Benjamin Abelow, M.D.: Could inexpensive generic drugs stop a dangerous pandemic?

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GREAT BARRINGTON — Whether or not the new coronavirus disease known as COVID-19 strikes the U.S. hard, events in China and elsewhere are a frightening reminder that modern societies are highly vulnerable to pandemics. Routine air travel and the concentration of populations in cities mean that pandemics spread faster today than in the past.

In even a moderately severe pandemic, the U.S. medical infrastructure would be overwhelmed. Basic supportive care would be unavailable for most patients. Hospitals themselves might function primarily as sources of contagion. The U.S. could find itself in a situation like the 1918 influenza pandemic, which infected 25 percent of the world's population and killed 50-100 million people, almost 700,000 of those in the U.S. In a more lethal pandemic, such as avian flu, the extent of illness and death would be much greater.

The process of developing, testing, and producing vaccines is slow and protracted. To produce even the first dose of a new vaccine typically takes at least six months. For novel viruses like COVID-19, the process takes much longer. Mass production of vaccine adds additional months, meaning that several waves of a pandemic may pass before widespread vaccination is possible. Antiviral drugs cannot fill the gap because they have shown only modest benefits in COVID-19 and several other viral infections. In addition, neither vaccines nor antivirals will be available in many developing countries; high costs and the lack of a vaccination infrastructure will leave whole populations exposed to unchecked infection.

Can anything be done to reduce the risks we face?

INCREASE TOLERANCE

A potentially effective approach exists, but it has been disregarded by public health officials and most of the scientists associated with them. The approach uses widely available, inexpensive generic medications to modify the "host response" to infection. Rather than trying to interrupt infection with vaccines, or to attack the virus with antiviral agents, these generic drugs may increase the body's tolerance to the infection, helping patients to survive till their own immunity develops.

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Among the most promising of such medications are the cholesterol-lowering drug atorvastatin (generic Lipitor) and the blood-pressure medication irbesartan (generic Avapro). Though not developed or marketed for this purpose, these drugs have immune-modifying effects. For example, they reduce the "leakiness" of cells that line small blood vessels; this may protect the lungs and other vital organs from the potentially lethal entry of excess fluid. Health professionals can legally prescribe these drugs "off label," that is, for purposes other than those formally "approved" by the FDA. These generics are produced in many countries and are available worldwide. The cost to treat a patient would be a few dollars.

A sizable body of basic science research, observational studies on various patient groups, and an informal treatment experience of Ebola patients in 2014 suggest that these medications might be effective. In Sierra Leone, West Africa, approximately 100 Ebola patients were treated with the combination of generic atorvastatin (40 milligrams per day) and irbesartan (150 milligrams per day) for ten days. Based on memoranda and letters shared among treating physicians, it appears that Ebola mortality was reduced to less than one tenth its usual 50-60 percent level. Because the host response to many pandemic viruses is similar, the same drug regimen might also prove useful in illnesses such as COVID-19, severe influenza, and SARS. This innovative treatment must be regarded as experimental but the risks seem to be low, as the medications are relatively safe and are currently used by physicians worldwide to treat millions of patients every day.

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For 15 years, David S. Fedson, M.D., a retired Professor of Medicine at the University of Virginia, as well as Steven M. Opal, M.D. of Brown University and a few others, have vigorously advocated that this approach be formally tested during a viral pandemic or among patients hospitalized with severe seasonal flu. Though many test opportunities have existed, and the cost of a small trial would be trivial, the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and the international infectious disease community have been unwilling to fund an exploratory trial. An entrenched vaccine-focused mindset, and perhaps also financial and career interests, may be blinding them to solutions outside the conventional box.

Fortunately, the idea of host-response treatment could empower communities to take matters into their own hands. This model would bypass the "top down" control exerted by health officials, elite scientists, and pharmaceutical and vaccine-company executives. It would operate "bottom up," at the community level, through the individual decisions and actions of local healthcare providers and informed citizens.

VARIOUS BENEFITS

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In a pandemic, local physicians and patients could jointly decide whether to use these medications off label. These physicians could then track the outcomes of comparably ill treated vs. untreated patients and pool their findings. Though subject to certain biases, this on-the-fly, comparative case series would be easy to organize, would preserve patient and physician choice and, in the absence of more definitive studies, could provide valuable information to the local community and perhaps beyond.

To download PDFs of this op-ed and a set of peer-reviewed journal publications to share with your health care provider, please visit HostResponse.Info. The goal is to educate the medical community and initiate a clinician-patient dialogue. Also consider sharing this information with the pulmonary/critical care departments, and the in-patient "hospitalist" staff, at local and regional medical centers; these doctors would have primary responsibility for treating hospitalized pandemic patients.

Please share a copy of this op-ed with friends and family in your email address book. Circulate it on social media. Contact senior management at large organizations, businesses, or corporations you are associated with; healthy employees and continuity of business operations are essential in a pandemic to prevent shortages of crucial products and services. Petition the CDC to formally test host-response therapies, starting with the atorvastatin-irbesartan regimen described above. Enlist the media and elected representatives to raise awareness and apply pressure on the CDC.

We all hope that our families and communities will not need to consider host-response treatment. But it is important to start a discussion now at the community, national, and global level, so that the approach outlined here becomes widely known and is eventually tested.

Benjamin Abelow, a resident of Berkshire County, holds an M.D. from the Yale University School of Medicine and previously served as a Lecturer in Yale's Department of Medicine.


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