Written by: Erin Yoo

*This article was researched, created, and written from mid-April to late-May of 2020. Statistics and stories are in accordance with such.

Global pandemics aren’t supposed to happen. Countries have created and strengthened their disease control organizations, conducted virology research, and designed outreach systems for the very purpose of preventing widespread disease. However, when it does happen, as it is happening now since early 2020, citizens rely on health forces and medical experts to control it. Citizens rely on government agencies and disease professionals to create vaccines, treatments, and accumulate data. Moreover, there lies another responsibility in the medical and political field: equality. It is their job to make sure that treatments and vaccines are affordable and accessible for all people. It is their job to make sure that implicit bias, whether sexism, racism, or ableism, does not play a role in who gets treated or served by healthcare workers. It is their job to make sure that all people have an equal chance at survival regardless of socioeconomic status, gender, race, physical ability, ethnic background, language barriers, etc. It is their job to make sure that healthcare treats everyone justly and fairly. Gilead Sciences seemed to ignore many of these responsibilities in many ways by attempting to monopolize on the coronavirus drug, remdesivir, in March of 2020.

Gilead’s Monopoly Move

On March 23, 2020, Gilead Sciences was granted an “orphan drug designation” for remdesivir, the drug they discovered in 2014 amidst the ebola epidemic in Africa (Silverman and Jarvis). The drug was and is widely theorized and thought to have a chance at treating and curing COVID-19 (Silverman and Kolata). This designation allows the company to have a monopoly over the drug for seven years, without a regulated cap on the price of the drug (Silverman and Maybarduk). 

Typically, this type of labeling only applies to drugs that treat rare diseases—diseases that affect up to 200,000 people in America at the time of application for the orphan drug designation (Silverman). However, SARS-CoV-2, the virus that causes the disease COVID-19 and formerly known as the 2019-nCoV virus, has affected much more than 200,000 people. As of May 22, 2020, over 5.2 million people have been infected, and over 338,000 of them have died (Cases [Google]). The reason Gilead Sciences was able to apply for the orphan drug designation was because the number of cases in the U.S. had not exceeded 200,000 as of March 23, 2020 (Maybarduk). 

According to the World Health Organization’s COVID-19 Situation Report 50, as of March 10, 2020—about two weeks before Gilead formally decided to take exclusive ownership over remdesivir—there were over 100,000 cases all over the world with over 4,000 deaths. THE WHO rated the risk assessment for the world population as “very high” (Coronavirus). The epidemic curve of cases outside of China on this date also shows an exponential increase of cases, particularly in Europe and the Americas. It would not be unreasonable to think that Gilead Sciences, a competent pharmaceutical corporation, could and should have predicted that the number of COVID-19 cases in the U.S. would exceed 200,000. Furthermore, the Centers for Disease Control and Protection (CDC) had announced that COVID-19 could become a pandemic (Silverman). If they were aware of the likely increase in cases and deaths due to COVID-19 at the time of their decision, the action of applying for an orphan drug designation becomes much more distasteful and reproachable.

Image of SARS-CoV-2 virus (magenta) taken by an electron microscope

Credits to National Institute of Health

Remdesivir

Remdesivir was first discovered by Gilead Sciences during the ebola crisis in Africa in 2014 (Jarvis). It was also tested on Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) patients, both of which are diseases caused by coronaviruses, as well as hepatitis patients. The drug was put on the back burner after it proved to be less effective at fighting ebola than a cancer treatment in Congo in 2019 (Davey and Kolata). It is currently being tested on COVID-19 patients after previous testing showed that remdesivir was somewhat effective in treating MERS and SARS (Davey and Jarvis and De Wit). 

