The Race to Own the Body
Cashing in on the human genome project
by Linda Pannozzo HighGrader Magazine May/June 2000

"You can't really patent a gene, you patent all the applications associated with that gene, at the end of the day, it's the same as patenting the gene - no one else can use it."
-Frank Beraud, Marketing Business Development Director, SignalGene Inc.

"The colonies have now been extended to interior spaces, the genetic codes of life-forms."
-from Biopiracy: The Plunder of Nature and Knowledge, by Vandana Shiva.

Earlier this year a British woman was the first person in the world to try to do something seemingly unthinkable. Donna Rawlinson MacLean tried to patent herself. Her application for the patent was titled "Myself" and her reasons for trying to do it were as good as any.
"It has taken 30 years of hard labour for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise," MacLean told British newspaper The Guardian.
That "unauthorized exploitation" MacLean was talking about is quickly becoming a force to be reckoned with, as genomics companies hustle to profit from the bits of information that come together to form a blueprint for life - our genetic code. And the potential profits are staggering. Sales of DNA based products and technology are projected to exceed $45 billion by 2009.
The drive for maximum return has put Celera Genomics in a race with the publicly funded Human Genome Project (HGP) to complete the map of the human genome. HGP wants all the data to be combined and freely accessed by the public. Celera wants to patent its gene discoveries.
When US President Bill Clinton and Britain's Prime Minister Tony Blair publicly supported open and free access to gene sequence data, stock prices in genetics companies tumbled. One of the companies hardest hit was Celera Genomics.
The Clinton/Blair support for public access left shareholders wondering how they'd make a return if gene information remained in the public realm. After all, can private companies profit without being able to establish an exclusive claim to our genes?
Celera Genomics is also no stranger to the spotlight. They've been making the news ever since scientist Craig Venter quit working on the $3 billion public Human Genome Project and set up Celera in l998. Since then, the Maryland company has been racing to complete the sequencing of the human genome in three years, four years faster than HGP's 2005 goal.
But things seem to be happening faster than even they expected. In January, Celera announced it had compiled DNA sequences covering 90% of the human genome. Then in April they announced they had completed the human genetic sequence, one year earlier than expected, but the sequence needed to be unscrambled.
This announcement led to a 24% jump in their stock prices. But, according to a recent Globe and Mail article, nearly half of their data had come from the public effort.
Taking the information from public research (which has been offered free on the Internet) and deciphering it, Celera has managed to create quite a business. A chunk of their revenues coming from "early access subscribers" - companies paying to use their databases. Pfizer Inc., Novartis Pharma, Pharmacia Upjohn (recently merged with Monsanto) and Amgen Inc. are the early birds signing five year deals.
They also charge university laboratories $5,000 to $20,000 for a subscription. In addition, Celera has filed for over 6,500 provisional patent applications to date. At $150 a pop these aren't really formal patent claims but a way for companies to buy time in an area that could later prove profitable. With a patent claim, they have a full year of grace time in which they have exclusive rights to assess the gene's commercial potential.

Nothing Like that Pure Laine Blood
Patenting life-forms started 20 years ago when, in l980, the U.S. Supreme Court ruled that Amanda Mohan Chakrabarty, an employee of General Electric, could patent an oil-eating bacteria. Eight years later the first living animal - a transgenic mouse containing genes from chickens and humans - was patented by DuPont Company.
Currently, well over 200 genetically engineered animals await patenting. Celera Genomics isn't alone in its race to profit from our genes. Some companies have even gone as far as to claim exclusive access to genetic heritage.
In l998, Iceland's Parliament created the Icelandic Health Sector Database Act - selling the genetic heritage of the heirs of the Vikings to the Reykjavik-based genomics company deCODE Genetics Inc. who turned around and signed a five year access agreement with Hoffman-La Roche for $20 million.
In theory, Icelanders have been isolated from external influences and have pure bloodlines - making it easier for scientists like deCODE's CEO Kari Stefansson to find disease-causing mutations in the genes.
Stefansson purchased family records and has access to the government's bank of tissue samples dating back to the early part of the twentieth century thus giving his company the complete medical histories of previous generations.
In January, Iceland's parliament granted deCODE an exclusive license to the database for 12 years. Rumours abound that the Icelandic government accepted $250,000 from deCODE while parliament was working to pass the bill. Press releases of both the World Medical Association and the Icelandic Medical Association oppose the government bill calling it a violation of patient confidentiality, the principle of informed consent and the freedom of scientific research.
As it stands, data is automatically collected from patients, assuming their consent, unless they officially opt out. To date, 17,240 of a population of 275,000 have done so.
Capitalizing on a country's heritage is also happening in Canada. SignalGene, of Montreal, has managed to sign exclusive agreements with Centre Hospitalier de Quebec (CHUQ) in Quebec City to obtain biological samples and detailed clinical data on 6,000 women with osteoporosis and 450 patients with psoriasis.
According to company spokesperson Frank Beraud, genomic companies want as little "background noise" as possible. The background "noise" in question is the lack of "purity" in genetic background. Intermarriage apparently complicates genetic material.
This is why SignalGene is so interested in Quebec's Francophone population, specifically the genetic code of the descendants of the first French settlers from the Saguenay Lac Saint-Jean region who apparently haven't done much mixing with other populations. Beraud says they have several patents issued or pending on applications of a gene.

