Human Stakeholders and the Use of Animals in Drug Development

• Author: Lisa A. Kramer,Ray Greek
• Date: 01 March 2018
• DOI: http://doi.org/10.1111/basr.12134
• Published date: 01 March 2018

Human Stakeholders and the

Use of Animals in Drug

Development

LISA A. KRAMER AND RAY GREEK

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 ani-

mal 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

Lisa A. Kramer is a Professor of Finance, at the University of Toronto, Toronto, ON, Canada.

E-mail: Lkramer@rotman.utoronto.ca. Ray Greek is President at the Americans for Medical

Advancement, Goleta, CA. E-mail: DrRayGreek@gmail.com.

V

C2018 W. Michael Hoffman Center for Business Ethics at Bentley University. Published by

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Road, Oxford OX4 2DQ, UK.

Business and Society Review123:1 3–58

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to abolish regulations and policies that require animal

use. Doing so will benefit pharmaceutical industry stake-

holders, including patients whose health depends on

drugs and the many people who rely on the financial well-

being of pharmaceutical firms.

There exists a significant business ethics problem related to

human well-being in the context of the drug development

industry.

1

The origin of this problem rests in false assump-

tions about science in the execution of drug research. An article in

Nature highlights the problem:

In the contentious world of animal research, one question

surfaces time and again: how useful are animal experiments

as a way to prepare for trials of medical treatments in

humans? The issue is crucial, as public opinion is behind ani-

mal research only if it helps develop better drugs. Conse-

quently, scientists defending animal experiments insist they

are essential for safe clinical trials, whereas animal-rights

activists vehemently maintain that they are useless (Giles

2006, p. 981).

We provide detailed evidence that the use of animals in the drug

development process is harmful to key stakeholders. There is a

rich literature which examines ethical issues—from the perspective

of animals

2

—arising from the use of animals in biomedical

research, testing, and science in general. See LaFollette (2011) and

Ferdowsian and Beauchamp (2013) for recent discussions of those

ethical issues. We purposely sidestep the ethical question of animal

well-being to focus instead on other stakeholders harmed as a con-

sequence of current drug development practices.

Who are these other stakeholders?

3

Investors represent one

group, since the managers of publicly traded firms are expected to

maximize shareholder value vis-

a-vis the theory of the firm and

agency theory; see Friedman (1970) and Jensen and Meckling

(1976); also see Martin (2011) for a critique of the modern value-

maximization proposition. Pharmaceutical firms additionally have

responsibilities to employees, suppliers, the general public, and of

course perhaps most importantly the patients for whom their

drugs are intended to treat. We posit that the vast majority of

4BUSINESS AND SOCIETY REVIEW

public firms in the drug development business are falling short of

their ethical responsibilities to all of these stakeholders, and we

contend this is due to a constraint imposed by regulators, specifi-

cally to require animal tests. This constraint was put in place

many decades ago and drastically and adversely affected the way

the pharmaceutical companies serve their stakeholders. Absent

this regulatory constraint, we argue drug development firms would

be naturally inclined to better serve their stakeholders. But with

the constraint, they fall woefully short of their potential to do so.

We propose a remedy—the abandonment of standards that

require the use of animal models in the drug discovery process—

that would allow firms like GlaxoSmithKline, Merck, and Pfizer to

vastly improve the way they meet their responsibilities to all of

these stakeholders, especially the patients themselves through

improved health outcomes, but also the other groups through the

improved profits that would arise from the development of safer

and more effective drugs.

We document the fact that animal-based research for drug

development is grounded on a scientific paradigm that is flawed.

We present voluminous evidence that this blind spot regarding ani-

mal modeling is depriving humans of promising treatments and

costing shareholders in the drug development business at least

scores of billions of dollars of foregone revenue annually.

4

Specifi-

cally, in many cases, results from animal-based research lead to

the labeling of drugs as safe that are ultimately found to be harm-

ful to humans, and animal-based research deems as harmful

many drugs that are in fact beneficial to humans (these are occa-

sionally discovered by accident later, but there are likely many

cases where beneficial drugs are discarded and never rediscov-

ered). If such instances were rarities, they might be considered

unavoidable perils along the pathway toward medical progress.

Unfortunately, we show these failures are commonplace. Overall,

the use of animal models in medical research has poor predictive

value in terms of its ability to distinguish between treatments that

will be helpful versus harmful to humans, a point we make by cit-

ing extensive evidence from biomedical research. Reliance on

animal-based research causes much more harm to humans than

the accidental good that arises from using animals in the context

of drug development.

5KRAMER AND GREEK