Coronaviruses mutate less frequently compared to other RNA viruses, or viruses that have RNA as its genetic material (instead of DNA); in fact, the mutation rate of coronaviruses is one-twentieth of the mutation rate of non-coronavirus RNA viruses (Kolata). A reason for this is that coronaviruses have a screening ability to ‘protect’ themselves from mutations that could weaken the virus (Kolata). Remdesivir inhibits RNA replication by inserting itself into the RNA. It does this while bypassing the coronavirus screening protection; so it helps the immune system fight the virus. Since, remdesivir has effectively killed many coronaviruses in lab tests and in animals, it provides hope for medical professionals in fighting COVID-19 (Kolata).

Remdesivir stops the growth of the RNA chain early on in the life cycle of the coronavirus and kills the virus (Zimmer). It is accordingly labeled as a “RNA polymerase inhibitor” drug because it blocks RNA synthesis, which is facilitated by the RNA polymerase. The drug itself mimics adenosine, a nucleic acid that makes up much of the genetic material of living organisms. Thus, remdesivir can be incorporated into the RNA of the coronavirus without being noticed as a mutation. It prevents the RNA polymerase from adding more nucleic acids onto the growing RNA chain, thereby destructing the virus (Jarvis and Rees). Some theorize that the drug changes the shape of the RNA chain so that it does not fit the RNA polymerase, preventing it from adding more nucleic acids onto the genetic replicas (Rees). However, the specific mechanisms of remdesivir at this stage are unknown (Jarvis). Remdesivir is also useful in that it only targets infected cells—healthy cells typically do not contain RNA polymerase. As of April 30, 2020, the WHO had deemed remdesivir as one of the “most promising” drugs to fight COVID-19. 

Credits to Chemical & Engineering News

Remdesivir Testing

However, as is the protocol in the medical and scientific community, more testing and evidence supporting the benefits of remdesivir are needed before it can be used to treat COVID-19 patients. As of early May 2020, there have been a number of studies in progress to test remdesivir on human patients, notably two tests in China, two from Gilead itself in California, and one from the National Institute of Health in the U.S. (Jarvis). The WHO has also created a paperless, universal study to treat a variety of COVID-19 treatment options, including remdesivir. 

On April 29, 2020, Dr. Anthony Fauci, U.S. disease expert, reported that data from a Gilead study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), showed remdesivir can reduce the time of recovery in coronavirus patients by about four days (Davey). This study measured the recovery and health of its patients by reporting daily scores based on a holistic seven-point scale. On the first day, patients were given 200 milligrams of remdesivir and subsequently given 100 milligrams for the rest of the days of treatment. They were also ‘swabbed’ every other day to measure their physical health (NIH). However, the study did not show any differences in overall survival rate between patients that did and did not receive remdesivir. In addition, the definition of “recovery” became more lenient throughout the study—though the results of remdesivir treatment is not what influenced scientists to redefine the term) (Davey and Kolata).

In contrast, a study from China, led by Yeming Wang and published in the distinguished medical journal The Lancet, showed no significant benefits for patients who received remdesivir than those who did not (Davey; Wang, Yeming, et al.). The study did show that there was a reduced recovery time in patients that received remdesivir compared to those who received the placebo treatment. It is also important to note that multiple COVID-19 patients did not complete their full remdesivir treatment due to adverse effects from the treatment. With this, there are still many differences between the two studies: The Wang study tested 237 patients, whereas the NIAID study tested around 1,000. The Wang study also gave patients other treatments alongside remdesivir which may have influenced the results (Davey). 

More studies and research show similar results: research published on February 4th by cell biology journal Cell Research found that remdesivir successfully combated the COVID-19 virus in lab tests; similar results were found by the University of Alberta; the University of Chicago Medicine found remdesivir reduced fevers and symptoms and successfully treated almost all patients; and Houston Methodist Hospital also discharged many patients with the help of remdesivir (Wang, Manli, et al.; University; Feuerstein and Herper; Levine). On May 1, 2020, the FDA approved remdesivir to be used in health care centers to treat patients who were and are severely ill (Kolata). Normally, the process for a drug to be approved for use in the U.S. by the FDA takes several months to a year, but the fast-paced nature of the pandemic pressured the FDA to reduce that timeline (Jarvis).

