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[SANET-MG] drug victim told to expect early death

A monoclonal antibody drug similar to the one described below was produced in modified maize. Its open field release for production was approved in France.The bureaucrats seem to think that secret field production of such crops is reasonable and they are unlikelyto take responsibility for injury to innocent by-standers near the secret fields.
Elephant Man drug victims told to expect early death
David Leppard
The Sunday Times (Britain), July 30 2006

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.

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.

The men were paid £2,000 each to volunteer as human "guinea pigs" in the trial at Northwick Park hospital, northwest London, last March. They suffered heart, liver and kidney failure and were left seriously ill after being given TGN1412. The drug was made by TeGenero, a German firm.

The men had been told by doctors they would not suffer any life-threatening illnesses.

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.

"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."

Modi's lawyer, Martyn Day, of Leigh Day solicitors, said the four victims he was representing were considering legal action against Parexel, the firm that ran the trial. He believes they are eligible for up to £5m in damages. The company denies responsibility for the outcome of the trial.

The Sunday Times has seen the medical assessment of four of the victims, completed last week by immunologist Professor Richard Powell.

According to Powell, one man, known simply as Patient A, "has definite early signs that a lymphoid malignancy is developing".
2.Renewed ordeal of the Elephant Men
David Leppard
The Sunday Times (Britain), July 30 2006

NAV MODI fears he may have only two more years to live. The 24-year-old from Forest Gate, east London, has just graduated from university and was looking forward to a career in his family's electrical business.

Now his future is uncertain. "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.

Modi is one of the "Elephant Men" who nearly died last March when he and five others took part in a drugs trial at Northwick Park hospital in northwest London.

Modi and his fellow patients were left seriously ill during the trial of the TGN1412 drug. His head swelled up like a balloon and he suffered multiple organ failure.

Ryan Wilson, 21, another guinea pig, suffered gangrene that made his toes and fingers go black. All his toes and three of his fingers will have to be amputated; he had heart failure, kidney failure, pneumonia, septicaemia and liver failure.

Mohamed Abdelhady, 29, a bar manager, suffered severe head and chest swelling. He was so bloated that his girlfriend Myfanwy Marshall said he was unrecognisable.

The patients had volunteered for the trial after being lured with the offer of £2,000 each to test the drug made by TeGenero, a newly formed German drug firm. Parexel, the American firm that administered the tests, told them there would be no serious side effects.

On March 13 this year, Modi and the other five patients were injected with TGN1412 while in the Parexel drug testing suite at Northwick Park.

At first, Modi recalled last week, he did not notice anything. But then a horrifying sequence of events began to unfold: "It started about 40 minutes later with a headache. A couple of minutes later that turned into a severe headache.

"It was like a huge, heavy foot was being pressed down on my head. I started moaning and crying, but the doctor just told me to calm down. He said it would go away. I begged him to do something. I told him the pain was killing me."

Modi then developed a back pain so severe that he was unable to lie down. "I was in such agony, I was jumping up and down on the bed and screaming." All around the other patients were going through similar agony.

Modi began retching, fainted, then stopped breathing; he was in and out of consciousness. Nurses tried to put an oxygen mask over his mouth but he kept pulling it off to be sick. The doctor gave him a paracetamol tablet. "I vomited that out in a couple of minutes." Soon afterwards staff administered pain-killing sedatives.

Modi woke up in the intensive care unit later that day. The next day he was visited by his girlfriend Divya Vegda, 22. Horrified by the sight of his swollen head, she later described him as looking like an "Elephant Man".

"My whole body was swollen up, puffed up like a huge balloon," said Modi. "It was like they had pumped gas into me."

Four months later he still suffers from occasional lapses of memory, severe headaches, back pain and diarrhoea.

He 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.

However, a study by Professor Richard Powell, an expert in immunology at Nottingham University, has changed all that. Last week Modi received the results of Powell's medical tests, commissioned by his lawyers to establish the extent of the damage the drug has done to him. The assessment has left him in a state of shock.

"The doctors told us we would be all right. They said they thought that in six months' time we would be normal," he said.

Martyn Day, the lawyer representing Modi and three of the other patients, showed them Powell's findings last week. "They face a lifetime of contracting cancers and all the various auto-immune diseases from lupus to MS, from rheumatoid arthritis to ME," he said.

With auto-immune diseases, the body attacks itself by mistake. Ironically, this is the type of condition the drug was being developed to treat.

Modi was the only patient last week willing to speak about Powell's study, which was based on detailed tests on their blood samples.

According to Powell, Patient A has developed signs of cancer: "It is highly likely (more than 50% chance) that A will develop auto-immune diseases and has definite early signs that a lymphoid malignancy is developing." This is a cancer of the lymphatic system that grows aggressively and will lead to death if left untreated.

Powell said Patient B had more than a 75% chance of developing auto-immune diseases. A split in his cells could possibly indicate an early sign of a lymphoid malignancy.

Modi's prognosis is equally worrying. Summarising the medical report, Day said: "It is highly likely that Nav will develop auto-immune diseases. His (cell analysis) may be an early sign that a lymphomatous process (tumour growth) is developing." Powell said Patient C was in the same situation.

The problem for all four, according to the report, is the depletion of T cells. A shortage or dysfunction in T cells can lead to destruction of the immune system, meaning the body cannot fight diseases.

Having studied Powell's results with his clients Day said: "They were devastated, particularly the client who faces the prospect of an early cancer."

Last Friday Powell produced further results that confirmed T cells could not be detected in the four patients.

When news of the disaster broke, TeGenero admitted liability. But it has since gone into liquidation and its insurance cover is worth only £2m, payable if court proceedings are not pursued. The company, set up for the purpose of making the drug, is not worth suing.

Modi reserves his greatest anger for Parexel, the American pharmaceutical services company. Its revenues are expected to be nearly £400m next year.

"They are supposed to be experts, but on the day of the trial they didn't seem to have the expertise. They gave me paracetamol when they should have given us steroids. That would have made a lot of difference. I would not have suffered so much. Parexel should be banned from further clinical trials. They nearly lost the lives of the six of us and could still do so."

Modi alleges that the company is trying to avoid responsibility for the fiasco. He and the others have received £10,000 in interim payments from TeGenero's insurer.

In a report two months ago, the Medicines and Healthcare Products Regulatory Agency highlighted procedural errors, accusing Parexel of keeping incomplete records. But it cleared the firm of causing the disaster, saying the reactions to the drug could not have been predicted.

Lawyers said the report was unsatisfactory. They have written to Parexel saying they hold it liable for damages as a result of its negligence and breach of contract. According to Day, Modi and the others may be entitled to between £2m and £5m to compensate for loss of future earnings and the cost of future medical care. Even if the case proceeds, Modi knows he may not live long enough to benefit from any payout.

"I have made the biggest mistake of my life," he said last week. "I feel like I've given away my life for £2,000. None of us is sure about the future. It could be that in six months' time we are dead."

Parexel did not respond when asked to comment.

Additional reporting: Anna Mikhailova

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