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The Humane Research and Testing Act of 2021 address the growing need to replace animals in research. The bill also calls for the acceptance of "valid and reliable" alternative testing methods.
Words by Aysha Akhtar
Recently, Representatives Alcee Hastings (D-FL) and Vern Buchanan (R- FL), following efforts by Citizens for Alternatives to Animal Research & Experimentation (CAARE), introduced a bill that would provide a needed boost to medical research.
If passed, the Humane Research and Testing Act of 2021 (H.R. 1744) will establish the National Center for Alternatives to Animals in Research (Center) under the National Institutes of Health (NIH). The bill follows nearly 30 years after Congress passed the NIH Revitalization Act to modernize many of the outdated policies and regulations carried out under the world’s largest biomedical institution. The 1993 law included a substantial section [Section 205] to address the growing need and opportunities to replace animals in research. In robust language, the Act called upon NIH “to conduct or support research into methods of biomedical research and experimentation that do not require the use of animals.” It also included language “for training scientists in the use of such [non-animal] methods that have been found to be valid and reliable,” as well as “encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable.”
Unfortunately, even though this legislation passed nearly 30 years ago, NIH has made little effort in replacing animal testing, even with a revolution that has unfolded in biotechnology allowing for superior human-specific research without animals. According to a 2012 National Research Council report, almost half of NIH’s funding is for testing that involves animal use, and this amount has remained stable over the years.
The Humane Research and Testing Act will mandate that NIH follow the law. Fundamental to reducing animal experimentation is the ability to track the number of animals used, yet precise numbers of animals used in U.S. research are unknown. This lack of transparency in what animals are used, how many are used, and how they are used makes it impossible for the public to know whether NIH is making any true effort in replacing animal tests. That is why, in addition to the creation of the Center, the Humane Research and Testing Act (HRTA) will require NIH to track and disclose the numbers of all animals used and document its progress at reducing them through mandatory bi-annual reports.
Importantly, the establishment of a Center will be an important step in ensuring scientific progress for human health. It is becoming increasingly recognized by scientific bodies that there is an urgent need for a sea change away from animal testing. Whatever role animals may have played in medical research in the past, today’s research deals with the subtle nuances of molecular biology and genetics. Interspecies differences in physiology, pharmacokinetics, and genetics significantly limit the reliability of animal testing.
And the proof is in the pudding. More than 90 percent of drugs and vaccines fail during human clinical trials, after passing animal tests. People enrolled in clinical trials put their lives at risk based on misleading safety tests on animals. Equally troubling is the very likely fact that many drugs that were abandoned based on animal tests may have worked wonderfully in humans. Most diseases have little or no treatment available. But how many missed opportunities were there because of the unreliability of animal testing?
New testing methods offer a way out of the quagmire that animal testing has caused. Human organs grown in the lab, human chip models, cognitive computing technologies, 3D printing of human living tissues, and the Human Toxome Project offer great promise in helping scientists understand the diseases that afflict us and find treatments. Much of their promise lies in the fact that these testing methods are based on human biology.
But more change is needed and needed faster. As long as NIH prioritizes funding of animal research, the development of innovative testing methods will be impeded. The Center will be tasked with developing, funding, and incentivizing innovative, human-based methods. The Center will also educate and train scientists to utilize these methods.
The HRTA was introduced one month before Congressman Hastings died from pancreatic cancer. His words drove home his strong belief that the HRTA will be transformative: “This legislation will not just reduce animal testing and research,” said Hastings, “but will ultimately improve medical treatments for humans as they are developed from beginning to end primarily with test subjects that replicate human biology and physiology.”
Will Congress honor Hastings’s legacy? Lives remain in the balance as long as the biomedical system is based on ineffective animal testing. A new center within NIH will help ensure that our tax dollars are used to fund the best and kindest medical science possible and pave the way for innovation.
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