Question What is the truth about hydroxychloroquine ?

Jul 2, 2020
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What is the truth about Hydroxychloroquine ?

How much is politics a factor in this ?

I can find little evidence that hydroxychloroquine does harm, its side effects are well researched and known - even the WHO references to stopping HCQ trials are vague - see link at the end

Prof Horby who lead one of the studies referred to that concludes HQC does not fight covid-19 sets out that the negative observational study about HQC retracted from the Lancet did a lot of damage and

"the suspension of numerous well-designed [HQC] clinical trials......is completely unjustified." (Links at the end)


Many observational studies peer reviewed and otherwise of patients in hospitals have shown hydroxychloroquine is effective in treating covid-19

The latest peer reviewed study from Italy published 29th July sets out how Hydroxychloroquine was randomly given, that those being treated had no other medication and that there was a control group. The result was a 66% lower death rate amongst those treated with hydroxychloroquine.

This is a very similar result to a US hospital study and without many of the "flaws" cited in the US study (see links at the end)


A total of 539 COVID-19 hospitalised patients were included in our cohort in Milan, from February 24 to May 17,2020 of whom 174 died in hospital (day 14 probability of death: 29.5%–95%CI: 25.5–34.0). We divided a subset of our cohort in three groups who started treatment a median of 1 day after admission: those receiving hydroxycholoroquine alone (N = 197), those receiving hydroxycholoroquine + azithromycin (N = 94), and those receiving neither (controls) (N = 92). Of the latter group, 10 started HIV antivirals (boosted-lopinavir or –darunavir), 1 teicoplanin, 12 immunomodulatory drugs or corticosteroids, 23 heparin and 46 remained untreated. The percent of death in the 3 groups was 27%, 23% and 51%. Mechanical ventilation was used in 4.3% of hydoxychloroquine, 14.2% of hydroxycholoroquine + azithromycin and 26.1% of controls. Unweighted and weighted relative hazards of mortality are shown in Table 1. After adjusting for a number of key confounders (see table), the use of hydroxycholoroquine + azithromycin was associated with a 66% reduction in risk of death as compared to controls; the analysis also suggested a larger effectiveness of hydroxychloroquine in patients with less severe COVID-19 disease (PO2/FiO2 > 300, interaction p-value<.0001). Our results are remarkably similar to those shown by Arshad et al.

Some important weaknesses of the analysis by Arshad have been pointed out (Lee et al., 2020) but not all of these apply to our study. Our propensity scores include some of the potential confounders that were missing in the analysis by Arshad (e.g. calendar day of admission, disease severity, cardio-vascular disease (CVD), baseline plasma CRP); second, we have excluded people receiving other drugs which could have biased the effect of hydroxychloroquine when used in combination. Third, although residual confounding is a possibility (e.g. people with CVD were more frequent in control), people in the control group were more likely to undergo mechanical ventilation that is a conservative bias. These results from two different real-life settings (Italy and USA), are conflicting with those of two large randomised trials (Horby et al., 2020, World Health Organization, 2020). Although unmeasured confounding remains the most likely explanation for the discrepancies, a robust meta-analysis is still lacking and we question whether hydroxychloroquine should be further tested. When best to start treatment is also a question that needs to be addressed in ad-hoc randomised studies.

Treatment with hydroxychloroquine, azithromycin, and combination in patients hospitalized with COVID-19
Author
SamiaArshada
Henry Ford COVID-19 Task Force1


The WHO states


interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect.





Peter Horby, professor of emerging infectious diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, said: 'The Lancet publication by Mehra et al has had major adverse impacts, resulting in the suspension of numerous well-designed clinical trials. This is completely unjustified.

'Even if the results were correct, observational data such as this, with its inherent weaknesses, should not be used to stop trials which will provide definitive and actionable answers.'

Professor Stephen Evans, pharmacoepidemiology at The London School of Hygiene and Tropical Medicine, said: 'In retrospect many readers and decision makers may well have placed too much reliance on that paper.'


Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the trial, said: ‘Hydroxychloroquine and chloroquine have received a lot of attention and have been used very widely to treat COVID patients despite the absence of any good evidence. The RECOVERY trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with COVID-19.
 
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Still not clear about if the data from the studies against the use of hydroxychloroquine is valid or not.

Here is a CNN interview with Prof Risch from Yale about the data showing why he believes the debate is flawed, plus a later follow on interview about the CNN interview on hydroxychloroquine

The basic point Prof Risch is making is that the trials which produced results showing no benefit were given to people who would have got better anyway so there would be no difference in outcome whether taking the medicine or not. He adds for data from such general trials to be meaningful they need to be given to 10s of thousands of people not a few hundred.

He also says the trials were not blind trials as the patients and Drs knew what medicine they were taking

Further Prof Risch states many drugs released by the FDA do not go through placebo blind trials so questions why Dr Fauci is placing such importance on this

According to Prof Risch the studies showing positive results for hydroxchloroquine were on sick patients who would otherwise have had about a 10% mortality rate

Its quite hard to find this data being debated rationally - its got way too political

View: https://m.youtube.com/watch?v=s_v-IVmy5wQ


View: https://m.youtube.com/watch?v=mcEoOm_5Dps
 
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I have now read the article in Newsweek on HCQ by Yale Professor Harvey Risch.

