- The call for a medical inquiry
The call for a medical inquiry
In 1997 a political party offered to hold an historic inquiry into animal testing if they were elected as government. Later that year they were elected, but never enabled that inquiry. Meanwhile many established medical organisations have supported calls for an inquiry. There has never been a formal medical inquiry into the alleged scientific value o animal testing and the rationale for enabling it to continue.
· 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 Health Committee inquiry into the influence of the pharmaceutical industry concluded that the regulatory standards for new drug approval require urgent review. 
· The Labour Government of 1997 - 2010 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." 
· The Nuffield Council report on animal experiments recommended: "At present, there is a relatively limited number of useful systematic reviews and meta-reviews that address the question of the scientific validity of animal experiments and tests. In principle, it would therefore be desirable to undertake further systematic reviews and meta-analyses to evaluate more fully the predictability and transferability of animal models" (p.xxxiii).
There is a great deal of medical opinion critical of animal testing, which can be seen here.
Animal testing of new drugs became mandatory following thalidomide, with the intention of preventing another such tragedy. Arthritis drug Vioxx (withdrawn in 2004) has now dwarfed thalidomide as the greatest drug catastrophe in history, yet Vioxx passed animal tests. 
Smaller drug disasters are commonplace: 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.  New human-based safety tests before and during clinical trials (such as microdosing) could prevent many of these deaths.
Reasons to assess the efficacy of animal tests include:
· 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. 
· 92% of drugs fail in clinical trials, having successfully passed through animal studies. 
· Sophisticated new methods of assessing drug safety include human tissues, DNA chips, virtual metabolism simulators and microdosing with PET and AMS scanners. 
· A 2005 study of animal and in vitro methods of predicting teratogenicity (potential to cause birth defects) spanning 40 years has found animal tests to be ineffective. 
· Scores of treatments for stroke have tested safe and effective in animals in recent years but not a single one has emerged as safe and effective for patients.  This is a typical failure.
· 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." 
Since then two Early Day Motions have been presented to parliament. Both were extremely successful, ranking in the top 1% of EDMs for that parliamentary session. Further political activity will take place to push for this inquiry, and more news will be placed here in the future.
References:1. The Stationery Office, HL Paper 150-1, ISBN 0 10 412102 5, p70
2. BMJ 2004; 328:514-517 Pound et al; "Where is the evidence that animal research benefits humans?"
3. Press release from Health Select Committee, 5th April 2005. Publication of Report: The Influence of the Pharmaceutical Industry (HC 42-1).
4. Written answer to Parliamentary Question from Mike Hancock, MP, March 31st 2004.
5. British Medical Journal 2004;329:1253. Dr David Graham, associate director of the FDA's Office of Drug Safety, said an estimated 88,000 to 139,000 Americans had heart attacks and strokes as a result of taking Vioxx, as many as 55,000 of them fatal. The number, he said, far exceeds earlier disasters such as the 100 children killed in the United States by an elixir of sulfanilamide in the 1930s and the 5,000 to 10,000 children born in the 1960s with birth defects related to thalidomide. Both events led to sweeping regulatory changes.
6. British Medical Journal 2004;329:15-19 Adverse drug reactions as cause of admission to hospital. ("Measures are urgently needed to reduce the burden on the NHS.")
7. e.g. Clin Pharmacol 1962;3:665-72Zbinden, G (1991) Predictive value of animal studies in toxicology. Regul. Tox. Pharm. 14: 167-177CMR Workshop - Animal Toxicity Studies: Their Relevance for Man Quay 1990 p 49-56 and p57-67Spriet-Pourra, C and Auriche, M (Eds) 1994 SCRIP Reports PJB, New York Garratini, S (1985) Toxic effects of chemicals: difficulties in extrapolating data from animals to man. Annu. Rev. Toxicol. Pharmacol. 16: 1-29 Zbinden, G (1993) Regul. Toxicol. Pharmacol. 17: 85-94 Calabrese (1984) Suitability of animal models for predictive toxicology: Drug Metab Rev 15: 505-523 Oser, BL (1981) J. Toxicol. Environ. Health 8: 521-642 Calabrese, EJ (1987) Principles of Animal Extrapolation. Wiley, New YorkOlson, H., Betton, G., Stritar, J., and Robinson, D. (1998). The predictivity of the toxicity of pharmaceuticals in humans from animal data-An interim assessment. Toxicol. Lett. 102-103, 535-538Regulatory Toxicology and Pharmacology 2000;32:56-67Drug Metabolism and Drug Interactions 2000;16:143-155Dr Ralph Heywood, former director of Huntingdon Research Centre, said: "... the best guess for the correlation of adverse reactions in man and animal toxicity data is somewhere between 5 and 25%."
8. Lester Crawford, FDA Commissioner, in The Scientist 6.8.04 "More compounds failing Phase I"
9. Microdose studies ("Phase 0" clinical trials) were endorsed by the European Agency for the Evaluation of Medicinal Products in January 2003, and were shown to be highly effective at predicting human metabolic profiles in a trial culminating in March 2005. See www.microdosing.co.uk. A ten-year international study proved that human cell culture tests are more accurate and yield more useful information about toxic mechanisms than traditional animal tests. Some companies (e.g. www.pharmagene.com) focus on safety and efficacy assessments in human tissues. Others (e.g. www.biopta.com) specialise in human pharmacological assessments during clinical trials, which could identify the cardiovascular hazards of a drug like Vioxx, for example, before it was marketed. Many companies specialise in virtual screening of drugs for potentially toxic effects. A wide range of predictive software is available, including complete clinical trial simulations.
10. Biogenic Amines 2005; 19 (2): 97-145 Bailey et al; "The future of teratology research is in vitro"
11. Nature Medicine 2002; 8 (1):5 Future of neuroprotective drugs in doubt, also Stroke 1990 21: 1-3.
12. Survey conducted by TNS Healthcare