From http://www.feedmag.com/dna/bookoflife.html {{<Begin>}} LAST MONTH, Donna Rawlinson MacLean took out an unusual patent with the British Patent Office. She created an invention she called "Myself." MacLean, a poet and casino waitress from Bristol, England, explained her reasoning to the Guardian. "It has taken thirty years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise." A few weeks later, San Francisco artist Marilyn Donahue copyrighted her DNA, documenting authorship by licking a stamp and sticking it on a self-addressed envelope. These are intended to be acts of protest, meaningful for their symbolic value, not their legal viability. But in the increasingly surreal realm of intellectual property, where the difference between organism and invention is anyone's guess, the claims of Donahue and MacLean are anything but absurd. Life as commodity is not a new idea: Slavery is a prime example. But never before now have humans possessed the tools to create life, and manipulate it at its most basic -- genetic -- level. Last Thursday, the human race finally deciphered the three billion digits of its own code, our DNA -- or what science writer Peter Gorner aptly describes as the "book of life." As the much-vaunted race to map the human genome comes to a close (the complete map should be finished this year), the race to make the map pay off begins. The implications fall just this side of comprehension: If we can learn to read the code that programs life, we can surely learn to write that code; if we can program life, we can create life. Because anything we can make we can sell, and nearly always do, we'll need to get a patent on that sucker before someone else tries to sell it first. Welcome to the gene-patenting debate. The future is now, and that scares a lot of people. With all the foresight and humanity Europe exercised when carving up Africa, biotech companies are rapaciously carving up your body in a sort of posthuman colonialism, racing each other and the government to gain exclusive rights over your genes. In the coming decades, our God-given traits may become as interchangeable -- and marketable -- as an Ikea modular home-entertainment system. We'll choose green eyes, or blue, eradicate baldness and back hair, and, with the latest brand of IntelliGene, never be stumped by the Sunday Times crossword again. It sounds beautiful -- and boring -- and, assuming one still believes in such things, quite possibly blasphemous. Yet this knowledge also presents opportunities that tax the imagination: an end to AIDS, cancer, schizophrenia, aging, and, it has been suggested, death itself. "This is a time of fantastic hope and fantastic progress," says Chuck Ludlam, vice president for government relations at the trade group Biotechnology Industry Organization, and a tireless apologist of the biotech industry. Indeed, the prospects are dizzying: Eden regained, our mortality a consumer choice. Eternal life on a very long installment plan. Of course, we're not there yet, and the road to Eden is paved with stock certificates. Last month, talks broke down between Celera, Inc., the private lab that will win the race to map the genome, and the federally funded, multinational Human Genome Project, which won't. The Human Genome Project, the ostensible good guys, organized and started the contest in 1990, under an altruistic mandate to not only map the genome by 2003, but to make that map available to the public. As such, it now deposits the information it gleans from its gene sequencing into the public domain via a Web site every twenty- four hours, thus immunizing it from patent hounds. Celera, which wants to get really, really rich, will market the fruit of its research on a subscriber-only database. Using what it calls "the world's largest civilian supercomputer," Celera finished the sequencing of the genome April 6. Celera plans to patent up to five hundred genes. The potential market is enormous, and the boom years have provided the biotech industry with eager investors. But if humanity is the ultimate beneficiary of genetic technologies, it is also, to a disturbing degree, the raw material as well as the manufactured product. And because corporate equity is only as good as its patents, the market has demanded, and received, the assurance that life itself can indeed be patented. "Investors," Ludlam points out, "have wallets. They don't have hearts." HOW CAN LIFE be patented? The Supreme Court opened the floodgates in 1980, allowing the first patent on a living thing, a bacterium that had been genetically altered to consume pollutants. Perceiving the unquestionable social good such a creature could provide, the Supreme Court ruled that while nature itself could not be patented, one might patent "anything under the sun that is made by man." Eight years later, Harvard won a patent on its special brand of mouse, the "Onco-Mouse" ("Onco" for oncology; the mouse is especially talented at developing malignant tumors). These precedents set the stage for current gene-patent policy. If you can isolate a gene in a petri dish, the patent office considers the gene to have been modified by the "hand of man," and thus eligible for a patent. Researchers must also show "utility," which now means being able to explain in the loosest of terms what function the gene might perform in the human body, and what desirable things we might be able to make it do instead. For example, Human Genome Services currently has the patent on a growth gene VEGF-2 that, when injected into the human body, can stimulate the creation of blood vessels. Hopefully it will someday make bypasss surgery obsolete. With VEGF-2, the gene and the medicine are one and the same. In other words, a gene in a very real sense can be an invention, and inventing is what the patent system was set up to encourage. Of the 140,000 genes in the 23 