Newsnight investigation raises questions about the safety of medical device clinical trials

Research by Newsnight, broadcast on 9 December, highlighted the extent to which researchers conducting a clinical trial into the comparative safety of stents versus open heart surgery had allegedly manipulated and failed to publish key data. 
 
Newsnight maintained that, as a direct result of that failure to publish the results of the trial, guidelines had been issued across Europe that had led surgeons to believe that the outcomes for patients implanted with stents and those undergoing open heart surgery were the same.
 
The data omitted from the published results has now been obtained by Newsnight and demonstrates that far from providing patients with comparable outcomes, the use of stents are linked with higher mortality rates. Professor Nick Freemantle, interviewed by Newsnight, commented that based upon the unpublished data accessed by the program it was now clear that stents had “definitely increased mortality”, contrary to the published results upon which surgeons in the UK have been relying since as early as 2010. Other sources included in the programme suggested that the increased mortality rate for patients implanted with stents, in comparison with open heart surgery, was as high as 35%.
 
In response to the program, the European Association for Cardio Thoracic Surgery (EACTS) published a statement commenting that:
 
“It is a matter of serious concern to us that some results in the EXCEL trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice….We deeply regret the obvious concern that this will raise for some patients and their families.”
 
The Newsnight program raises issues of patient safety – particularly for individuals involved in clinical trials of medical devices.
 
Earlier this year the UK medical device regulator, the MHRA, made the decision to withdraw a novel vascular stent product marketed in the UK as Nellix. 
 
The Medical Device Alert required all surgeons in the UK to “immediately stop further implants of the device”. In the alert the MHRA explained that they had “concerns over the safety and performance of the device two years after implantation. Specifically, we have noted a high rate of graft failure due to device migration”.
 
The product was initially trialled in the UK in 2013, however it took six years before the clinical researchers involved flagged concerns regarding increased mortality and morbidity in patients implanted with Nellix. 
 
Patients affected are likely to have been implanted with the Nellix system between 2013 and January 2019 in large vascular NHS centres, including Liverpool, Cambridge and St George’s in London. As a result of action taken by the MHRA earlier this year, those affected by the failure of the Nellix system will likely have been contacted already by their operating hospital and called for additional screening/monitoring.
 
Zahra Nanji, medical device safety lawyer, commented: 
 
“The recent Newsnight piece shines a spotlight on the extent to which clinical trial data can be manipulated. The motivations for that manipulation may be financial – with many trials sponsored by medical device manufacturers. As demonstrated by the trials of the Nellix stents, the consequences of failed clinical trials can be devastating for those patients affected. As patients we trust our doctors, it is vital that they have access to complete and accurate data in order to ensure patients are properly consented and safeguarded.” 

If you have been affected by health issues relating to your Nellix device please contact znanji@leighday.co.uk