Crucial information which could have warned researchers about the damage TGN1412 could do to human volunteers were not sent to UK regulators, say experts from The Netherlands.

You can read this report in The Lancet.

Six men became seriously ill almost immediately after being given the experimental drug – one of them, Ryan Wilson, has since had fingers and toes amputated.

The report recommends that in future:

— When experimental drugs are tested they should be given to just one person initially

— Experimental drugs which work on the immune system should be given to people who are already ill, rather than healthy volunteers

— More information should be given about how the experimental drug worked in animal studies

— More information should be given about how predictable the conclusions from the animal studies are

— Drug developers must make sure they provide all vital information for the trial assessors

— Evaluation for human experiments should be internationally consistent

According to the Dutch experts, scientists from TeGenero said that the part of the body where the drug binds is exactly the same in humans as in monkeys. However, they provided no detailed information to back this claim. In fact, the Dutch experts found the claim was false, as there were evident differences between monkeys and humans.

To see the report in The Lancet you need to be a subscriber:
Establishing risk of human experimentation with drugs
The Lancet 2006; 368:1387-1391

Written by: Christian Nordqvist
Editor: Medical News Today