E-DRUG: BBC Panorama on antidepressants and UK Regulatory Authority (2)
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Dear colleagues,
I have looked at the BBC documentary on seroxat with great interest and great sadness.
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 evidence.
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:
http://www.bbc.co.uk/newsa/n5ctrl/progs/panorama/latest.ram
]