The mining of DNA brings hope for cures and fears for privacy
Like Egill, his Viking forebear, Kari Stefansson is out for blood.
Egill, the violent, poetry-spouting, true-life giant at the center of one of his country’s greatest sagas, sliced and diced foreign peasants under the guise of defending and reaping wealth for his tiny island.
Stefansson, a 6-foot-5 neurologist, self-described poetry fanatic and arguably his country’s most famous citizen, is a much more modern sort: The only swipes he takes at his critics are verbal. His dream, though – to use his genetics company to collect and storehouse the DNA of his countrymen to ultimately fight disease – is as bold as anything the ancient warrior ever conceived. It’s also deeply controversial: Never before – in Iceland or any other country – has a private firm had such easy access to the veritable lifeblood of a people.
In short, Stefansson has gotten the government’s permission to get blood samples from every citizen of Iceland from which he will establish a genetic database. The database, he has said, will be used to find cures for some of the world’s most deadly diseases.
It also will be a moneymaker. Stefansson’s firm plans to sell the genetic information to drug companies and insurance firms. The chance insurance firms might use the information to discriminate against Icelanders who are likely to develop diseases is one of the second thoughts now occurring to people.
But what is happening here, ethicists say, is worth the attention of policy-makers beyond Iceland as scientists everywhere begin to unleash the power of the gene, leapfrogging ahead of the legal and social constraints that protect citizens and maintain order.
In the brave new world of DNA discovery, Stefansson is transforming what was once an ancient fishing village, literally called “smoky harbor” for its abundant hot springs, into an unlikely new capital of disease research.
Much the way Jules Verne used the gleaming Snaefellsjokull Glacier as the doorway to inner space in “Journey to the Center of the Earth,” modern Iceland is serving as the portal to a new world where even a person’s genes may be exploited.
Backed by a pledge from Hoffmann-LaRoche that could run as high as $200 million, Stefansson took his tiny firm deCODE Genetics Inc. public in July on a bold promise. (Hoffmann-LaRoche, the Swiss pharmaceutical giant, has a major operation in Nutley.)
By minutely examining the DNA in blood donated by native Icelanders, he said, he will crack the genetic mysteries of mankind’s common diseases, from cancer to hypertension. In the first day of public trading, the stock raised $173 million for the company.
But, like the old nursery rhyme, this scientific Pied Piper could have a dark side. Working over the past four years to lay the groundwork for his genetics campaign, Stefansson has cajoled this small nation with what some say is an exaggerated picture of Icelanders’ own uniqueness and captivated citizens with dreams of medical altruism. He took advantage, some say, of the fact that the techniques of gene research blossomed before a sense of rules and ethics had solidified. As a result, his company’s efforts to collect blood samples and gain access to medical records hinge on contracts with patients that may not reflect their best interests, at least in the minds of many bioethicists and human rights advocates worldwide.
“This is biopiracy, plain and simple, and not a good deal for the people of Iceland,” said Pat Mooney, executive director of the Rural Advancement Foundation International in Winnipeg, Canada, a nonprofit advocacy group that monitors the ethical uses of technology. “I worry about the long-term abuse of genetic information. I don’t think we’ve even begun to understand yet what dangers are engendered by all of this.”
WHY ICELAND?
Nature’s cauldron has shaped Iceland uniquely for its role as ground zero in the genetics revolution. The island, only slightly smaller than England, was formed 20 million years ago from magma spewing from the entrails of the Earth. It straddles the mid-Atlantic ridge at the merger of the North American and European tectonic plates. Geologically speaking, it is constantly in a state of precariousness – volcanic activity continues to form the island by slowly forcing the plates to separate. The island seems ceaselessly under siege by bad weather, earthquakes, volcanic eruptions, lava dust and glaciers.
An isolated environment so adverse to human expansion also makes, some believe, for an interesting gene pool, one where scientists hope diseases can be tracked through families. Among the tallest people on earth, Icelanders are descended from Nordic and Celtic stock. Wealthy since the end of World War II, 100 percent literate and in excellent health thanks in part to a nationalized medical plan, Icelanders trust their government, enough to allow it to stockpile all their medical records.
