Lawyer who represented participants in the TGN1412 drug trial to appear in BBC documentary
Gene Matthews, a partner in the consumer law and product safety team, who acted for four participants in their legal battle for compensation will appear in the BBC's The Drug Trial, Emergency at The Hospital
Posted on 21 February 2017
The BBC Two programme called The Drug Trial, Emergency at The Hospital airs tonight (Tuesday 21 February 2017) at 9:00pm and will be available afterwards on the BBC iPlayer.
It contains an interview with Gene Matthews, a partner in the consumer law and product safety team at Leigh Day, who acted for four of the men in their legal battle for compensation following the clinical trial of the drug, TGN1412, in March 2006. TGN1412 was a novel monoclonal antibody drug developed by TeGenero, a German biotech company, which was intended for the treatment of autoimmune diseases and leukaemia.
The Phase I trial (first-in-human testing) was conducted by Parexel at an independent clinical trials unit at the Northwick Park hospital.
Clinical and animal testing, including on non-human primates, had already been completed and seemingly did not indicate any safety issues connected to the drug.
The eight young healthy men who participated in the clinical trial would all be transferred to the intensive care unit at Northwick Park Hospital for severe and life-threatening reactions within hours of having the drug administered to them by intravenous infusion.
Each patient received the experimental drug in quick succession. Within 60 minutes, the first participants suffered severe headaches, muscle pain, nausea, vomiting, diarrhoea, severe fever, restlessness, rash and rigors.
After four hours, the volunteers developed hypotension, tachycardia and onset of respiratory failure. By the following day all the trial drug recipients had been admitted to the ITU at Northwick Park. Their symptoms progressed to multi-organ failure.
It was later established that the TGN1412 doses had caused a “cytokine storm” in the volunteers; an extreme and near fatal immune response.
The participants were hospitalised for periods of three to six weeks. The long-term effects on their immune systems remained unknown, though on discharge some were warned they may suffer an increased risk of cancers and auto-immune diseases.
Gene Matthews from Leigh Day, who acted for Rob Oldfield, amongst other trial participants in a successful compensation claim for their serious injuries, said:
“The TGN1412 clinical trial caused shockwaves in the medical, scientific and pharmaceutical communities and has changed the way in which first-in-human trials are now conducted.
“The apparent unpredictability of the adverse events associated with the trial drug raised significant alarms and the MHRA, which regulates clinical trials in the UK, tightened the regulations and new guidelines are now in place. In 2007, the European Medicines Agency, which protects public and animal health in 28 EU Member States, also improved EU wide regulations following this catastrophic incident. These improvements remain a very welcome development for all those volunteers participating in these important clinical trials.
“Despite this in January 2016 one man died and several others were left seriously injured during the Phase 1 clinical trial of painkiller BIA 10-2474 in Rennes, France.
“ANSM, the French national drug safety agency, has confirmed that eight volunteers received the fifth of the highest dose escalation of the drug simultaneously – seemingly a direct contravention of the EMA 2007 recommendations.
“More must be done to ensure that safe regulation is adhered to and increased transparency helps to ensure safety, at some point a human will always have to be the first to test a new drug. Inevitably, there will always be risks associated with clinical trials and an appropriate compensatory scheme should be put in place for when things do go wrong.”