The final investigation into the disastrous TGN 1412 drugs trial has presented 22 recommendations to the Health Secretary, the main one being that an advisory body to assess high-risk clinical studies should be established. It also recommends that volunteers who are ill, as opposed to healthy candidates, should be considered for some drug trials.
The TGN 1412 drugs trial, which nearly killed six male volunteers, took place at London’s Northwick Park Hospital in March this year. One victim’s head swelled up like the “elephant man” and another has had fingers and toes amputated. All six victims have been told their risk of contracting diseases due to impaired immune systems has gone up; this includes cancer and multiple sclerosis. They are considering suing the company that managed the clinical trial, Paraxel.
In addition to government action the pharmaceutical industry has revised its guidelines on clinical trial management and local and national bodies have agreed to improve communications.
Professor Duff who led the latest inquiry said he is confident the new recommendations, if adopted, would greatly reduce the likelihood of another disaster and ensure that the wellbeing of volunteers is put first.
A solicitor speaking for some of the victims expressed disappointment on behalf of his clients, suggesting that the report is the latest in a series of whitewashes and fails to point out who is to blame for the catastrophe.
TGN 1412 is an experimental drug for treating multiple sclerosis, leukemia and arthritis. It is a monoclonal antibody that stimulates the immune system’s T-cells. Tests on animals showed the drug to be safe. However, in this fated “first in man” trial the men who received doses of TGN 1412 suffered a massive inflammatory response (Cytokine Release Syndrome), and within 12 hours were admitted to hospital with multiple organ failure.
TGN 1412 was manufactured by the now insolvent German biotech company TeGenero.
Written by: Catharine Paddock
Writer: Medical News Today