[Originally published on July 29, updated 8/13/20]
Take the hydroxychloroquine challenge!
Well, it looks like we are back to talking about hydroxychloroquine. Here's what I know about this issue. Mind you, this is just about hydroxychloroquine and not the rest of the craziness with which we have been living. For context with all of the rest of the insanity, check out my database.
Part One
Our latest reincarnation of the issue is really part 2. The first part began in March with a Fox report of a small French study that touted the effectiveness of the drug. Almost immediately Trump vowed to make it more widely available. “It’s shown very encouraging – very, very encouraging early results,” he said at a press conference. “And we’re going to be able to make that drug available almost immediately. And that’s where the FDA has been so great. They – they’ve gone through the approval process; it’s been approved. And they did it – they took it down from many, many months to immediate.”
At the same press conference, FDA administrator Hahn said regulators were taking “a closer look.” “That’s a drug that the president has directed us to take a closer look at, as to whether an expanded-use approach to that could be done to actually see if that benefits patients.”
Another report, this time from the U.K. seemed to lend support to that view by finding "positive effects among COVID-19 patients who take a combination of hydroxychloroquine and the antibiotic azithromycin". Although the study garnered international attention, cooler heads cautioned not to make too much of a non-controlled study with a small sample size (26 people).
Nonplussed, Trump tweeted on 3/21/20 that "HYDROXYCHLOROQUINE and AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)....."
The CDC, following suit, immediately issuing an Information for Clinicians on Treatment Options for COVID-19 Patients. The document describes possible prescription information for coronavirus patients, while at the same time proposing hydroxychloroquine and chloroquine as a restricted option in coronavirus treatment.
The American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists cautioned against it use, issuing a joint statement on ordering, prescribing or dispensing COVID-19 medications. "We are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues; and that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. We strongly oppose these actions.
Regardless, the FDA granted Hydroxychloroquine and chloroquine, previously anti-malarial drugs, EAU (emergency use authorization).
A very short time afterwards, a paper in Annals of Internal Medicine, “Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic: What Every Clinician Should Know” warned that “data to support the use of HCQ and CQ for COVID-19 are limited and inconclusive.”
Concerned, the CDC removed its guidance to doctors about hydroxychloroquine on 4/7/20.
See also:
On 4/21/20, a panel of experts convened by the National Institute of Allergy and Infectious Diseases recommended against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of its potential toxicities.
The FDA followed suit, cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.
Trump, however dismissed the hydroxychloroquine studies, telling reporters that he has been taking the drug.
“I worked with doctors,” he began. “If you look at the one survey, the only bad survey, they were giving it to people that were in very bad shape, they were very old, almost dead. It was a Trump enemy statement.”
A short time later, on 5/22/20, a Lancet Article claimed that the malaria drugs hydroxychloroquine and chloroquine did not help coronavirus patients and may have done harm; People who received the drugs were more likely to have abnormal heart rhythms.
Part Two
The issues of the efficacy of the drug resurfaced anew on July 2nd when the Henry Ford Health System report was published in the International Journal of Infectious Diseases, a peer-reviewed, open-access online publication of the International Society of Infectious Diseases shows that treatment with Hydroxychloroquine cut death rate significantly in COVID-19 patients.
That, and the 5/27/20 article published in the American Journal of Epidemiology entitled: “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis” concerning the work of Yale professor of epidemiology Harvey S. Risch, reignited this debate. He concluded that theoretical fears of cardiac events were not borne out in real-world usage and were vastly overshadowed by lives saved.
[ED. NOTE:
On 8/4/20, some Yale Faculty members, writing with "grave concern", responded to Dr. Risch's "ardent advocacy".
While minority opinions, anecdotal evidence, novel interpretations and challenges to orthodoxies in a field can be important, at some point, the application of the scientific method generating evidence from multiple, well-designed clinical trials and observational studies does matter and should be heard over the noise of conspiracy theories, purported hoaxes, and the views of zealots.
You will see that people who want to push this drug cite either or both of these. They rarely bother to go digging any further.
Without belaboring Dr. Risch's work, feel free to investigate for yourself. For example, a 6/2/20 article "Hydroxychloroquine Misinformation Can Be Deadly: Let Patients Decide" speaks directly to his comments. And this article seriously critiques Dr. Risch's work. A few days after the publication of his comments, yet another study found no clinical benefit from use of hydroxychloroquine in patients hospitalized with COVID-19.
