"Weak and Meaningless" Guidelines for UK DTC Tests
The release of the UK Human Genetics Commission's A Common Framework of Principles for direct-to-consumer genetic testing services might seem well-timed, given the industry's recent bad publicity. Unfortunately, it sends entirely the wrong message. The Independent's headline nailed it:
Call to regulate do-it-yourself
genetic testing kits rejected
Dr Helen Wallace of GeneWatch UK spelled out the consequences:
"By issuing these weak and meaningless proposals the Commission is undermining plans to implement proper controls on misleading gene test marketing. It has become a voice for industry instead of a voice for members of the public. It should be ashamed."
The UK Human Rights Blog (written by legal specialists) suggested that it is "not difficult to imagine the issue of DNA home-testing coming before the courts" and that "the government may have to step in with more stringent regulation if this softly softly approach fails to address this still fuzzy ethical issue." The question of parental testing of children's DNA "when there is no specific clinical need" particularly exercised them, and also (it seems) a writer for The Times, which is now buried behind a pay-wall.
The Commission has been working on these principles for two years, with a 12-person committee that includes representatives from DeCode and Navigenics. They published a draft for comment last fall. GeneWatch UK responded with a 12-page, heavily footnoted, Word document that lambasted the draft as "the wrong approach" on many different grounds, citing scientific as well as regulatory concerns, and concluded:
Rather than adopt weak Principles with no mechanism for oversight, the HGC should recommend that the Government signs and ratifies the European Convention on Human Rights and Biomedicine, and its Protocols, including the Protocol Concerning Genetic Testing for Health Purposes. If it wishes to overturn the principles adopted in the Protocol, perhaps the Commission could explain why it considers why a 'right to know' invented by commercial companies (actually a right to be sold misleading rubbish by such companies) should take precedence over the rights adopted in this international instrument.
Update: The Lancet editorial on the guidelines calls them "welcome but insufficient" and notes acerbically that "the HGC is not a regulatory body, and there is no framework in place to monitor adherence to the guidelines, let alone enforce compliance." They conclude by stressing that "it is essential that regulators not only catch up but get ahead of the game to ensure that consumers are protected by something less ephemeral than guidelines."
Previously on Biopolitical Times: