Amrit Ray, Global President, R&D and Medical, Upjohn Division, Pfizer Inc.

Amrit Ray

The COVID-19 pandemic has created a number of challenges, including school closures, unemployment or underemployment, work-from-home policies, and social distancing requests from local governments. People are experiencing unease and looking for ways to best protect themselves and their families. It is in this light that we interviewed Dr. Amrit Ray, global president, R&D and Medical, Upjohn Division, Pfizer Inc., about the COVID-19 pandemic.

Despite early progress in containing the SARS-CoV-2 virus, we are seeing spikes throughout the country. What can we do to protect ourselves and others? How is the SARS-CoV-2 virus transmitted?

We all must do our part to help contain this virus, and the most effective ways to do that are accessible to all of us. Based on the way the SARS-CoV-2 virus spreads, the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) agree the following measures are protective:

• Maintain about 6 feet of social distance when around people.
• Cover your mouth and nose with a cloth face covering when around others.
• Wash your hands often with soap and water. If soap and water are not available, use a hand sanitizer that contains at least 60 percent alcohol.
• Routinely clean and disinfect frequently touched surfaces.

The virus that causes COVID-19 is released in respiratory droplets from infected people when they cough, sing, sneeze, or talk. These droplets can then contact the mouths or noses of anyone who is nearby, resulting in an infection. These virus-containing droplets can also be viable for some time on surfaces. Touching the infected surface and then one’s face can result in infection.

People may not know they are infected—they may feel completely well—but their respiratory droplets can contain infectious virus and they can unknowingly spread the disease.

Are there risk factors for developing and dying from COVID-19? What is the spectrum of disease that results from SARS-CoV-2 infection?

Although all age groups are at risk for contracting COVID-19 and for severe disease, our current understanding is that the probability of dying is greatest for people age > 65 and for those living in a nursing home or long-term care facility; the data is evolving. Others at higher risk for COVID-19 are people of any age with NCDs (noncommunicable diseases) such as hypertension, cardiovascular disease, diabetes, and chronic respiratory disease, especially if the underlying condition is not well controlled. Obesity also appears to place one at greater risk.

Emerging data suggests a disproportionate burden of illness and death among racial and ethnic minority groups. This may be due to living conditions, work conditions, underlying health conditions, and reduced access to care.

Infection with SARS-CoV-2 can be totally asymptomatic, have a period before symptoms appear (“pre-symptomatic”), and range from very mild to critical with fulminant lung disease and respiratory failure. We are also seeing the emergence of unusual syndromes associated with COVID-19. One observed in children, called multisystem inflammatory syndrome in children (MIS-C), can cause the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs to become inflamed.

How should people manage a family member who is infected? Do you recommend they isolate the individual from as many people as possible?

Having a family member diagnosed with COVID-19 can be challenging for those in the household, but with proper precautions, families can avoid spreading the virus. Most people with COVID-19 have mild symptoms and will therefore be able to recuperate at home. Recovering at home will help reduce the risk of spreading the virus to others. However, it may also increase the chance of infecting other household members. It is important for everyone to wash their hands often with soap and water for at least 20 seconds, especially before eating. Avoid touching your eyes, nose, and mouth with unwashed hands. Avoid close contact with the person who is sick. Keep a distance of at least 6 feet to help slow the spread of COVID-19. The sick person should wear a mask when around others, and the caregiver should also wear a mask when assisting the ill person. They should also cover coughs and sneezes with a tissue and discard it in a closed container. Clean frequently touched surfaces and objects. Finally, if symptoms worsen—for example the sick individual has trouble breathing, persistent pressure in the chest, or bluish lips or face—medical attention should be sought immediately. Since older adults and people of any age with serious underlying medical conditions are at higher risk for developing more severe illness from COVID-19, you should watch them closely for the warning signs that the illness is progressing.

Any advice on how we can cope with the changes resulting from the pandemic?

First, it is important to acknowledge that this is an unprecedented time with extraordinary changes in all aspects of life hitting us. It is okay and normal to feel stressed. To reduce the spread of COVID-19, people across many countries are being asked to practice social distancing and minimize physical contact. Consequently, many people are no longer participating in the social and professional activities that facilitated interaction with others. This can create a sense of isolation and overwhelm. It is worth repeating that this is a normal human reaction. However, if you find that the stress is getting in the way of your normal activities for a few days in a row, then you should reach out to your health care provider. Confidential and free resources are also available. For example, a list of resources is found on the CDC website. The CDC also provides suggestions for healthy ways to cope with stress.

These suggestions include being prepared for what to do and where to go if you or family/friends get sick and need care; taking care of your emotional health; taking breaks from watching, reading, or listening to COVID-19 news stories and social media; exercising; taking deep breaths; eating healthy food; getting plenty of sleep; taking time to unwind; avoiding excessive alcohol use and drugs; and (importantly) connecting with others. Talk with people you trust about your concerns and how you are feeling.

