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The Pseudo-Science Behind The Mysterious Assault On Hydroxychloroquine
This is a research article published as information for health care professionals and public officials, and for an open peer review. It is not medical advice.
Summary
I reviewed the scientific literature on hydroxychloroquine (HCQ), azithromycin (AZ), and their use for COVID-19. My conclusions:
HCQ-based treatments are effective in treating COVID-19, unless started too late.
Studies, cited in opposition, have been misinterpreted, invalid, or worse.
HCQ and AZ are some of the most tested and safest prescription drugs.
Severe COVID-19 frequently causes cardiac effects, including heart arrhythmia. QTc prolonging drugs might amplify this tendency. Millions of people regularly take drugs having strong QTc prolongation effect, and neither FDA nor CDC bother to warn them. HCQ+AZ combination, probably has a mild QTc prolongation effect. Concerns over its negative effects, however minor, can be addressed by respecting contra-indications.
Effectiveness of HCQ-based treatment for COVID-19 is hampered by conditions that are presented as precautions, delaying the onset of treatment. For examples, some states require that COVID-19 patients be treated with HCQ exclusively in hospital settings.
The COVID-19 Treatment Panel of NIH evaded disclosure of the massive financial links of its members to Gilead Sciences, the manufacturer of a competing drug remdesivir. Among those who failed to disclose such links are 2 out of 3 of its co-chairs.
Despite all the attempts by certain authorities to prevent COVID-19 treatment with HCQ and HCQ+AZ, both components are approved by FDA, and doctors can prescribe them for COVID-19.
Intro
Hydroxychloroquine (HCQ) was accepted as a COVID-19 treatment by the medical community in the US and worldwide by early April. 67% of the US physicians said they would prescribe HCQ or chloroquine CQ for COVID-19 to a family member (Town Hall, 2020-04-08). An international poll of doctors rated HCQ the most effective coronavirus treatment (NY Post, 2020-04-02). On April 6, Peter Navarro told CNN that “Virtually Every COVID-19 Patient In New York Is Given Hydroxychloroquine.” This might explain decrease in COVID-19 deaths in the New York state after April 15. The time lag is because COVID-19 deaths happen on average 14 days after showing symptoms.
But on April 21, several perfectly coordinated events took place, attacking HCQ’s use for COVID-19 patients.
The COVID-19 Treatment Guidelines Panel of the National Institute of Health issued recommendations with negative-ambivalent stance regarding the use of HCQ as a COVID-19 treatment. This surprising stance was taken contrary to the ample evidence of the efficacy and safety of HCQ and despite absence evidence of its harm. The panel also strongly recommended against the use of hydroxychloroquine with azithromycin (AZ), the combination of choice among practitioners.
On the same day, a paper (Magagnoli, 2020) was posted on a pre-print server medRxiv, insinuating that HCQ is not only ineffective, but even harmful. This not-yet peer reviewed paper, by unqualified authors with conflicts of interest, received wall-to-wall media coverage, as it if were a cancer cure. It used data from Veterans Administration hospitals, spicing its effects. The paper has shown to be somewhere between junk science and fraud.
Rick Bright, a government official who was probably more responsible for the low level of preparedness to the epidemic than most others, and had been re-assigned to a lower position earlier, emerged as a “whistleblower.” He claimed he had been demoted for opposing hydroxychloroquine, the claim to be soon debunked by documents bearing his signature. The media also gave him a wall-to-wall coverage.
On April 24, the FDA struck its own blow, issuing a stern warning against use of HCQ for COVID-19 treatment.
While these warnings are not binding to doctors, they do produce a chilling effect. Consequently, either patients do not receive necessary treatment, or they receive it with a delay, sharper decreasing its effect. This allows detractors to question HCQ efficacy even more aggressively. Below, I review problems in the NIH COVID-19 Treatment Guidelines and other sources, used to wage anti-HCQ propaganda.
(1/?)
NIH Panel Guidelines
The relevant section of (COVID-19 Treatment Guidelines Panel, 2020) is Potential Antiviral Drugs. The antiviral treatment recommendations (more accurately, failure to provide recommendations) include:
“Remdesivir
There are insufficient clinical data to recommend either for or against the use of the investigational antiviral agent remdesivir for the treatment of COVID-19 (AIII).
Clinical Data to Date:
Only anecdotal data are available.“
“AIII” means a strong position based on expert opinion rather than on evidence.
“Chloroquine or Hydroxychloroquine
There are insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19 (AIII).
When chloroquine or hydroxychloroquine is used, clinicians should monitor the patient for adverse effects (AEs), especially prolonged QTc interval (AIII).
Clinical Data in COVID-19
The clinical data available to date on the use of chloroquine and hydroxychloroquine to treat COVID-19 have been mostly from use in patients with mild, and in some cases, moderate disease; data on use of the drugs in patients with severe and critical COVID-19 are very limited.
[Follows is a description of some studies]“
Notice that CQ and HCQ are addressed together, although these are two different drugs, and HCQ is clearly superior to CQ both in efficiency and safety.
