During the 30 April IFPMA virtual media briefing on COVID-19 treatments, key global executives pushed beyond catchy headlines to discuss the current reality of COVID-19 R&D efforts.
MSD (Merck & Co. in the US and Canada) executive vice president and chief patient officer Julie Gerberding drew upon her valuable public health experience, including her stint as director of the United States Centers for Disease Control and Prevention from 2002-2009 (during which she led the US response to the 2003 SARS outbreak) to dissect the complexities behind the development of an effective COVID-19 treatment.
People need to have realistic expectations about the road ahead
Julie Gerberding, MSD
She reflected, “we also have to be realistic. From the MSD perspective, we know this first-hand because our Erbevo® vaccine for the Ebola virus infection was created and studied during the West African Ebola outbreak but took several years to become fully licensed.” She added, “I’m highlighting a few of the challenges because people need to have realistic expectations about the road ahead.”
For her, the first is the lack of understanding of the disease itself. She lamented, “we have so much to learn about the basic biology. Every day, we’re learning more and more about the pathogenesis: why some people are asymptomatic or have upper airway disease; why some people get lower airway disease [which] really falls into two major clinical syndromes. Now, we’re learning about the neurologic complications. We also don’t really understand the immune response.”
Secondly, she pointed out, “we have a lot to learn about the virus itself: how this virus affects the immune system, as well as how different hosts respond at the micro-molecular level and the biologic and clinical level,” emphasizing that “one of the most important things with this single-stranded RNA virus is: will a single drug approach be successful or will we see the emergence of resistance, like we have with so many other viruses in this family, where you actually need combination therapy or different targets to make sure that [your treatments are] not [in reality] selecting for resistance.” For this reason, MSD has announced a collaboration with the Institute of Systems Biology to monitor patients over longer periods of time*.
The potential safety of any vaccine or therapy is also a significant concern. It is a nuanced equation but as Gerberding explained, “when people are very ill, we recognize that some side effects are tolerable if [the therapy] can save a life but we will potentially be needing to [use the therapy] preventively in people with milder disease to prevent more downstream complications. Safety is then paramount importance.”
This was a timely reminder given the recent endorsement of hydroxychloroquine as a potential COVID-19 treatment by various political leaders and other stakeholders globally. Hydroxychloroquine is a malaria drug that has been touted an experimental coronavirus cure, most notably by US President Donald Trump, who announced that he had been taking it as a preventative treatment. However, the drug also comes with significant side effects, and on 25 May 2020, the World Health Organization (WHO) announced that it would temporarily drop hydroxychloroquine from its global study after a recently published Lancet paper highlighted that the drug increased the risk of heart problems and death in patients.
We do not want to over promise and under deliver but I think this is a daunting but doable challenge
Richard Saynor, Sandoz
As Sandoz CEO Richard Saynor highlighted during the same conference, “there’s been a huge amount of interest in hydroxychloroquine [but] at the moment there’s very little evidence to establish its use clinically. Data we have at the moment is generally from anecdotal studies or retrospective patient analysis. This doesn’t really inform the decision-making process or allow clinicians to make the right decisions on the best way to treat patients. It’s very easy to see headlines produced on very small retrospective studies or patient population studies that really just aren’t powered enough. The first priority from a Novartis point of view is publishing or supporting proper blinded, well-powered studies.” He also reminded the audience that Novartis is also “looking at a number of other compounds, with four other medicines that [they’re] currently evaluating.”
Last but not least, Gerberding underlined the “scale and magnitude of the demand for such a medicine in the context of a global pandemic” and stressed that “scaling is not easy, [with] the capital investment required [being] large.”
Gerberding ultimately concluded on a cautiously positive note: “when SARS occurred in 2003, we had a few companies step forward but none of those products ended up crossing the finish line. Fast forward to 2020 and [we have] 30 candidates just for antivirals and at least 70 candidates for vaccines. This is an unprecedented investment and engagement of the entire biopharmaceutical industry. We have multiple shots on goal. Most of them will not cross the finish line but I’m really very optimistic that a few will. We do not want to over promise and under deliver but I think this is a daunting but doable challenge.”