He argues that the FDA always lags behind purchasers’ procurement decisions. During the COVID-19 pandemic, the FDA fell way behind in its inspections. The Government Accountability Office reported that at the end of 2022, the FDA had not inspected 61% of critical overseas sites in five years. “And an FDA inspection merely reviews quality documents maintained by the manufacturer. They do not routinely test the medications themselves for quality,” Schulman says. In fact, he recently detected carcinogens in some generic drugs, even after FDA recalls, likely resulting from low-quality manufacturing processes.

“It’s been both exciting and frustrating to examine this market, which is a critical part of our healthcare system that has been largely neglected by the research community,” he says. “Generic drug shortages and generic drug quality are solvable problems. We need a new economic model that incorporates both price and quality into its infrastructure to deliver more for our patients.”

Findings from research conducted in a predominantly male patient population cannot reliably be used to guide the care of female veterans. As a spin-off of the Women’s Health Research Network, another initiative, the Women’s Enhanced Recruitment Process, is designed to improve the equitable representation of women in clinical trials. Led by Frayne and Karen Goldstein, MD, at VA Durham and Duke University, this program addresses the historical underrepresentation of women veterans in research to increase the inclusiveness of large VA trials. 

“We are working to ensure that women veterans are better represented in clinical research, which is crucial for developing effective treatments and interventions tailored to their unique needs,” Frayne says. 

To further support these efforts, the Women’s Health Evaluation Initiative (WHEI) leverages VA databases to inform national VA strategic planning and policy development. WHEI’s data-driven approach helps identify gaps in current research and care, guiding the development of targeted studies and interventions, and contributes to the VA as a learning healthcare system. 

While Frayne cautions that more is still needed, she has seen steady improvement in VA services for women veterans since she started as a primary care doctor more than three decades ago. The implementation of women veteran program managers and women’s health medical directors at every VA facility has expanded access to specialized care. Dedicated women’s health clinics are now common. 

The VA has also been focusing on culture change. For example, Women’s Health Research Network findings that identified harassment of women veterans led to national VA anti-harassment campaigns, and studies have shown subsequent improvements in women’s perceptions of the VA environment of care as safe and welcoming.

The Women’s Health Research Network’s body of work around culture change is just one example of its impact. As Frayne notes, “Our ability to quickly adapt and respond to emerging priority areas speaks to the robust infrastructure and partnerships we’ve built over the past 15 years.” 

Defining Risk Thresholds

If the testing does reveal a heart condition, Tso assesses the condition’s severity level and works with the patient to set risk-based exercise thresholds. 

Quantifying the danger is helpful. Most athletes want to keep exercising, he says, “but they don’t really want to push so hard they’re endangering themselves.” He may counsel an older runner with mild heart failure, for example, on safe intensity zones based on their own test results. The patient gets to continue doing what they love, and what may ultimately help their overall health, with a better understanding of where the risk lies.

Keeping COPD Patients Out of the Hospital

Eggert is working on increasing access to pulmonary rehabilitation – an eight- to 12-week program that combines education, breathing exercises, endurance exercises, strength work, and more – that is well-known to improve quality of life for people with COPD and other lung conditions. It also helps keep patients out of the hospital. “It’s just being grossly underutilized, and one of the biggest factors is lack of access,” says Eggert. 

Only about 5% of patients who could benefit from pulmonary rehabilitation use it. In rural areas, that number is even lower. It’s closer to 3% of patients who are likely to benefit. Stanford Medicine is partnering with an innovative virtual rehabilitation program to allow patients to work through the program without having to travel. 

Eggert, her team, and her collaborators throughout Stanford Medicine are reaching new frontiers, building new spaces, making the most of telehealth technologies, and providing better care for more pulmonary patients than ever before.

Harmonizing the Interagency Response

Relman and his colleagues attend many meetings each day with the various parties involved. They discuss ongoing responses and long-term planning. They try to find common ground, establish priorities, and ensure that good policies result. At the very least, Relman says, they work to see that “there aren’t disparate and contradictory actions.”

The H5N1 outbreak embodies the balancing act of government. As multiple institutions respond in harmony to stop the spread of H5N1 in livestock and humans, they must also build a long-term plan. 

Long-term planning includes asking educated what-if questions. Viruses mutate. Pandemic preparedness means anticipating possible mutations and developing countermeasures, such as tests, antivirals, and vaccines.

Relman’s task at OPPR is to provide the perspective of a career scientist and expert in infectious diseases and biological risk. In particular, he is personally most interested in the problem of anticipating future events, such as how viruses might evolve or how well-intentioned science might lead to consequential biological risk.

A Seasoned Expert in Advising the Government

Relman is no stranger to advising the U.S. government on future biological threats. He has an enduring commitment to national service. “I’ve always felt that’s just an important component of being a responsible scientist,” he says. 

For more than two decades, that commitment has included serving on the Defense Science Board for the Department of Defense and as an inaugural member of the National Science Advisory Board for Biosecurity. He is also a member of the National Academy of Medicine, part of the National Academies of Science, Engineering and Medicine, which advises the U.S. government on pressing matters of health and science. Relman’s work for the National Academies in general has been substantial, including influential work in the realms of laboratory science, international security, and future biological threats. 

Relman chaired a committee at the National Academies that provided advice to the U.S. State Department and co-chaired a panel for the U.S. intelligence community on Havana syndrome, a set of neurological symptoms and findings that was first reported in 2016 in U.S. government personnel based at the U.S. Embassy in Cuba. The origin of Havana syndrome and its national security implications continue to be a subject of debate, with Relman a prominent voice. 

“It’s rare for professors with strong academic research portfolios to also have a practical sense of issues that are important to public policy,” says RAND Corporation President and CEO Jason Matheny, who has worked with Relman in previous roles related to policy, including serving together on the National Academies’ Intelligence Community Studies Board. 

“I think there’s only a handful of people in this category of people who are as widely respected in the scientific community who spend a significant portion of their waking hours thinking about national security and public policy,” Matheny says. “Truly, I can only think of a few people who have committed as much as David has to these topics.”