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A Big Fish in a Small Gene Pool



                                          Friday, June 5, 1998 

            COLUMN ONE 
            A Big Fish in a Small Gene Pool 
              Undeterred by claims of 'bio-piracy,' a Harvard
            professor turned 'DNA prospector' in remote Iceland is
            leading a potentially lucrative attempt to conquer
            hereditary diseases. 
            By MARY WILLIAMS WALSH, Times Staff Writer
               
                      REYKJAVIK, Iceland--The warrior-priests
                      who brought Christianity to this remote island
                  a millennium ago must have been visionaries, at
                  least of the sort who could foresee any kind of a
                  future in such forbidding fields of the Lord. But it's
                  a stretch to say they might have known that the
                  exhaustive birth and death records they began to
                  compile on the faithful might one day be the
                  makings of a multimillion-dollar biotechnology
                  business. 
                       Yet such are the vagaries of DNA prospecting
                  here in the North Atlantic. A rare combination of
                  factors in Iceland--a national fascination with
                  genealogy, a highly homogeneous population, a past
                  fraught with disease and disaster, and one man's
                  entrepreneurial spirit--is transforming this small
                  land into a unique and potentially lucrative font of
                  genetic learning. 
                       "We have an opportunity to do the best human
                  genetics done anywhere in the world," said Kari
                  Stefansson, a former Harvard Medical School
                  professor turned "DNA prospector." 
                       His words may sound outlandish, perhaps, but
                  they are matched by an outsized dream, one of
                  gathering the entire genealogy of his homeland and
                  cross-referencing it with Iceland's excellent
                  collection of medical records dating to 1915. 
                       To this one-of-a-kind database would be added
                  the DNA samples of countless Icelandic donors,
                  plus the information gleaned from an extraordinary
                  collection of tissue samples, preserved in wax
                  blocks, of every Icelander who has been autopsied
                  since the 1930s. 
                       The purpose: to identify the precise genetic
                  causes of the 3,000 to 4,000 diseases that are
                  believed to be hereditary. Armed with that
                  information, pharmaceutical companies and others
                  presumably will have an easier time finding
                  treatments, diagnostic tests and preventive methods.

                       A population such as Iceland's is extremely
                  attractive to genetics researchers, who will travel
                  the Earth--increasingly, financed by biotechnology
                  companies--to study secluded peoples with high
                  incidence of disease. The reason: Disease-causing
                  genes are believed to stand out more clearly against
                  a uniform background than against one complicated
                  by ethnic mixing of the gene pool. 
                       But no one has attempted anything on the scale
                  of Stefansson's project, for which the
                  neuropathologist gave up a tenured professorship at
                  Harvard Medical School two years ago. 
                       "I have no regrets about leaving Harvard to do
                  this," said Stefansson, who was trying to determine
                  the genetic causes of multiple sclerosis before
                  returning to Iceland. 
                       "We are creating new knowledge," said
                  Stefansson, adding that the database will be
                  encoded for privacy. "We are building a new
                  industry in Iceland." 
                       Despite Stefansson's assurances of privacy, his
                  project has set alarm bells clanging here. Some
                  Icelanders fear that family health secrets could leak
                  out via his database and somehow be used against
                  them, perhaps by private insurers. 
                       In addition, some ethicists have begun alleging
                  that DNA prospectors like Stefansson are
                  committing a new offense they call "bio-piracy,"
                  exploiting remote peoples for their precious DNA,
                  which could lead to big-money drug patents or even
                  a Nobel prize. 

                       Drug Giant Is Enlisted; Analysts Take Notice

                       But such concerns have not deterred Stefansson,
                  who--with $12 million in venture capital in his
                  bank account two years ago--founded a company,
                  deCODE Genetics Inc., and equipped a research
                  lab that eclipses anything previously available at
                  Iceland's best hospitals. He has hired a staff of
                  nearly 200 and signed a multimillion-dollar
                  contract with the Swiss drug giant Hoffmann-La
                  Roche to seek the genes that are believed to cause
                  12 diseases. 
                       In the process, he has caught the eye of
                  biotechnology securities analysts, who expect his
                  start-up firm to go public within 12 months. 
                       "It's a company that's come a long way in a short
                  period of time," said Nick Woolf, an analyst at the
                  London investment banking house of BA Robertson
                  Stephens International. He called Stefansson's
                  arguments in favor of Iceland's special features
                  "compelling." 
                       Stefansson is looking for other big partners, but
                  in the meantime, the Hoffmann-La Roche agreement
                  has brought credibility to his project, as well as the
                  needed funding to study such well-known scourges
                  as schizophrenia, Alzheimer's disease, adult-onset
                  diabetes and stroke. 
                       Happily for Iceland, the terms stipulate that if
                  Stefansson's project gives rise to any treatments,
                  Icelanders will get them free. 
                       Although neither Stefansson nor Hoffmann-La
                  Roche will go into the details of the transaction,
                  both parties said it will be worth $200 million to
                  $300 million over five years, plus royalties, if
                  Stefansson's hunch is right that Iceland's unrivaled
                  attributes make it an irresistibly fertile hunting
                  ground for disease-causing genes. The total of all
                  such deals between pharmaceutical companies and
                  genomics firms has been estimated at about $2.4
                  billion as of last November. 
                       "We were very successful in convincing these
                  guys that we've got a very valuable asset,"
                  Stefansson said. "And I'm absolutely hellbent on
                  seeing to it that they're not disappointed." 

