Posted on 03/29/2020 10:58:40 AM PDT by Widget Jr
An old malaria medicine, hydroxychloroquine, has gone viral on the internet. But is it really an antiviral drug?
The medicine has been seen as a potential treatment for Covid-19, the disease caused by the novel coronavirus SARS-CoV-2, almost since outbreaks started. This week it made headlines, due in part to tweets from President Trump and in part because of a small French study of 42 patients that seemed to show that hydroxychloroquine, particularly when combined with the antibiotic azithromycin, helped decrease patients’ levels of coronavirus. Unfortunately, the rumors about the drug’s efficacy have also encouraged some to buy and even consume a similarly named fish tank cleaner; one person has died.
But a second study emerged last week from Shanghai University in China of 30 patients hospitalized for Covid-19. Whether patients received hydroxychloroquine or not, their body temperature returned to normal a day after hospitalization, and the time it took for levels of the virus to become undetectable was comparable. Unlike the study from France, the patients in this study were randomly assigned to either hydroxychloroquine or the control group, which makes the results more reliable.
Jun Chen, one of the authors of the Shanghai study, called the French study’s results “interesting” but said they needed to be evaluated in another randomized study.
“Both our study and theirs had many limitations,” Chen wrote. “But personally, I would say that hydroxychloroquine was not a ‘magic’ drug, if there is any antiviral effect. And in fact, hydroxychloroquine has never been effective in any viral diseases, despite its in vitro antiviral activity.” “In vitro antiviral activity” means that the drug stops the virus from infecting cells in the dish.
The first mention of the Shanghai study came from a paper in The Lancet Global Health, where the results were described as positive. One of the authors of the Lancet paper, Oriol Mitjà, wrote via email that changes on CT scans showed “that the drug has some efficacy” against Covid-19. In the Shanghai study, worsening of the disease that could be picked up on a CT scan happened in 33% of those on hydroxychloroquine (that’s 5 patients) versus 47% of those in the control group (7 patients).
Mitjà was even more optimistic about the French study, saying it has “new and stronger data.”
But objections have been raised to the French study paper, even as it’s bounced around the Internet. Fox host Sean Hannity even shared another doctor’s letter on his experience using the hydroxychloroquine/azithromycin combination on his television show on March 23.
Three statisticians published a review of the French study that argued that the way it was designed made the treatments look better than they actually are. They pointed to the lack of randomization, as well as an inappropriate control group composed partly of people who refused to take the drug. They also noted that the study dropped some patients from the analysis — the small study of 42 patients actually only included data from 36. The Shanghai study, which showed less impact from the treatments, adds to the questions about the French study, wrote Tim Morris, a statistician at the MRC clinical trials unit at University College, London.
“The [French] study gave very little useful information about whether hydroxychloroquine might help,” Morris wrote. “The Shanghai study is better (because they had a meaningful control group) but gives us very little information that hydroxychloroquine doesn’t help.” The data, he wrote, are “compatible with a wide range of possible effects,” which is statistician-speak for, “Nobody knows whether the drug helps or not.”
The Shanghai study, Morris wrote, is a step in the right direction toward some bigger, better trials that are kicking off. The first of these might give some answers in April — a short time when it comes to clinical trials, but potentially after the United States, and particularly New York City, will have seen a tsunami of Covid-19 cases.
Some doctors on the front lines will use these drug combinations, particularly with patients who are so sick they are on ventilators. As one doctor told me, the risks associated with these drugs, like heart rhythm disturbance or worsening psoriasis, don’t warrant not using them in patients who are in serious trouble. But there is also a need to conduct studies of them to find out if they are truly effective. New York Governor Andrew Cuomo signed an executive order saying that pharmacists should not dispense the drugs to treat Covid-19 unless they are part of a clinical trial. Studies for another drug, remdesivir from Gilead Sciences, are expected to read out in the coming weeks.
Zach Weinberg, one of the co-founders of Flatiron Health, a division of Roche, remembers the difficult transition of going from working in online advertising, where his first company was focused, to Flatiron, which is focused on cancer. In software, more data is better. In cancer, the wrong type of data can lead to conclusions that are not only incorrect but dangerous.
“Sometimes people confuse saying, ‘the study doesn’t tell you anything’ with saying the drug doesn’t work,” Weinberg said. “That’s a really important distinction. They’re not the same thing. I’m not saying the drug doesn’t work or does work. What I’m actually saying is nobody knows if the drug works or doesn’t work.”
His lesson: when dealing with a pandemic, listen to experts who are used to grappling with these problems.
“Society tends to put people who’ve been successful in one area on a pedestal, and draw the conclusion that means they’re expert at many things even though the expertise that they had in one area has nothing to do with the other,” Weinberg said.
About the Author
Matthew Herper
Senior Writer, Medicine
Matthew covers medical innovation — both its promise and its perils.
