UK drug trial: Monkeys affected
2006-03-22 08:09
London - The same drug that caused convulsions and organ failure in the first humans it was tested on in Britain - six previously young and healthy men - left monkeys with swollen glands, the drug company's chief scientist said on Tuesday.
The symptoms developed in the monkeys weren't the same as those suffered by men who took part in the trial, said Thomas Hanke, chief scientist at TeGenero AG of Wuerzburg, Germany.
The latest information, however, seemed to contradict the company's earlier claim that no "drug-related adverse events" occurred in previous animal tests.
The medical trial - one of the most disastrous in Britain - has raised fresh questions over the safety of such testing and whether volunteers have enough information to weigh the risks. Two men were still in a coma on Tuesday and four others were seriously ill but improving after participating in the trial last week. Two other men were given placebos.
No specific information about tests done on animals
"It felt like we stepped into some sort of horror film," Raste Khan, one of two men who were given placebos in the trial designed to test a drug for leukaemia and other ailments, said. "The three other men in my ward started vomiting, then they began to fall in and out of consciousness. The person on my left was begging doctors to help him. I was really scared and was just waiting for it to start happening to me."
The drug, which targets the immune system, is expected to cause glands to swell, Hanke said. The effects on the two monkeys - which survived - were only temporary, and warnings about temporary glandular swelling was disclosed to volunteers, he said.
Khan, however, said the language in the 15-page consent form for the test conducted by Waltham, Massachusetts-based Parexel was complicated, and there was no specific information about tests done on animals.
"You rush to read these papers with difficult medical terms. Then, they call you up within 10 or 15 minutes and expect you to give it back to them," he said.
The Medicines and Healthcare products Regulatory Agency - which authorised the trial - said there was nothing unusual about the results of laboratory and animal tests on the drug or the methodology for the human trials provided by Parexel and TeGenero.
What happened to the men, however, was "completely unheard of," said Sara Coakley, a spokesperson for the agency.
Tests must go on
Minutes after being injected with the drug, six men lapsed into comas, forcing doctors to put them on organ support machines, said Dr Ganesh Suntharalingam, who was treating the men at Northwick Park hospital in London.
"There could have been a manufacturing problem, some form of contamination, a problem with the drug's administration, or ... it could be that (defects with the drug) just didn't show up in preclinical data from the tests on primates," she said. "It will be weeks before we find out exactly what happened."
Some experts said the men should have never been injected at the same time.
"The idea you give six people an injection at the same time is unusual," said Kate Law, head of clinical trials for Cancer Research UK - Britain's largest cancer charity. "In any of our tests, we never test drugs on the volunteers all at the same time."
David Glover, former chief medical officer at biotech company Cambridge Antibody Technology, said testing drugs like TGN1412 must go on despite the tragedy. He cited drugs like Herceptin, which has made a big impact on the treatment of breast cancer.
"We need to understand the issues we face and look at creative solutions," said Glover.
- AP