On Black & White Swans: Coronavirus, Interferon and The Common Cold
March 12th, 2020
Serious, but unpredictable, respiratory disease outbreaks often starting in the Far East and mostly due to influenza viruses have swept across the world in 1918 (H1N1), 1957 (H2N2), 1968 (H3N2), and 2009 (H1N1). I should know having fallen quite ill to epidemic influenza A in 1957 and 1968. An aunt I never knew died at age 8 months just before Christmas in the pandemic of 1918. Thankfully my father, a 2-year old, survived.
The emergence of a new Coronavirus strain has drawn renewed attention to weaknesses in fighting respiratory viral illness: 1) the lack of development of effective antiviral agents for common respiratory infections that affect the entire population; 2) the slow speed of approval of antiviral vaccines against new strains; 3) impediments to early warning of emergent strains, particularly in China; and, 4) the near total dependency of the US pharmaceutical supply chain on raw and finished materials manufactured in China. This 2020 “black swan” pandemic reminds us that basic public health measures and systems are still relevant and the sustained investment and development of effective antiviral therapeutics and vaccines is critical and must be ongoing. CDC resources must be laser focused on infectious disease, not unrelated epidemiology activities, and they must work in concert with private enterprise to advance new vaccine and therapeutic technologies for rapid deployment.
Although virus infection outbreaks acutely focus our attention on contagion so too can new and potentially disruptive antimicrobial technologies, perhaps seen as a “white” swan event. In 1978 a rush of articles in Newsweek, The New England Journal of Medicine, New York Magazine, and other outlets heralded the use of interferon in the treatment of cancer, herpes and other viral disease. The era of therapeutic immunology had arrived! At the time Richardson-Merrell was both a prescription and OTC drug company which included the Vicks cough/cold products originated by the owners, the Richardson family, and pharmacist Joshua Vick. Management worried that the colds business could be effected by a “white” swan event — the emergence of an effective treatment for the common cold (as of now no such swan has yet to be seen). To not only monitor but to engage two things were immediately initiated: the addition of a physician scientist to the Board and the hiring of a strong R&D leader with a background in virology, the late James Sorrentino, Ph.D. While the company was still intently engaged in the OTC Monograph process started six years earlier (1972) affecting the fate of all OTC drugs an internal research staff was created to proactively investigate the common cold and evaluate treatments. In 1980 Richardson-Merrell divested the Rx business (Merrell) to Dow and became Richardson-Vicks, Inc (RVI), a consumer health and beauty care company. In 1982 I left medical research training at Yale to join RVI where I was soon to manage the clinical respiratory effort at the newly built Vicks Research Center in Shelton, Connecticut. Various relationships with academic researchers into the common cold had been recently established and sponsored. Working as collaborators and co-investigators the RVI research staff designed and conducted many clinical trials to better understand the pathogenesis of the common cold always with an eye to leverage points that we might exploit in support of claims, or as therapeutic candidates. These published efforts gave us insights into common cold including documenting the progression and treatment of symptoms providing a rationale for multisymptom relief, establishing proof that sinus congestion in colds is common, evaluating potential antiviral Rx candidates (interferon), potential switch candidates (naproxen, nasal steroids) while raising awareness of Vicks as the corporate “colds experts”. During the 1980’s we were prescient in evaluating the utility of most emerging OTC technologies in the common cold such as ibuprofen and Rx naproxen at the very dawn of the “Rx-to-OTC” switch era. Procter & Gamble inherited this momentum after its 1985 acquisition of RVI and the Vicks/Nyquil brands bolstering efforts. When the Richardson-Vicks facilities were shuttered in 1991-92 the ten year US effort on the common cold continued at P&G’s United Kingdom research centers resulting in the UK launch of Vicks First Defense®, a nasal spray colds preventative in 2005.
While the oral care and skin care categories have consistently been invested in scientific research to advance their businesses as far as I am aware this basic and applied research commitment into the virology and therapeutics of the common cold was nearly unique in its investment and seriousness. At its peak RVI had an internal virology lab, an in-house clinical development group, and was nearly the sole industry source of support of academic colds research outside the government. What Coronavirus reminds us is that OTC consumer health care companies must consider participating and engaging in the understanding of underlying causation of the illnesses they address and how treatment technology may evolve to disrupt it. Tactical options might include funding or sponsoring external applied and basic research, collaborations with academic researchers, identifying start-up companies with new insight into treatment or prevention, investing in qualified staff and capital equipment. The integration of committed and credentialed researchers in the consumer industry into the front line of disease understanding provides intelligence, coordination, and control of events that may affect a category of healthcare products, or reveal actionable and disruptive technology. With the current trend to move away from jointly owned OTC and Rx companies consumer healthcare companies cannot lose sight of their connection to disease. With the last generation of colds investigators now retired will the new Coronavirus and the national response to it wake us up again? Is this our 1978?