What to know about malaria drug and coronavirus treatment

Coronavirus

Some politicians and doctors are sparring over whether to use an old malaria drug called hydroxychloroquine against the new coronavirus.

President Donald Trump has suggested people have little to lose by trying it, but doctors say the evidence that it may help is extremely thin. It also hasn’t been proved safe for this purpose, and the drug has some potentially serious side effects, especially on the heart. Besides malaria, the drug is used to treat lupus and rheumatoid arthritis. The publisher of one study the president touted now has issued an “expression of concern” about its methods. 

Trump trade adviser Peter Navarro championed hydroxychloroquine in television interviews a day after the president publicly put his faith in the medication to lessen the toll of the coronavirus pandemic.

“What do I know, I’m not a doctor,” Trump said Sunday. “But I have common sense.” In promoting the drug’s possibilities, the president has often stated, ”What have you got to lose?”

But medical officials warn that it’s dangerous to be hawking unproven remedies, and even Trump’s own experts have cautioned against it.

The American Medical Association’s president, Dr. Patrice Harris, said she personally would not prescribe the drug for a coronavirus patient, saying the risks of severe side effects were “great and too significant to downplay” without large studies showing the drug is safe and effective for such use.

Harris pointed to the drug’s high risk of causing heart rhythm problems.

“People have their health to lose,” she said. “Your heart could stop.”

In a heated Situation Room meeting of the White House’s coronavirus task force Saturday, Navarro challenged the top U.S. infectious disease expert, Dr. Anthony Fauci, over his concerns about recommending the drug based only on unscientific anecdotal evidence.

Navarro, who has no formal medical training, erupted at Fauci, raising his voice and claiming the reports of studies he had collected were enough to recommend the drug widely, according to a person familiar with the exchange who spoke on the condition of anonymity to describe the blow-up.

Fauci has repeatedly said current studies provide only anecdotal findings that the drug works. In response, Navarro told CNN on Monday, “I would have two words for you: ‘second opinion.’”

Hydroxychloroquine is officially approved for treating malaria, rheumatoid arthritis and lupus, not COVID-19. Small, preliminary studies have suggested it might help prevent the new coronavirus from entering cells and possibly help patients clear the virus sooner. But those have shown mixed results.

This Monday, April 6, 2020, photo shows an arrangement of hydroxychloroquine pills in Las Vegas. President Donald Trump and his administration kept up their out-sized promotion Monday of an malaria drug not yet officially approved for fighting the new coronavirus, even though scientists say more testing is needed before it’s proven safe and effective against COVID-19. Trump trade adviser Peter Navarro championed hydroxychloroquine in television interviews a day after the president publicly put his faith in the medication to lessen the toll of the coronavirus pandemic. (AP Photo/John Locher)

Doctors are already prescribing the malaria drug to patients with COVID-19, a practice known as off-label prescribing. Research studies are now beginning to test if the drugs truly help COVID-19 patients, and the Food and Drug Administration has allowed the medication into the national stockpile as an option for doctors to consider for patients who cannot get into one of the studies.

But the drug has major potential side effects, especially for the heart, and Fauci has said more testing is needed before it’s clear that the drug works against the virus and is safe for such use.

HOW IS IT BEING USED?

The drug can help tame an overactive immune system. It’s been used since the 1940s to prevent and treat malaria, and to treat rheumatoid arthritis and lupus. It’s sold in generic form and under the brand name Plaquenil in the United States. Doctors also can prescribe it “off label” for other purposes, as many are doing now for COVID-19.

WHAT’S THE EVIDENCE?

Some small and very preliminary studies give conflicting results. One lab study suggested it curbed the virus’ ability to enter cells. Another report on 11 people found it did not improve how fast patients cleared the virus or their symptoms. A report from China claimed the drug helped more than 100 patients at 10 hospitals, but they had various degrees of illness and were treated with various doses for different lengths of time, and might have recovered without the drug — there was no group that didn’t get the drug for comparison.