My current understanding of Prof Risch's position is that HCQ is very effective when applied to certain high risk patients or as a general protection for the wider population. However the types of studies required to show the two separate benefits are very different.

I am unclear if the HCQ data is being manipulated. Prof Risch says in his CNN interview the negative data is flawed and explains why he also explains why the Dr Fauci's response to the studies showing HCQ is effective is flawed and why the data showing HCQ is effective is correct.

No one seems to have explained why Prof Risch's observations are not valid.

I find it strange that someone in his position would risk speaking out on this issue if he did not have good grounds for doing so.

One major peer reviewed study which was negative has been withdrawn after being published in the worlds top 2 medical journals/ publications.

HCQ has been taken as a preventive drug for malaria for many years so it should be a very safe drug even if given to people who dont need its medical protection.

www.newsweek.com/key-defeating-covid-19-already-exists-we-need-start-using-it-opinion-1519535

Opinion
The Key to Defeating COVID-19 Already Exists. We Need to Start Using It | Opinion
Harvey A. Risch, MD, PhD , Professor of Epidemiology, Yale School of Public Health
On 7/23/20 at 7:00 AM EDT


As professor of epidemiology at Yale School of Public Health, I have authored over 300 peer-reviewed publications and currently hold senior positions on the editorial boards of several leading journals. I am usually accustomed to advocating for positions within the mainstream of medicine, so have been flummoxed to find that, in the midst of a crisis, I am fighting for a treatment that the data fully support but which, for reasons having nothing to do with a correct understanding of the science, has been pushed to the sidelines. As a result, tens of thousands of patients with COVID-19 are dying unnecessarily. Fortunately, the situation can be reversed easily and quickly.

I am referring, of course, to the medication hydroxychloroquine. When this inexpensive oral medication is given very early in the course of illness, before the virus has had time to multiply beyond control, it has shown to be highly effective, especially when given in combination with the antibiotics azithromycin or doxycycline and the nutritional supplement zinc.

On May 27, I published an article in the American Journal of Epidemiology (AJE) entitled, "Early Outpatient Treatment of Symptomatic, High-Risk COVID-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis." That article, published in the world's leading epidemiology journal, analyzed five studies, demonstrating clear-cut and significant benefits to treated patients, plus other very large studies that showed the medication safety.

Physicians who have been using these medications in the face of widespread skepticism have been truly heroic. They have done what the science shows is best for their patients, often at great personal risk. I myself know of two doctors who have saved the lives of hundreds of patients with these medications, but are now fighting state medical boards to save their licenses and reputations. The cases against them are completely without scientific merit.

Since publication of my May 27 article, seven more studies have demonstrated similar benefit. In a lengthy follow-up letter, also published by AJE, I discuss these seven studies and renew my call for the immediate early use of hydroxychloroquine in high-risk patients. These seven studies include: an additional 400 high-risk patients treated by Dr. Vladimir Zelenko, with zero deaths; four studies totaling almost 500 high-risk patients treated in nursing homes and clinics across the U.S., with no deaths; a controlled trial of more than 700 high-risk patients in Brazil, with significantly reduced risk of hospitalization and two deaths among 334 patients treated with hydroxychloroquine; and another study of 398 matched patients in France, also with significantly reduced hospitalization risk. Since my letter was published, even more doctors have reported to me their completely successful use.

My original article in the AJE is available free online, and I encourage readers—especially physicians, nurses, physician assistants and associates, and respiratory therapists—to search the title and read it. My follow-up letter is linked there to the original paper.

Beyond these studies of individual patients, we have seen what happens in large populations when these drugs are used. These have been "natural experiments." In the northern Brazil state of Pará, COVID-19 deaths were increasing exponentially. On April 6, the public hospital network purchased 75,000 doses of azithromycin and 90,000 doses of hydroxychloroquine. Over the next few weeks, authorities began distributing these medications to infected individuals. Even though new cases continued to occur, on May 22 the death rate started to plummet and is now about one-eighth what it was at the peak.


A reverse natural experiment happened in Switzerland. On May 27, the Swiss national government banned outpatient use of hydroxychloroquine for COVID-19. Around June 10, COVID-19 deaths increased four-fold and remained elevated. On June 11, the Swiss government revoked the ban, and on June 23 the death rate reverted to what it had been beforehand. People who die from COVID-19 live about three to five weeks from the start of symptoms, which makes the evidence of a causal relation in these experiments strong. Both episodes suggest that a combination of hydroxychloroquine and its companion medications reduces mortality and should be immediately adopted as the new standard of care in high-risk patients.

Why has hydroxychloroquine been disregarded?

First, as all know, the medication has become highly politicized. For many, it is viewed as a marker of political identity, on both sides of the political spectrum. Nobody needs me to remind them that this is not how medicine should proceed. We must judge this medication strictly on the science. When doctors graduate from medical school, they formally promise to make the health and life of the patient their first consideration, without biases of race, religion, nationality, social standing—or political affiliation. Lives must come first.

