Press release: Latest findings on clinical trial suspension
I am unimpressed by the fact that the documentation released by the UK MHRA, the body responsible for finding out what went wrong with the experiment that left 6 men in the Northwick Park Hospital Intensive Care unit, has allowed large sections of the Clinical Trial Investigator's Brochure to be censored and withheld from the public. The most charitable interpretation is that it is to protect confidential intellectual property that the company has acquired, although we cannot be sure that it is not withheld in order to hide culpable misjudgements on the part of TeGenaro. In any case, if you have nearly killed 6 men in a clinical trial, you owe it to the world to share all information no matter how much it is worth to you, in order to prevent such tragedies in the future.
In future, the most obvious thing is to leave a 2 hour gap between administstering the drug to each subject. That way, it there is an immediate effect, (as there was in this case) only one person gets it, not the whole lot.
Second, from what I have seen, cytological testing was not done before human testing. TGN1412 must be tested on all manner of cells, to try to pick up one cell group that displays its toxicity, and that test must be run on all future drugs prior to testing on humans.
In the end, this is just one more example of how the interests of corporations take precedence over the interests of the human.