Wednesday, August 30, 2000

bookmark: connotea :: del.icio.us ::digg ::furl ::reddit ::yahoo::

BioMedNet News Iceland cold-shoulders genetics company
[requires 'free' registration]
"The Icelandic Medical Association and deCODE, the company set to run a national database of health information in Iceland, are unable to reach a compromise over whether the "anonymized" data should automatically include all patients' health records without consent. The company is playing down the problem, but most Icelandic doctors are opposed to "presumed consent." The CEO of deCODE says that the database still will be useful without needing to represent 100% of the population.

Reference: Abbott, A. 2000. Iceland's doctors rebuffed in health data row. Nature 406(6798):819."

Medscape The Icelandic Healthcare Database: A Tool to Create Knowledge, A Social Debate, and a Bioethical and Privacy Challenge
[requires 'free' registration]
"Should genetic material be collected from individuals for the purpose of studying human disease in specific populations? The native genome of Iceland offers a powerful and rare resource in genomic research -- a relatively homogeneous population. In this setting, the proposed Icelandic Healthcare Database, which would integrate medical information with genealogy and molecular genetic data, has driven a number of issues -- both ethical and scientific -- to the fore."

redux [03.20.00]
Wired News Chilly Genetic Reaction
"The Icelandic public is accusing its government of taking huge payments from the company licensed to create a nationwide genetic database of the country's entire population.

A public outcry escalated last week following newspaper editorials and a forum sponsored by Mannvernd, an organization strongly opposed to deCODE Genetic's plans to create the Icelandic Health Sector Database."

redux [02.06.00]
BBC News Iceland sells its genetic history
"It has never been done before and no-one really knows how successful it will be, but it has already divided the country and now the whole world is watching and waiting."

"The Icelandic Government has given a licence to a US-funded corporation to study the medical records, family trees and genetic information of each and everyone of the country's 270,000 citizens."

Icelandic Healthcare Database Overview
"A centralised database is an idea that requires this form of temporary protection in order to flourish, just as the author of a book requires copyright and, for a fixed period, exclusive right to sell the work. Without a special or exclusive licence of some form, it is impossible to establish a privately-run database."

redux [06.15.00]
New England Journal Of Medicine Rules for Research on Human Genetic Variation -- Lessons from Iceland
"DNA molecules are entirely separate from medical records. In the future, however, the DNA molecule and the medical record are likely to merge into one when it becomes possible to sequence a person's entire genome and put that information on a computer chip or disk. This is not deCODE's current project, but we should not wait until this step is taken to explore its implications. The most important questions would then be who has the authority to make such a disk in the first place; who owns the disk; who controls the use of the disk; and whether the disk containing the genome should be treated as specially protected medical information, as is the case for psychiatric and drug-dependency records? In clinical settings, it seems reasonable to treat such a disk as containing particularly private and sensitive medical information. It also seems reasonable to permit patients to agree to have their entire genome scanned without detailing the tens of thousands of tests that would be run. This is akin to consent to a battery of tests during an annual physical examination.

On the other hand, in a research setting, or when a specific genetic disorder is suspected, the creation and use of an individual patient's genome disk should be subject to the informed consent of the patient. And since they can be both separated from the medical record and readily recreated, research subjects should retain the right to have the files containing their genetic information destroyed at any time.

Iceland's experience with deCODE provides a useful catalyst for formulating fair and ethical rules for research on genetic variation. The Icelandic experience demonstrates that people are concerned about how genetic research is done, that medical-records research and DNA-based research are not the same, that community consultation is necessary but not sufficient to justify DNA-based research ethically, that the probable benefits of such research should be spelled out as clearly as possible, and that international standards for consent to and withdrawal from research should apply directly to research on human genetic variation. Rules for such research will retain their relevance even after it becomes possible to transfer all the genetic-sequence information in a DNA molecule to a computer disk."

redux [02.13.00]
The Daily Davos Beyond the Genome
"By the spring of this year, the first draft of the human genome -- the sequence of all the genetic instructions needed to make up a human being -- will be published on the Web. But that is only the end of the beginning. Scientists still have very little idea of what most of the 100,000 or so human genes actually do, and finding out will take them into a very different area of research.

The raw material of the genome program has been anonymous samples of DNA, manipulated by complex laboratory machines that turn out information like a production line turns out widgets. But the new era of post-genome research involves analysing real people and their confidential medical records. The records are needed to match the genes that people carry with the diseases they may develop. Only then will gigabytes of genetic data into new treatments for cancer or heart disease. And that is why socialised healthcare is a vital part of post-genome research.

Countries such as the U.S., which provide healthcare through private enterprise, are useless for this sort of genetic inquiry. Only those countries which have organized the delivery of healthcare to their population in a way that is independent of the marketplace have built up the universal medical records necessary to make sense of the patterns of disease."