Second, the drug has not been used properly in many studies. Hydroxychloroquine has shown major success when used early in high-risk people but, as one would expect for an antiviral, much less success when used late in the disease course. Even so, it has demonstrated significant benefit in large hospital studies in Michigan and New York City when started within the first 24 to 48 hours after admission.

In fact, as inexpensive, oral and widely available medications, and a nutritional supplement, the combination of hydroxychloroquine, azithromycin or doxycycline, and zinc are well-suited for early treatment in the outpatient setting. The combination should be prescribed in high-risk patients immediately upon clinical suspicion of COVID-19 disease, without waiting for results of testing. Delays in waiting before starting the medications can reduce their efficacy.

Third, concerns have been raised by the FDA and others about risks of cardiac arrhythmia, especially when hydroxychloroquine is given in combination with azithromycin. The FDA based its comments on data in its FDA Adverse Event Reporting System. This reporting system captured up to a thousand cases of arrhythmias attributed to hydroxychloroquine use. In fact, the number is likely higher than that, since the reporting system, which requires physicians or patients to initiate contact with the FDA, appreciably undercounts drug side effects.

But what the FDA did not announce is that these adverse events were generated from tens of millions of patient uses of hydroxychloroquine for long periods of time, often for the chronic treatment of lupus or rheumatoid arthritis. Even if the true rates of arrhythmia are ten-fold higher than those reported, the harms would be minuscule compared to the mortality occurring right now in inadequately treated high-risk COVID-19 patients. This fact is proven by an Oxford University study of more than 320,000 older patients taking both hydroxychloroquine and azithromycin, who had arrhythmia excess death rates of less than 9/100,000 users, as I discuss in my May 27 paper cited above. A new paper in the American Journal of Medicine by established cardiologists around the world fully agrees with this.

In the future, I believe this misbegotten episode regarding hydroxychloroquine will be studied by sociologists of medicine as a classic example of how extra-scientific factors overrode clear-cut medical evidence. But for now, reality demands a clear, scientific eye on the evidence and where it points. For the sake of high-risk patients, for the sake of our parents and grandparents, for the sake of the unemployed, for our economy and for our polity, especially those disproportionally affected, we must start treating immediately.

Harvey A. Risch, MD, PhD, is professor of epidemiology at Yale School of Public Health.

The views expressd in this article are the writer's own.
 
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Our modern technology allows us very precise data now. But the interpretation of data remains heavily biased. But even with this precise data available, there are very few studies and research without painted data. And if you have some years, you know painted data is common now.

In this virus case, there is huge incentive to paint the data........and the interpretation.

$$$ BIG $$$

HQC(in other forms) has been used for over one hundred years for the viral prevention, and for viral disease treatments and viral outbreaks. No one needed convincing with studies. Worldwide practice before studies.

Our modern science can not explain how the majority of our medicines work.

True knowledge remains very scarce. Not many look for it.
 
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Jul 2, 2020
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Our modern technology allows us very precise data now. But the interpretation of data remains heavily biased. But even with this precise data available, there are very few studies and research without painted data. And if you have some years, you know painted data is common now.

In this virus case, there is huge incentive to paint the data........and the interpretation.

$$$ BIG $$$

HCQ(in other forms) has been used for over one hundred years for the viral prevention, and for viral disease treatments and viral outbreaks. No one needed convincing with studies. Worldwide practice before studies.

Our modern science can not explain how the majority of our medicines work.

True knowledge remains very scarce. Not many look for it.

For those looking for data please review the chart at the end of Prof Risch's response to questions about his HCQ findings as an effective covid-19 treatment


This shows a chart of daily death rates in the Brazilian State of Para compared to the rest of Brazil

The state of Para purchased 90,000 doses of HCQ which it distributed on wide scale amongst people with covid-19.

In late May 5 weeks after the Para HCQ program began covid-19 averaged daily death rates peaked in Para at around 160 and then declined rapidly to around 40 in early July unlike the rest of Brazil where the daily death rate remained rising from around 700 to 1000.

Risch states no other state in Brazil used HCQ in this mass manner and so this indicates that the mass use of HCQ contributed to the decline in covid-19
 
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Here are the latest links on HCQ / hydroxychloroquine

Still way too political


" it would appear that to some extent the media and social forces — rather than medical evidence — are driving clinical decisions and the global Covid-19 research agenda. "





 
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A limited animal trial on an anti viral treatment referred to in the New England Journal of Medicine has shown that if the treatment is given before covid-19 infection then it is effective at stopping covid-19 and other viruses

The other finding was that if the anti viral was given within 3 days of contracting covid-19 the effects of the infection were greatly reduced.

This would seem in line with some of the claims made about hydroxychloroquine based the clinical trials referred to by Prof Risch from Yale.


"In a small-animal model of SARS-CoV-2 infection, prevention of infection or more severe disease was observed only when the experimental antiviral agent was given before or shortly after exposure. In the current trial, the long delay between perceived exposure to SARS-CoV-2 and the initiation of hydroxychloroquine (≥3 days in most participants) suggests that what was being assessed was prevention of symptoms or progression of Covid-19, rather than prevention of SARS-CoV-2 infection."

