The UK’s Vivisection Information Network recently issued a press release making a number of claims about botulinum, which is used to treat cerebral palsy in addition to its more famous role as the anti-wrinkle treatment Botox.
Each batch of botulinum is of different toxicity, so in order to ensure safety the potency of each batch is measured using the LD50 test, in which mice are given samples for the batch until a dose is reached that kills 50 percent of the animals.
The Vivisection Information Network claims that the test is unnecessary because a non-animal alternative is just as good. According to its press release,
A non-animal alternative testing method exists and is in use at a government appointed laboratory for the testing of Botox (Botulinum) (The National Institute for Biological Standards and Control). This test is called the SNAP-25.
. . .
[The press release urges people to call write letters to government officials and] Ask why the SNAP-25 is good enough for a Government appointed lab but not good enough for the pharmaceutical industry.
Fortunately, another UK animal rights groups, Animal Aid, has already provided the answer — the SNAP-25 test has not yet been validated to replace the safety tests that the LD50 test is currently used for.
As Animal Aid’s Andre Menache noted in the abstract for a lecture he gave in July,
The European Pharmacopoeia has set the regulatory framework for non-animal testing of botulinum toxin type A for injection (No. 2113; 5th edition EP). A non-animal immunoassay — the SNAP-25 endopeptidase assay – has shown excellent results with respect to the estimation of the potency of type A toxin in therapeutic preparations (ATLA 31, 381-391, 2003). Similarly, two rapid, non-animal assays have also been developed for botulinum toxin type B.
The only remaining obstacle to regulatory approval of these non-animal methods would appear to be the validation process. There is a moral imperative to give priority to the validation process with respect to these particular non-animal methods in view of the fact that this test requires over 80,000 mice in the UK alone every year.
Menache is referring to a January 2005 European Pharmacopoeia monograph that said,
After validation with respect to the LD 50 assay (reference method), the product may also be assayed by other methods that are preferable in terms of animal welfare, including 1 of the following: 1. endopeptidase assay in vitro; 2. ex vivo assay using the mouse phrenic nerve diaphragm; 3. mouse bioassay using paralysis as the end-point.
So why isn’t the SNAP-25 test used today? Because it hasn’t been validated yet. Companies making Botulinum couldn’t use the SNAP-25 test even if they wanted to, until it is validated. End of story.
Sources:
Don’t stand for Wickham lies. Press Release, Vivisection Information Network, December 11, 2005.
Botulinum testing — time to kill the LD. Andrew Menache, Animal Aid, July 2005.
LD50 Timeline. Humane Society of the United States, Accessed: December 12, 2005.