A report on the Milken Institute response
January 21, 2021
Plagues and pandemics have been humanity’s feared companions throughout history. Yet with each horrific episode, we’ve learned useful lessons:
- The 6th-century Plague of Justinian is estimated to have killed half the world’s population. With no effective treatments, only social isolation had any impact.
- The Black Death of the 14th century formalized the process of what we now call quarantines.
- It took hundreds of years, but the widespread use of a vaccine finally extinguished smallpox.
- Cholera was brought under control by urban sanitation, a civil engineering feat hat led to modern public health practices.
- Containment of the 1918 influenza pandemic was helped by widespread campaigns to educate the public with advice and information.
The Covid-19 pandemic is no exception. We’ve learned lessons from the past and continue to learn even as efforts to achieve full control proceed worldwide. Despite enormous human, social and economic devastation that will forever mark 2020 as a year for the ages, it was also a time of great advances in medical science and public health.
Our recent achievements are built on the solid base of previous support for science. America’s response to the 1957 Soviet launch of Sputnik, the first earth satellite, is usually credited with accelerating a space program that put U.S. astronauts on the moon only 12 years later. In 1958, Congress created the National Aeronautics and Space Administration (NASA) and the Defense Advanced Research Projects Agency (DARPA) while also passing the National Defense Education Act to expand higher education, especially in the sciences.
Perhaps an even greater, if more subtle, impact was the changed image of science itself. Many leading scientists who were students in the 1950s and 1960s will attest to the impact of these events on their career choice. It was suddenly cool to be a scientist.
Recent advances in genomics, bioengineering, drug development, surgery, medical instrumentation, imaging, virology and artificial intelligence have their roots in this period. The support given to America’s biomedical infrastructure over the past half-century has increased our current understanding of cancer, rare diseases, cardiovascular conditions, the brain and infectious diseases.
Accompanying these developments were effective programs to promote funding for basic, translational and clinical research. From the March of Dimes in 1938 to the National Cancer Act of 1971 to the 21st Century Cures Act, our nation’s financial commitment to medical science has been essential. These and several other programs, including annual appropriations for agencies like the NIH, comprise one leg of research funding’s three-legged stool. Another leg is the investment of pharmaceutical and biotechnology companies. The rest comes from philanthropists, charitable foundations and disease-specific research organizations.
My colleagues and I have worked for decades to help reduce the burden of suffering, disability and premature death from disease. Since the 1970s, our efforts have helped to transform the process of medical research, raise funds to support studies by thousands of physicians and scientists, and lead programs by non-profit groups calling for federal action to accelerate cures.
The Milken Institute’s FasterCures center began under the name CaP CURE in 1993. Originally focused on cancer, it evolved into an organization dedicated to accelerating medical solutions for all life-threatening diseases. It became a new model for active biomedical research foundations in the private, non-profit sector.
In preparation for the 1995 National Cancer Summit, we developed a 10-point plan for “rethinking the War on Cancer” that would move it “from a war of attrition to a plan of attack.” Three years later, we organized a massive March on Washington to call for greater federal funding of research. In the subsequent five years, Congress doubled the NIH budget and tripled funding for the National Cancer Institute. This was part of a broad campaign by untold numbers of patient advocates, scientists, clinicians, industry executives, academic medical center leaders, philanthropists, government employees and concerned citizens.
After nearly a decade of inflation had eroded the NIH increases, the Milken Institute convened a Retreat on Bioscience Innovation with leaders in medicine, business, venture capital, philanthropy and government to focus on the need for greater support of translational research. This played a significant role in the creation of NCATS–the National Center for Advancing Translational Sciences–one of 27 NIH institutes. When the coronavirus crisis emerged, NCATS lent its considerable expertise to the NIH response.
In 2012, we hosted the Celebration of Science in Washington. This event, dedicated to the proposition that science matters, helped build a groundswell of support for renewed commitments from government, industry and philanthropies. Congressional leaders of both parties participated and helped assure that NIH funding resumed its upward path. The last two White House administrations have maintained that budget commitment. Without it, the agency would have lacked the flexibility that allowed it to act quickly and decisively in response to Covid-19.
Our 2014 Summit on Public Health and Prosperity at the Atlanta headquarters of the Centers for Disease Control and Prevention carried forward momentum from earlier Milken Institute events and raised nationwide awareness of public health programs. Soon after, we announced the endowment and renaming of the Milken Institute School of Public Health at George Washington University.
