August 14, 2020

Author:  Devendra Mishra, Executive Director, BSMA, and Co-Editor, Bio-Intel (8/14/2010)

The COVID-19 pandemic has wrought havoc on healthcare to be aptly described as the apocalyptic crisis of the century. 165,000 human lives have been lost so far and 5.2 million people have been infected in the USA. Life as we have known has been traumatized. Vulnerabilities of the global supply chain have been exposed. But we are beginning to witness how a crisis brings out the best in us. It is being acknowledged in some quarters that restoration of a New Order will take place where quality of healthcare will be significantly better. The silent spread of the COVID-19 virus from Wuhan, China, to the rest of the world, has demonstrated how inter-dependent the regions of the world are. The practices of social distancing, wearing masks and hand washing have proved to be the individual responsibility and universal discipline required. The role of the Government in healthcare has gone from being enforcer of constraining regulation to becoming a catalytic agent for accelerated drug development and federal-directed producer of scarce resources. A renaissance is in the remaking of traditional models of business to achieve optimization with risk of onerous disruption in mind. Our ability to communicate, interact and receive information has reached a higher plateau of effectiveness. All this augurs well for a Better Tomorrow. Let us examine the early signs of evolution in progress.

Supply Chain, a National Asset & Everyone’s Concern

When the front-line responders treating COVID-19 infected patients in hospitals did not have sufficient personal protective equipment and medical supplies, the grim reality of source of supply and availability dawned on everyone. Governor Andrew Cuomo of the State of New York waged a war on the pandemic like a Chief Supply Chain Officer of Desert Storm. The Congress of the USA began hearings about the onerous dependence on China for APIs and medical supplies. Corporations began to seek alternate sources of supplies, away from China, and began to explore dual sourcing. Transportation companies discovered collaboration to be the best antidote. Internet-driven thermometers began to track spread of the pandemic. Over 100 vaccines have undergone clinical trials in no time. Researchers at Universities began to analyze and visualize the data by connecting the dots of infections, hospitalization and deaths. Every report in the media referred to the supply chain of the pandemic. From the person on the street to the executive on Wall Street, everyone has owned the supply chain perspective.

Paradigm Shift in Drug Development

Traditional drug development has cost billions of dollars per product, takes several years to get FDA approval, and has experienced risk of failure of 90% plus. Streamlining the process is emerging as the goal of finding vaccines and drugs which will help control the pandemic that is not going away. The government is playing an active role in a free market economy. The establishment of Operation Warp Speed (OWS) is the unthinkable outcome of the war on the pandemic. OWS is a partnership among components of the Department of Health and Human Services (HHS), including the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD). OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It coordinates existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA. Operation Warp Speed aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).

Protocols for the demonstration of safety and efficacy are being aligned to allow the trials to proceed more quickly, and the protocols for the trials to be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decided on their own protocols. Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally. This increases the financial risk, but not the product risk. Billions of dollars have been given to Johnson & Johnson, Moderna, AstraZeneca, Pfizer for the development of vaccines. Fourteen promising candidates have been chosen from the 100+ vaccine candidates currently in development—some of them already in clinical trials with U.S. government support. The federal government is making investments in the necessary manufacturing capacity at its own risk, giving firms confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine

Reinvigoration of the Defense Production Act (DPA)

A crippling aspect of the response to the crisis has been the inadequate protection of medical professionals because of the lack of personal protective equipment and medical supplies. Under the Defense Production Act (DPA), General Motors was ordered to produce ventilators and 3M to manufacture masks. DPA was born at the start of the Korean War and modeled after the War Powers Act of 1941 and 1942 to give President Franklin Roosevelt sweeping authority to control the domestic economy during World War II. This authority has been resurrected to deal with the pandemic, in addition to building the Strategic National Stockpile and having the Federal Emergency Management Agency deal with the Draconian event of a Black Swan.

Work Realignment Between Office and Home

The quarantine with stay at home mandate has forced people to redefine how work gets done with lifestyle changes and technologies have come to the rescue. Higher productivity, greater job satisfaction and some burn out have been the outcome where Zoom digital conferences have connected professionals. Google has announced that they will keep employees at home until at least next July, making the first major U.S. corporation to formalize such an extended timetable in the face of the coronavirus pandemic. The move will affect nearly all the roughly 200,000 full-time and contract employees across Google parent Alphabet Inc. Facebook has also allowed employees to work from home until the middle of next year. A shorter work week, more flexibility for work out of home and fewer physical offices may shape the work environment for the better.

Educational Facilities Upgrade for a Healthy Environment

More than half of the country’s 13,000 school districts need to update or replace multiple building systems in their schools, according to a new Government Accountability Office report. Those facilities issues include, more than 40% of school districts that need to update or replace heating, ventilation and air conditioning systems in at least half of their schools – an estimated 36,000 schools nationwide – that if left unaddressed could lead to indoor air quality problems and mold. In some cases, these problems have already caused schools to adjust their calendar year or shutter entirely. Parts of the HVAC system at one school GAO investigators visited in Rhode Island, for example, were nearly 100 years old. Another school in Michigan used an original boiler from the 1920s to heat the building. And officials in one Michigan school district told GAO investigators that about 60% of their schools do not have air conditioning. As the investment is made to enable students to come back to school, students are going to be happier and healthier.

Retrospection of the Traditional Business Models

Some of the fundamental aspects of business that have served the life Sciences industry well in the past are being questioned considering the inadequate response to the Coronavirus pandemic. The issues of risk management, inventory management, manufacturing and distribution network, and strategic sourcing are being revisited to help transform healthcare. The model of Total Cost of Ownership is being revised to incorporate risk of low-probability disruptions. Elimination of blind spots in the end to end supply chain is no longer a luxury, it is a grave necessity. The philosophy of collaboration is not an altruistic thought but a business imperative for many. Integration of systems across business partners is now prioritized as a short-term strategy and not a long term. Pooling of resources, a sound supply chain management principle, is a compelling solution in many cases. Strategic partnerships between businesses appears to be the low hanging fruit. If information is shared in real time, the bullwhip effect can be eliminated and demands met effectively.

Reawakening of the Moral Conscience

The COVID-19 pandemic has disproportionately affected racial and ethnic minority groups, with high rates of death in African American, Native American, and LatinX communities. One has experienced an elevated moral awareness of a societal problem and it in our nation character to address the challenge one it is identified. The mechanisms of these disparities are being investigated and are being conceived as arising from biomedical factors as well as social determinants of health. Minority groups are disproportionately affected by chronic medical conditions and lower access to healthcare that may portend worse COVID-19 outcomes. Furthermore, minority communities are more likely to experience living and working conditions that predispose them to worse outcomes. Underpinning these disparities are long-standing structural and societal factors that the COVID-19 pandemic has exposed. Clinicians can partner with patients and communities to reduce the short-term impact of COVID-19 disparities while advocating for structural change. Finally, the pandemic also affected the older segment of the demography which has scientific explanations. The excessive adverse impact on nursing homes conformed the unfortunate reality. The recognition of the problem is a major outcome. All this realization has come about as the crisis has been diagnosed and causes of the illness have been scientifically analyzed. Knowledge is power and power will drive the policies of the nation to eliminate these inequities and injustices.

Struggling through the restoration of the economy and livelihood, the early innovations augur well for the advancement of healthcare for all.