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.
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’.
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.