Hundreds of thousands of people were outraged when the Humane Society of the United States released an undercover investigation in March that showed beagles suffering in a toxicity test at a laboratory in Michigan. The findings revealed the cruelty of animal testing—the dogs were confined to cages and force-fed dangerous substances before being euthanized. With the help of our supporters, we persuaded Dow AgroSciences (now Corteva) to end its unnecessary pesticide test and release the dogs for adoption, but the case was just one example of the widespread, cruel testing and subsequent killing of animals that government regulators, including the Food and Drug Administration, often direct companies to do.

Portrait of Vanda Pharmaceuticals CEO Dr. Mihael Polymeropoulos
Vanda Pharmaceuticals CEO Dr. Mihael Polymeropoulos

One company—Vanda Pharmaceuticals—is taking a stand. Under the leadership of CEO Dr. Mihael Polymeropoulos, Vanda is suing the FDA for requiring a nine-month toxicity test on dogs for a drug designed to treat eczema. Arguing that the test is inaccurate and archaic, Vanda offered to conduct a more scientifically relevant test without using animals. The FDA denied the request and refuses to allow the drug to move forward.

Polymeropoulos says he will continue to fight against using animals in unnecessary testing–and he thinks his own three dogs would agree approve of his stance. “I haven’t talked with them about it specifically,” he says, “but I’m sure they support me.” 

In this edited interview with editorial director Emily Smith, Polymeropoulos talks about the importance of responsible, ethical testing methods—and how you can help support them.

Vanda is taking a remarkable stand. Why do you feel this issue is so important?

We became involved when independent analysis, our own data and the literature around the predictive ability of certain animal experimentation suggested that there was no justification for what the FDA was telling us to do—the nine months of toxicity testing on dogs. There was no evidence of it having an added value or a predictive validity, meaning whether the results of the test accurately predict how the drug will perform in patients. For Vanda, a highly scientifically driven organization, to conduct an experiment that does not have predictive validity and to do this experiment on animals, who will eventually be killed, is not acceptable. 

Were you surprised by the FDA’s rejection of your request to conduct an alternative test? 

We were surprised by two things: After we offered a scientific rationale that these types of tests should not be done, we were surprised that the response from the FDA was basically that these tests need to be done because they are requiring them. That was disappointing. The other surprise is that other companies have not contested this requirement, which is puzzling given that the overwhelming evidence is that these tests in dogs are of very low or no predictive validity.

How have animal welfare concerns inspired you in this fight? 

Vanda believes animals are sentient and we need to consider how these animals feel, even if they cannot tell us. We’re highly concerned with how we develop drugs and believe that  we should not develop them by any means possible. We’re truly committed to human safety, but not through animal experimentation whenever possible. 

What response do you have for people who argue that animal testing is necessary to ensure products are safe for humans?

All I have to say is follow the evidence. 

You are facing increased pressure from Wall Street to move forward with the dog test to get the drug on the market. Do you feel some in the industry are putting the bottom line above ethics?

I appreciate people’s anxiety. Vanda is completely focused on getting this potentially very promising drug to the patients who need it and doing it in the safest manner possible. There are plenty of alternative tests available to ensure enhanced drug safety without conducting unnecessary and archaic experiments. Patients deserve it, and certainly the animals deserve it, too.

What message do you hope your fight against the FDA sends to other pharmaceutical companies?

If you truly care about patient safety, do the right thing. Analyze your data, do away with unnecessary testing and move toward the wonderful discoveries and advances we’ve made over the last 20 or 30 years.

How can the public help?

We hope that our voice is amplified by people writing to the FDA and questioning how they know testing on dogs is the best way to protect human safety. I don’t expect the general public to know the scientific answer, but it’s important to ask the question. Engage members of Congress—they have the power to ask these questions and they should be asking these questions. We appreciate the action lawmakers such as U.S. Rep. Brendan Boyle (D-Pa.) and others have taken thus far to elevate awareness of the issues. This controversy can be quickly resolved if scientific rationale prevails. We’re very sure that the leadership of the FDA can act in this manner, and we can abandon antiquated policies and truly protect people and animals.   


SPEAK OUT: Encourage your representatives to help end unnecessary tests on animals. Find Their Contact Information

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