Author: Skúli Sigurdsson
Appeared in Tillmann Hornschuch, Kirsten Meyer, Gerlind Rüve, and Miriam Voß, eds., Schöne–Gesunde–Neue–Welt? Das Humangenetische Wissen und seine Anwendungen aus philosophischer, soziologischer und historischer Perspektive (Bielefeld fall 2002) (IWT-Paper 28). http://archiv.ub.uni-bielefeld.de/kongresse/workshop2002/
Bioethics Lite™: Two Aspects of the Health Sector Database deCODE Controversy
Skúli Sigurdsson July 2002
The accompanying two texts, “Springtime in Iceland and $200 Million Promises” and “Summertime in Iceland and Human Rights,” were written in the late spring and early summer of 2002. Four years into the controversy surrounding deCODE genetics Inc., its Icelandic subsidiary Íslensk erfdagreining, and the Health Sector Database (HSD) law of 1998, these pieces are meant to highlight two aspects of this complex and convoluted story. They can be read independently. At the end I offer some suggestions for those who want to delve deeper into the story.
Aspect I: Springtime in Iceland and $200 Million Promises
Spring in Iceland is a magic time. As one gazes at the mountains gracing the horizon in the Reykjavík area, white with snow and glistening in the glow of the evening sun, one wonders how it is that a few months earlier the same mountains were hidden in the darkness of the long sub-arctic winter night. Likewise, for ornithologists and bird watchers spring is an enthralling period, as the arrival of migratory birds from southern latitudes signals that spring and summer are just around the corner. Finally, the Icelandic parliament adjourns for its summer recess in April or early May. As is the wont of democracies worldwide, this is a much prized period for rushing through the parliamentary system pieces of legislation which might fare badly if exposed to a sufficient amount of critical light and sound discussion.
Spring 2002 fits this seasonal pattern. The migratory bird heidlóan (Eurasian golden plover, Pluvialis apricaria) has arrived, gradually it is getting lighter, and in early April just after Easter the Icelandic government announced a bill authorizing up to a $200 million loan guarantee for deCODE genetics Inc. DeCODE is the US mother company for an Icelandic subsidiary Íslensk erfdagreining, a controversial biotechnology company doing research on the genetics of a variety of common diseases.
According to a recent press release from the Icelandic Ministry of Finance, the loan guarantee is to be used by deCODE for entering into the field of drug development, based on discoveries made by the company in population genetics, and competitive advantages which it has accrued therefrom. The parliamentary bill contains similar assertions about deCODE’s achievements. These claims are made without any supporting evidence.
Achievements in Cyberspace
Such evidence exists overseas in the records of the Securities and Exchange Commission (SEC) in Washington, DC. This US government agency was established in the early 1930s in the wake of the Crash on Wall Street in 1929 and it regulates stock markets in the US. In the summer of 2000, prior to the dot.com and biotech boom coming to an end, deCODE launched a successful initial public offering on the Nasdaq hightech stock market.
In order to protect investors and maintain its credibility as a publicly traded company deCODE must supply the SEC regularly with information on its performance. DeCODE’s annual report to the SEC for the fiscal year ending December 31, 2001 (so-called form 10-K) is easily available on the website of the regulatory agency. This annual report, which incidentally is not mentioned in the parliamentary bill, sheds dry factual light on the scientific achievements of deCODE.
The company deCODE was established at the end of 1996 with $12 million provided by a group of US venture capitalists. In February 1998 it signed a research agreement with the Swiss pharmaceutical giant Hoffmann-La Roche for at most five years and potentially worth up to $200 million (to be more precise, for three years and twice extendable for one year at a time).
In an earlier form 10-K filed by deCODE (for fiscal year 2000) it says: “Under this agreement, we may receive approximately $70 million in research funding and more than $130 million in milestone payments that are linked to our progress in research efforts and commercialization.” Scrutinizing the most recent form 10-K (for fiscal year 2001) one finds out with a bit of simple arithmetic that to date deCODE has received from Roche for 1999-2001 $61.6 million and earlier it had received for 1998 $12.7 million. This is a total of $74.3 million.
