The (Im)Morality of Animal Testing Requirements

• Author: Sahar Akhtar
• Position: Political philosopher and economist who writes and teaches at the intersection of ethics, politics, and economics, and has written on the ethics of animal pain
• Pages: 841-858

SPECIFIC APPLICATIONS

The (Im)Morality of Animal Testing Requirements

SAHAR AKHTAR*

ABSTRACT

Regulations of all sorts raise a variety of ethical concerns, but animal testing

requirements pose a distinct issue. In this article, I demonstrate that these

requirements force organizations, businesses, and individual researchers to

engage in acts of (often significant) cruelty, and frequently without sufficient

justification.

TABLE OF CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 841

I. WHAT DO THE ANIMAL TESTS INVOLVE?. . . . . . . . . . . . . . . . . . . . 843

II. WHAT ARE THE CONDITIONS FOR CRUELTY? . . . . . . . . . . . . . . . . . . 847

III. IS IT CRUEL IF IT IS VITAL? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 850

IV. IS ANIMAL TESTING SUFFICIENT, NECESSARY, OR EVEN CAUSALLY

IMPORTANT? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 854

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 858

INTRODUCTION

In February of 2019, Vanda Pharmaceuticals filed a lawsuit against the U.S.

Food and Drug Administration (FDA). The company was in the course of devel-

oping the drug Tradipitant to combat gastroparesis, a serious chronic digestive

disorder. While developing Tradipitant, the FDA required Vanda to subject dogs

to nine months of toxicity trials. The dogs would either be injected with or forced

to inhale extremely large doses of the drug (in a previous Vanda trial, mice were

given 300 times the human dose). After administering the drug, scientists would

observe the dogs to measure their toxicity responses and then kill them in order to

examine any damage to their organs.

* Sahar Akhtar is a political philosopher and economist who writes and teaches at the intersection of

ethics, politics, and economics, and has written on the ethics of animal pain. © 2021, Sahar Akhtar.

841

Vanda’s lawsuit challenged this requirement. In their highly uncommon “Open

Letter” concerning the issue, the company wrote,

One type of study the FDA routinely mandates is a non-rodent toxicity study

of nine months’ duration, and it is typically conducted in young beagle dogs,

though it can also be conducted in non-human primates (e.g., monkeys) or

minipigs. For this type of study, all of the animals must be euthanized (or “sac-

rificed,” in the scientific jargon) at the conclusion of their study participation

so that their tissues can be analyzed. The animal studies the FDA demands . . .

have been considered routine in the pharmaceutical industry for decades, de-

spite the growing body of evidence discrediting such studies’ scientific value.

For this reason, drug companies typically conduct the studies reflexively, with-

out challenging the FDA . . . . Killing animals without a scientifically justified

purpose is unethical and inhumane.

1

Open Letter to the Food and Drug Administration, https://vandapharmaceuticalsinc.gcs-web.com/

static-files/7cb5755e-10ae-49c3-b353-b3fc335b0658 [https://perma.cc/6H3Y-NGS3].

The company then urged others to follow suit. The company stated: “Vanda is

therefore standing up to the FDA and hopes that other scientists, drug companies,

animal advocates, and the public will do the same.” The company concluded,

“Vanda refuses to sacrifice young beagles or other animals in a study that serves

no scientific purpose.”

2

More recently, Vanda, which is developing a COVID-19

vaccine, and Moderna Therapeutics, which has already developed one, chal-

lenged the idea that animal tests are “critical” for a successful vaccine.

3

Eric Boodman, Coronavirus Vaccine Clinical Trial Starting without Usual Animal Data, STAT

(Mar. 11, 2020), https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-

vaccine-trial-without-usual-animal-testing/ [https://perma.cc/XN4E-ZSDV].

Vanda’s

firm stance on toxicity trials is remarkable for several reasons. First, such a posi-

tion comes at financial risk. The company’s stock shares declined by 20% the day

after it announced its lawsuit,

4

Maxx Chatsko, Here’s Why Vanda Pharmaceuticals is Sinking Today, MOTLEY FOOL (Apr. 19,

2019), https://www.fool.com/investing/2019/02/06/heres-why-vanda-pharmaceuticals-is-sinking-today.

aspx [https://perma.cc/3BWQ-FYVS].

and by the end of the next quarter, it had declined

by almost 50%.

5

Alex Gangitano, Drugmaker Challenges FDA on Animal Testing, HILL (June 27, 2019), https://

thehill.com/regulation/court-battles/450551-drugmaker-challenges-fda-on-animal-testing [https://perma.

cc/AJ8N-F38V].

In many ways, Vanda serves as a great case study in the litera-

ture on shareholder, stakeholder, and associated business theories. Second, by

taking such a strong position, Vanda exposed a generally unknown but extremely

alarming FDA practice: the FDA regularly (virtually always) requires companies

and organizations to engage in acts of cruelty if they want to bring their drugs and

treatments to the market.

Government regulations generally raise a variety of moral concerns—for

instance, objections about waste, concerns about how they selectively benefit

organized interest groups at the expense of unorganized groups, worries that they

1.

2. Id.

3.

4.

5.

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