Botox FAQ

Botox FAQ

How bad is the abuse on mice for Botox? What do they do to the mice and what kind of pain do they go through?

The abuse is as bad as it can get for any animal in a laboratory. Botulinum toxin is one of the most powerful biological toxins known, which blocks transmission of nerve impulses to muscles. Each batch of botox, whether for medical or cosmetic use, is tested by injecting into the abdomens of the mice.

For each test, the mice are divided into 3 or 4 groups, each receiving different strengths of the botox, those in the highest strength group start showing signs of poisoning within hours, with paralysis of the lower body, leading them to stagger or be unable to walk. After about a day, the paralysis starts to affect the respiration muscles and the mice will gasp for air, start to literally go blue, and die of asphyxiation. However, to make matters worse from both a cruelty and science viewpoint, some of the animals die because their paralysis prevents them from reaching food and water, so they die of dehydration or starvation.

The tests are officially classed as ‘severe’, which is the highest category of suffering. Furthermore, these tests – known as Lethal Dose 50% (LD50) are at the very worst end of the severe category because they allow many of the animals to continue to suffer until they die (known as ‘death as the endpoint’). The mice are not given any pain relief because that is deemed to potentially interfere with the results. The psychological and physical pain these animals endure is almost beyond comprehension, ‘excruciating’ doesn’t quite cover it really.

What is the scale of botox testing in Ireland?

Ireland has long been the country with the most botox animal tests in Europe, per capita. The official statistics of 2021 reveal that about 53,000 mice were subjected to so-called ‘batch potency testing’, which is the type of test involving botox. This was out of a total of all painful animal experiments in Ireland in 2021 of 121,558. So botox testing accounts for the vast majority of animal cruelty in Irish laboratories. The year before 100,848 mice were killed for this purpose, in 2019 it was 92,887 mice, 2018 it was 138,846 mice and 2017 192,015 mice.

Back in 2008, animal tests increased massively from 64,378 to 112,825 annually. A year later they had shot up again to almost quarter of a million. This expanding slaughter was driven by the emergence of the botox industry in Ireland.

What work is the IAVS doing to stop it botox testing? Has it been successful yet?

In 2011, botox company Allergan, who have facilities in Co. Mayo, received approval for a cell-based test to replace the majority of their animal testing. Due to continuous protests by the IAVS and our partners in the European Coalition to end Animal Experiments (ECEAE), the companies Merz and Ipsen have since replaced at least most of their animal tests for botox.

We’ve been raising this in correspondence and meetings with officials from the Health Products Regulatory Authority (and its predecessor the Irish Medicines Board) for over a decade now. Botox testing in Ireland means that the country causes the greatest suffering in animal tests of any EU country per capita, so we have always emphasised this area to the Government. We have two main arguments:

1) The testing of cosmetic botox should not pass the legally required harm-benefit assessment because the benefits of marketing botox for cosmetic purposes do not outweigh the tremendous suffering the animals endure

2) Non-animal methods of testing botox have been cited as permissible for 17-25 years in the legal list of required toxicity tests for botox, pending final validation. The problem is, the companies and regulators have made very little effort to invest in the validation of the methods. Allergan were the first to get their non-animal test approved in Europe in 2013, which we think has meant they have stopped a majority of the animal tests they did before. The same or very similar test could be used by other Botox companies testing in Ireland - we believe they include Ipsen and Merz who finally got round to getting a non-animal test approved in 2018 and 2015 respectively - and recently we have deduced new companies have commissioned testing in Ireland (because the numbers remain very high despite the deployment of non-animal tests by Allergan, Ipsen and Merz, as well as comments by HPRA officials about the prospects of significant reductions in animal botox testing). But there is no obligation on Allergan etc. to share their technical knowledge behind their non-animal test because government prioritises commercial confidentiality rights over legal requirements to work to replace animal testing. We have been very frustrated at the lack of interest and urgency by the Irish Government to take pro-active action to encourage collaboration between the companies.

Have we been successful? We have been part of a wider push that has incentivised Allergan and others to replace some of their animal tests. Building on the national publicity we have routinely achieved over the past decade, we have urged the HPRA to ask the botox animal testers to at least look at reducing the number of animals for whom death is the endpoint.

What are our plans?

We are continuing to investigate, lobby and publicise the horrific scandal that is animal botox testing in Ireland. We are in the process of an FoI request with the HPRA to disclose retrospective assessments of documents pertaining to animal botox testing. Our initial analysis of the first batch of documents shows that the true level of suffering is being hidden in the publicly available information about the tests.

For example, we can compare two documents relating to the same animal testing project. First, there is an initial summary of the application to do a botox testing project (v033_2013q4) which has been published on the HPRA website. Secondly, there is the internal retrospective review of that project which the Government decided would not normally be published, but we have obtained through a Freedom of Information request (Botox test review 1).

The public document does not admit anywhere that death is the endpoint in these tests. However, the internal review document strongly emphasises it. In other words, the public document conceals the truth about the real severity of suffering endured by the animals. Sadly this fits a pattern where the regulators are biased towards the commercial interest of the companies as opposed to animal welfare and the public’s right to know what the government is authorising in their name.

What's the alternative to botox testing on mice?

For the batch testing of botox, the alternative is called a ‘cell-based assay’ (CBA) with some been validated for certain botox type products for a number of years. This is a passage from a scientific paper reviewing botox testing:

“… announcement by Allergan in 2011 that they had developed a cell-based assay (CBA) as a complete replacement for the batch potency test.22 Allergan’s assay was based on a human neuroblastoma cell line and a sandwich ELISA that measures the levels of cleaved SNAP-25.”

It’s technical stuff, but yes there are alternatives – the CBA used by Merz and Ipsen will be similar to Allergan’s. The other alternative of course, especially with cosmetic Botox, is to simply not use the product.

How you can help

The Irish Anti-Vivisection Society calls on the Irish Government to enact legislation immediately to ban the LD50 Botulinum Toxin Potency Test for cosmetic procedures.

 

 

Watch video on mice botox tests

The British Union for the Abolition of Vivisection (now Cruelty Free International) filmed the suffering of mice for botox-tests in a British research laboratory. Click below to view the video.