chromosomes that make up the genome, some 1,000 are already patented. Thousands more await approval. Eventually, critics say, the entire genome will be lorded over by large biotech firms. Even now, corporations, universities, and others are generating millions of dollars for their discovery of life. Why shouldn't Donna Rawlinson MacLean get in on the act? IT SHOULD BE noted that the vast majority of patents will require years of expensive, labor-intensive research before they emerge as a marketable product. The current controversy over gene patenting revolves around where we are going, not where we are now. Unfortunately, prognostication is difficult in light of the fact that the present has proven so cryptic. On March 14, Bill Clinton and British Prime Minister Tony Blair issued a vaguely worded joint statement outlining their commitment to "make the raw data from DNA sequencing available to scientists everywhere." Characteristically Clintonian, the statement was intended to mollify both opponents and proponents of gene patenting. Addressing a national television audience, Clinton acknowledged the need for patent protection in order to create an environment that encouraged the vast financial investment necessary to advance the science. But in another portion, he noted that "We must ensure that the profits of human genome research are measured not in dollars, but in the betterment of human life." Historically, the stock market only employs instruments used to measure the former. The statement triggered an instantaneous selling spree in biotech stocks. At the close of trading, the American Stock Exchange biotech index had dropped 13 percent. The media fueled the fire, playing the statement as big news in front- page reports. Both sides in the raging war over gene patenting interpreted the bilateral missive as a move toward a ban on gene patents, despite the fact the "agreement" was nothing more than a sentimentalized reiteration of the administration's four-year-old official policy concerning gene patenting. The public, including those with money in biotech, seemed to have no idea what these companies do. No matter. A Toronto Star op-ed trumpeted the statement as "long overdue," and the San Francisco Chronicle gave the story front-page coverage, under the headline "Call for Access to Genomic Data." It was days before cooler talking heads appeared on the financial talk shows to point out that placing raw genetic data in the public domain, which is what Clinton advocates, actually benefits most biotech firms. The frenzied pace of the sell-off slackened, but at its nadir the index had been drained of $30 billion. The specter of a ban on gene patents had spurred on the stampede. When the dust finally settled, one lesson emerged. Because the perceived equity of a biotech company is its ability to hold exclusive rights over a use of a gene, gene patents equal investment: no patents, no investment. And for this science to move forward, the biotech field will require unprecedented levels of investment. Whether or not we find gene patents offensive, on grounds moral or legal, our discomfort will be the toll we pay to enter the age of "fantastic hope and fantastic progress." ACCORDING TO BIO'S LUDLAM, that's a nominal toll to pay. In fact, Ludlam insists that gene patents aren't patents on genes at all. "Absolutely not," he says. This is, strictly speaking, a load of hooey. Gene patents are in fact exactly what they sound like, patents on genes. Ludlam tends to speak in absolutes, as one might expect the premier spinmeister for a multibillion- dollar industry to do. And if he isn't absolutely correct in asserting that gene patents are a chimeric straw man conjured by gene patenting's critics, neither is he absolutely wrong. You can't patent just a gene; you also have to understand how it functions in the body, or, in the language of the patent office, show its "utility." United States patent law currently considers DNA a chemical, and chemicals are patentable. As with the pollutant-hungry bacterium, as with Harvard's Onco-mouse, if it's been touched by the hand of man, you can patent it. Because of his bluster, it's easy to lose sight of the fact that Ludlam happens to be right that the United States patent system is absolutely the best way of advancing the genetic revolution. "Nobody's going to spend the tens of millions of dollars it takes to do this very, very difficult research if they don't have protection against theft from their commercial competitors," he says. Patents encourage companies to bring products to market with due haste. "First you have a race to invent, then you have a race to make something that will help people, because if it doesn't help people you're never going to get something you can sell. And this is what benefits patients. Patients want these companies racing." True enough, it is this race, more than anything else, that is responsible for the current blistering pace of discovery in the field. To wit: Biotech companies are responsible for 300 drugs that are currently in clinical trials. At least some of these will receive FDA approval. Celera, Inc. entered the race to map the human genome a full eight years behind the National Health Institute-sponsored Human Genome Project. Yet Celera crossed the finish line some three years ahead of the schedule originally set by the HGP. In February, another leader in the biotech field, Human Genome Sciences, received its 112th gene patent, on a gene that could lead to an AIDS vaccine. Millennium Pharmaceuticals, Inc. won a patent last month on a gene that could be used to determine if a patient is at risk for melanoma, the most common of all cancers. This landscape, of biopharmaceutical companies battling each other and the government in a riot to divvy up the spoils of our genetic code, is an ugly sight, but then, the free