On March 28, the United States CDC issued “Emergency Use Authorization” (EUA) for two medications, chloroquine phosphate, and hydroxychloroquine sulfate. On June 15, the CDC revoked the EUA claiming, “that the drug’s potential benefits for such use do not outweigh its known and potential risks.” So what changed within those 79 days?
Hydroxychloroquine was originally developed to treat Malaria but is now used to treat various autoimmune diseases, primarily rheumatoid arthritis. Rheumatoid arthritis is an autoimmune disease, meaning the patient’s white blood cells, which are supposed to be the body’s natural response to fighting infection, become overactive and try to attack healthy tissue in one’s joints. This causes immense inflammation and swelling for the patient. Non-steroidal anti-inflammatory drugs, such as ibuprofen target the symptoms of rheumatoid arthritis and can provide some degree of pain relief, but it is often not enough. However, hydroxychloroquine is a Disease-modifying anti-rheumatic drug (DMARD), which means it works to modify the disease, by suppressing the body’s immune and inflammatory response. Hydroxychloroquine is an incredibly effective medication for Malaria, and for many autoimmune diseases, and so it was one of the medications tested for its efficacy in combating SARS-CoV-2.
As is the practice for any novel virus, many medications that are already FDA approved for other medical conditions are tested as treatments to the new virus. This is done in order to speed up production, as if a drug is found to be a successful treatment, it would not have to go through full FDA approval in order to be mass-produced and disseminated to hospitals. Early testing for hydroxychloroquine showed promise. On February 4, a study was conducted in which hydroxychloroquine proved to be effective at blocking the coronavirus from invading cells, which the virus must do in order to spread across the body. This experiment, however, was conducted in vitro, meaning it was done on cultured cells in a laboratory as opposed to the human body, meaning that the supposed effectiveness of the drug did not translate to better treatment for SARS-CoV-2 patients. Doctors in China and France claimed that patients who were administered hydroxychloroquine were healthier than other SARS-CoV-2 patients; however, it is now known that these studies were incredibly small and did not have a test group. Despite early claims that hydroxychloroquine could work with SARS-CoV-2 patients, there is now mounting data that shows absolutely no difference between patients who were given hydroxychloroquine and those who were not.
Scientific studies alone are not what capitulated hydroxychloroquine to the forefront of the hunt for drugs combatting SARS-CoV-2. On March 21st, President Trump tweeted that hydroxychloroquine could be a “game changer.” Then on May 18, he told the press that he had been taking hydroxychloroquine for “about a week and a half.” At the time President Trump announced this, it was beginning to come remarkably clear that the drug could not cure SARS-CoV-2 in the way Trump thought it could. Additionally, as with any drug, there are possible side effects; the main concern for hydroxychloroquine is that it could cause abnormalities in a person’s heart rhythm, which means it should not be used for patients who are at risk for heart issues. President Trump, is in fact at risk for heart concerns, as he is known to have an incredibly high cholesterol level, which cardiologists say raises serious heart concerns.
The issues with the media attention around hydroxychloride, go beyond the possible side effects of the drug. After the first time, the President talked about hydroxychloride on March 19, pharmacies were inundated with first-time prescriptions for the drug, at more than 46 times the usual rate. With the unusual interest in the drug, pharmacies did not have the inventory to fulfill these requests, and many places faced extreme shortages of the drug. This meant that hundreds of thousands of people who had been taking hydroxychloroquine for years to treat rheumatoid arthritis or lupus found themselves at risk of not having their medication.
During a pandemic, many processes get expedited and agencies are generally more inclined to grant approval to treatments that show promise, even if they haven’t passed the testing that would otherwise be required. This speed is necessary for ensuring patients get the highest quality care; however, it is clear that in the case of hydroxychloroquine, premature decisions were made that had the potential to put lives at risk. The EUA granted on March 28 was based on studies that are now widely agreed upon to have been faulty and misleading, and the effects of this lead to hundreds of thousands of patients having to go without their necessary medication.
Ernste, Floranne. "How Do DMARDs Treat Rheumatoid Arthritis?" Spine Universe, 20 Feb. 2018, www.spineuniverse.com/blogs/ernste/how-do-dmards-treat-rheumatoid-arthritis.
FDA. Revocation of Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate. By Denise M. Hinton, Government Publishing Office, 15 June 2020, www.fda.gov/media/138945/download.
Gabler, Ellen, and Michael H. Keller. "Prescriptions Surged as Trump Praised Drugs in Coronavirus Fight." The New York Times, 25 Apr. 2020, www.nytimes.com/2020/04/25/us/coronavirus-trump-chloroquine-hydroxychloroquine.html.
Grady, Denise, et al. "What to Know About the Malaria Drug Trump Says He Is Using." The New York Times, 15 June 2020, www.nytimes.com/article/hydroxychloroquine-coronavirus.html.
Sandhu, Vaneet. "Hydroxychloroquine (Plaquenil)." American College of Rheumatology, Apr. 2020, www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Hydroxychloroquine-Plaquenil.
Wang, M., Cao, R., Zhang, L. et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 30, 269–271 (2020). https://doi.org/10.1038/s41422-020-0282-0