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."
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