Current Test Methods are Decades Old and Proven to be Poor Predictors of Both Human Safety and Efficacy, which Costs Lives and Money

á       92% of all drugs found safe and therapeutically effective in animal tests fail during human clinical trials due to their toxicity and/or inefficacy, and are therefore not approved.[1]

á       Over 50% of the drugs that gain FDA approval must later be withdrawn or relabeled due to severe, unexpected side effects that animal testing did not predict.[2]

á       A 2012 study looked at whether post-marketing serious adverse reactions to small molecule drugs could have been detected from animal data.[3] Animal data identified only nineteen percent of human adverse reactions, leading researchers to conclude animal data is not relevant to predict serious adverse human reactions to new small molecule drugs.[4]

á       Adverse drug reactions are the fourth leading cause of death in the United States, killing around 100,000 patients annually and costing up to $4 billion in direct hospital costs alone.[5]

á       Adverse drug reactions are between the 4th and 5th leading cause of death in the U.S., killing more people than all illegal drugs combined and costing the general public over $136 Billion in health care expenses.[6]

á       The cost of developing a new drug now ranges from $1.2 billion to $5 billion, while the number of new drug approvals is at historic lows. Of the 4,300 companies engaged in drug innovation, only six percent (261) have registered a new drug since 1950.

á       Worldwide, the pharmaceutical industry spends $50 billion per year on pharmaceutical research and development but produces only 21 new drugs per year (2008).

 

The US Government is Investing Millions of Dollars into Alternatives to Animal Testing.  Why?  Because they Know the Animals Tests DonÕt Work.

á       A 2011 National Academy of Science Report[7] concluded that animal models were not useful in assessing countermeasures to bioterrorism agents.  The report recommends that human cell-based 3D in vitro systems should be developed.

á       NIHÕs Tissue Chip for Drug Screening initiative, a collaboration between the NIH, Defense Advanced Research Projects Agency (DARPA) and U.S. Food and Drug Administration has committed nearly $76 million over the course of the five-year program, which was launched in fiscal year 2012.[8]

á       Many promising medications fail due to toxicity, despite promising preclinical studies in animal and cell models. These models are costly and poor predictors of drug response in humans.[9]

 

What Scientists, Regulators and Government Officials Say About Animal Testing

á       "We have moved away from studying human disease in humans. We all drank the Kool-Aid on that one, me included." With the ability to knock in or knock out any gene in a mouse -- which "can't sue us," Zerhouni quipped -- researchers have over-relied on animal data. "The problem is that it hasn't worked, and it's time we stopped dancing around the problem...We need to refocus and adapt new methodologies for use in humans to understand disease biology in humans."[10]

á       "Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies."[11]

á       "Consider just one stark statistic: Today, nine out of 10 compounds developed in the lab fail in human studies. They fail, in large part because they behave differently in people than they did in animal or laboratory tests."[12]

 

 

 

 

á       "If I did something in my academic lab that was wrong 50-60% of the time, even 30% of the time, people would think I was nuts, but thats how this industry works. We need to change how we approach this.Ó[13]

á       "A major problem in the pharmaceutical industry right now is that the drug development model is actually broken. It just does not work. It takes many, many years to get a drug to market, its incredibly expensive, innumerable animal lives are lost and then the results from animals usually don't predict what happens in humans. So this is a huge cost to the economy and to the pharmaceutical industry.Ó[14]

á       We are using the tools of the last century to evaluate this centuryÕs advances." [15]

á       "You really have to design the medicine for the species of interest ... You'll find it very rare to find a medicine that will work in both." [16]

á       "Given that many of these investigational anticancer drugs eventually fail, the animal models on which clinical trials are predicated must at best be limited in power, and at worst wildly inaccurate." [17]


[1] Innovation or stagnation: Challenge and opportunity on the critical path to new medical products. U.S. Food and Drug Administration Report, March 2004, p. 8.

[2] U.S. General Accounting Office. FDA Drug Review: Postapproval Risks 1976-1985. Publication GAO/PEMD-90- 15, Washington, D.C., 1990.

[3] Peter J.K. van Meer, The Ability of Animal Studies to Detect Serious Post Marketing Adverse Events is Limited, 64 Regulatory Toxicology and Pharmacology 345, 346 (2012).

[4] Peter J.K. van Meer, The Ability of Animal Studies to Detect Serious Post Marketing Adverse Events is Limited, 64 Regulatory Toxicology and Pharmacology 345, 346 (2012).

[5] JAMA. 1998;279(15):1200-1205. doi:10.1001/jama.279.15.1200

[6] JAMA. 1998;279(15):1200-1205. doi:10.1001/jama.279.15.1200

[7] National Academy of Sciences Animal Models for Assessing Countermeasures to Bioterrorism Agents, 2011

[8] National Institutes of Health Press Release, NIH funds next phase of Tissue Chip for Drug Screening program, September 23, 2014

[9] National Institutes of Health Press Release, NIH funds next phase of Tissue Chip for Drug Screening program, September 23, 2014

[10] 2014 Former NIH Director Dr. Elias Zerhoun, at NIH Record, Vol. LXV No. 13, June 21, 2013

[11] Mike Leavitt, Secretary of Health and Human Services, U.S. Department of Health and Human Services (Food and Drug Administration press release, FDA Issues Advice to Make Earliest Stages of Clinical Drug Development More Efficient, January 12, 2006).

[12] Andrew C. von Eschenbach, M.D. then Acting Commissioner of the FDA (prepared statement for FDA Teleconference: Steps to Advance the Earliest Phases of Clinical Research in the Development of Innovative Medical Treatments, January 12, 2006).

[13] "Don Ingber, M.D., Ph.D, Wyss Institute at Harvard at Microphysiological Systems Program Workshop at the FDA , May 2013

[14] Dr. Don Ingber, director of Harvard University's Wyss Institute of Biologically Inspired Engineering. Technology Review, July/August 2012

[15] The FDA Critical Path Initiative and Its Influence on New Drug Development, Janet Woodcock and Raymond Woosley Center for Drug Evaluation and Research, 2008

[16] Patrick M. O'Connor, head of oncology research for Pfizer, quoted in The New York Times, November 24, 2006

[17] Dr Alexander Kamb, Global Head of the Oncology Disease Area at the Novartis Institutes for Biomedical Research, Nature Reviews Drug Discovery, 4, 161 - 165.