TGN1412 – Day 14

July 5, 2006

Shut up in my hotel room, with decent internet access for the first time, I spent the day reading about the disastrous Parexel TGN1412 clinical trial I briefly mentioned on Day 0. Its the first time I read the full details and I found it chilling.

test tubes

The drug TGN1412 was a newly developed strain of antibody directly effecting the genes of the immunne system. It was genetically engineered using hamster DNA. Its first usage in humans took place in London in early March. Six subjects were hospitalized with extreme adverse reactions relating to a cytokine burst. Essentialy their immune system’s white t-cells starting attacking their internal organs. Within minutes of being injected they began puking and shaking. Their heads and neck and swelled up like watermelons and a few were reported screaming stuff like “My brain is on fire….” ! The most recent report I could find was from early May. At that point in time one participant was still hospitalised and facing amputation of his fingers, toes and, possibly, he feared, his hands and feet. All of them may face lifelong complications and unfortunately under British law their compensation money may be limited to 30 or 40 thousand pounds. I hope they have some good lawyers representing them. My heart goes out to them.

For anyone reading my diary interested in doing a clinical trial themselves, I urge you to read the following articles:
http://www.iht.com/articles/2006/04/07/news/drug.php
http://www.bloomberg.com/apps/news?pid=specialreport_index2&sid=aG3sg1rIkL4U&refer=news

at least so you know the worst case scenario. Yet consider that such an incident is extremely rare, and by itself does not invalidate clinical trials, rather points to the ongoing development of safeguards and informed consent.

It occurs to me that my diary until now has maybe the wrong focus. At least in terms of what most people are interested in. I’ve hardly conveyed any information about the actual drug being studied in my trial, and instead concentrated on my personal feelings about needles and catheters, and the social dynamic in the group of participants. Its not that I don’t find the pharmacology stuff interesting, but the drug is not as experimental as TGN1412 and so perhaps doesn’t warrant as much attention.

I’m going to go back and re-read the trial guide and my consent form though, because I wonder if I would have so easily volunteered if I knew what I know now about the TGN1412 trial. Of course, any doubts I have my be redundant if it turns out I received the placebo.

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