In a recent issue of BMJ, journalist Ray Moynihan wrote, “Beware the fortune tellers peddling genetic tests.” (Subscription required for full access.)
“For anyone concerned about the creeping medicalisation of life, the marketplace for genetic testing is surely one of the latest frontiers, where apparently harmless technology can help mutate healthy people into fearful patients, their personhood redefined by multiple genetic predispositions for disease and early death.
Again a tool that’s proved useful in the laboratory has escaped like a virus into the marketplace, incubated by entrepreneurs, lazy reporters, and the power of our collective dreams of technological salvation, this time in the form of personalised medicine to treat us according to our individual genetic profiles.
Evaluating genetic tests is a complex business, requiring assessment of how well the test measures what it claims to measure, how well the genetic variation predicts actual disease, how useful the results are in terms of treatment, and what the social and ethical issues might be. Clearly there’s potential for exaggerating the value of a genetic test, which is one reason Germany has imposed severe restrictions on direct to consumer testing. In the United States they’re talking of a new test registry on a government website, raising immediate concerns that it could lend legitimacy to unproved and potentially harmful products.
In Britain a government advisory body recently released a set of principles that it hopes will be taken up as a voluntary code of practice–a pusillanimous response already criticised as helping facilitate marketing rather than ensure proper regulation. Meanwhile the not for profit group GeneWatch UK warns that genetic tests may be used to sell unnecessary preventive drugs to healthy people and suggests that the tests be restricted to situations that produce health benefits and are ethically just.
(Genetics researcher David) Melzer believes that there’s a much wider problem of poor evaluation of diagnostic tests. Governments, he argues, should simply create a kind of compulsory Wikileaks for tests, with full disclosure of evidence, “so people know what junk they’re buying.”