Compelling reasons for an independent scientific evaluation of animal testing of drug safety

Approval for the TGN1412 clinical trial at Northwick Park hospital was based on demonstrated safety in animals – as is the case with all new drugs. Yet tests on human tissue (which are not legally required) could have averted the disaster: see here…

92% of drugs fail in clinical trials, having successfully passed through animal studies. Significant numbers of volunteers die in clinical trials because there is often no prior information on safety in humans – only assurances of safety in animals.

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 (figures exclude prescribing errors and overdoses). New human-based safety tests, such as microdosing and human DNA chips, could prevent many of these deaths.

Withdrawn arthritis drug Vioxx has dwarfed Thalidomide as the greatest drug catastrophe in history: claiming up to 140,000 lives. Vioxx caused hundreds of thousands of heart attacks, though animal tests predicted it would protect the heart. Clinical trials did reveal the risks but animal data was given more credence.

Several published studies assessing the prediction of drug side effects by animals have found them to be very poor predictors; correct only 5-25% of the time.

82% of doctors in an independent survey in 2004 were “concerned that animal data can be misleading when applied to humans” and 83% would “support an independent scientific evaluation of the clinical relevance of animal experimentation.” TNS Healthcare, who conducted the survey, has never disputed this, although our opponents try to claim otherwise.

The Toxicology Working Group of the House of Lords Select Committee on Animals in Scientific Procedures in 2002 recommended that “the reliability and relevance of all existing animal tests should be reviewed as a matter of urgency.”

A 2004 paper in the British Medical Journal concluded that “the contribution of animal studies to clinical medicine requires urgent formal evaluation.”

The recent Health Committee inquiry into the influence of the pharmaceutical industry concluded that the regulatory standards for new drug approval require urgent review.

This Government came to power promising a Royal Commission on animal experimentation. Yet Home Office Minister Caroline Flint stated in 2004 that the Government “has not commissioned or evaluated any formal research on the efficacy of animal experiments and has no plans to do so" and on 19th January 2006, Jane Kennedy, Minister of State for Delivery and Quality at the Department of Health, in a written answer to a PQ from Susan Kramer MP stated "There are no plans for an independent assessment of the use of animals as surrogate humans in either drug safety testing or medicinal research."

None of the three recent inquiries into the use of animals in research – all of which focused predominantly on ethics – compared animal tests with microdosing and other human-based safety tests: our key proposal.

The Advertising Standards Authority’s ruling againt the claim that "Some of the major advances in the last century would have been impossible without animal research" is hugely significant, as this claim is the very mantra of animal testing advocates.

Protecting the public from adverse drug reactions is an urgent priority, which demands an objective assessment of all aspects of the safety testing process. In light of TGN1412 and Vioxx, such an evaluation is the only responsible course of action.

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