While another report suggested that there was insufficient clinical data to either recommend or oppose the use of hydroxychloroquine for treating those infected with the deadly virus.
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Hydroxychloroquine tablets
The plan to use much touted anti-malarial drug hydroxychloroquine for treating COVID-19 patients has received a setback with more deaths being reported among those who were given the drug, according to a report.
While another report suggested that there was insufficient clinical data to either recommend or oppose the use of hydroxychloroquine for treating those infected with the deadly virus.
President Donald Trump, who has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients, said that he would look into the reports.
His administration has stockpiled more than 30 million doses of hydroxychloroquine, a large chunk of which has been imported from India.
“I don’t know of the report. Obviously, there have been some very good reports and perhaps this one’s not a good report. But we’ll be looking at it. We’ll have a comment on it at some point,” Trump told reporters during his daily White House news conference on coronavirus.
Trump was responding to a question on a study released by a group of scientists on use of hydroxychloroquine with or without antibiotic azithromycin for 368 COVID-19 patients.
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The unreviewed study submitted to New England Journal of Medicine for publication and posted online found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalised with COVID-19.
“An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone,” said the study that was funded by the National Institute of Health or NIH.
NIH in its report ‘Therapeutic Options for COVID-19 Currently Under Investigation’ said that there are insufficient clinical data to either recommend or oppose using chloroquine or hydroxychloroquine for treatment of COVID-19.
If chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects, especially prolonged QTc interval, it said.
The panel of NIH experts recommended against the use of the combination of hydroxychloroquine and azithromycin because of the potential for toxicities.
US Food and Drug Administration Commissioner Stephen M Hahn said that no final decision has been taken as yet.
“I’ve mentioned from this podium and in other venues before, what FDA is going to require is data from clinical trials, randomised clinical trials, hydroxychloroquine/placebo, to actually make a definitive decision around safety and efficacy,” he told reporters.
The first one is a small retrospective study at the VA. “And similar to the data we talked about before with the French study, this is something that a doctorate would need to consider as part of a decision in writing a prescription for hydroxychloroquine,” he said.
“But the preliminary data are helpful to providers. I want to ask them (doctors) to incorporate the data as we have it come forward. It’s not definitive data. It doesn’t help us make a decision from a regulatory review.”
“But doctors should incorporate that in the decision-making they make on a one-on-one basis,” Hahn said in response to a question.
Congressman Bill Pascrell said the report analysing hydroxychloroquine as a potential COVID-19 treatment at veterans hospitals is a bombshell indictment of the damage Trump and his administration does to Americans by putting politics before science.
“The world class medicine and doctors we enjoy today are the fruit of generations of painstaking work by our ancestors. Evidence-based science is the only way out of this crisis, not unproven miracle therapies personally favored by Donald Trump,” he said.
“Trump’s frequent touting of this treatment was deeply irresponsible, and may have heaped unnecessary pain and suffering, not to mention false hope, upon Americans struck by this terrible illness.”
“I have repeatedly warned the FDA about the danger of prizing Trump’s political pressure over scientific process. Unless we are guided by science and science alone, we will have more unnecessary deaths on our hands,” Pascrell said.
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From yesterday’s Arutz7:
http://www.israelnationalnews.com/News/News.aspx/279069
“Hundreds volunteer to be infected with COVID-19 to test vaccine. Effort aims to garner support for intentionally infecting humans with coronavirus to speed up the development of a coronavirus vaccine.“
http://www.israelnationalnews.com/News/News.aspx/279069
This is weird.
First of all, it must mean a very long confinement time for the volunteers because you cannot let them out to infect others.
Second of all, if this is in the US, I think it will never pass the ethics committee (or whatever this is called).
This kind of experiment needs a special permission.
There will be another study done soon by Novartis where there will be three groups also but the third group will be given a placebo and neither doctors nor patients will know who gets which medication or no medication.
Of course, the patients should be well matched among themselves (demographics, the severity of their illness, preexisting conditions, etc.) in order for the study to be valid. Which means that they probably need more than one study.
@ Reader:
Referring to Dr. Raoul study.
CNN reporting is political and malicious!
OH-Chloro was never meant to be single therapy.
Raoul used up to 6,000mg total treatment dose in a number of patients.
Many rhumatologists have stated that vey few patients on chronic plaquenil develop cv-19!
@ LIZ WATSON:
These researchers were not treating the patients. They just studied their medical histories after the fact.