Yeah, and in the meantime he doesn't want doctors to prescribe the cocktain that has proven results in recent weeks (1. Hydroxychloroquine 200mg twice a day for 5 days 2. Azithromycin 500mg once a day for 5 days 3. Zinc sulfate 220mg once a day for 5 days)
I thought the creed was "First do no harm". It isn't "Do nothing". If there is no harm prescribing these drugs to people that contract the virus, I would serious question the motives of the doctor that doesn't. Politics suck.
We know that the Trump pills work to some extent and we know that they might not be the treatment of choice for everyone, including those with heart conditions.
My thought would be is to use the Trump pills for those that will benefit until other treatments come on line. As for patients that the Trump pills may be dangerous? Use carefully unless other treatments options are available.
I thought the Shanghai study used other antivirals as the control, not a placebo.
Just read this summary sentence from the article you posted:
"But a second study emerged last week from Shanghai University in China of 30 patients hospitalized for Covid-19. Whether patients received hydroxychloroquine or not, their body temperature returned to normal a day after hospitalization, and the time it took for levels of the virus to become undetectable was comparable. Unlike the study from France, the patients in this study were randomly assigned to either hydroxychloroquine or the control group, which makes the results more reliable."
That should make you wonder. Why did the patients in the study get better nearly instantly, regardless of treatment?
If you read the study, you would see that the patients in the study all got better within a couple of days, even without treatment. In fact, they were either already cured, or nearly so. In essence the Chinese "study", if it is even real, took patients who were essentially cured anyway, gave them medicine, and then noted that the medicine had little effect on their progress - exactly as one would expect for any test administered to patients who at that point at least, didn't need the medicine.
There is no published evidence anywhere that COVID-19 patients are cured in a median of 2 days after diagnosis. But that is exactly what the Chinese research team found for their control group. And the range included 1 day.
"The median duration from hospitalization to virus nucleic acid negative conservation was 4 (1-9) days in HCQ group, which is comparable to that in the control group 2 (1-4) days..."
But no one is reporting that hospitalized COVID-19 patients are recovered and virus free within a median time of 2 days, with some recovering in 1 day, and the longest recovering in 4 days. The patients in the control group had already recovered from the virus. Similarly, the treated patients, except for the 9 day patient, recovered in a median time of 4 days, with one of the patients recovering in one day.
The Chinese paper cited in the article, if it is even real, has an idiotic experimental design. The big question for you, and everyone else hyping it is why is there such a big effort to undercut the research showing hydroxychloroquine does work. So why are you doing that?
Some Lupus patients have taken it daily for years.
So lets find out. Field trials, now.
No other medical group is reporting that untreated COVID-19 patients get better in a couple of days. The patients in the "study" must have already been almost cured.
This story misses the point.
It’s not hydrocloroquine alone. It’s a combo therapy.
Trial after trial says it does work. Only the stupid woman Governor of Michigan is fighting against it because President Trump mentioned it. Oh did I say she is a democrat?
My doc has been giving it to his COVID patients - he said they have been having the same good results
That may be anti-virals or just about anything you can imagine. Perhaps someone who reads Chinese can read the rest of the study and report back to us.
Regardless of what the control group received, they were nearly cured at the start of the study since they had a median time to no virus present of 2 days, with the longest being 4 days. So they were effectively cured in a median time of 2 days, far less than any reported total times for clearing the COVID-19 infection from onset to resolution.
The control group, if the study is real at all, were people who were already cured, and about to be released.
Chinese disinformation.
Brought to you by the lying liars of the lying Chinese government, who have been lying about this since November or before.
Gotta pay the vig...
The 1 thing we do know is it does work on Malaria, my Dad caught it in the Philippines. When a flare up happened it is what was given. It’s been used off label on Lupus, just as Plaquenil. From the side effects alone I’d have to say it is better than Plaquenil which is very rough on the Lungs. Trashed my niece’s.
Just don’t use Ibuprofen, doesn’t mix well with it..
I’ve been on an NSAID for a month after cataract surgery. It just ended yesterday. I’ve been really good about staying in because of that. I’m gonna look to see how long it stays in your syste.
Doctors talk to each other. They are prescribing this because it works. The successes are anecdotal - hundreds and hundreds of successful recovery anecdotes. That is how medicine was practiced before the FDA. Based on what is known right now, I would consider it an actionable malpractice to deny this option to a patient.
“A few non-clinical trials, doctors using medications on their own, and andanecdotal evidence are not proofs any one cure really works.”
check out these 140 (at the moment) papers published in 2020 regarding treating C-19 with hyroxychorolquine + azithromycin ... how many more studies and papers would you like?
A more important question is: if you or yours fell deathly ill with C-19, would you want those drugs to be tried?
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