HYDROXYCHLOROQUINE (HCQ), IVERMECTIN, CORONAVIRUS and RESEARCH FRAUDS
To see the writing on CORONAVIRUS (COVID-19), click on:
October 17, 2020
Uncertainty of outcomes of 'modern medical treatment' in COVID-19 is certainly evident. Plasma therapy is claimed to be beneficial and proved to be useless (PLACID trial of ICMR for convalescent plasma). And more disappointingly, the hope of preventing deaths by using many costly repurposed drugs is shattered by the world's largest clinical trial, the SOLIDARITY trial of the WHO. Numerous people in India lost their loved ones and their livelihood after borrowing and spending an average of ten lakhs of rupees on each patient on these expensive drugs of little value.
Orchestrated by ‘big pharma’ and ‘small research’, unethical promotion of ‘experimental’ medicines, even in children, and vested interests in treatment protocols, and Covid-related fraudulent research and publication (a write up on the demeaning activity is present in the references 7) have become almost a commonplace of ‘Covid business’. The ‘so-called evidence-based’ bugle blown by rich countries has become the marching tune for the poorer countries. How much money was wasted on needless investigations, and drugs of unproven efficacy ! The latest revelation is about “plasma therapy.” The CONCOR-1 trial results published on September 9, 2021 in Nature Medicine journal by Canadian researchers showed that ‘plasma therapy’ is ineffective and associated with worse clinical outcomes and serious side effects. 33 Nearly 36,000 people were treated in Maharashtra with ‘convalescent plasma’ which was sold at the rate of Rs. 60,000 per dose. Overall, with no specific drug available for COVID-19 and no respite from the infective ‘waves’, even 20 months after the detection of the virus, it seems that we are back at square one. Variants could reduce vaccine efficacy and thereby extend the Covid-19 crisis. Within a very short period, the virus developed variants of worry like Delta, Delta Plus, Kappa, B.617.3 (a sibling of the Delta), B.1.1318, Lambda (C.37), Mu, C.1.2 and AY.4 which may ‘escape’ the vaccines.
-- Dr. T. Rama Prasad, PAY WHAT YOU CAN Clinic, Perundurai.
“The person who takes medicine must recover twice, once from the disease, and once from the medicine.” -- William Osler
MODERN MEDICINE FIASCO -- 2020
Media were replete with controversial information about HCQ. The confusion is further compounded by a larger controversy about a study published in The Lancet medical journal on 22.05.2020 with a flurry of media coverage.
HCQ -- safe or deadly ? The Lancet & the WHO -- turned into a fiasco ?
An invisible virus killed about 400 thousand people within five months, in spite of 'modern medicine'. The SARS-CoV-2 virus also created 4,000 academic papers and a surge in flawed scientific studies. As of the end of July 2020, as many as 33 articles were found to be shady to attract retraction, withdrawal or tagged with "expression of concern".
One of the most high profile retractions was of a paper published in the prestigious Lancet medical journal on treating COVID-19 patients with the anti-arthritis drug hydroxychloroquine (HCQ). The study was withdrawn after a group of experts raised "both methodological and data integrity concerns" about it. And after decades of using HCQ, we are still debating whether the drug is safe or not with the publication of the fabricated data. A fiasco indeed.
Why did the World Health Organization (WHO) suddenly suspend the hydroxychloroquine (HCQ) drug trial ('Solidarity Trial') in COVID-19 patients ? And why the Indian Council of Medical Research (ICMR) is continuing to recommend HCQ to prevent COVID-19 among frontline health care workers exposed to high risk ?
One of the world's most prestigious medical journals, The Lancet, had published on 22.05.2020 the results of a study of a large 'multinational real-world registry analysis' of use of HCQ in COVID-19 patients (96,032 patients in 671 hospitals across six continents). The Boston-based hospital study revealed that there was no benefit and that there were increased ventricular arrhythmias and deaths associated with this drug. This has impacted all the activity around HCQ around the world and may have potentially catastrophic consequences. It is a high-profile and high-consequence study, while the whole world is reeling under COVID-19. The basis of the study was later acknowledged to be the completely fabricated data supplied by the dubious Illinois- Chicago-based database company called Surgisphere which is in cahoots with Dr. Sapan Desai of the US.
It is consequent to the publication in The Lancet that the WHO announced on 25.05.2020 suspension of its HCQ drug trial, out of safety concerns. It looked as though it was a 'knee-jerk' reaction. Of course, there are some more studies discrediting HCQ. But, HCQ has been in use for more than four decades for immuno-modulation in cases of arthritis, lupus, etc., apart from its use in malaria. Some patients have been on lifelong therapy with one tablet a day.
Touting of this drug by Donald Trump, the President of the US, and his outbursts at WHO about the 'Virus-China' issue may be a different story, as also the story that the motive of discrediting the low-cost HCQ is to make profits to manufacturers of costly alternative molecules like Remdesivir. But 'politico-medical links' are making rounds. The 'Lancet publication' of this study on HCQ kicked up a storm of criticism. A huge number of scientists and researchers alleged that the methodology and the data cited in the 'Lancet study' are flawed, fraudulent and fabricated. In addition, another study, published in The New England Journal of Medicine (another highly reputed journal), by some of the same authors on the subject of HCQ and cardiovascular diseases met with the same criticism.
Mainly three doctors are involved in these fraudulent publications and the Surgisphere scam -- 1. Dr. Sapan Desai, a vascular surgeon and the founder of 'Surgisphere QuartzClinical Global Database' which supplied the questionable data, 2. Dr. Mandeep Mehra, a renowned Harvard University vascular surgeon and professor, at Brigham Women's Hospital who was the lead author of the paper. 3. Dr. Amit Patel, a cardiac surgeon. All the three are Americans of Indian origin. Dr. Desai and the Surgisphere (a tiny Chicago-based 'global database' with just a handful of employees with very limited expertise) are involved also in another retracted publication connected with another molecule, IVERMECTIN, in the treatment of COVID-19.
An APOLOGY was tendered by the authors, and the articles in The Lancet and The New England Journal of Medicine were RETRACTED on June 4 / 5, 2020.
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EDITORIAL in THE HINDU of June 6, 2020
Shine a light: On retraction of a research paper
JUNE 06, 2020 00:02 IST
The scientific process must be protected from those seeking power and riches
Two weeks ago, a study in The Lancet, perhaps the most influential medical journal in the world, found no benefit from the use of hydroxychloroquine (HCQ), a well-known antimalarial, to treat sick COVID-19 patients. Today, that study stands retracted. As it had relied on a huge dataset of about 96,000 patients sourced from 671 hospitals in six continents, the World Health Organization, citing a ‘do no harm’ principle, suspended drug trials pending a safety review. This led to some countries in Europe withdrawing the drug from their own trials. Another study involving some of the same authors and relying on the same data published in The New England Journal of Medicine, which sought to answer questions on the associations between cardiovascular disease, COVID-19 and drugs that target the enzymes that play a role in facilitating the virus in attacking a host, has also been retracted. The Lancet study triggered a backlash from scientists who found problems with the methodology and, more importantly, the dataset. It emerged that mortality attributed to the disease in Australia did not match with the country’s own estimates; there was no way to tally patient records and the hospitals they were sourced from; and there were problems with the statistics deployed and the conclusions about the potential risk from the drug.
