Posted on 11/03/2023 9:14:22 PM PDT by SeekAndFind
People who received hydroxychloroquine were less likely to die than those who did not, according to a new study.
Just 0.8 percent of patients at a facility in France who received hydroxychloroquine (HCQ) and an antibiotic died, compared to 4.8 percent of patients who did not receive the drug combination, French researchers reported on Nov. 1.
"This study represents the largest single-center study evaluating HCQ-AZ in the treatment of COVID-19. Similarly, to other large observational studies, it concludes that HCQ would have saved lives," Dr. Didier Raoult, with Aix-Marseille Universite in Marseille, and his co-authors wrote.
The paper was published in the journal New Microbes and New Infections. It was released as a preprint earlier this year, but withdrawn because authors said they have changed their "analytic strategies."
Researchers examined records from 30,423 patients with COVID-19 who were treated at another institution in Marseille, IHU Méditerranée Infection. They included all adults who tested positive for COVID-19 and who were treated in the hospital as an inpatient or an outpatient between March 2, 2020, and Dec. 31, 2021.
The study set ended up with 30,202 patients because treatment information was not available for the 221 others.
Most of the patients received off-label prescriptions of hydroxychloroquine and azithromycin (AZ), a common antibiotic.
Of the set, 23,172 patients received the drug combination. The other 7,030 did not.
Among those who received the drugs, 191, or 0.8 percent, died. Among those who did not, 344, or 4.8 percent, passed away.
Those who received HCQ and AZ were more likely to survive regardless of whether they were inpatients or outpatients.
The biggest effect was recorded in outpatients aged 50 to 89.
Limitations of the study included drawing from records from a single center. Funding came in part from the French government.
HCQ has been cleared in both France and the United States for decades but not for treating COVID-19.
Dr. David Boulware, an infectious disease doctor at the University of Minnesota Medical School, said that clinical trial data do not support using HCQ against the illness.
"Hydroxychloroquine has not been shown to have any benefit in randomized clinical trials," Dr. Boulware, who was not involved in the new study, told The Epoch Times in an email.
"There is zero antiviral effect in humans, and zero reduction in hospitalization among 11 randomized clinical trials pooled together," he added, referring to a metanalysis he co-authored that was published in January. Dr. Boulware also helped carry out a randomized trial examining HCQ as a prophylaxis in people who were exposed to COVID-19, and found it did not prevent illness or confirmed infection.
Dr. Raoult and his co-authors acknowledged that several large randomized trials have found no benefits for HCQ against COVID-19, including a World Health Organization trial. But they said that the largest, funded by the World Health Organization and and United Kingdom government, suffered from "significant methodological problems," including high dosing during the first 24 hours.
The group also criticized smaller trials with similar findings as underpowered, including a trial in France that was stopped due to enrollment issues.
"In contrast, several large observational retrospective studies published in the literature, including a total of 47,516 patients report a benefit of using HCQ on the mortality of COVID-19 patients," the authors said, pointing to studies from France, Iran, and Spain.
They said the number of patients in the observational studies outweighs the number of patients in the randomized trials and support using HCQ as an early treatment.
Dr. Boulware said that observational data can suffer from serious problems, pointing to a response in 2020 to an observational U.S. paper that reported an association between HCQ with AZ and lower mortality among hospitalized patients.
Dr. Raoult and his co-authors acknowledged the limitations of observational data but lamented what they see as a dearth of clinical trials that use proper dosing.
"Unfortunately, few if any of the RCTs that have attempted to demonstrate the efficacy of HCQ on COVID-19 patients were run with an appropriate methodology," they wrote.
"Inadequate target (late treatment), excessive dosage of the drug, or inappropriate study power were the main troubles. While observational studies have also confounding factors, as discussed above, significant effect estimate differences between RCTs and observational studies are more likely to be linked to the quality of the study than to its design," they added, referencing a Cochrane Review that there was little difference between observational studies and clinical trials.
"In any case, since the epidemic has now vanished, it is no longer possible to conduct RCTs," they concluded. "Only observational studies can bring any more insights to support policy makers with repositioning of hydroxychloroquine in the treatment of COVID-19."
Dr. Raoult was director of the facility at which the patients were seen, but retired in 2022 after a French agency investigation found issues at the facility with regulation compliance. Several of his papers have since been retracted.
Dr. Raoult did not respond to a request for comment.
The new study came about a month after researchers in Belgium reported in another observational study that HCQ with AZ reduced COVID-19 mortality among hospitalized patients.
"Our study suggests that, despite the controversy surrounding its use, treatment with hydroxychloroquine and azithromycin remains a viable option," Dr. Gert Meeus, a nephrologist with AZ Groeninge Hospital, and other researchers wrote.
That group offered similar concerns regarding trials as the French group, including over the dosing levels.
I think the fact that Trump said it, was the reason they were so adamant it was harmful.
The 7,000+ who were denied this treatment….died as sacrifices.
I think the fact that Trump said it, was the reason they were so adamant it was harmful.
