By Suresh Kumar
In my inaugural column I promised to share facts and my perspectives on reality and to raise questions and paint a picture of the emerging future. My goal was, and is, to provoke thinking and encourage greater engagement in building better public health policies.
Now, in the midst of a pandemic and on the threshold of an election, I recap issues raised and the realities I foresaw before COVID-19. Indeed, patient-centricity and institutional trust, transparency and outcomes, and population health and prevention are the most frequently explored themes in this column.
Policy risks and consequences of inaction identified pre COVID-19 continue to hamper public safety. The following are summaries of some key points from three of my past columns:
- May 2018: Public health policies must address how to contain an epidemic. In the world of Trump there is little stability; raves, rants, and tweets lead to a crisis of trust between governments. Confusion and inability to see fact from fiction divide citizens and polarize perceptions.
- June 2018: There is no industry more global than healthcare. Disease and viruses cross borders with impunity. Enhancing global access to medicines and health services is good for business and keeps everyone safe.
- May 2019: There is increased public focus on global risk of disease and flawed readiness and response protocols to combat infectious disease. Some suggestions: affordable vaccines and medicines for vulnerable communities with pricing indexed to robustness of inoculation, funds for stockpiling, and public health and hygiene education programs.
EMASCULATED INSTITUTIONS DO NOT ENGENDER TRUST
The fixation to repeal the ACA even without an alternative resulted in inadequately funded healthcare programs and a hollowing out of revered public health institutions. Politics has further atrophied an already weak system with catastrophic consequences — loss of lives and steep economic costs. Those responsible for national health security need foresight to shape policy and fortitude to address consequences. Instead, HHS and BARDA’s inability to address risks highlighted in their simulations has shocked scientists, medical professionals, and the public.
Rapidly commercializing new therapies that prevent disease or alleviate suffering requires building capabilities and infrastructure and coalitions and collaborations. This is the essence of public policy. It has taken a pandemic to bring governments, private sector, and public/private partnerships together to develop a pipeline of probable interventions to combat COVID-19. Nationalistic fervor triggered an ill-timed divorce of the U.S. from the WHO. Could this derail scientific, manufacturing, logistics, and distribution collaborations necessary to safely convey vaccines from laboratories and factories to hospitals, clinics, pharmacies, and patients? Remember testing where products, protocols, supplies, collection sites, laboratories, and results were all compromised?
President Trump’s willful demeaning of using masks in public encouraged risky social behaviors. This is why the U.S. trajectory of COVID-19 remains resiliently resurgent and threatens to plateau at dangerously high rates of infection. The president publicly berates science, scientists, and scientific protocols. His obsession with usurping the responsibilities of public health institutions jeopardizes America’s path to herd immunity. When the need for transparency and collaboration was acute, few predicted a U.S. administration could be so disdainful of science, self-absorbed with go-it-alone proclivity, or inherently incapable of collaboration. This has emasculated functioning and stature of public health institutions:
The healthcare industry is less vilified today than a government perceived as being untrustworthy and dysfunctional. Companies have the burden to reassure a skittish public that science, not politics, will drive vaccine approvals.
This is why nine companies pursuing a COVID-19 vaccine pledged to “only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a Phase 3 clinical study designed and conducted to meet requirements of expert regulatory authorities.” Is this enough?
- June 2019: Should industries that tout higher purpose be held to higher standards? Is it time to steer ethical pharmaceutical companies back to their roots of transparency through regulations?
Unlike medicines that serve the sick, vaccines are preemptively administered to healthy populations. They must meet higher burdens of proof independent of political interference.
High standards require stronger pledges. For example, one such pledge could be, “Our first responsibility is to the patients we serve. We will apply for EUA only upon conclusively meeting or beating safety and efficacy endpoints agreed upon for Phase 3 studies that are subject to the higher of pre-COVID 19, recently enacted, or currently proposed FDA standards and protocols.”
Healthcare companies need not pander to politicians elected every four years: They must win public and regulatory institutional trust that endures beyond election cycles.
EMERGENCY USE AUTHORIZATIONS NEED TO BE MORE SCIENTIFICALLY STRINGENT
The FDA has not yet approved any medication, therapy, or vaccine to treat or prevent COVID-19. It has issued EUAs requiring lower evidence thresholds than approvals:
- March — June 2020: White House pressure led BARDA to request the FDA for a EUA for hydroxychloroquine on March 28. On June 15 BARDA concluded “this drug may not be effective … its potential benefits for use do not outweigh its known and potential risks,” resulting in the EUA being revoked.
- May — August 2020: The FDA issued an EUA for remdesivir, limited to patients with severe disease, defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. The EUA was expanded on Aug. 28, 2020 for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients.
- Aug. 23, 2020: White House coercion, not randomized placebo-controlled data and peer reviews, led the FDA to issue a caveat that “adequate and well-controlled randomized trials remain necessary for a definitive demonstration of COVID-19 convalescent plasma efficacy and to determine appropriate patient populations for its use” in its EUA for convalescent plasma treatment of hospitalized patients.
The president, playing scientist, doctor, CEO, and bully, gives agency scientists whiplash with his constant contradictions and diminishes the country’s public health agencies. Nine months into the pandemic the White House continues to push back on FDA advocacy for scientific rigor and independent panel reviews. Instead, it seeks to lower the bar and raise turf wars. The CDC also is tormented by on-again, off-again contradictions that have necessitated revisions to testing guidelines. Presidential impulses don’t make policy: Agencies that indulge White House interference vex medical practitioners, erode public trust, and endanger American lives.
COVID originated in China and struck Asia and Europe before the U.S. Most countries, unlike the U.S., expeditiously activated testing, contact tracing, social distancing, and personal hygiene initiatives to retard infections and mortality.
The behaviors of leaders matter; they drive public behaviors that also matter. Science matters. Our values matter. Our institutions matter. American lives matter.
COVID-19 has claimed more than 200,000 American lives. One of every five COVID-19 deaths is in the U.S. With 4 percent of the world’s population, America accounts for more than 20 percent of COVID-19 infections and deaths. Infections and deaths per million population are five times higher in the U.S. than the world at large. These tragic facts are the results of inadequate policy and inept leadership.
Americans have experienced “September Surprises” before. But now we should brace for “October Oscillations” and prepare for “November Nightmares.” Can we vote safely during a pandemic that has unleashed much suffering and death? Can citizens needing prescription medication continue to depend on the U.S. Postal Service to deliver them? America has a tryst with destiny on November 10 when the Supreme Court will determine the future of the ACA. Citizens will then determine, as I noted in August 2018, “if our policies adequately promote good health and secure well-being, both determinants of happiness” and if they “deliver the right to life, liberty, and the pursuit of happiness” enshrined in our Declaration of Independence.
SURESH KUMAR serves on the board of Jubilant Pharmaceuticals and Medocity. Formerly, he was U.S. Assistant Secretary of Commerce and Executive VP at Sanofi.