The AllTrials campaign, mainly funded through charitable contributions, faced the possibility of a serious setback to their work when they faced up to a legal team funded by the war coffers of Richmond Pharmacology. Richmond Pharmacology (RP) had took it upon themselves to oppose the Health Research Authority (HRA) regulations that required all phase 1 clinical trials to be registered. The judges decision, announced on the 28th of July, that the HRA has a clear legal right to monitor researchers’ compliance with legal and ethical obligations to register clinical trials, and a remit to impose sanctions on researchers who breach those obligations.
Ben Goldacre, author of Bad Pharma and co founder of AllTrials said of the case “It is ridiculous that it has taken 5 months of intense legal argument and cost probably hundreds of thousands of pounds, to get this statement of the status quo.”
What are the the solecisms of the Health Research Authority that you impeach them with
Prior to the case being heard the legal arguments of RP had changed on a number off occasions, as reported here. The case was heard in Manchester County Court on the 16th of July by The Hon. Mr Justice Jay. The arguments put forward by the counsel for Richmond Pharmacology in support of their judicial review were:
- Reduction in UK phase one trials due to increased regulation
- Confusing wording, lack of transparency, on HRA website page for sponsor declarations
- Publishing of commercially sensitive data would be disadvantageous to pharma companies
- The HRAs documents only set out good practice and not an absolute requirement for pharma companies and their sponsors to register; as their were no sanctions open to the HRA for non compliance
The presiding Hon. Mr Justice Jay was elevated to his position as a high court judge after acting as counsel for the Leveson enquiry. He dismissed the figures presented on the decline of phase one UK trials being due to regulation saying that it was as likely that “cheaper trials in India” was the cause. The judge appeared vexed by the primarily semantic driven arguments of “the lack of transparency” of the HRA web pages saying “What are the the solecisms of the Health Research Authority that you impeach them with”. The Judge also asked the counsel of RP “are you the only one complaining about this” to which the counsel replied by saying a Dr Ulrika Lorch (Medical Director at RP) had been elected on a body to debate phase one trials.
During the break for Lunch I spoke to Catherine a supporter of AllTrials who had travelled from Sheffield to attend the judicial review, she attended the trial ‘Because my son has been severely affected by the no disclosure of side effects in trials.” Catherine’s son had been taking an SSRI antidepressant, when his dose was doubled “He went completely physcotic, absolutely manic. He was taken in and diagnosed with schizophrenia.” Catherine’s hopes for the case were “That the HRA get what they want. That the phase ones are included [registered] so people don’t end up in a mess like my son.”
The Sense About Science team, representing AllTrials, became aware, during the break of an online report from the Ethical Medicines Clinical Group , which was critical of the judicial review instigated by RP. The report said “The judicial review brought by Richmond Pharmacology against the Health Research Authority – erroneous, a waste of public money and if left unchallenged by the biopharmaceutical industry, hugely damaging to it.”
I would hope that the ethical responsibility is seen as a legal responsibility
The counsel representing AllTrials was praised for his work for the trial by the judge saying “the defence has put up a powerful argument”. The main points of the defence argument were:
- The HRA being subject to the Care Act 2014 and therefore having a duty to protect participants of research and promote safe and ethical working.
- Duties of the HRA under the World Health Organisations Declaration of Helsinki.
- HRA having a specific statutory duty to promote safety, ethicacy and transparency.
- HRA made changes to web pages for sponsor declarations to make them clearer.
The Hon. Mr Justice Jay reserved his judgement on the case till the following week. Alice Fraser, who is about to embark on science degree at Manchester University, was present at the case as a supporter of AllTrials. Fraser had found the semantics heavy arguments of RP disappointing and was concerned about the ethics in the case “there was some dispute about ethical and legal responsibility and I would hope that the ethical responsibility is seen as a legal responsibility.”
Tracey Brown is a Director of Sense About Science, and a founding member of the AllTrials campaign, she was optimistic about the judgement to be made on the case “ The judge showed amazing insight into the issues and in challenging the version of events that was put forward… What became clear today is that there is a very strong ethical obligation, and the judge could not understand, and directly asked Richmond in fact, why you have a problem complying with the ethical obligations”. She was critical of RPs argument that increased regulation was responsible for the drop in clinical trials registered in the UK “because of the fact that the decline started well before any of the regulations mentioned.”
Organisations Supporting AllTrials
Brown went on to describe the long hard struggle for transparency by the AllTrials campaign “ Of all the challenges and barriers we have faced getting regulators involved, getting the other pharmaceutical companies engaged, of all the challenges this was the last thing we expected to happen. Because this concerns such fundamental ethical considerations”. She described her concerns when the judicial review was initiated “we realised that people could have thought ‘well that’s a strange little argument between one company and a regulator’, without realising that the potential for it, without any intervention to clarify what this is actually about; without that it could have ended up reversing not just what is going on in the UK, but could become something that would influence people world wide”. A summary of the case by Sense About Science can be found here.
The judgement of Mr Justice Jay mainly found for the defence saying that there were ethical and legal obligations for the HRA to register phase one trials, and that they could impose sanctions on anyone who did not comply. Ironically the judge accepted the claimants submissions that the relevant HRA website pages ‘failed the transparency test’, and these will probably need to be clarified once the Judge issues his order on the case.
Goldacre was disappointed that RP had ever pursued this case, but was happy with the judges decision “Today the judge did a very good service to every UK company working on clinical trials. They should celebrate and capitalise on this success, by telling the world that trials run in this jurisdiction produce reliable evidence, to the highest standards.”