Recalling that deCODE was to receive $70 million for research from Roche over a period of five years ($56 million for four years), the difference $74.3 million minus $56.0 million translates into scientific achievements worth $18.3 million or $4.6 million annually as milestone payments—this is far short of the grand $130 million milestone promise of 1998.
In notes to the parliamentary bill it says: “The methodology of using population genetics to develop drugs is just coming of age. DeCODE has progressed further in this field than most other companies in the world. In order to substantiate this claim one may point to the results which the company has achieved in its collaboration with Roche on investigating the heredity of several common diseases.”
As has been pointed out the results which deCODE have found in its collaboration with Roche according to the agreement of 1998 are worth $18.3 million. On the basis of such meager scientific achievements the Icelandic government is willing to give deCODE loan guarantees up to $200 million. The parliamentary bill has provoked strong criticism from the Icelandic financial and economic sector as it seems to favor the interests of a single company, distort the operation of market forces, and expose the Icelandic state to undue financial risk. Surprisingly, little attention has been paid to the scientific track record of deCODE in this public debate.
The introduction of the bill makes it quite clear that deCODE has not continued to attract foreign capital as was hoped in the mid- to late-1990s when information technology and the completion of the human genome project seemed to offer boundless new economic vistas. The US venture capitalists who placed the seed money for deCODE in 1996 got their money back in 1999, the Roche connection has only yielded a third of the much promised $200 million of 1998 and will not continue with the same strength. A good part of the $182 million acquired by deCODE on Nasdaq in July 2000 came presumably from Icelandic investors.
The Government Connection
With 600 employees, weak scientific achievements, and very high operating costs, deCODE will soon be faced with harsh economic realities. The recoil from such events would have considerable economic repercussions in Iceland and could cast unfavorable light on the ruling coalition government headed by Prime Minister Davíd Oddsson. As the government has been unwavering in its support of deCODE since the signing of the agreement with Roche in 1998, it is not hard to understand the introduction of the loan guarantee bill in the spring of 2002. There is little doubt that the government believes that it has acted reasonably and in the best long-term interests of Iceland by giving deCODE preferential treatment, thus hoping to spearhead the establishment of a new industry in Iceland.
The close relationship between deCODE, the government, the state bureaucracy, and the Icelandic media has made it possible to maintain such a belief system for many years and shield the system from relentless criticism and reports about rapidly dwindling fortunes of biotechnology companies like Celera and deCODE. They hoped to ride the wave of overly optimistic promises spawned by the quest for the holy grail of modern biology, the human genome project formally completed in the summer of 2000. It is only now in the spring of 2002 that the deCODE-government symbiosis is beginning to show signs of wear and the political cost of the expectations associated with deCODE has become obvious, even to stalwart supporters of Prime Minister Oddsson and his party.
The strength of the deCODE-government bond and the accompanying ties between Mr. Oddsson and the Chief Executive Officer of deCODE, Dr. Kári Stefánsson, had become firmly cemented in 1998. In the wake of the deCODE-Roche agreement a government bill was introduced in parliament which would make it possible to issue a license to an unspecified company to establish a database containing the health records of every Icelander alive and dead. The Health Sector Database bill had been written by deCODE and sent to the government in September 1997. On the eve of Easter 1998 it seemed a good opportunity for securing parliamentary approval of the HSD bill, yet the deCODE plan met with strong opposition delaying passage of the bill until December 1998. The HSD bill was strongly protested by the Icelandic Medical Association, scientists, concerned citizens, politicians, ethicists, and a critical non-governmental organization, Mannvernd, came into being. What has characterized the controversy ever since is the closeness of deCODE and the government, and the unwillingness of the government to listen to reasoned argument and seek scientific counsel from any but Dr. Stefánsson and senior deCODE staff.
