'Elephant Man' cancer victim breaks his silence
Rob Sharp
Sunday August 6, 2006
Observer
The victim of the disastrous 'Elephant Man' drug trial who contracted cancer has spoken out for the first time.David Oakley was one of six victims who suffered organ failure and pronounced swelling after being paid £2,000 to take the drug TGN1412 at Northwick Park Hospital in north-west London earlier this year.
Oakley, from Ealing, west London, has been told by doctors that he is showing 'definite early signs' of lymphoma.
He told the Mail on Sunday that he took part in the trial to raise money for his wedding in June to wife Katrina and added that the cancer diagnosis had left him 'devastated'. He has also been warned that he faces the risk of multiple sclerosis, lupus, ME, rheumatoid arthritis and other illnesses.
He told the newspaper that he had an 'aggressive' form of cancer and faces further tests to see what treatment is needed.
Oakley continued: 'It's very frightening. I'm trying not to be too down about the thought of having chemotherapy or that I might die. Katrina and I had planned to try for children six months after getting married, but we can't do that now. Everything is on hold.'
 Northwick Park Hospital in London was the scene of the drug trials |
Six men were left seriously ill after volunteering to take part in the trials in north-west London earlier this year.
David Oakley told the Mail on Sunday that he is now seeking compensation from Parexel, which arranged for the drug trials to take place.
There is no evidence to show Mr Oakley's cancer was caused by the experimental treatments.
Mr Oakley said he was first made aware of a potential problem about two months ago when blood tests revealed "cells that shouldn't be there", which he says indicate he has early stages of the disease.
He said: "It's an early sign of cancer. The best I could actually get was that if we catch it early enough it is treatable.
"At the moment I haven't felt any physical effects but the paperwork, the blood work, that's all there and apparently there are early indications [of cancer].
"I'm going to try and be as positive as I can and if mind over matter has anything to do with it, well, I'll give it a good try.
"I can't dwell on it because if I dwell on it I'm just going to go down in a heap."
Mr Oakley said he was particularly concerned about potential damage to his auto-immune system that could lead to illnesses such as rheumatoid arthritis and multiple sclerosis.
"If anything they worry me more because I don't want to be left in a situation where I'm stuck in intense pain and can't do anything about it.
"That's probably my worst fear."
He said that "someone has to be accountable and Parexel should be accountable. They made a mistake.
Seeking compensation
"Really I'm just trying to do my bit and pointing out their mistake. If someone doesn't point it out it could happen again and there's no way I would like to see someone else go through what we're going through right now."
Mr Oakley is now seeking compensation and said he hoped the company would "do the right thing" in respect to his claim.
BBC News attempted to contact Parexel on Saturday evening but was unsuccessful.
Parexel is a clinical research organisation which carried out the trial on behalf of TeGenero, a German pharmaceutical company.
Completely unexpected
The Medicines and Healthcare products Regulatory Authority (MHRA) has previously said Parexel failed to follow proper procedures.
It found there was no contract in place between TeGenero and Parexel at the beginning of the trial.
TeGenero has maintained that the men's reactions were "completely unexpected" and did not reflect the results obtained from the earlier laboratory studies.
Parexel has previously said all guidelines were followed during the drug trials.
U.K. Drug Trial Cut Volunteers' Immune Cell Levels, Study Says
Aug. 3 (Bloomberg) -- Three volunteers in a London drug trial that left six men with multiple-organ failure in March are at risk of developing autoimmune diseases, according to research done for their attorney.
Levels of an immune cell that controls the body's response to pathogens were cut by two-thirds, according to a report by Richard Powell, an immunologist who examined three of the men. Powell's report says the men have less than a third of the normal level of so-called regulatory cells. It is ``highly likely'' that the men will develop an autoimmune disease, he says.
The men took part in a March 13 test of a medicine developed by TeGenero AG, a German biotechnology company that's since filed for bankruptcy. The drug, a laboratory-produced antibody designed to treat arthritis, leukemia and multiple sclerosis. The volunteers were hospitalized for weeks after severe reactions to injections of the medicine at a Parexel International Corp. testing facility in north London.
``The guys have gone through a lot already and face a pretty horrendous future,'' said Martyn Day, an attorney for the men.
