The Decode Database
Last December, Iceland's parliament passed a bill that gives a biotechnology company the right to combine all of the country's genetic, medical and genealogical information in one database. The company, Decode, received the exclusive right to market the database abroad for 12 years. Decode has also signed a five-year contract with Hoffman-La Roche, a Swiss biotechnology company. The contract gives Hoffman-La Roche the exclusive right to access the database to explore the genetic origins of 12 diseases. In return, Hoffman-La Roche will pay Decode $200 million and give Icelanders free access to treatments developed through the partnership.
Decode aims to make the first database that contains an entire country's genetic information. Its database would also be the first to combine family, medical and genetic histories on such a large scale. Iceland uniquely suits this project due to its relatively small population of 270,000 people and its extensive genealogical and medical records. Sixty percent of Icelanders support the bill1, but a vocal Icelandic and international opposition is attempting to stop the law from being enacted.
This paper is laid out in three parts. First, the case in favor of the database is analyzed. Second, the opposing arguments against the database are presented. Lastly, grounds for compromise between the two cases are presented. Through these three sections, it becomes evident that though establishment of the database is supported, the method of implementing and controling the database needs to be changed.
Part I: The case in favor of the database
The database raises several complicated issues. The strongest argument in favor of the database is that it will enable researchers to make scientific progress that will benefit humanity. Dr. Claire-King, the American geneticist who discovered the first breast cancer gene, BRC1, is concerned about the ethical problems the database raises, yet she says the database " 'could become one of the treasures of modern medicine.' "2 Claire-King worked for 17 years to find BRC1, while a team of researchers using Icelandic genetic information found a second breast-cancer gene, BRC2, in two years.3 Since extensive genealogical and medical data on almost every member of the Icelandic population exists, researchers can combine family trees with DNA samples to find disease-causing mutations. The process is relatively simple in such enclosed populations, mainly a function of the small overall amount of genetic variability in Iceland. Therefore, establishing the database in Iceland provides the scientific community with an instrument that can significantly benefit society. Dr. Kari Stefanssonthe database's creatorconsequently argues that the ethical concerns raised against the database are insignificant when considered against science's ethical imperative to advance human medicine. He claims that researchers have a " 'moral obligation to do what [they] can to move forward,' " as well as a "medical right to develop medicine."4 According to database supporters, the moral imperative to advance medical development validates the existence of the database.
The database's other points of support are rooted in refutations of its opponents arguments. Opponents of the database claim it has many flaws. The first is that it violates privacy rights. Yet privacy is not a paramount issue in Iceland in comparison to some other countries. Everyone carries a national I.D. card, and genealogical information is considered part of the public record.5 The country has a national health care system, so it is immune to insurance companies who might use the database to exclude people with predispositions to genetic conditions. Additionally, the data will be encrypted to protect individuals. Therefore, the database in itself does not violate privacy rights.
Furthermore, database supporters argue that the database does not violate the principle of broad medical consent. All citizens will be included in the database unless they refuse to participate. If a citizen wishes to remove herself from the database, her past records stay in the database. The database's supporters, led by Stefansson, argue that this is necessary to gather a realistic data pool. Obtaining consent from every individual every time someone uses her DNA in an experiment is impractical, they argue.6 Supporters argue that the database cannot function properly with the imposition of broad medical consent requirements.
Part II: The case against the database
These arguments against Decode deal with the existence of the database and the manner of data collection. However, several more problematic issues must be examined first. Essentially, Decode is claiming the right to own genetic information. This seems inherently illogical; if genes are found in every human being, how can a company own the right to a gene? However, biotechnology companies have already patented genes, and therefore the database merely continues this trend and does not violate moral standards.7
Stefansson further argues that the database is his " 'intellectual property' " 8 and that he has a right to claim rewards from it. Stefansson debates that because he was the first to develop the process of combining records and DNA data on a mass scale, he deserves to profit from his idea. Profiting from information is not new, but profiting from genetic information on such a grand scale introduces a new level of ethical discourse. Stefasnsson utilizes a "free-market" economics argument to justify his position, but fails to address the ethical significance of patenting genetic information on such a large scale.
