The intentional misrepresentation of facts is one of the most disturbing (if not illegal) tactics that animal rights organizations use to convince the public that individuals and businesses involved with the breeding, raising, and care of animals for companionship, biomedical research, conservation research, sports, entertainment, and food and fiber, is inhumane.

We have previously described the intentional misrepresentation that pet stores sell puppy mill puppies based on the false statement that all commercial breeders are puppy mills. Puppy mills are substandard, unlicensed large scale facilities where dogs are improperly cared for.  Pet stores buy from licensed USDA facilities, or small breeders who exceed the humane standards of care required by law, not from substandard breeding facilities.

Similar misrepresentations of facts are pervasive from animal rights organizations opposed to the use of animals in biomedical research, even when that research benefits animals.

The following purported quote from FDA is repeated by groups like PETA and the Beagle Freedom Fund to “prove” that research in animals does not provide valid scientific results that can lead to successful drug approvals for human use:

The Food and Drug Administration has confirmed that 92 percent of drugs that test safe and effective in animals are failing in Phase I clinical trials.

The biomedical research community has attempted to explain why this statement is misleading by reviewing the original statement made by FDA.

For example, as posted on July 25, 2008 on Speaking of Research :

The statistic is from the FDA (Food and Drug Administration), used to illustrate inefficiencies in drug development. However the actual statistic is much broader, it should be:

92% of drugs fail during human trials

The original quote was:

A new medicinal compound entering Phase 1 testing, often representing the culmination of upwards of a decade of preclinical screening and evaluation, is estimated to have only an 8 percent chance of reaching the market.

In another post on Speaking of Research on January 23, 2013, guest author Professor Robin Lovell-Badge further explained:

Those opposed to animal research often point out that most drugs that pass the legally required toxicology tests in animals go on to fail in human clinical trials. They then go on to suggest that this shows that animal research does not work, or that it is proof that animals are not accurate models for humans.

However, this is misleading without an understanding of the relevant context and the reasons for the animal safety tests.

Dr. Lovell-Badge goes onto explain that preclinical testing includes both animal testing an non-animal testing, all performed to prevent harm to humans during Phase 1 clinical trials in humans which has proven to protect humans from drugs found to be unsafe.

This topic is also the subject of a report published in Regulatory Toxicology and Pharmacology, “Use of animals for toxicology testing is necessary to ensure patient safety in pharmaceutical development,” by Raja Mangipudy, John Burkhardt and Vivek J. Kadambi. See Regul Toxicol Pharmacol. 2014 Nov;70(2):439-41. doi: 10.1016/j.yrtph.2014.07.014. Epub 2014 Jul 21.

I agree with the authors’ conclusion:

[W]e believe that for the foreseeable future, drug development will continue to depend upon nonclinical experimentation in animal models to provide data in hazard identification and characterization for healthy volunteers and patients. While offering great promise, alternative in vitro systems that can entirely recapitulate the complexity of higher organisms have yet to be designed. Development of engineered 3-dimensional organ systems will create new opportunities to conduct hypothesis-driven research into specific organ system toxicities or provide models for screening compound libraries for toxicity during the lead optimization process. As for all surrogate systems, they will evolve over time as the science improves, but will still falsely predict negatives for unique toxicities that result from complexities not replicated within the in vitro test system. Translation of our complex human biology into safe and effective treatments will continue to require the use of humane animal testing (Nature Medicine Editorial, 2013).