Monkeys severely restrained for an inhalation study. For some the stress was so great that they suffered prolapses. Our DVD Save the Primates shows the monkeys’ reaction to what was happening to them.
the needs of individuals. The emphasis is, inevitably, on processing large numbers of test compounds, using large numbers of animals. We would submit that this can only lead to poor data.
This makes it all the more vital that scrutiny of project licences for commercial regulatory testing is carefully managed, and that group authorisations are not allowed.
During oral dosing study SOI/0052, several animals suffered from vomiting and salivation on numerous occasions128-130. Several monkeys produced black-stained urine on their cage floor131. One almost chewed off its finger, gnawing into bone, and continued chewing the hand after it had been dressed by the vet. Others were showing symptoms and behaviours such as tugging at chest skin, pushing their fists into their mouths, trying to bite through the metal food hopper, pushing large amounts of sawdust into cheek pouches, chewing metal and dragging teeth along the bars of the cage132 and also, five days later, showed signs of twitchy feet, indicating a kind of pins and needles sensation133, 134. Several animals were clearly distressed yet they were orally dosed as normal and returned to their cages. At around the same time, a study of the same product was started in rats and researchers had noticed the rats chewing their feet and eating sawdust132,134. Almost chewing off a finger is a very significant clinical sign, causing substantial pain, so as a result, the dose for one group was lowered.
Such events illustrate how predictive severity banding (which was not higher than moderate in this case) can often be wrong and that a new system incorporating retrospective review of such studies would better inform future tests as well as improve animal welfare protection. An inhalation study provided another example of how the severity of a procedure can be misjudged:
Over a period of time three monkeys on an inhalation study died or had to be killed due to partially collapsed and blocked lungs. Three other animals also collapsed but were revived. Necropsied animals were found to have blackened lungs135-140. Clearly these animals would have suffered a great deal.
Due to the severity of the problems and unexpected deaths an internal meeting was held where licensing implications were discussed137, as this study was licensed under a ‘mild’ severity limit protocol.
Home Office regulations stipulate “The project licence condition will be regarded as breached if the Home Office is not notified promptly…when a protected animal has… suffered (or is likely to suffer) more than is authorised by the severity limit”141.
© 2009 Animal Defenders International
A report on the use of primates in regulatory testing in a typical European commercial testing laboratory