Welcome back! After meeting with the leadership of all the IRBs, we decided to have a four-part series with the members. The first session began with introducing the current institutional review board structure in Liberia by the Regulatory Compliance and Ethics Manager of the John F. Kennedy Medical Center, Kokulo Franklin. After having written a thesis on the ins and outs of the Liberian IRB structure, Kokulo laid out an excellent potential national plan for the organization of the IRBs.

After Kokulo’s presentation, I presented the results from the needs assessment that we had conducted previously. I began my presentation by outlining the purpose of the needs assessment, which was to provide an up-to-date analysis of the strengths and needs of Liberia’s current research ethics review infrastructure. I then moved onto discussing the makeup of each IRB and the standardized protocol documents that each IRB had or did not have. From there, I discussed the demographics of the committee members and what they wanted to learn. For example, the top three research and research ethics topics that members wanted to know more about were ethical principles in research, international guidelines in research, and research with vulnerable populations (children, prisoners, etc.)

I closed the presentation by discussing essential points that will guide how we structure the rest of the sessions with the committee members. It was a fantastic experience getting to present my findings to all the IRBs. I wanted to create an engaging presentation, so there were times where I stopped and asked questions of the members. These conversations become valuable because I learned more about each participant as well as what the IRBs needed. Below are pictures of my presentation!

In the next session with the members, we will be discussing informed consent and how to work with vulnerable populations.

Statement for the Record Submitted to the U.S. Senate Committee on Foreign Relations Hearing: "COVID-19 And U.S. International Pandemic Preparedness, Prevention, And Response: Additional Perspectives" 

June 30, 2020

Senator Bill Frist, MD

Chairman Risch, Ranking Member Menendez, and other Members of the Committee, I am pleased to be given the opportunity to provide the Committee with my thoughts on global health security. I served for years, and I am grateful that you are taking up this critical topic.

Health is perhaps the most unlikely of topics to rise to the very top of our national interests globally and for consideration before the Committee. Because the ability of other countries to prepare for and respond to outbreaks directly affects our own health security, the pandemic compels us to rethink how we approach development assistance, cooperation, innovation, and international organizations. We now understand that the parts of the government over which the Committee has authority and oversight are not simply for development and diplomacy, but for our national security.

In 2005, as Senate Majority Leader, I gave a series of speeches regarding the necessity of preparing for a pandemic, proposing a six-part readiness plan. We were not prepared then, and while we made some progress, we were not prepared when it arrived this year. We are learning hard lessons, but important lessons about how to organize our government and prioritize our effort, and I am pleased to be able to contribute to that effort.

On December 8, 2005 at the National Press Club, I said, “A viral pandemic is no longer a question of if, but a question of when. We know— depending upon the virulence of the strain that strikes and our capacity to respond—that the ensuing death toll could be devastating.”1

My 2005 remarks were not a prediction, but a warning based on historical and medical facts. Awareness of the threat made it into popular imagination then, but it has escaped political will until now. Remarkably, the requirements are the same 15 years on because the threat is the same. Now is the time to put into motion for the next pandemic what we’re learning from the COVID-19 crisis.

Global Health Security and Domestic Health Security are One in the Same

The first great policy challenge is to point out the dangerous distinction often drawn between global health security and domestic health security. The distinction has contributed to our vulnerability. Our health security depends on the ability of all countries to detect, report on, and respond to outbreaks. Shared vulnerability requires a shared defense. That defense is only as strong as the weakest link.

While not necessarily intuitive, a huge part of effective infectious disease surveillance is maintaining federal support of global health. The next zoonotic disease transmitted from animals to humans will likely come out of Asia or Africa. The ability of developing nations to detect, track and contain a novel virus will be inextricably tied to the capacity of their own public health infrastructure, something that is vitally dependent on U.S. support. And their willingness to mutually share that critical infectious disease surveillance information and allow our scientists to reliably participate in its interpretation will depend on the integrity and trust of our diplomatic relationships.
Our national health, when it comes to recurrent deadly viruses and pandemics, depends on global health. While COVID-19 needs a “whole of government” approach that considers and coordinates both domestic and international response needs, it is exceptionally challenging to operationalize as the domestic–international divide is so fundamental to our laws and government and engrained in practice and thinking. The Federal Government is not structured in a way that allows for essential planning and coordination across accounts, departments, agencies, and authorities. Significant gaps exist between and among the collection of mandates of departments and agencies, and those mandates do not in the aggregate provide a capacity that is up to the job.

To ensure a comprehensive federal approach to global health security, Congress's fractured global health jurisdiction (which spans at least 10 different committee and subcommittee structures across both chambers) should be rectified by the establishment of separate bipartisan special committees or formal working groups that provide a coordinating, overarching vision for the regular committees of jurisdiction.
Additionally, the White House Office of Management and Budget should establish a senior staff role to ensure consistency of health security funding and management decisions across all agencies and accounts—domestic and international—as the George W. Bush administration did effectively.

Health Defense Funding is More Than Foreign Aid

Another challenge on the global side – the core business of this Committee – is that the programs necessary to address U.S. global vulnerability and threats are treated as foreign aid instead of strategic health defense investments. We have relied on emergency supplementals and ad hoc organizational structures. Observing closely for the past 25 years, I conclude – like our armed service defense – we must have predictable, consistent base funding for our public health security programs. We must remind ourselves that development assistance is actually a real national security imperative and not simply a so-called “soft power” instrument of subtle persuasion or a humanitarian imperative. Health security is national security, so let’s treat it as such.

We typically commit about one percent of federal resources to international assistance, but in our COVID-19 emergency packages, only one-tenth of one percent of funds have gone to help low- and middle-income countries in their COVID fight. We must recognize containing COVID globally is essential to halting its spread in the U.S., particularly as we begin to reopen our country for travel and business. (Indeed, New Zealand had just announced the eradication of COVID-19 when two infected U.K. travelers potentially reintroduced the virus, coming in contact with as many as 320 people.)

