In case you haven’t heard, there was a horrific medical accident in England. Eight gentlemen were taking part in the first human trials of an experimental drug known as TGN1412, which is an anti-inflammatory steroid.
It worked okay in animal tests, but when it was given to humans, disaster resulted. Of the eight gentlement in the test, two received placebos, but the other six collapsed and two of them have major organ failure.
EXCERPTS:
A volunteer taking part in the trial who was given a placebo and therefore escaped the effects described the appalling scene on the ward.
Raste Khan, 23, a television technician, said: "The test ward turned into 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 going 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 I didn’t know why."
Six volunteers suffered catastrophic reactions to trials of the new drug, TGN1412, at Northwick Park Hospital in Harrow, North-West London.
They were the first people in the world to test the drug, being developed by the German pharmaceutical firm, TeGenero, and designed to treat chronic inflammatory conditions and leukaemia. They were paid £2,000 each.
Four are in a serious condition but showing signs of improvement. Two remain critical.
More from The Sun:
"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"
More from Wikipedia:
Phase I clinical trials conducted by PAREXEL at Northwick Park Hospital, London, hospitalised 6 volunteers in March 2006, with at least 2 of them suffering major organ failure.
After the drug was administered to the last participant, the first participant started complaining of a severe headache, fever and pain and collapsed shortly after. Within a few hours, the remaining participants who received the actual drug had become ill as well, vomiting and complaining of severe pain. Within 12 hours all 6 had collapsed. At least one participant begged the doctors to "put him to sleep" because of the suffering.
Some of the men are reported to have experienced severe swelling with comparisons being made to The Elephant Man. According to doctors, this is caused by the large amount of fluids given as part of the treatment. The patients are being treated with anti-inflammatory steroids. Two of the men were reported to be in a critical condition with the remaining four being in a serious, but improving condition.
TeGenero has apologized to the families involved and insist that these effects were completely unexpected and that all protocols have been followed. An investigation of the case by authorities has now been commenced to find out if the reaction seen is due to a contamination of the drug given, a wrong dose being administered or if it is an inherent flaw in the drug. Criticism has been raised that 6 participants were given the drug in such a short time, which is against the recommendations of some standard literature.
The mention in the Wikipedia entery that police are investigating whether there is "contamination" in the drug given includes the possibility that there was deliberate tampering with the drug, which press accounts indicate the police are looking into.
The options here seem to be: (1) the drug is just harmful to humans where it isn’t to the animals used in trials, (2) accidental overdose, (2) deliberate overdose [highly unlikely], (3) accidental contamination, and (4) deliberate contamination.
The two with major organ failure are not likely to survive. Doctors are trying to flush the drug out of their systems, which produces the massive "Elephant Man"-like swelling that family members have reported.
Any way you go, let’s pray for these guys.
Praying.
I can’t help but think this could have been avoided. Granted I’m not studied in the medical testing field, it would seem reasonable that some cursory testing on humans prior to a full blown test could have been done to avoid this. That would have been more expensive of course, but to have a 100% failure rate like this seems like someone didn’t do proper diligence.
Well, this was the cursory test on humans. 8 people is hardly a full-scale medical trial. It’s just odd that animal testing, if done as they said it was, turned up nothing like what happened.
I can’t help but imagine the horror these men must have experienced, and then think about how much worse Hell and Purgatory are.
I know back in the old days, new medicines were tested on humans in a very gradual manner, starting with rubbing a little on the skin, and waiting 24 hours. Then they’d apply a little on a mucous membrane and wait 24 hours, and so on, working your way up to full dosage, but still allowing people to see if there was any bad side-effects.
Maybe they’ll take up this approach again after this incident.
Darn. The hamsters didn’t say a thing!
“Any way you go, let’s pray for these guys”
Amen.
God bless all who volunteer for phase one clinical trials so that others may benefit who come after them.
Campath-1H (the humanized monoclonal antibody derived from the brains of rats and cultured on hamster ovaries), which put my wife’s terminal leukemia into a two year remission, was similarly lethal to the first trial subjects. This high risk method is how proper dosage and administration is learned, and this is why initial clinical trials recruit those who have not responded to other accepted treatments.
One of the reports I heard, said that the drug had been tested on “lab mice & guinea pigs”. Assuming that this was an accurate & literally true statement, it sounded to me like there was a problem right there…
Wouldn’t you test on species less closely related to one another? My 1st thought was, 2 rodent species? Where is the diversity there? Were there no other animal tests before proceeding to humans?
Not smart. Not smart at all. Sounds like a recipe for disaster.
And, yes: praying here too!!
My daughter just told me that the latest news was that the men were recovering, I checked it out online and found this;
http://news.bbc.co.uk/1/hi/england/london/4820188.stm
Thought I’d come over and let you know since you were kind enough to bring attention to their plight.
God Bless.
Everyone ought to keep this incident in mind the next time they hear people protesting against the use of animals in medical research.
Everyone ought to keep this incident in mind the next time they hear people protesting against the use of animals in medical research.
Huh? Because testing on animals did SO much good THIS time?
Tim, people who protest against animals being used in scientific studies aren’t necessarily against drug trials using animals before they start to test humans.
They’re against testing skin and mucous membranes for irritation and reactions, when a cell culture can give you the same result. They’re against animal testing when it is needless to test on sentient beings.
I realize that there are legitimate reasons to oppose SOME animal testing. But there are those who oppose any and ALL animal testing, and that would only mean more scenarios like this one.
I am certainly against animal testing when it is not necessary. I am talking about the far-left animal rights wackos like PETA, who oppose even the idea of pet ownership.
Does anyone know whether the drug was tested on any other primates before this human test?
Tim, that is exactly my point!! Where were the tests on primates? (Or even beagles? Something that isn’t a lab rat!!)
A major plot element in “V for Vendetta” is drug testing gone wrong. Of course, the prime difference is that we’re hearing about the Parexel problem, whereas [you’d have to guess this one just from the trailer] in the film, it’s a far bigger problem, and the information is repressed.
OTOH, both happen in London . . .
MHRA – In whose Interests?
The recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.
News this week that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.
The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?
For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.
A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?
The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’
Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)
Birmingham, UK