The research does seem to suffer from sloppy design (at least). The medical professionals will pass judgement on the rest of it.
@ Reader:Everyone of the points that you make are accurate. If anything this “study” may indicate medical malpractice by the physicians involved.
@ stevenl:
Do you mean the original French study from several weeks ago (a Dr.’s report)?
This one doesn’t seem to be French.
An important detail about the French study.
Dose as high as 6,000 mg have been used!!!!
Not the case in the US!
@ Ted Belman:
Thanks.
The researchers admit that those receiving the drug had a more severe illness.
They claim they adjusted for this and other factors but they don’t explain exactly how they did it.
Also, the commenters (the ones who comment in detail at the bottom of the page) noticed (among other things) that NO HYDROXYCHLOROQUINE group WAS treated WITH AZITHROMYCIN (the antibiotic) – it was NOT a NO DRUG group.
The hydroxychloroquine group also had more cases of high blood pressure and diabetes and they were a bit older than the other groups.
This has not been peer-reviewed yet.
@ Reader:
I have hired a techie to solve the problem of comments going into trash. It shouldn’t be happening.
I am so glad you dug deeper regarding this study. How could Trump have been so wrong, I thought.
But without researching it I wandered iif the most at risk patients were given the trug. Thank you.
i A
OK. I made it shorter. This study examined the VA medical RECORDS of 368 men most of whom were black AFTER they had either died from COVID-19 or were discharged from the VA hospital (or several hospitals, I am not sure).
They do not talk about how they analyzed the data except describing the statistical methods they used, showing several small tables, and stating that they divided the patients in 3 groups.
They do state that:
“…hydroxychloroquine, with or without azithromycin, was more likely to be prescribed to patients with more severe disease, as assessed by baseline ventilatory status and metabolic and hematologic parameters. Thus, as expected, increased mortality was observed
in patients treated with hydroxychloroquine, both with and without azithromycin.”
They admit that the patients treated with the drug had a MORE SEVERE illness which might have caused more deaths but claim that they adjusted for it. They also claim that they adjusted for “comorbidity” (preexisting conditions?) but they don’t show any calculations or analysis of how they did this.
Under the abstract on
https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1
there are a few comments denouncing the study as bogus and a fraud.
Below that there are a few very detailed (and readable) critical comments.
OK. This study examined the VA medical RECORDS of 368 mostly black men who either died from COVID-19 or were discharged from the VA hospital (or several hospitals, I am not sure).
They do not talk about how they analyzed the data except describing the statistical methods they used, showing several small tables, and stating that they divided the patients in 3 groups.
They do state that:
“…hydroxychloroquine, with or without azithromycin, was more likely to be prescribed to patients with more severe disease, as assessed by baseline ventilatory status and metabolic and hematologic parameters. Thus, as expected, increased mortality was observed
in patients treated with hydroxychloroquine, both with and without azithromycin. Nevertheless,
the increased risk of overall mortality in the hydroxychloroquine-only group persisted after
adjusting for the propensity of being treated with the drug.”
In other words, they admit that the patients treated with the drug had a MORE SEVERE illness which might have caused more deaths but claim that they adjusted for it. They also claim that they adjusted for “comorbidity” (preexisting conditions?) but they don’t show any calculations or analysis of how they did this.
Under the abstract on
https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1
there are a few comments denouncing the study as bogus and a fraud.
From The CoV Frontlines…4-20-20 [Michael Hirt, MD]
After more than six weeks of helping my patients successfully avoid and fight Covid-19 (CoV), I am writing to provide my perspective on what works, why it works, and how you and your family can stay safe.
Before the pandemic hit Los Angeles, I developed an in-office, infection control strategy to keep both ourselves and our healthy patients safe, while providing critical health care access to ill patients. Sick patients have a separate entrance into the office, are masked and gloved before entering, and then are placed in private waiting and treatment rooms. Industrial air scrubbers were placed in all exam rooms and communal areas to prevent cross-contamination.
As a testament to the effectiveness of this operational strategy, my staff and I have remained healthy while caring for all of our patients.
In my office, we have seen dozens of CoV and related viral cases. I say ‘related’ because the quality of early testing has been unreliable. Many patients who clearly have CoV symptoms, have had blood tests consistent with CoV infections, and responded to CoV treatments were testing negative for CoV on nasal swabs, saliva, and antibody testing. So, either the testing was not accurate, CoV has mutated (think Covid-20), or both.
