Believe it or not, there are urgent healthcare issues facing our nation that are not exclusively pandemic-specific. As we move forward with a new administration in Washington, our thinking, planning and execution of a whole host of healthcare issues must all be informed by the tough and valuable lessons we have learned (and are still largely ignoring) from our battle against COVID-19.
1. The Urgency of Coordination
If a foreign nation invaded our shores, would the federal government insist defense responsibilities be organized by individual states? Would Washington quit the United Nations if we had differences of opinions about how to address similar aggression globally? Not likely. Visible threats normally provoke and require united responses. Alas, the current problems we’re dealing with relative to vaccine roll-out remind us how much we have learned – and how little we have absorbed. If, in March of 2020, I had predicted we’d have a well-stocked COVID-19 armamentarium replete with diagnostics, therapeutics and vaccines by the end of the year – I would have been accused of wishful thinking.
COVID-19 Urgency Lesson #1: If we learn nothing else from our pandemic experience, it’s that a key facilitator of velocity is broad participation. We can accomplish great things quickly when we work together. Our healthcare ecosystem, including the biopharmaceutical industry, academia, government health agencies, manufacturing logicians, hospitalists, healthcare workers, pharmacists, patients and caregivers all helped to accelerate our understanding of the virus, how to mitigate it, flatten the curve and save lives. Imagine what we will accomplish working together more regularly on a wide array of opportunities to improve the human condition? This is as relevant for COVID-19 as it is for the further development of the patient voice in drug development.
2. The Urgency of Innovation
Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap. Shortly before his death, I had the privilege of a private meeting with Nobel laureate Joshua Lederberg. We talked about the state of applied science, the prioritization of development science, biomarkers, and a host of other future-oriented issues. At the end of the meeting he put everything into perspective in a single sentence. He leaned over the table and said, “The real question should be, is innovation feasible?” Our pandemic experience proves that it is. But there are many issues beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate.
COVID-19 Urgency Lesson #2: Innovation is never as easy as it looks. Consider the imbroglio over convalescent plasma, clinical trial design and data collection. The reality is that innovation takes time. As any scientist will tell you, innovation happens step by step, one incremental innovation at a time. Innovation is hard. It takes about 10,000 new molecules to produce one FDA-approved medicine. Nonetheless, innovation is important. Beyond COVID-19, we must also embrace innovative technologies for medical records and prescribing. We need innovative clinical trial designs and molecular diagnostics so that we can develop better, more personalized medicines faster and for far less than the current $1 billion-plus delivery charge. We need innovation in access and reimbursement policies that rewards speed to best treatment rather than lower-cost patients per hour.
3. The Urgency of 21st Century FDA Regulatory Policy
Be honest, before COVID-19, did you even know what an Emergency Use Authorization was? To address urgent needs, the FDA issued EUAs for diagnostics, therapeutics and vaccines. How was this possible? It’s thanks to advances in regulatory science. Alas, the status quo is a harsh mistress. Too many people want to go back to the way things were. But there’s no turning back. While scientifically robust standards and practices are the twin underpinnings of regulatory science, they are by no stretch of the imagination etched in twin tablets by divine fire. Such an antiquated attitude only leads to a diminished desire to invest in innovation. The most potent way medicines regulators can enable innovation is by being a partner in advancing new approaches to both drug development and regulatory science. That also means a more three-dimensional view of “safety.” What does “safety” mean? How is it measured? What is its role in the benefit/risk proposition? Who is its arbiter and guardian? What are the ground rules? What are the pitfalls and opportunities presented by new technologies? Posing the tough questions is a crucial first step.
COVID-19 Urgency Lesson #3: The FDA can either be a sea anchor to or an accelerator of innovation. Change is uncomfortable. A universal truth from human behavioral science is that those doing the work are uncomfortable when the ground rules change. According to Rosabeth Moss Kanter of Harvard Business School, “The best tool for leaders of change is to understand the predictable, universal sources of resistance in each situation and then strategize around them.” The good news is that the FDA’s recognizes it must be a leader in regulatory science — the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products — by dint of true expertise rather than for simply “being the FDA.” COVID-19 has reinforced the FDA’s understanding that laying claim to the regulatory gold standard is a moving target.
4. The Urgency of Science
On Nov. 17, 1944, President Franklin Roosevelt wrote to Vannevar Bush, the director of the three-year-old Office of Scientific Research and Development, “New frontiers of the mind are before us, and if they are pioneered with the same vision, boldness, and drive with which we have waged this war we can create a fuller and more fruitful employment and a fuller and more fruitful life.” As Bush responded to the President in his 1945 report, “Science: The Endless Frontier”: “Science can be effective in the national welfare only as a member of a team, whether the conditions be peace or war. But without scientific progress no amount of achievement in other directions can insure our health, prosperity, and security as a nation in the modern world.” When it comes to healthcare writ large and regulated healthcare technologies specifically, quality is a sine qua non. We’ve learned a lot from COVID-19. How are we going to share that knowledge and maximize it to the fullest potential?
COVID-19 Urgency Lesson #4: Without science, nothing happens. Science must not be silenced or siloed. Science must be collegial, intramural and transnational. Science can be expedited but not rushed. Science cannot be politicized. And science must be trusted by all constituencies from highly degreed academics and regulators to family doctors and patients. Trust counts. We need not look any further than the fact that so many Americans do not trust the FDA process sufficiently to get vaccinated against COVID-19.
5. The Urgency of Preparation
When it comes to placing blame for the devastation of COVID-19, laying it all at the feet of Donald Trump is facile and dangerous. We were as a nation, unwilling, unable, and unprepared. This must never happen again.
COVID-19 Urgency Lesson #5: Be Prepared.
They say hindsight is 20/20, and if there’s one thing we take away from our fight against COVID-19, it’s the value of preparation. We need:
- A fully independent sustaining infrastructure for disaster preparedness and oversight
- A renewed commitment to national approaches for all microbial threats, foreign and domestic – and the means and methodologies to support all states, ensuring that the necessary tools and capabilities are readily available on a real-time basis
- A singular national source of authoritative advice that represents the consensus of best thinking and practices from clinicians, epidemiologists, allied health professionals and political entities — with the tacit agreement to always default to public health interests and truthful transparency
- An active engagement in global risk monitoring and data-sharing networks, to more rapidly detect and address these threats
- Improved development approaches via collaborative endeavors that fully adhere to rigorous scientific standards; our battle against COVID-19 will be judged by history, but a brutally honest and introspective analysis of our current successes and failures must act as a roadmap to protect future generations of Americans.
Aristotle reminds us, “Excellence is never an accident. It is always the result of high intention, sincere effort, and intelligent execution; it represents the wise choice of many alternatives. Choice, not chance, determines your destiny.” Nobody said it was going to be easy.