FDA Urged to Approve Chloroquine to Treat COVID-19

President Donald Trump said Thursday his administration will make the malaria drug chloroquine available “almost immediately” to treat the COVID-19 infection, but it will only be available under the “compassionate use” program until the drug undergoes a clinical trial under the FDA’s directive.

Studies are showing chloroquine can both “prevent and treat coronavirus” in the cells of primates, but it is not FDA-approved for COVID-19.

“Some doctors report very encouraging results quickly in very sick people,” Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, told Breitbart News about research into chloroquine to treat the COVID-19 – also known as SARS-CoV-2 – respiratory illness.

“Independent doctors may prescribe it off-label, but employed physicians might not be allowed to, by corporate administrators, because it is not FDA-approved for this indication,” she added. “No preventive or therapeutic meds are specifically approved for this.”

As Breitbart News’s James Delingpole observed, a study document prepared by Dr. James Todaro and Attorney Gregory Rigano concluded:

Chloroquine can both prevent and treat malaria. Chloroquine can both prevent and treat coronavirus in primate cells (Figure 1 and Figure 2). According to South Korean and China human treatment guidelines, chloroquine is effective in treating COVID-19. Given chloroquine’s human safety profile and existence, it can be implemented today in the U.S., Europe and the rest of the world. Medical doctors may be reluctant to prescribe chloroquine to treat COVID-19 since it is not FDA approved for this use. The United States of America and other countries should immediately authorize and indemnify medical doctors for prescribing chloroquine to treat COVID-19. We must explore whether chloroquine can safely serve as a preventative measure prior to infection of COVID-19 to stop further spread of this highly contagious virus.

The Centers for Disease Control and Prevention (CDC) states:

Chloroquine … is an antimalarial medicine… available in the United States by prescription only… Chloroquine can be prescribed for either prevention or treatment of malaria. Chloroquine can be prescribed to adults and children of all ages. It can also be safely taken by pregnant women and nursing mothers.

Dr. Martin J. Vincent, et al, also wrote in 2005 in a study published at the National Institutes of Health (NIH) when severe acute respiratory syndrome (SARS) was found to have been caused by coronavirus SARS-CoV:

Severe acute respiratory syndrome (SARS) is caused by a newly discovered coronavirus (SARS-CoV). No effective prophylactic or post-exposure therapy is currently available.

We report, however, that chloroquine has strong antiviral effects on SARS-CoV infection of primate cells. These inhibitory effects are observed when the cells are treated with the drug either before or after exposure to the virus, suggesting both prophylactic and therapeutic advantage. In addition to the well-known functions of chloroquine such as elevations of endosomal pH, the drug appears to interfere with terminal glycosylation of the cellular receptor, angiotensin-converting enzyme 2. This may negatively influence the virus-receptor binding and abrogate the infection, with further ramifications by the elevation of vesicular pH, resulting in the inhibition of infection and spread of SARS CoV at clinically admissible concentrations.

The researchers concluded that “chloroquine is effective in preventing the spread of SARS CoV in cell culture.”

“Favorable inhibition of virus spread was observed when the cells were either treated with chloroquine prior to or after SARS CoV infection,” they added.

“The nice part is it’s been around for a long time, so we know that if things don’t go as planned, it’s not going to kill anybody,” Trump said at a press briefing.

Nevertheless, Dr. Stephen M. Hahn, commissioner of food and drugs at the Food and Drug Administration (FDA), wrote at USA Today Tuesday:

While the Food and Drug Administration is working full speed, in collaboration with public and private sector partners, to help diagnose, treat and prevent this disease, presently there are no FDA-approved products to prevent, treat or cure COVID-19.

Orient said:

We need to get the FDA out of the practice of medicine. Also, it can shut down U.S. production lines for exceeding production quotas or a minor paperwork violation, but has no meaningful inspection of plants in China, on which we are dependent for 90% of our drug supply, including antibiotics and other things needed to care for critically ill patients.

“Hopefully the Trump administration is working on bringing essential manufacturing home,” she concluded.

Meanwhile, Orient recommends that those with a fever only treat it after consultation with a doctor:

Fever is not a disease. It is an important defense mechanism. Very high fevers (say 105 degrees) can cause brain damage, and children can have seizures. But don’t pop Tylenol or ibuprofen at the first sign of fever. Many of the casualties in the 1918 pandemic might have been caused by heavy use of aspirin. Like aspirin, popular nonsteroidal anti-inflammatories (NSAIDS), such as ibuprofen, also have detrimental effects on blood clotting. Try lukewarm sponge baths for comfort.

Orient recommends that Americans only go to an emergency room or urgent care facility if they are “severely ill.” She explained:

There will be sick people there, and you might catch something. You also might end up with a big bill, say for a CT scan you didn’t really need. And if you have the flu or a cold or COVID-19, and don’t need IV fluids or oxygen, they can’t do anything for you.

At home, Orient advises families to “clean and disinfect surfaces such as doorknobs, telephones, computer keyboards, toilets, and countertops often.”

“Virus can persist there for days,” she says.

She also urges Americans to ensure they are getting the vitamins they need.

“Most people may be vitamin D deficient,” she explains. “Your need for vitamin C escalates with infection. Some 50 tons of vitamin C was shipped to Wuhan, and studies of effectiveness are underway.”

UPDATE: The Stanford University School of Medicine and National Academy of Sciences Researchers told the Huffington Post that they were not associated with the study conducted by James Todaro and Gregory Rigano. This story has been edited to reflect that.