Phillips explores policy, ethics, and precision medicine

Forging ahead in her focus on the value of medical interventions and how to implement them most effectively and efficiently into health care, Department of Clinical Pharmacy faculty member Kathryn A. Phillips, PhD, is part of a team of authors published on May 20, 2024, in the Journal of the American Medicine Association (JAMA) who are tackling the complicated topic of state legislation and biomarker testing.

Reviewing legislation from 15 states that mandate coverage of biomarker testing––a lab method that checks for certain genes, proteins, or other molecules that may be a sign of a disease––Phillips collaborated with UCSF School of Medicine faculty member Grace Lin, MD, MAS, and UCSF Philip R. Lee Institute for Health Policy Studies faculty member Janet Coffman, PhD, and found that the impact of such legislation may be limited by lack of reach and by implementation challenges.

Translating research into practice and policy

Phillips is the founding director of the UCSF Center for Translational and Policy Research on Precision Medicine (TRANSPERS), which brings experts together to examine critical issues surrounding the translation of precision medicine into practice and policy. Analyzing the increasing numbers of states that mandate insurance coverage of biomarker testing, the authors concluded that the policy implications must be considered and addressed to assess whether the laws are useful.

States enacted the laws as a response to perceived barriers to care access. Increasingly, states are using legislation to mandate terms and conditions of insurance coverage for various circumstances, such as cancer screening and mental health treatment parity, but Phillips said there are no simple answers.

“A lot of states were putting out these new laws, but no one was really looking to see why did they come about, and what are they actually going to do,” Phillips said. “Our conclusion is that we need to follow up to see the results of these mandates, as opposed to just blindly passing more and more mandates.”

The research findings suggest additional approaches designed to address inequities. “There’s very little in the laws about how they’re going to measure success,” Phillips said. “Legislation might make a difference in some situations, but it’s not necessarily going to solve the problem, because there are a lot of reasons people may not get appropriate care.”

Phillips described a range of policy issues that put pharmacists on the forefront when it comes to legislation and regulation––at the federal, state, and local levels. “Pharmacy is critically important to precision medicine,” she said. “Isolating the impact of the mandate versus other factors is going to be challenging, but that’s what researchers do.”

Matching novel therapies with unmet needs

From diagnostics to pharmaceuticals to therapeutics, Phillips’ research continues with her selection to a National Academies of Sciences, Engineering, and Medicine committee that is examining patterns of alignment or mismatch between innovation and unmet clinical needs in developing novel therapies.

The committee, which is funded by Gates Ventures and the Peterson Center on Healthcare, will recommend strategies that spur and facilitate increased innovation with the goal of reducing health disparities.

“We’re looking at how we put innovation and resources into the biggest areas where there is need,” said Phillips. “And we have not just academics like me but people who are more familiar with things like venture capital and social innovation and who have real-world experience.”

Phillips said the committee will raise awareness about the fact that there can be gaps where drugs aren’t available and aren’t being invented, in areas where there is significant need. “Hopefully we’ll find some approaches that can be adapted and come up with mechanisms to focus more on those gaps.”

Pharmacy and ethics

In 2025, Phillips will further her work on improving scientific publication and open science as a scholar in residence with the Brocher Foundation in Geneva, Switzerland. Recognized for its promotion of multidisciplinary research on the ethical, legal, and social issues (ELSI) of new medical developments and health policies, the foundation hosts 50 researchers each year, allowing experts to collaborate on international ethics and health care issues.

Phillips will focus on open science, which she said has received a lot of attention since the White House Office of Science and Technology Policy (OSTP) declared 2023 the Year of Open Science. “The government requires federally funded research to be openly available, and that data must be shared, but of course, that’s easier said than done,” Phillips said, adding that the National Institutes of Health are actively trying to figure out and implement that guidance. She noted that Europe has taken the initiative in developing new approaches to open science, which could offer global insights.

“There’s a big push toward more transparency, and we’re going to see even more regulation and guidance on how to deal with AI, given that it is both a facilitator and a challenge to open science,” Phillips added. “I think this legislation is just fascinating.”