Showing posts with label hydroxychloroquine. Show all posts
Showing posts with label hydroxychloroquine. Show all posts

Sunday, September 12, 2021

How the Covid pandemic is changing science

How the Pandemic Is Changing the Norms of Science | Tablet - John P.A. Ioannidis: 

September 8, 2021 - "The crisis caused by the lethal COVID-19 pandemic and by the responses to the crisis have made billions of people worldwide acutely interested and overexcited about science. Decisions pronounced in the name of science have become arbitrators of life, death, and fundamental freedoms. Everything that mattered was affected by science.... One problem with this new mass engagement with science is that most people, including most people in the West, had never been seriously exposed to the fundamental norms of the scientific method. The Mertonian norms of communalism, universalism, disinterestedness, and organized skepticism have unfortunately never been mainstream in education, media, or even in science museums and TV documentaries on scientific topics....

"Indeed, change did happen — but perhaps mostly for the worst.... Lack of communalism during the pandemic fueled scandals and conspiracy theories, which were then treated as fact in the name of science by much of the popular press and on social media. The retraction of a highly visible hydroxychloroquine paper from The Lancet was a startling example: A lack of sharing and openness allowed a top medical journal to publish an article in which 671 hospitals allegedly contributed data that did not exist, and no one noticed this outright fabrication before publication.... 

"The pandemic led seemingly overnight to a scary new form of scientific universalism. Everyone did COVID-19 science or commented on it. By August 2021, 330,000 scientific papers were published on COVID-19, involving roughly a million different authors. An analysis showed that scientists from every single one of the 174 disciplines that comprise what we know as science has published on COVID-19....  At first sight, this was an unprecedented mobilization of interdisciplinary talent. However, most of this work was of low quality, often wrong, and sometimes highly misleading. Many people without subject-matter technical expertise became experts overnight, emphatically saving the world.... Many amazing scientists have worked on COVID-19. I admire their work.... However, alongside thousands of solid scientists came freshly minted experts with questionable, irrelevant, or nonexistent credentials and questionable, irrelevant, or nonexistent data.

"Social and mainstream media have helped to manufacture this new breed of experts. Anyone who was not an epidemiologist or health policy specialist could suddenly be cited as an epidemiologist or health policy specialist by reporters who often knew little about those fields but knew immediately which opinions were true. Conversely, some of the best epidemiologists and health policy specialists in America were smeared as clueless and dangerous by people who believed themselves fit to summarily arbitrate differences of scientific opinion without understanding the methodology or data at issue.

"Disinterestedness suffered gravely.... During the pandemic, ... conflicted entities were raised to the status of heroes. For example, Big Pharma companies.... Other potentially conflicted entities became the new societal regulators.... Big Tech companies, which gained trillions of dollars in cumulative market value from the virtual transformation of human life during lockdown, developed powerful censorship machineries that skewed the information available to users on their platforms. Consultants who made millions of dollars from corporate and government consultation were given prestigious positions, power, and public praise, while unconflicted scientists who worked pro bono but dared to question dominant narratives were smeared as being conflicted. 

"Organized skepticism was seen as a threat to public health. There was a clash between two schools of thought, authoritarian public health versus science — and science lost.... Honest, continuous questioning and exploration of alternative paths are indispensable for good science. In the authoritarian ... version of public health, these activities were seen as treason and desertion. The dominant narrative became that 'we are at war.' When at war, everyone has to follow orders. If a platoon is ordered to go right and some soldiers explore maneuvering to the left, they are shot as deserters. Scientific skepticism had to be shot, no questions asked. The orders were clear....

"This is a dirty war, one without dignity. Opponents were threatened, abused, and bullied by cancel culture campaigns in social media, hit stories in mainstream media, and bestsellers written by zealots. Statements were distorted, turned into straw men, and ridiculed. Wikipedia pages were vandalized. Reputations were systematically devastated and destroyed. Many brilliant scientists were abused and received threats during the pandemic, intended to make them and their families miserable." 