The bigger concern was that the data was supplied by Surgisphere Corporation, which had a handful of employees with limited scientific expertise, and claimed to have aggregated its numbers by compiling electronic health records in less than two months. Experienced clinical trial specialists said this was a labour-intensive process. Moreover, when aspersions about the data started to swirl, the company, citing client confidentiality, said it was unable to share its data sources for independent assessment. In their retractions, the journals have blamed Surgisphere for being opaque with its primary data. So far, neither journal has introspected on the peer-review process that led to these studies being published in the first place. In hindsight it seems obvious that a disinterested analysis would have raised eyebrows regarding data sourcing, but the post-COVID world is a panic-driven one that has left no institution or appraisal process untouched. The average peer-review takes weeks and the clinical trial process months, but now the expectation is that science delivers its results like magic. For years now, questions have been raised on the effectiveness of the traditional, time-consuming peer-review process and this has launched a welcome culture of papers being uploaded as preprints for review. In the present instance of the HCQ imbroglio, it is the independent effort by external scientists that brought the blight to light. The key lesson is that it is a mistake to assume the scientific process as one divorced from the influence of power, privilege, finance and politics. The means and methods to a scientific result matter more than results — only achieved through global scrutiny. Openness, more than blame game, is what the post-COVID world needs now.
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Artificial Intelligence
The involved ones in this malpractice are very ‘aberrantly intelligent’ doctors in the USA. The mischief is obviously present in the cases related to Marc Tessier-Lavin of Stanford University and Eugene Braunwald, a cardiologist at a Harvard institution. Prominent journals published 157 Covid-related papers, mostly assisted by ‘AI in medicine’, between January 2020 and October 2021 which were retracted. The stupidity in using such ‘Aberrant Intelligence’ in academics made the otherwise brilliant medical specialists ignominious.
The ‘tricks and tools’ of artificial intelligence had spilled over to medical research -- the episode of the infamous articles that were published and retracted in famous journals like The Lancet and The New England Journal of Medicine using allegedly fraudulent and fabricated data generated by the Surgisphere through ‘AI in medicine’ is an example.
UNFLINCHING FAITH
With the strong foundation laid by the earlier generations for science and medical research, people and professionals have reposed immense confidence in academics. With the changing times of the 'Modern Yuga', modern medicine has been changing its colours and coats as can be gauged from the aforementioned details. This metamorphosis has been going on for sometime subtly and insidiously. Numerous retractions took place. There is too much of evidence on this to ignore or just to dismiss it away as an aberration. “The world famous not-for-profit Mayo Clinic, Rochester, US which spends $500 million a year on research concluded in 2009 that data about harnessing the immune system to fight cancer had been fabricated, resulting in the retraction of 17 papers in nine research journals.” Cancer is a big money-spinner for the medical industry. And, COVID-19 sparked a surge of papers and flawed scientific research -- 4,000 papers and 33 flawed ones, the most high profile one being the one published in The Lancet.
Big business bosses stepped in long ago, gifting away 'Frying Pans' to 'Ferrari Cars'; 'Cocktail Dinners' to 'Cruise Holidaying'. Fake studies were manufactured; results doctored; presented in international conferences. As these are "normal", we are not supposed to talk about them. This takes me to January 25, 2019. We (MBBS batch mates) had a get-together at the Sai Priya Beach Resort, at Visakhapatnam, along the seafront with tranquil ambience and verdant lawns. There was a resplendent classical dance entertainment by the students of 'Kalakshetra' -- a real feast to the eye. A sumptuous lunch followed ... we 'old fossils' indulged like teenagers. The 70+ young-folk were chatting, singing, laughing, exchanging anecdotes, commenting ... I started commenting on the murky deals and the dirty goings-on in medical research and publications. My big brother took away the microphone from my hand to facilitate relevant discourse ! Another brother expressed that the get-together was not the street to wash dirty linen. That's the unflinching faith in the glorified 'Modern Medicine' !!!
THE IVERMECTIN STORY
The latest (October 22, 2020) news about ivermectin in India: experts decided on October 22, 2020 not to include Ivermectin in the National clinical management protocol for Covid-19.
In the search for ‘repurposed’ drugs in the treatment of COVID-19, the old (1981) drug ivermectin has come to the fore.
Ivermectin, an approved drug to treat various parasitic infestations – head lice, scabies, river blindness (onchocerciasis), stronglyoidasis, trichuriasis, ascariasis and lymphatic filariasis is under study for its anti-viral action as it was found to inhibit the replication of SARS-CoV-2 with an IC50 of 2.2 - 2.8 uM in monkey kidney cell culture. It may act against several distinct ‘positive-sense’ single-stranded RNA viruses, but its usefulness in clinical settings is yet to be proved. It is a potential anti-virus agent in Chikungunya and Yellow Fever. It is also used in cases of Dengue fever, Cancer, Zika and HIV as an immuno-modulator.
FABRICATED STUDIES
A 'Pre Print' of a study of Ivermectin of 1,900 patients in 169 hospitals in five continents documented an unbelievably low mortality (2%) in COVID-19 patients on ventilators. The Surgisphere and Dr. Sepan Desai are once again involved in the unholy fabrication of data which made doctors latched on to Ivermectin. And, grants flowed for research on Ivermectin. Such publications influenced rapid policy shifts, as the world seeks some treatment for COVID-19.
Ivermectin has grabbed headlines for wrong reasons. Based on the study data of Surgisphere, the company behind some discredited research studies (including those of HCQ), officials of Latin American countries recommended ivermectin as a possible coronavirus drug. Clinicians there say the effects have been extremely devastating. People emptied the drug stores and self-medicated with no scientific indications, and entered into a false sense of safety.
ADVOCATES FOR IVERMECTIN
Back in India the UP government officials approved (August 2020) ivermectin for treatment and prevention of COVID-19, based on the evidence of a handful of in vitro and observational studies. A publication on June 10, 2020 claimed benefits of lowering mortality at Florida hospitals. As of July 2020, ivermectin was being studied in 19 ongoing and 18 planned clinical trials.
One Prof. Thomas Borody from Centre for Digestive Diseases in Australia 'believes' that ivermectin with zinc and doxycycline is a cure for COVID-19. Prof. Ian Musgrave, a molecular pharmacologist from the University of Adelaide said: "Prof. Borody's 'belief' is to be taken with a grain of salt as ivermectin acts only in test tubes." Prof. Borody wondered why Australia didn't consider his recommendation to include ivermectin in COVID-19 treatment while the '"HUGE INDIA" approved it ! (Uttar Pradesh government approved it in August 2020.)
1-s2.0-S0019570720301025-main (1).pdf -- A group of senior doctors with vast clinical experience met on 19th July’20 under the aegis of Academy of Advanced Medical Education. The panel looked at Ivermectin, one of the old molecule and evaluated it's use in COVID 19 (Novel Coronavirus Disease 2019) manage- ment. After critical panel discussion, all the attending doctors came to a conclusion that Ivermectin can be a potential molecule for prophylaxis and treatment of people infected with Coronavirus, owing to its anti-viral properties coupled with effective cost, availability and good tolerability and safety.
