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.
He’s not very politically correct, which I like. Also worth noting that since the OP article, Raoult has released positive results on another 80 patients.
If I am dying, I don't to be part of a stupid study that may not give me the medication.
Anecdotal is a pejorative against anything pharmaceutical companies can not profit from...
The correct word is pragmatic medicine. Do what works in real life clinical practice.
Allow the drug companies to do their studies during their own time.
Forget it. Widget jr. lacks common sense. If he had the virus, he’d wait until Fauci finished his studies in 2021.
Im beginning to think that Fauci is missing a few screws..they dont even have that many dead in ITALY..they have 10,000 dead and they are the hardest hit country, you combine Italy and Spain and you wont have 100,000 dead
You’re welcome. Hope is good!
The best current information that I’ve been able to find is linked above in post 4.
Dr. Zelenski explains his “cocktail”, the selection criteria for who gets treated and when and his rationale for the treatment. He’s a clinician, who is, very bravely in my view, doing what he can to save his community, and to get that information out so it can be tried/tested elsewhere as well. He’s doing this with the full knowledge that there will be those in power who are going to attack him because if this turns out to work, they think it will help the president turn the tide in this country.
They hate us that much.
So, no, it’s not science, not yet. But it is medicine, and that’s what this doctor is practicing. We would prefer science, random double-blind studies and all the rest, but we just don’t have time.
The key, both in Marseilles by Dr. Raoult, and with Dr. Zelenski is early intervention, and the combination of the 2 drugs. Zenenski adds a zinc supplement, but no one knows if that’s critical. But that really can’t hurt.
“My Brother is an MD.
He had the symptoms. Chief of Staff at a hospital in the Dallas area.
Took the Hydroxychloroquine and was fine in 2 days”
Great to hear! Thanks!
What if monkeys flew out of my butt?
Doctors always prescribe off label. And they use simple clinical evidence, as we have with hydroxychloroquine/ azithromycin, to make treatment decisions. If they didn’t, people would be a lot sicker and the field of medicine would be unrecognizable.
The word “anecdotal” is very misleading. Every randomized, placebo controlled, statistically relevant and peer reviewed study was initially “anecdotal.”
The dirty secret is that big pharma has huge control over formalized studies.
Clinical trials may begin next week in New York for coronavirus treatments:
Many other centers are preparing or have trials underway.
Several clinical trial centers are getting ramped up to test hydroxychoroquine-azithromycin combo treatment ‘HCA Tx’ in clinical trials.
That costs money.
Reports/rumors are that Fauci is dragging his feet on funding HCA Tx trials because he long ago sold his soul to the vaccine lobby and his press statements appear to confirm this sellout/bias.
So the centers are getting $$$ from somewhere. But from where?
POTUS has been touting the promising reports of HCA Tx results. POTUS did not pull the results out of his butt. He’s getting reports likely from some stellar military physicians who tell him straight.
My bet is POTUS is directing a fund manager somewhere to greenlight the HCA Tx trials.
we are in a war.
And they do not know?
This is bullshit disinformation.
What is being used is a combination of drugs , not just Hydroxi-chloroquin, which shows that Big Pharm does not want what is working should be understood by the People.They rail against a single part of the therapy without revealing the rest of it because IT WORKS.But it has to be administered before the lungs fill with mucus.
But what President Trump’s agent, Rudy Giuliani has done is created a populist end run around the CDC ( Fauci) and the FDA. This to save lives.
If you are a Trump supporter you know what to do. Contact your physician and ask whether this therapy can be available if you need it. If not shop around. And if you find a Jewish doctor, you’re in like Flynn.The therapy cost of the drugs is $20.00, so it won’t break you.
Its really up to you.
