March 15, 2006

Clinical trials and the ethics and practicalities of animal testing

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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…

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  1. I think we should volunteer animal rights activists to take the place of lab rats. After all, we couldn't just do it on the base of offering sums of money to people with disclaimers (which in any case I bet would be cheaper than breeding and taking care of lab animals), as that would mean that only poor people with little other way of earning decent sums of cash would be being taken advantage of!

    15 Mar 2006, 21:07

  2. Hear hear (to all points, but especially the last). It's a thought that's occurred to me in the last couple of days too.

    15 Mar 2006, 21:24

  3. Anyone who wants to be reminded of the utter stupidity of humanity in general would be advised to check out the "have your say" section of the bbc website regarding this issue. Half the people seem convinced that this suddenly renders all animal testing pointless.

    I think the pick of the bunch was this gem:

    While I sympathise with the victims and their families, I'm glad this has been highlighted by the media. What more evidence do we need to highlight how pointless and cruel the pre testing of drugs on animals is.
    These brave folk, without knowing it, have been martyrs for the plight of innocent animals.

    Animal rights protestors scare me.

    15 Mar 2006, 21:31

  4. It is unfortunate that animal testing did not pick up on this side effect before the drug was tested on a human, but I can honestly see no other way of modelling the drug's effect on a human without administering it this way. There has been argument from animal rights protestors demanding the use of human cell lines to test drugs rather than animals. This would not demonstrate the effect of the drug on such a complex system.

    The only real improvements to the system would have to be the search for model animal systems that are closer to our own.

    If the animal rights activists had their way we would see many more instances of these situations arising from clinical trials. Would they care to volunteer for the task?

    16 Mar 2006, 09:54

  5. It would really have helped if I'd finished writing the title of this entry before I published it. Ah well, 'tis done now!

    Chris, that is what happens with the human trials now. Although the volunteers are not allowed to be 'paid' as such, they are reimbursed for their time, which can be to the tune of up to £200 a day. That equates to over a weeks' full-time work at the minimum wage. I think there are a lot of people who sign up for these trials purely for the monetary gain. Would there really be that many people volunteering for these potentially risky trials purely for the benefit of society at large?

    Joe: Haha, a prize for the most misled argument ever. Worrying…

    Richard, the animal rights activists would surely rage even more if more testing was done on closer animal systems, i.e. primates.

    16 Mar 2006, 11:01

  6. Sarah – I meant that the general public should "volunteer" rights activists (i.e. against their will if necessary), after all if rights of animals are so important to them then doing the important work of lab rats for science and medicine should surely be something they'd be prepared to undertake :-D

    16 Mar 2006, 14:33

  7. Ah, I see. Well, exactly. It's interesting that by trying to promote the rights of animals the protesters are not asking for equality between species, but rather demoting humans to a level below animals: we would replace them as the guinea pigs, so to speak. Unless they think drugs trials should be stopped completely.


    16 Mar 2006, 16:53

  8. Surely that should be "TeGenero AG"; they're a German company are they not?

    The point still stands though, that I am perfectly happy with the way drugs are tested before coming onto the open market, and this incident is precisely the reason why these products are tested on small numbers of individuals first, and the men involved were no doubt aware that they were taking risks, and had signed away their rights in the case of unforseen side-effects.

    Of course, there is speculation that the procedures might not have been followed to the letter, and that unpromising earlier tests had been covered up. If this is indeed the case then, well, we'll prosecute that bridge when we come to it.

    16 Mar 2006, 16:53

  9. Ah, yes – it seems I cannot read. Mistake rectified, thanks.

    Needless to say, I agree wholeheartedly.

    16 Mar 2006, 17:04

  10. Christopher Rossdale

    I'd love to see what they signed – and how aware the subjects were of the risks. If they understood that there was a very real threat to their lives they may not have taken a mere few hundred pounds – i'm talking in terms of emphasis on threat put by the company.

    16 Mar 2006, 18:57

  11. Well considering the fact that there are possibly hundreds of these trials carried out each year, and they've been doing these trials for years, and as far as I can tell, this is the first case of this severity I can remember, the chances of this happening to any trial subject are still pretty tiny. I'd still be happy to test drugs, although I have reservations on certain types of medicines, and I'm looking forward to seeing how much the payments go up by after this incident…

    16 Mar 2006, 19:35

  12. You took the words right out of my mouth, Paul. It's really nothing to do with the agreement they signed: I'm sure these document are pretty standard. The point is that their reactions were totally unpredictable and that potentially every trial carried out on humans for the first time could result in serious repercussions. If the company produced the drug according to the appropriate regulations there really was no knowing that it would be any worse than any other. A doctor quoted in the BBC reports said that this was the first time that a trial had backfired in such a serious way. In most cases the treatment results in little or no side-effects and the volunteer goes home with a tidy lump sum.

    It is concerning, however, that this case may discourage people from taking part in the future, or may increase the payments required to entice them to do it. However, any company that attempts to pay their volunteers more will probably be treading on dodgy ground as they are not supposed to pay them for their participation, but only reimburse them for their time spend under observation. With a drop in volunteer numbers will come a slowdown in drug licensing, which is concerning. I seem to recall that a drugs trial reported in the news recently was struggling due to a lack of volunteers: this case will, I'm sure, not aid the situation.

    16 Mar 2006, 19:55

  13. Michael Jones

    "I think we should volunteer animal rights activists to take the place of lab rats."

    That's the best idea I've heard for quite a while. There is a problem with it though… a rat bears a far closer resemblance to a normal human being than does someone who sends people death threats and digs up their grandparents' graves because they happen to breed guinea pigs which are used for testing.

    Incidentally I'm actually opposed to animal testing in principle, but, unlike some, I realise that in certain situations there is no feasible alternative.

    16 Mar 2006, 22:11

  14. I'll just pose a question for the sake of it – Would a critically ill 'animal rights activist' refuse treatment if it had been tested on animals?

    18 Mar 2006, 21:06

  15. Good point Dougie (hi btw) – been raised elsewhere too!

    18 Mar 2006, 22:35

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