Clinical trials and the ethics and practicalities of animal testing
Writing about web page http://news.bbc.co.uk/1/hi/england/london/4808836.stm
I'm sure no-one can have missed the reports in the news over the past few days about the men hospitalised as a result of taking part in a clinical drugs trial. Many murmerings of incompetancy have surrounded the reports, and I'm sure someone from TeGenero AG will have to answer some very tough questions in the not-too-distant future.
This story raises many, many issues, including:
- The manufacturer said that there was no indication in previous trials that such an extreme reaction would occur: clearly in some cases the results of trials are extremely unsual and at odds with previous testing. In order to take part in the trials the men would have to have acknowledged and accepted the risk involved: they were going in with their eyes open. That's why people often get paid large sums to take part, I guess. Provided that the manufacturer abided by the regulations, surely they cannot be held responsible for something they could not have forseen.
- The manufacturer will undoubtedly be criticised, but if there was not way of testing this reaction before clinical trials came about how could they have done more? It is very difficult to pin any neglect on the company if the means whereby they could have avoided it does not exist.
- Should more testing be done before drugs are put under clinical trial? If you examine this and any other case it might be argued that more thorough testing could have been carried out beforehand. But does the extra time and money spent balance out the risk? And are any extra tests actually possible or, if they are, likely to expose the problems?
- I'm going to be controversial here: this is an example of why we need to use animal models for drugs testing. This in an extreme case where the non-human recipients (including mice, I believe) did not share the same reaction as the humans. However, in most cases animal testing does give a good reflection of the human reaction, and as such has prevented many potentially harmful drugs from being tested on humans. The reaction from animal rights activists will be that we are animals too and that we shouldn't harm them before ourselves. But the problem is that if we want new drugs to be approved they have to be tested. If we cannot test on animals, many more humans will have to suffer and, potentially, die. Step forward all volunteers to take the place of laboratory mice…