Last year, the UK’s pharmaceutical industry body – the Association of the British Pharmaceutical Industry (ABPI) – released a survey on clinical trial reporting. A member of the public has gone through the survey, found out which companies’ trials didn’t report results and reported those companies for violating the ABPI’s Code of Practice. The ABPI’s self-regulatory body – the Prescription Medicines Code of Practice Authority – has now ruled on each of those cases and found that, as far as they are concerned, results from many of those trials don’t need to be made available because the trials were done in the past or outside the UK. For example, one ruling states:
“If these studies had no UK involvement the matter did not come within the scope of the UK Code. If these studies had UK involvement but were completed before 5 January 2006 they would be exempted under the 2005 Joint Position. … The results of studies that completed before 5 January 2005 did not need to be disclosed. Thus the Panel ruled no breach of the 2008 Code including Clause 2.” In the case of AUTH/2671/11/13 – Member of the public v Servier.
These old and non-UK studies are, of course, part of the evidence base for the medicines we use in the UK today. We need to know what was found in them.
Dr Ben Goldacre, co-founder AllTrials
Patients, professionals and policy makers expect the ABPI to show leadership in creating an ethical and professional pharmaceutical industry. Instead the ABPI is happy to help companies hide behind excuses.
The rulings are listed below:
- AUTH/2671/11/13 – Member of the public v Servier
- AUTH/2674/11/13 – Member of the public v GlaxoSmithKline
- AUTH/2666/11/13 – Member of the public v Sanofi
- AUTH/2669/11/13 – Member of the public v Shire
- AUTH/2665/11/13 – Member of the public v Genzyme (Sanofi)
- AUTH/2673/11/13 – Member of the public v Recordati
- AUTH/2670/11/13 – Member of the public v Otsuka
- AUTH/2657/11/13 – Member of the public v AstraZeneca
- AUTH/2662/11/13 – Member of the public v Novartis
- AUTH/2667/11/13 – Member of the public v Amgen
- AUTH/2654/11/13 and AUTH/2656/11/13 – Member of the public v Bristol-Myers Squibb
- AUTH/2661/11/13 – Member of the public v Ferring
- AUTH/2664/11/13 – Member of the public v Takeda