Iceland is one of those countries that everyone has heard of, but what does the average American really know about this small nation? We know it is located in the North Atlantic and it has a very cold climate, but that is about it. Most people do not know that Iceland is a unique country in many ways and these characteristics are making it very attractive to genetic researchers. The government of Iceland has decided to treat this genetic value as a natural resource (6) and sell it like a commodity to a private company (15). This has set off a heated public debate. To some, the arrangement holds endless possibilities for important scientific discoveries. Others believe it is unethical and fraught with potential problems.
Iceland was colonized in the 9th and 10th centuries AD by Norwegian Vikings and their Celtic Slaves. Today the island is almost 100% Icelandic - a genetic mix of the original colonizers. And this homogeneity does not appear to be disappearing any time soon. In 1996, 3,664 immigrants were living in Iceland. With a total population of 270,000, foreigners account for only 1.3% of the population, a level that has remained more or less constant for the last twenty years (10). Adding to the homogeneity are two natural "cullings" of the Icelandic population. An outbreak of the bubonic plague in the 15th century killed more than half the population. In the 18th century a volcanic eruption caused widespread famine and many deaths. Both of these disasters greatly reduced the number of potential mates leading to a very homogenous population. In fact, if you choose two Icelanders today at random, it is very likely that they are distantly related to each other (17).
There are several other populations around the world that are similarly homogenous, but what they do not have are the extensive genealogical records that Iceland does. Thanks to detailed birth, baptism, marriage and death registries kept by the Roman Catholic and Lutheran churches (17) many Icelanders can trace their family tree back 500 years or more (12). The University of Iceland also operates a registry of live births that dates back to 1840 (10). In addition to excellent genealogical records, the country has very detailed medical records. Iceland nationalized its health care system in 1915 allowing doctors today access to a complete set of records from the past 85 years (10).
These characteristics create a very ideal situation for genetic research. For one thing, it is believed that disease-causing genes stand out more clearly against a uniform gene pool than against a ethnically mixed gene pool (17). And a cross-index database of medical records, family trees and genetic information would greatly aid in the genetic research process. Scientist Kari Steffanson suggested just such a database to members of the Icelandic Parliament and this idea was introduced to Parliament as a bill titled "Draft Bill on a Health Sector Database". After much debate and several revisions, Parliament finally approved the legislation on December 16, 1998 by a vote of 37 to 20 (5). Stated simply, the objective of the "Law on a Health Sector Database" is to "authorize the creation and operation of a centralized database of non-personally identifiable health data with the aim of increasing knowledge in order to improve health and health services" (11)
The law also authorizes the Icelandic government to grant a private company the right to create, operate and profit from the database (15). On January 22, 2000 deCODE, a biotech company located in Iceland and incorporated in Delaware, was granted this license. (Kari Steffanson, the promoter of the law, also happens to be the CEO of deCODE.) By paying the $200 million licensing fee, deCODE will have the exclusive rights to the database for 12 years. It is allowed to market the data to companies and institutions outside of Iceland (14). deCODE has already taken advantage of this marketing potential by signing an agreement with Hoffmann-La Roche, a major Swiss pharmaceutical company. This arrangement gives Hoffmann-La Roche access to the database for the purpose of studying the genetic origin of twelve common diseases (3). deCODE received an estimated $200 million as payment for this five year deal which is the largest agreement ever between a genomics and a pharmaceutical company (10).
A simple example of how the database would work is as follows. A scientist would use a computer to call up the coded names of several generations of Icelanders with a particular disease. On the screen would appear a lengthy family tree which distinguishes the sick individuals from their well relatives. The scientist would study the family tree and narrow it down to one particular extended family that looks promising for research. He or she would then send the encrypted names of these individuals to the government Data Protection Commission. The Commission decodes the names and contacts the physicians of each individual and requests blood samples. The Commission then reencrypts the blood samples and sends them to deCODE. The DNA is extracted from the samples in the lab at deCODE. Then scanners are used to analyze the DNA by comparing the genetic patterns of the sick with the patterns of their unaffected relatives. The scanning findings are then passed on to deCODE’s statistical department. There the probabilities of damaged genes occurring in certain chromosome positions is calculated. This method has so far allowed the deCODE staff to map genes involved in multiple sclerosis, psoriasis, preeclampsia and familial essential tremor (17).