© 2020 Tuberculosis Association of India. Published by Elsevier B.V. All rights reserved.
“Ivermectin in the dose of 12 mg BD alone or in combination with other therapy for 5 to 7 days may be considered as a safe therapeutic option for mild moderate or severe cases of Covid-19 infection. It is cost effective especially when the other drugs are very costly & not easily available”.
And some advocated a preventive regimen : (1) High risk frontline workers -- 12 mg weekly; (2) Moderate risk workers & students -- 12 mg fortnightly; (3) Low risk people at home -- 12 mg on day 1, Day 7, and later monthly once. All until the pandemic is over !
Despite lack of robust evidence, many doctors have been following the above mentioned regimens. They may be endorsing the famous quote of the POTUS: “Lack of evidence is not evidence of absence of evidence.” !!!
MATTER OF CONCERN
Concerns have been raised that use of ivermectin in humans may do more harm than good. The hype has shifted from HCQ to Ivermectin. It's no wonder Miss Corona made people lose faith in "scientific" medicine ! She upended everything, promoted uncertainty everywhere.
On April 10, 2020, the FDA issued guidance not to use ivermectin for COVID-19. The Pan American Health Organization, a regional office of the World Health Organization, has issued a statement warning against the use of ivermectin to treat COVID-19. The statement notes that the antiparasitic drug is being investigated in clinical trials, but currently, “ivermectin is incorrectly being used for the treatment of COVID-19, without any scientific evidence of its efficacy and safety for the treatment of this disease.” For details go to the links below:
https://www.the-scientist.com/news-opinion/surgisphere-sows-confusion-about-another-unproven-covid19-drug-67635
https://www.drugs.com/medical-answers/ivermectin-treat-covid-19-coronavirus-3535912/
https://www.news.com.au/lifestyle/health/health-problems/coronavirus-australia-sydney-doctor-claims-cheap-head-lice-drug-could-cure-covid19-and-should-be-used-now/news-story/24b930fcec5e4ef33127b13d4356b0aa
https://www.isglobal.org/en/healthisglobal/-/custom-blog-portlet/questions-and-answers-about-ivermectin-and-covid-19/2877257/0
GOVERNMENT OF INDIA’s ADVISORY
Document No. 5 Ivermectin (Dr. T. Rama Prasad)
Ivermectin not to be included in Centre’s coronavirus management protocol (22.10.2020)
The experts of ICMR’s National Task Force for Covid-19 and the Joint Monitoring Group held its meeting on Thursday (October 22, 2020) to deliberate on whether the drug should be included in the national treatment guidelines.
INDIA Updated: Oct 23, 2020, 15:07 IST
| Press Trust of India| Posted by Ayshee Bhaduri New Delhi |
| |
Experts decided not to include Ivermectin in the national clinical management protocol for Covid-19 because of lack of sufficient evidence on its efficacy(Biplov Bhuyan/HT PHOTO)
Ivermectin, an antiparasitic drug, being touted as a possible treatment for the coronavirus infection will not be included in the Health Ministry’s Clinical Management Protocol for Covid-19, sources said on Thursday.
Some states including Uttar Pradesh are already using the drug off-label not only as a treatment option but also as a prophylaxis against Covid-19, a source said.
Already widely used against intestinal parasites and scabies, it is relatively a safe and cheap drug. The experts of The Indian Council of Medical Research(ICMR’s) National Task Force for Covid-19 and the Joint Monitoring Group held its meeting on Thursday to deliberate on whether the drug should be included in the national treatment guidelines.
“Following deliberations, experts decided not to include Ivermectin in the national clinical management protocol for Covid-19 because of lack of sufficient evidence on its efficacy based on randomised trials held in India and abroad,” a source said. The Health Ministry has allowed the use of Remdesivir for restricted emergency use purposes in moderate cases under “investigational therapies” in the Clinical Management Protocol for Covid-19.
The ministry has also okayed off-label application of Tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating Covid-19 patients in moderate stage of the illness as “investigational therapies”.
It also recommended Hydroxychloroquine for patients during the early course of the disease but not for critically ill ones. The centre has also included an inexpensive, widely used steroid Dexamethasone in treatment protocols for Covid-19 patients in the moderate to severe stages of their illness among other therapeutic measures. The ministry advised use of Dexamethasone, which is already used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects, as an alternative choice to Methylprednisolone for managing moderate to severe cases of coronavirus infection.
https://www.hindustantimes.com/india-news/ivermectin-not-to-be-included-in-centre-s-coronavirus-management-protocol/story-H2ahRiDO3nvCqktOBJGPjP.html
That's THE LONG AND THE SHORT of ivermectin.
To know more about the DRUG AFFAIRS, click on: http://drtramaprasad.blogspot.com/2017/04/hydroxychloroquine-hcq-and-coronavirus_29.html
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Document No. 5 Ivermectin (Dr. T. Rama Prasad)
Ivermectin not to be included in Centre’s coronavirus management protocol (22.10.2020)
The experts of ICMR’s National Task Force for Covid-19 and the Joint Monitoring Group held its meeting on Thursday to deliberate on whether the drug should be included in the national treatment guidelines
INDIA Updated: Oct 23, 2020, 15:07 IST
![]()
| Press Trust of India| Posted by Ayshee Bhaduri New Delhi |
Experts decided not to include Ivermectin in the national clinical management protocol for Covid-19 because of lack of sufficient evidence on its efficacy(Biplov Bhuyan/HT PHOTO
Ivermectin, an antiparasitic drug, being touted as a possible treatment for the coronavirus infection will not be included in the Health Ministry’s Clinical Management Protocol for Covid-19, sources said on Thursday.
Some states including Uttar Pradesh are already using the drug off-label not only as a treatment option but also as a prophylaxis against Covid-19, a source said.
Already widely used against intestinal parasites and scabies, it is relatively a safe and cheap drug. The experts of The Indian Council of Medical Research(ICMR’s) National Task Force for Covid-19 and the Joint Monitoring Group held its meeting on Thursday to deliberate on whether the drug should be included in the national treatment guidelines.
“Following deliberations, experts decided not to include Ivermectin in the national clinical management protocol for Covid-19 because of lack of sufficient evidence on its efficacy based on randomised trials held in India and abroad,” a source said. The Health Ministry has allowed the use of Remdesivir for restricted emergency use purposes in moderate cases under “investigational therapies” in the Clinical Management Protocol for Covid-19.
The ministry has also okayed off-label application of Tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating Covid-19 patients in moderate stage of the illness as “investigational therapies”.
It also recommended Hydroxychloroquine for patients during the early course of the disease but not for critically ill ones. The centre has also included an inexpensive, widely used steroid Dexamethasone in treatment protocols for Covid-19 patients in the moderate to severe stages of their illness among other therapeutic measures. The ministry advised use of Dexamethasone, which is already used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects, as an alternative choice to Methylprednisolone for managing moderate to severe cases of coronavirus infection.
https://www.hindustantimes.com/india-news/ivermectin-not-to-be-included-in-centre-s-coronavirus-management-protocol/story-H2ahRiDO3nvCqktOBJGPjP.html
During the 'Corona period', various drugs were permitted for 'emergency use / experimental use / compassionate use' by various authorities across the world without robust evidence of benefit. Some pharmaceutical companies and some hospitals had taken advantage of this to misuse the drugs or to facilitate profiteering. It's a sea-saw like situation with evidence for and against with shifting advisories which had become common. For instance, AIIMS and Health Ministry, on September 2, 2020, advised not to use favipiravir, pirfenidone, methylene blue, itolizumab, tocilizumab, etc too enthusiastically as sufficient evidence is lacking to support their use. We have to still learn on the go !