Also notice that the basic recommendation of “insufficient clinical data to recommend either for or against” is given to both HCQ and Remdesivir. However, the recommendation for HCQ goes further to state that when using HCQ, “clinicians should monitor the patient for adverse effects (AEs), especially prolonged QTc interval”. Practically, this means that HCQ should be used only in hospital settings. No such restrictions are set for Remdesivir, for which there is no clinical data available. It goes against all logic.
The demand to use HCQ only in hospital settings means:
HCQ treatment will be delayed until a patient decides to be admitted to a hospital, thus lowering HCQ’s efficiency
Hospitals will quickly become overwhelmed with COVID-19 patients
Then the Panel nixes HCQ+AZ:
“Hydroxychloroquine plus Azithromycin
The COVID-19 Treatment Guidelines Panel recommends against the use of hydroxychloroquine plus azithromycin for the treatment of COVID-19, except in the context of a clinical trial (AIII).“
This drug combination is the most effective and widely used treatment for COVID-19, and the Panel recommends against it!
The Panel criticizes some studies of patients’ treatment with HCQ+AZ for the absence of a control group. Stephen McIntyre tweeted about this argument long before the Panel used it: “there’s a very large control group of COVID19 patients not receiving this drug combination: hospitals and morgues are full of them.”
There are only two studies, quoted by the Panel against HCQ+AZ, (Molina, 2020) and (Chorin, 2020). Both are misinterpreted by the Panel.
Molina et al.
Despite (Molina, 2020)’s angry tone and aggressiveness, it reports no results contradicting efficiency of HCQ or HCQ+AZ. The paper describes treatment of 11 hospitalized COVID-19 patients, five of which had cancer, one had AIDS, and almost all were in a bad shape: “at the time of treatment initiation, 10 of the 11 patients had a fever and received nasal oxygen therapy.” Using HCQ+AZ, 10 of the patients’ lives were saved. The article’s point of contention is that when they tested these patients, 5-6 days after the treatment initiation, they still found CoV2 RNA in 8 out of 10. Virus RNA is a molecule. Some viral RNA remains in patients for weeks after full recovery, but it is neither harmful nor infectious. Detecting viral RNA depends on the sensitivity of the testing equipment. The study’s title is No evidence of rapid antiviral clearance or clinical benefit with the combination of hydroxychloroquine and azithromycin in patients with severe COVID-19 infection seems to be lost on the Panel.
Chorin et al.
The Panel also quotes (Chorin, 2020) as evidence that HCQ+AZ therapy causes QTc prolongation. QTc prolongation is not a health condition itself, but a warning sign that a person is at higher risk of torsades de pointes (TdP), heart arrhythmia, or tachycardia, which might lead to cardiac arrest and death (Simpson, 2020).
Nevertheless, none of the patients, treated with HCQ+AZ, suffered TdP or arrhythmia. Four patients died, but none of them had an arrhythmia. Other studies, in which COVID-19 patients are treated with HCQ+AZ, reported taking patients off this medicine after QTc exceeds 500ms. But the treatment may have already had its effect at that time or later, while HCQ remained in the bloodstream.
This study has no control group. It provides no information on whether QTc prolongation was caused by the disease or the therapy.
(2/?)
FDA Warning
(FDA WARNING, 2020), issued on April 24, piggybacks on the COVID-19 Panel Guidelines. It says
Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia.
This statement is confused, and probably not true about hydroxychloroquine. See below.
Be aware that there are no proven treatments for COVID-19 …
I think that HCQ+AZ is a proven treatment for COVID-19. There is a difference between proven treatment and approved treatment. HCQ+AZ is not approved but proven, because many patients have been treated with this combination and have recovered.
We have reviewed case reports … concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. These adverse events were reported from the hospital and outpatient settings for treating or preventing COVID-19, and included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death.
These are manifestations of COVID-19! See (Bansal, 2020) and (Wang, et al., 2020). The media hysteria played its role, too. The articles about the supposed dangers of HCQ, with detailed description of the symptoms, triggered complaints even before the April 24 warning. And there are people who tried to self-medicate – in the situation when authorities make it difficult to obtain prescription for HCQ – and took the wrong drug or overdosed. Also, QT interval prolongation is not an event, but an early warning.
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving hydroxychloroquine and chloroquine or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
Such an urging and advertisement guarantee that the FDA will receive mountains of complaints.
HCQ and AZ Safety
HCQ, CQ, and AZ
HCQ & CQ are two different drugs. HCQ is clearly superior to CQ. HCQ has already been selected over CQ. Discussing these two drugs as if they were co-equal in COVID-19 treatment is misleading and a sign of bad faith.
HCQ and AZ are some of the most widely prescribed drugs and have been prescribed for decades. HCQ is as safe as a prescription drug can be. AZ is an antibiotic, and it is as safe as an antibiotic can be.
Because these drugs have been prescribed so widely, their adverse effects have been studied. A few adverse events associated with them have been reported. Combining these few anecdotal cases, some medical researchers have raised some concern, as a precaution. Doctors understand this. Statisticians understand this. But unscrupulous media uses this information to mislead the naïve public and even public figures
Remdisivir is the opposite. It has been developed very recently and has been scarcely used. There is little information about its adverse effects. The corrupt news networks present this lack of evidence of adverse effects as evidence of the absence of adverse effects.
Much much more:
https://www.zerohedge.com/health/pseudo-science-behind-mysterious-assault-hydroxychloroquine