Decode is also uniquely positioned to study genetics in Iceland because its contract with Hoffman-La Roche will insure it against the lack of funding that has restricted the size of the Icelandic genetic research community. Stefansson argues that the $150-million expense of creating the database justifies the contract with Hoffman-La Roche. Thus, the contract with Hoffman-La Roche solidifies the database's economic viability and does not leave it vulnerable to shortcomings in future funding.
Although the case for the database rests solely on its potential benefit to Iceland and to the rest of humanity, opponents of the database argue that it will have negative consequences for humanity. Their first concern is privacy. Although people in Iceland have national health insurance, this does not protect them against future revisions of Iceland's health care policy. Future alterations away from a national healthcare plan might risk the privacy of Iceland's people.
Further, the current arrangement does not protect people in other nations without national health insurance. Insurance companies in the United States, for instance, might use Decode's discoveries to screen out high-risk applicants. Actors in the international community thus claim that their citizens' privacy rights are eroded with the initiation of the Decode deal.
Opponents also raise the issue of commodification of a country as an argument
against the database. This argument is phrased in various ways, including the idea that Icelanders have been " 'sold down the river' " by their government. Richard Lewontin, a professor of Zoology and Biology at Harvard, says that Icelandic citizens have been " 'turned into a tool for this one company, and that seems completely objectionable.' "9 Iceland's genetic record becomes the instrument by which Decode can generate profits. Decode's control of Iceland's genetic information therefore raises questions regarding the validity of a single company being able to profit unilaterally from an asset that seems to belong to a nation.
Accordingly, an important question arises: Should DNA have market value? Advancing technology has given value to genetic information, a previously unutilized resource. However, technology gives people the ability to procure and sell organs. Decode's opponents argue that a company's "rights" to profit from a gene are nonexistent in the same manner that organ sales are completely unethical. To clarify, organ sales are unethical because organs should not be distributed based upon market value but rather upon need. Genetic information should be accorded the same status.
The arrangement between Decode and Roche could also be highly problematic from a scientific perspective. Stefansson has said other Icelandic researchers will have access to the database, as long as they are not working for competing companies. However, this model flies in the face of scientific progress. Typically, scientific advances result from the combined efforts of many researchers at many different public and private institutions. One research center does not have the resources to try every conceivable strategy for developing disease treatments. So research facilities tend to develop one, or a few, strategies at a time. However, if a company with exclusive rights to study a particular disease-causing gene chooses an ineffective treatment strategy, or merely a more profitable strategy, the world will be denied access to effective treatments. The same argument applies to giving only Icelandic researchers access to the database. If scientists all over the world could use the data, the goal of increasing global health would be optimized. Thus, Decode's strict private ownership of the database violates the principle of the mobility of scientific information.
Opponents also argue that Iceland does not realize the value of its genetic information. Later stages of the bill include a provision that Decode would share its profits with Iceland, but those details are still unresolved. Jon Jonsson, a geneticist at the University of Iceland, claims that the Decode deal is unfair because "'you're exploiting a population that doesn't appreciate what it's giving away. It's like when you gave Native Americans the glass beads for Manhattan.'"10 Regardless of the current value of DNA, opponents to the Decode deal say that in the future, advancing technology will make the database incredibly lucrative. However, as the database legislation currently stands, Iceland and its people will receive only a minimal benefit from these future developments.
Perhaps the most compelling argument against the database is that it violates the medical institutional right to informed consent. Researchers usually presume a subject consents to an experiment unless she does not agree to it. Decode would reverse that presumption, not only by using data from deceased people in tissue banks, but also by requiring Icelanders to opt out of not into Decode's data pool.11 The idea of requiring people to exempt themselves from the database instead of signing themselves on to the project is highly suspect under the norms of current medical practice. Stefansson's pragmatic argument that informed consent would be too difficult to obtain from every Icelandic citizen does not address the moral problems associated with this ethical infraction. The act of giving DNA is akin to giving a doctor an exhaustive account of one's physical makeup. A person must agree to divulge highly personal information to a doctor. Test subjects must do likewise with their DNA to researchers. Consequently, researchers may gain information from a person's DNA that he or she probably did not know. In light of this fact, people should have the right to determine when their DNA will be used and the manner in which it is utilized. Thus, the current arrangement between Decode and the Icelandic government is problematic because it violates the ethical imperative of obtained consent.
