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Studies Will Show If Hydroxychloroquine Can Save Lives

Scientists are scrambling to set up studies. They hope to learn if hydroxychloroquine can save lives during the coronavirus epidemic.
Studies Will Show If Hydroxychloroquine Can Save Lives
Hydroxychloroquine sulphate tablets, in evaluation for treatment of COVID-19.Denmark, Mars 22, 2020

People paying attention to possible treatments for COVID-19 are hoping that hydroxychloroquine can save lives. They are very interested in the potential for this drug (HCQ) and another old malaria drug, chloroquine, to combat the coronavirus. But there is a lot of pushback from health professionals. Many say that there are no good studies that prove HCQ actually works against the coronavirus. They’re not wrong, but some pilot studies are intriguing. 

We Don’t Know If Hydroxychloroquine Can Save Lives in This Pandemic:

Skeptics:

There are no large, placebo-controlled trials of HCQ. Dr. Jerome Hoffman is an epidemiologist and emeritus professor of medicine at the University of California Los Angeles.

He told the BMJ (April 1, 2020):

“‘It would seem prudent,’ he said, for the government to ‘explicitly discourage off-label use of experimental treatments, such as hydroxychloroquine for covid-19, until clinical trial data strongly point to a true benefit.’”

Dr. David Juurlink is an internist and head of clinical pharmacology and toxicology at the University of Toronto.

He told the New York Times (April 2, 2020):

“Anyone who tells you these drugs work, or don’t work, is not basing that view on science. There’s reason to be optimistic, and there’s also reason to be pessimistic.”

Advocates:

People who have done some pilot studies acknowledge that large, well-controlled trials need to be done. But they also note that a lot of people have died and more are dying every day. Physicians have nothing to offer victims of the COVID-19 except supportive care, and ventilators are in short supply.

Some of the pilot studies from France and China have produced conflicting results. One Chinese study demonstrated no benefit from HCQ. Two French studies suggested there was some benefit, but critics note that this research was not double-blind and placebo-controlled.

The French team concludes:

“…the combination of hydroxychloroquine and azithromycin resulted in a clinical improvement that appeared significant when compared to the natural evolution in patients with a definite outcome, as described in the literature.”

Now, a new controlled clinical trial from Wuhan (medRxiv, March 31, 2020) reports some clinical benefit from hydroxychloroquine. The physicians recruited 62 patients with mild to moderate symptoms of COVID-19. They were randomized to usual care (no HCQ) or five days of usual care plus HCQ. The patients receiving the drug recovered more quickly and their chest x-rays demonstrated less pneumonia.

The authors conclude:

“The data in this study revealed that after 5 days of HCQ treatment, the symptoms of patients with COVID-19 were significantly relieved, manifesting as shorten in the recovery time for cough and fever. At the same time, a larger proportion of patients with pulmonary inflammatory has been partially absorbed in the HCQ treatment group, indicating the immune modulation and anti-inflammatory properties of HCQ in non-malarial diseases…Therefore, with antiviral and autoimmune regulation effects, HCQ should be a protector in SARS-CoV-2 infection. In the present study, the reduced risk of progression to severe illness in patients with HCQ treatment also explained the intervention effect of HCQ on the pathological process of the COVID-19.”

“Despite our small number of cases, the potential of HCQ in the treatment of COVID-19 has been partially confirmed.”

Another intriguing observation from this paper involves lupus patients. The authors note that of the 80 patients being treated for systemic lupus erythematosus (SLE) at this Wuhan hospital, none appeared to develop COVID-19. These patients had been taking long-term oral HCQ to control their lupus. Coincidence or a preventive effect of hydroxychloroquine?

The Chinese researchers call for large-scale clinical trials to confirm their preliminary findings. We could not agree more!

Trials Underway to Determine if Hydroxychloroquine Can Save Lives:

Several large trials are now underway in the U.S. One, conducted by the University of Minnesota, is recruiting 1,500 people who have come into contact with infected patients. It aims to determine whether hydroxychloroquine can prevent infection.

Another prevention trial is part of a collaboration between the University of Washington and New York University. It will enroll 2,000 exposed individuals.

Meanwhile, the state of New York is conducting an observational trial of the same compound to treat people with COVID-19. Results of all these studies should become available over the next several weeks or months.

No one knows if hydroxychloroquine can save lives. There are risks to this drug and its chemical cousin, chloroquine. Sudden cardiac death is the most serious. People with long QT interval on their electrocardiogram are the most susceptible. Read about this adverse reaction at this link

One Final Note:

Denise Hinton is the Chief Scientist at the Food and Drug Administration. We have communicated with her in the past and found her to be thoughtful and responsible.

She recently wrote:

“This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of 2019 coronavirus disease (COVID-19) when administered by a healthcare provider (HCP) pursuant to a valid prescription of a licensed practitioner…”

Some people have told us that this action was taken as a result of pressure from the administration. We hope that is not true. The FDA traditionally moves slowly and deliberately.

We would be surprised if the agency took this action without some reason to believe, as Denise Hinton states in her letter:

“that, when used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products.”

Only time and testing will tell if the FDA is right. We certainly hope to learn whether hydroxychloroquine can save lives, so we will be watching the trials closely.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Citations
  • Lenzer J, "Covid-19: US gives emergency approval to hydroxychloroquine despite lack of evidence." BMJ, April 1, 2020. doi: https://doi.org/10.1136/bmj.m1335
  • Chen Z et al, "Efficacy of hydroxychloroquine in patients with COVID-19: Results of a randomized clinical trial." medRxiv, March 31, 2020. doi: https://doi.org/10.1101/2020.03.22.20040758
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