criticises genetic testing decision
Genetics Alert (HGA;1) today criticised the decision of the Human
Genetics Commission (HGC) not to recommend strict regulatory control
over genetic testing. Instead, the HGC made weak recommendations to a newly-formed
regulatory agency which will have insufficient legal powers to
regulate genetic tests. The decision ignores mounting evidence in Britain and the US
of the harm that can arise from the exploitative marketing of
scientifically-unvalidated and unethical tests (2). This evidence clearly points
to the need for statutory regulation.
The HGC is
proposing that the new Medicines and Healthcare Products Regulatory
Agency (MHPRA) should harmonise regulation of genetic tests with
that of medicines.
Although the agency will be able to prevent the marketing of
tests which do not work, it will have no powers to prevent companies
marketing tests whose value in predicting disease is contested. It will not be able to
compel companies to provide proper genetic counselling. Neither will the new agency,
which is a technical regulator, be equipped to deal with broader
ethical and social issues that result from particular genetic tests,
eg. prenatal screening tests.
stresses that there is no need for over-the-counter marketing of
genetic tests. Such tests should always be taken under medical
supervision and should be accompanied by genetic counselling from
qualified personnel. Tests should not be given until their clinical
usefulness, as is the case with drugs, has been validated by a
director, Dr David King, said: "The new proposals are an advance on
the HGC's previous plan for industry self-regulation. But it has failed to bite
the necessary bullet of statutory regulation, and has simply passed
the buck. Despite the
marketing of extremely dubious tests, like so many Government
advisers before them, the HGC prefers to wait until we have a major
problem before it does anything. It is failing in its duty as
the Government's watchdog, which is to protect the
information contact Dr David King, 020 7704 6100.
Genetics Alert is a non-profit watchdog group funded by a leading
2. In the
USA, where genetic tests are currently not regulated we have already
without requirements for counselling or consent[i],[ii].
marketing of tests whose predictive value and medical utility is
that abuses children's rights[vi]
availability of unethical tests, such as prenatal sex selection[vii]
[i] Giardiello, F.M. et al 1997
New England Journal of Medicine 336
[ii] McGovern, M. et al 1999
Journal of the American Medical Association 287
[iii] Relkin, N. et al 1996 Annals
of the New York Academy of Sciences 802 149-171.
the Oversight of Genetic Tests: Recommendations of the
SACGT 2000 Secretary's Advisory Committee on Genetic
[v] Chandros Hull S. and Prasad
K. 2001 Hastings Centre Report 31 33-35.
[vi] Saltus R. 2000
Knight-Ridder/ Tribune Business and Market News March 27
[vii] Sachs, S 2001 New York Times
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