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Too clever by half: GMO drug in catastrophic trial

by brian Friday, Mar. 17, 2006 at 8:59 PM

The trial drug is not a chemical but a biological product, a genetically engineered "humanised" protein.

EXCERPTS: The girlfriend of one of the men, Myfanwy Marshall, said her 28-year-old boyfriend had swollen beyond recognition. She said his doctors had told her: "He needs a miracle; those were their words, he needs a miracle."

It is increasingly likely that the drug itself, given at the right dose, was to blame - an explanation that could have very serious consequences for research into the biological drugs called monoclonal antibodies...

The trial drug is not a chemical but a biological product, a genetically engineered "humanised" protein.

---

Relatives' fury over calamitous drug trial

Sarah Boseley, health editor

The Guardian, March 16, 2006 http://www.guardian.co.uk/frontpage/story/0,,1731919,00.html

Investigators began an urgent inquiry yesterday into the clinical trial that has left six healthy volunteers in intensive care, as scientists voiced fears the disaster could prove a major setback to developing cures for life-threatening diseases.

Nothing had been ruled out, said the Medicines and Healthcare Products Regulatory Agency (MHRA), leading the investigation. But although the police were still nominally involved, it was clear that a criminal act, such as deliberate tampering with the experimental medication, was unlikely. Scientists were left contemplating the possibility that the dangerous side effects of this drug in humans had not been, and perhaps could not be, detected in the normal animal trials.

Human error - the possibility that somebody on the trial staff gave the volunteers too high a dose of the experimental drug - is still being looked into, even though Parexel, the US-based contract company running the trial unit at Northwick Park hospital in Harrow, north London, denied it and insisted that everything had gone according to protocol.

The health secretary, Patricia Hewitt, described what happened as "shocking", but said she was confident everything was being done to look after the men and to discover what went wrong.

Last night, two of the men remained in a critical condition at Northwick Park hospital while four others were serious but showing some signs of improvement, according to a hospital spokeswoman.

The girlfriend of one of the men, Myfanwy Marshall, said her 28-year-old boyfriend had swollen beyond recognition. She said his doctors had told her: "He needs a miracle; those were their words, he needs a miracle."

Ann Alexander, a solicitor representing a 29-year-old man who is on a life support machine, said his family had complained of receiving "mixed messages" during their two meetings with the drug firm.

In the first meeting, they were told the drug had been tested on monkeys and dogs, and that one of the dogs had died. In the second, they were told it had been tested on monkeys and rabbits. Ms Alexander said she believed the drugs firm had pledged to give her client's family all the financial support they required, and added it was unclear what legal action might be taken."It has been a devastating tragedy, and these mixed messages cause great concern," she said.

The company said in a statement: "Parexel administered the appropriate dosage to the volunteers based on the protocols designed by the sponsor, TeGenero, and which were approved by the ethics committee and UK regulatory authority." TeGenero's chief scientific officer, Thomas Hanke, said last night that the company had apologised to the men's families, adding that the firm was "devastated" at the "shocking developments".

It is increasingly likely that the drug itself, given at the right dose, was to blame - an explanation that could have very serious consequences for research into the biological drugs called monoclonal antibodies which are the bright hope for better treatments in the future.

The trial drug is not a chemical but a biological product, a genetically engineered "humanised" protein. Unlike the old chemical entities, these monoclonal antibodies are designed to be accepted by the human body, which experts say makes it difficult to work out by animal testing what dose would be toxic to humans.

The volunteers took the drug on Monday - the first time that humans had been exposed to it. Within hours they were critically ill. Yet the MHRA and the regulatory authorities in Germany, where the biotech company TeGenero is based, had both examined the data from the animal tests and allowed the human trial to proceed.

When drugs are first tested on humans, doctors do not expect any response at all. But the six men who had taken the drug suffered a massive inflammatory reaction. Scientists are concerned that the incident may deter people from volunteering to take part in clinical trials.

Richard Gray, director of the University of Birmingham clinical trials unit, said: "It must have been a huge surprise to the people running the trial that something like this should happen. It is very, very rare indeed for something as catastrophic as this to happen."

http://www.gmwatch.org/archive2.asp?arcid=6349

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