Selling the Human Product
While huge amounts of money are being pumped into genomics research no one is quite sure where the pay off will be. One area pharmaceutical companies are already involved in is called gene therapy - the altering of genetic material in the living cells of patients. In Canada and the US, clinical trials in gene therapy have been taking place for several years.
With corporations racing to develop marketable products from genetic information, government regulations have done little in the way of slowing the pace in the name of safety.
There's nothing in the Canadian Food and Drug Regulations that deal specifically with gene therapy. Gene tampering is simply regulated as if it were a drug. Also lacking are Canadian guidelines for gene therapy.
Even more surprising was the news that Health Canada's Therapeutic Products Programme are hoping to cut the review period for new applications from 60 to 30 days. The shorter review period is being applauded by industry, and Health Canada says it hopes to - "stimulate clinical drug research."
Critics, however, argue that health safety is being undermined without full disclosure and transparency in clinical research.
Last September, for example, 18-year-old Jesse Gelsinger enrolled in a controversial gene therapy experiment sponsored by Schering-Plough Corp. at the University of Pennsylvania. The experiment began with an injection of genes into Gelsinger's liver. Within four days, his blood thickened, his eyes and ears swelled shut, his organs shut down and he died.
What Gelsinger's family didn't know was that about a year earlier two monkeys died after undergoing the same gene therapy technique. The corporate sponsors, however, never passed this information onto the Food and Drug Administration.
After Gelsinger's death The National Institute of Health cracked down on such experiments and received 691 reports of serious adverse effects. The majority of these incidents (652) had been seen before by the NIH. Gelsinger was clearly not the first to suffer from "adverse effects" from gene therapy - but his death was only the first reported. The public heard about Gelsinger's death because media accessed reports under the Freedom of Information Act.
In Canada, however, the specifics about the sponsors of clinical trials or the results of the clinical trials are considered confidential. Details of privately funded gene therapy trials are considered proprietary. To date, 30 clinical trials have been approved by Health Canada - all within the last five years.
In l997, a Novartis sponsored gene therapy trial at the University of Toronto resulted in the death of James Dent. Novartis, responsible for letting Health Canada know about the death within seven days, finally provided them with an autopsy report five months later.
According to Anthony Ridgeway, the Manager of the Biotherapeutics Division at Health Canada, the public may not have access to to what happens in the clinical trials but " any important safety information is made available through the informed-consent form and is kept up to date."
However, in the case of James Dent, the consent form he signed did not mention that other patients suffered adverse effects as a result of the experiment.
According to a recent Globe and Mail article, a few days prior to Dent starting the second phase of his treatment, another patient who was part of the same experiment died in Indiana. Consent forms may not be up to date and patients may not be fully aware of what they are consenting to.

Moratorium
One organization that is extremely critical of the private race to complete the human genome is Rural Advancement Foundation International or RAFI, an international organization based in Winnipeg. Spokesperson and researcher Hope Shand says most of the companies are not actually producing anything.
"Most are making money from subscription databases, but most do not have products - just patents."
Patenting genes is akin to colonizing the human body without actually creating anything, she says.
"Traditionally, products of nature were not patentable, but the courts have rendered this vacuous. As long as some form of human intervention is involved, isolation, manipulation, purification, it's potentially patentable."
Even the official site of the HGP raises the red flag. One daunting, ethical minefield that's bound to surface with all this genetic tinkering is germ-line therapy - genetic enhancements at the embryo level. HPB's web site states that a new class of people may arise in a world where genetic "enhancements" are possible. For those who can afford it, a genetic nip and tuck will give them social advantages as well as the ability to enhance their kids!
The web site warns: "germ-line enhancements that are passed on to succeeding generations could create a genobility with an unassailable lock on power and privilege...In the face of such a hardened class structure, the underclass is likely to rebel, in turn provoking anti-democratic repression by the genetic upper class."
Canada has placed a moratorium on research in the area of germ-line alteration and in the US, clinical trials are not being considered either. Maybe Donna Rawlinson is onto something.

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