So at first, this reads like a woops sort of deal:
Drug research experts from the Netherlands say UK regulators did not receive findings that might have warned them of damage TGN1412 could do. Okay, the information wasn’t there, the assessors made their decision based on what was there – seems perfectly sound, sensible, and tragic. But when you keep reading the article, small things jump out and become alarming. For example,
In the case of TGN1412, the scientists from the German company TeGenero reported that the site in the body where the drug binds was identical in humans beings and monkeys. However, no detailed data on such a comparison was included.
So the assessors read a claim and simply accepted the statement of the researchers, not fact checking what was presented to them? The article goes on to say
When the Dutch researchers explored this they found clear differences between humans and monkeys.
The research file on TGN1412 also lacked information about how the drug affects certain human immune cells compared to monkey immune cells.
Dr Adam Cohen, from the Centre for Human Drug Research in Leiden, the Netherlands, said: “Essential information was absent.
So not only was essential information missing, but the information provided was inaccurate? What exactly were the assesors doing? Grading for grammar?
On top of that, the Lancet article
recommends drugs which affect the immune system, like the monoclonal antibody TGN1412, may be best given to people who are already ill.
This in and of itself is problematic. While yes, often times the only way to test the effectiveness of a drug is to test it against the illness, the first stages of safety testing should not be done in an already vulnerable population. What needs to be done is the assessors overhauling their practices to actually look at the data being presented and verify it for accuracy and completeness before approving human trials. Yeah, the pharma company appears to have lied, but this shouldn’t be surprising – the pharmaceutical companies are out for their bottom dollar, and they’re going to push things as far and hard as they can. The people who are there to act as a safety check need to actually do safety checking! It’s that simple.