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Elephant Man Drug Did Harm Animals ; Test Made Monkeys' Necks Swell Up

Posted on: Sunday, 19 March 2006, 18:00 CST

By DANIEL BOFFEY

THE drug at the centre of the 'elephant man' testing scandal caused monkeys' necks to swell up before it was used on humans, The Mail on Sunday can reveal.

At least one of the mammals tested with the drug which left six men fighting for their lives in a London hospital last week suffered swelling of the lymph nodes.

The revelation flies in the face of claims by the German drug company involved that there had been 'no drugrelated adverse effects' during trials.

It also contradicts documents seen by this newspaper which claim that the volunteers were told that there had been no significant adverse effects in previous tests. The monkeys' reaction was considered serious enough for bosses at German drug manufacturer TeGenero to order doctors to monitor the immune system of the human volunteers and react immediately if they observed any swelling.

Professor Johannes Loewer, president of the Paul Ehrich Institute, the health ministry body that controls all research of biological drugs in Germany said: 'There were adverse effects in a certain dosage. Some of the monkeys developed an increase in the lymph nodes.' It was also revealed last night that that there had been an earlier alert about the risks of the drug TGN1412. A German newspaper reported that Clinical Immunology, an American-based publication for 'Why was testing approved in England?'

the medical research industry, published a study in 2002 warning of the problems involving human cells being adversely affected by the medication.

Hubert Hueppe, health spokesman of the conservative Christian Democratic Union in Germany, said: 'I ask why, despite this well- known risk, the testing in England was requested and approved by the British ethics commission and the relevant government authority.' Yesterday, two of the volunteers remained in a critical condition four days after taking part in the trial at Northwick Park hospital in Harrow, London. Two others are still receiving organ support. The others were off their support systems.

Last night it remained unclear whether they had been made aware of warnings about the drug's potential effects. Dr Thomas Hanke, the chief scientist at TeGenero, said he believed 'all relevant information' had been put into their consent forms.

But the information provided in documents given to each of the participants in the drug trial, seen by The Mail on Sunday, reads: 'No significant side effects have been seen in the animal studies.' As concern grew over how quickly the green light was given by the British authority for human trials of the drug, Silke Thomson, spokesman for the Medicines and Health Care Products Regulatory Agency, said: 'We assigned experienced expert assessors to review the original decision in approving the clinical trial, and we found nothing that would question our decision.'

Source: Mail on Sunday; London (UK)

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