Three gears of ‘Operation Warp Speed’ on the COVID-19 journey
The SARS-CoV-2 outbreak and COVID-19 pandemic appears to be wildly out of control. We have
The SARS-CoV-2 outbreak and COVID-19 pandemic appears to be wildly out of control. We have the greatest mass of infected Americans and the highest hospital census at any time, and all of the epidemic curves are pointing straight up. In its unbridled fury, the virus is on a certain course to cause panic, with an overrun of many U.S. hospitals. If this happens, mortality will skyrocket because there will be insufficient hospital resources to handle the numbers of patients needing hospitalization.
Was there some major aspect of the pandemic that we missed? We had a massive focus on contagion control, with nearly every major media interview and government briefing emphasizing the use of face masks and hand sanitizers and social distancing and lockdowns. Medical personnel did their part, treating hospitalized patients and learning the best mechanical ventilation techniques, diagnosing the complications of cytokine storm and internal blood clotting, and reducing mortality over long hospital stays. But by no means can the hospital be viewed as an adequate safety net — nearly all of the more than 260,000 U.S. deaths thus far have occurred in hospitals.
We have solid plans for a public vaccination program, which should close out the crisis. The missing element of our pandemic response must be early treatment of the infection, before it can spread to others and create such severe symptoms to warrant hospitalization. How could medical societies, government agencies, the media and their experts, and all other stakeholders have missed this crucial tactic in confronting the virus? When our public-private partnership, Operation Warp Speed (OWS), was announced, Trekkies who are in the age group where COVID-19 causes likely hospitalization and death, probably felt a surge of adrenalin juicing confidence that our biotechnology thrusters would deliver us in time to escape the rapidly spreading virus. As a result, we developed a vulnerable blind side.
Over the course of the crisis, millions of Americans were handed their positive test results and told to go home into quarantine for two weeks. These instructions lacked a sense of urgency or concern over COVID-19 being a potentially fatal illness, particularly for retirees. This segment of the patient journey indeed was on slowest gear of OWS, where the clinical trials of oral medications either were aborted or put on the slow track. To this day, the National Institutes of Health (NIH), Food and Drug Administration (FDA) and big pharma have produced no oral therapies for patients to take at home to lessen the intensity and duration of symptoms or reduce the chances of hospitalization and death.
The middle gear of OWS was intravenous treatments. The FDA recently authorized use of Bamlanivimab, an antibody directed against the viral spike protein to prevent its entry into cells. This infusion could be applied very early and, in my view, is ideally suited for emergency rooms, urgent care centers, or nursing homes where positive test results call for treatment on the spot before discharge to home. As an expensive IV medication, it will not be scalable or safe for patients already at home to come out of isolation and risk infecting others to attend infusion appointments. Nor will it be safe to expose health care workers going to a home without the benefit of negative pressure ventilation and full protection measures. Bamlanivimab will not stop the cytokine-mediated organ damage or fatal blood clotting, so patients still will need other medications, but no doubt doctors welcome its arrival.
The fast gear of OWS obviously was development of a vaccine. It makes sense, no matter how difficult this crisis has been for Americans, that a vaccination program must be the highest priority as an endgame. With so many people in this world, and our mobile society, we would not be able to stop the spread of infection without vaccination. Unfortunately, the vaccine is too late for thousands of people, and it is not the immediate savior for the mass of infected patients and impending hospitalizations of many over age 50 with medical problems. This may be our last surge of COVID-19, since this current epidemic curve is so large, building upon two successive waves; the number of Americans who have tested positive, and those who had mild cases and were never tested, is more than half the population. This means the vaccination program likely will phase in nicely with natural immunity to bring this war to its end.
I testified on Nov. 19, 2020, before the Senate Committee on Homeland Security and Governmental Affairs, making the case that the only option to prevent mass casualties before and during the implementation of the vaccine is to make an emergency public health pivot to early home treatment. Oral medications taken early is the only way we can keep COVID-19 patients at home and avoid spread of the infection to others when they break isolation to go to emergency rooms and hospitals. Currently available oral medications, when prescribed in a sequenced regimen, have been shown to reduce the risks of hospitalization and death. The other expert witnesses testified that the breadth of scientific information demonstrates that this approach indeed has worked, or has had a reasonable chance of success with acceptable public safety, and we should kick this into high-gear before more Americans die.
The hearing garnered considerable attention, and more Americans are receiving sequenced multi-drug therapy at home through telemedicine, 24-hour hotlines, and independent research programs. Many rely on the American Association of Physicians and Surgeons home-based COVID-19 treatment guide as a framework. Another hearing is set for Dec. 1, intended to overcome inertia and drive our governmental stakeholders to action assisting doctors and mid-level providers in responding to the distressed calls from patients at home with acute COVID-19 during the next few months. Removal of barriers for rapid prescription of anti-infective drugs, steroids, blood thinners and home oxygen will be critical to align all health agencies and physician organizations in response to this need.
Public health historians will look back and call out a blunder. The lack of investment, execution of large-scale clinical trials, and implementation of available oral medications in a sequenced regimen, conceptualized by doctors in early April, was responsible for the greatest amount of human suffering and death in our nation’s history. The avoidable loss of life is in the hundreds of thousands. The great gamble on the vaccine was a race in time in which “warp speed” was simply not fast enough for those ill now and over the months to come before immunity closes out the crisis.
Peter A. McCullough, MD, MPH, is an internist, cardiologist and epidemiologist in Texas. He has authored more than 600 cited works in the National Library of Medicine, including 23 on clinical aspects of the infection, and lectured across the world on contemporary medical issues. In response to the COVID-19 disaster, Dr. McCullough and colleagues published the first guidance for the medical treatment of ambulatory patients in the American Journal of Medicine. The opinions expressed here are his own.