The sacred oaths taken by doctors during graduation from medical school to “First do no harm,” the first words of the Hippocratic Oath, provide a powerful impetus for comments that have just been published in The American Journal of Medicine.
Researchers from Florida Atlantic University’s Schmidt School of Medicine and collaborators from the University of Wisconsin School of Medicine and Public Health urge all health care providers to prioritize compassion with reliable evidence about efficacy and security.
They recommend a moratorium on prescription chloroquine or hydroxychloroquine, with or without azithromycin, to treat or prevent COVID-19, with the exception of getting the evidence needed in randomized trials and loving use.
Despite the fact, or maybe partly due to the fact that there are no therapeutic or preventative measures for the COVID-19 pandemic in the United States, which accounts for less than 5 percent of the world’s population and about 30 percent of cases and deaths, prescription drugs are widespread nine times bigger than in the last few years.
This widespread use leads to national deficiencies in patients with lupus and rheumatoid arthritis, for whom hydroxychloroquine has been an approved indication for decades. These patients cannot fill their prescriptions.
On March 28, the US Food and Drug Administration (FDA) issued an emergency use permit for chloroquine and chloroquine hydroxy for the treatment of COVID-19. However, on April 24, the FDA issued a drug safety communication warning regarding chloroquine hydroxy disorders and heart rhythm disorders that can cause sudden cardiac death.
If this drug needs to be prescribed for patients with COVID-19, initial evaluation and serial monitoring are an absolute necessity. “
Richard D. Shih, M.D, Study First Author and Professor of Emergency Medicine, Florida Atlantic University
Shih is also a division director and founding program director for emergency medicine residency programs at FAU’s Schmidt College of Medicine.
Furthermore, the authors suggest that the convincing safety profile of chloroquine may be more real than it really is.
Data on safety comes from decades of prescription by healthcare providers, especially for their patients with lupus and rheumatoid arthritis, both of which have a greater prevalence in young and middle-aged women, whose risk of fatal cardiac outcomes due to hydroxychloroquine is very convincing. low.
In contrast, the risk of hydroxychloroquine for patients with COVID-19 is significantly higher because of fatal cardiovascular complications due to these drugs is much higher in older patients and those who have heart disease or risk factors, both of which are mostly male .
In basic research, hydroxychloroquine and chloroquine are structurally related and have similar mechanisms to inhibit the virus that causes COVID-19. Despite their structural similarities, in vitro, hydroxychloroquine seems to be more effective.
Additionally, when used for lupus and rheumatoid arthritis, hydroxychloroquine has fewer side effects, less drug interactions and is less toxic in overdoses.
The authors note that the evidence currently available is limited to eight published studies, five on hydroxychloroquine alone; two in chloroquine hydroxy plus azithromycin; and one in both in combination or alone.
Of these only three were randomized trials enrolling 225, 62, and 30 patients – all of them too small to provide reliable evidence. All three tested hydroxychloroquine alone versus the standard of care in China.
One showed no significant difference in cleansing the virus at 28 days, second, there was no difference in cleansing the virus at seven days, and third, some improvements in fever, coughing and chest computed with tomographic findings.
“With regard to hypothesis testing, only large-scale randomized trials with sufficient size, dosage and duration can reliably detect the most reasonable small to moderate effects, which can have enormous clinical and public health impacts,” said Charles H. Hennekens, MD, Dr.PH, senior writer, first professor Sir Richard Doll and senior academic advisor at FAU’s Schmidt College of Medicine.