Read more: https://www.tabletmag.com/sections/science/articles/pandemic-science

Monday, June 21, 2021

UK TV host calls lockdown biggest mistake in history

Neil Oliver: 'Lockdown is the biggest single mistake in world history' | Herald Scotland - Vicky Allan:

June 11, 2021 -"In the week in which calls have been made for 'freedom day' to be delayed in England, and in the wake of pausing of easing of restrictions in Scotland, archeologist and television presenter Neil Oliver has called the continued lockdown 'the world’s biggest mistake'.

"Speaking in an interview in the Herald magazine tomorrow [June 12], ahead of his debut as live show host on the new television channel, GB News, he said, 'I think it’s been mishandled from very early on. I think it’s the biggest mistake in world history. I’m not suggesting evil or malicious intent. I just think it’s a mistake....

"'I’m apolitical, but over the lockdown I have had opinions. I think it is the biggest single mistake in world history, and I’m just horrified by the damage that has been done. Whoever lockdown has saved, I think by an order of magnitude others have been hurt.'

"Seeing the footage coming out of Italy, he and his wife, he said, accepted the first lockdown as probably a good thing. 'But then it became clear to me the damage that was being done to the economy, and I became aware of the number of people I know personally that have been ruined by it, self-employed people that were getting no help, nothing for furlough. People who have had no support, no help, lost businesses, lost livelihoods and all the rest of it.'

"The period of the pandemic, he said, has seen a 'stymying and silencing of debate'. 'People talk to me all the time – people that I know quite well, but also people who come up to me for the first time. 'And they whisper. On the dog walk, miles from anywhere, people come up and they lower their voices, because they want to say that they think things are wrong.'

"The letters he received over the past year, and these conversations he had, and his sense that these 'views were not being reflected in the established media' were what, he said, had made him 'interested in being part of GB News'."

Read more: https://www.heraldscotland.com/news/19365417.neil-oliver-lockdown-biggest-single-mistake-world-history/

Bonus video: Dennis Prager said the same thing a year ago. 



Friday, April 23, 2021

NY patients win court battles to use ivermectin

Ivermectin Wins in Court Again: For Human Rights | Deseret News - Justus R. Hope, MD:

Apr 19, 2021 - "One dose of Ivermectin was all it took to get 81-year-old John Swanson off the ventilator. John’s wife Sandra could not believe it. His story is remarkably similar to other cases.... 

"Ralph Lorigo is the lawyer who now has won three court orders forcing New York hospitals to administer Ivermectin to dying patients. Incredibly, these three hospitals and their lawyers fought against the patients, arguing they did not have the right to receive the drug despite a valid prescription written by their doctors. In essence, the argument was that they did not have the right to try a potentially life-saving medication.

"In each of the three cases, the New York State Supreme Court Justices sided with the patient, and in each of the three cases, the patients made near-miraculous recoveries after the Ivermectin was given. In each case, these patients were in the Intensive Care Unit on ventilators, unable to breathe on their own, and universally, after the drug was given, they rapidly improved and were able to breathe on their own.

"Judith Smentkiewicz made national news in January when her family hired Lorigo after the hospital refused a fourth dose of Ivermectin..... Attorney Lorigo and his associate Jon F. Minear reported, 'This lady was on a ventilator, literally on her deathbed, before she was given this drug. As far as we’re concerned, the judge’s order saved this woman’s life.'

"The family of Glenna "Sue" Dickinson happened to see a newspaper article of Judith's remarkable story, and they decided to try Ivermectin as well. Sue Dickinson, 65, contracted COVID-19 on January 7, 2021 ...  and was placed on a ventilator on January 17. The hospital staff advised that her chances of survival were about 40 percent [but] refused to give Sue the Ivermectin. Lorigo and Minear  sought an injunction. State Supreme Court Justice Frank Caruso ordered the hospital to provide the Ivermectin. Dickinson, like Swanson, and Smentkiewicz, came off the ventilator and improved as well.... 