A shame on researchers and a blot on reputed medical journals.https://healthimpactnews.com/2020/editors-of-the-lancet-and-the-new-england-journal-of-medicine-pharmaceutical-companies-are-so-financially-powerful-they-pressure-us-to-accept-papers/
Editors of The Lancet and the New England Journal of Medicine said: "Pharmaceutical companies are so financially powerful that they pressure us to accept papers."
In a videotaped interview on May 24, 2020, Dr. Douste-Blazy provided insight into how a series of negative hydroxychloroquine studies got published in prestigious medical journals. He revealed that at a recent Chatham House top secret, closed door meeting attended by experts only, the editors of both The Lancet and the New England Journal of Medicine expressed their exasperation, citing the pressures put on them by pharmaceutical companies.
He states that each of the editors used the word “criminal” to describe the erosion of science.
He quotes Dr. Richard Horton who bemoaned the current state of science:
“If this continues, we are not going to be able to publish any more clinical research data because pharmaceutical companies are so financially powerful; they are able to pressure us to accept papers that are apparently methodologically perfect, but their conclusion is what pharmaceutical companies want.”
This confession by the editors of the reputed medical journals reveals the extent of the rot in research and publication. They lamented but didn't resign -- that's the height of the vulnerability to venality !
The medical scientific literature is infested with financially motivated, shoddy, studies aimed at promoting products and, when a life-saving, non-patentable product, proves effective, scientists are hired to author study reports that are designed to tarnish scientists’ reputations, and to proclaim findings that refute legitimate findings. In this case, studies designed to “debunk” the effectiveness of hydroxychloroquine against COVID-19.
You may be wondering what anybody gets by fraudulently bring a bad name for hydroxychloroquine (HCQ). It's a simple business tactic. HCQ is a cheap drug -- even if millions of tablets are sold, the profit that is made would be very small. If HCQ is given a bad name, one has to go for the next alternative - remdesivir or some other very costly drug which gives fat profits. So, the manufacturers sponsor (influence, bribe or buy the researchers) these studies to document results as they want them to be, and do "something" to get the studies published in "reputed" medical journals. It's as simple as that. That's the BIG PHARMA's business !
THIS SEEMS TO BE WHAT "Modern Medicine" IS ALL ABOUT NOWADAYS. CHEATING. SHAMEFUL. See the full text in the link cited below:https://healthimpactnews.com/2020/editors-of-the-lancet-and-the-new-england-journal-of-medicine-pharmaceutical-companies-are-so-financially-powerful-they-pressure-us-to-accept-papers/
The reading into this link also reveals the weakness and the vulnerability to venality of the editors of the so-called internationally reputed medical journals.
Consequent to the uproar, the WHO made a U-turn and declared consideration of continuing its HCQ drug trial on June 5, 2020, whereas the RECOVERY TRIAL, a large UK-based study, stopped including HCQ for treating COVID-19 on June 5, 2020 as there was no evidence of benefits. Professor Martin Landray, a co-leader of the study said that this drug is useless for treating COVID-19. https://edition.cnn.com/2020/06/05/health/hydroxychloroquine-uk-recovery-trial-bn/index.html .
Again on June 17, 2020 the WHO made another U-turn and announced that HCQ testing is halted in its SOLIDARITY trial as many trials (SOLIDARITY, RECOVERY, COCHRANE review, etc) showed no benefit in treatment of COVID-19.
Has Donald Trump disturbed the mental balance of the WHO !!!
Meanwhile, the ICMR of India published its study indicating that four or more doses of HCQ reduced the risk of getting COVID-19 among frontline healthcare workers (May 28, 2020 -- IJMR, ahead of print publication).
-- another twist to the dance of HCQ -- the just published first RCT study finds no benefit as a preventive -- a jolt to the advocates of the drug as a preventive. In another scene of the drama, results of a first high quality HCQ study, of RCT protocol standards, carried out in the US (University of Minnesota) is published in The New England Journal of Medicine (June 3, 2020) which concluded that the infection rate was the same in the group which took HCQ and the group that didn't take the drug. So, HCQ is useless in preventing COVID-19. On seeing this publication of the RCT study of post-exposure prophylaxis, the advocates of HCQ prophylaxis must be squirming in their seats. Go to the link below:
https://www.nejm.org/doi/full/10.1056/NEJMoa2016638 There may be political ramifications and the invisible strong hand of the pharmaceutical industry behind the uproar about the 'Lancet study'. There seems to be a reflection on various personalities, politicians, researchers, institutions, research bodies, the peers who review articles, drug control authorities, academic bodies, publishers and international organisations -- the image of The Lancet, The New England Journal of Medicine and the WHO is particularly tarnished.
The world is run on money, politics and publicity ! In good old days, we used to take whatever is published in reputed journals as gospel truth. Now we view them with suspicion just as many patients look at many hospitals with suspicion, nowadays !!!The suspicion is strengthened by the government orders to shut some 'COVID HOSPITALS' in India for overcharging and fleecing the patients.
Research and published results used to be cold and clinical facts. Black and white. Times have changed. Now they come with modern costumes, trendy ideas and emotions. Did you come across the scientific study, published in the New England Journal of Medicine, whose observations suggest that gazing at beautiful bare breasts make men healthier and live longer ? Search for my comment on this on my blog -- T. Rama Prasad.https://in.dental-tribune.com/news/lancet-faces-severe-criticism-from-scientific-community-hydroxychloroquine-study-is-hiding-data/
Hydroxychloroquine (HCQ), the controversial anti-malarial drug, now repurposed for use in COVID-19, has become another facet of the fiasco of modern medicine in the context of the coronavirus. There has been a great interplay of politics, publicity, personalities, science, common sense and nonsense. The pandemic of panic seems to have influenced even the WHO, the FDA of the US and the ICMR of India. While there is no robust and credible evidence in favour of HCQ, either for treatment or prevention, as it stands today, people have taken medicine into their hands just as sometimes they take law into their hands, and made the drug out of stock in many medical shops across the world.
A reading into the link cited above underlines the need for medical men, the academic bodies and the regulatory administration to think and act scientifically. Or else, the evidence put forth may be as good as that for 'Gangajalam' or 'Gomoothra' ( Ganges river water or cow's urine ). Evidence obtained by 'Observational studies' gives some information without definite rational validation and sometimes associated with bias and misleading. Evidence obtained by well-conducted 'Randomised Control Trials (RCT)' gives robust and credible scientific knowledge. Ideally, a drug is to be studied by RCTs to determine the efficacy and safety. Then only the study attains academic validity which can stand the test of scientific scrutiny. Incidentally, the "Lancet study" is an observational study.
