Thursday, April 06, 2006

TGN1412 Trial Northwick Park Hospital Censored

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.

1 comment:

Fiddy said...

MHRA - In whose Interests?

The recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.

News this month that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.

The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?

For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.

A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?

The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’

Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)

Birmingham, UK