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Call for stricter controls on gene tests

10 September 2004
By BioNews
Appeared in BioNews 275

The pressure group GeneWatch UK has called for stricter controls on the marketing of genetic tests, and wants the Commons Select Committee on health to consider the issue. According to a report in the Guardian newspaper, GeneWatch is concerned about recent lobbying by pharmaceutical company Roche, which wants the US Food and Drug Administration (FDA) to relax the regulations surrounding the marketing of such tests. 'Roche has ghost-written its own regulation which seeks to put its profits before people's health', said Helen Wallace, deputy director of GeneWatch.

Along with two other smaller companies, Roche sent draft guidelines to the FDA for consideration last June. They apparently include a requirement that the test in question accurately detects the genetic variation it is intended to detect, but no requirement for evidence of the link between the gene variant and the disease it is associated with. GeneWatch is concerned that companies are already preparing to sell tests that predict a genetic susceptibility to common diseases. 'Most claims that genes increase a person's risk of common conditions, such as heart disease, depression or obesity, later turn out to be wrong. Unregulated genetic testing would mean that we could all be frightened into taking medicines for illnesses that we are never going to get', said Wallace.

Roche said that its draft guidelines would help solve a problem, by providing standardised gene tests to laboratories that are putting together 'home brew' test kits. Confirming the link between the genetic test and the disease would be down to the labs themselves. But many scientists are concerned about such tests, because common diseases are caused by the interplay of many different genetic and non-genetic factors, which cannot currently be tested for. UK cardiovascular genetics specialist Hugh Montgomery says that thousands of genes will play a part in heart disease, including those that determine how stressed a person is, as well as those involved in determining cholesterol levels. 'To suggest that by a genetic test in the polygenetic diseases we are going to be able to tell you anything at all about your risk is frankly ludicrous', he said.

SOURCES & REFERENCES
GeneWatch calls for controls on genetic test marketing
PHGU September Newsletter |  10 September 2004
Watchdog seeks controls on scary gene tests
The Guardian |  9 September 2004
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