Selling our Souls: The corporations that profit from owning our genes
The 2.91 billion base pair sequence of the human genome was published last month. This sequence contains the 30,000 genes which are the blueprint for our bodies. The Genome International Sequencing Consortium published contained the 61 page article "Initial sequencing and analysis of the human genome" in the February 15th issue of Nature (GISC, 2001), while Venter et al (a group of privately funded scientists, most of whom work for Celera) published the 47 page article "The Sequence of the Human Genome" in the February 16th issue of Science (Venter et al, 2001).
The publication of these two sequences of the human genome marked the end of a competitive struggle between the publicly funded Human Genome Project (ran by the Genome Internatinal Sequencing Consortium) and the publicly traded Celera. The Human Genome Project was initiated to make the sequence of the human genome publicly available for research. A year ago the pharmaceutical giant Perkin Elmer decided that the human genome would be valuable and started up Celera to sequence the human genome itself. Celera now calls itself the "largest DNA data factory" and reported earning $20.3 million in its second quarter ending December 31st, 2000 (Applera Corporation Newsroom, 2001).
There was some concern whether Celera would release their sequence of the human genome to the public. After some negotiating Celera agreed to a compromise. Academic users may access Celera's data if they are using it for research and will not distribute it. Commercial users are subject to restrictions and/or fees (Science Magazine, 2001). Other companies are taking Celera's lead and selling access to databases of the human genome. The mega-corporation CuraGen has created the 'Genescape' Internet site. And Hyseq, another genomic giant, has opened 'Genesolutions.com'.
Genesolutions.com is an interesting site. Web browsers sign up, enter a credit card number, and begin searching Genesolutions.com. They pay a variable fee per nucleotide accessed. If a researcher encounters an especially interesting sequence and related data and wishes to obtain a license for the proprietary gene, a US$10,000 charge to a Visa, Mastercard or American Express instantly removes it from Hyseq's online access and earns the researcher a license from Hyseq.
The precedent for patenting life was set in 1980 when the US Supreme Court allowed a patent on a bacterium that had been genetically altered to consume pollutants. The Supreme Court ruled that "anything under the sun that is made by man" could be patented. This set the stage for current gene-patent policy. DNA is considered to be a chemical under current US patent law, and chemicals are patentable. The patent office considers a gene to have been modified by the hand of man if it is isolated in a petri dish and thus eligible for a patent. (Howe, 2000).
A patent on a gene is not a regular patent. A corporation cannot just patent a gene, they also have to show the gene's utility. They aren't patenting the gene in your body or my body. They are isolating it and turning it into a useful form. They need to have done something novel that is going to be useful to somebody. The National Institute's of Health has issued a set of guidelines about patenting that states that corporations must show a high degree of novelty, utility, and non-obviousness before they can patent a gene. According to Francis Collins, the head of the Human Genome Project, this gives the corporations incentive to do research while ensuring that they cannot monopolize information and hinder more research (Collins, 2000).
In reality all that a corporation has to do is isolate a bit of a gene and then they can patent it. Scientists can find pieces of DNA called express sequence tags that correlate to genes. They do this by using cDNA formed from the mRNA our bodies use to make proteins. By sequencing the piece of cDNA scientists can decode a little piece of a gene. This simple procedure of decoding the express sequence tag qualifies as being unique and useful enough that corporations can patent it (Cook-Deegan, 2000).
Corporations are now discovering that the real money in genomics lies in the polymorphisms. According to Dale Pfost, Ph.D., Orchid's president and chief executive officer "Orchid estimates the genetic diversity market is now over $1 billion and will continue to increase through the natural outpouring of information from all the sequencing efforts around the world." The Human Genome Project was of one genome. In reality there are 6 billion genomes, each one with slight variations. US patent law allows for the patenting of Single Nucleotide Polymorphisms (SNP), which are sections of DNA that have the smallest possible variation of only one base pair. Corporations are hoping to patent SNPs that fall within specific genes so that they can develop diagnostic kits, monitoring instruments, and even 'designer' drugs tagged to the specific DNA of wealthy customers (Hammond, 2000).