There is evidence to say that the study published in The Lancet is a flawed presentation. Read the following comment which is from the link cited below:
" More than 100 scientists and clinicians have sent an open letter to The Lancet's editor, Richard Horton, and the paper's authors asking them many uncomfortable questions, but have failed to receive convincing answers from the authors. How can a drug like Hydroxychloroquine produced in such huge quantities for a country as populous as India, safely consumed by millions & millions of chronic users for so many decades without any adverse effects, suddenly get a negative report in 2020 when it's most needed for a pandemic such as COVID -19 ? " ( https://in.dental-tribune.com/news/lancet-faces-severe-criticism-from-scientific-community-hydroxychloroquine-study-is-hiding-data/ ).
Peter Ellis, Chief Data Scientist, Nous Group alleged that the data in the high-profile and high-consequence 'Lancet publication' are completely fabricated. Surgisphere, a Chicago-based data analytics company that supplied data for this study said that one hospital in the study was mistakenly classified under 'Australasia Continental' designation instead of 'Asian Continental'. The truth for the discrepancies is yet to come. Meanwhile there had been devastatingly damaging negative press publicity against the "monumental" study ! ( https://theprint.in/health/why-researchers-are-questioning-lancet-study-that-linked-hcq-to-higher-covid-death-risk/432896/ ).Some other criticisms
EDITORIAL in THE HINDU of June 6, 2020
Shine a light: On retraction of a research paper
JUNE 06, 2020 00:02 IST
The scientific process must be protected from those seeking power and riches
Two weeks ago, a study in The Lancet, perhaps the most influential medical journal in the world, found no benefit from the use of hydroxychloroquine (HCQ), a well-known antimalarial, to treat sick COVID-19 patients. Today, that study stands retracted. As it had relied on a huge dataset of about 96,000 patients sourced from 671 hospitals in six continents, the World Health Organization, citing a ‘do no harm’ principle, suspended drug trials pending a safety review. This led to some countries in Europe withdrawing the drug from their own trials. Another study involving some of the same authors and relying on the same data published in The New England Journal of Medicine, which sought to answer questions on the associations between cardiovascular disease, COVID-19 and drugs that target the enzymes that play a role in facilitating the virus in attacking a host, has also been retracted. The Lancet study triggered a backlash from scientists who found problems with the methodology and, more importantly, the dataset. It emerged that mortality attributed to the disease in Australia did not match with the country’s own estimates; there was no way to tally patient records and the hospitals they were sourced from; and there were problems with the statistics deployed and the conclusions about the potential risk from the drug.
The bigger concern was that the data was supplied by Surgisphere Corporation, which had a handful of employees with limited scientific expertise, and claimed to have aggregated its numbers by compiling electronic health records in less than two months. Experienced clinical trial specialists said this was a labour-intensive process. Moreover, when aspersions about the data started to swirl, the company, citing client confidentiality, said it was unable to share its data sources for independent assessment. In their retractions, the journals have blamed Surgisphere for being opaque with its primary data. So far, neither journal has introspected on the peer-review process that led to these studies being published in the first place. In hindsight it seems obvious that a disinterested analysis would have raised eyebrows regarding data sourcing, but the post-COVID world is a panic-driven one that has left no institution or appraisal process untouched. The average peer-review takes weeks and the clinical trial process months, but now the expectation is that science delivers its results like magic. For years now, questions have been raised on the effectiveness of the traditional, time-consuming peer-review process and this has launched a welcome culture of papers being uploaded as preprints for review. In the present instance of the HCQ imbroglio, it is the independent effort by external scientists that brought the blight to light. The key lesson is that it is a mistake to assume the scientific process as one divorced from the influence of power, privilege, finance and politics. The means and methods to a scientific result matter more than results — only achieved through global scrutiny. Openness, more than blame game, is what the post-COVID world needs now.
The ICMR seems to have based its recommendations of preventive HCQ among high-risk frontline workers in the battle against COVID-19 on the evidence of some observational studies. Two small observational studies in France and South Korea found some benefit of treatment and prevention. The Direct-General of the ICMR, Balram Bhargava said on May 26, 2020 : "We've weighed the risks and benefits and concluded that we can't as of now deny this (preventive HCQ) to our frontline workers battling COVID-19." As finding a new preventive drug may take several years and marketing a new vaccine several months or years, HCQ seems to be a practical, cheap, reasonably safe and probably effective agent for prevention of potentially lethal COVID-19 infection in high-risk groups. The Chief Scientist of WHO and the former Director-General of the ICMR, Dr. Soumya Swaminathan said on May 26, 2020 that the WHO's decision on pausing 'Solidarity' trial does not imply that India should pause testing HCQ as a preventive. However, Dr. Soumya stressed that India ought to be doing stricter trials to test the efficacy in staving off the infection in asymptomatic people at high-risk of contracting the virus.
ICMR made a small observational study on its own during the past few months. The study says that four or more doses of HCQ reduced the risk of getting COVID-19 among frontline healthcare workers. But it had drawn a flak. Dr. Amar Jesani, editor of Indian Journal of Medical Ethics said "The ICMR Director-General Dr. Balram Bhargava and Dr. Gangakhedkar were involved in the decision making on HCQ use. So they should not have been involved in a research project to collect evidence in support or against their policy." It's a conflict of interest. Dr. Anant Than, a bioethics expert, pointed out that since the senior ICMR leaders are co-authors, it would have been a good practice to have a 'Conflict of Interest' statement. (TNIE, 02.06.2020).
The study highlights the potential antiviral and anti-inflammatory properties of HCQ with respect to its low cost of therapy and excellent oral bioavailability high tissue concentrations in the lungs relative to the plasma levels and acceptable safety profile. Click on the following links:
And the WHO seemed to be abundantly cautious about continuing its HCQ drug evaluation trial. The Director-General of the WHO, Tedros Adhanom Ghebreyesus said on May 25, 2020: "In the light of a paper published in the Lancet that showed people taking HCQ were at higher risk of death and heart problems, there would be a temporary pause on the HCQ arm of its global clinical trial." In yet another fiasco, the WHO made a U-turn and announced on June 4, 2020, consideration of resumption of the HCQ arm of the 'Solidarity' drug trial !
And, yet in another twist, on July 4, 2020, the WHO announced ending of HCQ trial in hospitalised patients with COVID-19, as there was no evidence of benefit.
Opinions vary according to perceptions -- may be right or wrong, a conundrum of medical science ! And, some published studies give us right knowledge and some may mislead us. One has to precisely weigh the benefits and risks. Cardiac malfunction and retinopathy are the feared side effects of HCQ which might have been blown out of proportion. And some might have overrated the benefits.
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On May 27, 2020, France, Italy and Belgium have stopped using HCQ for treating COVID-19. These three countries were hardhit by the coronavirus.
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| Trump and Fauci at a White House briefing on 20.03.2020 |
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| The Hindu, May 20, 2020 |
You may be wondering ... what the US president Donald Trump has got to do with Hydroxychloroquine !
"Chloroquine (HCQ) has been approved by the Food and Drug Administration (FDA) of the US to treat the Coronavirus COVID-19," said Donald Trump.
"The FDA would need to determine that in a clinical trial ... it's not yet approved," said the FDA Commissioner Stephen Hahnc.
