the article "THE ICELANDIC DATABASE CONTROVERSY" below came via the privacy forum digest (see http://www.vortex.com/privacy.html). i thought it interesting on several levels.
first, the general media spin, when i've heard this project mentioned, has been very positive, as in - "wow think of all we can learn about genetics from this population." i've heard little about possible negative ramifications, so i was glad to see these issues raised.
second, the idea that the genetic information of an entire nation will be owned and publicly traded on the stock market is mind boggling. i dug around a little on the company's site to verify items in the article and found that part of the public relations important to the venture is that the database/company is owned by icelanders.
<< "Islensk erfdagreining is an Icelandic subsidiary of DeCODE << Genetics, Inc. which is incorporated in Delaware, USA. A majority of << DeCODE is owned by Icelandic stockholders. Non-Icelandic stockholders << include the original venture capitalists and the Swiss pharmaceutical << company F. Hoffmann La-Roche."
as the article below points out, u.s. venture capital is behind the project. my guess is that 49% is owned by "non-icelandic" shareholders and most of the rest by the icelandic scientists etc. who manage the company. so perhaps it would be more accurate to say "A majority of DeCODE is owned by (25?) icelanders."
in any event, the company plays up the non-us angle with the press, e.g. this article mentioned on the DeCODE web site:
>> DeCODE expands the European gene map
>> An article about the European Life Sciences Conference in
>> Amsterdam discusses the recent growth of biotechnology companies in
>> Europe and their attempt to break into the U.S. dominated field of
>> genomics research. DeCODE Genetics’ population based method for
>> locating genetic mutations is described and DeCODE’s $200
>> million deal with Roche is mentioned.
>> The Financial Times, April 26th 1999
third, and most obvious, are the privacy issues.
perhaps to head off criticism, DeCODE will seek consent for the most egregious invasion of privacy. according to the company's faq, "individual consent will be obtained from each Icelander who is willing to give a blood sample for genotyping," but "the medical, genealogical, and resource use information will be coded and placed into the database without seeking active informed consent."
the faq (if one can believe the company) states directly that the database will "only yield information on groups of people, their health and disease, and risk factors. It will yield no information on individuals, not even coded data on individuals, to ensure that such information will not be used to identify specific individuals...The database will not contain data that could be linked to identifiable individuals." of course one might reasonably ask why it is necessary to include the "triple coded" identifying information if the database will not "yield" such information. one might also ask how genotyping information can be separated the identity of the person being "genotyped."
(http://www.database.is/rm_qa.html lists what kind of information will go into the database?).
one small protection, probably exacted with great difficulty, is that "a patient may request at any time that any existing or future information about him / her not be placed or stored in the database. In addition, the bill precludes the collection of medical information for a period of 6 months after the passage of the database bill to allow Icelanders the opportunity to opt out of the database prior to its construction." but who knows how much protection this concession will actually provide for icelanders?
begin forward message:
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Date: Wed, 12 May 1999 15:22:26 -0700 From: Peter Marshall <techdiff at ix.netcom.com> Subject: "Decoding Developments in Iceland" [forwarded excerpt]
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From: J. Erlendsson <joner at hi.is> Date: Mon, 03 May 1999 12:41:29 +0100
THE ICELANDIC DATABASE CONTROVERSY Decoding developments in Iceland
Bernhard Palsson and Snorri Thorgeirsson
As we write these comments, a 12-year license, which grants exclusive rights to Iceland's entire health care database, is about to be given to an American company, with a majority ownership of American venture capital funds that also hold a majority on its board of directors. This license would contain highly controversial conditions such as "presumed consent" that would allow the company to use the personal data of any individual in the database without their permission or "informed consent." Iceland's sovereignty is effectively at stake.
