UK pharma deluged with trial data complaints

A new tactic in the battle to force pharma to disclose trial data has been revealed – a deluge of allegations that firms are not following the UK industry's own self-regulation code.

The Prescription Medicines Code of Practice Authority (PMCPA) is the UK pharma industry's self-regulatory body, and passes judgement on complaints from healthcare professionals, other pharma companies, and members of the public.

In what looks like a co-ordinated campaign to force UK pharma companies to disclose data under their own existing Code of Practice, the regulator has been flooded with 24 separate complaints.

The volume of complaints is unprecedented for the PMCA, which usually deals with one-off cases from doctors and rival firms complaining about misconduct or sharp marketing practices.

The new cases on the PMCPA website – all titled 'clinical trial disclosure' - involve 20 different companies, including GSK, Sanofi, AstraZeneca and Pfizer, and relate to alleged non-disclosure of data on specific drugs, such as AstraZeneca's Iressa and GSK's Benlysta.

The full list of ongoing cases can be found here:

http://www.pmcpa.org.uk/cases/Pages/ongoing-cases.aspx

The identity of the complainant, however, remains a mystery - the PMCPA process allows complaints to remain anonymous, and no-one has come forward to declare their role in the new tactic.

Keeps data transparency in public eye

The anonymous complaints are very much in line with the AllTrials campaign, which was launched in January 2013 and calls for all past and present clinical trials to be registered and their results reported.

However a spokesperson for Sense About Science, one of the organisation's co-ordinating the AllTrials campaign, said it knew nothing about the PMCPA complaints, and was not involved in their submission.

Whatever the identity of the PMCPA complainant or complaints, their aim is clearly in support of the AllTrials movement, which has been able to claim significant victories so far.

GSK broke ranks with the rest of the industry in signing up to the campaign in February 2013, with Janssen following suit in January this year. Both firms have signed up to campaign's requirement to give access to full clinical study reports (CSRs), provided the data is used by researchers for legitimate scientific reasons.

Many other companies have made their own arrangements for greater data disclosure, but generally cite concerns about potential misuse of data for not signing up to all the AllTrials demands.

Pro-transparency campaigners such as Ben Goldacre regularly point out that even where clear regulations exist requiring data disclosure, many pharma firms do not comply.

The new PMCPA complaints are clearly aimed at highlighting this problem, although there are signs that more than half of the cases have been rejected by the PMCPA committee; where cases are listed with the term 'complainant may appeal', this suggests that it has already ruled in favour of the pharma company. There are, however, eight cases - including ones against Amgen, Genzyme, Pfizer and Novartis - where both complainant and respondent can currently appeal, suggesting that the PMPCA has found breaches of the Code.

The PMCPA cannot impose tough sanctions on member companies, but it can censure those not following the Code, and order them to rectify the problems – which in this case would involve disclosing data.

Most of the complaints were submitted on the same day – 18 November 2013 – and the PMCPA is still making its way through each of the cases, having not issued a definitive ruling on any of them yet. A spokesperson for the PMCPA says some cases could be resolved within the next month, but that those subject to appeals might only be concluded in the summer.

European legislation on its way?

Clause 13 of the UK pharma industry Code of Practice states that pharma companies are expected to register current and future trials within 21 days of enrolling the first patient.

The Code then demands that results must then published within one year of marketing authorisation or one year from completion for marketed products. This is in line with an international Joint Position on the Disclosure of Clinical Trial Information issued by the global pharma industry in 2010.

But transparency campaigners believe that voluntary measures don't go far enough, and cannot be effectively enforced.

The AllTrials campaigners are backing new European legislation on clinical trial reporting which could be passed into European law if members of the European Parliament vote in favour of it on 3 April.

Links

All-Trials – not much to argue with but much to discuss

Patient perspectives: Les Halpin