I think that’s only part of it. I believe big pharma knew they had the jab coming and didn’t want anything to get in its way. HCQ is at generic status and therefore nowhere near as profitable. Follow the money.
the hydroxy-ivermectin-azithromycin combo is even more effective against covid ... i personally know multiple people who rapidly recovered from covid when it first appeared and was quite deadly ... most had their fever break and felt better within 24 hours of starting treatment ...
1. Ivermectin as a prophylactic.
2. Add Hydroxychloroquine as treatment when symptomatic.
(Zelenko protocol)
New Microbes and New Infections: A real journal, but not a prominent one. It claims an impact factor of 4, meaning that its articles are not cited much in other articles.
The inclusion of Peter McCullough as an author is questionable. I don't know why the French researchers would have included him, as he has already demonstrated that he is a quack with respect to Covid treatment. Baylor University, his former employer, will not allow him to claim any affiliation with the university because of his antivax and Covid misinformation efforts.
The article itself acknowledges (in the Discussion) that most random control trials (RCTs) of hydroxychloroquine show no benefit. It then goes on to say that their methodology was flawed, their sample sizes too small, etc. And then it says that observational studies do show a benefit. The problem is that observational studies are highly prone to bias, making them a good reflection of what the study authors want to find but not such a good representation of the facts. The suggestion that all of the other studies showing no benefit to HC should reanalyze their data is unprofessional. If one study shows a result different from all of the other studies, it is what is called an "outlier." There are various reasons studies might be outliers. An outlier should not be interpreted as the definitive source of any scientific information.
Finally, this study was not a study of HC. It was a retroactive review of outcomes of patients who received HC and azithromycin. It is doubtful that the patients would have benefited from HC, as they did not have malaria. However, viral infections often cause people to get bacterial infections, so the antibiotic azithromycin could have had a therapeutic effect. But maybe not, it's hard to tell in a retrospective observational study.
Indeed. From what I understand, zinc greatly enhanced its effectiveness.
The efficacy of the pcr would be the same for both those who took and did not take the treatment right? So let’s say 90% or any X% of those taking treatment were not significantly ill. Would it be a different % for those that did not?
Yes, manufactured easily, cheap, and over a billion doses given worldwide. A miracle drug. One of 10 WHO essential medicines for years.
Re: The inclusion of Peter McCullough as an author is questionable.
Why? Dr. McCullough is a practicing Phycisian and Cardiologist who has experience treating Covid patients with Hydroxychloroquine. He maintains a medical practice in Dallas, and has published lots ( perhaps hundreds) of articles in medical journals and has received numerous awards.
He is Fellow of the American College of Cardiology, the American Heart Association, and the Society of Critical Care Medicine. He is also a member of the American Society of Echocardiography and the American Society of Nephrology.
That he is not now affiliated with Baylor University because of his antivax stance does not disqualify him from studying about his medical observations when treating patients.
I would not dismiss him as some sort of quack just like that.
RE:The article itself acknowledges (in the Discussion) that most random control trials (RCTs) of hydroxychloroquine show no benefit.
I direct you to the REASONS for the RCTs and their limitations. It says
[QUOTE]
Both trials should be considered as late treatment trials as the randomization occurred upon hospital admission, including as an ICU patient. Both suffer from significant methodological problems, as the HCQ doses during the first 24 h (2400 mg) were four times higher than the highest recommended dose of 600 mg. Mortality was no different between the treatment and control groups, but a careful review of the causes of mortality in the two groups would be worth investigating.
[END QUOTE]
Other RCTs they investigated suffer from small sample size, were underpowered and reach inaccurate conclusions, but as a whole serve as a reference for policy makers.
However, in the large sample sizes. Here is what the study observes:
[QUOTE]
several large observational retrospective studies published in the literature, including a total of 47,516 patients report a benefit of using HCQ on the mortality of COVID-19 patients.
The number of patients involved in these studies largely overweighs the number of patients included in RCTs.
Interestingly, these observational studies report that HCQ is associated with survival and the effect is greater in early treatment.
[END QUOTE]
I also direct you to the CONCLUSION of the article.
It says:
“Overall, this study represents the largest single-center study evaluating HCQ-AZ in the treatment of COVID-19. Similarly, to other large observational studies, it concludes that HCQ would have saved lives.”
You may disagree with its conclusions, but this article makes this conclusion even as it acknowledges the limitations of this study ( many such medical articles do that as well. )
Dingbat does.
Because SCIENCE™!
...She has no problems commenting on all kinds of doctors and scientists as quacks, and says proudly that a doctor isn't a scientist and can't comment out side their area of expertise.
But when you do mention someone, she immediately derides them as a quack (including someone she claims was her own doctoral thesis advisor).
But she still manages to say her claimed degree gives her magical expertise to comment on anything related to the clot shots.
Oh, I almost forgot.
She took calculus!
Dingbat, you said that Covid-1984 had been compared to natural viruses, and was 96% similar to a bat virus. Or was it rat?
Can you find the species of bat, and present a chart which shows the %congruity (as it were) along either the entire protein, or along the entire nucleotide, between COVID1984 and the nearest animal based-virus?