Also reported in the past week are the results of random community testing for CoV antibodies. The purpose of these studies was to determine just how many people have already had CoV but did not know it, either because they had no symptoms or the symptoms were so mild as to have an insignificant impact on their health. The results of these studies indicate that up to 85 times more people have been infected with and completely recovered from CoV than had been previously thought. Extrapolating these numbers to the general population of California would mean that over 2.3 million people in our state have already had CoV.
This means that the overall death rate of CoV is dramatically lower than previously thought and is similar to that of a bad flu virus.
The studies also tell us how to respond to the CoV pandemic because we now know that our focus should not be on how many people might contract the virus but who will contract the virus. It is clear that CoV is a virus that picks on grandparents, not grandkids. In Los Angeles county, 89% of all CoV fatalities have had other underlying medical conditions that caused these patients to get sicker…quicker. These CoV at-risk medical conditions include high blood pressure, diabetes, lung diseases, and heart disease.
And for all those between the ages of 40 and 64, it has been my clinical experience that this population also tends to have fairly mild but sometimes more moderate flu-like symptoms, including a chest heaviness, chest pains, and shortness of breath. Very rarely, a patient in this age bracket can have severe CoV lung disease, but this remains very uncommon as a percentage of all those who have contracted CoV.
In attempting to keep the 40 to 64 year olds from progressing into a personal CoV crisis, treatment needs to be given early in the course of the illness. This means that these patients should be seen and tested for CoV ideally within the first five days of symptoms. However, the first CoV symptoms tend to be fairly mild: fatigue, low grade fever, dry cough and headache. So, many patients wait at home, thinking that they are not sick enough to come to the doctor’s office. This is a mistake because CoV pneumonia can happen as soon as seven to eight days after the relatively benign CoV symptoms start.
If my team can get to patients with mild to moderate symptoms, we can start the life-saving treatments that include scientifically-supported prescription medications, intravenous therapies, and nutritional supplements. These treatment protocols have provided significant relief to all of our affected patients, and none thus far, have required any advanced hospital care or ventilator support.
These effective CoV treatments work much like a fire extinguisher works to put out small house fires. If you get to the fire when it is still small and manageable, a fire extinguisher is a remarkably effective tool. If you wait until the fire has begun to consume more than one room, then you will need a fire hose to put out the fire. This doesn’t mean that fire extinguishers do not work, only that they work best (and are less damaging than a fire hose) when used early.
The lesson here is that if you have any cold or flu-like symptoms, you should get tested right away and then treated promptly to prevent unnecessary worsening of the CoV illness.
So, based on my ‘frontline’ experience, the CoV science, and the reported CoV population/infection data, grandchildren and young adults can restart their lives right now, but grandparents and other vulnerable populations need to remain in quarantine. Those between the ages of 40 and 64 can also safely venture out and get back to work in an organized rollout, but need to see a healthcare provider and get tested within the very first days of any respiratory symptoms. This includes patients who think that their runny nose, sore throat, and tickle cough are just their usual ‘allergy’ when these benign symptoms could represent the start of a more serious CoV illness.
To make testing readily available to all who need it, my office was amongst the first to offer drive through, nasal swab testing. In addition to nasal swab testing, we offer CoV saliva testing (just spit in a cup), five-minute antibody testing (to see if you’re still fighting or done with CoV), and blood serology testing (to see if you were previously exposed to CoV). Blood serology testing can also be ordered at any local Quest lab near you for your convenience.
As the World reopens, there will be more CoV cases. And that is OK, as long as we keep CoV from reaching the elderly and the vulnerable. Remember, it is not how many people get CoV but who gets CoV. Everyone else who is not at increased risk can be safely treated or evaluated in doctor’s offices, via telehealth, and drive-through testing.
And California is doing great from a collective CoV health standpoint. We continue to have one of the lowest per capita CoV death rates (number of deaths per million population) in the US and the world. Our per capita death rate on par with states like Idaho, Kentucky, Kansas and Tennessee. And we compare more favorably than Austria, Netherlands, and Sweden, all countries that have started to reopen their economies.
CoV related deaths inLos Angeles County and California seemed to have peaked on April 19th and death rates have declined to levels that were last seen in early April. Additionally, hospitalizations and ICU admissions are also quickly trending down. Our CoV curve has been successfully flattened. We know who still needs our collective protection. We have effective treatment strategies for our workforce.
These are the criteria for taking the heavy foot off of the economic brakes and applying some thoughtful pressure to the accelerator that throttles California’s businesses.
Michael Hirt, MD