Genes are the staple of an emerging industry known as genomics. As Stefansson guessed before anyone else, the blood of his Viking brethren offers an unbeatable combination – an accessible, mostly willing, pro-technology population with genetic histories that are easy to trace.
In what is becoming a billion dollar global race to comb genes for clues to develop new disease-fighting drugs, Stefansson is emerging as one of the “gene kings” on a par with his American counterpart, Craig Ventner of Celera Genomics Inc.
“What Kari Stefansson is doing is unsurpassed – no one anywhere else in the world is even close,” said Klaus Lindpaintner, director of genetics for Roche in Basel, Switzerland, with obvious admiration. “I think it’s the world’s foremost gene-mapping company.” In gene mapping, scientists search through billions of pieces of DNA – short for deoxyribonucleic acid, the chemical essence of all genetic matter – to document every gene in the human body. One reason they do this is to find defective genes that may be at the root of diseases.
Now that scientists have completed a draft of the human genome, the blueprint of life, the rest of the world may start to place a special emphasis on peoples’ genes and how to extract commercially and medically important information from them. Icelanders, though, are already there.
“So many of the issues that are being discussed and debated in the United States are already, in a slightly different way, being played out in Iceland,” said Mike Fortun, a bioethicist who is spending a year at the Institute for Advanced Study in Princeton to write a book about deCODE and Iceland. “This is an issue that is going to be pretty much everywhere in the years to come – namely, what happens to the kinds of information that can be extracted from people’s bodies as biomedical researchers become more and more capable of converting body tissues and cells into information. How do you go about doing that well? The question is one that everybody should be concerned about.”
Coming as it does out of this fabled land of fire and ice where large glaciers lie next to steaming lava fissures, Stefansson’s grand vision – for himself and all of Iceland – may someday earn him a place in the kind of saga for which the country is known. What no one yet knows is whether he will be portrayed as a hero or an ogre. In Iceland today, that is anybody’s guess.
THE PERFECT SETTING
About 40 minutes outside Keflavik International Airport, after zipping along winding roads through flat, dramatic landscapes, a traveler will arrive at the coastal capital, the country’s nerve center, where half of the island’s population lives. It’s a post-Apocalyptic landscape – where a Utopian society lives in cream-colored boxes with colored roofs, ringed by lava fields, wind- and rain-whipped by the North Atlantic. It’s a perfect setting for Stefansson’s vision of the future. But not all Icelanders see the 21st century the same way. One of them is Skuli Sigurdson, a historian of science who teaches at the University of Berlin and the University of Iceland here. Sigurdson is deeply critical of deCODE and governmental actions supporting the firm.
Sigurdson constantly brushes back a mane of thick, dark blond hair off his forehead. When he talks, he folds his arms across his chest, almost as if he is hugging himself.
As he whips his tiny silver Nissan along winding city streets, pointing out the preserved homes of dead artists, he points to the American fast-food restaurants that have sprouted up – Pizza Hut and Domino’s Pizza and McDonald’s are just some of them. In another generation or so, the traditionally lean, fish-eating Icelanders may be combating diseases seen in America – heart disease and diabetes, he said, as they take on some American dietary habits.
People are talking about two things, he said. There’s been a rash of traffic fatalities, mostly in Reykjav?k, tied to the city’s ever-growing population. His mother was killed in a traffic accident here in 1998. The other big item is the economy – will it stay as strong as it’s been?
“The most important thing happening in the country is barely discussed but on everyone’s minds,” he said. “DeCODE has raised the cosmic hopes of so many that they fail to see the dangers inherent in the system.”
Later, at his yellow, concrete home in a well-to-do neighborhood in the city’s north quarter, he gazes sadly through his living room window at the blue-green Faxafloi Harbor. “I’m not against healing the world,” he said. “I’m against unregulated research, against megalomania. I’m not willing to tolerate it.”
