The Centres for Disease Control and Prevention (CDC) has changed text on their website to remove guidance for physicians on the possible usage of hydroxychloroquine and chloroquine, two drugs touted as a wonder cure for covid-19 by Donald Trump, on patients.
Per Reuters, the page titled Information for Clinicians on Therapeutic Options for Patients with COVID-19 has changed from earlier this week, when it stated that both drugs have “in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2.” While the page said that “optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown,” it also listed possible doses “reported anecdotally” by physicians.
On Tuesday, the page was slashed by several paragraphs and only states that clinical trials are ongoing, as well as that the Food and Drug Administration has approved emergency use of the drug for patients not eligible to participate in those trials.
According to Reuters, medical experts found the original language to be extremely unusual, as the CDC does not typically recommend action based on anecdotal evidence. The page also only briefly mentioned severe cardiac side effects known to develop in some patients who take hydrochloroquine and azrithomycin; while Mayo Clinic genetic cardiologist Dr. Michael Ackerman told NBC News the drugs are “really, really safe” when administered properly, that does not mean they are safe to treat every patient.
Estimates of how much of the population falls in what Ackerman called the “danger zone” run as high as 11 per cent (though the study that found that number involved just 84 patients). Meanwhile, Trump’s comments have helped propel a rush on supplies of the drug, driving patients with lupus and arthritis that rely on it to treat painful symptoms.
“Why would CDC be publishing anecdotes?” Dr. Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, told Reuters. “That doesn’t make sense. This is very unusual.”
Former Harvard Medical School dean Jeffrey Flier told Reuters that the revised version “states the facts without in effect recommending that physicians prescribe the drugs despite a lack of adequate evidence.”
As the scale of the ongoing pandemic became clear, Trump on numerous occasions has praised the two drugs with terms like “a game-changer,” “something really incredible,” and “looking very, very good” when combined with azithromycin. To say that’s jumping the gun is an understatement, as the available evidence on the drug goes both ways.
Trump’s initial assessment was based on a small-scale French study published by the International Society of Antimicrobial Chemotherapy—which has since issued a statement saying the research did not meet their “expected standard” and failed to meet “scientific scrutiny and best practices.” The society also claimed that Jean-Marc Rolain, who happened to be both their editor-in-chief and a co-author of the study, had no involvement in its pre-publication peer review process.
New York University School of Medicine ethics division chief Art Caplan told CNN the French research was “pathetic,” noting that the authors excluded six cases out of their initial pool of 26. Those six were all pulled off the study for varying reasons: three were put in intensive care, one died, another was taken off the drug after experiencing side effects, and one did not actually have coronavirus at all.
Caplan told CNN that only publishing results from the remaining 20 subjects amounted to “cherry picking” and a “thumb on the scale.” Feinstein Institutes for Medical Research CEO Dr. Kevin Tracey told CNN that the study was a “complete failure” and useless as an evaluation of potential effectiveness.
Other evidence has been anecdotal. Dr. Vladimir Zelenko, a family doctor in Kiryas Joel, New York, has been in the news after claiming that he had treated hundreds of patients with hydroxychloroquine, azrithomycin, and zinc sulfate and achieved a 100 per cent survival rate. A Los Angeles physician, Mend Urgent Care CEO Dr. Anthony Cardillo, has also claimed that he has prescribed it to patients who were “very, very ill and within 8 to 12 hours, they were basically symptom-free.”
University of Toronto clinical pharmacology chief Dr. David Juurlink urged caution about these claims, telling the New York Times that “Anyone who tells you these drugs work, or don’t work, is not basing that view on science.” Per NBC News, doctors handling seriously sick patients at ICUs across the country have reported no notable impact from prescribing patients hydroxychloroquine.
“When you give it to somebody who is already super sick, it’s likely not going to make an impact because the damage is already done,” Dr. Ken Lyn-Kew, a pulmonologist at Denver’s National Jewish Health hospital, told NBC. “I’m not convinced it works… I’ve not seen anybody have anything near what I would call a miraculous recovery because of hydroxychloroquine.”
Patients with lupus, arthritis, other conditions are *already* on hydroxychloroquine.
And we are diagnosing them with covid19 *LEFT AND RIGHT*
If it does work, it‘s not as good as you hope it is.
And don’t give me any flimsy “resistance” excuses.
STUDY THE DRUGS!
— Jeremy Faust MD MS (ER physician) (@jeremyfaust) April 5, 2020
However, that uncertainty goes both ways. Tracey told CNN that despite the low quality of the French study, other small studies have shown that the drug might work, and its anti-inflammatory properties may help prevent covid-19 patients from experiencing a potentially fatal immune response called a cytokine storm. Juurlink told the Times that “There’s reason to be optimistic, and there’s also reason to be pessimistic.”
In the meantime, the CDC page reiterates “There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19.” It no longer lists suggested doses for patients.