"We do it under the auspices of a protocol that would give us information to determine if it's truly safe and effective ... the evidence you are talking about is anecdotal, not that of a controlled clinical trial ... so you can't make any definitive statement about it, " said the head of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci.
"I am a "big fan" of Chloroquine ... I am a man that comes from a very positive school ... I am a smart guy ... I feel good about it ... it has been prescribed for many years for people to combat malaria ... it's very effective and strong ... so we will see ... you are going to see," retorted president Trump.
At a long-winded White House briefing on 20.03.2020, President Trump enthusiastically and repeatedly promoted the promise of the anti-malarial and anti-rheumatoid arthritis drug Chloroquine (Hydroxychloroquine / HCQ) in the treatment of Coronavirus COVID-19. The scientific heads present at the meeting didn't endorse his statement. It looked like a clash between the temperamental Trump's faith and the scientific temper of medicine. So, Trump is at odds with his experts.
The NCDC in its twitter handle on Friday said: “@WHO has NOT approved the use of chloroquine for #COVID19 management. Scientists are working hard to confirm the safety of several drugs for this disease.
At the same time, the FDA has approved the "COMPASSIONATE USE" of chloroquine to treat coronavirus patients in the US (
https://techstartups.com/2020/03/19/fda-approves-compassionate-use-anti-malaria-drug-chloroquine-treatment-coronavirus/ ).
The profound interest of President Donald Trump in HCQ surprised everybody. He had also stated that he does not own a company that produces HCQ. HCQ is unique -- no other drug enjoyed this much of global publicity and the strong patronage by none less than the President of the US. If interested to read more about what Trump said see the reprint attached at the end of this paper.
The optimism about this drug is based largely on favourable reports from experts in China and France. But, researchers stress that the reports are not based on carefully controlled studies which are the only way to be sure that a drug really works.
With confusion about Chloroquine swirling and the public demand to know about it surging, media made all this a big news and brought Chloroquine and Corona into focus. Rheumatologists in the US were furious of patients calling every few minutes about the panic buying and the resultant shortage of Chloroquine caused by the White House briefing.
The facts seem to be like this: Chloroquine (and its analog Hydroxychloroquine (HCQ) which is a tad less toxic but of the same efficacy) is an old and well-established drug to treat malaria, rheumatoid arthritis and lupus erythematosus. There has been some evidence - anecdotal and scientific as well - to suggest that Chloroquine is an effective and safe drug to treat the disease SARS which is a sister of COVID-19. There is also some evidence to say that it is very effective in treating COVID-19, and there is some evidence to say that it is useless. As this disease is only a few months old, not much of irrefutable and scientifically valid evidence is available today for the FDA to approve.
However, some impressive data have been put forth about its beneficial role in treating COVID-19 disease, but there is nothing much to conclude about its efficacy in preventing development of COVID-19. The study material available so far is so scanty that statements made on the preventive value of Chloroquine in normal or high risk population lack scientific validity and academic authenticity. However, some are batting for its prophylactic (preventive) value out of common sense tempered with scientific perception. Some in the high risk category like those working in hospitals and the aged are already taking Chloroquine / Hydroxychloroquine in some countries, in the present day global-panic-set-up, with the fond hope that they may escape from the clutches of corona. Unfortunately, one man in Arizona died when he self-medicated himself with an overdose of hydroxychloroquine.
A team of researchers has used an optical mapping system to observe exactly how the drug creates serious disturbances in the electrical signals that govern heartbeat.
https://www.sciencedirect.com/science/article/pii/S1547527120305269?via%3Dihub
As finding a new preventive drug may take several years and marketing a new vaccine several months or years, hydroxychloroquine / chloroquine seem to be a practical, cheap, reasonably safe and effective agent for prevention of potentially lethal COVID-19 infection in high-risk groups. But, despite the urgency created by the perilous pandemic, we should not abandon sound scientific reasoning. The internationally reputed medical journal LANCET published 0n 22.05.2020 an article of a large multinational real-world registry analysis of use of HCQ in COVID-19 patients. The study revealed that there was no benefit and that there were increased ventricular arrhythmias and deaths associated with this drug ( https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext#seccestitle70 ).
Consequent to this publication, WHO suspended its HCQ drug trial, over safety concerns.In medical research, there is nothing which is finally conclusive -- look at what Shekar Mande, Director-General of CSIR said about the publication in
The Lancet and the action taken by the WHO. The ICMR seems to have set aside this evidence in
The Lancet while extending HCQ prophylaxis to more front-line workers on 22.05.2020 ( the same day when the above data were published in the
Lancet ), perhaps, after weighing the possible benefits and risks.
Touting of this drug by Trump and his outbursts at WHO about 'virus-China' issue is a different story. -- Dr. T. Rama Prasad
ANTACID is ANTICORONA !!!
Forget about HCQ. Now we have the $ 21 million entertainment with the antacid FAMOTADINE (Pepcid). Read the photocopy below. This is how our world class research goes on in the affluent America ! Earlier, we were entertained with the idea of 'injecting disinfectants & sunlight' to prevent Corona !
BREAKING NEWS on 23.03.2020
New Delhi: The National Task Force COVID-19 constituted by Indian Council of Medical Research (ICMR) on Monday recommended the use of hydroxy-chloroquine for the treatment of COVID-19 for high-risk cases amid increasing cases of coronavirus outbreak in India which has claimed 7 lives and 415 confirmed cases till today.
The ICMR National Task Force said only high risk cases can be placed under chemoprophylaxis with hydroxy-chloroquine:
- The Asymptomatic Health care workers involved in the care of suspected or confirmed cases of coronavirus (Covid-19)
- Asymptomatic household contacts of laboratory confirmed cases.
"Hydroxychloroquine is recommended only for a healthcare worker who is treating a #COVID patient. Secondly, it's recommended only for persons staying and caring for a household positive patient. They can take that only for prophylaxis, only for prevention," said ICMR Director-General Balram Bhargava.
The Drug Controller General of India (DCGI) has also approved the protocol recommended by the ICMR National Task Force for restricted use in emergency situation.
Recommendation for empiric use of hydroxy-chloroquine for prophylaxis of SARS-CoV-2 infection (COVID-19)
Background:
Hydroxy-chloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from available evidence of benefit as treatment and supported by pre-clinical data. The following recommendation for the use of hydroxy-chloroquine as a prophylactic agent against SARS-CoV-2 infection is based on these considerations, as well as risk-benefit consideration, under exceptional circumstances that call for the protection of high-risk individuals.
The National Taskforce for COVID-19 recommends the use of hydroxy-chloroquine for prophylaxis of SARS-CoV-2 infection for selected individuals as follows:
Eligible individuals:
- Asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19
- Asymptomatic household contacts of laboratory confirmed cases
Dose: - Asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19: 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks; to be taken with meals
- Asymptomatic household contacts of laboratory confirmed cases: 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 3 weeks; to be taken with meals
Exclusion/contraindications:
- The drug is not recommended for prophylaxis in children under 15 years of age.
- The drug is contraindicated in persons with known case of retinopathy, known hypersensitivity to
hydroxychloroquine, 4-aminoquinoline compounds Key considerations:
- The drug has to be given only on the prescription of a registered medical practitioner.
