Recently, Stanford Medicine’s Dean Lloyd Minor interviewed Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, on the state of America and COVID-19—representing an infectious disease scientist’s “worst nightmare.” Steamed online, the discussion centered on the challenges associated with this pandemic, including: 1) the need for an effective widespread vaccine, 2) focus on early-acting treatments to prevent disease progression and hence hospitalization, 3) the lack of public health infrastructure for effectively dealing for outbreaks of this magnitude, and 4) an explanation as to why in the U.S. the pathogen surges, while in other countries it does not. Fauci called out some successes, including the progression of two treatments thanks to randomized controlled trials during the pandemic, and he pointed to other potential clinical research targeting COVID-19. Finally, Fauci doesn’t think academic medical center talent, capacity, and resources are sufficiently leveraged in combating the disease. TrialSite News provides a different point of view on the interview topics as well as a critique of what wasn’t discussed.
Operating on ‘Pure Adrenaline’
Dean Minor asked Dr. Fauci what was actually a deep and profound two-part question to kick off the interview. Perhaps telling of the constraints Fauci himself faces on a daily basis, he wasn’t able to answer either question, and hence moved on to the controlled meta narrative or scripts that can be a norm for the top of agencies in Washington, D.C. Due to the unbelievable pressure in Fauci’s position, including non-stop 18-hour work days, Dean Minor wanted to know: 1) if Dr. Fauci had time to reflect on the implications of this pandemic, and 2) how he dealt with the stress associated with the pandemic personally. Fauci went on to repeat that this pandemic is unprecedented, without any sharing of who he is as a person.
He gave no indication of whether he finds ways to think critically about what he, the NIAID, and the overall research apparatus is doing in this pandemic. Finally, there was no mention of how he deals with the stress of his position on a personal level. In Washington today, any sign of humanity could be perceived as a weakness, and given Fauci’s current tensions with the Trump administration, he certainly has his guard up. By stating that he “operates on adrenaline,” one could interpret Fauci’s lack of response to the two questions as suggesting he doesn’t have time to reflect, but rather he is continuously reacting to the intense and continuous stimuli in the research environment. Also, he probably has had to emotionally “check out” after decades of operating under Washington DC’s political, social, and economic, not to mention psychological, intensity.
Need to “Pull Back”
Fauci compared America to Europe and Asia and noted that many other countries are doing better than the U.S. in terms of COVID-19 controls because they conducted more systematic and methodical shutdowns for longer periods of time. If one reads between the lines of Fauci’s response, he doesn’t think that America did a good job responding to this pandemic, and of course he carefully avoids politics but does emphasize that it is likely the country (or least a number of regions) will certainly need to pull back. This does not mean a complete shutdown, but a regime of carefully-control conditions on the ground. Acknowledging that a complete shutdown is not economically feasible, he did convey, “So you’ve got to shut down but then gradually open.” Citing what he believes are good guidelines for these actions, Fauci suggested they were not followed. Now, where the pandemic rages, authorities must “step back” or “pull back” and “proceed in a very prudent way, of observing the guidelines of going from step to step.”
So, what does this mean? In addition to ongoing measures such as masks, social distancing, and rigorous handwashing, if the pandemic continues at this pace, expect more societal and economic constraints. From keeping some schools closed, to restricting what businesses can remain open to the public, to controlling how many people can congregate in the public in areas where the virus is surging, the needed steps are a blow to society. This is where America is headed because it didn’t follow the proper guidelines in sufficient numbers of areas, according to Fauci.
Priority Research Areas
The interview response offers some glimpse into Fauci’s thinking about priorities for clinical research. Acknowledging the two approved drugs in the United States (Remdesivir and Dexymethasone), none of these address people who have been infected but have no symptoms to mild symptoms, which is the majority. An absolute key component, alongside the vaccine breakthrough, are interventions that impede or slow down the disease progression so less people become severely ill and die.
Fauci declared, “What we really need, and we’re on track of getting, are interventions that can be given early in the course of disease to prevent people who are vulnerable from progressing to the requirement for hospitalization. And those are antiviral drugs, convalescent plasma, hyperimmune globulin, monoclonal antibodies, and a number of direct-acting antiviral agents.” In a calculated and measured comment, he says, “I believe we are on a good track to get there reasonably soon.” Without mentioning names of companies or investigational products, he suggested that there are multiple candidates in “various states of clinical trial” and one or two of them in Phase 3. Hence, Fauci is “cautiously optimistic” about the pharmaceutical sector’s prospects for targeted vaccines and therapies, hoping that by the end of 2020 and into 2021, one or more vaccines and therapies will be available. TrialSite knows from sources that Fauci is personally excited about certain investigational products, such as REGN-COV2 (a monoclonal antibody) for example.
