How the UK drug regulator looks at access to data, and EMA meeting 22 Nov

[Peter Gøtzsche]

Dear all,

thanks so much Trish for telling people what this is all about! I
never thought I should live long enough to see this happening when I
wrote our first letter to the EMA in 2007. Our plan was to expose to
the world how foolish the arguments of drug agencies were by writing a
paper about our experience with a concrete case, two slimming pills,
and then hope to make some progress from there. So, we were highly
surprised when, in 2010, the ombudsman's press release about EMA's
maladministration made EMA change its policies 180 degrees.

Our respect for the UK regulator, the MHRA, was already at the very
bottom, and it wasn't strenghtened by Kent Woods' comments at the EMA
meeting that everything was fine as it was. I regard him as a thing
from the past, like EMA's former director Thomas Lönngren was. The
train has left the station and Kent Woods obviously missed it.

I must tell you this: the MHRA denied giving us access to anything
saying the workload was too much, even though we asked for very
little. But then I reminded the regulator about the EMA's new policy
after 2010, and also that the UK was in fact a member of the EU
(although many British people might not feel it that way), and this
ultimately worked.

Today, I have compiled what happened over 7 pages. Please read it;
very interesting story, all about protecting companies, not patients!

bw

Peter