Iceland was the first to undertake the creation of a database of the health records of its 288,000 people. Its founders boasted about the homogeneity of the DNA of its small population, descended from the Vikings, and its detailed genealogical records, dating back hundreds of years. But Skúli Sigurdsson has shown that what was once the centrepiece of perceived national progress has in fact turned into a fading mirage as numerous promises made by the state and the company entrusted with the enterprise have been broken.
Estonia started a similar project in 1999, which promised to be even bigger. Estonias population is five times larger than Icelands. However, the clinical records are not up to Icelandic standards. Estonia has a long history of being overrun and plundered by others, including the Danes, the Swedes, the Germans, the Poles and the Russians. The country gained independence only in 1991, when the Soviet Union collapsed.
Scientists in Estonia admittedly got the idea for the Estonian Gene Bank from Iceland but wanted to improve it. One of the first comments made by the Estonian Genome Project Foundation (EGF) was that they would not repeat the mistakes of Iceland. Public outrage arose in Iceland after the licensing of Icelands health records database to deCODE Genetics Inc., a Reykjavik-based company that received anonymous health and genetic data without citizens consent.
Andres Metspalu, a professor of biotechnology at the University of Tartu who proposed the Estonian DNA database in 1999, said that Estonia would not give the DNA to private companies. According to the leaders of the Estonian Gene Bank Project (EGBP), their project meets the requirements of informed consent in accordance with Estonian legislation. In Estonia, unlike Iceland, he promised, participating DNA donors would receive feedback.
In May 2003, one of the family doctors trained to counsel participants in the Estonian Gene Bank Project (EGBP) confessed in the main national newspaper that her sole motivation in taking part was the chance to acquire her own personal gene card/map in three years time.
According to Krista Kruuv, Chairman of the Management Board of the EGF, the planned genotyping will enable more exact and efficient diagnoses of illnesses, determination of development risks thereof, and improvements in treatment. Kruuv, and Dagni Krinka, head of the Estonian Genome Projects laboratory, said that the DNA donors would however have to wait for at least three and maybe up to five years to receive such a personal gene card/map (see The Chronicle of Higher Education Volume 49, Issue 33, page A16).
Kruuv also wrote in various Estonian newspapers that people should be motivated to participate in the project because although they may be well today, some day they may fall ill. Donors would have an advantage, as in case of illness there would be no need to examine them so thoroughly: important information would already be available on their personal gene card/map. To my knowledge, this is not yet possible, and is moreover unlikely to be so for the foreseeable future.
It is evidence, however, of the careful path to recruitment being prepared by those who have been employed to facilitate the informed consent of donors to the Estonian Gene Bank. The personal gene card/map is a small but important part of a myth created in order to persuade Estonians that their health is going to be vastly improved, with the help of a gene card they can start queuing up for now.
Doctors have been promised that they will receive 10% extra pay in return for high quality work for the EGBP. One family doctor who will fill in the questionnaires asking donors about their health, genealogy, lifestyle, nutrition, work habits, environment, said that if the donors did not know the answers to all the questions, it did not matter: blood samples would be taken anyway. My question is: will such an approach really provide the necessary data for a modern, evidence-based databank which Estonians could rely on one day to tailor drugs and treatments to their personal genetic profile?
A slice of history
The Estonian Genome Project Foundation (EGF) was founded in 2001 by the Government of the Republic of Estonia for the preparation and implementation of the Estonian Gene Bank Project.
The Estonian Gene Bank has started to build an extensive file of health questionnaires and blood samples. This information regarding three quarters of the 1.4 million citizens is entrusted to a central electronic database. The project is expected to take around five years to complete. The plan is also to include children between 7-15 years of age, which contradicts the Declaration of Helsinki and other international documents.
According to Andres Metspalu, the key figure in developing the idea of the EGF and EGBP, the two main goals of the project are:
- to identify disease genes within a group of patients with a given disease;
- to help to create an Estonian health database with personal gene data to which each participant in the project shall have access.
Metspalu and others hope that all the hard work will be rewarded by genetically tailored treatments for both those who donated their blood and others.
