Mar 16 2006

Criminal Medicine

Published by at 12:03 am under All General Discussions

The stories about a drug trial having gone terribley wrong indicates a serious short coming in the animal trials, if not some criminal negligance:

Myfanwy Marshall, 35, said her boyfriend, a 28-year-old British man who had taken part in drug trials before without adverse side effects, felt ill 80 or 90 minutes after being given the drug on Monday.

He is now in the intensive care unit at at Northwick Park hospital in north-west London.

Five other men were also admitted to the intensive care unit at Northwick Park from an independent medical research unit on the hospital campus after taking part in the trial.

They had reacted badly to the drug, which is to treat chronic inflammatory conditions and leukaemia.

And this:

The test ward turned into a living hell minutes after we were injected. The men went down like dominoes.

First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode.

After that they started fainting, vomiting and writhing around in their beds.

It was terrifying because I kept expecting it to happen to me at any moment. But I felt fine and didn’t know why.

An Asian guy next to me started screaming and his breathing went haywire as though he was having a terrible panic attack.

They put an oxygen mask on him but he kept tearing it off, shouting ‘Doctor, doctor, please help me!’ He started convulsing, shouting that he was getting shooting pains in his back.

These kinds of basically allergic responses would not happen if proper animal testing was performed. Trials in primates , epecially chimpanzees, is mandatory to make sure the drug is not activating a response mechanism as opposed to controlling it. Apparently that is what happened here with protocols not being followed:

DRUG trials that left six healthy volunteers fighting for their lives did not conform to best medical practice, The Times has been told.

Senior doctors expressed concern that all six were given the same dose of the experimental drug TGN1412 at the same time. According to the standard medical text, trials of this sort should avoid giving all the doses simultaneously. The Textbook of Pharmaceutical Medicine specifically gives warning that such practices can be “very difficult to manage” and “put subjects at unnecessary risk”.

If in the animal trials, supposedly passed, this was not the process then these people should face severe sanctions for putting innocent people at risk. People rightfully assume human trials are the final stage of an exhaustive process to ensure no harm can possibly come to human patients. But apparently there were serious issues in the animal tests, and these so called scientists basically ignored the warning signs:

There was confusion last night about whether the drug had been tested successfully on animals before the tests on human volunteers.

“They [the drugs company] said there was an oversensitivity in monkeys,” Ms Marshall said. She went on to say that in the tests a “dog and some animals had died . . . so they reduced the amount to humans”.

Having a BS in Biology and familiar with animal testing of products this disaster demonstrates clear criminal negligence and recklessness. I would not accept this kind of dodgey answer if I was the government:

Thomas Hanke, chief scientific officer of TeGenero, last night refused at a press conference to say whether animals had died during earlier tests. “There has been no issue on the safety of the drug on animals. This is not relevant,” he said. He said the drug had been tested on mammals but not dogs or rats.

Well explain what it was tested on! Birds, Mice, Platapusses? They are all mammals. They should have had some primate trials given the purpose of this drug.

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