TV Scope: Dispatches: The Drug Trial That Went Wrong, Channel 4, Thursday, September 28th
Last March, eight healthy male volunteers went to the clinical pharmacology unit of contract research company Parexel in north London.
The company's website made the prospect of taking part in a drug trial sound attractive - volunteers were to be paid for their time, which they could spend reading or relaxing "with digital TV, pool table, video games, DVD player, and now free internet access".
But for participants in the trial of drug TGN1412 in March, there was little opportunity to relax.
Shortly after being injected, those who received the placebo looked on in horror as the other six men rapidly became seriously ill, some screaming in pain, vomiting and collapsing.
Dispatches journalist Brian Deer followed the story of the worst affected volunteer, 20-year-old plumber Ryan Wilson, who went into a coma after the trial.
Wilson survived, but he lost sensation in his fingers and has since had his toes amputated. His immune system may also have been damaged, and he will need to be monitored for a decade.
This was supposed to be a standard trial of a monoclonal antibody with the potential to treat rheumatoid arthritis, leukaemia and multiple sclerosis. So what went wrong?
In a five-month investigation, Deer narrowed it down to a couple of possible reasons.
One, he contends, is that the sponsoring drug company TeGenero failed to carry out adequate tests in the lab on how the drug interacts with human cells.
The UK medical watchdog MHRA disagrees, saying it was happy with the standard of testing before the March trial.
Another potential reason Deer suggests is that the drug was infused too quickly into the patients. This was a "reckless" approach, according to one expert.
Whatever the reasons, the dose of TGN1412 delivered in London last March evoked "cytokine release syndrome" in the young men, where cells of the immune system pump out inflammatory chemical messengers.
The recipients suffered intense pain and multi-organ failure, and the Parexel staff appear not to have been prepared for the dramatic response.
While many of the men were out of the woods within 48 hours, Wilson was not so lucky. Throughout the programme, Deer charted Wilson's slow recovery, walking beside his wheelchair and catching him in moments of bravery and doubt.
Deer had plenty of access to Wilson, a likeable character who refused to mope about his blackened and senseless digits, and to his mother, who wants lessons to be learned so no one has to go through this again.
Meanwhile, the interactions we saw with the drug company, the medical watchdog and Parexel were limited, and a belligerent Deer did not accept their answers.
Disasters like TGN1412 are mercifully rare in the hundreds of clinical trials carried out each year in the UK, and an expert committee has now called for even tighter regulation of monoclonal antibody trials and more conservative dosing regimes.
TeGenero filed for insolvency in July.
(Review by Claire O'Connell)