Exactly what caused six men to react so catastrophically to an experimental drug during a Phase I clinical trial last month in the UK looks set to occupy some of the best scientific minds for a long time to come.
While expert opinion is divided over whether or not there were grounds for halting the trial prior to testing it on humans, public opinion seems to accept that it was a terrible accident. And it may even be that something positive will emerge from the incident.
The clinical trials process has come under the spotlight and - apart from the predictable reactions from the animal rights groups - it seems to have stood up to its unaccustomed scrutiny rather well. Naturally, people were shocked by what happened to the six men, but it has highlighted the crucial role that animal testing plays in drug safety.
Something went badly wrong this time, but there is little to support suggestions from some quarters that TeGenero, Boehringer Ingelheim or Parexel were reckless in proceeding to human trials. TGN1412 was tested on both rodents and primates with little or no indication of toxicity - and the dose given to the human volunteers was 500 times lower.
People do not appear to have been put off participating in clinical trials. Quite the reverse, in fact: the publicity has generated a flood of volunteers - a good proportion of whom say they are altruistically rather than financially motivated.
It was unfortunate that the news about the TGN1412 trial emerged only hours after the announcement that larger doses of AstraZeneca's Crestor (rosuvastatin) could potentially reverse cardiovascular disease. As usually happens, the bad news eclipsed the good.
Perhaps the coincidence was not as unfortunate as it seemed. Without human volunteers there would be no new drugs on the market, and without new drugs millions of people suffering from painful, debilitating and life threatening conditions would be condemned to a life without hope.
There is no progress without some risk. Someone has to be first, and those who volunteered for the TGN1412 trial deserve not only our sympathy but our admiration and gratitude. It would be interesting to know whether anyone from the pharma industry now feels a moral obligation to be a trial volunteer.
If any reader has participated and would like to share their experience, please do let me know.
Hilary Ayshford
Editor