The 41-year-old professor waves toward Mount Esja, the hulking volcanic mountain that is a symbol of this northern nation´s capital city, and notes that the simmering debate over the fate of this coun try´s genes has assumed a similar place in the country´s social landscape always there, almost too ob vious to talk about.
PRIVACY BARELY AN ISSUE
In ways that Americans could never fathom, Icelanders trust their government. The notion of public advocacy organizations, like the American Civil Liberties Union or even the Sierra Club, holds little appeal. “We never fought for our rights, we were always fighting for our freedom,” said Ragnar Adalsteinsson, one of Iceland´s top human rights attorneys, speaking of the centuries-long struggle to win independence from neighboring powers, which came in 1944.
This lack of awareness of the right of personal freedoms like privacy, as he sees it, is what allowed the Icelandic government 30 years ago to create ID numbers for every citizen that are used in every business transaction, from renting a video to borrowing a library book.
This obliviousness, Adalsteins son said, could also mean that citizens have not caught on yet to po tential dangers of a new gene cul ture, such as genetic discrimination. Some fear that the information contained within genes, such as susceptibility to fatal diseases and mental illnesses, could eventually be used against people if the information does not remain private. Companies may not want to hire someone who may develop a debilitating disease. Some repercussions could be personal Some people, in the future, may not be considered “marriage material” if they are genetically predisposed to an illness like depression.
DeCODE´s leadership, Adalsteinsson said, came up with the perfect place for this experiment a country where data and privacy protection is not much of an issue.
Outside the capital, where intellectuals debate the merits of de Code, ordinary Icelanders say if their country can help mankind it should. Oddny Josefsdottir, who runs a luncheonette and food mart at an Esso Station on Highway 35 in Annossysla, about 50 miles south of Reykjavik, is one of them.
Josefsdottir grabs a hot dog and the daily paper, the Morgunbladid, for a quick lunch break. She wears her auburn hair cropped short and sports simple clothes – jeans and a cotton top. Her eyes are clear blue. Many tourists bound for the conti nent via cheap plane tickets stop at her place for a quick bite. With only one day in Iceland, most head to one spot – Geysir, the hot spring from which everyone else draws the name. She and her husband run the store and own a farm nearby, where they raise sheep and horses. “But we have no time to ride,” she complains. “We are too busy.”
Has she heard of the company deCODE? “Oh, everyone in Iceland knows about that,” she said with a sigh.
So what does she think about participating in a database for genetic research? “I think it´s good,” she said. “There are so many terrible diseases. We have to do something about it. If we can help, well, I think that´s good.”
Caption: Icelandic children at a day care in Reykjavík.
PHOTOS BY JON NASO/THE STAR-LEDGER
THE DNA FACTORY
Unadorned with any logo save for a tiny inscription on its front door, a nondescript beige office building on an industrial road called Lynghals at the city´s edge contains all that´s needed to fulfill the DNA dreams of Kari Stefans son. It certainly doesn´t look like the place that contains the office of one the richest men in Iceland. Nor does it look like headquarters for this country´s fastest-growing company.
Inside, it´s a different story. The vitality is almost palpable. Artwork is splashed across walls in every corridor. Raucous laughter spills out of a cafeteria as well as the aroma of a high-quality coffee blend.
Like a hive of bees, different groups dedicated to separate tasks are spread throughout the building, all bent on the same overall goal. In the labs, where deCODE´s 300 employees sport sparkling lab coats, it is all business. In room after room, visitors do not hear any background music or light banter among these extremely focused workers.
This factory of the future has one product – DNA. Here, the goal is to find genes that lead to a specific disease – any one of 25 that deCODE is interested in tracking. The trick is to compare samples with others to find patterns among families. The more comparisons that can be done, the more reliable the results. The matter at the heart of the operation – DNA extracted from blood samples – moves through a series of labs, in assembly-line fashion.
“What you see here is the best of the best, state of the art,” said Eirikur Sigurdsson, a communications specialist for deCODE who holds a master´s degree in molecular biology. “To be here is to do something important.”