With social distancing measures in place, connecting online, through social media, or by phone or email is crucial. This is the time to show compassion toward others and exercise resilience to deal with stress. At Pfizer Upjohn, we have been encouraging our colleagues around the world to practice the “Three Bs,” notably to “Be Smart, Be Safe, and Be Well.”

Can you share any ethical considerations raised by COVID-19?

The pandemic raises a number of ethical considerations. As a company focused on relieving the burden of NCDs, we at Pfizer Upjohn are acutely aware that this pandemic is exacerbating existing health disparities. As a result, already vulnerable patients are even more vulnerable and need our continuing attention to ensure they have fair access to health care. COVID-19 is affecting patients with NCDs more than those without chronic conditions—both in terms of disease impact and also because people with NCDs rely on an existing supply chain of medicines. As we think about the impact of COVID-19, we also must consider social determinants of health and how the downstream impact of the pandemic on, for example, unemployment and resulting economic distress can cause or amplify health disparities. These are examples, and there are numerous other ethical considerations in relation to the conduct of ongoing clinical trials and the development of new vaccines and treatments.

Ethical considerations are also important in how we care for employees during the pandemic. Over the past few months, we’ve all found ourselves in situations in which colleagues are dealing with personal health issues, loss of loved ones, financial insecurity when any family member loses their job, and loneliness as we all isolate in our homes. Additionally, we must be cognizant and sensitive that COVID-19 has had a profound impact on the mental health and well-being of individuals around the world, including frontline health care workers, essential workers, and the general population. This is reflected in recent comments from health experts at multilateral organizations such as the United Nations and WHO. In this unique crisis, we must be even more thoughtful about how we, as managers and employers, give our employees the tools and resources to support them and minimize any strains.

Are there any positive outcomes that may result from the COVID-19 pandemic?

On a professional level, there is a renewed sense of passion and commitment in our industry that science will win, and a sense of ownership that this is a particularly important moment for science to pave the way forward for society. We are seeing an extraordinary pace in clinical trials, in part due to collaboration and coordination among companies all working toward a singular goal. While this accelerated development timeline may not have been possible under normal circumstances, I think we will continue to be able to take today’s learnings to set new standards for the future on what is possible when we take transformative approaches. We hope to have new precedents for how we can bring therapies to market under the ticking clocks of urgency we all feel today.

With this ethos, the level of collaboration at every level of the health system—and across industries and broadly in society—has been truly inspiring. There is no person unaffected by this pandemic, and people in communities around the world are rolling up their sleeves to donate supplies and food, check in on their neighbors, and do their part to keep themselves and their communities safe.

On a personal level, although the pandemic is creating new challenges and overstretching families, it is also affording many loved ones more time together and opportunities to recharge.

How can statistics help advance scientific knowledge, vaccines, and treatments during a pandemic using both randomized controlled trials and real-world evidence?

I am an advocate of evidence-based medicine and therefore an advocate of statisticians! Statisticians can play critical roles and make significant contributions throughout global health emergencies, including the COVID-19 pandemic. In the face of novel viruses without established vaccines and treatments, statisticians play an important role in medical research and public health decision-making by helping to filter through troves of complex information, rigorously analyze, and draw well-founded conclusions. Statisticians can examine the burden of disease (e.g., incidence, prevalence, attack rate, years of life lost, case fatality rate, and population mortality rate) and virus transmissibility (replication and mutation). They can project the spatial-temporal changes of the cases and deaths under various conditions, evaluate the accuracy of diagnostic tests (sensitivity, specificity, positive predictive value, and negative predictive value), and assess the outcomes of treatments (efficacy, effectiveness, safety, and health care resource utilization). Accurate, credible, and reliable information is needed, as well as sound statistical analysis, analytic programming, and unbiased interpretation of results. For these purposes, maintaining data integrity and ensuring data transparency are among the numerous ethical aspects to consider.

Randomized controlled trials (RCTs)—considered the gold standard of scientific evidence—are of paramount importance during the COVID-19 pandemic. RCTs are valuable in the development of vaccines, and the WHO guidelines on clinical evaluation of vaccines were developed in response to requests from national regulatory authorities for assistance in the evaluation of clinical trials, both during the clinical development and regulatory reviews. Through careful protocol development and statistical analysis planning, the effect of an intervention can be evaluated and compared with no intervention as a control.

Beyond RCTs, the 21st Century Cures Act helped define and spur the use of real-world data (RWD). Such RWD can come from various sources, including electronic health records, claims and billing activities, product and disease registries, patient-generated data such as in home-use settings, and data gathered from other sources that can inform on health status, such as mobile devices. Given social distancing measures and the health risks associated with reopening, the adoption of telemedicine is being accelerated, which can yield both structured and unstructured data for timely insights. This raises the need for ever-more thoughtful analytical techniques, resulting in interesting new challenges for statisticians and all of us passionate about medical research.

Editor’s Note: Dr. Amrit Ray is an employee of Upjohn Division, Pfizer Inc. The views expressed are his own and do not necessarily represent those of his employer.