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The Physicians Committee
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June 28, 2017  

 

EPA budget proposal cuts research capabilities

Groundbreaking research to develop 21st-Century, nonanimal chemical assessment methods is at risk. Amazing examples include advanced robots that can screen thousands of chemicals at once, 3-D human livers that can test how humans metabolize pesticides, and a virtual embryo that predicts how chemicals will affect unborn children.

Sen. Tom Udall (D-N.M.), a sponsor of the 2016 Lautenberg Chemical Safety Act for the 21st Century, denounced plans to cut funding to the Office of Research and Development, calling the proposed budget “offensive.”

"I’m glad to hear you [EPA Administrator Scott Pruitt] say you support robust implementation of TSCA," Udall said. "Yet this proposal cuts programs that are vital to TSCA, such as the Office of Research and Development—cut in half—and core agency functions like enforcement. We can’t just build a wall around the TSCA office and expect it will perform."

When the Lautenberg Act passed Congress and was signed into law last year, stakeholders—including nonprofit organizations, labor advocates, and the chemical industry—celebrated. The new law gave the EPA important new powers—and responsibilities—to assess and manage chemical risks. The EPA must assess the tens of thousands of chemicals in the environment, starting with the most dangerous. It must affirm that new chemicals entering the market will be safe for their intended use. And it must consider the risks of chemicals on sensitive populations such as young children, and the risks of mixtures of chemicals.

Recognizing that our current test methods, mostly based on animals, are not up to this task, the authors of the Lautenberg Act required that the EPA and the chemical industry reduce and replace animal tests, and prioritize the development of new test methods and strategies that do not use animals. As required by the law, the EPA is currently drafting a strategic plan to develop nonanimal test methods that will help it assess chemical risks, for publication by June 2018.

The EPA must also prioritize from the thousands of chemicals in the environment to determine which are the most dangerous, for further study and regulation. With its Endocrine Disruptor Screening Program for the 21st Century, the EPA demonstrated how new tools can be used successfully. It has screened more than 1,800 chemicals using a set of in vitro rapid tests in combination with computer prediction algorithms, focusing government and private resources on high priority chemicals and saving tens of thousands of animals.

As it develops these groundbreaking tools, the EPA is leading the world in making data about how chemicals cause toxicity publicly available for researchers, industry, and the general public to use. In the past 10 years, the National Center for Computational Toxicology had made data on hundreds of thousands of chemicals publicly available. This means that as the EPA conducts its own research, it spurs more research at our nation’s universities, speeding progress to replace outdated animal tests with more human-relevant methods.

The EPA needs the research being conducted by the Chemical Safety for Sustainability research program and the National Center for Computational Toxicology in order to meet the responsibilities Congress gave it when it passed the Lautenberg Act. We urge EPA Administrator Scott Pruitt to maintain funding for these vital programs in its FY2018 budget to ensure continued protection of public health, the environment, and animals.

 

June 20, 2017  

 

Physicians Committee Scientist Leads New ‘Canadian Centre for Alternatives to Animal Methods'

From the back of a napkin to reality: The Physicians Committee’s Charu Chandrasekera is set to lead the first Canadian center for the research and validation of alternative methods.

Millions of animals are used each year for studies of fundamental biology and disease, drug development, and toxicity testing. Despite decades of extensive research—often in animals—we still do not fully understand human biology and disease mechanisms. Fully 96 percent of drugs tested to be safe and effective in animals fail in human clinical trials. Therefore, there is an urgent need to transition from animal testing to humane and human-relevant methods to advance human medicine.

Many countries across the globe have already established nonanimal alternatives research and testing centers, and finally Canada joins them. Last week the University of Windsor in Windsor, Ontario, Canada, announced that it has established the first Canadian center dedicated exclusively to human-centered biomedical research and testing, the Canadian Centre for Alternatives to Animal Methods (CCAAM) and its subsidiary, the Canadian Centre for the Validation of Alternative Methods (CCVAM).

The University of Windsor is a comprehensive academic institution located on the Canadian border, across the river from Detroit, Mich. Since 1857, the University has been a progressive and inclusive community that comes together to study, to learn, to teach, and to serve. It places high priority on creativity and collaboration, and respect for ethical social values. CCAAM will contribute to that legacy.

The vision of CCAAM is the replacement of animals in Canadian biomedical research, education, and regulatory testing through 21st century science, innovation, and ethics. CCAAM/CCVAM will develop, validate, adopt, and promote alternatives in Canada through extensive research, academic, and regulatory initiatives in partnership with national and international academic, industry, government, and public sectors, including Health Canada and Environment Canada.

CCAAM plans to establish a state-of-the-art research infrastructure to enable fully humanized research and testing using only human biomaterials and human-based methods. Through in-house, external, and multicenter collaborative efforts, CCAAM will develop research initiatives to study fundamental human biology in health and disease.

CCAAM will develop unique first-in-its-class undergraduate and graduate academic programs in animal replacement science to educate the next generation of scientists, ethicists, and policymakers.

Through these various initiatives at CCAAM/CCVAM, Canada will officially join the global alternatives community and contribute to this field in a uniquely Canadian way.

The Physicians Committee plans to collaborate with CCAAM closely on many fronts to replace the use of animals in research, education, and toxicity testing. The Physicians Committee’s vice president of research policy, Kristie Sullivan, M.P.H., and director of research advocacy, Ryan Merkley, will serve on CCAAM’s advisory council.

