In the April 6, 2006 LA Times, Mr Abramson made a shocking revelation when he said, "the FDA recently approved "phase 0 studies" in which human beings can be given minuscule doses of experimental drugs even before animal studies are completed."
A recent case in the UK demonstrates the dangers that could occur in such a study. In March 2006, six otherwise healthy men ended up in a London hospital in critical condition after participating in the trial of a new an anti-inflammatory drug, called TGN1412, to treat conditions involving the immune system, such as leukemia, multiple sclerosis and rheumatoid arthritis, conducted by the US based company, Parexel International Corp, on behalf of the German drug maker TeGenero.
The worst affected of the six men, Mohamed 'Nino' Abdelhady, called the Elephant Man because of the extreme swelling of his head, on April 5th, told the Daily Mail that he is plagued by nightmares.
"I felt as if I had rocks on my head," he recalled, "and I must have started hallucinating."
"Help me," he told the newspaper that he screamed, "I'm dying."
Ryan Wilson, the most critically ill man, begged doctors to put him to sleep because he was in such agony. His family was warned that his heart, lungs and kidneys failed.
His sister-in-law Jo Brown, recalled the horrific moment when they saw Mr Wilson in intensive care. She told reporters that his head had swollen to nearly three times its normal size, and that his neck was the same or wider than his head and that his skin had turned a dark purple.
Mr Wilson remained in a coma for three weeks, and upon awakening, learned that he may lose parts of his fingers and toes, which had turned black because of his reaction to the drug.
"I'm told it's like frostbite and my fingers will just fall off," he told the UK's News of the World recently.
In addition, Mr Wilson also suffered from heart, liver and kidney failure, septicemia, pneumonia and dry gangrene and is considered very luck to be alive, according to News Target on May 20, 2006.
The Parexel research was at the Phase I stage, where a drug is tested for safety with a small number of people who are given a tiny dose under careful supervision, not to determine whether the drug works, but to check for side effects, according to Q&A Drug trials by BBC News on March 16, 2006.
Experts say the recruitment of subjects for the Parexel trial left much to be desired. The web site that announced the recruitment hardly mentioned the potential risks, but elaborated at great length about the good pay, free food and "plenty of time to read or study or just relax, with digital TV, pool table, video games, DVD player and free Internet access.''
Parexel also recruits by placing ads online or in local papers, where critics say, they draw the attention of the young and poor. Once on the books, recruits often get automatic offers. "The offers keep rolling in via text message," Tom de Castella, a former Parexel volunteer said in the March 19, 2006 Times Online. " £650 for three days here, £1,000 for a week there," he said.
Ethicists shown the Parexel consent form, which is supposed to describe the experiment and its risks, told Bloomberg News, "the document didn't sufficiently inform participants of the therapy's possible dangers or properly depict the treatment as a novel drug that can disrupt the body's immune system."
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