2006_08_01_archive

Animal tests responsible for Elephant men drug disaster, UK official body

says

The so-called "Elephant Man drug victims", the 8 healthy volunteers

affected by the TGN1412 drug trial disaster of last March in the UK,

have just been told to expect early death. A medical assessment by

immunologist Professor Richard Powell indicated that they face

contracting cancer and other fatal diseases.

This is the umpteenth disaster caused by the bio-medical research

establishment's obstinate reliance on animal testing.

The drug in question, TGN1412, had indeed been tested on animals, as

is unfortunately always the case, including non-human primates.

The company conducting them claims that these experiments showed the

drug to be safe.

The result of the investigation into this incident by the Medicines

and Healthcare Products Regulatory Agency (MHRA), the UK government

official regulatory body, says:

"...this product showed a pharmacological effect in man which was not

seen in preclinical tests in animals at much higher doses" (emphasis

added).

In their report, the MHRA found no deficiencies in the drug's animal,

pre-clinical and clinical work: everything was in order, including

dose measurement and administration. In short, the MHRA thought that

the actions of the companies involved did not contribute to the

serious adverse reactions.

Similarly, German Regulatory Authorities inspected the production,

manufacture, testing, storage and distribution of the material, and

found no deficiencies which could have contributed to the tragic

adverse events.

The MHRA concluded that the most likely cause of the adverse effects

in trial human subjects was an unpredicted biological action of the

drug in humans.

When tested on animals, then, the drug had appeared to be safe in

animal models, but researchers have observed that there are reasons

why these may not be indicative of the response in humans. Other

similar drugs, tested safe on animals, have previously shown side

effects in human trials.

Even the British Medical Journal is starting to see the writing on the

wall for animal research:

"Why were all eight volunteers given the drug at the same time?

Several observers have asked whether minimal standards should include

observing a single dose in a single carefully monitored individual,

rather than relying solely on dose as a function of animal lethality."

(emphasis added)

And the BMJ goes on to say:

"Relative lack of severe toxicity in animal models should never be

construed as a guarantee of safety in man, as the story of thalidomide

taught us." (emphasis added)

In Britain the Early Day Motion 2088, a new bill tabled by the Member

of Parliament David Taylor, argues for more government funding for new

technology advances, such as micro-dosing, which would make human