Iceland’s DeCode Genetics Struggles Toward Goal of A Nationwide Medical Records Database

The gene-hunting biotechnology company DeCode Genetics may be best known for its quest to establish and commercialize a database of the personal medical records of all the citizens of Iceland (see “Iceland’s Dilemma: Privacy vs. Progress,” available at www.cio.com/printlinks).

But today, three years after Iceland’s Ministry of Health granted an exclusive license to DeCode to create the Icelandic Health Sector Database, it remains empty.

Delays in obtaining necessary government approval, continuing opposition from doctors and financial struggles at DeCode are raising doubts about the project’s viability. “The impression of everyone here is that the database will not be a reality,” says Steindor Erlingsson, a historian and author of Our Genes, a recent book about DeCode that was published in Iceland.

Under the 1998 law establishing the health record database, DeCode does not need individual consent for use of private medical data, but the database must meet security and privacy standards set by the government’s Data Protection Commission.

The problem of personal identification of information from the database remains “most challenging and most urgent to curb,” says Hordur Helgi Helgason, deputy commissioner of the Data Protection Commission. Helgason says that the commission has received and evaluated about half of the material it will want to examine to determine whether DeCode’s database design adequately protects Icelanders’ private records.

Helgason says DeCode’s delivery of specifics on the database plan has been slower than either the government or the company expected. Changes to the database structure proposed by DeCode have further slowed the approval process.

Beyond this process, many of Iceland’s doctors are resistant to the Health Sector Database, even though the Icelandic Medical Association won a concession in August 2001, when DeCode promised to find a way to make data entry reversible at a patient’s request.

Dr. Petur Hauksson, chairman of the opposition group Mannvernd, says that despite the agreement, many doctors remain opposed to it. “It will cause an uproar in the hospitals if it’s forced through,” Hauksson says. The database can be saved, he says, but only if Iceland will change the law to “ask consent, and tell [Icelanders] what will happen to the information. With cooperation this could be done and will be a valuable resource.”

At DeCode, delays in establishing the national database have not slowed gene-hunting efforts. Through direct collaborations with doctors, DeCode has collected disease data and DNA samples, with full consent, from 80,000 Icelanders?or close to one-third of the population. Uniting clinical and genetic information with publicly available genealogical data, the company used its proprietary software to identify genes involved in stroke, hypertension, obesity, schizophrenia and osteoporosis. Last year, DeCode’s success led to major research agreements with drug giants Roche and Merck. Early this year it partnered with IBM to sell its Clinical Genome Miner discovery software system to other researchers.

DeCode remains committed to the national database, but it is not depending on it for success. “Our main work is finding genes linked to disease, and drug targets. The Icelandic Health Sector Database is supposed to supplement the data we now have on 80,000 people?a significant portion of the population,” says company spokesman Edward Farmer. “Our basic core of work is going very well and is not affected by this, but it’s something that we want to do.”

Even if the politics get sorted out, the struggle to build the Iceland database is another among several challenges DeCode faces. DeCode lost more than $100 million in the first nine months of 2002, after taking in just over $30 million. Last September, the company laid off about one-third of its workforce in an effort to cut costs and reach breakeven in 2003. DeCode shares that sold for nearly $30 in 2000 now rate about $2, giving the company a market cap of a little more than $110 million.

And the estimated cost to build the Icelandic Health Sector Database? Between $135 million and $250 million.