The following are excerpts from a report by Dr. Andre Menache BSc (Hons) BVSc, MRCVS, on the Congress hosted by the International Association of Biological Standardisation held in London Sept 1998, entitled: "Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use".
"The good news is that many non-animal alternatives in the field of vaccine testing already exist today."
"Today, the biggest challenge facing the wider acceptance of non-animal alternatives is not science, but regulatory authority. For example, the Expert Committee on Biological Standardisation (which puts out WHO guidelines and recommendations for biological products) permitted a choice between in vitro (i.e. non-animal method) and in vivo ( i.e. using live animals) potency testing of diptheria vaccine a decade or so ago; the European Pharmacopoeia still does not permit this………So here is a clear example where a regulatory authority is responsible for holding up a scientifically accepted non-animal alternative, which could have been put to use ten years ago, and thus would have spared thousands of animals lives."
The following are just a few examples of scientifically sound non-animal methods which have received regulatory approval:-
1. The WHO in 1997 approved an in vitro method for testing Hepatitis A and B vaccine. So far 119 countries have adopted this method for Hepatitis B and 79 countries have adopted the method for Hepatitis A.
2. Traditionally, rabbits were used to test for fever-producing substances (Pyrogens). Several years ago rabbits were replaced by the blood cells of the horse shoe crab (the Limulus amoebocyte lysate assay, or LAL for short). Although the LAL test did not require the crabs to be killed, it must have caused them considerable stress and pain to be captured and bled. Today there is a completely non-animal technique available, using whole human blood (e.g. unused blood from human blood banks). This test also has a wider range than the animal-based tests, since it is sensitive to a wider range of bacterial toxins.
3. The production of monoclonal antibodies (Mabs) traditionally required
the use of live mice, which had an antigen ( a protein) injected into their
abdominal cavity. This would stimulate the mouse immune system to produce
large amounts of antibody, causing their abdomen to distend painfully.
This test, called the "mouse ascites test " has now been replaced in several
countries by an inexpensive in vitro membrane technique. Switzerland banned
the use of the ascitic mouse in 1994, the UK just recently (1999)
and the US expects to phase out the mouse test over the next 5 years.
"In addition to vaccine testing, the IABS congress covered the
production and testing of other biological products such as insulin and
various hormones……….the best known example is the potency testing of insulin.
Insulin is no longer obtained from pigs. It can now be produced from genetically
-engineered cells in the laboratory. The resulting insulin is chemically
far purer than pig insulin and easier to standardise. However, mice and
rabbits were still required to test the potency of the insulin. But since
1990, animals have been replaced by a sophisticated method called HPLC
(high-pressure liquid chromatography) which also gives more accurate results
than the previous animal tests."
" The scientific community, spurred on by the public conscience, is
discovering that non-animal methods not only avoid suffering, but they
also produce better scientific results."
HUMAN CLINICAL AND EPIDEMIOLOGICAL STUDIES, CADAVERS, COMPUTER SIMULATORS AND HUMAN CELL CULTURES ARE MORE RELIABLE, LESS EXPEMSIVE, MORE PRECISE AND MORE HUMANE THAN ANIMAL TESTS.
"Sounds more like an improvement than a substitute"! as Gordon Baxter, co-founder of the Pharmagene Laboratories - a UK company that uses only human tissues and computers to develop and test drugs - says, "If you have information on human genes, what’s the point of going back to animals?"