However, it is difficult to weigh the importance of this breach of medical ethics. One may argue that the principle of informed consent holds only when some harm may come to the individual. Subjecting someone's DNA to tests is a very different act from subjecting her to surgery without consent. Donating DNA does not remove anything from a person's body that is irreplaceable.
Furthermore, Stefansson's assertion that the database project must be developed as a moral obligation to medical progress is valid, but not absolute. Does a moral obligation to spur medical progress exist? Medicine has a moral obligation to improve human health. This obligation aims at the general improvement of the human condition. Medical progress should not exist in a context isolated from human well-being. Therefore, the decision to undertake any medical procedure should always account for ethical issues. There is no clear "moral obligation" for medical progress comparable to obligations to respect human privacy and well-being. Consequently, the idea of a medical right to develop medicine is highly conditional, and it is never absolute. Database development must always come secondary to the health and well-being of the patient or patients. Through this analysis, Stefansson's claimed "rights" and "obligations" for medical progress carry little weight in the Decode discussion.
Most importantly, the database does not have to be developed by a private firm such as Decode. The second breast cancer gene, BRC2, was discovered in Iceland by the Icelandic Cancer Society. Decode is clearly not the only organization equipped to do genetic research in Iceland. Those who oppose the database therefore argue that the agreement between Decode and the Icelandic government and the accompanying agreement between Decode and Hoffman-La Roche violate important ethical standards and protectable interests of the global community.
Part III: Arriving at compromise
The conflict between the database's benefits to humanity and the harms of both the database itself as well as Decode's ownership of the database present ground for compromise. All governments attempt to catalog their populations in different ways. The United States, for example, carries out a periodic census of the entire country. The census raises ethical concerns similar to those raised by Decode's database. For instance, opponents claim that insurance companies who want to screen out potentially expensive clients will misuse Decode's discoveries. Some argue that census data is also used against people in poor communities when companies decide not to locate businesses in those communities after examining census income data. Under this analysis, the Decode database is merely an extension of a commonly accepted practice, and its opponents are wringing their hands for no good reason.
However, DNA is a different kind of information than income status. It is intimately involved in the physical integrity of a human being. Knowledge of a citizen's income may give you a hint as to what that person's economic status will be in 10 years, but knowing that a person has the breast cancer gene requires action; the person has the right to know that information. For this reason, the Decode database is not merely a collection of information similar to a census. Thus, the decision to give this information to a private company that has not agreed to objectively serve patients' interests is highly suspect and problematic.
Consequently, those who argue that Decode (a representative of private interests) is duping the Icelandic people are probably right. As the arrangement stands, Decode could be an incredibly lucrative investment.12 This does not sink Stefansson's dream of a combined genealogical, medical and genetic database. It merely reasons that he should share some of the profits with Iceland. He has already agreed to reimburse Iceland in the form of improved computerized databases for the national health care system. However, Iceland is free to negotiate its own compensation. Iceland will already receive free treatments if Hoffman-La Roche develops any treatments under its exclusive contract.13 Thus, Iceland will probably reap some benefit from Decode, although not a purely monetary one. The lack of profit sharing between Decode and Iceland is not an argument against the deal, but rather an issue that may be further negociated.
