At the risk of stating the obvious, anyone is entitled to have a theory and
shouldn't be criticised unduly if it seems fairly implausible ("Do you
seriously mean to tell us, Dr Copernicus, that ................?").
It's the next bit which is difficult; before proclaiming a theory as truth
it should be subjected to tests which are capable of falsifying it, with
the results exposed to informed criticism through peer review and
publication, and in the case of proposed treatments with evaluation of
safety and of effectiveness through randomised controlled trials. All this
costs a lot of money and takes a considerable time, but raising false hopes
is an unkind thing to do when there is so much at stake.
As far as we (members of this mailing list) are concerned, the issue is
when potentially/purportedly diagnostic tests should be offered. Once
again, there should be evidence that testing can bring benefit. Because
safety is less of an issue with testing than with treatment the standards
can be relaxed a bit, but we still need either trial-based evidence of
benefit or a presumption of benefit because the testing can separate
patients into useful categories. If the tests are not yet validated in this
way then patients/subjects/relatives should be told that the test is
experimental and still under evaluation, and may not be of direct benefit
to them. And in this situation they probably should not be asked to pay for
it.
If the patients should not pay, then insurance companies or governments may
well feel they should not pay either. In relation to drugs, the
pharmaceutical companies pay for evaluations of their products but most
diagnostic tests do not attract that degree of financial support (or
ultimate financial return). One of the issues which clinical chemists must
address is how test evaluations are to be funded; by research grant
support, by using hospital resources, or by requiring a formal process
before a test is approved (which will add to costs and tilt the balance of
innovation even more towards industry)?
John Whitfield
Clinical Biochemistry
Royal Prince Alfred Hospital
Sydney, Australia
Phone (+61) 2 9515 5246
Fax (+61) 2 9515 7931
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