Like a carnival barker selling snake oil, President Trump repeatedly has touted the use of chloroquine, an antimalarial drug, and hydroxychloroquine, another antimalarial drug that also is used to treat lupus and rheumatoid arthritis, as a “game-changing” treatment for COVID-19. No scientific evidence exists to back up Trump’s claims; the data on which he bases his statements are derived from poorly designed studies and anecdotes.

Should the federal government — particularly the president — encourage the use of a drug for a purpose other than that for which it was approved by the U.S. Food and Drug Administration? Absolutely not.

First, doing so can be dangerous. Both chloroquine and hydroxychloroquine have serious — and sometimes fatal — side effects. Trump casually says, “Try it, what do you have to lose?” The answer: Your life.

Both can damage the heart muscle and lead to heart failure. They also can cause a change in the electrical activity in the heart that can lead to a life-threatening and often fatal abnormal heart rhythm.

To make matters worse, some reports indicate that COVID-19 can cause inflammation of the heart muscle. That could make these patients more susceptible to chloroquine and hydroxychloroquine’s adverse cardiac events. Moreover, critically ill patients, including those with respiratory failure due to the coronavirus, often develop severe blood electrolyte abnormalities that further increase the risk of dangerous abnormal heart rhythms. If these drugs are used widely to treat COVID-19 and are subsequently shown not to work, no benefit will have been provided, but some patients undoubtedly will have been harmed.

It wouldn’t be the first time. History is filled with examples of long-term use of major treatments that were believed to be effective based on inadequately designed studies but later were shown to be ineffective and, in some cases, result in worse outcomes once well-designed clinical trials were conducted.

Second, promoting an FDA-approved drug for unapproved uses may trigger hoarding and subsequent drug shortages, so that patients with diseases for which the drug is FDA-approved and has been shown to be safe and effective may not be able to get critically important treatment. This is happening thanks to Trump’s reckless promotion of hydroxychloroquine; patients with lupus and rheumatoid arthritis who have been treated successfully with hydroxychloroquine have not been able to refill their prescriptions.

Third, promoting an FDA-approved drug for unapproved uses could interfere with and delay the conduct of the well-designed, randomized clinical trials necessary to find out whether a drug is safe and effective for the unapproved use. Rather than consenting to enroll in a randomized trial, many patients who have heard Trump advocate the use of chloroquine and hydroxychloroquine may be unwilling to enroll in a trial and take the chance of getting a placebo.

The longer it takes to find out whether these drugs are safe and effective for treating COVID-19, the longer the period of potential exposure of a large group of patients to an ineffective but harmful treatment.

In touting chloroquine and hydroxychloroquine, Trump has invoked the “Right to Try Act,” which was passed in 2018. Again, the carnival barker is misleading his audience. The Right to Try Act doesn’t even apply to this situation; it applies only to experimental drugs that have not yet been approved by the FDA for any use and therefore are not on the market. Chloroquine and hydroxychloroquine were approved by the FDA for marketing in the United States in 1949 and 1955, respectively.

A doctor doesn’t need the Right to Try Act to prescribe chloroquine or hydroxychloroquine to COVID-19 patients. The law already allows a doctor to prescribe an approved drug for any use.

Further, the FDA for decades has had a program for seriously ill patients with limited or no treatment options to access experimental medications. It’s called the Expanded Access program, and it provides for FDA review of experimental therapies used outside the context of a clinical trial, thereby helping to ensure that proposed uses of the treatments do not pose unacceptable risk. Roughly 99 percent of these “compassionate use” requests are approved by the agency.

Trump should step away from his carnival booth and let qualified public health experts take the lead in truthfully informing the public about treatment options for COVID-19.

Dr. Michael Carome is director of Public Citizen’s Health Research Group. He wrote this for InsideSources.com.

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