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Drug trial disaster demands urgent animal testing review
Government investigation's terms of reference must be widened
The report by the Medicines and Healthcare products Regulatory Agency (MHRA) that the TGN1412 monoclonal antibody trial disaster was not due to contamination or mis-dosing reinforces the urgent need for an independent review into the medical utility of animal testing.
TGN1412 had been tested in both rats and monkeys. The drug company in question, TeGenero, had mistakenly assumed that because the antibody reacted with both its human target protein and a similar protein in cynomolgus monkey cells, that tests in monkeys would predict human reactions. But despite the fact that the human doses were 500 times smaller than in the primate tests, a catastrophic chain reaction occurred in the human volunteers that was entirely unanticipated by the monkey tests.
The TGN1412 case demonstrates that even those animals claimed to be the "best" models give false reassurance regarding human safety. It also comes hard on the heels of the Vioxx disaster, the biggest in history, and the discovery that adverse drug reactions are our fourth leading cause of death: killing over 10,000 people a year in the UK and costing the NHS £466 million. There is a growing body of evidence indicating that animal research is a public health disaster, and that the practice serves the commercial interests of drug companies rather than the basic needs of patients for safe and effective medicines.
In its initial statements to the media, the MHRA admitted that animal tests had failed to predict the human reactions in this instance, and indicated the need for an investigation into their reliability. This position has been supported by many experts, including Dr David Glover, and formerly chief medical officer at Cambridge Antibody Technology. He has suggested looking at micro-testing - testing small amounts on people - as an alternative to animal testing for such drugs.
However, the review announced by Health Minister Lord Warner does not include the validity of animal testing for monoclonal antibody treatments in its terms of reference.
But it is surely incumbent on the government to reassess whether it is moral, and indeed legal to subject animals to painful, distressing and lethal experiments when the results are not applicable to humans. Unfortunately, it seems that the pro-vivisection posturing of the government is preventing it from conducting an open and honest assessment of animal testing, even in cases where its invalidity has been explicitly acknowledged.
It is vital that the government listens to the concerns of its own regulatory agency and scientific experts, and broadens its review of this horrific episode to consider the scientific and ethical validity of these animal tests.
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