Brian Deer has been using the Freedom of Information Act to look into TGN1412:
Confidential documents obtained by The Sunday Times and Channel 4’s Dispatches programme reveal the drug was administered on average 15 times more quickly to the volunteers than to monkeys in earlier safety studies. The possibility that such a crude error led to the disaster is likely to raise questions over whether the government’s Medicines and Healthcare products Regulatory Agency (MHRA) scrutinises trials adequately and protects the public from the risks of new medicines.
After the “Elephant Man†trials at Northwick Park hospital, London, in March, which left two men fighting for their lives and all six in intensive care, the agency said the reactions resulted from an “unexpected biological effectâ€. However, experts say the drug, TGN1412 — one of a new generation of “magic bullet†treatments targeting the immune system — was infused so quickly into the volunteers that the potential for life-threatening problems was foreseeable.
Brian Deer’s Dispatches programme will be on Channel 4, Thursday at 9pm.
One Comment
I think the MHRA have very effectively managed to deflect any blame on their part in this matter-they approved the application after all. The point of the MHRA is that they should be constantly reviewing the expertise within the agency in line with developments in medicine. TGN1412 is not the first monoclonal antibody on the market-and it would not be first in class for leukaemia either. Reading the Duff report the recommendations are woolly at best and I’m not sure the interim guidance would protect patients. It seems as if they have not thought through the challenge presented to them properly, for example they are advocating the use of NO(A)ELs- the pharma industry are using MABELS which use far smaller concentrations and have been for some time for even NCE’s. Isn’t it time we have an Agency that is relevant to our times, with appropriate in-house expertise so that they can produce clear and effective guidance?