Safer Medicines - putting patient safety first

Putting patient safety first

Frequently Asked Questions

As long ago as 1964, Dr J Gallagher, Medical Director of Lederle Laboratories, admitted:

"Animal studies are done for legal reasons and not for scientific reasons"

This is echoed today by Professor Johannes Doehmer of the Technical University of Munich, who quips:

"Animal studies have value, because they are required by law."

Why does animal experimentation continue?

Many factors perpetuate animal experimentation, the most obvious of which is momentum. The tradition is so deeply ingrained that the whole system is based on it. "Technological lock-in" and "status quo bias" are powerful factors here. As the authors of the "Toxicity Testing in the 21st Century: A Vision and a Strategy" report noted, they expect the "paradigm shift" away from animal tests towards human biology-based methods to encounter resistance, as toxicological testing practices are "deeply ingrained". They state that "policies designed to overcome tendencies to resist novel approaches and maintain the status quo will be important".

Another factor is that many researchers are far removed from patient care and really believe that by experimenting on animals they are helping to cure human disease. Also, they attract grant money based on how many papers they publish in the scientific literature. It is much easier and faster to publish papers using animals than by doing human-based research.

Pharmaceutical companies continue to do animal tests because regulators require them and because they provide liability protection in court when drugs injure or kill people, despite the fact that the animal tests themselves are scientifically worthless.

Animal tests became mandatory following the thalidomide tragedy in the 1960s - ironically, since they failed to prevent that disaster. Since then, both regulators and pharmaceutical companies have become very familiar with animal tests and readily accept them when they tick all the necessary boxes. As a reviewer for the US FDA (the world's major drug regulator), Dr Anita O'Connor, acknowledged: “Most of the animal tests we accept have never been validated. They evolved over the past 20 years and the FDA is comfortable with them.”

Sadly, the regulatory system has not really changed since thalidomide. Vioxx (2004) was the biggest drug recall in history, leaving many tens of thousands of deaths in its wake. Richard Horton, editor of The Lancet, said: "This is a public health emergency which raises grievous questions about the adequacy of our regulatory system."

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