- Advised to consult with a physician for any adverse event or potential drug interaction before initiation of medication
- The prophylactic use of hydroxychloroquine to be coupled with the pharmacovigilance for adverse drug reactions through self-reporting using the Pharmacovigilance Program of India (PvPI) helpline/app.
- If anyone becomes symptomatic while on prophylaxis he/she should immediately contact the health facility, get tested as per national guidelines and follow the standard treatment protocol.
- All asymptomatic contacts of laboratory confirmed cases should remain in home quarantine as per the national guidelines, even if they are on prophylactic therapy.
- Simultaneously, proof of concept and pharmacokinetics studies be taken up expeditiously.
Findings from these studies and other new evidence will guide any change in the recommendation
As there is no clinching evidence in favour of Chloroquine as a preventive drug of COVID-19, a large scale prospective double-blind controlled study is being planned ... a study sponsored by University of Oxford on the efficacy of Chloroquine in preventing COVID-19 -- May 2020 to May 2022 ( https://clinicaltrials.gov/ct2/show/NCT04303507 ). According to the protocol of this study, a loading dose of 10 mg per kg of body weight of Chloroquine base is to be followed by 150 mg per day for 3 months. Some people in India have already started taking Chloroquine, and if the trend catches up, the stock on the shelves would vanish as happened in the US ! Right now we don't know for certain the protective value of Chloroquine April 13, 2020
Now, there seems to have come a critical day when Hyroxychloroquine is to be considered as a preventive drug in high risk groups in general population -- read the following situation in Maharashtra State of India:
The US president Trump had declared that Chloroquine was approved in the US to treat COVID-19. But Fauci, the top US expert in infectious diseases, contradicted it saying that the drug needs to be studied for its efficacy against the coronavirus and that the claims are only 'anecdotal' !
The following is a report in the press: ...
19 hours ago - Hospitals and doctors are wiping out supplies of Chloroquine, an unproven coronavirus treatment. Lack of definitive evidence has not stopped exploding ...." One Chinese publication indicated that Chloroquine may be beneficial in treating Coronavirus Pneumonia ( https://www.ncbi.nlm.nih.gov/pubmed/32164085 ).
May 23, 2020:
In view of favourable reports on the preventive value of HCQ (observations during the past two months by ICMR, AIIMS & some other hospitals in New Delhi), the Ministry of Health and Family Planning has now recommended extension of the preventive medication by HCQ to other front line workers -- surveillance workers, paramilitary and police personnel. ( Ganges river water or cow's urine )
Geneva: The World Health Organization (
WHO) on Friday warned that the
antiviral drugremdesivir should not be used to treat Covid-19 patients no matter how ill they are as there is no evidence it works.
"The panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others," Xinhua news agency quoted the WHO's Guideline Development Group (GDG) panel as saying in a statement. "Any beneficial effects of remdesivir, if they do exist, are likely to be small and the possibility of important harm remains," the panel added.
The WHO recommendation, published in the British Medical Journal, was based on an evidence review that included data from four international randomised trials among more than 7,000 hospitalised patients.
" Do the drugs Remdesivir, Tocilizumab, Itolizumab, Virafin, Favipiravir, Molnupiravir, Bamlanivimabn, Etesevimab, Casirivimab, Imdevimab, Sarilumab, Plasma, HCQ, Doxycycline, Ivermectin, etc cure COVID-19 ? Remdesivir costs now (April 2021) more than Rs. 20,000 per one dose in the 'black market' though WHO warned against its use to treat COVID-19 patients ! (https://health.economictimes.indiatimes.com/news/pharma/who-warns-against-remdesivir-for-covid-19-treatment/79316549 )" -- Dr. T. Rama Prasad
COVAXIN STORY
"COVAXIN" is an indigenously developed inactivated vaccine at the Hyderabad-based (India) vaccine manufacturer, Bharat Biotech. It's permitted to do Phase I & II human clinical trials in June 2020 --results expected in October 2020. Meanwhile the ICMR chief kicked up a 'scientific storm' by 'ordering' completion of the trials 'quickly' so that the vaccine could be ready for use by August 15, 2020 !
The directive drew a severe flak from the scientific community for fast-tracking and cutting corners in medical research. Then the chief backtracked and made a whimpering clarification that he meant to 'cut red tape' to hasten the process. Thus the 'August 15 Independence Day balloon' burst with a bang, putting our hopes of getting 'Independence from Corona' to rest. Robust clinical trials take time.
CELEBRATE INDEPENDENCE DAY with corona vaccine. Even the baby is laughing at the idea ! Fast-tracking medical research studies. Can we produce a baby in one month by getting nine women pregnant !!! -- T. Rama Prasad.
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Here are some excerpts from some articles:
" ... Some unanswered questions are here: How chloroquine will act as a prophylactic drug ? How it acts as a therapeutic agent against COVID-19 infection ? Why Trump is saying chloroquine is a game changer in the fight against the COVID-19 ?
Chloroquine acts on host target respiratory cells by:
Chloroquine increases the endosomal pH required for the virus- host target cell fusion. Increase in the pH disrupts the normal viral function.
In SARS-coronavirus, which is a sister to COVID-19, chloroquine was found to interfere with the glycosylation of cellular receptors of the virus. This interference eventually resulted in no association between the host target cell and the virus.
Chloroquine acts as an ionophoric agent for Zinc ions and thus increases the influx of zinc ions into the cytoplasm of host target cells regardless whether the host target cells are infected or not.
All the above-mentioned mechanism is on the host cells and COVID-19 cannot mutate and cause resistance to these 3 mechanisms. The first 2 mechanisms inhibit the virus-target host cell union. Chloroquine results in disablement of ACE2 (Angiotensin converting enzyme 2) terminal glycosylation which leads to the morphological change; ACE-2 is a surface receptor found on target host cell. This results in the disruption in the association between the COVID-19 and target host cell as COVID-19 requires ACE-2 receptor to attach to a cell.
Because the action is on the target host cell, Chloroquine won’t develop resistance therapeutically. If a person uses Chloroquine as a prophylactic agent (500mg once in a week for adults and 8.3 mg per kg once in a week for children) against COVID-19 then, it will act for pre-infection and post-infection benefit. If a person does not get exposed to the COVID-19 infection after taking Chloroquine (say for 3 weeks) and then some viruses enters and try to infect target host cells, the Chloroquine mechanism “a” and mechanism “b” will prevent the union of virus-target host cell. If some of the viruses enters the target host cell, there Zinc ions are waiting to adhere to the RNA dependent RNA polymerase enzyme of the virus and stops COVID-19 polymerization intracellularly. If COVID-19 mutates inside the cell several times, even then the Zinc ions will actively inhibit the viral multiplication inside the host respiratory cells, irrespective of the viral strain. Even if COVID-19 virus manages to escape from Zinc ions trap and releases from the host target cell cytoplasm into the interstitial matrix, intercellular space, and tried to re-infect some of the healthy target host cells, Chloroquine will prevent the re-union of viral genome with target host cells via mechanism ‘a’ and mechanism ‘b’ and the infection will halt in the preliminary stages itself and complications like COVID-19 pneumonia will not develop. Chloroquine molecules will not lose its effectivity in an individual pre and post infection.