"Ivermectin is widely used by physicians, as there are now 51 studies from around the world, with 50 showing clear benefit and one showing neutral.... Experts worldwide have called for the global and systematic use of Ivermectin to prevent and treat COVID-19. Physicians have recently written about a profit motive by regulatory agencies and Big Pharma to block cheap, safe, and effective treatments like Ivermectin and HCQ [hydroxychloroquine] in favor of ... vaccines and medicines like Remdesivir.... Remdesivir cost[s] $3,100 per dose [while] Ivermectin costs about $2 per dose. It is safer than Tylenol or most vitamins, says Dr. Pierre Kory of the FLCCC Alliance, a group of expert physicians promoting access and information through a nonprofit organization. Dr. Kory and Mr. Lorigo have teamed up to help other hospitalized patients gain access to the life-saving drug....

"The big problem is that information promoting Ivermectin is often censored or silenced as quickly as it is provided. Facebook, Reddit, Change.org, YouTube, and others have recently taken down posts on Ivermectin citing violation of 'community standards.'  Physicians who employ good judgment and scientific studies are considered violators, as well as those who publish factual accounts of Ivermectin-based recovery stories. A recent article exposed the link between large pharmaceutical corporations and government regulatory agencies who have financial entanglements and massive conflicts of interest.

"The disinformation campaign is evident with the publication of articles attempting to cast Ivermectin in a false light, referring to it as an 'animal dewormer' that might be a 'bad idea' for humans to use. In reality, many drugs are common to both humans and animals for treatment, including antibiotics, antifungals, and antiparasitic agents....

"Satoshi Omura won the 2015 Nobel Prize in Medicine for his discoveries leading to the development of Ivermectin. In his praise for Ivermectin and its potential to help in the COVID-19 pandemic, Dr. Omura recently compared Ivermectin to Penicillin, 'one of the greatest discoveries of the twentieth century'.... Ivermectin has already been adopted by 25 percent of the world’s countries to prevent and treat COVID-19.... However, censorship, corruption, hospital lawyers, and disinformation campaigns have continued to stand in the way of its widespread acceptance in the United States. Many have never even heard of it.

"Ivermectin recently won in court in South Africa after a protracted legal battle. Ralph Lorigo has now won his third State Supreme Court Injunction in New York. Will legal strategies also be required in the US to gain FDA approval for Ivermectin to treat COVID-19?"

Read more: https://www.thedesertreview.com/opinion/letters_to_editor/ivermectin-wins-in-court-again-for-human-rights/article_98d26958-a13a-11eb-a698-37c06f632875.html

Saturday, September 12, 2020

WHO trials overdosed HCQ patients, MD says

WHO and UK trials use potentially lethal hydroxychloroquine dose--according to WHO consultant | Anthrax Vaccine blog - Meryl Nass, M.D.

June 14, 2020 - "The Solidarity Trial is a WHO-led conglomeration of many national trials of treatments for Covid-19.... The hydroxychloroquine arm of the Solidarity trials restarted enrolling patients June 3, after being halted May 25 by WHO Director-General Dr. Tedros Adhanom Ghebreyesus and the Executive Group of the Solidarity Trial... after publication of the Lancet Surgisphere study, which claimed that patients who received chloroquine or hydroxychloroquine had 35% higher death rates, but the Lancet study was retracted 13 days after publication.... The HCQ Solidarity trials are currently ongoing.... The doses were not specified on WHO's list of the drugs to be trialed, nor were they specified, surprisingly, in WHO's April 8 four-person 'consultation on chloroquine (CQ) dosing'....

"Last week, I was alerted to the fact that India's ICMR, its official medical research agency, had written to the WHO, telling WHO that the hydroxychloroquine doses being used in the Solidarity trial were 4 times higher than the doses being used in India.  Then I learned that Singapore had been hesitant to participate in the WHO trial due to the hydroxychloroquine dose....  