June 16, 2017  

 

Integrated Chemical Environment

We are exposed to hundreds of chemicals every day. Thus, assessing chemical safety is a huge public health and environmental issue. Regulators have historically assessed chemical safety with animal tests. Given the ethical and scientific issues with using animals, however, there has been a large push to replace animals with nonanimal tests. In order to organize data from methods that have already been developed and to speed the development of more methods the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) has launched the Integrated Chemical Environment (ICE).

ICE is an open source web-based resource that integrates in vivo and in vitro data, high throughput screening data from the Tox21 consortium, and physicochemical property data from 10,000 chemicals. Making these data available to test method developers, companies, and other governments will speed the development of new methods and approaches to predict or test the safety of chemicals without animals. Furthermore, integrating data that compares the results of new methods with old methods or human responses, much of which have been generated over many years of validation studies, will also help speed the validation of new methods and combinations of methods.

Perhaps the most exciting feature of ICE is the incorporation of in vivo to in vitro extrapolation (IVIVE) information.  As the name implies, this feature would provide tools to assess safe doses of chemicals or drugs in a whole organism based on the doses that caused harm in an in vitro assay. NICETAM also has plans to link the IVIVE feature to biological pathways, which would be a valuable tool to predict the toxicity of chemical substances.

Just in time for the summer, ICE is undergoing its first version update in July (v1.1). One useful tool to be added in July is a workflow for the prediction of skin sensitization without animal testing. Skin sensitization refers to the potential of a chemical to cause an allergic skin reaction that can be quite painful to people, and to animals who are used in tests to assess it. The tool uses results of chemical prediction tools based on a chemical’s structure and other features.

Although this tool is fairly new, its utility is promising with respect to integrating data to answer hypotheses about chemical toxicity and to adding value to increasing test methods that do not use animals. What we can already assess with certainty is that the efforts of NICETAM, and the development of ICE, are great strides towards replacing the use of animals in chemical safety testing and developing reliable and scientifically valid methods to achieve that goal.

ICE can be found at https://ice.ntp.niehs.nih.gov.

Bell SM, Phillips J, Sedykh A, et al. An integrated chemical environment to support 21st-century toxicology. Environ Health Perspect. 2017;125(5):054501. doi: 10.1289/EHP1759.

May 30, 2017  

 

Did you know our federal government has a permanent committee that works to evaluate and promote alternatives to animal testing?

Congress established the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in 2000 to promote acceptance of alternative safety tests that protect human health and the environment.

Alternative means the approach either refines procedures to lessen animal pain or distress, reduces the number of animals used in a particular test, or replaces animals with tests that don’t use animals, such as cells, tissues, or predictive computer models.

On May 23, ICCVAM held its annual public forum. Representatives from 16 member agencies, including the Environmental Protection Agency, the Food and Drug Administration, and the National Institutes of Health shared updates on progress and plans.

Elizabeth Baker, Esq., (right) with the NICEATM deputy director, who coordinates ICCVAM, at NIH
Elizabeth Baker, Esq., (right) with the NICEATM deputy director, who coordinates ICCVAM, at NIH

One of the most exciting updates was the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods’ (NICEATM) presentation of a new national roadmap to modernize chemical and medical product testing by replacing and reducing animal testing. This roadmap is compelling because all of the ICCVAM member agencies agreed on its vision, mission, and goals. The EPA discussed progress it is making on a pilot project to move away from acute toxicity test requirements for pesticide formulations, or final products, and the availability of scientifically valid replacement approaches for assessing skin allergy for global use. Finally, the Department of Defense, the National Center for Advancing Translational Science, and the Food and Drug Administration are conducting a scientific evaluation of tissue/organ chips that would replace animals for pharmaceutical, food safety, and other testing.

The Physicians Committee works with federal agencies and other stakeholders toward the common goal of replacing traditional animal tests with more accurate approaches that are based on human biology. During the presentations, three ICCVAM speakers publicly thanked the Physicians Committee for hosting workshops, providing expert resources, and establishing training opportunities on modern alternative approaches.

The Physicians Committee’s senior science policy specialist, Elizabeth Baker, Esq., provided a comment on ICCVAM-related activities to complement a written comment we submitted in advance of the meeting. In the comment, we commended good work from some member agencies and called upon others to do more to advance alternatives.

The next opportunity for public comment and engagement with ICCVAM is on Sept. 18-19 at the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting. At this meeting, we will offer advice that supports use of alternative, human-focused approaches to better protect patients, the environment and animals.

May 11, 2017  

 

It happens more often than it should: Patients experience serious or even fatal complications during clinical trials for not-yet-approved medicines. But complications can also happen after the Food and Drug Administration (FDA) approves the drug and it is sold to patients.

Drugs should be tested using human biology-based methods such as tissue chips and modeling approaches to give us a better sense of how humans will react to the treatment. Animal tests simply can’t ensure safe medicines, but the FDA still requires animal tests for all new medicines.

A study published this week confirms the scope of the problem. Doctors found that 32 percent of FDA-approved medicines from 2000 to 2010 were “affected by a postmarket safety event.” This means they were either withdrawn, required black box warnings, or led to FDA safety communications after patients began taking them.

The study raises concern about how well medical products are tested, particularly given recent pressure on the FDA to speed up the approval process. One way to speed the approval of safer treatments is to accept modern tests that are based on human biology.

The Physicians Committee is working to make testing faster and more human-relevant. We support the development of new approaches and train regulators how to use them. Additionally, we are working with lawmakers and leading patient safety groups to change FDA regulations and National Institutes of Health funding practices. These science, policy, and educational advances will help safeguard patients by giving the FDA better information before approval decisions are made.

Want to learn more? Check out this episode of The Exam Room to hear our experts discuss medical safety:

 

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