market usually does resemble the scene of an accident. Yet, unlike other industries -- tobacco, say, or petroleum -- at least with biotechnology the interests of humanity dovetail a bit with the interests of capital. As Ludlam puts it, "If you're going to wait for the government to bring these lifesaving products to market, you're going to have a very long wait." But there's a big difference between placing highly conditional trust in a highly imperfect system and blind faith in the invisible hand of the market. Even the most ardent of biotech champions would not suggest that the field go unregulated. The ethical, social, theological, and even logistical questions posed by genetic science are vast, and pressing. Though we may still be several decades away from reaping the fruits of the current genetic discoveries, there have already been what many view as egregious abuses either in the collection, the development, or the patenting of genetic material. In the 1970s, John Moore underwent treatment for cancer at the UCLA hospital. His doctor discovered that Moore's spleen tissue produced a protein usable to fight cancer. Without informing the patient, UCLA created a cell line from his tissue, obtained a patent from their invention, and sold it. Moore's cell line is now estimated to be worth $3 billion. Moore learned of the UCLA "discovery" years after the fact, and understandably slapped them with a suit. In 1990, the California Supreme Court decided against Moore, ruling that once the cell had left his body, he was no longer entitled to any property rights over it. Critics label this bio-piracy, and it goes on all the time. Many of the valuable advances in genetic knowledge have been gained through organisms gathered in underdeveloped countries, and these have led to patents now generating billions of dollars in revenue. The "donor" country, needless to say, sees none of it, though this situation may be changing. "I think people in the industry, not to mention lawmakers and the judiciary, are becoming much more sympathetic toward the victims of bio-piracy," says Lori Andrews, the former chair of the federal commission on the legal, ethical, and social implications of the Human Genome Project. She is a professor specializing in genetics law at Chicago-Kent College of Law, and the author of The Clone Age: Adventures in the New World of Reproductive Technology. Andrews also serves as a de facto watchdog over the genetics industry. She says that Moore is hardly an isolated case. For example, a cell mutation known to cause breast cancer was collected from several Ashkenazi Jewish women without their knowledge. "The irony is that this same genetic information could be used to discriminate against them," Andrews says. Because many of the current applications for genomic science lie in diagnostics (DNA screening) as opposed to therapeutics (treatment) which is still in a rudimentary stage of development, a gap has formed between "diagnosis and treatment," she says. "In that gap, insurers, employers, and schools are already discriminating against people who may not even be sick, but just show a propensity for a genetic disease." No one questions the seriousness of the confidentiality issue. Group insurance programs are currently prohibited from discriminating based on genetic information about patients, but as even Ludlam admits, Congress needs to adopt more sweeping measures to protect patients who wish, or need, to undergo DNA screening. Both Ludlam and Andrews advocate legislation that would provide a double layer of protection for patients. The first would be laws protecting patient confidentiality. The second would ban all forms of genetic discrimination. ABOVE AND BEYOND any specific legislation, or the fine-tuning of the patent process, however, Dr. Audrey Chapman feels that what's most needed at this juncture is simply informed public debate, and, moreover, a public institution saddled with the mandate to facilitate such education and conversation. "Often people who are interested in hypothesizing about the science, or about the policy, have no idea if this is scientific fiction or scientific reality. It's really important if we're debating any of these issues that we understand the science and understand the social implications of the science." This is always the pipe dream, of course: An informed, thoughtful electorate willing to do the homework and consider the consequences of the direction they take as a society. And despite troubling precedents such as a nation's collective indifference regarding universal health care, the current spate of public fascination with the human genome gives grounds for optimism. An informed society, after all, and the consensus they could produce, is our best insurance that this science that promises so much might fulfill its potential without compromising our human dignity in the process. Jeff Howe is a frequent contributor to The Village Voice and Time Out New York. {{<End>}} A<>E<>R ~~~~~~~~~~~~~~~ Integrity has no need of rules. -Albert Camus (1913-1960) + + + + + + + + + + + + + + + + + + + + + + + + + + + + The only real voyage of discovery consists not in seeking new landscapes but in having new eyes. -Marcel Proust + + + + + + + + + + + + + + + + + + + + + + + + + + + + "Believe nothing, no matter where you read it, or who said it, no matter if I have said it, unless it agrees with your own reason and your common sense." --Buddha + + + + + + + + + + + + + + + + + + + + + + + + + + + + It is preoccupation with possessions, more than anything else, that prevents us from living freely and nobly. -Bertrand Russell + + + + + + + + + + + + + + + + + + + + + + + + + + + + "Everyone has the right...to seek, receive and impart information and ideas through any media and regardless of frontiers." 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