"Drugs for the prevention of infections must have an excellent safety profile. When hydroxychloroquine was initially promoted as a possible solution to SARS-CoV-2 infection, the safety of the drug was emphasized."

" it would appear that to some extent the media and social forces — rather than medical evidence — are driving clinical decisions and the global Covid-19 research agenda. "


I believe this is the study referred to

 
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The International Journal of Antimicrobial Agents

THE ROLE of hydroxychloroquine in the prevention and fight against coronavirus was the subject of an observational study published in The International Journal of Antimicrobial Agents, which describes how a healthcare worker infected with the novel coronavirus traveled freely for several days within a long term care hospital before being diagnosed with the virus.

This group of patients have been particularly open to infection

It was not possible to quarantine everyone who had come into contact with the healthcare worker So, they treated 211 healthcare professionals and patients with hydroxychloroquine. After 14 days, nobody tested positive for the coronavirus.



There was a large COVID-19 exposure event at a long-term care hospital in Korea.

Post-exposure prophylaxis using hydroxychloroquine was provided to 211 individuals.

Disease development was successfully prevented without severe adverse events.


International Journal of Antimicrobial Agents
Volume 55, Issue 6, June 2020, 105988

Short Communication
Can post-exposure prophylaxis for COVID-19 be considered as an outbreak response strategy in long-term care hospitals?


Author links open overlay panelSun HeeLeea1Kyong RanPeckc
Show more
https://doi.org/10.1016/j.ijantimicag.2020.105988Get rights and content

Highlights


In the context of the ongoing COVID-19 pandemic, management of exposure events is a concern.

There was a large COVID-19 exposure event at a long-term care hospital in Korea.

Post-exposure prophylaxis using hydroxychloroquine was provided to 211 individuals.

Disease development was successfully prevented without severe adverse events.

ABSTRACT
In the context of the ongoing global outbreak of coronavirus disease 2019 (COVID-19), management of exposure events is a concern. Long-term care hospitals (LTCHs) are particularly vulnerable to cluster outbreaks because facilities for patient isolation and healthcare personnel to care for these patients in isolation are difficult to arrange in a large outbreak situation. Although several drugs have been proposed as treatment options, there are no data on the effectiveness and safety of post-exposure prophylaxis (PEP) for COVID-19. After a large COVID-19 exposure event in an LTCH in Korea, PEP using hydroxychloroquine (HCQ) was administered to 211 individuals, including 189 patients and 22 careworkers, whose baseline polymerase chain reaction (PCR) tests for COVID-19 were negative. PEP was completed in 184 (97.4%) patients and 21 (95.5%) careworkers without serious adverse events. At the end of 14 days of quarantine, all follow-up PCR tests were negative. Based on our experience, further clinical studies are recommended for COVID-19 PEP.
Keywords
Post-exposure prophylaxis
Hydroxychloroquine
SARS-CoV-2
COVID-19
Long-term care hospital
1. Introduction
The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a pandemic on March 11, 2020 [1]. South Korea has had a rapid surge in cases of COVID-19 since February 18, most of which were linked to the religious group Shincheonji [2]. To date, 81% of total Korean cases occurred as clusters [2]. Long-term care hospitals (LTCHs) are particularly vulnerable to cluster outbreaks because facilities for patient isolation and healthcare personnel to care for these patients in isolation are difficult to arrange in a large outbreak situation. Furthermore, patients in LTCHs are at high risk if they become infected. Although several drugs have been proposed as treatment options, there are no data on the effectiveness and safety of post-exposure prophylaxis (PEP) for COVID-19. On February 23, a hospital social worker at an LTCH in Busan was diagnosed with COVID-19 after attending a religious service of Shincheonji 7 days earlier, and inpatients and hospital staff were exposed to her. This paper describes the outbreak response strategy used in the LTCH, including PEP using hydroxychloroquine (HCQ).
 
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Interesting article Hydroxychloroquine reduced by half the risk of a potentially fatal heart condition in newborns who were at high risk for it.

Our study shows hydroxychloroquine as the first, safe, and highly effective drug for preventing pregnant women at risk from having another child with congenital heart block," said lead author and rheumatologist Dr. Peter Izmirly, associate professor of medicine at NYU Langone Health in New York City.

Congenital heart block affects as many as 1 in 15,000 live births. About 75% of babies who survive it will require at least one pacemaker during their lifetime, and some may need a heart transplant.

 
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Results from Vadodara in India of Hydroxychloroquine HCQ given for up to 3 weeks to 100,000 high risk non infected/asymptomatic people who had close contact with a covid-19 infected person show

After 1 week of HCQ treatment
100 infections and
12 deaths
After 2 weeks of HCQ treatment there were
48 infections
1 death
After3 weeks of HCQ treatment there were
43 infections
1 death

[it is reported that approx 50,000 had 1 week of HCQ and 50,000 2-3 weeks of HCQ treatment]

These look very positive results with no real side effects reported

This is a big observational report, it is unclear what conflicts of interest etc may be present but if the data is reliable it is very positive.

