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The Limitations of Drug Testing in Animals

A Wall Street Journal story today looks at an important question in science, in policy-making, and in journalism: “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.”

Two examples from the story:

Many times, however, subtle results in animals are unclear and scientists just don’t know what to make of them. 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.”

Another example of the confusing disparities that can arise in testing is the case of the popular sleep drug Lunesta. It won FDA approval despite the fact that tumors appeared when rats and mice took huge doses of a closely related chemical cousin of the medication. Some FDA reviewers were concerned enough initially to recommend rejection of Lunesta. After further analyses, however, agency officials concluded the data from human testing didn’t suggest a signal for cancer in people. But you won’t see the issue highlighted in the company’s ubiquitous green-moth commercials for the drug.

Journalists who report on preliminary findings from animal research without strongly emphasizing the inherent weaknesses in trying to interpret such findings are not serving the public.

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