President Trump has arranged for millions of dosages to come into our country from Israel’s Teva Corporation....Free. Availability will be no problem
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THIS CAN SAVE YOUR LIFE
EXCELLENT NEWS: Hydroxychloroquine Treatment Effective on 699 Patients
Must see video: https://www.youtube.com/watch?v=1TJdjhd_XG8&t=586s
Dr. Vladimir (Zev) Zelenko
Board Certified Family Practitioner
501 Rt 208, Monroe, NY 10950
845-238-0000
March 23, 2020
To all medical professionals around the world:
My name is Dr. Zev Zelenko and I practice medicine in Monroe, NY. For the last 16 years, I have cared for approximately 75% of the adult population of Kiryas Joel, which is a very close knit community of approximately 35,000 people in which the infection spread rapidly and unchecked prior to the imposition of social distancing.
As of today my team has tested approximately 200 people from this community for Covid-19, and 65% of the results have been positive. If extrapolated to the entire community, that means more than 20,000 people are infected at the present time. Of this group, I estimate that there are 1500 patients who are in the high-risk category (i.e. >60, immunocompromised, comorbidities, etc).
Given the urgency of the situation, I developed the following treatment protocol in the pre-hospital setting and have seen only positive results:
1. Any patient with shortness of breath regardless of age is treated.
2. Any patient in the high-risk category even with just mild symptoms is treated.
3. Young, healthy and low risk patients even with symptoms are not treated (unless their circumstances change and they fall into category 1 or 2).
My out-patient treatment regimen is as follows:
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
The rationale for my treatment plan is as follows. I combined the data available from China and South Korea with the recent study published from France (sites available on request). We know that hydroxychloroquine helps Zinc enter the cell. We know that Zinc slows viral replication within the cell. Regarding the use of azithromycin, I postulate it prevents secondary bacterial infections. These three drugs are well known and usually well tolerated, hence the risk to the patient is low.
Since last Thursday, my team has treated approximately 350 patients in Kiryas Joel and another 150 patients in other areas of New York with the above regimen.
Of this group and the information provided to me by affiliated medical teams, we have had ZERO deaths, ZERO hospitalizations, and ZERO intubations. In addition, I have not heard of any negative side effects other than approximately 10% of patients with temporary nausea and diarrhea.
In sum, my urgent recommendation is to initiate treatment in the outpatient setting as soon as possible in accordance with the above. Based on my direct experience, it prevents acute respiratory distress syndrome (ARDS), prevents the need for hospitalization and saves lives.
With much respect,
Dr. Zev Zelenko
I am of the opinion that the “bail out” should have included funding for a wide variety of inexpensive drug trials. I am under the impression that it did not.
*********************************
Heartily agree. If such funding wasn’t included in the bailout, it should come from somewhere else for that purpose. Surely some federal entity like the CDC has discretionary budget for that kind of thing.
I’m sure the FDA is on the case - within 10-20 years they will let us know if hydroxychlorquine is approved. Much will hinge on whether or not mice get cancer after eating 10 pounds of the stuff every day.
The stuff has been around for 70+ years. It’s been used by militaries around the world. It’s side effects are very well-known. Shut down the “ambulance chasers” for awhile, use it and see. What is there to lose by trying it if people are dying. The RATS are doing everything in there power to make this worse. That alone, is enough suspicion that they had some kind of hand in this. Once we’re through this, they need to have their azzes kicked to the curb....like for a hundred years, if not outright publicly hanged.
The hatred for Trump is so strong they would rig this. They think this thing is the only chance of taking Trump out so they will do whatever it takes to make it as bad as possible.
“If’’ is the middle word in ‘’life’’. We’ve got to give this medication a try.
BullSH*T it doesn’t work.
If the author is implying that we should wait 12-24 months for double blind randomized trials before doctors are allowed to use the therapy, then he is advocating letting tens of thousands to millions die (depending on the model you believe). If this disease is as serious as the hysteria merchants insist, why would any promising treatment (with a half century of use for other ailments attesting to relative safety when medically supervised) why would they discourage its use?
We’ve been hearing about this treatment for almost two weeks. You would think we would know something by now.
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