These findings were supported by a later studies published in the IJMR for a smaller group of health care workers treated for 6 weeks. Reservations were expressed that there may be a conflict as those conducting the IJMR study had been involved in approving the use of HCQ for treating Covid-19



Vadodara Health Officer Dr Devesh Patel is quoted as saying "HCQ has not been used as a prophylactic… To us, it has shown positive results. We have the numbers"


In India HCQ has been used extensively as a prophylatic outside the hospital setting to give protection to those at high risk. The reports provided from the area of Vadodara of the end of June were that around 350,000 high risk people had receiced HCQ and 100,000 of those had been closely monitored.

The treatment was 400mg taken twice on the first day and 400 mg per week for a minimum of three weeks.

Results the 100,000 monitored all had close contact with an infected person.

A. 48,873 who took one dose of HCQ, 102 turned Covid-19 positive and 12 died
B. 17,776 who took two doses of HCQ 48 turned positive and 1 died.
C. 33,563 who took three HCQ doses, 43 tested positive and 1 died.


 
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Some updates on the hydroxychloroquine summarizing various experts opinions and the experiences of some Democratic party politicians who said HQC probably saved their lives. I point these out because HQC has got so politicized and the comments are very clear.

On the experts opinion I note that the HQC doses given in some of the HQC trials are at a very high level - much higher than the Drs or other experts prescribing or promoting the use of HQC recommend. This seems strange.

HQC can be toxic in high doses - full article and link for the section below is at the end of this post

Meryl Nass, MD, ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia, and toxicology. As a biological warfare epidemiologist, she investigated world’s largest anthrax epizootic, in Zimbabwe, and developed a model for analyzing epidemics to assess whether they are natural or man-made. She is also an expert on Gulf War Syndrome and its relationship to the anthrax vaccine given to troops and is active in assisting legal teams defending anthrax vaccine refusers and ill service members in the U.S. and Canada.

Meryl Nass wrote

“The drug is very safe when used correctly, but not a lot more can potentially kill,” she wrote in a June 14 blog post.

She pointed to a 1979 World Health Organization (WHO) review that said a single 1,500 mg dose of chloroquine base is considered toxic and 2,000 mg can be fatal (pdf). Chloroquine has similar potency as HCQ. A 200 mg HCQ pill contains 155 mg of the base drug. That suggests anything above 1,900 mg of HCQ at once can be considered a toxic dose, while a single dose above 2,500 mg could be deadly.

Moreover, it takes about a month for a human body to excrete half the ingested drug, “so the cumulative amount is important,” Nass said.

The 1979 paper notes that a daily base dose of 1,200 mg (about 1,550 mg in pills) “has been tolerated for at least a few days.” But it adds that this dosage “appears to be a limit which should not be exceeded.”

Nass specifically took issue with the United Kingdom’s Recovery trial, which used a 2,000 mg HCQ dose in the first 24 hours and 400 mg every 12 hours for nine more days (pdf). She also criticized the now-halted WHO’s Solidarity trial which proposed to use 1,600 mg in the first 24 hours and then 400 mg twice a day for nine more days, according to the Canadian and Norwegian arms of the trial.

Nass called these dosage regimens “non-therapeutic, toxic, and potentially lethal.”


Democratic state representative from Detroit is crediting hydroxychloroquine — and Republican President Donald Trump who touted the drug — for saving her in her battle with the coronavirus.




Democratic New York City Councilman says hydroxychloroquine saved his life after a near-fatal run-in with COVID-19 in March.

Paul Vallone, who represents northeast Queens, took the drug along with a standard Z-pack — given for bacterial infections — and came back from the brink almost immediately.

“I couldn’t breathe, very weak, couldn’t get out of bed. My doctor prescribed it. My pharmacy had it. Took it that day and within two to three days I was able to breathe,” Vallone told The Post. “Within a week I was back on my feet.”

Though Vallone went public with his coronavirus diagnosis in an April 1 Twitter post, saying he was experiencing “mild symptoms,” his actual condition was considerably more severe. Vallone’s initial prognosis was particularly grim, as he also suffers from sarcoidosis, an auto-immune disease that attacks his lungs.

“We were in panic mode when I went down because I didn’t have a lot of immune response,” he said. “I needed something to stay alive.”

Hydroxychloroquine “worked for me.”

Vallone’s brother Peter, a former City Councilman and a current civil court judge in Queens, also became a convert after his brother’s illness.

“I guess all those doctors who are prescribing it are right. This drug is already on the market and the patent is up so it’s cheap. A new drug won’t be. So big money does not want this drug to be used. Always follow the money,” Peter Vallone said in a May 12 Facebook post, sharing a link to an NYU study touting the drug.





There are many studies on the effectiveness of hydroxychloroquine (HCQ) in treating COVID-19, but only a handful of them adhere to the highest scientific standards. Even those, however, fail to answer some of the most pressing questions.

The debate over HCQ turned into an information tug of war after President Donald Trump endorsed its potential early on. Each side now accuses the other of getting swayed by politics.

Each side has its arguments, but when they’re all put together, it turns out that some of the most crucial questions still haven’t been definitively answered. For example, is there a way to use HCQ to prevent the most at-risk people from dying of COVID-19, if caught early?