Since the spring of 1998 the controversy has received tremendous international media attention, thus constantly undermining a government assumption that the case could be kept within Icelandic borders. The dramatic failure of containment is aptly symbolized by the fact that the best source of information about the work and promises of deCODE is the website of SEC. In 1998 Dr. Stefánsson spoke eloquently of the promise of the Health Sector Database which still does not exist; now, four years later, he promises drug discovery.
What he does not mention is that deCODE is now obliged to provide Roche according to a new research agreement (effective as of February 2, 2002; the 1998 one has not been extended for the fifth year) with blood samples ($50 per unit) it has “harvested”, to use the language of the most recent SEC form 10-K (Exhibit 10.46 item 9.1), from the countless patients who have participated in deCODE’s research on a variety of common ailments. These persons sincerely believed that they were contributing to the progress of science and medicine. But perhaps like the cod and herring swimming in the icy waters offshore, they are instead being turned into a new form of raw material.
Aspect II: Summertime in Iceland and Human Rights
The Icelandic parliament passed the controversial $200 million loan guarantee bill for deCODE at the end of the spring session in early May 2002. That was just in time for the media, police, political establishment and state bureaucracy to gear up for a meeting of NATO foreign ministers held in Reykjavík about a fortnight later. In preparation for this event, a small section of Reykjavík was cordoned off, in order to guarantee the security of the foreign dignitaries.
The last twenty years have seen the proliferation of security and crime-prevention measures in Iceland, the emergence of private security firms, anti-burglar alarm devices installed in countless homes and businesses, growing drug consumption being met with special police units, and Iceland’s accession to the Schengen Agreement on European gateways. Yet, during these sunlit days in May this trend reached new heights as the Icelandic police stepped up its security measures thousandfold in order to meet the criteria of foreign security experts haunted by memories of worldwide anti-globalization protests and the events of September 11, 2001. The NATO meeting gave the government an opportunity to demonstrate that Iceland was a real nation and a trustworthy member of the North Atlantic Alliance, an opportunity said to justify the high cost of hosting the meeting. The extraordinary scale of the security measures made one wonder whether a group of aliens from outer space had briefly visited the West End of Reykjavík.
The Falun Gong Debacle
The Icelandic government continues to delight its citizenry with foreign wonders and spectacles. In the middle of June the President of the People’s Republic of China and General Secretary of the Communist Party of China, Mr. Jiang Zemin, and a large entourage visited Iceland. He was repaying the visit of Ms. Vigdís Finnbogadóttir, President of Iceland (1980-1996), to China in the mid-1990s. As Mr. Zemin was the mastermind behind the brutal suppression of the student protest at Tiananmen Square in the spring of 1989, his visit provoked considerable local criticism. As it became known that the Chinese government had done its utmost to prevent members of the persecuted opposition group Falun Gong entering Iceland and had been partly aided in its efforts by the Icelandic government, the local criticism became more vociferous.
In contrast to the NATO meeting a month earlier, no political mileage was to be gained from demonstrating superior Icelandic security prowess and simply allowing members of the Falun Gong to visit Iceland in large numbers to protest human rights violations in China. As such expression of discontent and basic political rights would have entailed costly security measures, an easier approach was adopted: to bar Falun Gong from entering Iceland or board Icelandair aircraft overseas. Some members of Falun Gong who had reached Icelandic soil were even briefly detained in a school, turning the school, close to Keflavík International Airport and US/NATO military base, into a detention camp for unwanted aliens. The question as to who belonged to Falun Gong was resolved with the aid of lists which had circulated far and wide in diplomatic-security channels.
Mr. Zemin’s visit became dominated by the Falun Gong protesters strong local expression of support for their plight, bureaucratic confusion, awkward responses by the Justice Minister, Ms. Sólveig Pétursdóttir, and contemptuous comments by Prime Minister Davíd Oddsson about the local critics. The local media covered the visit extensively depicting Mr. Zemin in the company of Mr. Oddsson and the President of Iceland, Mr. Ólafur Ragnar Grímsson, at Thingvellir, the site of the old Icelandic parliament Althingi (e.g., Morgunbladid June 16, 2002).
