Regulation of gene tests for inherited diseases urged: Steve Connor reports on fears that commercial exploitation of screening could result in poor advice and lack of counselling for those most at risk

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The Independent Online
LEADING medical scientists have called on the Government to regulate the use of genetic tests to screen the population for inherited disorders.

They fear that as more and more genes for common diseases are discovered the commercial pressure to force gene tests on an unwary public will become overwhelming.

The Clinical Genetics Society, a group of the most eminent medical geneticists in Britain, said the Department of Health should establish a system of monitoring and controlling genetic screening. 'There is an obvious commercial pressure,' John Burn, Professor of Human Genetics at Newcastle University and a spokesman for the society, said. 'Some form of central or statutory body needs to be formed. It needs someone to control highly questionable developments particularly in the private sector.'

Professor Burn said the two main worries about the haphazard introduction of genetic screening programmes were that people might be given poor advice because of technical limitations of the tests and that testing 'on the cheap' would lead to little or no psychological counselling when results were positive.

The Nuffield Council on Bioethics, set up in 1991 to consider the ethics of bio- medical research, submitted a report to the Department of Health last December calling for urgent measures to regulate genetic screening. At present there are no licensing procedures needed for genetic tests, unlike medicines, and no need for clinical trials.

The council wants the Government to exert more control over the introduction of genetic tests and establish firm guidelines on the use of genetic information by employers and insurance companies.

Medical researchers are particularly concerned about gene tests that inform people of a high risk of a disease later in life. Last week, for instance, scientists announced the discovery of the gene that predisposes women carriers to breast cancer. The discovery is the prelude to a genetic test that could be sold within two years. Even before the scientists at the University of Utah had made the find, they had set up a company to patent and exploit the gene discovery. Myriad Genetics, of Salt Lake City, said that it had applied to patent not just the gene, but the mutations in the gene that can give rise to breast cancer, along with any tests or therapies that may arise from the research.

The company, like others in the field, has also targeted other disorders with a genetic basis - from heart disease to obesity - and anticipates that further gene discoveries will 'usher in a major new field of medicine in which the disease can be assessed earlier and more accurately. The company believes that the genetic information business represents a significant commercial opportunity because the market for testing for the genetic predisposition to cancer, heart disease, and other significant diseases potentially includes the entire population.'

Mark Skolnick, a co- founder of Myriad Genetics and leader of the Utah team that found the gene, said many women in families with a history of breast cancer would want to have the test and wider use in the population at large was a distinct possibility.

But many scientists are worried about the pressure to introduce gene tests too soon. Ellen Solomon, a breast cancer scientist at the Imperial Cancer Research Fund in London, said few people in Britain had thought of the implications of a test for a predisposition to breast cancer. 'The public is not ready, GPs are not ready and women are not ready,' she said.

Such a test, would only apply to a fraction - less than 5 per cent - of the women who develop breast cancer. The simplest and clearest benefit of such a test would be to give relief to some women, at risk of inherited breast cancer, who prove negative, she said. However, even for these women the risk of non-inherited breast cancer was still present. Meanwhile, those women who had the defective gene faced 'very difficult decisions' about what they should do because even women known to have inherited it might not develop the disease.