However, things seriously kicked off around the Fourth of July holiday. Days after the Henry Ford Health System report was published, Trump was tweet-touting the drug again. While Trump has his reasons for kicking the anthill, you might want to take a look at "A flawed Covid-19 study gets the White House’s attention — and the FDA may pay the price" for what the experts say is wrong with that study. Researchers have severely criticized the Henry Ford study as not meeting the standards set for medical research. One researcher set out the problems he saw for an assessment that the the flaws in the analysis made the conclusions reached invalid. In "Clarifying the record on hydroxychloroquine for the treatment of patients hospitalized with COVID-19" University of Albany researchers also made observations critical of the Henry Ford study. Asked to comment on the efficacy of the study during his Congressional testimony, Dr. Fauci's comments mirrored those criticisms.
Faced with this barrage of detractors claiming heresy, Henry Ford issued a statement: "We've acknowledged the varying conclusions multiple studies have reached, along with the limitations of our retrospective [hydroxychloroquine] study as well as those of other published studies on the topic."
Regardless of whether it's the initial phase of this debate or the more recent Henry Ford/Breitbart-video, the science guys always come down on "don't do this".
Faced with this barrage of detractors claiming heresy, Henry Ford issued a statement: "We've acknowledged the varying conclusions multiple studies have reached, along with the limitations of our retrospective [hydroxychloroquine] study as well as those of other published studies on the topic."
Regardless of whether it's the initial phase of this debate or the more recent Henry Ford/Breitbart-video, the science guys always come down on "don't do this".
For example, as recently as 7/23/20 "Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19" was published in the New England Journal of Medicine finding that "among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care". See also.
We are now caught in what is essentially a counterproductive force of will and personality. While it seems like a century ago, it was only two days ago that the video with “America's Frontline Doctors”, along with a push from the president, managed to convince apparently many to abandon logic and science. Dr. Stella Immanuel, a primary care physician in Houston, declared that no one need fear the coronavirus that has so far killed more than 150,000 people in the United States and more than 650,000 worldwide. "This virus has a cure. It is called hydroxychloroquine, zinc, and Zithromax."
In addition to her comments, also in attendance was Dr. Simone Gold, who claimed to head the group,an organization comprised of "some doctors" and others involved in the anti-vaccination movement. Dan Erickson, one of the two YouTube Bakersfield doctors, also spoke at the news conference.
In spite what caution would dictate, the following day Trump doubled down on hydroxychloroquine. “Many doctors think it is extremely successful, the hydroxychloroquine coupled with the zinc and perhaps the azithromycin,”
That was followed later that evening by Dr. Fauci, dismissing the President's medical advice: “The overwhelming prevailing clinical trials that have looked at the efficacy of hydroxychloroquine have indicated that it is not effective in [treating the] coronavirus disease.”
Dr. Deborah Birx subsequently joined him in this assessment that scientific evidence does not support claims that hydroxychloroquine is effective in treating COVID-19, despite its touting by President Donald Trump.
"It's not productive or helpful for me to be making judgments on right or wrong but what I can say is what I've said all along, that the overwhelming body of data from trials that were well run, randomized placebo controlled trials, indicate that hydroxychloroquine is not effective in treating coronavirus disease," Fauci recently told Congress.
"It's not productive or helpful for me to be making judgments on right or wrong but what I can say is what I've said all along, that the overwhelming body of data from trials that were well run, randomized placebo controlled trials, indicate that hydroxychloroquine is not effective in treating coronavirus disease," Fauci recently told Congress.
On 7/29/20 Scott Gottlieb, former Trump FDA head went on one of the Sunday shows and said that "We can definitively say hydroxychloroquine doesn't work".
https://www.axios.com/hydroxychloroquine-coronavirus-scott-gottlieb-trump-a7b60575-91db-4239-8c86-59b993c55358.html Following him closely was White House coronavirus testing czar Adm. Brett Giroir who said that he “can't recommend” hydroxychloroquine to treat COVID-19. While hydroxychloroquine “looked very promising” at first, he noted that five studies had found that the anti-malarial drug does not help COVID-19 patients.
“At this point in time, there's been five randomized-controlled, placebo-controlled trials that do not show any benefit to hydroxychloroquine, so at this point in time, we don't recommend that as a treatment.”
[ED NOTE:
On 8/7/20 Newsweek ran a story about a report claiming that more than 100 People had died in U.S. while taking Hydoxychloroquine for COVID-19
In the first half of 2019, 3,251 adverse events were recorded in patients taking hydroxychloroquine or its derivatives, with over 2,441 said to be serious as the individual was hospitalized, disabled or died. In the first half of this year, 6,588 adverse events were recorded, with 6,233 designated serious.
As of today, the debate isn't about the development of other drugs and vaccines, things that are actually positive and moving in the right direction. No, while we're ostensibly debating about the efficacy of a drug, what is happening is more tribalization and factionalism. We're looking at this health issue through a political prism, focused on whether we like what the medical professionals and scientist say and we're doing it at a time of utmost peril.