The official visit of the President of China demonstrated a weak tradition of human rights and civil liberties in Iceland, which together with an expanding national security apparatus and eagerness to satisfy external security demands, makes novel forms of classification and exclusion possible. The restrictions imposed on members of the Falun Gong travelling to Iceland were unusual in Icelandic diplomatic-political history but not a novelty internationally speaking.
In December 1998 the Icelandic parliament voted into law a bill which enabled the Icelandic government to grant a license to a private company to construct a database with the health records of all Icelanders dead and alive. The license to construct the Health Sector Database was granted in January 2000 to Íslensk erfdagreining, the Icelandic subsidiary of deCODE genetics Inc. (incorporated in Delaware). The passing of the law was a charged political issue in Iceland and became an international cause célèbre, not the least because the law contains a curious human rights novelty. The HSD law foresees that inclusion of health data into the database shall be based on presumed consent, not informed consent, as is the norm internationally for biomedical research.
The reason Icelandic lawmakers, aided by the senior deCODE staffers who had drafted the original bill, insisted on presumed consent was that the Health Sector Database was supposed to mix commerce, science and public health in novel ways, and that ostensibly the whole could be described as an epidemiological entity. The last strand in this gargantuan mixture explained in part the interest of the state in passing the law and giving the license to deCODE. The current coalition government of Prime Minister Davíd Oddsson (in power since the spring of 1995) envisioned acquiring a powerful tool for controlling escalating health costs in the public health system. Other motives for the unwavering government support of deCODE and the HSD blueprint was the hope of helping to establish a new industry in Iceland, and an overweening ambition to contribute to worldwide improvement of health.
Little attention to deCODE’s business plan, along with an exaggerated focus on public health or epidemiology meant that an argument could and was made that presumed consent sufficed for including health data into a fraction of the HSD. Nothing describes better the surreal character of the debate concerning the HSD bill in Iceland in 1998 than the fact that the debate focussed nearly exclusively on consent and whether cryptological means could render all data channeled into the HSD anonymous. That would formally have satisfied the criteria of epidemiologial research where presumed consent is the norm, but not for the hybrid HSD as a whole. This surreality was made possible by the fact that deCODE was not required to submit a detailed business plan whereby it would have been possible to parse the HSD into its commercial, scientific and epidemiological parts and bring the debate down to earth from its foggy PR heights.
It is tempting to conclude from the fact that deCODE was not required to submit a detailed business plan for the HSD to the Icelandic parliament that no such plan existed. This interpretation is made more plausible by the fact that a non-confidential corporate summary which started to circulate widely in Iceland in the second half of 1998 contained no such detailed description of deCODE’s plans.
This interpretation is made still more plausible by material distributed at a conference in Mannheim, Germany, February 20-21, 1999, where Dr. Kári Stefánsson, Chief Executive Officer of deCODE, spoke. In this information package (© deCODE genetics Inc., 1998) it says that the company “is currently negotiating with the Icelandic government to compile a database that will contain the following information:
* Genotypes of all Icelanders or a large proportion of the nation (based on deCODE’s own research).
* Genealogy of all Icelanders two or three centuries back in time (based on deCODE’s current database).
* Phenotypes of all genotyped individuals (based on data collected from local health-care providers). In the beginning this will be focused on disease information: onset, response to treatment, and histopathology.
* Resource use with an eye on cost control (based on data supplied by health authorities and others).”
These four items constituted deCODE’s dream list in 1998. The third item corresponds to the HSD idea except that the law of 1998 makes it possible to link the phenotype database (health sector database) to databases containing genotypic and genealogical information. The fourth item corresponds to the epidemiological part of the HSD. There is nothing in this construction which necessitates use of presumed consent. But what is essential is the idea of comprehensiveness signalled by “all Icelanders” and “all genotyped individuals” whereby exclusive access to Iceland and Icelanders turns out to be a key corporate asset.
