Re: Orphan Drug

GB wrote:
"The Todal" <deadmailbox@xxxxxxxx> wrote in message news:47t5c6Fh9bmqU1@xxxxxxxxxxxxxxxxx

Some people will say: let's not criticise the drug company or the people organising the trial unless something comes to light to show that they *knew* that this would happen. To me, it is enough that they knew it *might* happen. As far as I'm concerned, testing drugs on humans is fine, provided you know for sure that the most that can happen is some discomfort that can be reversed and will leave no lasting ill-effects.


That's impossible to know for sure.



If they genuinely had no idea what could happen, then they should have found another way of testing it and perhaps it would have been forgiveable if they had administered it just to one person.


The Times (fount of all my knowledge, at least on this) reports that Textbook of Pharamceutical Medicine recommends that the test should not have been administered to all 8 people at once.




Indeed I pointed this out yesterday. It certainly look like this trial was badly conducted. Full doses seem to have been given to all volunteers, all on the same day. If so that would be serious negligence maybe even corporate manslaughter (if anyone dies). Doses should be increased gradually given on separate days in case the drug is contaminated or triggers a reaction. This does not seem to be a drug trial so much as a game of Russian roulette with syringes.
.

Relevant Pages

  • Re: Orphan Drug
    ... As far as I'm concerned, testing drugs on humans is fine, ... Textbook of Pharamceutical Medicine recommends that the test should not ... Full doses seem to have been given to all volunteers, ... This does not seem to be a drug trial so much as a ...
    (uk.legal)
  • Excellent coverage of LDN in todays Daily Mail (a UK national newspaper)
    ... Could low doses of a drug for alcoholics ease the agony for sufferers of MS? ... 'It's possible patients with MS who use LDN will have no further progression ...
    (alt.support.mult-sclerosis)
  • Re: Co-Dydramol (dihydrocodeine) has me knackered
    ... I think you would be very well served by explaining that you are having ... difficulty with the sedative effects of this drug, but that it is giving you ... Perhaps he will be able to devide your doses so ... don't want to loose my right to this drug. ...
    (alt.support.chronic-pain)
  • Re: Large scale study of the effectiveness of prayer
    ... I think the design of the trial can be ... If the drug had been given to a different subject every few ... They did stagger the doses, but, yes, one of the criticisms is just that, that there ought to have been a big enough gap to detect the problem. ...
    (uk.philosophy.humanism)