Showing video clips of rabbits in tiny boxes and rows of horseshoe crabs having their blood drawn, representatives from an animal welfare group and legislators yesterday urged the government to amend regulations to reduce unnecessary animal testing for drug production.
After conducting an investigation of 25 local pharmaceutical companies between 2006 and this year, the Environment and Animal Society of Taiwan (EAST) said it found that all 25 firms did animal testing — 18 companies used rabbits for pyrogen testing, while seven companies used horseshoe crabs for Limulus amebocyte lysate (LAL) testing.
An EAST research member said that while animal testing is usually not required in the production of generic drugs — drugs for which the patent has expired and that can therefore be made by other pharmaceutical companies — pyrogen testing still uses animal subjects. Pyrogen testing is undertaken to detect if bacterial toxins are present in vaccines and medications that could cause fever in humans.
Rabbits used for pyrogen testing are often locked in tiny boxes for more than three hours during the experiments, and liquids are intravenously injected into their ears to observe changes in their body temperature, she said.
Because rabbits are easily frightened, some die during the tests, while others are repeatedly subjected to abuse, she added.
EAST director Chen Yu-min (陳玉敏) said anxiety may cause the rabbits’ temperature to rise during the tests, and forcing them into a fixed position for hours may also cause their blood circulation to slow — both of which affect the accuracy of the tests.
The LAL testing method uses blood drawn from live horseshoe crabs, but the crabs grow very slowly, usually taking from 13 to 14 years to grow into full adulthood. Some researchers have suggested designating the crabs as a protected species, the EAST member said.
Because the crabs’ maximum tolerance to blood withdrawal is not known, many horseshoe crabs die when drained of too much blood during tests, she said, adding that death rates from these tests are between 10 percent and 20 percent.
Quoting Council of Agriculture statistics, the group said an estimated 19,500 rabbits have been used for pyrogen testing alone in the past 30 years, and that while rabbits have a life expectancy of about five to 10 years, many of the those in tests die in three to four years.
The group said the European Centre for the Validation of Alternative Methods has developed an alternative methods that are more effective for detecting pyrogen, such as the Monocyte Activation Test (MAT), which uses human blood.
Food and Drug Administration senior technical specialist Wang Der-yuan (王德原) said the agency is uncertain whether pyrogen testing can be fully replaced with MAT, but that it would add the method to the Chinese Pharmacopoeia.