"The Solidarity trial is registered but the registration fails to specify dosages. The registration of the Canadian portion of the Solidarity trial informs us of its HCQ dose: ten 200 mg tablets during the first 24 hours (800 mg initial dose, 800 mg 12 hours later then 400 mg every 12 hours for 9 more days).  This is 2.0 grams during the first 24 hours, and a cumulative dose of 8.8 grams over 10 days.... The Norwegian Solidarity trial uses dosing identical to Canada....

"How is the drug hydroxychloroquine normally used?  For chronic daily use in systemic lupus erythematosus, rheumatoid arthritis or Lyme disease, patients receive between 200 and 400 mg daily....  In acute Q fever, 600 mg daily may be given at the start of treatment. For acute attacks of malaria, 1,500-2,000 mg may be given over 3 days. Professor Didier Raoult's group in Marseille used 600 mg daily for up to ten days in 1061 Covid-19 patients, and reported 8 deaths, a mortality rate of 0.75%, all over 74 years of age....

"What is a toxic dose?  All experts agree on this: '... chloroquine has a small toxic to therapeutic margin,' according to Goldfrank's Toxicologic Emergencies.  The drug is very safe when used correctly, but not a lot more can potentially kill.  Prof. Nicholas White, a Wellcome Trust Principal Research Fellow and expert in malaria treatment, who attended both WHO consultations on the chloroquines, has confirmed this.... The WHO hired a consultant to explore the toxicity of chloroquine in 1979. The consultant, H. Weniger, looked at 335 episodes of adult poisoning by chloroquine drugs. Weniger on page 5 notes that a single dose of 1.5-2 grams of chloroquine base 'may be fatal.' According to Browning and Goldfrank, the pharmacokinetics and potency of chloroquine and hydroxychloroquine are almost identical.... 

"The [independent UK] Recovery trial used 1.86 grams hydroxychloroquine base (equal to 2400 mg of hydroxychloroquine) in the first 24 hours for treatment of already very ill, hospitalized Covid-19 patients.  The Canadian and Norwegian Solidarity trials used 2,000 mg of HCQ, or 1.55 grams of HCQ base in the first 24 hours. Each trial gave patients a cumulative dose during the first 24 hours that, when given as a single dose, has been documented to be lethal. (The drug's half-life is about a month, so the cumulative amount is important.)  The doses used in these trials are not recommended for therapy of any medical condition, which I confirmed with Goodman and Gilman's Pharmacology textbook, the drug's US label, and the online subscription medical encyclopedia UptoDate.... 

"Excessive dosing makes it impossible to assess therapeutic benefit, if any, of HCQ. Furthermore, because there are over 400 trial sites, and relatively few subjects in each, unexpectedly high trends in mortality are likely to be missed at individual trial sites. Finally, testing the drug only in hospitalized patients means that the window of time during which HCQ would be expected to provide the most benefit, early in the illness when viral titers are rising, has passed....

"To sum up: 

  1. In the UK Recovery trial, and in WHO Solidarity trials, HCQ is used in a non-therapeutic, toxic and potentially lethal dose.
  2. HCQ is furthermore being given, in clinical trials, too late in the disease course to determine its value against SARS-CoV-2.
  3. Collection of limited safety data in the Solidarity trials serves to protect trial investigators and sponsors from disclosures of expected adverse drug effects, including death.
  4. It appears that WHO has tried to hide information on the hydroxychloroquine doses used in its Solidarity trial.  Fortunately, the information is discoverable from registries of its national trials....

"Update June 18:  I sent a tweet to WHO Director General Tedros informing him of these findings 3 days ago.  I also emailed WHO's Dr. Restrepo, inquiring about the doses used in the Solidarity trial.  I am very pleased to report that WHO stopped this deadly trial yesterday, with no fanfare ... on the basis of the Recovery trial result ... as well as WHO data. I like to think my investigation has helped save some lives."

Sunday, August 2, 2020

Thousands needlessly dying due to HCQ politics

The Key to Defeating COVID-19 Already Exists. We Need to Start Using It | Newsweek - Harvey A. Risch:

July 23, 2020: "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....

"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."

