogether, thus eliminating the incentive for scientists to piggyback on government research and then leave for the private sector.


After all, Celera’s scientists may have been talented and creative, but they clearly benefited from sequencing technology developed in federally funded labs. Venter’s own ideas about shotgun sequencing were conceived within laboratories funded by the National Institutes of Health (NIH). Why not pull the plug on gene patents and thus eliminate the private-sector windfalls that make top scientists stiff Uncle Sam?


Because eliminating the profit motive might kill the entire biotech industry. There’s a better solution, and it’s based on an old principle: If you can’t beat them, join them. Right now, the government is a de facto incubator for private com panies like Celera. Why not admit it and make the private investors start paying their share of the basic research whose benefits they eventually reap?


THE RIGHT TO patent genes was established a decade ago, when the Supreme Court recognized a patent claim by a California-based company named Amgen. The patented gene, called EPO, helps create a medical product that coaxes blood to grow, thus making it a key drug for patients with anemia.


Since that ruling, biologists working in both federal and private labs have been trying to patent more genes like Amgen’s blood-growing cash cow. Celera, according to Venter, hopes to focus on “100 to 300 targets from among the thousands of potential targets” in the human genetic sequence and then characterize them in detail.


If Congress undid the Supreme Court’s decision and passed a law outlawing gene patenting, it might prevent scientists like Venter from jumping to the private sector.


And the House Committee on Science has been holding hearings to consider doing exactly that. But private-sector researchers argue that banning gene patents would kill corporations’ incentive to invest in research. And they are probably right.


Even Bernadine Healy, while she was director of  the NIH, admitted, “Patents are important to commercialization in the biomedical field because they provide the exclusivity that encourages industry to invest the resources necessary to bring an invention from the discovery stage through the stages of development, clinical trials, and regulatory approvals, and ultimately into commercial production.”


So some in Congress are pushing another idea: Instead of banning gene patents, write stricter contracts between researchers and the government. Under the Bayh-Dole Act, federally funded researchers (in collaboration with their host institutions, such as universities or nonprofits) can retain the titles to their own discoveries. To prevent federally funded researchers from exporting their work into the private sector, perhaps all that’s needed is a modified act that would let the government retain partial control on research performed with public funds.


But here, too, the cure might be worse than the disease. Repealing Bayh-Dole would make host institutions that receive federal money unappealing places to work Fortune hunters—the kind who patent genes—would be even more likely to leave for private industry, where the financial rewards would be easily and directly available to them. The institutions that receive federal funding would be left with fewer and less-talented researchers to draw upon.


A THIRD STRATEGY makes more sense. The Human Genome Project should have spent a smaller amount, perhaps a few million dollars, to let scientists like Venter test new techniques and streamline production. When these sequencing efforts finally matured, the NIH should have pushed the projects out of its nurseries and let their inventors hunt for private investors to finance their expansion and further development. Scientists like Venter would still have left the NIH. But they would have been forced to do so early on, before the government pumped in millions of public dollars.


Such a system would benefit not only scientists eager to jump to the private sector but also those who wished to stay in the government’s employ. One of the problems with the genome project was that most of its scientists were not like Venter. They were academics primarily interested in cutting-edge science; they preferred precision to speed and scientific advance to commercial application. Having them compete with the private sector on a project like mapping the genome—which, after the technique had been settled upon, devolved into a relatively tedious task—was a bad idea from the start. In an incubator system, these scientists could continue to do what they do best: cutting-edge science that is intellectually important but not necessarily financially rewarding.


Incubator models are not perfect. Encouraging the exodus of scientists into private-sector biotechnology will mean fewer patents—and less money—for the NIH. But, as small-scale projects are exported into private industry, the NIH will save the massive up-front expenses incurred during their expansion and thus avoid embarrassing debacles like the genome project. And spawning a cadre of competing scientists would also ensure that a single company doesn’t run off with all the patents—which is what Celera is now in a position to do. With the obvious exception of projects involving national security the government should keep its money for brilliant but smaller ideas that will never turn a profit. There’s nothing wrong with scientists becoming millionaires. But the public shouldn’t have to pay for it.


SOURCE:

NEW REPUBLIC Magazine

May 8, 2000 Vol. 222 No. 19 Issue 4,451



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