IS ANYONE OUT THERE LISTENING?

With the days' old news of the latest drug trial disaster dogging the heels of the pharmaceutical industry, it seems bizarre to still be hearing calls for animal research to be further increased. It is only one of countless examples of drugs that have tested safely on animals only to cause serious side effects or death in humans, and is the latest controversy to be associated with anti-inflammatory medication, following the withdrawal of Vioxx, one of a group of Cox-2 inhibitor drugs. Vioxx was voluntarily removed from sale by its manufacturer last year following evidence suggesting that it was linked to an increased risk of heart attacks and strokes. Concerns have also been raised about other Cox-2s, including most recently Celebrex, which a study linked to heart attacks this month.

Scientists themselves have admitted that animals had been used in exhaustive tests to assess the 'safety' of TGN1412, the experimental anti-inflammatory biotech drug now under fire, yet nothing in the animal data, it was alleged in a Channel Four interview yesterday, shed any light onto why this might have occurred. Animals had safely (?) been given 500 (!) times the dose administered to the six healthy men in phase 1 of the clinical trial on Monday, yet within hours of being fed TGN1412, the human participants started displaying signs of severe organ failure and extensive inflammation caused by a breakdown of the immune system. With cancerous and immune cells from mice introduced into their blood stream, and with only animal tests to rely on to prove the relative safety of the drugs in humans, these six healthy men, who volunteered for the drugs trial have become victims of the travesty that is vivisection, and hopes for their recovery remain pessimistic.

The men, who had been offered £2,000 to take part, were recruited by the US company Parexel, for the trial in its 36-bed unit on the Northwick Park hospital campus. They reportedly signed a contract warning that side effects in rats and mice included 'increased urine volume, decreased faeces, redness of the skin', and that dogs experienced 'increased heart rate and decreased blood pressure'.

TeGenero, the German biotech company that brought what it hoped was an exciting, innovative drug into its first human trials, insisted that nothing in the laboratory work and animal testing performed prior to the human trials would have warned of the extreme reaction in the volunteers. Whether we choose to believe whatever cover-up jargon is released, all that's as may be. It may be worth noting that a leading drug safety expert warned that in the case of genetically engineered biotech drugs, such as the one involved in the trial, there is no way of knowing what allergic reactions they might induce, since they are not structured from known compounds with predictive properties: they are made from complex proteins, and as such are biological products, with unknown properties. The TGN1412 drug was designed to bind to rogue immune cells and over-stimulate them, making them burn out and die.it seems the design system was seriously flawed or seriously over-zealous.

There will no doubt be many questions outstanding for some time to come over the disastrous biotech drugs trial; a global alert was issued immediately the news broke and a trial of the same drug, which had been approved but not started in Germany, was suspended. There is dismay among contract testing companies involved in testing new medicines: they fear volunteers will be unwilling to step forward. Around 300 phase 1 safety trials in which drugs are tested for the first time on humans, are run each year in the UK. They require several thousand human guinea pigs who are paid an average of £150 a day, according to the Medicines and Healthcare products Regulatory Agency who approved the trial of TGN1412.

Yet all this proves once again that the only test that proves whether a drug is safe for use in humans, is the test that is carried out on humans, and that it is in the clinical trial stages that researchers actually find out both whether a drug is safe and more importantly, effective. Animal experiments tell us about animals, not about people. The results of animal studies can never guarantee the safety or efficacy of human medicines or other products because of the fundamental biological, anatomical and biochemical differences between the species. No matter how many new animal research laboratories are built around this country, or around Oxford, no matter how many South Parks Rd sites the Government subsidies at the expense of the taxpayer to the tune of millions of pounds, those facts will hold true. Animal testing is immoral, and unscientific. This week's victims are a testimony to that fact.