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Human Stakeholders and the Use of Animals in Drug Development
Author(s) -
Kramer Lisa A.,
Greek Ray
Publication year - 2018
Publication title -
business and society review
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.524
H-Index - 21
eISSN - 1467-8594
pISSN - 0045-3609
DOI - 10.1111/basr.12134
Subject(s) - legislation , business , pharmaceutical industry , drug development , drug , food and drug administration , human health , human use , risk analysis (engineering) , process (computing) , pharmacology , public economics , medicine , microbiology and biotechnology , environmental health , political science , economics , law , computer science , biology , operating system
Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation‐mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies from journals including Nature , Science , and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration (FDA) and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well‐being of pharmaceutical firms.