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2006/04/14, 11:25 AM
This was sent to me...pretty scary stuff....
Beware the Ides of March, an unnamed seer told Julius Caesar in Shakespeare's play...
And if only the 6 formerly healthy young male volunteers that took part in a British study for an experimental drug had had such a soothsayer looking out for them on the Ides this year, they might be OK now. Instead, at the time of this writing, 2 of these men are in comas, and the other 4 are hospitalized and slowly recovering from grotesque symptoms brought on by a shady drug trial.
According to the UK's The Independent online edition, the 6 subjects were rushed to the Intensive Care Unit at the hospital that was hosting the small-scale trial - all of them suffering from multiple organ failure after popping an experimental anti-arthritis and MS drug called TGN1412. The eyewitness accounts of the aftermath of the test dosage are truly horrific...
One witness, one of 2 extremely lucky young men who were fortunate enough to be in the placebo "control" group, watched as some of his fellow subjects started tearing off their shirts in agony shortly after downing their dose of the chemical. Others wailed that they felt as if their heads would explode, or felt stabbing pains in their back, according to the Independent piece. Apparently, all of them ended up passing out, vomiting, and writhing in pain as though palsied within an hour.
Can you imagine being one of the guys in the control group, wondering if any minute you were going to be similarly stricken? That kind of torture would be grounds for a lawsuit as surely as those who were affected, in my opinion...
One of these poor victims, a 21-year-old plumber's apprentice, experienced swelling of the head and neck to three times their normal size. The day after the incident, he still could not breathe without artificial aid, and doctors estimated his chances of survival as slim. Another of these victims is on a lung-pump, and can barely move his eyelids. One article on the trial quotes his girlfriend as saying the once-strapping young man now looks "like the Elephant Man."
Sounds like something out of The Island of Doctor Moreau, doesn't it?
Too bad this is truth, not fiction. The story hasn't made the major news that I can detect in this country. I bring it to you now only to reinforce what I've been saying to you for years - that prescription drugs are powerful, body-altering, and sometimes highly dangerous chemicals. And that drug trials are far from safe. Despite drug companies' denials, I'm inclined to believe it when people come forward and report problems - like the families of teens who've killed themselves after (or during) early-stage trials for antidepressants or ADHD drugs...
I also mention this extreme story to show that drug makers are far from perfect when it comes to exercising every option when it comes to drug studies' safety.
According to the Independent piece and an article by the UK's Times online, the trial that left these 6 unfortunate souls battling for survival left a lot to be desired from a due diligence standpoint...
A universally recognized standards manual called the Textbook of Pharmaceutical Medicine specifically cautions against administering doses of new or experimental drugs to all trial subjects simultaneously - in case unexpected reactions (like multiple organ failure) should occur.
As it turns out, TGN1412 had NEVER been tested on humans before, and so certainly qualified for the extra caution this standards manual called for. Whether the drug has ever been tested successfully on animals before was unclear, the various reports indicate.
The anti-inflammatory drug was being tested by an American firm called Paraxel for its German Manufacturer, Tegenero AG. According to one of the lucky "control group" subjects, four executives he assumed were from Paraxel were supervising the trial at the beginning, but were nowhere to be found after people started transforming into elephant men...
An investigation into the incident has been launched by Britain's Medicines and Healthcare Regulatory Authority, in cooperation with the Scotland Yard. I'll keep you posted on this story as it develops.
And if you think this kind of careless testing only happens in Europe, think again.
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Strength and Honor!
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