Academic Medicine, FDA and America’s Poor Health
(Remarks as prepared for delivery)
The Departments of Medicine at our academic institutions are critical core elements of American medicine. Their tradition and foundational basis for primary care and derivative specialty care have been an essential pillar supporting the revolution in our understanding of health and disease, and they have trained a large proportion of physicians. Similarly, the US Food and Drug Administration is admired throughout the world as the “gold standard” of regulatory agencies. As core members of the ecosystem for the continuum of biological discovery, medical product development and the practice of public health and medicine, we can rejoice in the recognition that the U.S. is the world’s leader in discovery science, innovation and the development of novel medical products.
Unfortunately, despite the enormous and continuing innovation in our system, we are failing in the post-market, clinical care part of the continuum. Our life expectancy is in decline, and other measures of our health status are also inferior to the outcomes experienced by those who live in other high-income countries. Our overall life expectancy has dropped to 76 years, and remarkably, JAMA Internal Medicine published yesterday that male life expectancy in the U.S. has dropped to 73 years. The Commonwealth Fund headline, “Accelerated Spending, Worsening Outcomes,”1 tells the story.
And, as we all know, these poor outcomes are far from uniformly distributed. Disparities as a function of race, ethnicity, wealth, education and geospatial location are profound and widening. A college degree is associated with an 8.5 year longer life and differences of more than a decade in life expectancy are common when we go from urban areas and university towns to rural areas. The massive disparities in wealth and the distrust in science and our foundational institutions like government and universities are growing in parallel with the negative direction of our health outcome patterns. In other words, people like us are generally doing well, but many of those around us are not.
There is a common saying: blame is toxic, but accountability is essential. Neither the FDA nor academic internal medicine deserves the blame for this situation, but I also believe that we need to seriously examine our level of accountability and changes that we can make to help what needs to be an “all hands on deck” effort to change this trajectory. I am an avid fan of education, the pursuit of knowledge and evidence-based medicine—my roots as a physician and a human being are deeply embedded in the culture of academic medicine. But I believe that we must accelerate the pace of change to do our part to reverse this trajectory.
Here is my short list of hoped for changes. I do not pretend to have the expertise to know if these are the right directions, but I hope they will stimulate a good discussion and action for this is not a time to sit on the sidelines; we need to be in the arena.
1. Create and sustain a post-market evidence generation system
As the “evidence based medicine” movement has gained traction, there is general acceptance that we should practice based on the best evidence. Indeed, a cycle that begins with discovery, proceeds through clinical trials to sort out which proposed interventions have benefits that outweigh risks, and moves on the quality measures and implementation has been a standard element of the academic medicine fabric. Unfortunately, we have insufficient evidence for many important questions about medical and public health practice.
The law requires that the FDA decides about marketing medical products based on data from adequate and well controlled clinical studies demonstrating that the risks outweigh the benefits for a particular indication in a particular population in order to be allowed to market a medical product. There is a common misconception that evidence generation stops at that point, when in fact, many questions are left on the table. How does the new medical product compare with other options? How do we combine interventions to optimize outcomes? In which subpopulations is the benefit risk balance tilted towards benefits or tilted toward unacceptable risk given the expected benefits?
This issue was discussed in a report from the Reagan Udall Foundation that was released yesterday. We need to work together across federal agencies, health professions, and the private sector to construct a post-market evidence generation system.
2. Teach about the need for participation in evidence generation
Many clinicians and administrators have a rudimentary understanding of how evidence is generated, how to interpret it and the application of evidence to individual health care and population health. There is also a common view that we should be evidence consumers, but not enough professionals and institutions are committed to being evidence generators. Clinical research, and especially clinical trials are often seen as an expensive “add-on” to practice. As practice has become increasingly financially driven and revenue dependent, clinicians feel pressure not to participate. Admitting that one does not know which treatment option is best is seen as reducing patient confidence and time consuming to explain.
3. Improve our scientific communication—counter misinformation
The FDA is embarking on an effort to improve public understanding of how the FDA works but, more importantly, to provide plain language support for the science and clinical evidence that supports or detracts from the use of medical products, food options, and tobacco products. The Reagan Udall Foundation put out a report last month that gives us a playbook for communication and countering the pervasive misinformation that is leading many people to make bad decisions about their health. While vaccination is an obvious example, we could go through the list of leading causes of death and disability and find that misinformation is much more pervasive in the lives of susceptible people and communities than valid, reliable scientific information. The government cannot solve this issue alone. In fact, most experts believe that universities, academic medical centers, professional societies, community colleges and businesses must join together if we aim to turn these trends around.
4. Adopt modern tools of Artificial Intelligence (AI) to lift clinicians out of box-checking hell
In my early years of doing rounds on the Duke Cardiac Care Unit and seeing patients in clinic, I spent my time talking with patients and families, teaching and considering treatment options. Notes were written by house staff and I checked the notes. These days, clinicians spend huge amounts of time clicking boxes to complete billing records and notes with insufficient time for patient care and learning. I have great hope that AI assistance will re-enable clinicians to care for patients and participate in the learning that is core to our profession.
5. Support policies that increase our clinician workforce
The demand for healthcare and the supply of clinicians is out of balance. Particularly in primary care, there is a major shortage. The dilemma for traditional departments of medicine is that the focus on quality and competition for residency and faculty slots has led to a culture of excellence. Unfortunately, this culture is available only to a minority of today’s patients and the wealthy and highly educated get in line first. I love the quote from Ed Yong in the Atlantic: “Technological solutions drift into society’s penthouses. Pandemics (e.g. diseases) seep into its cracks." We need a substantial increase in our primary care workforce and some combination of digital technology and specialty care that makes access a reality.
6. Push the system to align margin with better health outcomes
Almost everyone I speak with is aware that the optimization of financial margin in our current system is not aligned with optimization of health outcomes. I do not realistically expect this to change in the near future as reimbursement is deeply mired in a political process. Don Berwick’s essay “Salve Lucrum” in JAMA tells the story well. But while we must keep our institutions solvent and you must generate margin in your institutions to pay for the teaching and research missions, we can also continue to develop the evidence about how to spend our health money to solve the problems we’re confronting. Eventually, our computational capabilities, AI, and geospatial referencing will give us the guidebook for allocation of resources, and it will look quite different than our current health system configuration.
For the first time we now have vaccines for all three major respiratory illnesses that kill people my age: Covid, flu and respiratory syncytial virus. Yet, the combination of vaccine skepticism and fatigue have produced weak vaccination results and parents are seeking exceptions to vaccine requirements for their children in record numbers. We need to work together to reverse these trends and save lives over the upcoming holidays.
Thanks for all you do and I look forward to our discussion.