Pharmaceuticals and Treatments – Where Do We Go Now?
Opinion Analysis by Karim Jandali Rifai
April 27th, 2020
Amidst several touts by President Donald Trump over controversial coronavirus treatments, including hydroxychloroquine and Remdesivir, not to mention the reference to disinfectants as a possible treatment, no conclusive evidence is present to support using these drugs. However, with the limited time and exponential growth of the number of cases, the United States Food and Drug Administration (FDA) is working on facilitating medical countermeasures to treat and prevent the disease1. In an endeavor to save time and avoid years of tests and research, scientists and public health agencies are looking to use current antiviral drugs approved for other diseases as a way to treat Covid-19.
`On Friday April 17, Gilead Sciences shares jumped 8% after a STAT NEWS report which shows “promising” results from a clinical trial of Remdesivir. Remdesivir is a drug originally manufactured by the research-based biopharmaceutical company “Gilead Sciences” to treat Ebola and other related viruses by inhibiting the virus’ ability to replicate. Although the drug was shown to be ineffective against Ebola, a study published in 2017 by researchers at the University of North Carolina, Chapel Hill, shows how Remdesivir is effective against Middle Eastern Respiratory Syndrome (MERS-CoV) and Sever Acute Respiratory Syndrome (SARS-CoV), both of which belong to the coronavirus family. Researchers of this study assessed the activity of this drug using Human Airway Epithelial cell cultures which can model human lungs in vitro and demonstrated Remdesivir’s broad-spectrum efficacy against human and zoonotic coronaviruses and multiple coronavirus genogroups2. Using the enzyme RNA polymerase, viruses replicate by copying their genetic material; however, when injected in humans, Remdesivir metabolizes into a Triphosphate molecule which can insert into the RNA chain of the virus and terminate viral replication3.
During an interview with CNBC news, Scott Gottlieb, former commissioner of the Food and Drug Administration, said that the drug would be most effective when administered early as it blocks virus replication before having a lot of viral load on board4. According to Gottlieb it is not a cure, but can mitigate the worst outcomes in high-risk patients.
Gottlieb’s statements came after a STAT news reporter broke the news about a patient who participated in the study done by the University of Chicago Medicine. The patient suffered from shortness of breath, fever, and a dry cough; after four days of Remdesivir treatment, the patient was discharged. The clinical trial conducted by the University of Chicago medicine is in its third phase where study participants are randomized to participate in a double-blind study. Once phase III clinical trials are shown effective, a new drug application is submitted to the FDA which then reviews the results and decides whether to approve the treatment for patients with the type of illness. Of the 125 patients with COVID-19 who participated in Gilead’s clinical trials, only two died and the rest were discharged. However, according to Jeremy Faust, an attending physician and instructor at Harvard Medicine, the problem the Gilead’s clinical study is that it lacks a control group and excludes patients with multi-organ failure. The study should include a control group receiving a placebo in order to know that actual effectiveness of the drug on patients. Without a control group, we wouldn’t know whether the patients were recovering normally or if the drug actually helped them recover.
While most people are looking forward to the development of a vaccine, researchers say that it probably won’t happen before the end of next year. Typically, vaccines take up to ten years and billions of dollars to develop according to Dr. Greg Poland, director of the Mayo Clinic's Vaccine Research Group. Therefore, repurposing current drugs in the market is our best bet when it comes to fighting the virus through antiviral drugs. Currently, Gilead Sciences is looking at seven more trails, and a double-blind placebo-controlled study involving more than 800 patients with critical, severe, and moderate cases that should come out by late May 5 .
Our only hope of getting life back to normal now is through ramping up testing and increasing contact tracing; which relies on tracing an infected person’s movement, who they’ve come in contact with, testing those people, and isolating them. Through this system, governments are able to break transmission chains of the coronavirus on a large scale. South Korea was able to do so through prioritizing public health over privacy, and changed the law in order to collect patient’s data and security, so that websites are able to gather information allowing everyone to see where a person with a confirmed case has been. This policy allowed South Korea to avoid aggressive lockdowns and flatten the curve. On April 10, Apple and Google announced that they are working on an application that would be able to assist in contact tracing 5 .
Using Bluetooth technology, the application will notify smartphone users if they have been around someone who tested positive for COVID-19. Users who have tested positive for the virus will be able to upload their information to the cloud, and anyone who has been near a person who has tested positive will get notified; users will not know who or where they have contacted that person to ensure individual privacy, but they can still take action to get tested and make sure they have or haven’t contracted the virus as well. The advantage of using Bluetooth technology over GPS is that Bluetooth cannot tell where you are which is important for privacy, and the information uploaded will only be stored on the phone rather having a centralized database.
Apple announced that the application program interface (API) will be available to software developers by April 28, and the second part of the plan would be issuing a system update to build in contact tracing at the operating system level.