[Spectator] At Thursday’s White House press briefing, President Trump and FDA Commissioner Stephen Hahn announced that the FDA has approved the "compassionate use" of the antimalarial drug chloroquine to treat patients infected with Coronavirus 2019 ("COVID-19"). Under extreme or exigent circumstances, the FDA may permit physicians to medicate patients with experimental drugs. The term "compassionate use" ordinarily refers to dosing a patient with a drug that has not been approved by the FDA for any purpose.
Since the 1940s, however, chloroquine has been FDA-approved and safely used to treat and prevent malaria. It has also been used to treat HIV and autoimmune disease. Its side effects are well known and, generally speaking, nonexistent to mild. As such, chloroquine is not an experimental drug requiring FDA permission before it can be prescribed. Instead, even though the FDA has not given blanket approval for its use in COVID-19 cases, physicians have been and are free to prescribe it for "off-label" (i.e., non-FDA approved) use.
On March 13, 2020, James M. Todaro, M.D., and Gregory J. Rigano, Esq., working in consultation with researchers from the Stanford University Medical School, the University of Alabama at Birmingham School of Medicine, and the National Academy of Sciences, presented a report titled "An Effective Treatment for Coronavirus (COVID-19)." Here's the report's explosive opening summary:
"Recent guidelines from South Korea and China report that chloroquine is an effective antiviral therapeutic treatment against Coronavirus Disease 2019. Use of chloroquine (tablets) is showing favorable outcomes in humans infected with Coronavirus including faster time to recovery and shorter hospital stay. US CDC research shows that chloroquine also has strong potential as a prophylactic (preventative) measure against coronavirus in the lab, while we wait for a vaccine to be developed. Chloroquine is an inexpensive, globally available drug that has been in widespread human use since 1945 against malaria, autoimmune and various other conditions. (Emphasis added.)"
The report states that neither the Centers for Disease Control and Prevention (CDC) nor the World Health Organization has published "treatment measures against COVID-19" and that United States medical centers are "starting to have issues with traditional [treatment] protocols." Since China and South Korea have had "significantly more exposure and time to analyze diagnostic, treatment and preventative options," the United States and the rest of the world can "learn from their experience."
The report states that the COVID-19 "treatment guidelines" developed by South Korea and China are "generally consistent, outlining chloroquine as an effective treatment." For example, data from the clinical trials in China show that "patients treated with chloroquine demonstrated a better drop in fever, improvement of lung CT images, and required a shorter time to recover compared to parallel groups" and that chloroquine has "so far shown no obvious serious adverse reactions in more than 100 participants in the trials… Chloroquine was selected after several screening rounds of thousands of existing drugs" and "is undergoing further trials in more than ten hospitals" throughout China. |