As previously mentioned, the WHO has also established a universal study to test four treatment options in a single, randomized trial: Remdesivir, lopinavir/ritonavir (HIV treatment), lopinavir/ritonavir with Interferon beta-1a (multiple sclerosis treatment), and chloroquine/hydroxychloroquine (malaria and rheumatology treatment). Over 100 countries are currently participating in the study, probably because of the efficiency and simple requirements of the study. This blind, anonymous study randomly assigns adult COVID-19 patients to either local standard of care (LSOC) or one of the four treatment options though a computer. Hospitals and countries submit data electronically—no paperwork required—which is a fairly easy task for even the most overloaded and strained hospitals (Solidarity). This study may provide greater insights into greatly effective COVID-19 treatments through its global perspective.

Conclusion

The orphan drug designation was created by the federal government to motivate companies to find and develop medicines for rare diseases (Thomas). The orphan drug designation also benefits newer, smaller companies hoping to attract investors. Companies whose drug is granted the orphan drug label are given “protocol assistance by the FDA,” research money, and deductions for other drug application and license fees (Antos). Gilead, a large, veteran pharmaceutical company that made almost twenty-three billion dollars in sales as of 2019, is not a small company (Gilead). They do not need introduction to investors and fee reductions that many younger companies would benefit from through the designation. 

To give Gilead the benefit of the doubt, one reasonable benefit that would apply to the company from the designation is a faster approval timeline. However, the orphan drug designation is not the only way medical organizations can get their drugs out to stores faster. The Accelerated Approval track, Priority Review track, and Fast Track approval processes all provide ways for companies to get their medicines out to patients faster than the normal FDA approval process (Development). There are still questions to be asked about the ethical aspects and motives behind Gilead’s decision. If Gilead was truly putting American lives first, it may be hard to understand why they chose to monopolize on remdesivir, especially because there are other ways to speed up FDA approval. 

Remdesivir has not been proven, perhaps yet, to be a guaranteed effective treatment and prevention measure for COVID-19 patients. Nevertheless, much data shows that those who are given remdesivir seem to have quicker recoveries, most especially when given remdesivir in earlier stages of the disease (this may be due to the fact that remdesivir works against the RNA of SARS-CoV-2 in the earlier stages of the virus). Thus Gilead’s attempt to monopolize on remdesivir, a drug that shows some promise, can appropriately be labeled as unethical. Additionally, the U.S. government has already given Gilead Sciences millions of dollars to create and develop remdesivir. Similarly, U.S. studies on the effects of remdesivir have been funded by American citizens through taxpayer dollars. Should these studies help conclude that remdesivir is an effective drug against SARS-Cov-2, it would not be fair to Americans if the prices of the drug were extremely expensive and controlled by a single corporation. 

A monopoly on a potential lifesaving treatment during these chaotic, desperate, tragic times is simply immoral. Remdesivir, and all other COVID-19 treatments and prevention methods, should be easily accessible to all members of the United States and around the globe. Taking advantage of the incredible need for a COVID-19 treatment and medicine to make large profits cannot be justified, especially when it results in countless deaths. 

As a response to Gilead’s attempt at a remdesivir monopoly, many health organizations, such as Public Health, and even U.S. Senator Bernie Sanders criticized Gilead and asked the remdesivir creators to repeal their decision (Thomas). Fortunately, Gilead Sciences has since reversed their decision to monopolize on remdesivir. On March 25, 2020, Stat (STAT news) senior writer Ed Silverman and the New York Times published articles stating that Gilead Sciences had withdrawn the orphan drug designation for remdesivir (Silverman and Thomas). In efforts to prevent and save millions of American lives and lives around the world, companies should not take advantage of the COVID-19 emergency and monopolize on lifesaving treatments.

Sources and References

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