Product liability solicitor Brian McFerran discusses clinical trial transparency and a recent judicial review against the UK Health Research Authority
A recent High Court case has brought the issue of clinical trial transparency back into focus. Richmond Pharmacology Ltd, a clinical research company, brought a judicial review action against the UK Health Research Authority contending that the HRA had been wrongly asserting that those carrying out clinical trials were under a legal duty to register their trials on publicly available websites and to publish data about the outcome of such trials.
On 28 July, Mr Justice Jay ruled that registration and publication of clinical trials prior to September 2013 was not a legal requirement and the wording of the HRA’s website was unlawfully ambiguous and potentially misleading.
The case would suggest that the HRA attempted to give retrospective effect to their (lawful) requirement to register clinical trials and the Court found they had blurred the lines between legal requirements and ethical duties. In reality, the judgment is unlikely to have any long term bearing on this area of law with the coming into force of the new EU Clinical Trial Regulations in 2016/2017.
So why does transparency matter? I think it would astound most people if they were aware of the lack of clinical trial data available to doctors and the historical shroud of secrecy that surrounds drug regulation. In 2014, it was reported that only 53% of clinical trials are published in journal articles1. Furthermore, trials with positive results for a manufacturer are more likely to get published.
Most people trust their GP and believe they have access to the necessary data to help them make an assessment about whether a particular drug is suitable for them. Doctors need the results of clinical trials to make informed decisions about which treatment is best, but the reality is that only a fraction of the data generated by clinical trials is available for review. Perversely, manufacturers then expect doctors to make a judgment on whether the benefits of prescribing a medicine to a patient outweigh the risks.
This issue is best exemplified by the swine flu scare in 2009 when the government dropped an eye-watering £424m stock-piling Tamiflu before they had a good look at all the raw data. 5 years later the Cochrane Collaboration (a not-for-profit organisation that undertakes unbiased systematic drug reviews) reported Tamiflu had little to no impact on the complications of flu infection, barring reducing the duration of symptoms by a few hours.
Until recently, drug companies were under no obligation to publish trials with unfavourable results and were not breaking any laws as a result. Negative trials could be quietly discontinued and results buried, whilst most positive results could be published and submitted to the appropriate regulator for review.
Thankfully, in recent years the tide has started to turn with legislators, regulators and even some drug manufacturers getting on board with transparency.
In a massive victory for transparency campaigners, spearheaded by the AllTrials campaign, the European Parliament voted in April 2014 to adopt the EU Clinical Trials Regulation which will require that all drug trials conducted in Europe are registered with clinical study reports made publicly available following completion of the trial. However, the legislation does not require manufacturers to publish historical data.
So what happens when people are injured by a defective drug or medicine? Personal injury claims against drug manufacturers are far from straightforward under UK law. For a drug that already has market authorisation, a claimant has to establish under the Consumer Protection Act (“CPA”) that the safety of the drug is not as such as ‘persons generally are entitled to expect’ and the drug caused the injury they allege. It is a difficult legal test, but one of the starting points for lawyers is looking at clinical trial data to see if the benefits of a particular drug really outweighed the risks. This is a difficult task at the best of times, but becomes impossible when faced with incomplete data. A drug company may be obliged to disclose all clinical trial data as part of the legal process, but this may only occur years into a claim.
For a drug that does not have market authorisation, a clinical trial participant can bring a claim if they are harmed as a result of being involved in the trial. The Clinical Trial Compensation Guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) suggest that if a claimant can demonstrate that the harm was caused by participation in the clinical trial, the Pharma company will pay compensation without the claimant needing to prove fault. In reality there is a gaping hole in the ABPI regime because the final arbitrator of whether or not the harm was caused by the drug is, in fact, the Pharma company itself (most rational people would think that an independent arbitrator would be sensible in the circumstances). An injured person could also consider bringing a claim in the Courts for breach of contract (that contract stemming from the consenting documentation they signed when they enrolled on the clinical trial). They may also attempt to claim under the CPA but would face the problems identified above.
Whilst the recent European legislation is a positive step, it doesn’t solve the problem of the countless unreported trials on medicines that we are continuing to use today. Making historical data available presents a major challenge, but it is one that drug companies need to meet. Patients have been empowered in recent years by greater access to knowledge and they have come to expect instant access to information so they can make up their own minds about what treatments they choose to undergo.
Further, this isn’t just a European issue, for transparency to work, it needs to be global. The AllTrials campaign has recently set-up a US branch signing up an impressive 50 patient support groups already.
Ultimately, transparency isn’t just about good scientific principles and promoting good clinical decisions by doctors, it is about empowerment and access to justice for people injured by dangerous drugs and medical devices when the safeguards built into regulation have failed them.
There is no question that ever-developing technology makes the job easier. It was almost unthinkable 20 years ago that hundreds of thousands of pages of text could be uploaded to cloud storage in minutes.
The recent High Court case highlights the fears within the pharmaceutical world about commercial confidentiality, but the Court ruling won’t derail the transparency campaign. The public’s appetite for information will only increase and greater transparency in respect of all medical treatments, including drugs and medical devices, is inevitable.