It all starts in a room with a view of blue-gray mountains and an ever-changing sky where a group of lab workers, among them Signy Si gurdardottir, a mechanical engineering student from the University of Iceland, fishes out DNA from a solution in a multistep process that separates the clear genetic goop from human blood. “I´m still not sure what I want to do with my life, but this seems pretty interesting,” Sigurdardottir said.
Stefansson has worked hard to convince his countrymen that part of the bounty of creating deCODE is a biotech industry in the country, bringing with it high-level jobs.
Like explorers, these scientists are looking through the microscoically minute terrain of genomes, which contain the entire set of operating instructions found at the core of most human cells. The genome´s letters form a code – composed of 3.2 billion pairs of chemi cal bases – that uses symbols to communicate meaning, both by their location in the overall order and their physical proximity to other symbols in the group.
The sequencing conducted by the researchers can be likened to mapping out a route from Newark to Nova Scotia, walking the entire distance and recording every ridge and valley.
Using multimillion-dollar batteries of gene sequencing machines, the researchers characterize each of the 40,000 genetic samples collected so far, identifying each one´s unique sequence of base pairs, chemicals that confer what is known as individuality. Then the fun begins.
Stefansson has contended that gene-hunting among Icelandic DNA should be easier here than anywhere else. Scientists believe many diseases begin with genetic mistakes known as mutations. Ste fansson wants to find the genetic roots of common diseases. The basic idea is this If Icelandic people possess similar genetic backgrounds, their DNA should be so similar that their disease mutations will stick out like sore thumbs.
DeCODE scientists combine DNA samples with comprehensive genealogical histories. This way, they can track these so-called pre-disposition genes over successive generations. “In Iceland, it is possible to construct these large and distant relationships so you can go from the person that you had initially identified with the disease to a person who is a cousin six times removed who also has the disease,” said Lindpaintner, the Roche executive and a cardiologist. “It gives you a very high discriminatory power to actually find the gene.”
Historians estimate that, over time, about 750,000 Icelanders have existed. Records describing about 650,000 of them are contained in the genealogical database that deCODE has gained access to.
Genealogy is an obsession in Iceland, with good reason. The country is devoid of the ancient public architecture that so distinguishes the landscape of the rest of Europe, but its 276,365 present citizens cling like drowning people to the rafts of history and culture.
Their genealogical tables trace family bloodlines back a thousand years. Where other cultures have cathedrals, Icelanders have their epic poetry, encapsulating and enshrining their ideals and anguish in its highly complex story lines and meters, known to every schoolchild in the land.
Like the rest of his countrymen, Kari Stefansson has an abiding interest in Icelandic history. Born in the capital to a popular radio newscaster and a homemaker and raised with four siblings here, he attended the university then went on to spend 20 years in the United States studying brain-based diseases at the University of Chicago and Harvard University. In 1994, as chief of the division of neuropatho logy at Beth Israel Deaconess Hospital in Boston, he became consumed with the connection between genes and disease.
At that time, he was a faculty member and physician-researcher at Harvard University Medical School, specializing in the treatment of patients with multiple scle rosis. This incurable nervous system disorder often causes paralysis and partial loss of vision.
Multiple sclerosis may be caused by a virus that infects people before they are 15 years old. There also may be a genetic component – certain genes that control the body´s immune system are associated with multiple sclerosis.
LOST CONFIDENCE
To be a part of a program that might find a cure for multiple sclerosis, Sigubjorg Armannsdottir was game to explore any frontier – genetic or otherwise, a show of bravado she now regrets. As an activist in an Icelandic multiple sclerosis patient advocacy group, Armannsdottir met Stefansson on one of his trips to the capital. Forceful, well-spoken and magnetic with his shock of white, fashionably disheveled hair, Stefansson persuaded the group to participate in a gene study.
“Kari said, ´I am going to find the gene,´” said the 51-year-old Armannsdottir, who has used a wheelchair since 1988. “We got all our families to participate.”
