PCRM’s Article About Cruelty-Free Insulin Assay Published in Clinical Biochemistry
In the January issue of Clinical Biochemistry, scientists and researchers with PCRM explained the method they used to develop the world’s first cruelty-free insulin ELISA. The article will serve to promote the use of the new technique and encourage chemists, biochemists, immunologists, biologists, and other scientists around the world to develop and use alternatives to other tests that use animal-derived ingredients.
The ELISA, or enzyme-linked immunosorbent assay, is a method of detecting specific proteins in complex protein mixtures—in this case, insulin in human blood. Laboratories traditionally detect human insulin using antibodies produced by cells that had been placed into the abdomens of living mice. The procedure, called the ascites method, is so cruel that it is banned in some European countries. Even when the antibodies are produced from cells in test tubes, fetal bovine serum is commonly used to grow live cells. The serum is obtained from bovine fetuses by puncturing their hearts without anesthesia.
PCRM decided to develop its own assay when PCRM President Neal Barnard, M.D., launched a clinical trial in 2003 to test the effect of a low-fat vegan diet on patients with type 2 diabetes. PCRM worked with researchers at Linco Research of St. Charles, Mo., to develop this cruelty-free insulin assay.
The cruelty-free assay works as well as the traditional one—or even slightly better. In addition to having ethical advantages, growing cells without animal serum ensures that fewer variables are introduced into experiments, meaning that results are easily reproducible by different laboratories. The method outlined in Clinical Biochemistry, the official journal of the Canadian Society of Clinical Chemists, permits the growth of antibody-producing cells in a medium free of animal serum, enabling scientists to make cell cultures safer and more humane.
PCRM’s insulin assay is now marketed by Millipore (formerly Linco Research) as the company’s preferred assay for human insulin. Millipore has sold enough kits to run almost 10,000 insulin tests, and researchers are so pleased with the accurate results that PCRM’s cruelty-free assay has replaced the conventional kit sold by the company.
ACTION ALERT: Urge the FDA to End Mandatory Animal Testing
We want to demonstrate to the Food and Drug Administration that there are many thousands of people who support alternatives to animal testing. The FDA’s own statistics reveal that 92 percent of drugs tested as safe and effective in animals fail when tested on humans. Of the remaining 8 percent of the drugs that reach the public, more than half are relabeled or withdrawn because of serious toxic effects that were not predicted by animal experiments.
Without further efforts to encourage the use of nonanimal tests, drug companies will continue to put countless human and animal lives at risk. Proven and less expensive alternatives to animal testing are available and are widely used in Europe. Tell the FDA that it is time for a change. Write to the FDA commissioner and urge him to end mandatory animal testing for every drug sold in the United States:
Andrew C. von Eschenbach, M.D.
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857