Posted on 03/20/2006 5:31:22 AM PST by Born Conservative
The drug trial victim whose head ballooned in size so much that his sobbing girlfriend said he resembled the Elephant Man said he couldn't resist the £2,000 fee for the tests. Mohammed Abdalla, 28, had planned to use his £2,000 fee for being a guinea pig to make his family in Egypt financially secure.
He wanted to set up his brother Mahmood in business and look after his father, an imam, and desperately ill mother.
Yesterday, as the London bar manager's dreams were disclosed, it emerged that scientists had warned about the damage the drug could do to human tissue four years ago.
They discovered it had an adverse affect on human cells, but astonishingly this did not prevent it being tested on people.
It has also emerged that researchers tried out the drug on monkeys, and their necks swelled up.
The revelations came as a friend of Mohamed said that he had regarded the £2,000 fee as too good to miss.
He said: "Usually the drug companies pay a few hundred quid, but this was a bit of a jump. But he laughed off the risk.
"I was really worried. I told him that no one would offer that much money if they didn't know there was a huge risk attached. But he said he needed the money to pay off debts."
The drug, TGN1412, which is designed to beat rheumatoid arthritis, leukemia and multiple sclerosis, left them writhing in agony with their heads "ballooning" in size.
Mohamed and 21-year-old plumber Ryan Wilson are still fighting for their lives in intensive care at Northwick Park Hospital in North West London a week after the trial went wrong.
The side-effects made Mohamed's head swell so hideously that his girlfriend, Myfanwy Marshall, compared him to the Elephant Man.
Six volunteers were given doses of TGN1412 and suffered violent reactions which made their immune systems attack their internal organs. There was some progress in the condition of the other guinea pigs yesterday with three of them being taken off life support machines.
Last night, a close friend of Mohamed in Cairo told the Mail: "I last spoke to him two weeks ago and there was no mention of the medical trials.
"But he did say that he was planning to come to Egypt in the summer with a big surprise for his younger brother Mahmood that he hoped would set him up financially for life. It is so tragic if that is why he is in the situation he is in now."
Only Mohamed's father has been informed of the disaster, and he is keeping it from his two sisters, brother and mother.
The friend said: "His mother has got a very serious heart condition, so serious that we have no doubt that it would kill her to know what has happened to him."
Mohamed married a British woman in Egypt four years ago, but they divorced and, his friend said, the settlement cost him his savings.
He said: "Mohamed was fond of his family and adored children and wanted children of his own. But his wife was reluctant because it would have involved converting to Islam. When they divorced, he was forced to give her his life savings as part of the settlement." He added: "Mohamed is loved by everyone, always the one in the group resolving disputes, always wanting everyone to get along."
Mohamed, deputy manager of the Heads and Tails bar in Farringdon, Central London, lived in a small flat in Kensington with his friend Gamal Ragab, 28, a PhD student who also works as a restaurant manager.
Karwan Najim, who knows both men, said: "Ragab is really upset and has been visiting the hospital every day. Mohamed is a really happy guy, always really nice and polite to me."
One expert said yesterday the six men may never fully recover.
Professor Trevor Smart, head of pharmacology at University College London, said that as well as any permanent damage to their organs, there could be long-term disruption to their immune systems.
The tests on monkeys were carried out in Germany, where the drug's manufacturer TeGenero is based. Professor Johannes Loewer, president of the Paul Ehrich Institute, which monitored the research, said: "There were adverse effects in certain doses. Some of the monkeys developed an increase in the lymph nodes." He added: "No monkeys died to our knowledge."
An earlier alert about TGN1412 came four years ago. A study published in 2002 in the US medical journal Clinical Immunology warned that it adversely affected human cells.
TeGenero has insisted that "extensive preclinical tests showed no sign of any risk".
A strange tale...this woman is probably much better off.
I would say the lawsuit will set up his family for life..so in a way he got what he bargained for...
Sounds like TGN1412 could be used as a chemical weapon.
"There was some progress in the condition of the other guinea pigs yesterday with three of them being taken off life support machines."
Human life is worth so much in Britain that three
very ill human beings are called guinea pigs.
I don't think so - England has a very different tort system and with socialized medicine - I don't think you can even sue.
Yes, you can sue. But the payouts are not substantial as in tehe USA. Also you can bet he had to sign a waiver when he took the fee.
Well a signed release or not, if this stuff was noted to be nasty, someone should be in trouble....I would never be involved in medical tests but one would think by the time they get to humans these medications are somewhat safer than this one appears to be...
But then again there are some people who think animal testing in wrong...
I'm confused. Are they testing this drug on people who don't have the conditions for which it's a treatment?
I don't see how socialized medicine comes into this. These were healthy volunteers being paid to be test subjects by a private company. If there is proof of negligence on the part of that company or on the part of the drug manufacturer then I should think there is a possibility of them being able to sue for damages.
Under socialized medicine - there are no private medical companies. They all do the bidding of the state as they all are controlled by the state.
This was just a test for safety in humans. Well they got their results.
This drug is a designer drug, which was supposed to cause a large activation in white blood T-cells. It was hoped that the activation would reset the immune system and stop the T-cells from attacking a person's own cells causing arthritis and other auto-immune deseases.
What the drug seems to have done, however, is cause EVERY T-cell in the body to go into massive overdrive attacking everything in sight.
There are other similar drugs which activate specific reponses in a few specialized T-cells. This one turns them ALL on and doesn't give them a specific virus, bacteria, cancer cell etc. to seek out.
