Imagine trying to replicate the Mediterranean diet, which is rich in plant foods and includes limited amounts of olive oil, wine, meat, dairy products, and eggs, with a biscuit made from dairy protein, fish meal, and vitamins. Now, imagine feeding the biscuits to monkeys in an attempt to gauge the benefits of a Mediterranean diet on human mood and behavior.

This absurd premise is at the heart of a 2.5-year research study at Wake Forest University School of Medicine that was published in 2019.

On Oct. 5, 2022, the Physicians Committee for Responsible Medicine (PCRM) filed federal complaints requesting investigations into the university’s study that used 43 primates—kept four to a cage—three of whom died during the experiment. 

The Animal Welfare Act (AWA) allows the use of animals in studies only when a researcher first considers alternatives to procedures that may cause more than momentary or slight pain or distress to an animal. A proper alternatives search would have revealed nonanimal methods for human nutrition research and an abundance of peer-reviewed literature demonstrating the equivalence or superiority of models based on human biology.

Even if the diet could have been appropriately mimicked for the primates, the research at Wake Forest was a waste since the Mediterranean diet has already been studied extensively in humans.

A cross-sectional study that included 3,172 adults examined the association between adherence to Mediterranean dietary patterns and the prevalence of psychological disorders among a large population. The researchers reported that the components of a Mediterranean diet were associated with lower odds of depression, anxiety, and psychological distress.

Additionally, this meta-analysis suggests that adhering to a healthy diet, a traditional Mediterranean diet, and avoiding a pro-inflammatory diet is associated with a reduced risk of depressive symptoms or clinical depression. There are many more examples.

This duplicative research is a waste of animal lives and taxpayer money.

Wake Forest’s Mediterranean diet studies using primates have received $13.5 million in federal funding via grants from the National Institutes of Health (NIH) since 2007. Furthermore, the principal investigator of this research at Wake Forest has received more than $20.4 million in NIH funding since 1988, most of which has been used to conduct research using monkeys.

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and NIH Office of Laboratory Animal Welfare (OLAW) recently confirmed to PCRM that both agencies are investigating our complaints.

Should the investigations find fault with Wake Forest, the USDA could impose civil penalties and/or stop the university from conducting future research using animals. The NIH could suspend funding for current grants supporting human nutrition research using primates.

My colleagues and I eagerly await the results of the federal investigations.

Meanwhile, I have some ideas for how Wake Forest could transition away from research models using animals and employ more scientifically sound tactics.

A growing number of more human-relevant research methods that can replace animal experiments are available. For example, microphysiological systems use human cells to recapitulate complex cellular and tissue interactions that occur in the human body and are advancing our understanding of the mechanisms of disease and accelerating drug development. And computational modeling can answer important nutritional questions from the cellular up to the physiological levels. Both are promising technologies that can provide more reliable data than research using animals.

Clinical studies are the gold standard for understanding the impacts of diet on human health and can be conducted ethically and safely. They can be prospective observational studies, in which a cohort of participants is followed over a period of time. Or they can be done via a randomized clinical trial, in which individuals are divided into groups and directed to follow different diets.

Studies assessing physical, biochemical, genetic, and behavioral effects can be designed and powered to allow highly controlled observations in both laboratory and real-world settings that are directly applicable to clinical work. 

For dietary studies, in particular, those conducted in humans tell us much more about human health than feeding homemade biscuits to chronically confined—and therefore stressed—monkeys.

Regardless of the outcome of the federal investigations requested by PCRM, Wake Forest should move away from animal testing and begin using research techniques that are more humane and produce results that better predict human health outcomes.

Bio: Janine McCarthy, MPH, is the science policy program manager at the Physicians Committee for Responsible Medicine (PCRM), a Washington, D.C.-based national nonprofit composed of 17,000 doctor members that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research.

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