Horrible TGN1412 Drug Trial Gets Even More Horrible

I have written before, first here, and then here, about the horrible TGN1412 drug tests that went so disasterously wrong in Britain. And now, an update:

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

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…

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…”

“I have made the biggest mistake of my life,” [Modi] 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.”

Read the full, horrible story at The Times Online.

Comments

  1. Bill Standley wrote:

    And now news that the FDA is testing the water for doing away with informed consent for “emergency research”. Imagine the drug companies lining up to make use of that loophole!

    http://www.wnd.com/news/article.asp?ARTICLE_ID=51880

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