AllTrials victory in judicial review

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

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.”

Conrad Bower

Richmond Pharmacology instigates judicial review to suppress transparency in clinical trials


Organisations Supporting AllTrials

The long hard fight for more openness in drug trials is being threatened by a company called Richmond Pharmacology, which is opposing the Health Research Authorities plan to register all clinical trials. Richmond Pharmacology are challenging the HRAs plans for greater transparency in clinical trials by instigating a judicial review of the HRAs proposals to prevent them coming into force.

Sense About Science is a small charity, and a founding member of the AllTrials campaign, that is determined to prevent Richmond Pharmacology from derailing the plans for increased transparency in clinical trials. They have taken the risky step of committing their lawyers to intervene in the judicial review, this could result in financial catastrophe for the charity if their case is unsuccessful.

We know that withholding the results of clinical trials costs lives, wastes money, inflicts avoidable suffering and harm on patients

The  AllTrials campaign was started in 2013 and its stated aim is for ‘all past and present clinical trials to be registered and their full methods and summary results reported’. It is a global initiative formed by a coalition of members; in the UK these members include: Sense About Science, Ben Goldacre (of Bad Science), British Medical Journal and the Cochrane Collaboration. The author of ‘Bad Science’ Ben Goldacre is passionate about promoting good science and is an active campaigner for AllTrials. He has recently appeared in a promotional video called ‘AllTrials: Make clinical trials count’ in which he says ‘We know that withholding the results of clinical trials costs lives, wastes money, inflicts avoidable suffering and harm on patients. And so I don’t think it is any longer tenable to say we didn’t know’.

A well documented example of the harms that can occur when clinical trials are not published is Seroxat; a selective serotonin reuptake inhibitor(SSRI) anti-depressant developed by GlaxoSmithKline and first marketed in 1992. In 2003 it was revealed that it was responsible for a higher risk of suicide in adolescents taking Seroxat (a.k.a. paroxetine) for depression. It turned out that GlaxoSmithKline knew this risk and had suppressed clinical data that proved it. There was also evidence of deliberate, suppression of unfavorable Seroxat research results, a GSK internal document stated “It would be commercially unacceptable to include a statement that efficacy [in children] had not been demonstrated, as this would undermine the profile of paroxetine”. In 2012 GSK were ordered to pay $3 billion dollars by the US Justice Department for their part in suppressing data on the increase in suicide risk in juveniles on Seroxat, and then marketing the drug to treat juveniles with depression.

kind donations have played a significant role in our decision to take on this struggle for clinical trials transparency

James Cockerill a campaigns manager with Sense About Science says ‘letters of support, offers of help and kind donations have played a significant role in our decision to take on this struggle for clinical trials transparency.’ The amount of money donated to Alltrials currently stands at £72,877 from 2782 donations, and they will need more to stop Richmond Pharmacology and its backers succeeding in court. Donations are still needed here, and the petition in support of AllTrials can be signed here.

Richmond Pharmacology is a firm based in London that specialises in providing small scale clinical studies, usually testing a new potential drug, for the first time in humans, on a small number of volunteers. Their clients include leading pharmaceutical companies and biotechnology firms, and business is good with a reported 44.1% increase in total sales reported in 2014.

Organisations Supporting AllTrials

Organisations Supporting AllTrials

According to Cockerill, time and cost consuming games are being utilised in the oppositions legal strategy ‘Richmond has now changed their argument three times and has altogether abandoned some arguments it relied upon earlier…Richmond then asked the Court not to allow AllTrials to be heard. We had written to Richmond and the HRA outlining our planned argument to the court and inviting their response. HRA replied to us, Richmond did not. Instead they went straight to the Judge and asked him not to hear us.’ Then at the very last minute Richmond asked for a substantial change to the case ‘They want the Court to declare that no trial sponsor or person running a trial has any legal requirement to publicly register any clinical trial unless the sponsor has given a legally binding commitment to do so’.

Manchester County Court

Manchester County Court

Richmond are also trying to undermine the AllTrials case by telling the court ‘AllTrials references to international rules and protocols are irrelevant and will only add to their costs’. An initial hastily arranged court case, by Richmond, in Manchester on Monday the 29th of June 2015 was cancelled and has now been rescheduled for the 16th of July in the Manchester County Court. The case has a David vs Goliath element due to the limited funds of Sense About Science and the considerably larger funds of Richmond Pharmacology. The result of this case has serious implications for the health of people in the UK, and the rest of the world; let’s hope David wins.