The BUAV, along with our colleagues in the European Coalition to End Animal Experiments (ECEAE), has today welcomed the announcement by Allergan that EU approval of its in vitro, cell-based assay for use in the stability and potency testing of BOTOX® and VISTABEL® has been gained*.
The USA, Canada and Switzerland have already approved the in-vitro test for both medical and cosmetic versions of Botox.
Michelle Thew, Chief Executive of BUAV states: “We are pleased that Allergan has achieved approval by the European regulators for the first non-animal based assay for the potency and stability testing of Botox® and Vistabel®. This is a significant step forward. Allergan has shown that it is possible to replace the cruel mouse bioasssay. We now call on those companies manufacturing botulinum toxin products, including Ipsen and Merz, to follow Allergan's lead.”
The traditional animal test for the batch release of all botulinum products uses mice and is designed like the Lethal Dose 50 (LD50) tests. LD50 tests determine the dose at which 50% of the mice would die and involve severe suffering for the animals. Mice are injected into their abdominal cavities with the toxin and then, over three days, are observed to see if they have died or are showing signs that they will die shortly from the toxin.
The BUAV has long campaigned for an end to the cruel use of animals in botulinum toxin tests and recently welcomed the chance to discuss the next steps in this effort with Allergan. In the recent meeting, Allergan confirmed that the company aims to end all animal testing for the commercial (batch) release of BOTOX®, Botox Cosmetic and VISTABEL® once all stages of regulatory approval has been cleared.
* European countries that have approved the alternative:
For BOTOX®, Ireland serves as the Reference Member State in the Mutual Recognition Procedure. The other countries involved are Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxemburg, Norway, Portugal, Spain, and Sweden. National licence variations have been filed in the other European Union countries are are thrfore waitng for approval seperately.
For VISTABEL® (called VISTABEX® in Italy), France serves as the Reference Member State covering 29 countries in the EU, namely Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Take Action by writing to Ipsen: Sample letter below
190 Bath Road
I was shocked to learn that your company conducts cruel animal experiments for the batch testing of Dysport®. I am appalled at the treatment of the mice used in these tests, uncovered by the recent BUAV investigation at your contracted testing facility, Wickham Laboratories in the UK.
As you know, for the LD50 test, groups of mice are injected with different doses of the substance in the abdomen. Many of the mice suffer from paralysis, impaired vision and respiratory distress. After up to three or four days of suffering, if left, they die of suffocation. Attempts by staff to intervene and kill the mice before they died this agonising death often failed. The BUAV investigation found that many more mice died from the effects of the toxin than were killed.
Although the European Pharmacopoeia lists this test for every batch of botulinum toxin, there is an alternative test that does not use live animals which is allowed. It is in your hands to use this alternative method.
I urge you to cooperate with the other manufacturers of botulinum toxin products to achieve a deletion of the mouse LD50 test in the European Pharmacopoeia.
Until I am assured that you are no longer using the LD50 test, I will encourage all my friends not to use your botulinum toxin products.
I look forward to hearing from you.