DOCTORS who saved the lives of six men after they suffered multiple organ failure while taking part in a drugs trial have described the dramatic challenges they faced.

Ganesh Suntharalingam and colleagues at Northwick Park Hospital in northwest London struggled to keep the men alive after they suffered a “cytokine storm” — a massive overreaction of the immune system — when trials of the drug TGN1412 went disastrously wrong.

Breathing problems, headaches, severe nausea and back pain led to abnormal blood clotting, plummeting blood pressure and tissue peeling off the ends of their fingers, the doctors said.

Writing in the New England Journal of Medicine, Dr Suntharalingam said that the reaction experienced by the men could help the understanding of a phenomenon that may occur again in future trials.

The participants became ill shortly after they were given the drug, which was designed to treat chronic inflammatory conditions and leukaemia.

When one patient became so ill that he had to be put on a ventilator, the doctors put the other five into intensive care as a precaution. Some of the men became very disturbed, their blood pressures dropped and their organs began to fail.

The doctors described a dramatic two weeks during which the previously healthy men developed symptoms that looked like a serious infection known as sepsis, which led to difficulties in breathing.

The adverse effects of the drug were so severe that the girlfriend of one victim described him as looking like an “elephant man”.

The drug is a monoclonal antibody, a protein engineered to affect CD28 cells in the immune system. The men were paid volunteers in a study run by the American drug research company Parexel International on behalf of TeGenero, a German biotech firm which has since filed for insolvency.

It took weeks to stabilise the patients and lead them to slow recovery. A cytokine storm can kill, and has been described in patients with avian influenza.

A commentary by Arlene Sharpe, of Harvard Medical School, and Abul Abbas, of the University of California, said that laboratory animals showed the same response. This may be because they are often kept in very clean environments and their immune systems are never challenged.

“Regulatory authorities who tested TGN1412 from the same batch as the infused drug found no errors in its manufacture, formulation or administration, and found no contamination,” the researchers said.

They said that scientists running clinical trials should be aware of the danger and learn how to handle such cases. “There are clearly going to be more trials in the field of molecular biology,” Dr Suntharalingam said.

The journal’s editor, Jeffrey Drazen, added that as long as scientists continued to manipulate biology, it was probably impossible to prevent similar cases.

“We must do what we can to minimise risk, but the future health of the population demands that we do not let adverse events put an end to medical progress,” he said.

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