During the course of the past five years, she has lost confidence in Stefansson, and ultimately, his company. She doesn´t believe that a gene for the disease exists. She says she has given away precious matter merely for Stefansson´s commercial gain – part of the de CODE business strategy is to sell genetic information to insurance companies and offer up DNA sup plies as the basis for partnerships with drug companies.
“You should be careful about giving people false hope,” she said, speaking in hushed tones over coffee in the city´s historic district. Like others in Iceland who oppose deCODE, she is afraid to speak too loudly about Stefansson. The coun try is small and the company politically powerful. People like Arman nsdottir fear repercussions. Perhaps, she says, her genetic information will be used to harm future generations of relatives.
Nearly two years ago, she asked for the help of government authorities to retrieve her DNA sample from deCODE so that it could be destroyed. So far, she has been unsuccessful. “When you wake up and realize it´s too late, that the data will never go away, it´s a nightmar ish feeling,” she said.
At the same time Stefansson was working with multiple sclerosis patients, he realized that the prac tice of biological research was changing to look much more like the “big science” investigations of current physics work. “I realized it was going to be very difficult to do meaningful research in a small lab in a university,” Stefansson said last fall during a conversation in Boston during which he jumped between his fascination with the poet William Carlos Williams and the rightful uses of science.
“I saw the need to build up a larger unit for the work that I was doing. One of the ways to do that was to build up a large company,” he said.
He circulated a business plan to venture capitalists seeking to raise $12 million for a for-profit company built around the idea of studying Icelandic genes and marketing the information.
The big powerhouses of human genetics, both in universities and industry, he argued, were searching for “appropriate populations” on which to apply the new tools of bio-technology, he wrote, from gene sequencing machines to “bioinfor matic” computer programs that merge statistics with biology. The race, he said, would go to the swift, not the clever The next big steps in the genetics of human diseases would be taken by those who had access to the most suitable populations rather than by those who asked new questions or developed new technologies.
Using words that would ring across Iceland for years to come, he said that the Icelanders are a genetically homogeneous people and displayed strong “founder” effects – meaning they bore the genetic imprints of their forefathers, muta tions and all, to a stronger degree than other genetically mixed peoples because of geographic isolation and the natural disasters that trimmed the population in successive waves.
Returning home, he said, was inevitable. “This is something that simply started to grow in me, be cause I am Iceland, my people have lived in Iceland for 1100 years,” he said. “I was always on the way home.”
Stefansson took his idea to 12 venture capitalists around the world; seven of them provided the $12 million he needed. By 1996, Ste fansson was on his way. While he was working to establish his company, he made headlines about ad vances in multiple sclerosis research, which yielded clues about possibly important areas of genes. He never actually came up with the gene. But he used the enthusiasm of multiple sclerosis patients to build excitement for his project.
THE DIVERSITY QUESTION
One of those paying attention was Einar Arnason, a scientist who for years had been listening closely to Stefansson´s assertions that Icelanders were uniquely homogeneous. Arnason, whose eyes crinkle like Santa Claus when he is amused, thought the idea seemed odd.
To Arnason, a respected population geneticist at the University of Iceland, the story of the founding of Iceland, he knew from his knowledge of history, was controversial. No one seemed to be quite sure whether it was Nordic, or a mix of Nordic and Celtic influences, or whatever else. As for Stefansson´s pronouncements of population bottlenecks such as those created by Iceland´s topography and history, and the so-called founder ef fects, Arnason was suspicious.
He began combing the scientific literature. From his knowledge of genetics, which was substantial, he had never known Icelandic genes to be especially homogeneous.
The matter is vital because it bears very closely on whether de CODE´s gene-sleuthing techniques will work.
His investigation would take more than a year. In a piece published in the August issue of Na ture Genetics, Arnason posited that Icelanders are as diverse as many populations in Europe. The paper, written by Arnason and other geneticists at the University of Iceland, presents evidence that the original founding population was genetically quite diverse. Using a 1973 study of 11 blood groups and enzymes, the scientists calculated the level of genetic diversity in Iceland. It closely resembles, they found, Denmark, England, Norway and Scotland.
