Putting A Price on Icelanders

Reykjavik-based deCode Genetics has combined the health records of every Icelander, living or dead, with their genetic and genealogical data -- and plans to sell access to it

Colin Woodard / SF Chronicle 23oct00

Their homeland is a primeval island on the fringe of the Arctic Circle, a wind-battered land of frigid deserts, towering glaciers, active volcanoes and barren lava fields.

Icelanders have built a prosperous nation here on the back of a single industry: fishing, which still accounts for more than 50 percent of Iceland's economy.

Now, Icelanders have discovered another profitable resource in their own genetic heritage and historic isolation. The trouble has been establishing a national consensus on how to go about exploiting one of the most valuable treasures in the modern era of genomic medicine.

Earlier this year, Iceland's government granted a license to a private company to set up a computerized database containing the health care records of the entire nation. These records, which date back to 1915, include details of laboratory tests, disease diagnoses, treatments and outcomes of virtually every Icelander, living or dead.

The company, Reykjavik-based deCode Genetics, will cross-reference the health care records with genealogical and genetic databases in a combined processing system. Subscribers will pay to use the unique system to research possible links between disease and genetic inheritance.

The license and the health database law that made it possible have been the subject of acrimonious debate here and abroad about ethics, privacy, and the human genome.

The Icelandic Medical Association has criticized the plan as a serious violation of personal privacy, one that is damaging to the doctor-patient relationship. The association and deCode have met to resolve ethical differences, but so far no agreement has been reached.

One physician-led citizens group, called Mannvernd, has said it intends to sue the government and deCode to test the constitutionality of the licensing arrangement.

``Iceland's health care information has been commercialized and our genetic information has been turned into a commodity,'' says Petur Hauksson, a clinical psychiatrist and chairman of Mannvernd.

The main reason Iceland is so attractive to gene hunters is that the country has experienced little immigration within the past 1,100 years. Almost all of the 275,000 people living here are descended from a small group of ninth century Norse and Celtic settlers.

That creates an isolated, homogenous population with little of the genetic ``background noise'' common in other societies. That greatly simplifies the search for genetic mutations and links to diseases.

Icelanders are also passionate genealogists, and researching family trees has long been a national pastime. By gathering genealogical documents into a computerized database, deCode can trace the family relationships of almost every person who has ever lived here.

With the consent of patients, deCode has begun collecting blood samples from thousands of Icelanders. The DNA in those samples is isolated and genotyped and entered into a genetic database.

Ultimately, the company will be able to cross-reference the health care, genealogical and genetic information of many of the country's citizens in an effort to identify disease genes. The key information will be encrypted by a government-appointed body to protect individual privacy.

``The reason we have medicine as it exists today is because our parents and grandparents supported and participated in medical research,'' says deCode founder and president Kari Stefansson. ``I'm convinced that most people in this world are willing to make sacrifices when it comes to our medical privacy to make sure that we can advance medicine.''

DeCode says its combined data processing system could assist in developing new and more effective treatments for inherited diseases. It has also helped attract dozens of Icelandic scientists back to their home country, fueling an increasing high-tech medical sector.

The company, which is registered in Delaware, will pay Iceland $12 million for the exclusive right to create and operate the health care database for 12 years. DeCode also has a $200 million research collaboration with the Swiss pharmaceutical giant Hoffmann-La Roche, which is deCode's largest shareholder with 13.3 percent of the company's stock.

The company enjoys the support of more than 75 percent of Iceland's population, according to opinion polls, and most of the country's political leaders.

In July, deCode's initial public stock offering raised gross proceeds of $198.7 million. The stock, however, has not exactly turned Wall Street on its ear -- it has recently been trading around $18-$20 a share, about the same as when it debuted.

``It's another stab in the dark for investors because it's really hard to pick which biotech companies will be successful,'' said analyst Steven Tuen of IPO Value Monitor in New York.

Opposition from Iceland's medical community focuses on several issues, mostly involving privacy and profit.

One-third of the country's physicians have declared that they will not turn their patients' records over to deCode, despite the company's assurances that individual identities will be protected.

``Nobody was asked if they want their health information released because the law says you don't have to,'' said Gudmundur Bjornsson, a hospital director and former head of the Icelandic Medical Association. ``We offered to help deCode obtain the informed consent of every Icelander alive, but they said no.''

Icelanders can opt out of the health care database by filing special paperwork, and nearly 20,000 have done so. But those who do not or cannot file -- including the deceased, newly born or mentally ill

--are presumed to give their consent.

As in the United States, genealogical information is considered to be in the public domain. DeCode does obtain informed consent to take blood samples, sequence DNA and cross-reference that information with the other two databases in the system.

Iceland has been criticized by many bioethicists for its use of ``presumed consent'' in the creation of the health care database. But Stefansson says this is in accordance with research practices throughout the western world.

``In the United States you have enormous databases containing the health records of millions of individuals,'' he said. ``They're also based on presumed consent.''

George Annas, head of the health law department at Boston University's School of Public Health, noted that medical records in the United States can be used without consent provided that individuals cannot be identified by researchers. Use of children's records is generally considered unethical, he said.

``What's unusual here is that Stefansson will be rolling that information together with genetic and genealogical data,'' Annas said. ``He doesn't know where that's going to take him.''

For the medical ethics field, Iceland is in uncharted waters.

``Iceland gives the whole world an opportunity to think through issues that nobody has been able to do yet,'' Annas added. ``It's a good opportunity at fairly low cost to try to sort through these issues.''