Other researchers in China reported that cough, pneumonia and fever seemed to improve sooner among 31 patients given hydroxychloroquine compared to 31 others who did not get the drug, although fewer people in the comparison group had cough or fevers to start with. Four people developed severe illness and all were in the group that did not get the drug. These results were posted online and have not been reviewed by other scientists or published in a journal.

Finally, the small study from France that President Donald Trump touted as evidence of the drug’s benefit is now in question. The head of the journal that published it has put out an “ expression of concern ” about its methods.

Some of the 26 people given hydroxychloroquine in that test were not counted in the final results, including three who worsened and were sent to intensive care, one who died a day after later testing negative for the virus and one who stopped treatment because of nausea.

The French study was published in an International Society of Antimicrobial Chemotherapy journal. The society’s president wrote on its website that the report “does not meet the society’s expected standard.”

Larger, more rigorous studies are underway now.

WHAT’S THE RISK?

The drug can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage. Taking it outside of a scientific experiment adds the risk of not having tracking in place to watch for any of these side effects or problems and quickly address them if they do occur.

A pharmacist shows a bottle of the drug hydroxychloroquine on Monday, April 6, 2020, in Oakland, Calif. President Donald Trump and his administration kept up their out-sized promotion Monday of an malaria drug not yet officially approved for fighting the new coronavirus, even though scientists say more testing is needed before it’s proven safe and effective against COVID-19. Trump trade adviser Peter Navarro championed hydroxychloroquine in television interviews a day after the president publicly put his faith in the medication to lessen the toll of the coronavirus pandemic. (AP Photo/Ben Margot)

Navarro told Fox News Channel’s “Fox & Friends” that doctors in New York hospitals are already distributing the drug to COVID-19 patients and that health care workers are taking it in hopes of being protected from infection.

Asked about his credentials for pushing the drug, Navarro cited his doctorate in social science and said that “in the fog of war, we might take more risks than we otherwise would.” He added, “I’d bet on President Trump’s intuition on this one.”

Administration officials say Trump’s embrace of the drug stems from his desire to provide “hope” for the American people as the death toll mounts and he looks to avoid political consequences from the outbreak.

At least one other world leader has also promoted the drugs. Brazil’s President Jair Bolsonaro has touted the benefits of hydroxychloroquine and azithromycin, saying he’s heard reports of 100% effectiveness when administered in the correct dosages.

Trump’s interest in the drug was piqued in part by coverage on conservative media.

On March 16, Fox News ran a segment on a small French study promoting the effectiveness of hydroxychloroquine in treating the coronavirus. Hours later, attorney Gregory Rigano appeared on a prime-time show and said evidence suggested it could rid the body “completely” of the virus.

Almost instantly, just as the projections of the virus’ impact on the nation grew more dire, the drug’s promise bounced around the echo chamber of the conservative media. Just three days later, Trump himself made the first mention of the drug.

Among the loudest voices in the president’s ear has been Rudy Giuliani, the president’s personal attorney, who has spoken to Trump about the drug and advocated it in interviews and his new podcast. He has had, as guests, several experts touting the drug and made a few late-night phone calls to the White House residence.

“I discussed it with the president after he talked about it,” Giuliani said. “I told him what I had on the drugs. Others around him believe it too.”

The president’s son, Donald Trump Jr., on Friday tweeted a link to an article about the drugs’ possible success and added: “Waiting for others to write this up. The Democrats and the media must be really upset because they tried to destroy @realdonaldtrump for being hopeful that this would be the case.”

Across Europe, there has also been a recent spike in demand for the drugs even as regulators caution against their unlicensed use.

Last week, the European Medicines Agency warned doctors that since there is no proof yet of the drugs’ effectiveness, they should be used only in clinical trials or under emergency use provisions.

The jump in demand for the drugs has meant in some instances that patients who rely on hydroxychloroquine for lupus or other conditions are seeing their supplies diverted for COVID-19.

If hydroxychloroquine is proven to work well against COVID-19, its sales would jump, but pharmaceutical analysts say they don’t know of any company or individual that stands to make a windfall. That’s because there’s so much competition and the vast majority of prescriptions filled are for generics.

For most people, the virus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia, and death.

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