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PZI Briefs Congressional Leaders

by the PZI Team

February 7, 2023

In December, when Congress passed the FDA Modernization Act 2.0 with strong bipartisan support, it demonstrated the potential for legislation to advance ethical, innovative medical research that protects and benefits both people and animals.

It also demonstrated the growing support for eliminating unethical research and cleared the way for more advancement.

By removing the antiquated FDA requirement for animal testing in the early stages of drug development, the bill will encourage drug developers to adopt current modern, ethical testing technologies, and it will drive innovation and development of additional technology.

“When physicians and scientists have examined how animal experimentation translates to human outcomes, they have found serious problems with methodology, clinical relevance, predictive value, and the reproducibility of results.” ~ Dr. Hope Ferdowsian

The bill significantly moved the needle, but how can we continue the momentum?

Given the frequency of legislative and regulatory efforts to modernize medical research, including through nonanimal methods—what role can Congress play in driving advancements?

And how can Congressional staff feel prepared to approach these seemingly complex scientific and medical issues?

PZI's expert team speaks to Congressional legislators and staff about the science and ethics of transforming medical research
PZI’s President, Dr. Hope Ferdowsian, and our panel of experts speak to Congressional legislators and their staff about the need to transform medical research.

A Congressional Briefing on Transforming Medical Research

At Phoenix Zones Initiative, we have answers to those questions, and on Monday, January 30, PZI and a team of experts in medicine, science, and ethics delivered an educational briefing on Capitol Hill to inform lawmakers and their staff about advancements in science and ethics relevant to transforming medical research.

The panel included

Hope Ferdowsian, MD, MPH, FACP, FACPM, Physician and Public Health Specialist, Professor of Internal Medicine at the University of New Mexico School of Medicine, and co-founder and President of PZI

Dr. Ferdowsian discussed issues such as the importance of ethics in science, the range of what’s happening in the industry—including the limitations of animal research—and the need to advance a better medical and scientific paradigm.

Paul A. Locke, JD, MPH, DrPH, Scientist and Attorney, and Associate Professor at Johns Hopkins School of Public Health

Dr. Locke reviewed the importance of the FDA preparing for new approach methods—such as through the recent passage of the FDA Modernization Act 2.0. He discussed the need for funding (such as via the NIH) and pioneering new approaches to patient-centered research. Dr. Locke also highlighted how Congress can drive progress toward research without animal experimentation.

Jim Corbett, CEO and Board Member, Emulate, Inc.

Mr. Corbett highlighted some of the current and emerging advances in science and technology, including how new methods deliver better patient outcomes than can animal research. He also discussed what biotech companies need in terms of taxpayer funding and oversight.

L. Syd M Johnson, PhD, Philosopher, Bioethicist, and Neuroethicist, Associate Professor of Bioethics and Humanities, SUNY Upstate Medical University Center for Bioethics & Humanities

Dr. Johnson discussed how The Belmont Report transformed human research ethics, and why we need to extend similar protections to other animals. She outlined what happens in animal research, the failures of the Animal Welfare Act, and what Congress can do in terms of funding and oversight.

Barbara J. King, PhD, Anthropologist, Professor Emerita, William and Mary, award-winning science writer

Dr. King shared her perspective as a patient who has survived cancer. She also discussed how her experiences have deepened her empathy for animals, and why it’s vital that all research is grounded in ethics and values.

As Michelle Blake, PZI’s Policy and Partner Engagement Specialist noted,

“I think we’ve truly reached the tipping point. The public, doctors, scientists, and lawmakers on both sides of the aisle are increasingly ready to end unethical, unreliable research. We are ready for change. The animals need it, and those of us who depend on the medical system–which is every one of us–need it too.”

PZI team members also met with key House and Senate offices to explore future legislative opportunities to advance modern, ethical research.

As part of her presentation to Congressional staff, Dr. Hope Ferdowsian discussed the hierarchy of evidence in medicine that practicing physicians use to treat their patients.
As part of her presentation to Congressional staff, Dr. Hope Ferdowsian discussed the hierarchy of evidence in medicine that practicing physicians use to treat their patients.

Next Steps for Creating a Roadmap to Transform Medical Research

One of PZI’s key goals in 2023 is to operationalize our roadmap toward an innovative, ethical, patient-centered research framework without animal experimentation.

PZI will convene a series of roundtables this spring, drawing together thought leaders and experts in medicine, public health, law, and policy to identify the most viable and effective pathways to advance policy and foster cultural change through education, legislation, regulation, and the judicial system.

Roundtable discussions will center around the principles set forth in The Belmont Report, which a Congressionally appointed committee created to protect human research subjects from harm and exploitation.

Roundtable participants will explore issues such as how to extend research protections to animals (similar to those in The Belmont Report), how to shift the research paradigm, and how to overcome roadblocks to the adoption of new approach methods.

After the roundtables, PZI will circle back with allies on the Hill and build collaborations to advance a modern, ethical, patient-centered research paradigm.

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