European Geneticists Take a Strong Stand on Direct-to-Consumer Gene Tests
Posted by Marcy Darnovsky September 9, 2010
Biopolitical Times
Scrutiny of the freewheeling direct-to-consumer gene test industry is building in the US: just in the past few months, Congress and the FDA have held hearings, the GAO conducted a "sting" investigation, the public health departments of several states have gotten into the act, and public interest groups including the Center for Genetics and Society and the Council for Responsible Genetics [PDF] are weighing in.
European conversations about public oversight of DTC gene test companies also appear to be gathering steam. Last month, the UK Human Genetics Commission released a set of voluntary guidelines for DTC gene tests, but they were blasted as "weak and meaningless" by the public interest group GeneWatch UK, and criticized as "insufficient" and "ephemeral" by an editorial in The Lancet.
Now the European Society of Human Genetics has released a much stronger statement [PDF] on DTC gene testing "for health-related purposes." It calls for implementation of a protocol on gene testing that was added in 2008 to the Council of Europe's Convention on Human Rights and Biomedicine, and for national laws, which already exist in some European countries, to require "a responsible medical person to be involved before a genetic test is provided."
The statement succinctly summarizes the range of concerns and recommendations about DTC gene tests that are increasingly being voiced both in the U.S. and Europe. Some excerpts:
European conversations about public oversight of DTC gene test companies also appear to be gathering steam. Last month, the UK Human Genetics Commission released a set of voluntary guidelines for DTC gene tests, but they were blasted as "weak and meaningless" by the public interest group GeneWatch UK, and criticized as "insufficient" and "ephemeral" by an editorial in The Lancet.
Now the European Society of Human Genetics has released a much stronger statement [PDF] on DTC gene testing "for health-related purposes." It calls for implementation of a protocol on gene testing that was added in 2008 to the Council of Europe's Convention on Human Rights and Biomedicine, and for national laws, which already exist in some European countries, to require "a responsible medical person to be involved before a genetic test is provided."
The statement succinctly summarizes the range of concerns and recommendations about DTC gene tests that are increasingly being voiced both in the U.S. and Europe. Some excerpts:
- "Various companies hold out that DTC genetic testing enhances an individual's autonomy and control over his or her future. ESHG underlines that this can occur only when consumers are offered adequate pre-test information, including counselling and psychosocial support when appropriate, and when the tests offered are of good quality and medically relevant."
- "Aggressive marketing strategies and slogans for DTC genetic testing might overstate the potential for predictive information of such tests and overrate its future health implications. All this is likely done to increase test uptake and artificially create new demands, that is, to earn money."
- "The clinical utility of a genetic test should be an essential criterion for deciding to offer this test to a person or a group of persons….For many recently developed tests, evidence for clinical utility is not available."
- "[T]he ethical, legal and social implications of the tests provided should be considered extensively in all of its phases (research, development and transfer into clinical practice). In light of these criteria, the ESHG opposes the premature DTC commercialization of various genetic tests."
- "The ESHG is concerned with the inadequate consent process through which customers are enrolled in such research. If samples or data are to be used in any research, this should be clear to consumers, and a separate and unambiguous consent procedure should take place.
- The Tempest: Following the Storm of Reactions after the GAO Report
- "Weak and Meaningless" Guidelines for UK DTC Tests
Correction: An earlier version of this post incorrectly identified the Convention on Human Rights and Biomedicine. Both the Convention and the added protocol on genetic testing for health purposes are instruments of the Council of Europe, an intergovernmental agency comprising 47 European countries that was set up in 1949 "to promote democracy and protect human rights and the rule of law in Europe."