We cannot close our borders until a vaccine is developed and all 300 million Americans are inoculated. Nor can we completely shut down our economy and livelihoods. So, while protecting our own people is first and foremost, supporting global response efforts are essential to keeping Americans safe.

Viruses are indifferent to a country’s borders. Our response must be global as well as domestic.

Federal Incentives, Private Sector Innovation, and a Vaccine

One of the main thrusts of my 2005 preparedness plan was that the challenge requires much more than simply the public sector alone, and we must summon the creative force, ingenuity, and entrepreneurial spirit that we are known for an that brought us to victory in the Second World War. The role of our private sector and industry is essential to success.

But the powerful commercial markets that incentivize and drive innovation do not naturally exist for an unknown threat or in other instances where need does not provide actual demand due to poverty. Those areas are where our most acute vulnerability lurks. Addressing that vulnerability requires that the government create through policy and incentives the demand for innovations and the environment and playing field to foster it.

For example, Project BioShield when it was enacted in 2004 was intentionally an advance 10year appropriation, established to allow the government to guarantee a market for chemical, biological, radiological, and nuclear (CBRN) medical countermeasures. But since 2014, there hasn’t been an advance appropriation, and instead it is reliant on the annual appropriations cycle. That doesn’t send a powerful message to the private sector.

Additionally, we must recognize when it comes to competing global interests, it is not a zerosum situation. Today, exactly as I said in 2005, we simply do not have the domestic pharmaceutical manufacturing capacity in this country necessary to cover our own needs. The greater the capacity to produce a vaccine globally, the better off we are. Access must be addressed proactively before it is a politically explosive as well as economically and ethically catastrophic. While the World Health Organization Access to COVID-19 Tools (ACT) Accelerator has little chance of really corralling every player to share “equitably” before meeting their own needs, participation or cooperation now will at least be the point on which countries will judge one another. China will exploit the hole in U.S. engagement in at least two ways: providing products and access directly to countries and by pressing the idea that the global rules-based, capital system is the cause of any vaccine access failure. We should consider constructive ways to engage globally to counter this narrative, including participating in the Coalition for Epidemic Preparedness Innovations.

Learning from the Past – PEPFAR

Finally, I would offer that the United States has so much at hand to deploy in this effort, and we’ve made progress in ways that we don’t fully appreciate. For about two decades now, with the leadership and support of the Senate, we have led on a global health effort that has truly changed the course of history. We undertook this effort for reasons of moral conviction, charity, and of value for money and proven effectiveness among our foreign assistance programs.

The President’s Emergency Plan for AIDS Relief (PEPFAR) program provides an exceptional example of strategic health diplomacy. The theory of strategic health diplomacy is that investments in health programs have the potential not only to have extraordinary positive impacts on health, but also to advance key strategic and foreign policy objectives. And without question, this humanitarian effort has yielded incalculable diplomatic and development dividends that were never assumed or contemplated. Created in 2003 by President George W. Bush and a bipartisan group of legislators I helped lead, PEPFAR has prevented millions of deaths, including 2.7 million averted infections to children at birth, and now supports almost 16 million people with lifesaving treatment.

At its peak, HIV/AIDS was killing three million people each year – more than died in the entire Korean and Vietnam Wars combined. PEPFAR is the single largest commitment any one country has ever made to combat a disease. PEPFAR’s effects beyond public health is a topic I sought to understand as part of my work with the Bipartisan Policy Center (BPC). Our research indicates that the 2014 – 2015 Ebola outbreak in PEPFAR countries was mitigated by the health system capacity developed significantly through PEPFAR funding, including such practical tools as improved laboratory capacity that allowed for quicker diagnoses, and on-the-ground human resources better equipped to surveil, report on, and respond to a public health crisis.

Our 2018 BPC report, which I co-authored with Senator Daschle, calls on Congress to continue in the vein of PEPFAR the same dedication and effort to global health security. PEPFAR demonstrates both the essential role of American leadership in health, but also that the reasons for doing so extend far beyond what might be the original focus. We found that countries with higher PEPFAR investment have: had greater growth in worker productivity and economic development than other countries; experienced greater improvements in World Bank indicators of governance, including government effectiveness, regulatory quality, and rule of law; and had improved perceptions of the United States, which strengthens government-to-government relationships and builds the capacity for U.S. ambassadors to address other, more contentious issues.

With respect to the current pandemic, in our most recent Bipartisan Policy Center report we call on Congress to allocate additional funding to the next supplemental package to support vulnerable countries around the world. We recognize the critical importance of the funding and effort of the Federal Government thus far, but we believe that – given the continued trajectory of the pandemic – those resources are not enough to adequately build capacity and support vulnerable countries around the world.

Contagious threats cannot be treated like are exceptional, rare events. Simple facts of globalization and increasing population will increase frequency and perhaps severity of epidemic and pandemic threats. The good news is that we can invest in domestic health security capacity, multilateral health security capacity, and our ongoing global health programs for mutually reinforcing benefits.

One of the most vexing and problematic factors in our lack of preparedness is the cycle of hype and fizzle regarding pandemics. The worst predictions don’t come to pass. But the fact that you cannot prove what didn’t happen or quantify what our investments and preparedness prevented, creates a sense that our response was necessarily an over-reaction. This cycle trains us to weigh the threat less each time. We must not fall prey to that mindset again. Now is the time to act.

1) Read the full 2005 remarks here: https://www.forbes.com/sites/billfrist/2020/05/06/we-failed-to-act-on-pandemic-preparedness-after-sars--we-cannot-make-that-same-mistake-again/#46118a4e6281