The Institute’s FasterCures center was heavily involved in efforts to achieve passage of the 21st Century Cures Act, which streamlined the drug-approval process and provided $6.3 billion for new initiatives in precision medicine, studies of the brain, cancer and regenerative medicine. I testified in favor of the Act on Capitol Hill and wrote an op-ed article urging Congress to pass it. FasterCures is now actively supporting new legislation to extend and improve provisions of the Cures Act.
In the 10 months since the coronavirus created a national emergency in the United States, we’ve been at the center of a historically unprecedented scientific whirlwind. Research scientists, healthcare providers, government officials and major companies threw aside their parochial interests to cooperate. A new international peer-to-peer research culture took root and grew organically. While the Manhattan Project, the Apollo Program and the Human Genome Project had each taken years to plan and execute, the comparably ambitious Covid project came together in a matter of weeks. We believe this remarkable achievement signifies a permanent culture change. We will never return to the old ways.
The NIH quickly created a public-private partnership called ACTIV–Accelerating Covid-19 Therapeutic Interventions and Vaccines–to prioritize research, advance pre-clinical treatments, speed testing of vaccines and treatments, improve clinical-trial capacity, and accelerate vaccine evaluation.
Vaccine manufacturing was a major issue. In normal times, pharmaceutical companies don’t invest in large-scale production of a new medicine until trials are complete and the FDA approves. There is too much business risk if approval is withheld. The Operation Warp Speed team understood that many people could die while waiting for a vaccine if it wasn’t available at the earliest possible date. Therefore, the Biomedical Advanced Research and Development Agency (BARDA) within the U.S. Department of Health and Human Services, contracted with industry partners for pre-approval manufacturing. This has greatly accelerated availability of more than one billion vaccine doses. It wasn’t a perfect process, but it is destined to save many lives.
A parallel NIH initiative that Congress funded in April 2020 is RADX–Rapid Acceleration of Diagnostics–with the goal of developing accurate, fast, easy-to-use and widely accessible testing so the nation can return to near-normal life as soon as possible. This entrepreneurial initiative, which thrusts a federal agency into a role not unlike a venture capital firm, has plans to make millions of tests per week available to Americans, particularly those most vulnerable or disproportionately impacted by Covid-19. It is a major challenge to develop user-friendly tests that provide fast results with few false negatives and false positives–all at low cost.
The 10 centers of the Milken Institute have played a crucial role in the public-private responses to the crisis. As early as February 2020, the Institute estimated that Covid-19 would cost the nation more than $1 trillion a month in direct costs. Even this huge sum greatly understates the total impact because the human costs, including the effects on families, are not included. This clearly justified massive spending to mitigate Covid’s effects.
We focused on six areas: education, testing, prevention, care, cures and economic support. In March, as part of the education focus, I initiated a series of podcasts featuring interviews with more than 125 global leaders in health, government, industry and academia. Guests included physicians, Nobel laureates in science, philanthropists, military leaders and CEOs of the major companies developing vaccines and advanced therapeutics.
FasterCures launched the Covid-19 Treatment and Vaccine Tracker as a research acceleration protocol. The goals included increased collaboration, minimal clinical trials duplication, and a clearer regulatory pathway for small research groups. The center created public policy recommendations and worked to minimize funding delays and other roadblocks. We collaborated with BARDA and several vaccine developers to facilitate the ramp-up of manufacturing. Racial and ethnic disparities in healthcare and research–disparities that Covid-19 amplified–received additional attention.
We must act on the lessons of this crisis, mindful that more pandemics lie ahead. Nor should we forget that the overwhelmingly tragic deaths and destruction of lives they bring are accompanied by many collateral impacts. Covid-19 led to:
- Disrupted, suspended, delayed or cancelled clinical trials for other diseases.
- Closed laboratories as scientists were pulled away to work on Covid.
- Excess morbidity/mortality because fearful patients delayed important treatments.
- Delays in age-dependent childhood immunizations.
- Delays in time-sensitive screening tests (colonoscopies, mammograms, etc.).
- Permanent disabilities that could have been prevented by timely physical therapy.
- Use of illegal opioids in place of clinically centered pain management plans.
- Increases in suicides, spousal abuse and child abuse.
- Setbacks in efforts to stamp out the few remaining reservoirs of the polio virus.
- Employee layoffs at hospitals and small physician/dental practices that lost revenue.