HCQ has been used for decades to treat ailments including malaria and lupus. It’s a cheap drug with manageable side effects, such as headaches, dizziness, and an upset stomach. In people with certain heart conditions, it can affect the heart rate, according to the American College of Cardiology, which recommended increased monitoring for at-risk patients.

In theory, HCQ should be helpful in inhibiting COVID-19 by prying open the infected cells to allow zinc, which is naturally present in the human body, to enter the cell and slow the replication of the virus.

Several doctors who have been both vocal and successful in using HCQ to treat hundreds of patients have explained that the point of using the drug is not necessarily to cure a patient or suppress all symptoms. Their argument is that HCQ can slow the virus down and allow the body to build up immunity against it so that the body can get over it on its own.

The main benefit should be to give people most at risk of dying of COVID-19, particularly the elderly, a chance to survive, with manageable symptoms and without a need for hospitalization. HCQ is thus best combined with a zinc dietary supplement and possibly an antibiotic, azithromycin, to prevent secondary bacterial infection, explained Dr. Vladimir Zelenko of Monroe, New York, who’s reported promising results among his patients.

Anecdotal evidence and a dozen studies indicate this is the case.

But none of these studies are both controlled and randomized, which diminishes their value. For a study to match the scientific golden standard, it needs to be conducted on a sufficiently large number of truly random people so the specific makeup of the group (such as its demographics) doesn’t influence the results. The group is then divided in half. One half gets the drug and the other, the control group, gets a placebo. The outcomes for the two groups are then compared.

Yale epidemiology professor Harvey Risch, one of the proponents of HCQ treatment, noted that many drugs have been adopted for use without randomized controlled trials.

But other experts remain unconvinced, pointing to the handful of randomized controlled trials of HCQ that do exist. None of them showed statistically significant benefits in treating COVID-19 with the drug.

Risch and others have criticized what they see as design flaws in these studies.

Some of the studies looked at hospitalized patients in serious conditions. But in those cases, it was already too late for HCQ to help, Risch argued. Others looked at people in early stages of the disease, but most of their participants were people under 50 without serious health issues. These people usually go through COVID-19 without serious complications anyway.

None of the studies used the HCQ-zinc-azithromycin combo that appears to have been the most effective in clinical practice.

Also, some of the studies included only a minority of people who’d actually tested positive for COVID-19. Other participants were included based on symptoms (such as cough, fatigue, headache, or fever) and risk of contact with the virus (such as by sharing workplace with somebody who’d tested positive). The virus that causes COVID-19, SARS-CoV-2, isn’t the only one causing such symptoms, leaving the possibility that some of the people didn’t have COVID-19 to begin with.

Furthermore, the studies used much higher doses of HCQ than what clinicians on the ground seem to recommend.

Zelenko prescribes 200 milligrams (mg) of HCQ every 12 hours for five days.

In contrast, the controlled randomized studies mostly used doses ranging from 1,200 mg to 2,400 mg in the first 24 hours, followed with 600 mg to 1,200 mg daily for the next 4 to 21 days.

This didn’t sit well with Meryl Nass, a physician and chemical toxicity expert.

“The drug is very safe when used correctly, but not a lot more can potentially kill,” she wrote in a June 14 blog post.

She pointed to a 1979 World Health Organization (WHO) review that said a single 1,500 mg dose of chloroquine base is considered toxic and 2,000 mg can be fatal (pdf). Chloroquine has similar potency as HCQ. A 200 mg HCQ pill contains 155 mg of the base drug. That suggests anything above 1,900 mg of HCQ at once can be considered a toxic dose, while a single dose above 2,500 mg could be deadly.

Moreover, it takes about a month for a human body to excrete half the ingested drug, “so the cumulative amount is important,” Nass said.

The 1979 paper notes that a daily base dose of 1,200 mg (about 1,550 mg in pills) “has been tolerated for at least a few days.” But it adds that this dosage “appears to be a limit which should not be exceeded.”

Nass specifically took issue with the United Kingdom’s Recovery trial, which used a 2,000 mg HCQ dose in the first 24 hours and 400 mg every 12 hours for nine more days (pdf). She also criticized the now-halted WHO’s Solidarity trial which proposed to use 1,600 mg in the first 24 hours and then 400 mg twice a day for nine more days, according to the Canadian and Norwegian arms of the trial.

Nass called these dosage regimens “non-therapeutic, toxic, and potentially lethal.”

Neither Nass nor representatives for the Solidarity trials respond to requests for comment.

Peter Horby, contact for the Recovery trial and Oxford professor of Emerging Infectious Diseases and Global Health, responded with the following comment:

“The loading dose and maintenance doses of hydroxychloroquine used in the RECOVERY trial were carefully selected based on knowledge of the absorption and distribution of the drug and the drug concentrations needed to inhibit the SARS-CoV-2 virus. The dose selection was done with a world recognised expert in the pharmacology of antimalarial drugs. … The doses were designed to achieve the concentrations needed to inhibit the virus as quickly and safely as possible. We looked carefully at data on hydroxychloroquine toxicity. The doses used in RECOVERY are very unlikely to cause toxicity. … Regarding the long half-life of hydroxychlroquine, the regimen we used is predicted to result in concentrations that are at the upper end of those observed in the treatment of rheumatoid arthritis.”

