Chloroquine and Hydrochloroquine are approved for off-label usage. This means the medications can be used in a manner not specified by the Food and Drug Administration (FDA). President Trump thinks they should be tested to discover whether they’re effective at treating the symptoms of COVID-19.

With the novel coronavirus outbreak of 2019 (COVID-19) now in the 2nd quarter of 2020, companies around the world are working overtime to produce effective treatments.  In the United States, chloroquine, along with a similar drug hydroxychloroquine, have been making headlines since March 19, 2020 when, during his press conference, President Trump mentioned chloroquine as part of a potential treatment for COVID-19.  

Chloroquine, sold under the brand name Aralen, is an antimalarial medicine.  It can be prescribed for either prevention or treatment of malaria.  Chloroquine is also prescribed to treat rheumatoid arthritis, and lupus.  Hydrochloroquine, common brand name is Plaquenil, is also used to prevent or treat malaria.  Combined with other drugs, it is also used to treat lupus, and rheumatoid arthritis.  Both Chloroquine and Hydrochloroquine are approved for off-label usage.  This means the medications can be used in a manner not specified by the Food and Drug Administration (FDA). 

Speaking on the potential of these antimalarial drugs treating COVID-19, President Trump said, “I think it could be a game changer, and maybe not, and maybe not. But I think it could be, based on what I see, it could be a game changer. Very powerful – they’re very powerful.”  That’s pure Trumpian speak through and through.  Trump supporters get it.  It’s not difficult for the red hats to discern the message.  They know Trump thinks these drugs might have potential to treat COVID-19, but there’s a chance that maybe they will not be effective. 

Stephen Collinson with CNN wasted no time spinning out this headline – Trump peddles unsubstantiated hope in dark times.  Not to be outdone, over at Politico, Sarah Owermohle churned out this headline – ‘Bad advice from the president’: Trump touts unproven coronavirus drugs.  News commentators at CNN and MSNBC joined in with their ridicule and scorn for the President.  To paraphrase their collective liberal talking point – Trump is killing people with his delusions of grandeur. This is not dramatization either.  David Scharfenberg / Boston Globe had this headline – Donald Trump’s coronavirus advise just might kill us.  Nothing brings folks together in a nonpartisan way to fight a deadly global pandemic better than headlines like these. 

As recently as April 1, 2020 CNN’s Marshall Cohen came up with this helpful and reassuring headline – The dangerous disconnect between Trump’s rhetoric and the reality for potential coronavirus treatments.  It’s as if some of those news reporters who dislike the president do not want a treatment or vaccine for COVID-19 to be found if it means that Trump could benefit politically by such discoveries.  No doubt, many readers have long since drawn this conclusion. 

Now the good news.  Globally, there are 20 or more drugs, or combination of drugs being tested as potential treatments for COVID-19.  In China, the drug combination of Ganovo + Ritonavir is in Phase IV trials by the company, Ascletis.  Fujifilm is testing Avigan.  The drug Remdesivir is being tested by the pharmaceutical company Gilead in the United States, China, and South Korea.  In the United States, the University of Minnesota is testing those anti-malaria drugs – hydrochloroquine and chloroquine.  Other U.S. companies along with researchers like Roche, Humanigen, OncoImmune, CytoDyn, NeuroRx, Roviant, and Mount Sinai are working aggressively to come up with effective treatments that will save the lives of those patients suffering from the worst of COVID-19.  There are many other companies around the world fighting in this effort too. 

Just like other medications prescribed for a wide host of aliments, some will be effective for certain people, but not others.  Some side effects will be prominent for certain people, and nonexistent for others.  Combinations of different drugs will be the best treatment for one group of patients, while a different combination will be more effective for others.  And it is true that for a small percentage of patients, side effects may prove deadly.  However, for a dying patient, the risk / benefit ratio is flattened when compared to a patient that has tested positive for COVID-19 and is experiencing only mild flu-like symptoms. 

A patient that is dying from COVID-19 has the right to try hydrochloroquine or chloroquine, with the complete understanding that the FDA has stated that chloroquine phosphate and hydroxychloroquine sulfate are not FDA-approved for treatment of COVID-19.  However, the FDA also had this to say in response to an Emergency Use Authorization (EUA) request made by Dr. Rick Bright, Ph.D, Director of the Biomedical Advanced Research and Development Authority (BARDA): 

Based upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding use of chloroquine phosphate or hydroxychloroquine sulfate in the setting of COVID-19.

FDA encourages the conduct and participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of these products in treating COVID-19. FDA is issuing this EUA to facilitate the availability of chloroquine phosphate and hydroxychloroquine sulfate during the COVID-19 pandemic to treat patients for whom a clinical trial is not available, or participation is not feasible.

Having concluded that the criteria for issuance of this authorization under 564(c) of the Act are met, I am authorizing the emergency use of chloroquine phosphate and hydroxychloroquine sulfate, as described in the Scope of Authorization section of this letter (Section II) for treatment of COVID-19 when clinical trials are not available, or participation is not feasible, subject to the terms of this authorization…

The FDA position on hydrochloroquine or chloroquine will continue to evolve as more data is collected.  The position is not static.  At present time, these drugs may be used for COVID-19 emergencies only.  The FDA, based on results described by foreign medical personnel, as well as small trials results, see the benefit of these drugs outweighing the risk posed to a patient dying from COVID-19.  This position is exactly what President Trump expressed during his March 19, 2020 White House press briefing.  The doomsday doubters in the press corps like accusing the President of giving people unsubstantiated hope or false hope.  That’s just mean-spirited nonsense.  Hope does not need to be substantiated.  Hope is about being optimistic – especially during calamity.  And where there is truly no hope, would not still being hopeful be a better state of mind?