                       Iceland a Fertile Spot for Genetic Research 
                       So just what is this asset? Why would
                  Hoffmann-La Roche, and the other health-based
                  firms considering partnerships with Stefansson,
                  want to sink their millions into this treeless and
                  volcano-studded island sitting astride a fault line in
                  the North Atlantic? 
                       The answer has to do with Iceland's daunting
                  history of disease, isolation and natural disaster.
                  However awful these may have been to live
                  through, they turn out to be advantages when it
                  comes to genetic research. 
                       Few non-Icelanders have had the stomach to
                  move here since the Vikings first settled the island
                  in 874. Since then, the indigenous population has
                  twice been harshly "culled": A bubonic plague
                  outbreak in the 15th century wiped out more than
                  half the population, and a volcanic eruption in the
                  18th century caused widespread famine. 
                       These catastrophes severely reduced the number
                  of people for Icelanders to choose as their mates,
                  leaving today's population of 270,000 nearly
                  homogeneous. 
                       "If you choose two [Icelanders] in the 20th
                  century, it's very likely that they are distantly
                  related," said Hakon Gudbjartsson, chief computer
                  engineer for deCODE. "If you go back to the 15th
                  century, you can more or less connect everybody to
                  the same ancestors." 
                       Already, geneticists have scoured other odd
                  corners of the globe, studying small, inbred
                  populations and the diseases that afflict them. The
                  South Atlantic islanders of Tristan da Cunha have
                  been examined for the clues they may offer to
                  asthma researchers, for example, while the Pima
                  Indians of Arizona have been studied for diabetes.
                  In the most well-known example, the genetic
                  secrets of Huntington's disease were revealed
                  through research on an isolated community in
                  Venezuela. 
                       What makes Iceland superior even to these
                  geneticist-friendly outbacks, said Hoffmann-La
                  Roche research department spokesman Eckart
                  Gwinner, is its passion for genealogy and public
                  record-keeping. 
                       "You have, in Australia and in underdeveloped
                  countries, populations that are very homogeneous,"
                  he said. "But with them, you don't have the data.
                  Iceland has a unique situation concerning the
                  homogeneity of the population and the connection
                  with information coming from blood banks and
                  hospitals and so forth." 
                       As Stefansson tells it, his homeland's public
                  fascination with social data collection can be
                  traced to the 9th century, when Iceland established
                  Europe's first parliamentary democracy, complete
                  with courts, laws and penalties. One thing this early
                  political system didn't have was law enforcement,
                  so the earliest Icelanders had to rely on their
                  extended families to carry out any sentences the
                  courts handed down. 
                       "So, it was terribly important to know who was
                  related to you," Stefansson said. 
                       When the Roman Catholic proselytizers arrived
                  in their open boats, they improved upon this
                  record-keeping tendency by maintaining complete
                  birth, baptism, marriage and death registries at the
                  parish level. The Lutherans kept up the habit after
                  the Protestant Reformation, when theirs became the
                  state religion. 
                       These church registries are the building blocks
                  of all genealogical research in Iceland, along with
                  such modern-day aids as census tracts, daily
                  genealogy columns in the newspapers and the huge
                  supply of genealogy how-to books and software
                  available here. 
                       Gudbjartsson, who is overseeing the creation of
                  deCODE's database, said that within three years the
                  company will have acquired and computerized all
                  such Icelandic family data--insofar as it
                  exists--going back to the 17th century. 
                       While his department does that, deCODE's
                  laboratory researchers have begun receiving blood
                  samples from Icelandic medical patients and
                  extracting the DNA they contain. 
                       The DNA, which can be preserved indefinitely,
                  will be cross-indexed against the genealogy
                  database. First, however, both the DNA and the
                  family trees must be encrypted off-premises by a
                  government Data Protection Commission to protect
                  the participants' privacy. 
                       Stefansson, who says DNA-donor anonymity is
                  the key to maintaining Icelanders' goodwill and
                  cooperation, has warned participants that they
                  won't get individual diagnoses or medical advice in
                  exchange for their blood samples. 
                       "We're discovering the qualities of the group,
                  not of the individual," he said. 
                       Still, Stefansson's activities and the deeper
                  issues they raise have shaken up this
                  mono-industrial nation, where the main scientific
                  preoccupation up until now has been the careful
                  management of fish stocks. 
                       "It was like dropping a bomb" when deCODE
                  appeared on the scene, said Alfred Arnason, chief
                  geneticist at the Reykjavik blood bank. 
                       Arnason, who is closely watching Stefansson's
                  project, said he can see the value in acquiring,
                  cross-referencing and encrypting Iceland's
                  genealogical and medical data. What he cannot
                  understand is how Stefansson can sell this
                  information to companies like Hoffmann-La Roche
                  without making it proprietary. 
                       And if Stefansson is allowed to copyright his
                  database, Arnason said, what will become of the
                  other scientists who now freely use Iceland's
                  national health records for research, lower in
                  profile and smaller in scope though their work may
                  be? What will happen if Stefansson's industrial
                  clients refrain from publishing their findings until
                  they can secure patent rights? 
                       "That would hinder science, not enhance it,"
                  Arnason said. "If he wants to chase genes, that's all
                  right. Everybody is chasing genes nowadays. But
                  I'm in favor of everybody having the same right to
                  do their studies and not to monopolize data." 
                       Arnason and about 200 other Icelandic scientists
                  recently sent an open letter to the government in
                  Reykjavik urging a go-slow approach on regulating
                  DNA prospecting. 
                       Stefansson, for his part, said he understands the
                  misgivings about the increasing role of private
                  industry in medical research. But he argued that
                  human genetics research has become so costly that
                  it can't progress without the big grants and
                  enormous pools of shared data that only the private
                  sector can provide. 
                       "The classical university labs are simply too
                  small to do advanced research anymore," he said,
                  recalling his own work on multiple sclerosis at
                  Harvard. "The only way I saw it financially
                  possible [to continue] would be to establish a
                  company." 
                       And, despite the unease Stefansson has aroused
                  in the Icelandic scientific community, the public
                  here seems well disposed toward his project--to
                  say nothing of the jobs, fame and economic
                  diversification it could mean for Iceland. 
                       "I view this agreement [between deCODE and
                  Hoffmann-La Roche] as a huge step toward
                  securing high-technology industries an important
                  role in the Icelandic economy," Iceland's prime
                  minister, David Oddsson, said in February when
                  the deal was announced. Oddsson added that "the
                  government of Iceland will do its best" to create a
                  good working environment for Stefansson's
                  research. 
                       And after a recent television documentary about
                  deCODE aired here, 70% of the callers to the
                  station's opinion hotline said they likewise
                  supported Stefansson's work. 

