There have been many suggested treatments for coronavirus, but are we moving too fast rolling out untested treatments? That’s what some scientists are saying as they question the wisdom of rushing certain treatments without fully evaluating the potential outcomes and risks.
According to an article in the Journal of the American Medical Association (JAMA), written by Andre C. Kalil, MD, MPH, “Although many drugs have in vitro activity against different coronaviruses, no clinical evidence currently supports the efficacy and safety of any drug against any coronavirus in humans, including SARS-CoV-2.”
While some of these treatments, like the antimalaria drug hydroxychloroquine (HCQ), are showing promise, it may be a bad decision to jump too quickly on a treatment without fully evaluating its effectiveness and potential risks.
A member of Focus on the Family’s Physicians Resource Council explains, “The efficacy of HCQ for treatment of COVID-19 has not been established. Currently, no reliable evidence exists to support the routine use of HCQ for COVID-19. Not only is there no evidence to support its use, there are also good reasons NOT to use it, including the possibility of life-threatening cardiac toxicities.
“The current surge of popular support for HCQ as a potential “cure” is based on a single small, open-label, uncontrolled, non-randomized study. Several randomized, controlled clinical trials are underway and we need these results to know about efficacy and safety. Based on very little evidence, some institutions have included HCQ as a treatment option to be considered in moderately or severely ill patients, at their doctor’s discretion. Fueled by media reports, outpatient prescriptions for HCQ have skyrocketed and now patients who rely on HCQ as maintenance therapy for conditions such as lupus and rheumatoid arthritis are having trouble getting their medications due to supply shortages. This is a prime example of an unintended harmful effect caused by spreading unsubstantiated information.”
While many Americans may feel anxious about this response or that the scientific community isn’t acting quickly enough, but treatments, even in the midst of a crisis, must receive a proper review before forced onto the public.
It’s understandable to try any drug treatment to help a patient, but there are immense risks if something doesn’t go through the proper review process. A rush to rollout a treatment for everyone without fully evaluating it in various studies could increase the risk for complications and side effects. For example, Dr. Kalil argues that there is no way to know if the decision to administer a “last resort” type of drug had any effect at all, positive or negative, since there is no control group to compare it to. A control group receives no treatment, the standard treatment or a placebo in order to determine the efficacy of the drug.
Most medical studies run through a series of tests in order to determine if a certain treatment is effective. Usually, it starts with doing research and some simulations to see if the theory has merit. Once the possible treatment has reached a certain threshold, scientists then run through a series of tests on either rats or rhesus monkeys, which share many similar characteristics to humans. If those tests go well, then the drug will move onto human testing. But even there, it can be ethically problematic.
In the event of testing a cancer drug, the patient who’s in the control group will likely forego treatment while on the placebo and could die as a result. For patients who are terminal, it may be worth the risk, but the outcome has no guarantee and could shorten their lifespan.
“Compassionate use of drugs that have not been previously approved for clinical use (e.g., remdesivir) could cause serious adverse effects that were not previously detected because of the very small number of exposed patients,” Kalil wrote.
Drugs also have certain reactions as well. For example, “chloroquine/hydroxychloroquine, azithromycin, and lopinavir-ritonavir have a variety of adverse effects, including QT prolongation, torsades de pointes, hepatitis, acute pancreatitis, neutropenia and anaphylaxis.” With many of the coronavirus patients being older, these drugs could result in death from either the coronavirus or the treatment, and it would be difficult or impossible to know without a control group, which takes time to create especially in an ever-evolving situation like a pandemic.
The Focus PRC member states that, “There are numerous clinical trials underway to study the safety and efficacy of potential COVID-19 therapies. These include investigational new drugs as well as off-label use of established drugs. Some of these are being evaluated for direct antiviral effect, while other drugs are intended to modify the host inflammatory response. There is an urgency to the situation, but if we don’t conduct these studies properly, we run the risk of failing to discover the most effective therapeutic pathway in the midst of this pandemic. (This was a lesson learned the hard way during the recent Ebola outbreaks).”
Though Ebola is far different to COVID-19 in terms of fatality rate and infectiousness, it definitely faced a similar situation. Dr. Kent Brantly, the first American doctor diagnosed with Ebola, was given two different types of treatments while infected: ZMAPP and a blood transfusion from a young man who recovered from Ebola and had antibodies that could help. The decision to give Dr. Brantly these treatments, especially ZMAPP, was difficult and done after the doctor originally slated to receive ZMAPP died (there were only six doses available). After all, no one knew if it would help or what would happen. He fully recovered, but at this point it’s unknown what the long-term side effects of ZMAPP were and if the blood or the drug were helpful or if he simply was able to overcome the disease through therapeutic treatments.
There is a steep learning curve going on as medical experts rush to figure out what will work as a treatment for the coronavirus, but the proper steps must be taken. If not, then we may kill people faster by giving them a drug that either doesn’t work or puts certain patients at more risk than the coronavirus itself.