MHRA report on drug trials23rd May 2006
A report by the Medicines and Healthcare products Regulatory Agency (MHRA) has criticised the firm which carried out the drug trial which left six men seriously ill.
All six previously healthy men suffered multiple organ failure after being given TGN1412, which is designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis. One is still in Northwick Park hospital, and is said to be making steady progress.
The MHRA said that "unexpected biological effect" was the cause of the adverse events. The MHRA found the drug was given in correct doses and there was no sign of contamination or manufacturing errors, however it lists a catalogue of administrative errors. Parexel failed to follow several trial procedures including keeping proper patient records, ensuring 24-hour medical cover, and checking insurance.
Parexel failed to complete the full medical background of a trial subject and the medical history of one of the volunteers was not updated. There was also no contract in place between TeGenero, the makers of the drug, and Parexel at the beginning of the trial. In addition, the MHRA reported one of the doctors involved did not have adequate training or experience. Two of the volunteers were allowed to leave before it was confirmed they had received the placebo.
At the time of the trial, Professor Herman Scholtz, from Parexel, said the clinical research organisation had followed regulatory, medical and clinical research guidelines during the study.
The solicitor representing two of the men has called the MHRA report "totally inadequate" and said it was "a whitewash". The solicitor said it leaves many questions unanswered, and it gives no detailed information about the pre-clinical trials, about which there has been conflicting information.
The government has set up a working group to examine the transition from animal to human testing of new drugs. It will be chaired by Gordon Duff of Sheffield University, and is set to produce an interim report within three months of starting work.
Four of the volunteers who were taken seriously ill during a drugs trial have been given unconditional interim payments of £10,000. Their lawyer said the money was given by insurers to help in the short term. They had contested an initial £5,000 offer when it also emerged that the men may not receive adequate compensation because the pharmaceutical firm that developed the drug lacks sufficient insurance coverage.
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Title: MHRA report on drug trials
Author: Sue Knights
Article Id: 375
Date Added: 23rd May 2006