Tragic Drug Trial Participant Has Early Signs Of Cancer

Featured Article
Main Category: Litigation / Medical Malpractice
Also Included In: Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 06 Aug 2006 - 11:00 PDT


David Oakley, who took part in a drug trial that went tragically wrong earlier on this year in London, says he has now developed early signs of cancer. He is seeking compensation from Parexel, the company that carried out the trial. The drug trial made six healthy volunteers become seriously ill in March 2006, two of them almost died.

According to Oakley, some blood tests he had done a couple of months ago indicated that there were cells in his blood that should not be there. Apparently, these strange cells indicate the onset of cancer. He says doctors have told him that as it has been detected very early his illness is treatable.

Speaking to The Mail on Sunday, a British tabloid newspaper, Okley said "I'm going to try and be as positive as I can and if mind over matter has anything to do with it, well, I'll give it (treament) a good try. I can't dwell on it because if I dwell on it I'm just going to go down in a heap."

Oakley added that he is extremely concerned about damage that may have been done to his immune system. He worries more about developing such diseases as rheumatoid arthritis or multiple sclerosis where he is 'stuck in intense pain' without being able to anything about it, than the cancer. He said that someone has to be held accountable, Parexel should be accountable as the mistake was theirs.

The MHRA (Medicines and Healthcare products Regulatory Authority), UK, did find that Parexel had not followed procedures properly. Apparently, there was no contract between TeGenero, the makers of the drug, and Parexel, who carried out the trial. Parexel claimed it had followed procedures to the letter.

The experimental drug was aimed at treating chronic inflammatory conditions and leukaemia. During the trial the neck of one of the volunteers had swollen to three times its normal size. A girlfriend of one of the trial participants, in a BBC interview in March 2006, said her boyfriend 'looks like Elephant Man'. According to her, his head had become wider than his waist.

There were eight healthy volunteers in the trial for TGN 1412 (name of experimental drug). Two were given a placebo while the other six were given the experimental drug. All six who received the drug became seriously ill, two of whom nearly died. The ones who took the placebo were fine.

The Association of the British Pharmaceutical Industry (APBI) said it had never heard of anything comparable to that tragedy in a clinical trial. The trial was in its first phase of tests on humans.

The volunteers were paid £2000 ($3,800) each for taking part in the trial.

Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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