Zinc is present in ample amount in the human body. In normal conditions, the Zinc is not present in free state in the cell. The increased level of Zinc ions is not toxic to the cells and cells excrete the extra Zinc ions into the extracellular space. Zinc is commonly present in red meat, legumes, nuts, milk, cheese, eggs, whole grains etc. Garlic increases the absorption and bioavailability of Zinc inside the body. So, some persons who aren’t taking Zinc rich foods in ample amount should take zinc supplements and garlic daily.
Safety of Chloroquine - it is well tested as it is given for malaria prophylaxis and autoimmune diseases like rheumatoid arthritis and lupus erythematosus. Now a days it is indicated in SARS infection as it is a broad antiviral agent. Through its ionotropic action on zinc intracellular influx, chloroquine is also used as an anti-cancerous drug.
The long-term use of chloroquine (4 years) may cause its accumulation in the eye. There are some concerns about its use in glucose-6-phosphate dehydrogenase enzyme deficient children but in the recommended prophylactic and therapeutic doses, Chloroquine is safe to be used in children. Some persons may complain of acidity and nausea, but it can be relieved if Chloroquine is taken after meals.
Prophylactic dose in malaria is 500 mg once a week in adults and 8.3 mg per kg once a week in children. In these doses it may be effective against COVID-19 too as a prophylaxis. The therapeutic doses against COVID-19 as used in China, America and India are Chloroquine 500mg BD for 5 days with other anti-viral drugs like Oseltamivir, Lopinavir, Ritonavir, etc., and in complicated COVID-19 pneumonia cases, Chloroquine may be used for 10 or more in the same amount.
Hydroxychloroquine is less toxic but the original Chinese work was based on chloroquine phosphate. Hydroxychloroquine can be used with equal efficacy. If one starts prophylactically with Chloroquine, then one must stick to chloroquine and must not switch over to hydroxychloroquine and vice-versa. This switch over may result in increase of QT interval.
REFERENCES
Zhu N, Zhang D, Wang W et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med 2020
Gao, J., Tian, Z. and Yang, X., 2020. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. BioScience Trends.
Vincent, M., Bergeron, E., Benjannet, S., Erickson, B., Rollin, P., Ksiazek, T., Seidah, N. and Nichol, S., 2005. Virology Journal, 2(1), p.69.
https://youtu.be/U7F1cnWup9M ... "
A therapeutic agent that prevents infection with novel coronavirus is highly desirable–especially for persons with high-risk exposure (e.g healthcare professionals) as well as persons with comorbidities (heart disease, diabetes, etc) and compromised immune systems. Ground-breaking in vitro studies demonstrate potential efficacy of hydroxychloroquine as a prophylactic for novel coronavirus infection in primate cells.
Note: Hydroxychloroquine (brand name Plaquenil) is an inexpensive, globally available drug (tablet) that was approved for widespread medical use since 1955. It is commonly used today to treat malaria, systemic lupus erythematosus and rheumatoid arthritis.
The study is part of the initiative from an independent group of scientists and physicians working on an open-data clinical trial for prevention of COVID-19, through the use of hydroxychloroquine in combination with other therapeutic agents. The group is now calling on President Trump to allow Americans to use the drug.
Unlike a typical commercial drug trial, the objective of the group is to share trial data with the public* and health-care professionals as close to real-time as possible (with a reasonable level of data quality assurance). Given the rapidly spreading coronavirus pandemic, the group is looking for every possible means to fast-track the effort. You can read their draft paper at
https://www.covidtrial.io/
“ …Despite FDA warning, Trump says he is taking hydroxychloroquine WASHINGTON, MAY 19, 2020
-- Sriram Lakshman in THE HINDU International.
U.S. President Donald Trump has said he has been taking hydroxychloroquine (HCQ) for “a couple of weeks” to help ward off COVID-19 infection. The drug, traditionally used in the treatment of malaria, rheumatoid arthritis and lupus, has not been proven to be effective in COVID-19 prevention or treatment. The drug can sometimes have severe side effects, including arhythmia, which can be fatal.
“You’d be surprised at how many people are taking it, especially the front-line workers before you catch it. The front-line workers — many, many are taking it. I happen to be taking it. I happen to be taking it,” Mr. Trump told journalists during a meeting with restaurant executives on Monday.
“Hydroxychloroquine?” “When?” “Now?” reporters asked, to which Mr. Trump responded in the affirmative.
“A couple of weeks ago, I started taking it. Because I think it’s good,” he said.
“I’ve heard a lot of good stories. And if it is not good, I will tell you right. I’m not going to get hurt by it. It has been around for 40 years for malaria, for lupus, for other things. I take it,” he said, adding that he hoped to soon not to be taking it because other solutions would be available.
Mr. Trump also said he did not own a company that produced HCQ and wanted Americans to feel good and that the drug has an impact, especially early on.
He also confirmed that he was also taking a zinc supplement and had taken a single dose initially of azithromycin, an antibiotic.
“All I can tell you is, so far I seem to be okay,” Mr. Trump said.
FDA warning
The Federal Drug Administration (FDA), the U.S.’s drug regulator, issued a warning about HCQ last month saying it should not be taken outside a hospital setting or clinical trial due to heart rhythm problems (the advisory did not pertain to FDA-approved use of the drug for the treatment of malaria, lupus and rheumatoid arthritis).
The White House released a memorandum from Sean P. Conley, the President’s osteopathic physician, that Mr. Trump had tested negative for several COVID-19 tests he had taken in recent days and that the President was “in very good health.”
Dr. Conley’s memorandum suggested that the choice of prophylactic medication was not an obvious one. “After numerous discussions he and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relative risks,” he wrote.
India, a major producer of HCQ, had sent shipments of the drug to the U.S., days after Mr. Trump had asked India to lift a ban on the drug’s export. The U.S. has, according to Mr. Trump, stockpiled more than 29 million doses of HCQ. …”
The ICMR seems to have based its recommendations of preventive HCQ among high-risk frontline workers in the battle against COVID-19 on the evidence of some observational studies. Two small observational studies in France and South Korea found some benefit of treatment and prevention. The Direct-General of the ICMR, Balram Bhargava said on May 26, 2020 : "We've weighed the risks and benefits and concluded that we can't as of now deny this (preventive HCQ) to our frontline workers battling COVID-19." As finding a new preventive drug may take several years and marketing a new vaccine several months or years, HCQ seems to be a practical, cheap, reasonably safe and probably effective agent for prevention of potentially lethal COVID-19 infection in high-risk groups. The Chief Scientist of WHO and the former Director-General of the ICMR, Dr. Soumya Swaminathan said on May 26, 2020 that the WHO's decision on pausing 'Solidarity' trial does not imply that India should pause testing HCQ as a preventive. However, Dr. Soumya stressed that India ought to be doing stricter trials to test the efficacy in staving off the infection in asymptomatic people at high-risk of contracting the virus. 
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Considering zinc ions and the garlic one inorganic and the other organic seem to play an important role in the metabolic system.Your review of the work with references seems worth for future research.As I studied body fluid is nothing but modified sea water.some ions are in excess yet some are deficient...balance imbalance and unbalance is tricky mechanism in cellular metabolism.Learnt a lot from your article my dear Respected Dr.
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