I know it's a bit late for you, but believe me, developing medicines for
children is a nightmare.
For the simplest case, it is not only very difficult to find volunteers
for clinical pharmacology work (pharmacokinetics in kids may be
different), but informed consent a minefield. Structured collection of
body fluids is very difficult.
We are developing a new medication for patients ages 6 and up.
One of the biggest barriers in School age children is that every time
you want to evaluate them, they have to take time off school (parents
might believe that is a problem when it is not for their direct
benefit), and have to have a carer to accompany them. Sponsors like us
find that we have to cover double travel costs and out of pocket
expenses (e.g.loss of earnings for parent).
There are two issues: doses of existing medicines that are used for kids
in the same way as adults and medicines specifically aimed at kids. The
latter are problematic, as sometimes they are for rare diseases, and
there is little commercial incentive for developing medicines for
children.
Needs to be incentives for the industry to specifically generate
paediatric data, or conversely, now you cannot get a new licence for
that age group unless there is data.
Dr Martin Goldman
Senior Medical Advisor
Forest Laboratories UK Ltd
tel +44 (0)1322 550550
direct line +44 (0)1322 429355
fax +44 (0)1322 555469
www.forestlabs.com
-----Original Message-----
From: Trefor Roscoe [mailto:[log in to unmask]]
Sent: 16 August 2004 18:32
To: [log in to unmask]
Subject: Paediatric pharmacology
Hi all,
Tomorrow morning the Government are making an announcement about
developing safe and effective medicines for children (following on from
the RCPCH report in May)
I have been asked to be interviewed by BBC news for a short item on the
6 and 9 O'clock news.
Anything anyone thinks I should be talking about?
Trefor
Dr Trefor Roscoe
Medical Information Consultant
www.medical-legal.co.uk/services.htm
P 0114 251 0447 M 07771 982 670
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