Patients with lupus are experiencing difficulties in accessing medications hydroxychloroquine and chloroquine, 2 medications currently being investigated as potential treatment for the coronavirus 2019 disease.
Patients with lupus are experiencing difficulties in accessing medications hydroxychloroquine (HCQ) and chloroquine (CQ), 2 medications used widely by patients with lupus and that are currently being investigated as potential treatment for the coronavirus disease 2019 (COVID-19).
The recent shortage follows misinformation that people with lupus who take HCQ are not at risk for the virus and that HCQ has been approved by the FDA as COVID-19 treatment. Currently, there is no approved COVID-19 treatment, and although both HCQ and CQ are under consideration for use against coronaviruses, these statements by the FDA do not reference COVID-19, but the broad category of illnesses known as coronaviruses.1
Furthermore, a study based in Brazil was halted early for safety concerns after patients with COVID-19 taking a higher dose of CQ developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia.
“We can say that this drug is likely not 100% effective in preventing or treating COVID, and that SLE (systemic lupus erythematosus) patients should not let their guard down,” Jean Liew, MD, administrative lead for the Global Rheumatology Alliance told FactCheck.2
In fact, the COVID-19 Global Rheumatology Alliance, an alliance formed to help guide rheumatology clinicians in assessing and treating patients with rheumatologic disease and supported by the Lupus Foundation of America, has gathered information on 110 validated patients: 36% with rheumatoid arthritis (RA), 17% with psoriatic arthritis, and 17% with SLE, or lupus. Based on data collected in their registry, the group was not able to report on any evidence supporting the protective effect of HCQ against COVID-19. However, this is a rapidly developing area of research and due to the low number of participants, the group’s findings are not conclusive.2,3
Pat Wildman, vice president for Advocacy & Government Relations for the Lupus Foundation of America, said in a recent video that the shortage involving HCQ and CQ began overseas. As the virus spread throughout Europe and Asia, there were studies conducted in China and France examining the potential of HCQ and CQ to treat COVID-19.4
“At that time, we were watching it to see what the studies would produce […] both for the demand [in the United States] and what it would mean for HCQ and CQ. The increase of demand for the 2 medications really spurred us to action on a number of different levels to address the verified shortages of the medications for people with Lupus,” Wildman said in the video.
Lupus is a chronic autoimmune disease, meaning that the immune system is dysfunctional and attacks a patient’s healthy tissue making it less effective at fighting infections. Medication that suppresses the immune system, which patients with lupus take, can also limit their body’s ability to respond to infections. As a result, people with lupus are less able to fight off bacteria and viruses, such as COVID-19.5
Teri Rinehard, of Okeechobee, Florida, a patient with lupus and RA told WPEC CBS 12 that her conditions affect her immune system, which means that contracting COVID-19 could be deadly. She previously used HCQ, but has since had trouble obtaining the medicine she needs to function on a daily basis. “I’m scared to go out and get anything. I can’t walk. It’s like your whole world stops. You don’t have the energy. Muscle pains,” Rinehard told CBS 12.6
To address concerns surrounding HCQ and CQ drug shortages, the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists issued a joint statement recently on the inappropriate ordering, prescribing, or dispensing of medications (such as HCQ) to treat COVID-19. The statement highlighted the important role that physicians, pharmacists, and health systems play in being stewards of health care resources during times of emergency and national disaster.7,8
In a video for the Lupus Foundation of America, Wildman said that the organization is addressing the challenges that people with lupus are facing.
“One of the first things that we did was recognize that there is a supply issue, that there [are] simply not enough drugs to meet the needs of people with lupus, people with rheumatoid arthritis, and to meet the needs of people with COVID-19. So, one of our first actions was to reach out to the pharmaceutical industry, to the manufacturers of HCQ and CQ, to urge them to step up production and help address these supply challenges that we were seeing. We’re really happy to see that the industry is doing that. Manufacturers who produce HCQ and CQ have stepped up production, and even manufacturers that have produced those medications in the past or companies who never do so before are stepping up as well,” Wildman said in the video.4
Additionally, in partnership with the Arthritis Foundation, the American College of Rheumatology, and the American Academy of Dermatology, and the Lupus Foundation of America reached out to the White House Coronavirus Task Force, to discuss the federal government’s primary role in addressing the challenges with COVID-19, issues for people with lupus, and other conditions. These organizations urged the task force to work with the industry to step up production as well as to address COVID-19 restrictions, reckless prescribing, stockpiling, quantity limits, off-label restrictions, and inappropriate and unreasonable prescribing.
According to the CDC, HCQ is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. In the United States, several clinical trials of HCQ for prophylaxis or treatment of SARS-CoV-2 infection are planned or will be enrolling soon.5