Drug Trials - volunteers suffer multiple organ failure
15/03/2006
I would like to thank you again for the speedy and sensitive way in which you have dealt with this matter. I would have no hesitation in recommending your firm to anyone in the future.
Pamela, Castleford
An investigation has begun by The Medicines and Healthcare products Regulatory Agency (MHRA) into the clinical research company Parexel following a drug trial which has left six men in intensive care.
Parexel, a US company were conducting the trial of a drug to treat conditions such as rheumatoid arthritis and leukaemia at a research unit based at Northwick Park Hospital. Parexel confirm that they followed regulatory, medical and clinical research guidelines during the drug trial.
The MHRA will investigate the research unit and has also informed the Department of Health, the local strategic health authority and the police. As well as suspending the clinical trial authorisation (CTA), the MHRA will also review the application which was granted authorisation.
Two of the six men are reported as being in a critical condition and all remain in intensive care. Eight men took part in the clinical research, but two men were given a placebo. After taking the oral drug, the men suffered symptoms such as poor breathing and heavy swelling to the neck and head.
The drug has been identified as TGN 1412 manufactured by TeGenero AG, a small German pharmaceutical company, being developed as a treatment for rheumatism. As an inflammation suppressant the drug also has potential as leukaemia medication.
Alexander Harris, who are representing a number of patients injured by the arthritis drug vioxx, commented that "drug manufacturers and clinical research companies need to take responsibility for ensuring drug trials are conducted as safely as possible and that any possible risks are minimised and thoroughly explained to volunteers."
Back to news
If you would like us to provide you with advice with regard to your potential claim, please complete our brief claim form. We will reply to your enquiry within one working day.
Fill out our quick claim form
If you would like to speak to someone directly about your claim, please call our friendly team on:
0870 024 0558