How did this remarkable turn of events come to pass? In August of 1996, deCODE Genetics Inc. was founded and incorporated in the state of Delaware. The company issued 20 million shares and sold 12 million to a group of seven American venture funds at a $1 per share. A wholly owned Icelandic subsidiary was established, and with $12 million the company started operations in Iceland. By the end of 1997 it had 45 employees, a number that has grown to 250 today. In early 1998, deCODE signed the largest deal at that time in genomics with Hoffmann-LaRoche, valued at up to $200 million over a five-year period. This partnership was focused on linkage studies in 12 diseases. deCODE then sold an additional 2 million shares to Icelandic investors at $5 per share. These shares trade publicly in Iceland, and have recently been trading at more than $22 per share, bringing the market capitalization of deCODE to close to $500 million.
By all measures deCODE was a roaring success, and it was initially well received in Iceland, bringing the benefits of high-paying jobs in a high-tech industry. Its energetic president and CEO received manifold praise and recognition for his accomplishments, including a nomination in the magazine Red Herring in 1998 as one of the world's top 10 entrepreneurs.
However, deCODE's troubles began in March of 1998, when it helped formulate a bill introduced into the Icelandic Parliament Althingi.... It authorizes the establishment of a centralized health care database, which includes detailed health care records and the ability to correlate them with genealogical and genotypic information(1). One controversial part of the bill is that it includes the provision that in exchange for paying for the construction of the database-estimated to cost over $100 million-an exclusive 12-year license would be granted for its use. The proposed law included a number of features that were unprecedented, to say the least, with regard to prior general medical, scientific, and ethical practices in the conduct of R&D of health care products. Naturally enough, the bill attracted considerable attention and there was and is a strong opposition to it both domestically and internationally. Coverage of this issue has been extensive(2)....
This database will contain genotypic data, and thus the most intimate information about the individuals who will provide tissue samples for the database. With advances in human genomics being so rapid, it is hard to tell how much will be read (correctly or not) into genotypic information obtained over the coming 12 years. Although we are promised that maximum effort to maintain privacy will be made, in a small country like Iceland, the individuals in the database can be identified with as little as three pieces of readily available information (such as gender, date of birth, parent's date of birth).
deCODE plans to go public. Thus, all the information in the centralized database and its intrinsic value will be traded as a commodity on international markets. Comprehensive hereditary and health care information for a whole nation, in a format in which every individual and his/her characteristics can most likely be identified! Nothing less than Iceland's national identity is at stake....
Realizing this, a group of Icelandic physicians in an open letter(3) made a plea to the board to reconsider its actions just before the passage of the bill, in which they cited severe criticisms of all or parts of the bill by no less than 30 Icelandic ethical and scientific associations. Their effort was predictably to no avail-perhaps understandably, as it is the venture funds that stand to gain the most, well over $200 million if the current share price holds up. Their capital gains, if and when realized, will not even be taxed in Iceland, and it is unclear what long-term benefit if any the Icelandic nation will receive from this process. Since Iceland is only a thousandth the size of the US, 250 high-paying jobs there are equivalent to 250,000 high-paying jobs in the US....
Needless to say, human genetic research can be conducted in Iceland as elsewhere without implementation of controversial issues. Interestingly, such research can be performed without the creation of such a centralized database and an infringement on the exclusive license. Many genealogical databases exist in private hands, as do patients' registries (and some are explicitly excluded in the bill) and disease-specific physician-patient groups and societies....
REFERENCES
1. English version of the legislation is found on brunnur.stjr.is/interpro/htr/htr.nsf/pages/gagnagr-ensk 2. Hodgson, J. Nat. Biotechnol. 16, 896-897 and 16, 1017-1021 (1998); see also Nat. Genet. 20(2), 99-101 (1998), Science 280, 890-891(1998), Sci. Am. February 1998, p. 24. 3. See www.mannvernd.is/english/index.html, item 12.12.98.
Bernhard Palsson is professor of bioengineering and adjunct professor of medicine, University of California, San Diego, La Jolla, CA.
Snorri Thorgeirsson is laboratory chief, experimental carcinogenesis, National Cancer Institute, Bethesda, MD.
The views expressed here are the authors' own, and do not reflect the opinions of their home institutions.
e-mail: bpallson at be-research.ucsc.edu.