Studying a small, isolated population is not a new research technique. Inhabitants of the South Atlantic island of Tristan da Cunha have been studied to learn more about asthma. Diabetes research has been done on the Pima Indians of Arizona. And important information on Huntington’s disease was discovered while studying an isolated community in Venezuela (17). And as proof that genetic research can be just as fruitful in Iceland, great strides have been made in breast cancer research by public institutions in Iceland. In 1996, cancer researchers detected an alteration in the BRCA2 gene of male Icelandic breast cancer patients. Using tissue samples from a national cancer registry, the scientists were able to analyze the DNA of past patients as part of the follow-up study (10). They found the same BRCA2 mutation, (a 5 basepair deletion in exon 9 on chromosome 13,) in 16 of 21 Icelandic families with a history of breast cancer. They were also able to determine the risk of breast cancer for carriers of this gene (16).
Despite all of the potential medical knowledge to be gained from the deCODE database, there are many concerns surrounding its implementation. One of the main worries is the privacy and security of the database. As described above, all data is encrypted rather than entered anonymously. With this encryption it is always possible to trace information back to an individual. The potential for hacking or a breakdown in encryption software is disturbing. Also, in such a small country a few distinguishing genetic characteristics could be enough to deduce the identity of certain individuals, eliminating the protection of the encryption (3).
Another controversial aspect of the database is that patients will not be asked for their consent before their records are deposited in the database. Instead consent is assumed unless an individual fills out certain forms allowing them to opt out of the process (5). This goes against standard ethical and medical practices which require fully informed consent from patients (2). This aspect of the database is not a fault of deCODE’s, but rather a potential weakness in the law passed by the Icelandic government. By establishing the database this way Parliament is making the decision on consent on the behalf of all Icelanders, an action that many disagree with (3).
Even though individuals will supposedly be unidentifiable, the country of Iceland as a whole is clearly identified as the population being studied and this could lead to unfair generalizations. For example, let us say hypothetically that the work of deCODE identifies a gene mutation that increases the risk of a disease like schizophrenia and this gene is found in many Icelanders. People could jump to conclusions and assume that Icelanders are more predisposed to schizophrenia than other groups. This is a problematic and incorrect assumption. The discovered mutation does not increase their likelihood of getting the disease any more than anyone else. Rather, all the discovery tells us is that science found this Icelandic mutation first. Other populations could have different mutations that could also raise their risk. Although incorrect, such generalizations may occur anyway and if they do Icelanders are at risk of facing discrimination from insurance companies and employers (9).
Another questionable aspect of the database is that it is being maintained by a profit-driven business currently preparing for its initial public offering. The company is valued at about $1.5 billion and some estimate that its value will quickly grow to $2 billion or more (4). This gives many people an uneasy feeling that Iceland may be exploited for private profits (3). One should question whether it is ethical to allow deCODE to profit from Iceland’s genes which are a public resource (15). And as a business that will soon have shareholders, one must also be concerned with the motivation behind deCODE’s actions. Instead of keeping the integrity of the database their first priority, their loyalty may shift to their shareholders and the bottom line.
It should also be taken into consideration how the license will affect other public and private researchers in Iceland. deCODE is the country’s largest biotechnology company and some worry that it will begin to hoard most of Iceland’s available research money which will weaken the ability of rival organizations compete (12). Other Icelandic researchers are also concerned that deCODE will develop a monopoly over the data contained in the database. deCODE does not have exclusive rights over the usage of the database, but there are strict conditions that must be met before other researchers can access the database. They must agree not to use or divulge information that will in anyway adversely affect the business interests of deCODE. However this criteria is practically impossible to meet as deCODE’s research efforts are so widespread almost any work carried out in the public domain will have a negative effect on deCODE’s commercial interests (2). Many scientists believe that all biologists should have unrestricted access to the database. After all, scientific research usually progresses more successfully when information is shared (17).
The success or failure of this database project also has very important implications in terms of public opinion on genetic research. If something goes wrong (privacy violations, exploitation, etc.) the image of genetic research will be tarnished. A negative experience in Iceland may hurt research opportunities all over the world. If unethical practices are uncovered, people will be less likely to participate in future studies (3).
