Therapeutics for Covid-19 are here.
As research continues on Covid-19, several treatments are showing promising results in reducing mortality rates and shortening the time of recovery. At the same time, the United States is experiencing drug shortages with key medications. These drug shortages threaten the continuation of these new Covid-19 treatments.
Dexamethasone recently reached headlines. A preprint paper published in MedRxiv reported that the drug appears to reduce the 28-day mortality rate of patients on ventilators by one third. Dexamethasone is an immunosuppressant. Counterintuitively, for many of the worst sufferers, the Covid-19 patient’s own immune system can cause significant damage to organ tissue. Cells release small proteins called cytokines to initiate an inflammatory response. With a Covid-19 patient, an out-of-control cytokine storm can cause multiple organ failure. Treatment through use of the corticosteroid dexamethasone reins in the immune system’s response.
Anticoagulants (blood thinners), like heparin, have shown promise. Data from a study reported in the Journal of Thrombosis and Haemostasis show that anticoagulants reduce 28-day mortality rates for people with severe Covid-19 infections. Originally discussed as a respiratory disease, Covid-19 now appears to cause gastrointestinal, cardiovascular, and even neurological problems. In a study reported in the Journal of the American Medical Association, one in five Covid-19 patients also had injuries to their hearts. Scientists suspect that Covid-19 patients’ innate immune responses cause an excess of blood clotting proteins, which can lead to lethal complications, such as pulmonary thromboses, heart attacks, and strokes. Blood thinners like heparin are now an essential treatment for Covid-19.
Remdesivir, an antiviral, is also now a potential Covid-19 treatment. A preliminary report in the New England Journal of Medicine has linked the intravenous use of remdesivir with lower mortality rates and shortened recovery time in Covid-19 patients over those who received a placebo. On October 22, 2020, remdesivir became the first FDA approved treatment for the coronavirus.
The novel coronavirus is not as novel as it once was. Scientific studies on Covid-19 are providing new promising treatments. Consequently, with treatment, Covid-19 is not as lethal as it once was. It is imperative, though, that America not run out of these vital drugs.
The effects of drug shortages would be dire.
America has seen how devastating shortages of key medical supplies can be. In March and April, when personal protection equipment (PPE) and ventilators were in a critical shortage, the results were dire. Nurses and doctors had to beg for masks. There was constant terror that the healthcare workers would contract the pandemic. States had to bid amongst each other for ventilators.
Fortunately, bad as it was, the situation never reached the level of the crisis in Italy. There, doctors had to make difficult ethical decisions about who they would give a ventilator and who they would not. Ventilators and PPE are in greater supply now. However, there are many key drug shortages. The continual surge of Covid-19 hospitalizations has the potential for America to run out of the only medicines we have for Covid-19. If critical, key drugs shortages occur, mortality rates will certainly increase again. As a result, doctors might be forced into the uncomfortable position of deciding who is worthy of getting treatment.
The U.S. has outsourced its supply chain.
The short-term outlook is still grim. Over the last few decades, most of America’s pharmaceutical manufacturing has been outsourced abroad. According to Mordor Intelligence, 80% of active pharmaceutical ingredients come into the United States from India or China. Moreover, 40% of America’s generic drugs are estimated to come from India. In recent months, congressional leaders have been pushing to move the pharmaceutical supply chain back into the United States.
Steps have been taken. The Drug Enforcement Agency (DEA) has increased the production and importation of key controlled substances. The U.S. Food and Drug Administration (FDA) has permitted outsourcing of some drugs in short supply. Phlow, a U.S. based public benefit drug manufacturing corporation, received a $354 million base award to make essential medicines in the U.S., including critical Covid-19 drugs. It will take time, though, to ramp up production and transfer manufacturing back into the U.S.
It may never happen. Some pharmaceutical companies have pushed back against the idea. They have cited the environmental liabilities and labor costs of building factories in the U.S. as significant factors preventing the relocation of their facilities.
Fortunately for our short-term pharmaceutical security, China has controlled the Covid-19 outbreak. Thus, its manufacturing base has been ramped up. India’s role in the supply chain is more concerning. The pandemic continues to surge in the country, and 1.35 billion people live in various stages of lockdown. Even if pharmaceutical manufacturing continues as normal, India will likely sequester key Covid drugs for itself rather than export the drugs. A similar situation at the beginning of the pandemic caused an N95 mask shortage in the U.S. when Asian countries prevented mask manufacturers from exporting masks.
The drug supply crisis has already started.
The U.S. already has problems with its supply. The company Gilead produces remdesivir, and it has a monopoly on its production. Supply shortages have increased calls for ending the monopoly and allowing generic forms to be produced. The company has stated that they will have produced enough of the drug to meet demand by the end of October.
The majority of producers of dexamethasone, the immunosuppressive steroid that causes a reduction of mortality rates in ventilated patients, are in China and India. According to Reuters, after the findings on the benefits of dexamethasone were announced, dexamethasone orders increased by 600%. Supply is now exceeding the demand, which is troubling because the FDA has reported a shortage of injectable dexamethasone since 2019.
Anticoagulants, like heparin, are vital for removing blood clots and reducing the risk of strokes, heart attacks, and thromboses. The majority of heparin suppliers are in China or Italy. According to the FDA drug shortage database, injectable heparin sodium chloride is also currently in a shortage.
For patients who have to go on a ventilator, sedatives like ketamine are essential. The body’s respiratory system fights against the mechanical respiration of a ventilator. Because of this, the natural bodily reflexes need to be suppressed. Ketamine is produced in India and Europe and is presently in short supply in the U.S. according to the FDA database. Without proper sedatives, hospitals will not be able to use ventilators on Covid-19 patients.
The list of key Covid-19 drugs that are needed but in short supply continues: Fentanyl, morphine, paralytics, and analgesics. As the pandemic continues to rage through the United States, America needs to maintain supplies of all key drugs or face higher mortalities rates. A recent October report from the Center for Infectious Disease and Policy has found that 72.5% of the 40 drugs used for Covid-19 are in short supply.
Drug shortages affect everyone.
Drug shortages will not only affect Covid-19 patients, it will also affect non-Covid-19 patients. Healthcare practicioners use these drugs to treat Covid-19. However, our doctors also use the drugs for other ailments. If a drug runs out for Covid-19 patients, non-Covid patients will also lose treatments. Dexamethasone is also used with auto-immune diseases like lupus and leukemia. Anticoagulants like heparin are used with arterial and heart surgery. Running out of any drug will have a compounding effect on a range of health conditions.
America is still in the midst of reopening its economy. As America discusses when to enter the final phases, America needs to keep in mind that flattening the pandemic’s curve revolves around not only making sure hospitals have enough beds and Intensive Care Units (ICU) but also making sure there is a sufficient supply of vital drugs for all patients so that we don’t have drug shortages. When a drug runs out, a lot of unnecessary suffering will happen.