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Trials on Trial

18th March 2006

30032006_GreenCell1.jpgOn Monday 13th March, eight healthy volunteers took part in a phase 1 drugs trial at Paraxel's clinical pharmacology research unit at Northwick Park Hospital in northwest London. Six of the volunteers - who received the active drug rather than a placebo - rapidly developed catastrophic multi-system failure and were immediately entered into intensive care.

Two were still in a critical condition at the end of the month and doctors have predicted they could be comatose for as long as a year.

"This allegedly unprecedented event in clinical research represents a very human tragedy, one which will probably change for ever the face of clinical drug development," said the BMJ. The Times agreed; there are so many safeguards now built into drug trials that events such as the TGN1412 calamity are virtually unknown because problems are identified at the pre-clinical stage. So the implications of what happened are potentially "enormous.".

So what are the implications? At first sight it isn't quite clear; inquiries are still being conducted into what exactly went wrong in this particular trial. With each day that passes new fragments of information appear in the media but the question of whether this was an unfortunate and unpredictable disaster or whether there were errors in the manufacturing process or the way the trial was conducted will take time to surface.

Were the trial volunteers given the drug simultaneously and if so, why? What were the results of animal testing? Had risks been identified beforehand? Doubtless there will be lessons to be learned.

One of the key questions raised is the way in which trial volunteers are recruited. On the internet today you can still find a plethora of adverts enticing "healthy young male volunteers" with "computer games, DVD's, wide screen TV, digital channels and internet - and free meals." There is virtually no mention of risk anywhere.

The size of the payments have also come into question; the TGN1412 volunteers were each paid around £2,000. And while most people would have anticipated a decline in volunteers following the publicity surrounding TGN1412, the clinical trials industry has seen an increase in applications as more healthy young "but broke" males have woken up to this new potential source of income.

The Daily Telegraph reports the concern of the biotechnology industry that this very public disaster could lead to a "crackdown on regulations", perhaps even causing a reconsideration of the processes that allow drugs to progress from animal to human testing that will make it difficult to develop new medicines.

But perhaps this is not such a bad thing? A central problem now under the spotlight is whether these processes are appropriate for modern drug development, which has shifted from conventional and relatively simple chemicals to complex biotech drugs produced through genetic engineering.

TGN1412, for example, is in a class of drugs known as MABs - based on monoclonal antibodies - and which led to Cambridge researchers winning the 1984 Nobel Prize. These drugs have huge potential to help people with deficient immune systems but rely on being accepted by the human body. Laboratory mice only share 68% of their DNA with humans so it is much harder for scientists to judge from animal testing whether the drug will be safe for man.

There are also questions for the UK. At any one time, as many as 300 Phase 1 trials are in progress, involving about 2,500 people. This represents half of all Phase 1 trials in Europe. Why? "Because the regime is laxer here," says The Week. Perhaps not for much longer; there is already evidence that drug companies are fleeing Europe and the US to test their new medicines in developing countries where regulations are not so stringent.

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