Do no harm
New life-saving medicines require rigorous tests on humans — but how do we avoid a repeat of the “Elephant Man” drug trial?
The Sun / Evening Standard
- Bill Borrows
The Drug Trial That Went Wrong is on Wednesday at 3.30pm Radio 4. Add it to your collection
Ad
In March 2006, out-of-work actor Rob Oldfield was sitting with three strangers in a room at Northwick Park Hospital in north-west London, waiting to be injected with a drug known only as TGN1412. It was part of a clinical trial by Parexel, an American research organisation, on behalf of German biotech company TeGenero. Oldfield would receive £2,000 for taking part.
The drug was administered at 8am, and soon after Oldfield began to feel cold. As his condition deteriorated, he vomited, and acute discomfort gave way to alarm when medical staff arrived with “life-support stuff” for one of the other trialists.
The TGN1412 test failings led to major safety reforms. Getty
The participants experienced a severe immune reaction known as a “cytokine storm”, leading to multiple organ failure, and were transferred to intensive care. Oldfield’s mother was advised to say goodbye to her son. Fortunately, after three weeks in hospital Oldfield made a full recovery. Others were less fortunate: one participant had his toes and parts of his fingers amputated. The incident received widespread media coverage, with sensational headlines such as “We saw human guinea pigs explode” and “My brain was on fire, my head had swollen… I was the ELEPHANT MAN”. The trial continues to be referred to in the media as the “Elephant Man” drug trial.
As new regulations for running clinical trials are being rolled out for the first time since that watershed moment in British medical history, Dr Margaret McCartney presents The Drug Trial That Went Wrong on Radio 4. “What we wanted to do with this programme was be fair,” explains the Glasgow GP. “We have examined what happened and what the two sides of the argument are today in terms of innovation versus safety.”
TGN1412 was designed to manipulate the immune system and was developed in the hope it would revolutionise treatment of leukaemia and rheumatoid arthritis. It had already passed animal testing; Oldfield and his cohort were the first-in-human subjects. “The animal study seemed to say it was safe,” says McCartney. “However, humans don’t carry the same type of receptors that the drug acted on. They didn’t know what they didn’t know.”
As Professor Sir Gordon Duff reported following his investigation into the events at Northwick Park Hospital, there were certain procedural protocols in place that exacerbated the situation. “Looking back, there were things that obviously shouldn’t happen again, such as giving patients the drugs very quickly, one after the other,” says McCartney.
This process meant that there wasn’t enough time for immediate adverse reactions to be taken into consideration. Duff also noted that pre-clinical development studies failed to predict a safe dose for use in humans, even though the regulatory requirements were met. “Professor Duff found that there were lots of things that could be improved upon in terms of safety,” says McCartney. His report contained 22 recommendations for the industry around the timing and size of doses, the tightening of pre-clinical trials and consultation with independent experts.
A passionate advocate for evidence-based medicine who volunteered for the Novavax trial during the pandemic, McCartney endorsed those recommendations and now welcomes the new regulations that will come into force on
28 April 2026 and bring the NHS in line with medical bodies in other developed countries.
However, she’s also keen to acknowledge that, “There’s always pressure to come up with new, better drugs. HIV used to be a fatal condition, and now it’s managed because we have drugs that really work. At the same time, we also know that drugs have side effects and that the marketing departments of pharmaceutical companies are very keen to persuade us as doctors to prescribe more, newer drugs.
Ad
“The question, really, is about how we are going to navigate that safely in the future and make sure we give high-quality, effective drugs to patients, while also not doing anyone any harm.”
Authors
Bill Borrows
Ad
Ad
Get the Christmas double issue
Too much to watch at Christmas? Let Radio Times do the choosing to find something the whole family will enjoy.
Loading...
Ad
Loading...