And find out when the chart was made?
Coming in from right field.
All you had to do was check the cases in countries with malaria
My wife has taken hydroxychloroquine for decades for an autoimmune disease. It is a critical drug for her.
She was hospitalized in 2020 for COVID. They refused to allow her to take her HCQ. They were apparently afraid it would cure the COVID.
That doesn't count, because you don't need a PhD to do it.
Don't you understand *SCIENCE* ?? /Dingbat mode OFF>
There us NO reasoning, with a bot.
Seriously.
The posting style/frequency is just too obvious.
So? Where is his experience in designing and running clinical trial studies of drug safety and efficacy? Where is his experience in designing vaccines or antivirals? What experience does he have in investigating the molecular events that occur in cells during virus infection and replication? What experience does he have in designing PCR assays to identify and characterize novel viruses? What experience does he have in culturing viruses and extracting and sequencing their genomes?
I can keep going. The point is that as a cardiologist, his expertise in Covid is limited to the effects of Covid infection on the heart. He does not have the relevant experience or education to speak as an expert on the topics of the infective process or the immune response following vaccination.
So?
What is going on here is an attempt by McCullough and (perhaps) coauthors to make the case that a retrospective observational study is more robust than a randomized control trial.
It is not.
The "methodological problem" in which 4x the FDA recommended dose of hydroxychloroquine (HCQ) was administered to the patients and no effect was seen does NOT imply that the FDA recommended dose would have had an antiviral effect. With 4x the dose, any antiviral effect of HCQ would have been augmented. (Like if you have a headache, taking two NSAID pills is more effective than taking one.) All that this study showed was that increasing the dose of HCQ by four-fold was not harmful to the patients.
Enrolling a patient "late" into a treatment trial is not a methodological flaw. It's hard to enroll patients ahead of time in a trial of treatment for an acute condition. How can anyone possibly know ahead of time that they are going to catch a severe enough case of Covid to require an ICU stay?
RCTs are, in fact, quite robust. Ideally, no one knows whether the enrolled patients are in the treatment arm(s) or the control arm of the study. Ideally, the randomization occurs in a way as to "match" the patients in control and treatment group in terms of age, gender, obesity, heart conditions, etc. Ideally, the randomizer's only contribution to the trial is to randomize study participants and keep records so that after the trial, the patient data can be sorted and analyzed appropriately.
Other RCTs they investigated suffer from small sample size, were underpowered and reach inaccurate conclusions, but as a whole serve as a reference for policy makers.
Again, these are not significant methodological limitations. The trial only has to be large enough to ensure that it contains enough patients for the deaths in the participant population statistically match deaths expected in the entire population. Patients in the ICU for severe Covid have a fairly high death rate* as compared to patients who only have to quarantine at home. Since the death rate is high and the purpose of the study is to show whether HCQ decreases deaths, the study can be small and still show acceptable statistical significance. In addition, since the purpose of the RCT is to compare efficacy of a specific treatment, all other factors in the trial are kept as consistent as possible. All patients in the trial receive standard-of-care.
On the other hand, retrospective observational studies can have significant drawbacks. For one thing, depending on the variable being observed, there is considerable bias in sample selection, especially if the study author has a preconceived notion of what the study is supposed to prove. For example, a study that purports to show that HCQ improves survival might separate the patient population in such a way that the controls who did not receive HCQ are older than the recipients of HCQ. In this example, there would be a higher survival rate of patients receiving HCQ, simply because they are younger and the mortality of Covid increases with age. There can be bias involved in formulating the underlying assumptions about the study. There is also variability of treatment modality, making it difficult to separate the effects of HCQ specifically from the effects of the other treatments given to the patient. Etc.
I did use an observational study for one of the references below of how deadly Covid is in patients with severe enough disease to warrant ICU care. This study is a little better than an observational study which depends on combing through medical records to try to discern efficacy of treatment. The only criteria for study inclusion was that patients with lab-confirmed Covid were admitted into the ICU. The only outcome measure was whether they survived. There was no attempt to determine efficacy of treatment protocols.
*Mortality in patients admitted to intensive care with COVID‐19: an updated systematic review and meta‐analysis of observational studies. --41.6% mortality of Covid ICU patients.
ICU and Ventilator Mortality Among Critically Ill Adults With Coronavirus Disease 2019. --28.6% mortality in Covid ICU patients.
Overall, this study represents the largest single-center study evaluating HCQ-AZ in the treatment of COVID-19. Similarly, to other large observational studies, it concludes that HCQ would have saved lives.
So, this is a retrospective observational study of patients who received two drugs, not just one. I think that I already pointed out that the antibiotic can improve the chance of survival by suppressing bacterial infections that often occur as a result of viral infection. In order to say that HCQ conferred a survival benefit, they would have had to compare mortality of patients who received HCQ-AZ with mortality of patients who received neither drug or who received only one of the drugs.
Etc. Do you really think I did not read the McCullough et al. discussion of RCTs and why (they say) I shouldn't place much weight on RCT outcomes? Of course I read it.
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