All of these negative attributes have led to very vocal protests by various groups in Iceland and abroad. Physicians and scientists are among the most outspoken. In addition to everything already mentioned, the members of the Icelandic Medical Association (IMA) are worried that the transfer of information to a third party will undermine the confidence and trust of patient-doctor relationships (15). The Ethical Council of the IMA is advising physicians not to collect data for the project (8). Already 44 general practitioners and 109 hospital specialists have pledged not to submit data (5). The Bill of a Health Sector Database also triggered a formation of a citizens group titled Mannvernd. They work to promote "ethical standards in medical research, scientific research and in the biotechnology industry in Iceland" (8).
But not all Icelanders have an unfavorable opinion of the database. Public opinion polls in late 1998 showed that 58% of Icelanders were in favor of the database and only 19% were against it (10). Despite all the seemingly negative qualities, the bill does hold the potential to offer several benefits to the country of Iceland. For one thing, any medicine Hoffman-La Roche develops from its work with deCODE will be provided free of charge to Iceland (12).
Another benefit is the creation of a large number of new jobs. At its research and administrative headquarters near Reykjavik, deCODE employs almost one of every 1,000 Icelanders. Most of the jobs are high-tech so the population will not evenly benefit from the growth of deCODE, but the company will do much to reverse the brain drain that has drawn Iceland scientists away from their homeland. Already many scientists who were pursuing research abroad have returned to work for deCODE (13).
While people may be skeptical that this database is under the control of a private corporation, there are many benefits to it being located in the private sector. The costs of genetic research have become exorbitantly high and it is often difficult for public research institutions to get much accomplished without the large grants and enormous shared data pools that are only found in the private sector. Stefansson knows about these financial difficulties first hand. He himself was a researcher at Harvard University doing work on multiple sclerosis. But a lack of funds made him decide that the only way he would really make headway would be to establish a private company (17). It is estimated that it will cost up to $150 million to fund deCODE’s research. This amount is more than twice Iceland’s entire research budget (1). In a way, deCODE is doing Iceland a service in providing the financial resources to carry out such a project.
The strongest argument in favor of the database is that it will be an invaluable tool in the development of new or improved methods for prediction, diagnosis and treatment of a variety of diseases (2). Some could go so far as to say that it is our duty to study this isolated and virtually undisturbed population before it is contaminated with outside genes. Iceland is an irreplaceable genetic resource that we should not ignore. And the resource holds knowledge that all the patients around the world currently suffering from a genetic disorder need now, not years from now when the database guidelines are perfected (13).
From this short discussion of the Icelandic Health Sector Database, it is clear that this is a very complicated issue. In theory, the database has the potential to generate very useful information, but all of the controversy surrounding the database should be taken as a warning signal. It is natural for people to be alarmed when something so new is attempted, however their uneasiness does not mean the database is a bad idea. It simply means that things should be taken slowly so that everything is done right and all of the potential problems can be avoided. It appears as though some amendments may need to be made to the database law, but once things are running smoothly Iceland and the world will reap the benefits of increased genetic knowledge.
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2. Chadwick, Ruth. "The Icelandic database - do modern times need modern sagas?" British Medical Journal. 319:441-444 (August 14, 1999).
3. Coghlan, Andy. "Selling the family secrets." New Scientist. December 5, 1998.
4. Durman, Paul. "Nasdaq listing beckons deCODE." The Times (London). February 10, 2000.
5. Enserink, Martin. "Iceland OKs Private Health Databank." Science. 283:13 (January 1, 1999).
6. Gizbert, Richard. "Profiling an Entire Nation." ABCNEWS.com. Accessed February 1, 2000.
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11. "Law on a Health Sector Database." Mannvernd. Accessed February 17, 2000.
12. Lyall, Sarah. "A Country Unveils Its Gene Pool and Debate Flares." The New York Times. February 16, 1999.
13. Nickerson, Colin. "Perfect for Genetic Research, Some Icelanders Are Wary of Losing Privacy." The Boston Globe. January 20, 2000.
14. "Norse Code." The Economist. December 5, 1998.
15. Sullivan, Patrick. "Move to market gene pool angers Iceland’s Mds." Canadian Medical Association Journal. 161:305 (August 10, 1999).
16. Thorlacius, Steinunn et. al. "Population-based study of risk of breast cancer in carriers of BRCA2 mutation." The Lancet. 352:1331-1339 (October 24, 1998).
17. Walsh, Mary Williams. "A Big Fish in a Small Gene Pool." The Los Angeles Times. June 5, 1998.