“Our results show that the Icelandic population does not fulfill these criteria and therefore Iceland is not an ideal population,” Arnason said in an interview. “They could just as well do their stuff in Switzerland or New Jersey.”
What´s more, Arnason said, his analysis matches the data in a paper by Stefansson and Jeff Gulcher, one of DeCODE´s top scientists.
DeCODE, however, insists that its conclusion is based on studying a larger group than Arnason did. Arnason rejects that interpretation and is ready to argue it out in the scientific literature where, he said, the debate belongs.
Stefansson repudiates the at tacks of critics, scientific and other wise, as being the product of envy. “These are people who wish they had thought of these ideas themselves, it´s all about envy.”
The only thing that Arnason en vies, he said, is the spectacular new lab building being constructed by deCODE on a piece of property next to the University of Iceland. It will house university faculty conducting joint research with the genetics firm. Arnason and other colleagues in the university´s own Institute of Biology department have been waiting for more than a decade for new quarters – they are currently housed off campus in a ramshackle, labyrinthine building once used for tanning sheepskins.
The danger in treating the Icelanders as a homogeneous population, if they are really not, is that the technique used to search for disease genes is more likely to generate false positives, pointing to specific regions of the chromo somes that are unrelated to the disease, says Arnason. The work, he believes, will not provide useful information because it is based on a flawed premise.
Scientists at deCODE dispute this. Arnason´s work, however, ap pears to have had at least one ef fect so far. Stefansson describes Icelanders differently from how he used to. He and his countrymen are now “relatively homogenous.”
ENTER THE GOVERNMENT
In deCODE´s approach, the recipe for a full analysis of Icelandic genes calls for three ingredients – DNA samples, extensive family histories and detailed medical records. To gain access to all three required the help of the legislature.
Tomas Zoega, a rosy-cheek psychiatrist at the concrete tower known as the Landspitalinn, the country´s gloomy central mental hospital, was one of the first to learn what Stefansson planned to do. Invited to a meeting at the state Ministry of Health in late March of 1998, Zoega and 10 other leading physicians were seated at a conference table. Over coffee and cake, they were apprised of a government plan to create a centralized medical database to be operated by a private company.
It was clear that some of the people in the room were already familiar with the proposal, Zoega said. Right away, he worried aloud about the privacy of his patients and whether they wanted any of their treatment records in the hands of a private company. Many of them, he knew, would be physically incapable of defending their rights in public.
In about a week´s time, the rest of Iceland learned of the plan. In the week before Easter Week, a major family holiday event in Christian Iceland, and close to the end of the legislative session, a bill was introduced into the Icelandic Parliament, called simply “A Bill on Medical Databases.”
“To the complete surprise of Iceland´s scientific and medical community, the bill proposed that an unnamed licensee, which everyone knew to be deCODE, would be given the right to install a computer terminal in every physician´s office in Iceland, collect disease and prescription information on each patient who visited, combine this information with their medical history as maintained by the national health care system, and build a centralized database that took these medical histories; and inter-linked them with deCODE´s computerized genealogies and their newly processed genetic information,” said Mike Fortun, the bioethicist. “And deCODE would have exclusive, monopoly rights to this database for 12 years.”
In exchange, the company agreed to pay the country $12 million a year. Also, any drugs developed as a result of research there would be given to Icelanders for free, Stefansson said. “Glass beads for the natives,” sighed Sigurdson, the science historian.
Since the proposal first was aired, it´s been a long and tangled tale. After all, this is not a country composed of faint-hearted people – the two most in-demand delica cies on Viking holidays are ram testicles and shark that has been rotting in the ground for four months.
A protest group emerged practically overnight comprising physicians, scientists and others.
“It is a dispute between a wealthy businessman and idealists, between government and scientists, between powerful people and a voluntary organization, between the country´s largest firm and a grassroots movement, between one of the world´s largest pharmaceuti cal firms and one of the world´s smallest nations,” said Petur Hauksson, the sad-faced, gentle-spoken psychiatrist who founded Mannvernd, a nonprofit human rights group, in October 1998.
