The continuing use of animal models in clinical research is “hindering the development of new treatments” and “harming the human stakeholders of the drug development industry,” said Lisa Kramer, PhD.
Kramer, a professor of finance at the University of Toronto, presented her argument as to why animal studies should be avoided from a business cost/risk decision-based perspective during AAPS PharmSci 360 earlier this month.
According to Kramer, drugs with predictive values exceeding 99% have been withdrawn from the market due to life-threatening side effects/deaths in a small fraction of the target population.
"The practice of collecting non-human animal model data prior to advancing to human clinical trials has been shown both to allow harmful drugs to advance to market and to prevent safe and effective products from advancing," she said.
"It is not an exaggeration to say that predictive outcomes for humans would improve in the drug development enterprise if we made decisions about which drugs to advance by flipping a coin rather than using results from non-human animal models."
Kramer noted that failure is seen at nearly every phase of drug development, with the primary reason for these failures being efficacy, the secondary reason, safety.
Additionally, many drugs that were once ruled out based on results from animal models would have been “lost forever if not for accidental later discovery,” she said.
Understanding the risks
According to Kramer, clinical trial participants also are not fully aware of the risks of entering a study based on the results of animal trials.
“I think if they knew this at the front end, they wouldn’t feel as keen about participation,” she said. “They are facing these risks almost blindfolded.”
Citing similar concerns, the Center for Responsible Science (CRS) recently filed a lawsuit against the FDA after its citizen petition to update current informed consent regulations was denied.
Kramer said the FDA has the power to revise its interpretation of the laws governing research in animals, though she said it is unlikely to do so without action from Congress.
She added, “If the answers we are looking for don’t lie in animal models, then that’s not a good place for us to keep looking.”
Kramer also today commented on the FDA’s proposed study which looks to reduce the number of clinical trials conducted in dogs.
She told us, “Data from one species are simply uninformative overall with respect to other species' responses, and it's promising to see this aspect of science incorporated in the FDA's proposal.”