The report, which was passed on by Day, doesn't stay what illness the men may develop. Lupus, Crohn's disease or the skin affliction psoriaris are all auto-immune diseases. Powell's report doesn't give data for the men's immune cell levels before the experiment.
In the trial, six men were given a laboratory-produced antibody designed to treat arthritis, leukemia and multiple sclerosis at a Parexel facility in north London. The six were hospitalized for weeks after severe reactions to injections of the medicine.
Some of the swelling and side effects may have been reduced had Parexel's staff given the volunteers injections of large doses of steroids as called for in the plan for the test, Day said in an interview. The men didn't get high doses of steroids until 16 hours after the start of the side effects, he said.
Day is trying to negotiate a settlement with Parexel, which is based in Waltham, Massachusetts. Officials at Tegenero and Parexel didn't immediately return telephone calls.
Doctors call for worldwide help in race to save lives of men who collapsed 'like dominoes' in drug trial
· Seriously ill volunteers on organ support machines
· Questions over why six people were dosed at once
Friday March 17, 2006
Guardian
Doctors treating six young men who have become seriously ill after taking part in a drug trial are consulting experts around the world to try to save their lives, it emerged yesterday.The novel nature of the drug TGN1412, which was being given to people for the first time and which provoked massive inflammation in their tissues and internal organs, means that no one has any direct medical experience to call on.
"The exact sequence of what's happening here is unique," said Ganesh Suntharalingam, clinical director of intensive care at Northwick Park hospital, in Harrow, north London, where the men are being treated.
The US company which conducted the testing, Paraxel, said it followed the rules for drug research. But last night a former executive expressed surprise at the simultaneous application of the drug. "The issue of six people getting this at once is troublesome to me," said the former executive in the company's clinical research services, who asked to remain anonymous. "It is common sense not to dose six individuals with the drug at once where there is no prior human experience."
The men are on organ support machines and receiving steroids to dampen down their immune systems.
The drug was being developed to treat immunological diseases "such as multiple sclerosis, rheumatoid arthritis and certain cancers", said the makers, the German biotech firm TeGenero.
One of the two participants given a placebo instead of the drug, yesterday gave a graphic account of the distress caused. "The test ward turned into a living hell minutes after we were injected," said Raste Khan, 23, a television technician who had signed up for the £2,330 fee for the trial. "The men went down like dominoes. They began tearing their shirts off complaining of fever, then some screamed that their heads were going to explode. After that they started fainting, vomiting and writhing around in their beds."
Myfanwy Marshall, 35, the girlfriend of one of two men in a critical condition, appealed for international medical help through Ann Alexander, a solicitor.
Ms Alexander said: "Our client's family is sickened by what has happened ... it is their intention to seek widest possible attention to this tragedy in the hope that ... the scientific and medical community around the world will come forward with suggestions for treatment." She said that there was family concern not just about the lack of information but also the "inconsistency" of what was available. "While the doctors are doing everything they can to treat the symptoms they actually don't know what's gone wrong."
She added: "I don't feel [the drugs firm] have issued a proper apology. The words 'I'm sorry' mean an enormous amount to someone who has suffered like this."
The investigation by the Medicines and Healthcare Products Regulatory Authority could take weeks but scientists believe the drug itself caused the disaster, and that its potential to have such a damaging effect in humans did not show up in trials carried out on mice and monkeys.
Human error was a possibility, but the drug was made up and shipped to London by the large German pharmaceutical firm Boehringer Ingelheim. The human volunteers were given one five-hundredth of the dose that had proved toxic in other animals. "That's a very large safety margin," said Roberto Solari, chief executive of Medical Research Council Technology.
He said it was "very unlikely" the volunteers got an overdose 500 times what it should have been. It was more likely, though this was speculative, that the drug had provoked a reaction in humans that was different to that in animals.
TGN1412 is a humanised monoclonal antibody, a genetically engineered protein that is part mouse but mostly human. Almost all monoclonal antibody drugs aim to suppress an immune system reaction - but this does the opposite. "It is designed to turn on white blood cells, particularly a sub-set called regulatory cells," Dr Solari said. Inflammatory reactions in rheumatoid arthritis are caused by too many cells in the immune system being turned on. This drug tries to turn on other cells which have the power to switch off the trouble makers.
It is possible, Dr Solari said, that "instead of switching on the regulators, we have switched on the activators and super-induced the immune system".
