TR: Who are the customers for your various products?
STEFANSSON: The discovery stuff goes mainly to pharmaceutical companies and diagnostics companies. The database services, to academic and other kinds of health-care institutions. The software systems we are marketing to health-care providers, the pharmaceutical industry, biotech companies, software companies. The breadth of customer is considerable. This is not just biotech companies serving pharmaceutical companies.TR: There has been a lot of controversy surrounding deCODE’s creation and licensing of a database containing the health records of every Icelander.
STEFANSSON: The database has been controversial mostly for the wrong reasons. There are all kinds of reasons to be skeptical of collection of personal information, and I think that we can never be too careful when we do that. But most of the controversy was focused on misinformation, the insistence that we were working on biological samples without informed consent and things of that sort.
TR: How do you reassure the public of the value of these databases?
STEFANSSON: There is no question in my mind, nor in the mind of anyone who has looked at this carefully, that this is an extraordinarily important approach, and people should take it. The only question is, What is the price? What are the sort of ethical and societal dilemmas that you have to overcome to be able to take this approach? If you’re going to do a large study that involves a large number of people, a whole population, you have to establish some sort of a consensus in the population whether it should be done-what some people call community consent. In Iceland, people took my suggestion to do this sufficiently seriously that the parliament passed a law. We could easily have done it without a law, but the parliament passed a law. There was a societal debate that lasted for nine months. There were 700 articles written in the country’s three newspapers; there were 140 television and radio programs addressing this. It was probably the most debated issue in the history of our republic, and on the eve of the parliamentary vote, a poll showed that 75 percent of people supported the bill, 25 percent were against. And now, under one and a half years after the bill was passed, there was another poll taken showing that the support had risen to 91 percent.
But societal or community consent is not enough. You have to have some sort of consent at the level of the individual: What is the “how” of the collection of this data? Does it comply with current practice in the use of health-care information? By law in Iceland, the information in this database is only information produced in the process of delivering health care, nothing else. Permission to cross-reference it with information from DNA is entirely dependent on an explicit informed consent from those who have given us DNA.
TR: How does this differ from the way information is usually collected for medical research?
STEFANSSON: Health-care information is going to be collected with presumed consent [in which permission is assumed and must be specifically refused], and there’s not a single place in the world where people use information produced in the process of delivering health care with anything except presumed consent. There is not a single significant study in your country where people have demanded informed consent for the use of information produced in the process of delivering health care. So this is exactly in keeping with that, and before you decide anything else, you should think about the consequences of demanding informed consent for secondary use of health-care information. It’s a serious decision, because you would not be able to do epidemiology as we do it today. If it had been required in the past, we wouldn’t have the health-care system that we have today; there’s no question about it. When you come today to seek health care, you’re using the consequence of the fact that your parents and their parents allowed the use of their health-care information. Simply to discover knowledge. And if you refuse to do the same, you’re going to diminish the probability that your children and their children will have health care of the same quality.