- Closing of small businesses, especially those owned by minorities and women.
As always, the most vulnerable are the most affected by these collateral effects. Low-wage workers don’t enjoy the option of working from home–and they continue to bear the greater disease risk. They deserve all possible assistance.
The following policy steps will better prepare America and the world for the next crisis:
- Establish a more-robust early warning system for emerging pandemic threats worldwide. Under the guidance of an advisory group of esteemed global experts, FasterCures has already launched an Early Warning Initiative to monitor, identify and track threats. A complete system will go even further by quickly determining the source and direction of any pathogen causing an outbreak as well as its pattern of mutation. Advancing technology has helped: in 2003, it took 149 days to create even a partial sequence of the SARS-1 virus; by 2009, it took 77 days to sequence the swine flu bug; a full sequence of SARS-CoV-2 took only 12 days. One model for this work is the Africa Pathogen Genomics Initiative launched with support from Illumina Corporation, the Gates Foundation and the Africa CDC. However, too many countries still lack sequencing capability for any disease. That’s a gap that must be closed.
Other forms of surveillance can start at the community level by monitoring internet searches and pharmacy sales. Separately, other groups must monitor animal health for signs of zoonotic disease outbreaks. Finally, any surveillance system must identify not just novel viruses, but also emerging antibiotic resistance and potential biological terrorism.
- Expand young investigator programs. Academic medical centers have suffered devastating revenue losses because Covid-19 forced the cancellation of many elective surgeries and outpatient programs. This has been particularly discouraging to the next generation of researchers, many of whose laboratories had to close or cut back. Yet long experience has shown that investments in early-career physicians and scientists pay among the highest returns of any health spending.
The idea that young investigators most often propel science is not new: Einstein was 26 when he published the Special Theory of Relativity; Salk was 30 when his work on polio was funded. Thousands of medical researchers have developed important advances in our understanding of disease soon after completing their formal studies. This has produced incredible advances over the past several decades. There is every reason to believe that young researchers will be in the vanguard of successful responses to future pandemic threats. The importance of youth was well described by Pearl Buck, the first woman to win the Nobel Prize in Literature: “The young do not know enough to be prudent,” she said. “They attempt the impossible–and achieve it–generation after generation.” We will all benefit by supporting this cohort, diversifying its members, and recruiting the most promising future medical/science graduates to choose research careers.
- Foster greater collaboration among researchers worldwide. To their immense credit, academic medical research centers, the global biopharmaceutical industry and government agencies joined forces in an effort to defeat their two common enemies–the SARS-CoV-2 virus and time. This was unprecedented since researchers have too often viewed other institutions as competitors, not collaborators. Our ongoing challenge is to maintain a collaborative culture after the crisis has passed. We need greater long-term incentives that encourage sharing of preliminary research results.
- Support bioengineering programs in the NIH and all science agencies. The incalculable benefits of bioengineering programs like the human genome project continue to enrich a wide array of scientific investigations. Funding of such programs helps assure that federal agencies are able to act quickly and effectively in the same way that DARPA gives the Department of Defense needed flexibility and scientific capacity to respond when threats emerge.
- Build manufacturing capacity before it is needed. Covid-19 has shown the importance of building vaccine, therapeutics and testing manufacturing capacity before the next pandemic strikes. It is not an easy sell politically to spend taxpayer dollars on facilities that may lie dormant for years. Yet we know from experience that it will save lives.
- Involve patients more completely in research and development. Disease-specific research organizations have been effective partners of government, industry and academic centers. They bring a patient perspective that has been shown to improve the quality of research and increase its gender, racial, ethnic and age diversity.
- Create a more sustainable model for funding and governing international health agencies. Groups like WHO, CEPI and the World Bank can be most effective when they are assured consistent funding sources and professional governance free of unnecessarily extraneous influences.
Nearly three decades ago, the Milken Institute launched what became FasterCures based on the concept that time equals lives. Now is the time to double down on what has worked well so we will never again face a pandemic unprepared. Just as America created NASA and DARPA as permanent forces for defense preparedness, the nation needs a permanent force to confront emerging health threats. Sputnik launched more than a satellite–it launched American science as a force for good in a way that we haven’t seen in more than half a century. Covid-19 is our new Sputnik moment. Let us use it to recommit to bioscience progress and preparedness on behalf of all the world’s people.
Mr. Milken is chairman of the Milken Institute.