One of the most utilized anti-viral medications during this pandemic is an intravenous drug called Remdesivir. Since the early days of SARS-CoV 2 in the country, it has been approved for compassionate or off-label usage – meaning that inspite of the absence of convincing studies regarding its efficacy, it can be prescribed because there are only a few alternative drugs that can be given, none of which is proven effective.
Remdesivir mimics the structure of nucleic acid components, tricking the viral machinery to mistake it for the real structure needed to synthesize its viral component. It is like an imitation product that one purchases at a store which looks legit, only to find out after a single use that it actually defective. Most anti-viral drugs such as those used to treat HIV and chickenpox actually do this, so it is not a novel mechanism of action.
“Safety is always a primordial concern for any new drug that wants to penetrate the market. Once it is proven safe, the next step is to find out its efficacy.”
But why is it only approved for compassionate use?
The approval of a drug for therapy is a tedious process. First, it has to pass through safety standards. Safety is always a primordial concern for any new drug that wants to penetrate the market. Once it is proven safe, the next step is to find out its efficacy. An increasing number of samples are needed to prove this, as it needs to reach a certain critical value to attain a statistically significant outcome. The recruitment of participants for this is also a challenge at is has to be as representative of the target population as possible. You do not want to give a drug to a child, for instance, if it was only tested in adults beforehand. You should factor in the variables, of age, sex, health status, and ethnicity into the equation.
“Once it is approved and the Drug Administration stamps its approval, there is no absolute guarantee of safety once it reaches the mass market.”
Finally, once it is approved and the Drug Administration stamps its approval, there is no absolute guarantee of safety once it reaches the mass market. You may have heard of certain drugs that were pulled out of drugstores after they were administered to the general population due to dangerous side effects. Thus, after the drug reaches drugstores, a post-marketing study is also undertaken to monitor its safety and effectiveness.
Thus, the approval of a drug takes due diligence. And this takes time.
In the absence of clinical studies, however, when the health of the people is at stake, one can administer medications for compassionate use. These are carefully monitored, however, for any clear signs of danger. So far, Remdesivir has proven its worth as a possible treatment modality. Let’s hope that further studies can really prove its worth against COVID-19.
Other drugs may also be given for COVID-19. Antibiotics, which do not really target the eradication of viruses, have been given with limited success. Steroid medications may help alleviate symptoms of breathing difficulty. One of the biggest challenges in medicine is finding an alternative treatment when there is none. Sometimes, the best way to manage a disease is simply to manage it symptoms, and to let the body’s immune mechanisms do the rest.
“After all, the most important mantra of a doctor is still “First, do not harm.”
For those who rely on alternative treatments, ensure that qualified physicians are overseeing the treatment of the disease. COVID-19 is complicated as it is, and experts are still baffled with its manifestations. The last thing that you would want to do is to aggravate a precarious condition by taking an unproven drug without being monitored. After all, the most important mantra of a doctor is still “First, do not harm.”