August 1

2006: TGN142, A catastrophic experiment

TGN1412 stimulated the immune system’s T-cells to catastrophic levels; the experiment nearly killed all human subjects. All human subjects in a Phase I drug trial testing a genetically engineered experimental monoclonal antibody drug, TGN1412, face life-threatening multi-organ failure.

The drug, which bypasses the immune system’s natural control mechanism, was manufactured by TeGenero (a German company). It was tested for the treatment of multiple sclerosis, leukemia and arthritis. German authorities had refused to allow the drug to be tested in Germany. But the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorized Parexel, a US contract research organization (CRO) to conduct the experiment at London’s Northwick Park Hospital.

Six previously healthy male volunteers (aged 19 to 34) were the subjects of the drug trial that put the entire body’s immune system in overdrive, causing a violent reaction in ALL the subjects; following the rapid infusion with the antibody, they nearly died. All the volunteers faced life-threatening conditions involving multi-organ failure requiring hospitalization and Intensive Care. They suffered respiratory deterioration, renal impairment, pulmonary infiltrates requiring blood replacement. Furthermore, their cognition was badly affected—they had difficulty concentrating and inability to find words to complete spoken sentences. One victim’s head swelled up like the “Elephant Man” and another had fingers and toes amputated. Read more here and here

Documents revealed that the MHRA which authorized the trial was notified beforehand that there was this risk of cytokine release: they were informed that a previous incident involving a similar drug had provoked a serious adverse reaction in human volunteers. (Drug Firm Knew of Risk, Guardian, 2006) Parexel’s own literature mentioned the possibility of life-threatening adverse effects, and indicated that in case of a cytokine storm, the antidote to be administered was a certain dose of a certain steroid. Yet, the acutely ill subjects of TGN1412 were not treated with the recommended antidote; they were only given painkillers.  When the hospital staff finally discovered what was needed, they lacked sufficient doses of the drug to cope with the crisis.  (“Everybody thought We Were Toxic Waste,” Guardian, 2007)

An immunologist who wished to be anonymous stated:

You don’t need to be a rocket scientist to work out what will happen if you non-specifically activate every T cell in the body.”  (S. Bhattacharya & A. Coghlan. Catastrophic immune response may have caused drug trial horror. New Scientist, 2006)
“What was happening was that a drug supposed to dampen the immune system, to stop it attacking itself, ended up destroying it, and the volunteers’ organs were shutting down.”
(The Guardian, 2007)

After the catastrophic effects, the victims of the deadly TGN 1412 experiment were informed they were at increased risk of contracting multiple sclerosis, cancer and other fatal diseases as a result. Read more (here and Pharma Strategy Blog, 2008)

The MHRA –which approved the experiment – issued a report exonerating itself and Parexel, dismissing the catastrophic consequences as: “an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions.”

Dr. Mae-Wan Ho and Prof. Joe Cummins refute the claim that the immune response was “unpredicted,” citing FDA warnings on monoclonal antibody drug labels:

“the problems associated with MAB drugs are widely recognized. One drug approved for treating multiple sclerosis (MS) was associated with several deaths from brain infections, probably because it blocked immune cells migrating to the brain to fight infections. That drug was voluntarily suspended pending further studies.

The other MAB drugs approved are almost without exception associated with severe side effects, in many cases including death. These drugs provide, in most instances, treatment of last resort for terminal or highly debilitating disorders. For that reason, the risk of administering the treatment has been deemed acceptable provided that consent for treatment is truly informed.”

Collapse of Science and Ethics: Failure to follow precautionary medical principle:
Given the possibility of serious risks involved with monoclonal antibodies, why were six people simultaneously exposed to an experimental drug that had not been tested in humans?
A former executive at Parexel expressed surprise that all six volunteers had been simultaneously exposed to the drug, stating:“It is common sense not to dose six individuals with the drug at once where there is no prior human experience.” (ISS, 2006)

  • Why did the experimenters and the MHRA fail to follow the simple safety measure of testing the drug sequentially, rather than exposing all six volunteers simultaneously?
  • Did the MHRA have all the information available when it approved the trial?
  • Were the volunteers fully informed about the known and foreseeable risks of monoclonal antibodies? Was the informed consent document adequate?

Read more “London Drug Trial Catastrophe – Collapse of Science and Ethics, Institute of Science in Society, 2006

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