Why the NIH Budget Needs Gutting

One of the agencies slated for cuts under the Trump administration's proposed budget is the National Institutes of Health, the biggest funder of biomedical research in the world.

A budget reduction could help humans as well as sparing the lives of animals, and should be supported. Here's why:

NIH awards fully 40 percent of its research funds to experiments that use dogs, rabbits, monkeys, mice, and other animals as "models" for humans. The return on this $12 billion expenditure has been dismal, with little of this experimentation translating into cures or effective treatments.

Biological and genetic differences between species mean that results of animal studies usually don't translate well to humans. A 2014 review published in the British Medical Journal reported, "Even the most promising findings from animal research often fail in human trials and are rarely adopted into clinical practice. For example, one study found that fewer than 10% of highly promising basic science discoveries enter routine clinical use within 20 years."

A 2015 analysis concluded that up to 89 percent of animal studies could not be reproduced, a fundamental step used to confirm the validity of scientific results, meaning that at least $28 billion is wasted every year.

The current NIH administration admits that this is a serious issue. Director Francis Collins has written, "Preclinical research, especially work that uses animal models, seems to be the area that is currently most susceptible to reproducibility issues."

Yet animal experimenters continue to give patients false hope. Witness the recent failure in a late-stage clinical trial of Eli Lilly's much-hyped Alzheimer's drug, solanezumab, which had been tested "successfully" in mice and monkeys.

These species don't suffer from Alzheimer's disease, so experimenters fiddle with their genome in order to create an unnatural buildup of amyloid plaques similar to, but not the same as, those in afflicted human brains. The result: Mice obtain relief from symptoms that look like — but aren't — Alzheimer's. And human patients continue to suffer.

The clinical failure rate for new Alzheimer's drugs now stands at a staggering 99.6 percent. Cancer drugs that work in animals have less than a 7 percent chance of succeeding in even the earliest clinical trials.

The failure of animal studies for HIV and AIDS to translate into useful human vaccines was recognized more than 20 years ago when, in 1995, NIH instituted a moratorium on chimpanzee breeding, acknowledging the failure of studies with chimpanzees, our closest living relatives, to produce clinically useful data.

Since then, experimenters have turned to other primates and species for HIV/AIDS research and run into even more problems. Macaque monkeys are being injected with simian immunodeficiency virus (SIV), which isn't closely related to the most widespread form of HIV, HIV-1. Because of differences in these viruses, antibodies that neutralize SIV have no effect on HIV and vice versa.

Add to this the genetic variances in immune systems between primates and humans and it's no surprise that AIDS researcher Mark Girard has stressed, "Extrapolating from vaccine protection results in non-human primate [SIV/SHIV] studies to efficacy in man may be misleading."

Understandably, these differences are compounded in the next most commonly used species, mice.

Thinking ahead to alternative methods in HIV research, U.K. scientists have stated, "Existing animal models predicting clinical translations are simplistic, highly reductionist, and therefore, not fit for purpose" and that the failure of clinical trials "questions the suitability of current animal models with respect to congruency with and extrapolation of findings for human hosts."

Multiple systematic reviews have documented the overwhelming failure of animal experimentation to benefit human health in many other areas, including diabetes, cardiovascular disease, mental illness, addiction, and more.

NIH is well aware of this too. In its most recent five-year strategic plan, the agency stated, "Petri dish and animal models often fail to provide good ways to mimic disease or predict how drugs will work in humans, resulting in much wasted time and money while patients wait for therapies."

Yet it continues to fund dead-end experiments.

The agency must tackle this waste head-on by diverting funds from flawed animal experimentation to promising animal-free, human-relevant research methods.

In just one of many examples, tiny human brain "organoids" — models of living brains created from three-dimensional cultures of neural cells — have allowed researchers to identify the root causes of a rare genetic disorder that leads to fatal brain malformations. Previous studies on this condition, known as Miller-Dieker syndrome, relied on mouse models that scientists admit were critically flawed.

NIH must also conduct systematic reviews of all areas of research in which animals are used. When chimpanzee studies were subjected to this analysis, it was determined that they could be performed in other ways. NIH acted on this information and shut down the funding, sparing both chimpanzees and our tax dollars.

We deserve wiser use of our money. Patients deserve cures. And the animals deserve to be left alone.

DAN MATHEWS is PETA’s senior vice president of campaigns. EMILY TRUNNELL, Ph.D., is a scientist with PETA.