Researchers proposed the EGBP to the government before there was any public debate. The project has been approved neither by the Faculty of Medicine at Tartu University, the only medicine faculty in the state, nor by the board of the Estonian Academy of Sciences. When asked about the project, Andres Lehtmets, the then president of the Estonian Medical Association said that his association had no official opinion at all.
The Estonian health care system is chronically underfunded, while the majority of the Estonian population is oppressed by poverty and the problems of everyday life. Yet for many years, millions of Estonian crowns were poured into the account of the EGBP, at the expense of overall health care.
However, the Estonian Gene Bank was established by the Estonian Human Genetics Research Act of 2000. In the same year, the private US company EGeen was founded (Andres Metspalu is its Chief Scientific Officer) to finance the project and commercialise its results for drug and diagnostic developments. EGF is the owner of the database, and acts as the public service front for a commercial enterprise. EGeen is the exclusive commercial licensee of the database. The company holds exclusive rights to money-making ventures that rely on the data for the next twenty-five years. It will give a percentage of its profits back to the Estonian Genome Project Foundation to run the project.
Incentives and consent
The pilot phase of the sample collection was launched in three counties in October 2002. The pilot study largely financed by investors of EGeen International was used to evaluate the overall feasibility of the larger project. According to the original schedule the Pilot Project should have involved 10 000 donors. Recently the EGF has reported that the number of gene donors was only a tenth, nearly one thousand at the end of the pilot project. At present the plan is to include the other counties of Estonia gradually.
During the pilot phase, those family doctors trained for participation in the EGBP sent the completed consent forms and blood samples of gene donors to the Estonian Gene Bank by courier. Doctors received 250 crowns, i.e. US-$17, for each interview with a donor lasting about an hour. (The basic salary of a doctor is 42 crowns per hour.) The compensation per donor increased in proportion to the overall number of consenting donors, and created its own partial interests. The economic benefit entices the physician to get involved in the project: the more patients he convinces to become donors, the better for him.
Donors family members are not required to give their consent to be part of the EGBP, but the questionnaires also contain questions about them. Doctors are asked to draw up the family tree for each donor. (See: Estonian Human Genetics Research Act, chapter 3, §14, 3). Questionnaires containing health and genealogy data are sent to the Estonian Gene Bank electronically, where the data is encoded and the consent forms archived. Blood samples are sent directly to the laboratory. The DNA separated from the blood samples will be preserved in the storage facilities of the Estonian Gene Bank.
Secrecy and exploitation
The EGBP has no organised opposition. Such information about the Estonian Gene Bank as does surface in the national media is clearly propaganda. Within the Estonian Gene Bank, in fact, a department for public relations was set up in its earliest days. At first, it was kept secret that the Bank had a commercial plan.
Only now is the consent form informing donors that their tissue donations may have some commercial value, and that their anonymous data may be commercially exploited. Foreign newspapers on the other hand have been pointing to the commercial significance of the EGBP. (See: Andreas Webers article Sold nation in Süddeutsche Zeitung, 23 November 2001).
The initiators of the EGBP pledged themselves to be acting in accordance with such generally recognised codes of ethics as those contained in the Human Genes Research Act, the Convention on Human Rights and Biomedicine of the Council of Europe plus its Additional Protocols, the Helsinki Declaration of the World Medical Association, and the Universal Declaration on the Human Genome and Human Rights of Unesco.
Participants in the Estonian Gene Bank may not withdraw their data at any time as required by the ethical documents mentioned. The Estonian Human Genetics Research Act, chapter 2, §12, 7 declares for example that a gene donor has the right to withdraw his or her consent until his or her tissue sample or the description of his or her state of health is coded.
The EGBP has chosen to ignore many of the basic requirements of medical ethics. Even today, the EGBP has undergone no appraisal by an independent ethical committee. The Estonian Gene Bank has an ethical committee whose members are appointed by the Estonian Gene Bank Board. The leaders of the EGBP say that the independence of the EGBP ethics committee is guaranteed by the state salary being paid to its members. Nevertheless, members may be removed by the Estonian Gene Bank Board at its own discretion (See: Estonian Human Genetics Research Act, chapter 6, §29, 4,5).
Unfortunately, Estonian medicine has no previous track record in informed consent. Its physicians have for years taken paternalistic decisions regarding the examination and treatment of their patients. Counselling does not flourish in Estonia in the way it might be understood in the western world.
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