Doctors skeptical of Trump-touted drug, but try it for their sickest

Grady Ambulance crews arrive wearing masks at the hospital with patients on Tuesday, April 7, 2020. JOHN SPINK/JSPINK@AJC.COM

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Grady Ambulance crews arrive wearing masks at the hospital with patients on Tuesday, April 7, 2020. JOHN SPINK/JSPINK@AJC.COM

Top Georgia hospitals report they are using hydroxychloroquine, or an earlier version known as chloroquine, to treat COVID-19, sometimes in combination with a powerful antibiotic. Some doctors said they see anecdotal evidence the drugs might work.

But several public health experts told The Atlanta Journal-Constitution more research needs to be done before it’s known how effective the drugs really are, and others said publicity over hydroxychloroquine could dissuade volunteers from joining clinical trials for other treatments.

» COMPLETE COVERAGE: Coronavirus in Georgia

» MORE: Coronavirus and Georgia hospitals

“We are only a little over a month into the outbreak, so we are still learning, and we need more time to analyze the data,” said Dr. Aneesh Mehta, an infectious disease doctor and associate professor of medicine at Emory University. “And we don’t have enough.”

The interest in hydroxychloroquine intensified after President Donald Trump recently touted it as a wonder drug against COVID-19. On Tuesday, Doug Collins, a Georgia congressman and one of Trump’s staunchest allies, announced a deal with a generic drug maker to donate some 200,000 doses of the medicine to the state.

Chloroquine was developed in the 1930s to fight malaria, and hydroxychloroquine, which has fewer side effects, was developed during World War II. Mehta said hydroxychloroquine is most widely used today for autoimmune conditions such as lupus, and arthritic conditions including rheumatoid arthritis.

Georgia’s top doctor, Commissioner of Public Health Kathleen Toomey, warned practitioners last month about “misinformation” regarding the drugs and the coronavirus.

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Hydroxychloroquine pills, used to treat malaria and other diseases, is being used by some medical providers in Georgia. The drug is not yet officially approved for fighting the new coronavirus, and scientists say more testing is needed before it’s proven safe and effective against COVID-19. AP PHOTO / JOHN LOCHER

Hydroxychloroquine pills, used to treat malaria and other diseases, is being used by some medical providers in Georgia. The drug is not yet officially approved for fighting the new coronavirus, and scientists say more testing is needed before it’s proven safe and effective against COVID-19. AP PHOTO / JOHN LOCHER

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Hydroxychloroquine pills, used to treat malaria and other diseases, is being used by some medical providers in Georgia. The drug is not yet officially approved for fighting the new coronavirus, and scientists say more testing is needed before it’s proven safe and effective against COVID-19. AP PHOTO / JOHN LOCHER

“Research is underway to test these drugs and newer antiviral agents, but there is no definitive evidence of effective treatment at this time,” Toomey wrote in a letter dated March 22.

Even the nation’s top infectious disease expert, Dr. Anthony Fauci, a key member of Trump’s coronavirus task force, has urged the public not to consider hydroxychloroquine “a knockout drug.”

In a press conference Wednesday with Gov. Brian Kemp, Toomey told reporters the hydroxychloroquine donated by Amneal Pharmaceuticals will go solely to hospitals to treat COVID-19 patients. But she pleaded with doctors to be judicious in prescribing the drug.

“My plea to physicians is always, please, ensure that we have an adequate supply of these drugs for our lupus patients and the rheumatoid arthritis patients whose lives may depend on having access to this in our communities,” she said.

‘No predicting who will do well’

Mehta said the mainstay of treatment for COVID-19 remains supportive care and includes oxygen and monitoring electrolytes and other conditions such as inflammation in the body.

Some patients with COVID-19 may develop blood clots. And COVID-19 patients are also at higher risk for a secondary bacterial infection, which can be treated with antibiotics, he said.

Trials of new antiviral drugs are underway nationally, including at Emory’s hospitals.

Studies also are scrutinizing the use of chloroquine and hydroxychloroquine, both on their own or in combination with azithromycin, commonly known as a Z-Pak.

In laboratory studies, hydroxychloroquine can stop the virus from invading cells. But it isn’t yet fully understood what happens in humans.

ABOUT HYDROXYCHLOROQUINE

Hydroxychloroquine is a prescription medicine that was approved decades ago to treat malaria. It is also used to treat autoimmune diseases like rheumatoid arthritis and lupus.