The patients may recover, but there will be significant damage done (and there won't be any bacteria or viruses left in them either.)
Drugs like this would make good bio-weapons.
I'm not sure how applicable this is, but when I went to an ethics seminar here a year ago they said in the human trials part of it that the amount of money offered for completion of a trial should be high enough to compensate for the person's time, but not be so high that it would induce someone to ignore the risks because that could violate informed consent. I wonder just what these people were told about the risks and how much more they were offered than in comparable trials. I also wonder how strict these guidelines are in the US and if holding the trial overseas made things simpler for the company.
Confusing to me as well. When I read about it last week, it seemed as though the test subjects were healthy, and not afflicted with the diseases targeted by the medication.
Why should someone be in trouble? Throughout history, researchers HAVE to use human beings in drug trials. If they didn't there would be no polio vaccine or any of the drugs that are used to successfully treat cancer. I think it's scary that this case is getting a lot of attention. Now researchers are put on the defensive - something that will possibly prevent future drug "cure-alls".
A person doesn't need to have the disease if all you're trying to do is determine whether the drug has adverse effects or not. Testing its efficacy would be the next step.
One possible award: peanuts
This doesn't have anything to do with socialized medicine.
This was an American company doing the testing, so I suspect they will have success suing over here.
It sounds like the drug should have been eliminated for consideration in the animal trials. If you do shoddy work in the animal trials and then move on to human trials when there's good reason to expect adverse effects, that's unethical.
You can sue in the UK, but the level of damages awarded are decided by the judge, not by the jurors, so you don't get $9m for spilling hot coffee on your dumb self!
Medicine in the UK is not 'socialized' - we have a national health care system which is free at the point of delivery plus a well-developed private healthcare system for those who wish to spend more.
I agree, check post 4.
yup , it appears that their endocrine system[s] took quite a whack ,...
as an interested layman , I listen to my body's ebb and flow daily ,...
I'm always amazed with new info about human physiology
you very obviously know very little about healthcare in the UK. private health companies exist in the UK and very profitable they are too. pretty much any medical procedure carried out by the NHS can be done privately - cancer care, orthopedic work, anti-natal, childbirth, heart surgery - you name it.
if you wish to look a fool then carry on, otherwise read up on your subject before commenting.
the drug was tested for the first time on humans by giving it to healthy adult males. if there were to be side effects probably better to find out what those side effects might be before discovering them in the treatment of a critically ill four year old with lukemia.
That is socialized healthcare...
. . .okay. . .and then what happened? (The swelling went 'down' (?). . .they are permanently disfigured and/or in pain? They now are suffering from some debilitative disease?
What happened post the 'neck swelling'. . .no 'deaths' that they know of. . .sounds like this depends on the meaning of 'death'. . .
. . .surely a consideration not lost on those who manufacture these drugs. . .and with a 'government' watching. . .
. . .and a - 'h e l l o' -
"Drugs like this would make good bio-weapons."
No it would not. Too expensive to make, and delivery requires IV administration, which makes it impractical as a BW.
I need to see pictures.
"I'm confused. Are they testing this drug on people who don't have the conditions for which it's a treatment?"
In phase I trials, drugs are usually tested in healthy volunteers (except in oncology, where they are usually tested in patients).
Very informative - thanks!
Correction- it was an American CRO (contract research organization) doing the testing for a German biotechnology company. It is the German company that as the sponsor that has the ultimate responsibility (and liability).
Their immune system, not endorcine sytem, took a whack.
Check post 28.
I think you totally misread that.
I took it as denigrading to the study, not the patients.
Stating that the study/Drs is treating them like guinea pigs.
Impying that is shorter than:
"There was some progress in the condition of the other very ill humans, which these researchers treated like guinea pigs, yesterday with three of them being taken off life support machines."
It all depends on how the chemical can be broken down and absorbed by a person. We don't know if the chemical can be absorbed by the skin or lungs, or ingested in the stomach. To many unknown factors.
But we now know what happens if you turn a person's immune system on full blast.
It's an antibody to CD28, Paul. We know how it can be absorbed - only IV, not oral or inhalation. Lousy BW.
That is nice to know.
HA! That was so damn wrong...
Thanks for the explanation. I need to brush up on my immunology.
Choice is socialization?
I think I said that it was testing the American company was doing. I doubt they will be absolved of any responsibility.
You are factually incorrect. Private medical and pharmaceutical companies operate in the UK. Many are publicly listed at the London stock exchange. This case only has a tangential connection to socialised helathcare.
"I think I said that it was testing the American company was doing. I doubt they will be absolved of any responsibility>."
They will be absolved - the sponsor is the one that bears responsibility, unless it can be proven that the CRO did not follow the instructions. In this case, the problem was with the drug, not its administration, hence the responsibility it completely that of the sponsor.
"I think you totally misread that."
Thanks for the clairication.
Just wanted to add that research into this area should not stop.
If you can take the extreme of an antigen drug that turns on every T-cell in the body and makes them go beserk offset by drugs that just gently nudge a few of them to become a little more active, then there might be a happy medium where you just get enough of a response that viral or bacterial infections are stopped in their tracks by our own immune system. In addition, a properly designed antigen drug really could turn off immune cells involved in arthritis, asthma and other auto-immune deseases.
Lots of dangers still; but lots of promise as well. More "safety" required as well of course.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.