What about Commitment to Low Cost, Available Drugs?
Unfortunately, the question wasn’t asked and of course nothing along these lines was offered by Dr. Fauci. TrialSite’s perspective is worldwide. So, a large number in the network reside in low to medium income nations. In many communities around the world, it isn’t so easy to set up expensive, comprehensive randomized controlled trials in the middle of a deadly pandemic—although Fauci is very clear in the interview that pandemics are good opportunities for formal research.
In poorer countries, there must be a strategy implemented for off-label and low-cost investigational product candidates that can be widely accessible to the vast majority of populations. A key goal in many parts of the world is to find low-cost, available medicine that slows this pathogen down. There are some emerging possibilities that TrialSite has been reporting on, but those won’t be addressed by people in authority positions, at least not those in Washington. A growing chasm between the expectations of various research, medical, and government power centers versus the realities on the ground, so to speak, are apparent in the interview answers.
Although Fauci believes pandemics are actually good opportunities to leverage well-planned and designed randomized controlled trials, this unfortunately precludes much of the world’s ability to fund them, and increasingly the United States’ funding for that matter.
Why? Due to a combination of debt, polarized income distribution, and the associated declining earning power of significant swathes of the population within America itself, it begins to look more like a low to middle-income nation than an advanced rich nation in many regards. Nearly 30 million Americans have no health insurance, for example.
This unfolding dichotomy leads to profound shifts in ideology, paradigm and politics, leading to a more fragmented and hostile world of various “camps” or demographic-driven cultural realms, those that are impacting health care and research.
Formal, NIH-blessed research policy is designed for one reality, while other realities co-exist in the other “real worlds.” For example, one establishment’s requirement for a randomized controlled study is satisfied (to some) in another community by one physician treating 20 successful COVID-19 cases.
Back to the Establishment POV
Fauci celebrates the breakthroughs of Remdesvir and the potential of Dexymethasone thanks to randomized trials during the pandemic, however these are limited in applicable therapeutic use cases. Fauci acknowledges that a confluence of elements, from individuals playing their part by following pandemic guidelines to biopharma companies innovating with the development of therapies and hopefully successful vaccines, will pull America (and the world) out of this pandemic situation over time.
Does Fauci Address Health Inequality?
Fauci has a profound underlying concern with equity and fairness. He has witnessed firsthand the harm from limiting care based on economic strata or ethic/racial attribute, acknowledging the discussion of health care inequity is “like a broken record” where “minority populations are disproportionately negatively impacted by diseases like this.” He saw this firsthand in the HIV/AIDS crisis back in the early 1980s, and as it has progressed since then. Still, African-Americans, which make up 13% of the national population, today represent 45% of new HIV cases. And these demographics carry higher risks to exposure with certain jobs and, of course, comorbidities (high blood pressure, diabetes, obesity, etc.).
But he is guarded and must watch what he says publicly, and he probably cannot see holistically the dynamics unfolding in real time.
A Camp-Driven Multi-Polar World?
The apex of research operates at the nexus of politics, ideological agenda and money, as the organizations such as the NIH/NIAID aren’t simply objective research intermediators, but actually, must broker and facilitate science with political and private economic forces. This is no easy position for a mild-mannered scientist or physician. Fauci cannot address the true health implications underlying structural forces impacting access and outcomes, in pandemic period or not, as the fact that huge swathes of minority and also white populations are experiencing declines in earning power and a general degradation in standard of living. COVID-19 only accelerates this ongoing trend of a bifurcated world that perhaps resonates with a Charles Dickens quote long ago.
This is reflected in U.S. based health outcomes. According to some classifications, the United States health care system ranks 37th while its expenditure in total and per capita exceeds any other nation. Put simply, in the United States, the government and population spend ever more amounts on health care; and on average, collectively the population’s health degrades. Although, with money and access, the United States offers the best doctors, hospitals, drugs, and technology in the world. TrialSite has suggested, unpopularly, that what has emerged is not a health care system but a “sick care system” driven by a systemic requirement for growth in revenue and bottom line. Large health systems, loaded up with demanding investors and debt, must produce results, which means revenue growth and profits. Hence, there can’t be frank talk about a systematic and programmatic pursuit for low-cost, highly-available approaches to COVID-19—nor for that matter, discussions about how to reduce demand for drugs in the first place through better, healthier living. That kind of talk can get one in trouble in Washington.