In a recent essay Gillian Beer discusses the central role played by the idea of the islands for the theorizing of Charles Darwin. She observers that “Islands are dramatic evidence of how slight environmental differences privilege and require different characteristics.” Furthermore, she notes: “Island sites also tax the powers of observers by the hope they seem to hold out of providing a complete record.” (In Lenoir, ed., Inscribing Science [Stanford University Press, 1998], pp. 119-139)
Iceland, vikings and the island condition have been central ingredients to deCODE’s PR ever since the founding of the company in the fall of 1996. This is illustrated by an article which appeared in Time in the fall of 1997 entitled “The New Icelandic Saga” which, incidentally, noted that the former President of Iceland, Ms. Finnbogadóttir, was a member of the company’s governing board (she resigned in December 1998). The colorful past was emphasized in a widely circulated article by Michael Specter which appeared first, entitled “Decoding Iceland”, inThe New Yorker in January 18, 1999 (subsequently reprinted as “Cracking the Norse Code” in Sunday Times, March 21, 1999). And deCODE’s first corporate logo had a map of Iceland with a magnifying glass above it highlighting the four letters A, G, T, C of the DNA alphabet.
The corporate performance of deCODE is lackluster and after trading for $18 per share at the initial public offering on Nasdaq in July 2000 the shares have been in steady decline and now hover around or slightly below the $5 per share line.
These hard financial facts mean that in addition to securing loan guarantees from the Icelandic government deCODE needs to convince shareholders and investors that it is still a viable player in the genomics field. A standard strategy in that game is to generate publicity—preferably abroad—which when it reaches Iceland has the aura of deep truths.
A recent article entitled “A High-Resolution Recombination Map of the Human Genome” (Nature Genetics June 2002) authored by deCODE scientists fits this pattern. It received considerable publicity in Icelandic media and Morgunbladid, a staunch supporter of deCODE, noted the coverage which this result had received in The Wall Street Journal and The New York Times.
An article in the Times by Nicholas Wade begins by stating: “In the year 874, Viking crews from western Norway started to drop in on Ireland, capture an allotment of young Celtic women and sail off to a remote island beyond the reach of retribution.” (“A Genomic Treasure Hunt May Be Striking Gold,” June 18, 2002) The article in the Times then continues along familiar lines, noting the Icelandic interest in genealogy (described as “obsessive”) and auspicious genetic endowment (described as “relative homogeneity”). The former is now supposed to reach back 1,100 years (in the information material distributed by deCODE in Mannheim in February 1999 the depth was still only two or three centuries). The latter has been hotly contested and is no longer maintained in deCODE-related publications (e.g., in American Journal of Respiratory and Critical Care Medicine vol. 164 ).
Sifting through the familiar tales and inaccuracies in Mr. Wade’s article two salient details emerge. First, is the observation that deCODE now has blood samples from some 65,000 Icelanders (a sizable portion of a total population of 286,000) which gives a concrete measure of how far deCODE has come to reach the vision set out in the Mannheim information material in 1999, namely to collect “Genotypes of all Icelanders or a large proportion of the nation (based on deCODE’s own research).” Second, although privacy is mentioned in the article it completely passes over questions of presumed consent or the proposed Health Sector Database. I believe that this omission is highly significant as it illustrates that the HSD is no longer a central feature of deCODE’s corporate vision.
It may very well be that the HSD was never meant to acquire the significance it received in public and parliamentary debates in Iceland in 1998. But it proved impossible to bring the HSD bill quickly through parliament at the end of the spring session in 1998. As neither the government nor deCODE had a reserve plan in case parliamentary approval could not be quickly gained, the intense controversy which ensued meant that the HSD acquired a significance far out of proportion to its financial worth.
