On March 16th of this year, Abhi wrote about a first-in-man trial in the UK which went horribly awry for six volunteers who experienced heart, kidney and liver failure after they were given an experimental drug made by German firm TeGenero, called TGN 1412:
It is an anti-inflammatory agent makers hoped would become a lucrative treatment for rheumatism, leukaemia and multiple sclerosis.[link]
When we first posted about this nightmarish story, Doctors said they were “in the dark” and that they did not know exactly how these human guinea pigs would be affected. Unfortunately, now it seems we have an answer—and it is tragic:
Victims of the disastrous “Elephant Man” drugs trial have been told they face contracting cancer and other fatal diseases as a result of being poisoned in the bungled tests. [link]
Nav Modi, 24, whose bloated face and swollen chest led to the nickname “Elephant Man”, said he did not know how long he would live.[link]
“It’s a really bizarre feeling when you discover you might be dead in a couple of years or even in a couple of months,” he said. “I feel like I’ve given away my life for £2,000.”[link]
It seems that not only were the volunteers (quite predictably) assured before participating in the trial that they would not suffer any life-threatening illnesses, they were told that after it was obvious that the test results were disastrous, too.
Four months later he still suffers from occasional lapses of memory, severe headaches, back pain and diarrhoea. (Modi) and the others had been led to believe that while their symptoms might persist for a while, their long-term future was not at risk.[link
Wrong. So very wrong.
One of the six victims was told last week he is already showing “definite early signs” of lymphatic cancer.
He and three others have also been warned that they are “highly likely” to develop incurable auto-immune diseases.[link]
They’re now in the process of passing a law that decrees drug experiments be tested only on the ill, not the healthy. Which must be a comforting thought when you get diagnosed with something scary. No animals were available for comment…
What a ridiculously terrible situation. Prayers out to the victims. Hopefully they and their families are compensated for the rest of their lives.
I see posters for medical trials every other day on the subway. As a broke grad student, I’ve been tempted by the money offered for ‘routine checkups’ or other tests associated with new drugs. It’s always been the thought of not interfering with my body unless I’m forced to, that kept me away.
Even though such mishaps may be rare, am I glad that I was never that broke!
Does anyone in the pharma industry know the process for bringing a drug to market. Some of this is not totally new and i am hoping someone can lay out the steps and explain the context with respect to the two following cases.
the thalidomide case comes to mind. just as a refresh for those out of it and for those discussing prescription drugs catering to female reproductive health – thalidomide was prescribed as a cure for morning sickness – the testing was insufficient, and it led to some 15k cases of kids being born with malformed limbs. very sad.
on another note – a lot of the big labs ‘experiment’ on the third world population prior to bringing drugs into the market. it may not be particularly insidious if there are checks and balances placed before the human trials. the mmr (measles mumps rubella) vaccine is a case in point. i know it was made available for ‘test runs’ in india and taiwan before it came to the united states.
more research in pure sciences is needed before clinical trials. after all we just produce engineers, lawyers and real estate agents. the pure sciences need intelligent people and should attract more of them. the govt should fund more science courses