There are no “silver linings” in the dark cloud of Covid-19. Yet if history repeats itself, substantial biomedical innovation will emerge from this pandemic, as necessity fosters innovation.
During World War II, the invention of deep-tank fermentation propelled the production of pharmaceutical-grade penicillin from 80 million units per month in 1942 to 650 billion units per month in 1945. This innovation had a huge impact on saving lives: At the end of World War I, the death rate due to bacterial pneumonia was 18%; by the end of World War II it was less than 1%.
Historian Niall Ferguson compares Covid-19 to the so-called Asian flu pandemic of 1957-1958, caused by the H2N2 virus, based on infection and mortality rates. It emerged in East Asia in the winter of 1957 and arrived in coastal cities in the United States that summer. It ultimately killed 116,000 Americans and a total of 1.1 million people worldwide.
To explore the effect pandemics might have on innovation, I turned to the United States Patent and Trademark Office’s (USPTO) database. During the years of the Asian flu pandemic and two years afterward, the USPTO registered a 57% increase (118 vs. 75) in patent applications related to therapeutics compared to the four years before the pandemic, with an 86% increase (13 vs. 7) related to vaccines.
Fast forward to November 2002 when the first case of “atypical pneumonia” was reported in Guangdong province in China. That marked the emergence of severe acute respiratory syndrome (SARS). Two months later, the World Health Organization issued a global alert about the outbreak. Before it was deemed contained in July of 2003, SARS-CoV-1 — the virus that caused the disease — had spread to some 29 countries, infecting 8,096 people and claiming 774 lives.
This outbreak also generated a marked acceleration of innovation. To discover its impact, I searched ClinicalTrials.gov, a public registry of clinical trials maintained by the U.S. National Library of Medicine. I found a 52% increase (865 vs. 569) in the number of clinical studies for the seven leading causes of death from January through December of 2003 compared to the same time period in 2002.
SARS also sparked an increase in patent applications. Between January 2003 and December 2004, the USPTO registered 60 applications claiming treatment, vaccine, prevention, diagnosis, detection, characterization, and sequencing of SARS or coronavirus. In contrast, there had been just two such applications in the two previous years.
Although it is too early to tell how Covid-19 will shape future biomedical innovation, it is a more far-reaching pandemic than the SARS outbreak in 2003. Covid-19 has already spread to more than 200 countries, infected more than 13 million people and claimed more than 500,000 lives.
But from the “fog of war” have again come rapid efforts at innovation, and the pharmaceutical industry has quickly pivoted its global research and development toward Covid-19. A small glimpse of its impact on innovation may be seen during April and May of 2020, shortly after the World Health Organization declared it a pandemic on March 11. ClinicalTrials.gov shows a 73% increase (462 vs. 267) in clinical studies for the seven leading causes of death, compared to the same months in 2019. Looking deeper, the number of studies related to respiratory infection skyrocketed by 791%. As might be expected, SARS-CoV-2 studies contributed the vast majority of this dramatic increase.
There was, however, also a substantial decrease in the number of studies related to stroke, chronic obstructive pulmonary disease, and Alzheimer’s disease when compared to the same period last year. That may be explained by hospitals channeling resources and bed capacity to meet the influx of Covid-19 patients, while at the same time patients were choosing to stay home and tough it out due to fear of contracting the highly contagious virus. Simply put, there were fewer patients to enroll in studies unrelated to SARS-CoV-2. And that was likely compounded by the industry’s cautionary approach to starting studies when continuity cannot be ensured.
Covid-19 quickly created its own pharmaceutical development universe. Thirty percent of all 1,735 global studies in ClinicalTrials.gov in April and May of 2020 were related to SARS-CoV-2. There was only one such study in April and May of 2019.
Time will tell if a flood of innovation for new treatments, diagnostics, and prevention will emerge from the Covid-19 pandemic. My guess is that history will repeat itself and we will see a significant increase in the number of related patent applications. I also anticipate that the large dip this spring in the number of clinical studies for three of the seven leading causes of death is a consequence of the pandemic and will self-correct as the outbreak wanes.
If, however, the narrow focus on Covid-19 continues for much longer and non-Covid-19 studies continue to take a back seat, we may be on a long road to recovery.
I expect good innovation — maybe even great innovation — to emerge from the battle against the pandemic. I believe it will also have another lasting legacy: strengthening public faith in the good the pharmaceutical industry can deliver. It’s innovation capital I hope we use well.
Valdas Jurkauskas is a pharmaceutical scientist specializing in chemistry, manufacturing, and controls for drug development and commercialization.