                       Team Looks Back at Several Generations 
                       In his lab, where panoramic windows overlook
                  an otherworldly landscape of treeless mountains
                  rising out of the sea, staff geneticist Hreinn
                  Stefansson--no relation, or at least not a close one,
                  to Kari--demonstrated the way deCODE hopes to
                  use Iceland's special qualities to identify genes. 
                       First, he called up the coded names of several
                  generations of sick Icelanders on a computer
                  screen. 
                       "This is a great tool for us, like an overview of
                  the disease," he said, scrolling through a lengthy
                  family tree in which the sick people appear as
                  black dots, the well people as white dots. 
                       Once a researcher like Hreinn Stefansson has
                  found an extended family that looks promising, he
                  or she takes the encrypted names back to the
                  government Data Protection Commission, which
                  decodes them and contacts the patients' physicians,
                  asking for blood samples from both patients and
                  disease-free relatives. Although Kari Stefansson
                  and his staff are not involved in this step, the
                  bio-entrepreneur said he has heard of only two
                  families so far that said no when approached. 
                       The Data Protection Commission then
                  reencrypts the blood samples and returns them to
                  deCODE, which begins the process of extracting
                  the DNA. Next, scanners analyze the DNA,
                  comparing the genetic patterns of the sick and the
                  disease-free relatives. These findings are sent to
                  deCODE's statistical department, which uses them
                  to calculate the probabilities of damaged genes
                  occurring in certain positions on the chromosomes. 
                       Using these methods, Kari Stefansson said, his
                  staff has so far been able to "map" some of the
                  genes involved in multiple sclerosis; psoriasis;
                  preeclampsia, a condition marked by dangerously
                  high blood pressure during pregnancy; and familial
                  essential tremor, a condition which causes
                  uncontrollable trembling in the elderly. "Mapping"
                  a gene means narrowing the number of places
                  where it might appear on a chromosome from about
                  3 million to a couple hundred thousand. 
                       Much more work must be done before the
                  individual genes can be identified, a complicated
                  process in diseases where more than one gene is
                  involved. But Hreinn Stefansson said the speed
                  with which deCODE was able to identify the
                  location, or "locus," of the familial essential tremor
                  gene showed how powerful deCODE's methods
                  are: The search took the lab less than three months. 
                       "We were very happy," he said, "because many
                  people had been working on this disease for years,
                  and they hadn't been able to find the locus." 

                  
                  Copyright Los Angeles Times