Tuesday, August 01, 2006

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 testing far safer and accurate.