March 15, 2006

scientist react to Parexcel drug trial tragedy

Two men are critically ill and another four are seriously ill in the intensive care unit of Northwick Park hospital after taking an anti-inflammatory drug as part of a drug trial.

Professor Chris Higgins, Director of the MRC Clinical Sciences Centre, said:

“Many antibody therapies treat and cure thousands of patients across the world. It would be a disaster if this one very serious incident impeded the development of new antibody therapies for serious diseases such as arthritis and cancer.”

Karol Sikora, Professor of Cancer Medicine and honorary Consultant Oncologist at Imperial College School of Medicine, Hammersmith Hospital, said:

“Monoclonal antibodies are very powerful selective tools to target specific proteins on the surface of cell. They have been used extensively as treatments for cancer, e.g. herceptin, and they can also target specific cells that regulate the immune response. In this case the antibody seems to have had very surprising side effects which were not predicted by extensive laboratory and animal studies. This is a very unusual situation and at this stage it is difficult to work out what is going on with the six men volunteers. One speculative possibility is that there was a cross reaction of the antibody with the desired target and some other protein, for example on kidney cells, resulting in kidney failure in the volunteers. This seems more likely than a contaminant.”

Dr Sophie Petit-Zeman, Director of Public Dialogue, Association of Medical Research Charities, said:

“Our hearts go out to the men involved in this trial, and their families. Developing new treatments is a complex journey from lab-based research to human studies, each step building on the one before. All new medicines undergo extensive laboratory and animal tests before being assessed in people and patients also rely on clinical trials to evaluate non-drug treatments, from medical devices and surgical procedures to psychological therapies, as well as new potential for existing treatments. It is essential to fully investigate what went wrong here, and minimise the chances of it happening again, while keeping in mind the track record of medical progress for patient benefit that has and will continue to accrue from clinical trials.”