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BAN THE BOTOX - Letter to the Committee on Safety of Medicines
Posted 30 June 2006
26 January 2004
Professor Gordon Duff
Committee on Safety of Medicines
1, Nine Elms Lane
London SW8 5NQ
Dear Professor Duff
It has come to our notice that thousands of mice are being poisoned to death to test the latest cosmetic craze: 'Botox'. In barbaric and unreliable LD50 experiments - essentially outlawed by the government in 1999 - the animals are injected with the toxin and suffer symptoms including impaired vision, paralysis of the body, and paralysis of the diaphragm, which leads to death by suffocation.
Botulinum toxin has several therapeutic applications but its use in cosmetic procedures is the area that it is booming. According to the International Society of Aesthetic Plastic Surgeons, botox injections were the second most popular cosmetic procedure amongst women in 2001. The toxin is regarded as the one of the most dangerous substances to human beings and has the potential to be used as a biological weapon. We recognise that the law requires that each batch has to be assessed for potency before being marketed. However, it is entirely unacceptable that a blanket licence is granted by the Home Office for botox batch-testing, regardless of the market (pharmaceutical or cosmetic) for which the batches are destined. Despite the fact that the government supposedly no longer issues licences for testing cosmetics on animals, we understand from the Fund for the Replacement of Animals in Medical Experiments (FRAME) that each batch is tested on mice in LD50 'procedures'. (Krys Bottrill, 'Growing Old Disgracefully: The cosmetic use of botulinim toxin', ATLA 31, 381-391, 2003.)
Not only is this experiment extremely cruel, it is so crude as to have no real value in terms of human risk assessment. For each batch that is tested, at least 100 mice are divided into groups and injected with different dilutions to monitor what level will kill half the mice in a particular group.
The government acknowledges the LD50 test to be a 'severe' procedure and made a pre-election pledge to ban it completely. In 1999, a partial prohibition came into effect, whereby it was outlawed - other than for 'exceptional scientific grounds'.
As the chemical industry made efforts to phase out the LD50, its use decreased dramatically in the years preceding the ban. This downward trend should have continued. However, according to FRAME, numbers increased significantly in 2001, with a further rise in 2002. This increase in the number of LD50 poisoning tests correlates with the surge in popularity of botox injections.
It is reasonable to assume that, as the injections become increasingly popular, more and more of the toxin is produced and tested, driving up the number of LD50 tests.
In summary: a cosmetic product is being tested on animals in a cruel and outdated procedure that was essentially outlawed in 1999. A number of in vitro tests for botox toxicity are available - which, unlike the LD50 test, are accurate and reproducible.
It is unacceptable that a 'luxury' product intended to eliminate wrinkles is causing the slow, agonising death of thousands of animals. Animal Aid is calling upon the Home Office to close the loophole which permits the testing on animals of botox destined for the cosmetic industry. Also, to insist that all LD50 testing is replaced with superior non-animal test methods without delay.
In light of the fact that this dangerous toxin has not been adequately assessed for safety, until that action is taken, we call upon the Committee on Safety of Medicines to recommend a ban on the use of botox for cosmetic procedures. We are further urging people contemplating botox injections to consider that this dangerous toxin has not been adequately assessed for safety AND that many animals have been pointlessly abused and killed in the manufacture of the product.
Director, Animal Aid