The initial bill was stopped by Mannvernd. Most objectionable, the group said, was the law´s as sumption of “presumed consent” – the state would automatically assume that a record would be entered into the database, unless instructed otherwise.
The group demanded that legislators insert a clause that would allow citizens to “opt out” of the database if they so desired.
After several delays, Iceland´s Althing – the world´s oldest democratic legislature – approved the database bill on Dec. 17, 1998, with 37 in favor and 20 against, and six members absent. The notion of opting out was included because of pressure exerted by critics.
Last January, the Icelandic government granted deCODE a 12-year license to operate the data base and market the information it contains together with the company´s own genomics data of the Icelandic population. The information is to be encrypted – the data of individual records will be made incomprehensible by a computer program to those without a decoder.
Many don´t believe those protections will be adequate. “I know what those records hold,” said Anna Atladottir, a 50-year-old medical records secretary at the University of Iceland Hospital. “The pa ternity of your children; incidences of mental illness. You wouldn´t be lieve what is in these records.”
She has elected to opt out of the database, joining about 18,000 others, and persuaded most of her entire extended family to do so, as well. In such a small country, where everyone knows everyone else, she said, it wouldn´t take deCODE – or anyone else – much to figure out who was who, even if the names were encrypted. “All you need is a little information and you can figure out a lot,” she said.
Six months ago, the Icelandic Medical Association embarked on discussions to resolve its members´ basic concern about the law, insisting that the transfer of data should be based on informed, rather than presumed, consent. In August, discussions between the parties broke off.
Furthermore, opponents accused the company, which had launched itself on the Nasdaq stock exchange in July, of painting an overly optimistic picture of the discussion to shareholders. De CODE´s English translation news release, medical association members said, gave a more positive slant to the discussions than was actually true.
Stefansson, in response, said his firm does not need the association´s approval to proceed with the database on the basis of presumed consent. He predicted that negotiations would ultimately work out.
LAW DRAWS A CHALLENGE
Still, a showdown looms – most Icelandic doctors oppose presumed consent and have said they will not hand over records that are not already in hospital databases.
Early this year, members of Mannvernd announced their inten tion to file suit against the Icelandic government to test the constitutionality of the health care da tabase act. “If we win our lawsuits, it will derail the database project because the government would be forced to change the act,” Hauks son said. “If not, the European Human Rights Court in Strasbourg will be asked to decide whether the act is in accordance with the Human Rights Declaration.”
Stefansson insists his database and the overall goals of his company are popular in Iceland. Hauksson agrees “A majority of the public seems not to care I couldn´t care less, they say, whether they use my sore throat. This extreme individuality shows a disregard for those seriously ill who can be discriminated against. We who oppose – physicians, scientists and concerned public – get great support from patients and others who are not willing to stand forward in opposition to the government, their health professionals, and other powerful forces.”
Stefansson has still not been able to use the medical records database – it doesn´t exist yet. The records are slowly being stored in digitized form, he said. He reported that his scientists continue to make progress, finding success in using the blood samples taken from disease patient groups over time. The company said it has already isolated genetic sequences within certain Icelandic families in a host of hereditary illnesses including schizophrenia, a common form of Alzheimer´s disease, stroke and osteoarthritis.
“They haven´t found any gene and until they do they cannot claim that one exists,” scoffed Arnason at the company´s research that refers to mapping a locus, a chromosomal region of unspecified size. “They have to bring out the evidence for their claims and lay the hard facts on the table. If indeed they do have any hard facts.” Roche officials said they are ec static with the pace of progress there, describing it as setting a “gold standard” for the industry.
DeCODE has made six contractually agreed-to research discoveries they refer to as “milestones” with Roche and four more are expected to be announced in the coming year, Roche officials said. According to documents filed with the U.S. Securities and Exchange Commission, deCODE had received $34 million in research funding and milestone payments from Roche as of March 31.
