دانلود رایگان مقاله انگلیسی مردم سهامدار و استفاده از حیوانات در توسعه دارو - وایلی 2018

ABSTRACT

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 wellbeing of pharmaceutical firms.

CONCLUSIONS

In spite of decades of research that demonstrates the lack of predictive value of animal testing for determining the safety and efficacy of drugs, the pharmaceutical industry continues to rely on data from outmoded animal-based research and animal-based tests that are still routinely employed by scientists. This is costly to society in many ways: patients who suffer adverse reactions to drugs that appeared safe in animals; patients who fail to experience benefits from drugs that appeared to be effective in animals; patients facing an opportunity cost by missing out on drugs that might otherwise have been found to be safe and effective; harm to investors, employees, and suppliers due to the billions of dollars wastefully expended not only on animal tests but also on the much-more-costly human clinical trials that build on the misleading results of animal tests; and harm to various other parties. In contrast, the abandonment of animal modeling is in the best interest of those to whom pharmaceutical companies bear responsibility, even irrespective of the interests of animals.

National drug regulatory agencies like the U.S. FDA and conventions like the Nuremburg Code and the Declaration of Helsinki require animal modeling prior to administering a drug to humans. These regulations and codes are outdated and must be changed. The pharmaceutical industry has one of the most powerful lobbies on Capitol Hill and would have little trouble in updating Congress and asking them to mandate that the FDA eliminate the animal 34 BUSINESS AND SOCIETY REVIEW testing requirements. The pharmaceutical industry should also educate Congress regarding the misleading and wasteful nature of basic science research that relies on animal modeling. This is necessary because universities, as entities that profit from animal modeling, are a strong lobby promoting the continuation of animal modeling. There is currently no lobbyist for human-based research. Unless the pharmaceutical industry takes these issues seriously, patients will continue to suffer and die prematurely, and the rest of society will continue to bear sizable, avoidable costs.