The Human Genome Diversity Project (HGDP) is a worldwide, academic-led effort to collect, sequence, and store human genetic diversity. The HGDP's goal is to broaden the study of the human genome beyond North America and Europe. But many of the people targeted by the HGDP are concerned that their genes are being patented for corporate profit. There is not much government supervision of the HGDP and the HGDP has some ethical issues, such as the commercial use of samples, the lack of consultation with the targeted people, and issues relating to the informed consent of research subjects (Hammond, 2000).
There are many large corporations profiting off of our DNA by finding polymorphisms. deCODE Genetics Inc. is a population-based genomics company in Iceland. The company is using the unique genetics of the Iceland population with its homogeneity and extensive genealogical and medical records to find valuable genetic resources (from deCODE's website <http://www.decode.com>). In 1998 deCODE received somewhere between $140 and $280 million from the Gene Giant corporation Hoffman-LaRoche for its unique genetic resources (Iceland Review, 1998).
By searching for polymorphisms researchers at Columbia University discovered a gene associated with baldness in a Pakistani village (Ahmed et al, 1998). The market for products related to hair loss is one of the largest in the world, with consumers in the US alone spending an estimated US$7 billion annually on treatments. This could easily be used for corporate profit.
Kiva Genetics (they can be found at <http://kivagen.com>) is a company based in San Francisco. They focus on developing proprietary tools to 'aid in the analysis of genetic sub-populations with a focus on ultrahigh throughput SNP-genotyping.' HvrBase is a company based at the Max Planck Institute in Leipzig and the Zoology Institute of the University of Munich (at <http://www.zi.biologie.uni-muenchen.de/science/mtdna/hvrbase/>). HvrBase is mostly dedicated to sequences from indigenous peoples, including mitochondrial DNA sequences on approximately 2,000 indigenous people from over 40 countries.
Millennium Pharmaceuticals (they can be found at <http://www.mlnm.com/>) is a US company that is doing genetics studies in China. They have at least 14 projects underway in China, involving as many as 200 million Chinese citizens. Hyseq is a California company that is collaborating with the University of California at San Francisco (UCSF) to collect and sequencing SNPs and other variations in DNA samples from 20,000 'genetically diverse individuals'. These individuals are all patients at UCSF's affiliated San Francisco hospitals. UCSF researcher John Kane is being paid an undisclosed amount of money to build Hyseq a giant genetic database. Hyseq can then sell data to its pharmaceutical company clients, as well as develop (and patent) its own medical research on the samples (Hyseq Press Release, 1998).
There is apparently a lot of money to be made in isolating human genes and there are a lot of companies that are working to find genes that they can patent. Already many thousands of human genes have been patented by the corporations that isolated them. They patent the genes both so that they can specially design pharmaceuticals with the genes (and then patent and sell the drugs), and so that other companies will have to pay them royalties to use those particular genes in their research.
Millennium Pharmaceuticals, Inc. patented a gene that it can use to determine if a patient is at risk for melanoma, the most common of all cancers (Howe, 2000). Human Genome Sciences, received its 112th gene patent (on a gene that could lead to an AIDS vaccine) in February 2000 (Howe, 2000). Celera told the press last October that it had filed for 'preliminary patents' on over 6,500 full or partial human genes (Hammond, 2000). Human Genome Sciences reports that it has filed for patents on 6,700 human genes (Hammond, 2000). CuraGen announced last August that it has identified 120,000 human SNPs and that they will be 'aggressive in making patent filings' on them (Hodgson, 1999). Incyte announce in November 1999 that it 'has filed patent applications covering an estimated 50,000 individual human genes. The company was issued 79 new U.S. patents covering full-length genes during third quarter, bringing its total number of issued and allowed full-length gene patents to 453.' (Hammond, 2000).
We have given corporations the right to own our genes. There is profit to be made by using DNA sequences found in different human populations so corporations will exploit those populations to get their genes. Once a corporation has isolated the gene of a human that corporation has the right to patent that gene. And corporations are patenting genes by the thousands. We are giving the rights to our own bodies away to corporations so that they can make money.
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