GMW: GM drug victims told to expect early death

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GMW: GM drug victims told to expect early death

" GM WATCH " <info

Mon, 31 Jul 2006 22:38:09 +0100

 

 

 

 

GM WATCH daily

http://www.gmwatch.org

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1.Elephant Man drug victims told to expect early death

2.Renewed ordeal of the Elephant Men

 

More disturbing news about the catastrophic drug trial involving

genetically engineered monoclonal antibodies. The victims have now

been told

they face contracting cancer and other fatal diseases.

 

As you read this article, it's worth remembering that the GM maize

that's been approved for open field trials in France has been genetically

engineered to produce monoclonal antbodies for clinical purposes. All

such monoclonal antbodies are associated with severe side effects.

 

As Prof. Joe Cummins, Dr. Mae-Wan Ho and Prof. Peter Saunders have

warned, these GM maize trials are bound to contaminate our food supply.

" Yet transgenic crops with these drugs are being tested in secret

locations and unsuspecting members of the public are exposed without

their

knowledge or consent. "

http://www.gmwatch.org/archive2.asp?arcid=6812

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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 " .

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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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