Four years later there still exists no HSD, no agreement has been made with the largest hospital in Iceland, no computer infrastructure has been installed in health institutions, and deCODE is unwilling to pay the high preparatory costs which the health instititutions have incurred. After all, why should the company do so? The HSD controversy has given it a recognizable international profile, it has made Dr. Stefánsson a minor international celebrity, and it has demonstrated to the company the lengths to which the Icelandic government is willing to go to accommodate the requirements of the company.
The most important legacy of the HSD law is that it has provided a two-track legal framework for conducting research in biomedicine in Iceland. One track is international where informed consent is the norm. The other track is the special Icelandic track where presumed consent is the norm. Standard regulatory norms have furthermore been seriously weakened as illustrated by the fact that the HSD lies outside the jurisdiction of the Icelandic National Bioethics Committee. What must be so attractive about the Icelandic bioethics two-track system for deCODE is that sometimes you drive along track one, sometimes along track two. As the informed consent forms employed by deCODE in its research along track one (yielding 65,000 blood samples) contain options whereby the participants surrender most control of future use of their DNA the final outcome is as if they had enlisted in deCODE’s research according to presumed consent along track two
Violating international bioethical norms and infringing on basic human rights must have seemed a small price to pay for the Icelandic government majority; after all, deCODE is a thriving enterprise employing around 600 persons. In a country with a weak tradition of civic liberties and human rights, it seemed a perfectly adequate solution to offer alarmed and anxious citizens the chance of opting out of the HSD. In the spring of 2002 about 20,200 Icelanders (roughly 7% of the population) had opted out of the HSD, which only exists as a legal entity. On the other hand, the opt-out database registering discontents exists, kept by Office of the Director of Public Health. This opt-out database is a singularity in democratic societies, i.e. a database managed by the state essentially registering political opinion. It is a striking icon for the Icelandic Sonderweg in bioethics.
The opt-out database is undoubtedly secure and anonymous although to date it has not been subject to the same stringent security tests as the HSD. It is impossible for the public to know who has opted out. But it is possible to know who cannot do so. Neither the dead nor children and teenagers (to the age of 18) can opt out. The poignancy of this strange situation is graphically brought out by a case pending in the Icelandic judicial system. A teenage daughter has taken the Icelandic state to court requesting that health data pertaining to her deceased father be barred from entering the HSD. The lawyer for the plaintiff is Mr. Ragnar Adalsteinsson and the case is strongly supported by Mannvernd, a critical non-governmental organization, established in October 1998.
Mr. Adalsteinsson is the leading legal expert in Iceland in the field of human rights and civil liberties. Incidentally, he represented members of Falun Gong as they wrangled with state bureaucrats and police in early June 2002 in Iceland.
Suggestions for Further Reading
It is best to start by consulting the English-language section website of Mannvernd, Association of Icelanders for Ethics in Science and Medicine (www.mannvernd.is). It is also helpful to look at the website of deCODE (www.decode.com). Finally, the website maintained by the author contains a sub-section devoted to the Health Sector Database deCODE controversy (notendur.hi.is/sksi).
The article “Springtime in Iceland” appeared in German translation in a weekend supplement to tageszeitung April 20-21, 2002 (translation Mona Singer). It appeared in Icelandic translation on the public website Silfur Egils (www.strik.is) May 1, 2002 (translation Skúli Sigurdsson). A preliminary version of the article “Summertime in Iceland” was presented at a workshop on science, politics and governance held at Wissenschaftskolleg zu Berlin, Germany June 21-23, 2002. I thank for helpful discussions, encouragement and assistance Bogi Andersen, Sarah Brownsberger, Lorraine Daston, Egill Helgason, Mike Fortun, Gudsteinn Bjarnason, Sheila Jasanoff, Martina Keilbart, Reinhard Krause, Heinz Reddner, Gerlind Rüve, Elvira Scheich, Mona Singer, and Stefán Pálsson.