E-drug: Unlicensed drug use in European countries (cont'd)
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[The below reported action apparently follows a BMJ publication of
only 2 weeks ago. The power of science! Should the bill be accepted,
it would provide a wonderful opportunity to study the impact of this
political intervention on unlicensed and off-label drug use. Distributed
as fair use. Hilbrand Haak, E-drug co-moderator]
BMJ 2000;320:208 (22 January)
MP introduces bill to protect children from unlicensed medicines
Gavin Yamey BMJ
Andrew Love, Labour MP for Edmonton in north London, introduced a
bill in the British parliament last week aimed at reducing the risk to
children from unlicensed and untested medicines.
The bill aims to strengthen the testing and licensing of medicines for
children, giving them the same protection as adults afforded by the
1968 Medicines Act. It has all party support and is backed by the
Consumers' Association and the Royal College of Nursing. An early
day motion supporting the measure and calling for doctors to give
more information to parents on drugs prescribed to their children was
signed by over 100 MPs.
In a recent Europe-wide survey, 67% of children received drugs
prescribed in an unlicensed or "off label" manner (8 January, pp
79-82). In the United Kingdom, the Consumers' Association is
concerned about the possibility of underdosing or overdosing of
worthwhile treatments, and the underreporting of adverse reactions by
doctors using drugs in this way.
Mr Love's bill calls for there to be a statutory duty on the government
to provide data on the use of medicines in children, particularly on
adverse effects. It also recommends that new drugs should be tested
on sick children in the context of rigorously designed clinical trials
with adequate consent. The bill does not suggest testing drugs that
are already in use.
Mr Love said: "The lack of a system of proper testing and licensing
means that doctors are left to sink or swim with their own knowledge
and clinical judgment. A lot of doctors recognise the inadequacies of
the system they are working in the dark. At the end of the day, they
will get blamed if anything adverse happens."
Recent EU guidance suggests that new drugs that are likely to benefit
children should be studied in children themselves, though there is little
evidence that this guidance is being followed (Br J Clin Pharmacol
1999;48:15-8). In the US, the Food and Drug Administration has
offered an incentive to pharmaceutical companies to carry out such
studies, which involves a six month extension to the drug patent.
Professor Imti Choonara, of the academic division of child health at
the University of Nottingham and one of the authors of the European
survey, believes that such financial incentives will need to be offered
to the European pharmaceutical industry to encourage the testing of
new drugs in children.
Regarding drugs already in use, Professor Choonara commented: "The
only way to get old drugs studied is if the Department of Health and
European Union say this is a problem area. The funding will have to
come either from introducing a new tax on the pharmaceutical
industry, which will be met with resistance, or by putting a portion of
the licensing fees into a central fund."
The Royal College of Paediatrics and Child Health broadly supports Mr
Love's bill, though it is concerned about the proposal to establish trials
of new drugs in children who are already ill. A spokesman from the
College said: "This could involve having to give placebos, or at the
very least a less efficacious treatment, to sick children. The other
major concern is precisely how you get consent from a sick child."
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