Many hospitals are now giving it to coronavirus patients because there is no proven treatment, and they hope it will help. Clinical trials with control groups have begun across the world.

Like every drug, it can have side effects. It is not safe for people who have abnormalities in their heart rhythms, eye problems involving the retina, or liver or kidney disease.

The epidemic is moving so fast that doctors are trying approaches when only preliminary data suggests there may be a benefit. Though chloroquine and hydroxychloroquine haven’t been approved by the U.S. Food and Drug Administration to treat COVID-19, the agency has given hospitals the OK to try.

The drugs are known to have powerful side effects — including heart arrhythmia, which can lead to heart attacks — but the risks are well-known. Doctors who spoke to the AJC said patients are screened through a risk-benefit analysis for cardiac and other pre-existing conditions.

Patients with cardiac problems, and those with retina problems, for example would be at a higher risk for complications, Mehta said.

Doctors who spoke to the AJC said they are only using hydroxychloroquine for hospitalized COVID-19 patients who are severely ill or at high-risk of becoming severely ill.

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In Albany, which is facing one of the world’s worst COVID-19 outbreaks when measured by deaths per capita, Dr. Kathy Hudson, chief of staff at Phoebe Putney Memorial Hospital, said her team is seeing some anecdotal evidence the drug is working.

“The ones on hydroxychloroquine, initially they seemed to do better and not require the higher levels of oxygen,” she said.

Phoebe doctors are prescribing five-day treatments of hydroxychloroquine along with a Z-Pak. Initially, Phoebe had a limited supply in the first few weeks, though the hospital group has more of it now.

“We didn’t use it for every patient. We couldn’t,” she said.

Hudson said she knows more study is needed, not only into hydroxychloroquine, but also into the pre-existing conditions and other factors that put people at highest risk of dying.

“The biggest frustration for the clinician side is there’s absolutely no predicting who will do well or who does not,” she said.

More trials needed

The Piedmont Healthcare and Emory hospitals are not using the drug in conjunction with a Z-Pak.

Mehta said Emory doctors discuss hydroxychloroquine as an option with patients and their families to see, “if this is something they would like or not.”

Dr. Amy Hajari Case, Piedmont’s medical director of pulmonology and critical care research, said Piedmont also advises its outpatient providers not to prescribe hydroxychloroquine for their COVID-19 patients.

Case said she doesn’t know if the drug is working or not because there hasn’t been time to study it in a controlled clinical environment.

“The only way to know is to look at those randomized and controlled trials comparing the outcomes to patients who are getting hydroxychloroquine and those who are not,” she said.

Results from clinical trials on the drug are probably weeks or a few months away, which is fast in medicine but not for a frightened public.

Case said Piedmont hopes to take part in new antiviral trials in the coming weeks. But the promotion of hydroxychloroquine is potentially undermining trials of that drug and new antiviral medications, she said.

“People have to be willing to participate in a randomized placebo-controlled study,” Case said. “If they’ve been led to believe that hydroxychloroquine or chloroquine is beneficial, they may not take part.”

“That might set back some of this very promising clinical research,” she added.

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Chris Reed, a 46 year-old with lupus, said he is worried about being able to continue getting his medication with new demand for the drug because of coronavirus. CONTRIBUTED

Chris Reed, a 46 year-old with lupus, said he is worried about being able to continue getting his medication with new demand for the drug because of coronavirus. CONTRIBUTED

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Chris Reed, a 46 year-old with lupus, said he is worried about being able to continue getting his medication with new demand for the drug because of coronavirus. CONTRIBUTED

Shortages for non-coronavirus patients

The buzz around hydroxychloroquine is leaving patients who rely on the drugs for chronic diseases concerned about being able to fill their prescriptions.

Teri Emond, chief operating officer of Lupus Foundation of America’s Georgia Chapter, said she has heard from at least 15 people with lupus having trouble getting the medication. Emond recommends patients talk to their pharmacist, and look into getting the medication mailed.

Chris Reed, a 46 year-old with lupus, said he’s taken the twice-daily medication for more than 25 years. He relies on it to prevent flare-ups and complications such as organ damage.

He said he’s running low on a 90-day supply.

“I am living in great fear of not being able to get my medication and I am due to get it in two days,” he said.