Many Animal-Based Drug Studies Are Seriously Flawed, New Research Shows

Many of the most commonly used drugs in the United States have gone through animal-based studies before being approved by the FDA. With regulations becoming stricter over the years, and more humane processes being introduced, animal-testing remains one of the most effective ways to develop suitable drugs.

It is surprising that so little data on harm appear in the published scientific literature.

At least, that’s what we’ve been led to believe up to now. A new study led by pharmacologists at the University of California has revealed that serious design flaws exist in far more animal drug trials than previously believed. Researchers led by Lisa Bero, a pharmacologist at the University of California, San Francisco, School of Pharmacy, analyzed 63 studies in which cholesterol-lowering drugs were tested on animals before moving on to human trials. The studies were a mixture of government and privately funded drugs, all involving medicines known as statins –examples of which include Crestor, Lipitor, and Zocor. We’ve already reported on FDA warnings that statin use could lead to memory loss and diabetes, but the researchers’ new suggestion that testing was commonly flawed raises fresh concerns over just how rigorous the regulation process is. Philly.com reported last week that animals in many of the studies analyzed by the researchers were not divided between placebo and treatment groups, one of the basic requirements of high-quality trials. As many as half of the studies included in the report failed to take this step. Other common flaws included:

"Not a single animal study we looked at assessed adverse events following the statin intervention," Bero said in a university press release. “As toxicity data from animal studies must be submitted to drug regulatory authorities before a compound can proceed to testing in humans, it is surprising that so little data on harm appear in the published scientific literature."

Science Daily also reports that the initial impetus for the study was to “explore whether or not industry-funded animal studies also would be likely to yield more positive outcomes for the companies' drug candidates.” Surprisingly, Bero’s conclusion found that non-industry studies more often had results that favored the drugs, compared to studies funded by industry.

It’s a confusing result, but one that highlights perfectly how drugs marketed by pharmaceutical companies can be far less safe than widely believed. Hopefully the results of Bero’s research will prompt more rigorous standards for animal-tested drugs, ensuring that patients in the future don’t have to deal with unexpected side effects caused by statins and other drugs.