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  • In Praise of Corporate Bravery
  • Clair Linzey and Andrew Linzey

Animal advocates are often the first to criticize pharmaceutical companies for their treatment of animals used in experiments. But pharmaceutical companies are just one part of an institutionalized system of animal experimentation, in which they are legally required to test products on animals in order to get their drugs approved by governmental regulators.

In February 2019, one company, Vanda Pharmaceuticals, took the brave step of challenging that requirement to test on animals. Vanda has been developing tradipitant, a potential drug treatment for several conditions including gastroparesis, which is a serious chronic digestive disorder. The U.S. Food and Drug Administration (FDA) requires information to confirm that a drug is safe to test on humans before moving to clinical trial testing. This is standardly done through longevity toxicity testing in animals. However, if the drug company submits other scientific evidence to support that the drug is safe for human trials, the FDA is supposed to consider this evidence on a case-specific scientific basis. In the case of tradipitant, the FDA did not consider other evidence sufficient, even though it included a 3-month study in rats and another 3-month study in dogs. Instead, the FDA insisted that a 9-month nonrodent toxicity study be completed. This kind of toxicity study is performed using young beagle dogs; the study itself causes suffering over a 9-month period, at the end of which the dogs are killed to enable an evaluation of the drug's effects on their tissue. In response to the FDA, in an almost unheard-of step by a pharmaceutical company, Vanda filled suit against the FDA to challenge the ethics of the requirement.

Mihael H. Polymeropoulos, MD, Vanda's president and CEO stated: "We believe that there is no scientific justification for the requirement that tradipitant be tested in a nine-month dog study, given its currently understood safety profile in both animals and humans, and further, that these studies should not be a routine requirement for all sponsors" (Vanda Pharmaceuticals, 2019a). Further, he argued that [End Page v]

the FDA is ignoring a large body of published scientific evidence which concludes that these chronic dog studies do not offer any additional useful information. That policy is based on old, outdated science and requires the killing of too many dogs without any scientifically justified purpose. Yet, companies have been reticent to stand up to the FDA and demand that it change its policy. Vanda is unwilling to accept the status quo.

(Vanda Pharmaceuticals, 2019a)

The basis of Vanda's argument is that the experiment is unethical because it is unnecessary and because the longevity study is in itself based on outdated science, rendering the test itself unscientific. In short, as they explain in their open letter, "Vanda refuses to sacrifice young beagles or other animals in a study that serves no scientific purpose" (Vanda Pharmaceuticals, 2019b).

This action by Vanda has not come without cost to the company. Vanda's share price fell 19% once it announced it was pursuing legal action against the FDA (Chatsko, 2019). In corporate terms, where companies live and die by the market, to take such an ethical stand, knowing it would likely adversely affect their share price, is an example of corporate bravery worthy of praise.

It is an even braver position now that we know that the court has ruled against Vanda and upheld the FDA's requirement for the 9-month toxicity test (Gilgore, 2020). The court stated that Vanda "has not shown that FDA's interpretation of the study is 'unreasonable,' and so its argument fails" (Gilgore, 2020). Vanda is still considering its response to the ruling.

The case and its subsequent ruling are an example of the institutionalization of animal experimentation. Vanda actively wants to perform fewer unethical experiments but is being required to do so by the FDA in order to try and bring their product to market. It is the institutionalization of animal experiments that remains the key hurdle in reducing the number of animal experiments worldwide. As we have argued elsewhere, experimentation "represents the institutionalization of a preethical view of animals" (Linzey & Linzey, 2018...


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