"The promising diabetes drug Galvus recently got turned back by the U.S. Food and Drug Administration.
"About 5,500 patients had taken the medicine in clinical trials at that point, but the problem apparently wasn't with them. The agency was worried because some monkeys who were given high doses of Galvus developed skin lesions. Humans who took normal amounts of the drug for as long as two years didn't get the sores, but the FDA refused to approve the drug until it saw more testing in people who might be at higher risk.
About that drug the article later tells us, "In the case of the new Novartis drug Galvus, James Shannon, the company's global head of pharmaceutical development, told investors that Novartis researchers 'do not understand -- do not know -- the mechanism of the skin findings' in monkeys. They do know that 'humans appear to react to Galvus in a very different way.'"
The article says that the FDA's decision not to approve the drug until it saw more testing in people, "spotlighted an important unresolved scientific question: What do the results of animal studies really tell us about humans? That question still puzzles researchers even though guinea pigs, lab rats and their brethren have long been part of experiments."
We read: "In the pharmaceutical world, animal tests provide vital clues about experimental drugs and help prevent humans from being exposed to serious dangers. The animals are given far bigger doses than a person could likely tolerate, and are tested under circumstances that would be impossible with a human volunteer -- such as during pregnancy. That's why animal trials are still done, despite the concerns of animal-rights activists and others about the distastefulness and expense of sacrificing so many blameless critters."
It tells us "Before regulators approve a drug, it typically has been tested on hundreds of animals. The FDA requires initial testing in at least two species: one rodent, one nonrodent. By the end of the process, mice, pigs, rabbits, dogs, monkeys and other animals may have been used."
It says that Animal tests "at least give a broad sense of the effects of a drug" but "Many times, however, subtle results in animals are unclear and scientists just don't know what to make of them."
And we also read: "It can happen that a product doesn't hurt animals, but turns out to be poisonous to patients. That occurred with the catastrophic British trial of an experimental biotech drug called TGN1412, meant to treat leukemia and other diseases. It didn't cause problems when given to monkeys and other species. Then six people took it in a small initial study and had life-threatening convulsions and organ failure. British regulators blamed an 'unpredicted biological action of the drug in humans' that wasn't foretold by the 'apparently adequate' preclinical studies."
You'll find the whole article on line at: http://online.wsj.com/article/SB117519602221153510.html
While the article still overstates the value of animal tests to humans, and pays only passing attention to the ethical implications, this balanced discussion of the issue in a conservative paper can only be seen as a huge step forward. Animal testing has been the unquestioned status quo for so long -- how wonderful to see these questions raised.
The article opens the door for letters to the editor on the issue. The Wall Street Journal takes letters at