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Drug trials

Health officials call for access to unpublished studies during drugs trials

Wednesday, December 13, 2006 by: Jerome Douglas
Tags: drug trials, drug studies, patient safety


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(NewsTarget) A recent drug trial that almost killed six volunteers is being investigated by volunteers who are intent on preventing a repeat of the near-tragedy. The volunteer scientists are part of a group of British-government appointees led by Professor Gordon Duff.

The group has called for tighter controls to ensure no danger signals are missed in the run up to a trial. Specifically, the volunteer group emphasized the requirement to collect safety information from unpublished clinical studies. In addition, information and advice from independent specialist experts should be provided, according to Prof. Duff.

The experimental drug TGN 1412 was given to six men at Norwick Park Hospital in north London this past March. As a result, all men suffered a large variety of side effects -- including pain, vomiting and organ failure. One of the men was described as looking like "the elephant man" after his head became swollen.

Another one of the men lost part of his fingers and toes through a frost-bite reaction to the experimental drug, which was developed by the German biotech company TeGenero. TGN 1412 was designed to treat rheumatoid arthritis, leukemia and multiple sclerosis.

TeGenero's experimental TGN 1412 was meant to subtly "re-tune" the immune system -- but instead, the drug sent the immune systems in the six men into overdrive. Although laboratory and animal tests suggested the drug was safe, all six men almost died from the drug's side effects.

The working group established by Prof. Duff published an interim report in July, and this week's final recommendations broadly confirm the earlier findings -- but call for more changes relating to the medicine's regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has been accused of being too lax in its decision to approve the TGN 1412 trial in an effort to get the drug to market faster.

Duff's report specifically states that the MHRA should take independent advice -- possibly from an expert advisory group or medicines commission -- into account in the future before considering approval of all drugs.

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