The real flaw with the Decode-Hoffman La Roche arrangement is the concept of owning exclusive rights to genetic research. Scientific information may be construed as private property. For instance, oil companies kept geological information about the earthquake-prone Los Angeles area secret for years, on the grounds that such information constituted corporate property.14 But scientists would do well to ask themselves whether that same standard should apply to genes. There is simply no basis for claiming a gene as property. Genes cannot be said to "belong" to anyone. How can a company "own" something that you or I might carry in our bodies? The company didn't put it there or create it; it merely discovered it. When biologists discover a new species, they don't patent it that would be absurd. When physicists discover a new element, it takes its place in the periodic table and scientists all over the world are free to experiment on it. Even though the gene itself cannot be patented, once a gene is discovered, the process used to find it and the means of amplifying it may be patented.
The relationship between ownership of the gene and ownership of the process of "gene making" creates a real dilemma in regards to the Decode deal due to its massive scale. This is the main problem with the Decode-Hoffman-La Roche arrangement. Biotechnology companies have already patented genes. Private institutions frequently fund public institutions under the condition that they will have exclusive rights to use any discoveries. Is this good science? More importantly, can this type of scientific ownership be justified when the scale is an entire country? It is difficult to say; after all, public institutions might never do substantial basic research if pharmaceutical companies were not funding them. Consequently, many of the issues raised in the Decode debate are issues that the world must eventually face. Stopping Decode will not stop all potential abuses of genetic information in the future.
However, the bill that grants Decode its existence is flawed according to existing ethical standards. International laws protect a subject's right to withdraw herself and her personal data from experiments after giving initial consent.15 Additionally, the arrangement treats DNA as a commodity rather than a form of personal information. At a minimum, the law must not take effect until Decode agrees to allow test subjects the option to learn medically relevant information that Decode finds while analyzing their DNA. The law must also reverse Stefansson's presumption that medical consent cannot be obtained because it would pose an impractical burden on the organization. Citizens must not participate until they have given informed consent, and if they choose to stop participating in the study, Decode must remove their DNA and medical records from the database. Consequently, the company should be required to notify subjects of medically relevant information if they wish to hear it. Failure to do this would violate present standards of medical ethics and inherently violate elements of international law.16
Stefansson is justified in claiming the database as his intellectual property. He may charge people who wish to use it. However, he should not be allowed to grant exclusive rights to Roche to work with genes he may find. If one accepts the premise that collaboration improves the quality and speed of research, this provision is necessary to advance the goal of global health.
Part IV: Conclusion.
Both supporters and opponents of the database make valid arguments. On one hand, medical and social imperatives support the establishment of the database. On the other hand, this paper asserts that ownership of the database by a private firm such as Decode would clash with current ethical and social norms. Iceland is in a precarious position. The opportunity to develop a genetic database that can provide humanity clues, hints and possible answers to medical questions that have plagued civilization is, to say the least, powerful. However, Iceland's lack of funds forces the country to turn elsewhere - mainly to private funds. These private sources, such as Decode, create potential social and ethical harms that undermine the benefits of the database project. One promising solution could be to develop the database under the auspices of an international organization. Such an organization would need to address the issues of informed consent and compensation for Icelanders. If those issues could be resolved, an international organization could provide the infrastructure necessary to complete the project, as well as an opportunity for scientific and ethical collaboration and progress. The Decode database raises issues that cross national boundaries, and citizens of all countries should participate in discussion and utilization of such a powerful tool.
1 Michael Specter, "Decoding Iceland." The New Yorker, January 18, 1999.
2 Specter, 1999.
3 Ibid.
4 Ibid.
5 Specter, 1999.
6 Specter, 1999.
7 Nicholas Wade, "Gene study bolsters hope for treating diseases of aging." The New York Times, March 5, 1999.
8 Michael Specter, 1999.
9 Andy Coghlan, "Selling the family secrets." New Scientist, December 5, 1998.
10 Robert Kunzig, "Blood of the Vikings." Discover, December 1998.
11 Coghlan, 1998.
12 Coghlan, 1998.
13 Specter, 1999.
14 Sandra Blakeslee, "Seismic team detects a killer beneath Los Angeles." The New York Times, March 5, 1999.
15 Andy Coghlan, 1998.
16 Andy Coghlan, 1998.