Unproven Drugs with Cardiac Side Effects Being Used on Coronavirus Patients

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Hydroxychloroquine, brand name Plaquenil, has been approved by the FDA for combating malaria, lupus, and rheumatoid arthritis. French doctors found a positive result in some of their COVID-19 patients when combining the drug with the antibiotic azithromycin.

David Kroll, a pharmacology professor at the University of Colorado, says the French data is flawed because what kind of respiratory support patients received is unknown, what other drugs were being given is unknown, and there is no mention of patients’ previous health-risk profiles. Kroll noted that hydroxychloroquine has significant neurological side effects and cardiac effects. He is concerned that patients also were given azithromycin, because cardiac side effects is one of its hallmark side effects. Putting the two drugs together without knowing the effect is unconscionable, he says. [There is no data available on the cardiac-related illnesses or deaths that may have occurred – which could have been reported as COVID-19 deaths.]. -GEG

A Harnett County man with the coronavirus has taken a turn for the worse and is now in the hospital, his wife said Saturday.

“Jeff has been admitted, he is on oxygen, and they are treating him with the Malaria medication,” Toni Hensley wrote on her Facebook page Friday. “He may have a pneumonia or fluid in his lung as well.”

Jeff Hensley, 57, started feeling ill on March 4 while working in Hawaii, his wife said earlier this week. He returned home March 7 and asked three times to be tested for COVID-19 — twice to coronavirus hotline operators and once to his doctor.

Officials declined to test him because he did not have a fever. When one did develop — on March 12 — he drove himself to Cape Fear Valley’s North Pavilion in neighboring Cumberland County, Toni Hensley said. He was tested there and the results came back the next day as presumptively positive. The Centers for Disease Control and Prevention have since confirmed the test was positive.

Toni Hensley, a traveling nurse, spoke from her home on Saturday. She said her husband was admitted to the hospital Thursday after having trouble breathing. He is now suffering from pneumonia, as well as the coronavirus, she said.

Toni Hensley said her husband was feeling a little better but will remain in the hospital because he still needs oxygen.

ANTI-MALARIAL DRUG?

Toni Hensley said her husband told her that he is being treated with an anti-malarial drug. She wasn’t sure which one. The U.S. Food and Drug Administration has not approved any drugs for treatment of coronavirus, but studies have been ramping up.

NC Health News could not confirm whether Jeff Hensley is being treated with hydroxychloroquine, which has received media attention in recent days.

When asked on Friday, State Health Director Elizabeth Tilson said she was not aware of anyone in North Carolina receiving such treatment.

“To my knowledge, we are not doing any clinical trials in North Carolina,” Tilson said. “But that has been something high on our radar, and we’re going to be reaching out to our academic partners to understand if anybody’s doing that or if there’s any interest in a clinical trial and some of the pharmaceuticals.”

But the drug has recently made a splash, after a news conference Thursday, where President Donald Trump said hydroxychloroquine could be a “game-changer” in the fight against COVID-19.

“It has shown very, very encouraging early results, and we’re going to be able to make that drug available almost immediately, and that is where the FDA has been so great,” Trump said during the news conference. “It’s gone through the approval process. It’s been approved. They took it down from many months to immediate.”

“That is just (expletive) irresponsible,” said David Kroll, a pharmacology professor at the University of Colorado, when he spoke about Trump’s comments. Kroll has done extensive research on herbal remedies and their use in medicine. Hydroxychloroquine is a descendant of one of the original herbal drugs, quinine, once widely used against malaria.

“For a leader of a country to say something like that,” Kroll said, “the data are not there.”

Hydroxychloroquine, brand name Plaquenilhas been approved by the FDA for combating malaria, and some French doctors found a positive result in some of their COVID-19 patients when combining the drug with the antibiotic azithromycin.

But Kroll said that even though the mechanism of action for hydroxychloroquine, at first blush, might have an effect against the virus, you can’t just throw drugs at a patient who’s critically ill.

“I want to see the data (for the French outcomes) and I want to see the standard of care,” Kroll said.

He noted that there could be a multitude of confounding factors for the French data: what kind of respiratory support were patients getting, what other drugs were they getting, what were the patients’ risk profiles before being given the drug. All of those need to be somewhat standardized so that researchers and physicians can tease out what actually made the difference.

”Unless you’re studying it, you don’t know if the drug really was effective or not,” Kroll said. “When you do that, open the flood gates, collecting and interpreting that data really depends on the other things that people are getting.”

He noted that hydroxychloroquine is a powerful drug with significant neurological side effects that include confusion, agitation and sleep disruption, as well as cardiac effects.

He said the way the drug works seems to make sense in that it could possibly be used against a variety of viruses because of the way it disrupts the enzymes that a virus needs to reproduce. He said it’s an educated conjecture, but definitely not proven.

Nonetheless, Kroll said he’s hearing from pharmacology colleagues that people are getting prescriptions for the drug and snapping it up, so much so that orders for the drug have more than doubled this month and the price has shot up, according to data from Premier, a group purchasing and consulting organization.

“The average monthly units ordered for hydroxychloroquine was 8,800 from January 2019 through February 2020, or about 4,400 units ordered every two weeks. From March 1-17, we saw 16,110 ordered – a 260 percent spike compared to typical demand,” Premier reported on its website.

Kroll also worried that giving people azithromycin without studying the combination of drugs could result in one of that drug’s hallmark cardiac side effects.

“I worry that people will start taking azithromycin and getting arrhythmias from it,” Kroll said. “It’s crazy.”

RESEARCHERS SCRAMBLING

Hydroxychloroquine is one of dozens of drugs that researchers are racing to test and see if they’ll be of use for fighting COVID-19 infections.

Scientific American reported in late February that an antiviral drug called remdesivir is also showing promise in the fight against the coronavirus.

NBC News reported Thursday that early signs show remdesivir given to people who become very sick from the virus could start working within 24 hours of the first dose. The experimental treatment is thought to block the virus from reproducing itself in the body.

Another antiviral drug called favipiravir or Avigan showed promise in clinical trials in China, media outlets have reported.

The Washington Post reported Thursday that no treatments for coronavirus have been approved, though “medical investigators around the world are studying several widely available drugs, including chloroquine (sic), to see whether they can have a positive effect.”

The FDA posted on its website Thursday that it is working with other government agencies and universities that are investigating the drug as a treatment for the coronavirus.

The FDA said hydroxychloroquine has been approved for treating malaria, lupus and rheumatoid arthritis. Medical investigators are now trying “to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease.”

According to the Washington Post’s report, “doctors in China, South Korea and France have reported that the (chloroquine) treatments seem to help. But those efforts have not involved the kind of large, carefully controlled studies that would provide the global medical community the proof that these drugs work on a significant scale.”

Kroll said he’s sympathetic to the physician researchers who are trying all of the tools in the arsenal to fight the infection.

“We don’t have the luxury to do (studies) as empirically as we would in a different time,” he said.

Read full article here…

Additional source:

https://www.medicinenet.com/hydroxychloroquine/article.htm#what_else_should_i_know_about_hydroxychloroquine_plaquenil

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