World’s largest funder of medical research and the limitations of animal experimentation

Neural pathways in the brain. Source: Flickr/ NICHD

Neural pathways in the brain. Source: Flickr/ NICHD

In December 2015, the National Institutes of Health (NIH) released the NIH-Wide Strategic Plan, Fiscal Years 2016–2020: Turning Discovery Into Health. NIH is the world’s largest source of medical research funding. It consists of 27 institutes and centres (ICs), along with program offices, which collectively are referred to as ICOs. The Strategic Plan had been requested by Congress.

The NIH receives nearly thirty billion dollars a year from the US Government, and the total number of active grants in 2014 was more than 47,000.

Because a broad research portfolio is critical for carrying out NIH’s mission, the agency’s portfolio of grants and contracts covers the full range of biomedical, behavioral, and social sciences research, from basic to applied. (p. 5)

While NIH institutes and centres have their own strategic plans, the document is meant to lay out a common approach for priority setting across all NIH’s components.

The plan has four objectives:

  1. advance opportunities in biomedical research in fundamental science, treatment and cures, and health promotion and disease prevention;
  2. foster innovation by setting NIH priorities to enhance nimbleness, consider burden of disease and value of permanently eradicating a disease, and advance research opportunities presented by rare diseases;
  3. enhance scientific stewardship by recruiting and retaining an outstanding biomedical research workforce, enhancing workforce diversity and impact through partnerships, ensuring rigor and reproducibility, optimizing approaches to inform funding decisions, encouraging innovation, and engaging in proactive risk management practices; and
  4. excel as a federal science agency by managing for results by developing the “science of science,” balancing outputs with outcomes, conducting workforce analyses, continually reviewing peer review, evaluating steps to enhance rigor and reproducibility, reducing administrative burden, and tracking effectiveness of risk management in decision making.

What about animal experimentation?

In the following, I will focus on the part that animal research plays in this Strategic Plan.

Like Australia’s largest funding body of biomedical research, the National Health and Medical Research Council (NHMRC), the NIH funds experimentation on animals. Unlike the NHMRC, the NIH is explicit in acknowledging the limitations of such research AND dedicates significant funding to the development of more human-relevant research.

Discovery of potential therapeutic targets and candidate therapies are essential first steps in the development of new treatments and cures, but they are far from the only steps. The transition of scientific discoveries to human clinical trials has become increasingly costly and time consuming, with a great number of candidate therapies failing to cross what has been dubbed the “Valley of Death.” NIH-funded research will play an increasingly important role in identifying hurdles in this process, as well as generating approaches for accelerating the development and testing of potential treatments and cures. … Development of a new therapeutic is a long, costly, and risky endeavor. Currently, a novel drug, device, or other medical intervention takes about 14 years and $2 billion to develop, with a failure rate exceeding 95%. (p. 19)

So what are the human-relevant methods that are mentioned in the document and supported by grants?

Organs-on-chips and Tissue Chip for Drug Screening

Tissue Chips. 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. To address that challenge, NIH, DARPA, and FDA are collaborating to develop 3D platforms engineered to support living human tissues and cells, called tissue chips or organs-on-chips. An integrated body-on-a-chip is the ultimate goal. (p. 38)

… the development of innovative ’tissue- and organ-on-a-chip’ systems is helping to bridge the gap between fundamental and translational science, providing new models of complex pathology for understanding basic mechanisms of disease. (p. 15)

Toxicology in the 21st Century (Tox21)

Tox21 researchers aim to develop better toxicity assessment methods to quickly and efficiently test whether certain chemical compounds have the potential to disrupt processes in the human body that may lead to negative health effects.

The “better” in the above quote surely refers to the unpredictability of animal testing.

New innovations such as molecule cross-coupling methods and human 3D organoid technologies

Despite the many exciting scientific opportunities for speeding the development of treatments and cures, significant challenges remain. Over the next 5 years, NIH will support research aimed at addressing a wide range of obstacles that lie at various points throughout the therapeutic development process. … To improve the efficiency, relevance, and accuracy of preclinical research, NIH will catalyze powerful innovations, including molecule cross-coupling methods that will open a vast new frontier of “chemical space” and human 3D organoid technologies that will be better than animal models. (p. 22)

Like the mouse running around and around in the wheel, animal experimentation is getting nowhere. Medical science has moved on, and it’s time to move away from outdated methods.

Despite acknowledging the proven usefulness and further potential of non-animal methods, the NIH continues to fund animal experimentation. But it’s a step in the right direction. It will waste fewer resources on unreliable methods using animals, and continue and strengthen investment in more reliable, often cheaper and faster, human-relevant research methods.

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