He referred to two studies, one on clinical pharmacology of HCQ and one on HCQ overdoses, that both indicated that HCQ doses used in the Solidarity and Recovery trials shouldn’t have reached potentially deadly levels. The overdose study estimated the dosages would result in about one in 50,000 risk of death for a 150 lb person and one in 500 risk of death for a 90 lb person. The study noted, however, that the estimates were based on some 300 overdose cases that involved people younger “than in the majority of more seriously ill COVID-19 patients.”

There has been at least one randomized controlled study by the U.S. National Institutes of Health (NIH) that used lower HCQ doses (800 mg on day one, 200 mg for four more days), but it’s been halted without publishing complete results. The NIH stated in a press release that the data indicated HCQ “provided no additional benefit compared to placebo control for the treatment of COVID-19 in hospitalized patients.”



Serious Gilead / Remdesivir / Veklury and CDC conflicts of interests within the CDC/NIH Panel providing Covid-19 treatment guidance need more disclosure and investigation - why isnt it happening ?

Reported CDC / Gilead financial conflicts are set out in time limited CDC financial disclosure filings - on the CDC web site



Other conflicts which are non financial or date back more than 11 months dont need to be disclosed.

Gilead Conflicts

2 of the CDC / NIH Covid-19 Panels 3 co-chairs have long term links to Gilead which are not declared.

The third co-chair is Dr Clifford Lane who co-authored a postive study on Remdesivir as a Covid-19 treatment

However Dr Lane does not need to declare any indirect connections to Gilead or Remdesivir / Veklury on his CDC disclosures such as co-authoring papers finding in favor of Remdesivir



Further Dr Fauci and Dr Lane published a joint paper which was generally in favor of remdesivir and against hydroxychloroquine


Why is this important ?

The 3 co-chairs select the panel members who set out the Covid-19 treatment guidelines for the USA

Approx 18 of these selected panel memebers are said to have known links to Gilead

8 members of the panel have currently declared financial links to Gilead the maker of Remsedivir - one treatment the CDC has promoted for use against Covid-19 (though some trials have been stopped and limited benefits shown)

In March 2020 - 9 Covid-19 panel memebers declared financial connections to Gilead.

A further 7 members panel are said to have longer term connections with Gilead that they are not required to declare

2 more Covid-19 panel members are said to be on Gilead advisory bodies which they are not required to declare

Gilead was the Pharma Company with the most conflicts declared by Covid-19 Panel members - by a huge margin

Further details about the above Gilead conflicts see the link to docu video below by 5 times Emmy Award winning journalist

QUESTION

Are safe, and possibily effective and cheap medicines being pushed to one side in favor of expensive solutions that have not been shown to be effective.

CONCERNS

The CDCs relationship with big pharma is too close particularly at the level of reserchers and decision makers and the revolving door of jobs between the CDC and big pharma. CDC researchers and others own CDC funded patents

Further info at the end of this post about these conflicts

Dr Fauci owns 8 CDC funded patents and Dr Clifford Lane owns 4 and both receive annual payments from these patents.

After licensing the commercial rights to these Fauci/Lane patent treatments to drug maker Chiron Corp., (later bought by Norvartis) Fauci’s CDC division subsequently spent $36 million in taxpayer money testing the treatment on patients in one experiment alone.

Dr Clifford Lane is one of the 3 key co-chairs of the CDC Covid-19 Guidance Panel.


National Institute of Allergy and Infectious Diseases Director Anthony Fauci and NIAID Deputy Director H. Clifford Lane since 1997 received royalties of $45,072.82 each for the development of interleukin-2, an AIDS treatment they invented with NIH physician Joseph Kovacs.

Other Countries

Similar Gilead conflicts have been highlighted and reported in France amongst leading French Drs - see link to paper submitted for peer review below

The paper sets out a review of payments made by Gilead to 98 leading French Drs correlated with how they did not support the use of Hydroxychloroquine in France - which is seen as an alternative to Remdesivir.

Note only 13 of these 98 French Drs did not declare a financial connection with Gilead.

A. the 13 Drs who received the biggest financial payments from Gilead were publically most strongly against the use of Hydroxychloroquine in France - high correlation

B. the 13 Drs who received no payments from Gilead most were strongly in favor of the use of Hydroxychloroquine in France - high correlation

See links below

Emmy Award Winning Journalist Interviews below from around 7 minutes 50 seconds into the video it sets out info from the CDCs website on financial conflicts with Covid-19 panel members and Remdesivir


View: https://m.youtube.com/watch?v=zB-_SV-y11Y


CDC Official Financial Conflict Disclosure with Gilead


French Gilead Financial Conflict Paper



Further Info on CDC Funded Patents and Conflicts

Over many years Congress, the Inspector General of Health and Human Services, Whistleblowers and Journalists have reported huge failings in transparency and conflicts of interest at the CDC. Little seems to have changed over the years as confirmed by whistleblower disclosures etc.

