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[e-drug] BBC Panorama on antidepressants and UK Regulatory Authority (2)

E-DRUG: BBC Panorama on antidepressants and UK Regulatory Authority (2)

Dear colleagues,

I have looked at the BBC documentary on seroxat with great interest and great 

During my time as a journal editor and as a regulator I have met most of the 
colleagues who have been interviewed and many of them have been good friends. 

However, I have a feeling that the system of drug regulation has broken down 
since the EU guidelines have introduced the summaries. Orginally the idea was 
that such summaries should have been written by independent experts, but there 
are not enough of them and there was immense pressure from industry that their 
own experts were quite capable to write such summaries. 

At the same time the sheer volume of the raw data increased to such an extent 
that it became almost physically impossible - also because of lack of 
experienced staff - to draft independent new analyses. The content and 
conclusions of the summaries are taken for granted and accepted as full 

Agencies tend to recruit young inexperienced physicians and pharmacists with 
almost no knowledge of epidemiology, statistics, clinical pharmacology or even 
clinical medicine, as reporters, simply because they are easier to get and much 
cheaper. After some years in regulation they are eagerly taken up by industry. 

I have some personal experience myself with independent analysis of raw data, 
and my experience has mostly been negative. On the one hand it is extremely 
time consuming and frustrating, and it has shown me that some industries (there 
are many good exceptions!) use very sophisticated methods to cheat regulators. 

On the other side it is very difficult to convince both national and EU 
committee members that the raw data show results which are diametrically 
opposed to the conclusions presented in the summaries; they (many of them are 
"opinion leaders") tend to disbelieve the reporting scientist and may even 
ridicule his/her conclusions. Outside pressure on the committee members can be 
intolerable and even unacceptable, but the public and their political 
representatives are ignorant about this. 

I sincerely hope that the initiatives of the Vancouver group and the Cochrane 
collaboration may change the attitude of the industry and the regulators.

Best wishes,

Leo Offerhaus

[See the programme live this week (needs broadband, Realplayer) at:

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