DeCODE has met with further criticism, however, for the consent forms it gives to patients willing to give blood for disease studies. Though described in a title on the form as “informed consent,” the document actually comes more under the heading of “broad consent,” experts said, as it asks patients to sign on for a study, agreeing that the material donated could be used in ways that can´t be predicted at the present time. In the United States, such a form would be outside the realm of standard practices, officials said.
Noatun, a centralized, private facility that collects blood for de CODE, is located in a bland strip mall on the outskirts of this modern city. Here dozens of Icelanders come daily in an outing that more resembles a family picnic than a trip to a diagnostic lab. These adults, either mothers, fathers, grandparents, aunts, uncles or cousins, have been summoned by a telephone call.
They´ve been asked by deCODE employees to participate in a disease study. DeCODE´s workers get the names from family doctors who have teamed up with the genetics firm.
The research subjects roll up their sleeves and in a matter of minutes have donated about a test tube´s worth of blood.
Blood is being drawn also at the many government-run health clinics located all over the country. And there´s no sign of it letting up.
“What haunts me about all this is that we have a huge pharmaceutical company involved here that has no real ties to Iceland and could someday just move on to some other small country,” said Sveinn Gudmundsson, a ruddy-faced physician who manages the spotless, state-run blood bank in the capital and does not allow its samples to go to deCODE. “I feel as if we are being drained. Do we really want to see Iceland bled dry?”
5. CHRONOLOGY: Iceland’s historical time line
9th century: Iceland’s first inhabitants were Irish monks followed by Iceland’s first permanent settlers who came from Norway. This was the Age of Settlement, traditionally defined as the period between 870 and 930, when political strife on the Scandinavian mainland caused many to flee.
999: Iceland’s settlers opted for a parliamentary system of government. Iceland became a Christian country and flourished during the next century.
13th century: The enlightened period of peace that had lasted 200 years ended. The country entered the infamous Sturlung Age, a turbulent era of political treachery and violence. The opportunistic Norwegian king Hakon Hakonarson promptly stepped in, and Iceland became a Norwegian province to be plundered mercilessly.
14th century: The volcano Mt. Hekla erupted in 1300, 1341 and 1389, causing widespread death and destruction. Recurring epidemics also plagued the country, and the Black Death that struck Norway in 1349 effectively cut off trade and supplies. Iceland was brought under Danish rule.
16th century: Disputes between church and state resulted in the Reformation of 1550, and the imposing of Lutheranism as the country’s religious doctrine. Throughout the next two centuries, Iceland was crippled by Danish profiteering.
1874: Denmark’s grip on Iceland was broken when Iceland drafted a constitution and was permitted to handle its own domestic matters.
1918: Iceland was released from Danish rule, making it an independent state within the Kingdom of Denmark, with Copenhagen retaining responsibility for defense and foreign affairs.
1940: Denmark was occupied by Germany.
1944: Iceland realized that the Kingdom was in no position to continue overseeing its affairs and, a year later, requested independence. It was granted.
1970s: The British incurred Icelandic wrath when they refused to recognize Iceland’s expanded territorial fishing rights. For a few years, fights between Icelandic gunships and British warships during the so-called Cod Wars became a regular feature of the fishing season.
1980s-90s: Iceland’s economy has looked shaky; fishing quotas have been cut back and unemployment has risen.
2000: Hoping to reverse the economic downturn, the government approved an unprecedented deal with the corporation deCODE Genetics, allowing it to database detailed genetic information and eventually the DNA coding of all 270,000 Icelanders. This relatively homogenous gene pool of blue-eyed, blonde descendants of a few Viking colonists promises to provide insight into genetic diseases as well as a steady income for the country; hundreds of millions of US dollars are already rolling in.
CREDIT: 1. Yahoo finance/THE STAR-LEDGER
2. DAMIKO G. MORRIS, THE STAR-LEDGER
3. Lonely Planet World Guide/THE STAR-LEDGER
Copyright © 2000 The Star-Ledger. All rights reserved. Reprinted with permission.
“Chance favors the prepared mind.”
— Louis Pasteur
Kitta MacPherson