Its long overdue to have full transparency with disclosure of all historic payments and relationships made (not time limited) - the pharma company should have these records



One physician who voted to recommend the rotavirus vaccine on the FDA’s advisory committee received $255,000 per year in research funds from the maker of the vaccine, Wyeth Lederle. She received a waiver from the FDA to vote on the issue because her research for Wyeth focused on other vaccines.

One member of the CDC’s advisory committee who was not allowed to vote on the rotavirus vaccine because of a conflict was allowed to participate in closed-door working group meetings that drafted the committee’s recommendations for the vaccine. He was also allowed to make an impassioned plea for approval of the vaccine at the full committee meeting.

Another member of the CDC’s advisory committee held a lucrative patent on a rival rotavirus vaccine under development by Merck. Despite this conflict, the doctor voted three times on recommendations regarding Wyeth’s vaccine. It was not until the committee voted to rescind its recommendation of the rotashield that he recused himself because of a “perception of conflict.”


CDC members own numerous patents associated with vaccinations and regularly receive funding for their research work from the very same pharmaceutical companies who manufacturer vaccinations which are ultimately sold to the public. This situation creates an obvious conflict of interest, as members of the ACIP committee benefit financially every time a new vaccination is released to the market.

CDC members also own other medical patents paid for by CDC funds and then used or bought by big pharma . In 2005 387 then current members of the CDC were receiving royalty payments for work funded by the CDC and 51 were doing research on patients involving patents they had developed. Another 500 + ex CDC memebers were also receiving royalty payments.

 
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Mainstream press should investigate the Gilead financial links with NIH staff

US Government CDC / NIH Covid-19
Treatment Guideline Panel Members financial ties to Gilead

Financial and other links to the phrama company Gilead

Gilead makes remdesivir which Dr Fauci and the CDC promoted as a possible Covid-19 treatment

There appears to be a massive conflict of interest

This is the same panel that put a brake or "break" on Hydrochloroquine

Watch the youtube video below from 7mins 50 secs for the financial conflict details also set out below (though the whole video is good)

NIH Covid-19 Treatment Guideline Panel Members

9 members reported links to Gilead
and
7 more members
(including 2 of the committes 3 leaders)
had links to Gilead that were beyond the 11 months required for formal reporting and
2 other members were on Gileads advisory panel

other NIH Treatment Panel Members were paid consultants or received other financial benefits from Gilead


View: https://m.youtube.com/watch?v=zB-_SV-y11Y


No members were connected with any company that makes Hydroxychloroquine


Gileads Covid-19 treatment was promoted by Dr Fauci and the CDC

FRENCH Financial Conflicts

Separately a French study shows the financial links French Drs approving the formal use of Hydroxychloroquine have to Gilead and the way they voted in favor or against using Hydroxychloroquine appears almost 100% correlated with the amount of money they recieved from Gilead


Full PDF of the Paper above


Our results show a correlation (correlation coefficient = 1) between the amount received from the Gilead Sciences company and public opposition to the use of hydroxychloroquine in France. This should open up the debate on the role of the interest links of doctors with pharmaceutical companies in the medical and scientific public debate.
Here is the latest Financial Disclosure link for the CDC / NIH Covid-19 Treatment Panel and Gilead

COVID-19 Treatment Guidelines Panel Financial Disclosure for Companies Related to COVID-19 Treatment or Diagnostics

8 members CDC / NIH currently disclose recent financial connections with Gilead July 2020.

10 other Covid Treatment Panel Members are reported as having longer dated connections with Gilead

An older report from March 2020 shows 9 panel members with Gilead financial connections

 
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Here is a link to all the clinical studies, trials and research on hydroxychloroquine. Each study is summarized and there is a link to the original published study data. There are around 140 studies to date of which 82 are used to reach conclusions on human treatment



In Vitro, Ex Vivo, Meta, Theory, Safety, Review, News, and Retracted items are not included in the percentages and study count. There is a total of 139 items.
 
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Latest updates on all the hydroxychloroquine / HCQ studies to 9th September 2020.

74% of studies (out of 99 treatment studies) incidate a positive benefit from HCQ in treating covid-19, particularly when HCQ is used before a covid-19 infection or as a treatment early in any covid-19 infection HCQ produces the best results.

99 treatment studies were from a database of all 164 programs that have looked at HCQ and published their findings. Full info and program name provided plus link to study

www.c19study.com

Global HCQ studies. PrEP, PEP, and early treatment studies show efficacy, while late treatment shows mixed results.

In Vitro, Ex Vivo, Meta, Theory, Safety, Review, News, and Retracted items are not included in the percentages and study count.

There are a total of 164 items in the study list. Recently added studies - 9th Sept

Positive/negative effects vary in degree and certainty, please read the papers or descriptions thereof for more details. Every study has some limitations when considered in isolation (for example confounding factors; sub-optimal treatment regimens; dosing regimens that may be too low, too high, or insufficiently account for the long half-life of HCQ; large treatment delays; small sample sizes; lack of focus on severity; reliance on Internet surveys; and patient characteristics very different from the most at-risk population).
 

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