March 16, 2006
TGN1412Health and Medicine
TGN1412 is the current designation given to a trial drug that is being tested in the UK as a treatment for leukemia. The first human trial resulted in some horrific results earlier today. First the background though:
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Another human trial gone horribly wrong |
Two men were in critical condition Wednesday in a London hospital and four others were seriously ill after taking a new drug in a trial supervised by a Waltham, Mass.-based company.British regulators ordered the immediate suspension of tests of the drug, developed to treat autoimmune and inflammatory diseases and leukemia.
“Two patients remain critical and four patients are serious but showing some signs of improvement,” Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said in a statement. “The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body…” [Link]
Here is how things took a turn into science fiction territory and became plain scary for the volunteers:
The girlfriend of a man fighting for life after taking part in a pharmaceuticals trial has said the drugs he was given have left him looking “like the Elephant Man”.“His chest is puffed out. He is already a big kind of guy but his face is out here, like Elephant Man, it’s completely puffed.
She added: “They haven’t got a cure. This is not leukaemia. This is a drug they have never tested on humans before so they don’t know what they are dealing with. It’s completely messed up their vital organs…” [Link]
A couple of the hospitalized volunteers appear to have been of South Asian origin.
Another volunteer who was given a placebo describes the madness that ensued:
A VOLUNTEER who escaped the drug test disaster told last night how he saw six healthy young men turn into wailing wrecks within minutes.
Human guinea pig Raste Khan — who did not know he had been given a harmless placebo in the test — said it was like a horror film unfolding before his eyes.
The 23-year-old TV technician added:
The test ward turned into a living hell minutes after we were injected. The men went down like dominoes.
First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode.
After that they started fainting, vomiting and writhing around in their beds.
It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and didn’t know why.
An Asian guy next to me started screaming and his breathing went haywire as though he was having a terrible panic attack.
They put an oxygen mask on him but he kept tearing it off, shouting ‘Doctor, doctor, please help me!’ He started convulsing, shouting that he was getting shooting pains in his back. [Link]
Once upon a time I was a human test subject as well. Never for new medications though. Unless they can promise to turn me into Spiderman (or the Green Goblin) I think I’d be too scared to now.
abhi on March 16, 2006 12:06 AM in Health and Medicine · T·r·a·c·k·b·a·c·k address · Direct link · Email post
Ah, I can't wait to see what Asians in Media Sunny will say about this, considering he's anti all animal testing and pro paying poor people to take part in drug trials. (link) ;)
some clinical trials are safe, and not really invasive, those that test psychology, and breathing patterns, sleep, etc... i've done a few myself.. and they are pretty safe...
i'm surprised, that this drug was used on humans... because i'm wondering if they had data from animal trials beforehand..as i think that mice/other animal subjects/etc would have had the same reaction.... was there animal testing done before going into this phase I trial and subjecting human beings???? this reminds me of the unethical trials from recent past (The Tuskegee Syphilis Experiment)
when you're fighting cancer though.. you will try anything.. it's despair...and the empty straws one will pull on for a chance of cure/prolongation of life.... i see it everyday.. and it is truly sad... there are quacks out there who sell urine as cure for brain tumors, and people flock to them... no joke... it's just people latching onto a human beings despair in order to make a quick buck or two..... just horrific.
Are you referring to Dafoe as a human trial gone wrong? :-)
as it pretty clearly demonstrates the foolishness of animal testers' assumption that humans and non-human animals will react the same way to a substance.
There are exceptions to every rule. Animal testers in general are not "foolish" -- you are, if you think that most of the drugs on your shelf did not go through a period of animal testing.
Hey, Dafoe is from Wisconsin and, therefore, in all ways perfect.
I think this is the opportunity for Abhi to enter that phone booth. Ideas for a cape abound.
My father's colleagues work on the Northwick Park site where the trial took place. Their Intensive Care director told him that four of the six men are conversant, alert and ready to go home. They do not require further treatment.
The two that are critically ill are in a much better condition now. Both are conscious, one is conversant.
Well, they did apply 4 the testings. They wanted easy money,but it turned really wrong.
I feel for them, but just sometimes, when you dance with the devil, U have to wait untill the song is over...
Changing the culture of research
See this weeks BMJ (August 5):
http://bmj.bmjjournals.com/
Editorial
Further lessons from the TGN1412 tragedy
New guidelines call for a change in the culture of research
BMJ 2006;333:270-271 (5 August), doi:10.1136/bmj.38929.647662.80
As eight young men assembled at a London hospital on 13 March this year, they
had no idea that within an hour their lives would be changed irrevocably and
they would have contributed to a fundamental rethinking of the development and
testing of new drugs. The first trial of TeGenero's TGN1412 (a T cell agonist)
in humans took place at Parexel's clinical pharmacology research unit at
Northwick Park Hospital, London. The events that followed fuelled speculation
not only into the conduct of the trial and the nature of the drug, but also
into aspects of research as diverse as comparative molecular biology,
bioethics, and health economics.
The Medicines and Healthcare Products Regulatory Agency initiated an
investigation, but the BMJ and other journals called for a more far reaching
inquiry independent of the regulatory agency that had approved the trial. On 5
April the agency released its interim report, and the government announced that
an independent Expert Scientific Group, chaired by Professor Gordon Duff, would
be appointed "to learn from the Parexel clinical trials incident." On 25 July
this group released their interim report and recommendations. ..
http://bmj.bmjjournals.com/cgi/content/full/333/7562/270?ijkey=whP3FyWKdYWdMvy&keytype=ref
The drugs were tested on mice.
The measured minimum dose that had hazardous side effects was scaled DOWN by a factor of 500 and administered to humans (previous doses to mice had no side effects)
however, the scientists that administered the doses were stupid.
the antibodies of TGN1412 were raised against the human antigens.
if the scientists had done a simple flow cytometry experiment and done a 10 minute calculation, they could have avoided giving this dose to the humans in the clinical trial and figured out that they had to give a much smaller dose. However, biologists and doctors think they are too high and mighty for mathematical calculations and computational modeling.