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

Tuesday, July 7, 2020

Hydroxychloroquine cut COVID19 death rate 50% in Michigan hospital study

by George J. Dance

By now I am sure we have all heard of hydroxychloroquine (HCQ), the anti-malaria drug and arthritis treatment that may or may not be effective against COVID-19. There certainly has been plenty of debate on the drug online: A google search for "Hydroxychloroquine COVID" turns up 65 million hits. Sadly, though, for a debate supposed to be "guided by the science," little of that deals with science. As with mask wearing, HCQ has become a political "issue," and for much the same reasons. Masks are good or bad because the Orange Man doesn't wear them. HCQ is bad or good because the Orange Man uses it. (Choose an option depending on how you feel about the Orange Man.) 

Unlike with masks, though, scientific information is needed to estimate the benefits and risks of HCQ. That is the main reason the blog has refrained from mentioning the drug; in all the debate I have followed, there has been nothing worth mentioning. There was a study in The Lancet that found using HCQ not only saved no lives but led to more deaths, from cardiac arrest; but before I could find space for it on the blog, Lancet had retracted the paper.

Today I discovered a new study, "Treatment with Hydroxychloroquine, Azithromycin, and Combination in Patients Hospitalized with COVID-19,"  by Samia Arshad et al., published in the International Journal of Infectious Diseases on July 1. The paper was an observational study conducted in the Henry Ford Health System (HFHS), a six-hospital chain in southwest Michigan, by the Henry Ford COVID-19 task force. The full study is online at ijid.com, and can also be found at https://doi.org/10.1016/j.ijid.2020.06.099 

Arshad et al investigated the medical records of the more than 2,500 patients hospitalized as COVID-related admissions (defined as having a positive PCR-RT viral test in the hospital) between March 10 and May 2. Of those, some had been treated with HCQ; some with a combination of HCQ and azythromycin (AZM), an antiobiotc; some with AZM alone; and some with neither drug. The differences in mortality rates were striking:
  • Of 409 patients given neither drug, 108 died, or 26.4% [95% CI: 22.2%-31.0%]​.
  • Of 147 patients given AZM alone, 33 died, or 22.4%. [95% CI: 16.0%-30.1%]
  • Of 783 patients given HCQ and AZM, 157 died, or 20.1%. [95% CI: 17.3%-23.0%]).
  • Of 1202 patients given HCQ alone, 162 died, or 13.5%. [95% CI: 11.6%-15.5%]).

Charted, the data gives a simple and clear picture: those receiving HCQ had a mortality rate almost 50% below those who received no drugs. Of course, that apparently simple and clear picture could actually be counfounded by numerous variables. The authors point out that those can include "1) patient demographics: age, gender, race, body mass index (BMI) on admission [as well as] 2) clinical characteristics: admission date, discharge date, length of stay (LOS), comorbidities including: cardiovascular disease (CVD), chronic lung disease, chronic kidney disease (CKD), hypertension, asthma, chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunodeficiency, and cancer (defined as active or past/resolved)."

The task force "used Multivariable Cox regression models and Kaplan-Meier survival curves ... to compare survival among treatment groups while controlling for demographics (e.g., age, gender), preexisting medical conditions (e.g. CVD, lung disease) and clinical disease severity (mSOFA, O2 saturation). Bivariate comparisons of the 4 medication groups were made using analysis of variance or Kruskal-Wallis tests for continuous variables, and chi-square tests or Fisher exact tests for categorical variables."

In addition, the researchers were able to exactly match two cohorts - 190 who had received HCQ, and 190 who had not - with "identical underlying patient characteristics." "The Cox regression result for the two propensity matched groups ... indicates that treatment with hydroxychloroquine resulted in a mortality hazard ratio decrease of 51% (p = 0.009)."


"The results of this study," the authors conclude, "demonstrate that in a strictly monitored protocol-driven in-hospital setting, treatment with hydroxychloroquine alone and hydroxychloroquine + azithromycin was associated with a significant reduction in mortality among patients hospitalized with COVID-19." (They also demonstrate that HCQ used alone was associated with a greater reduction. than the combination.)

The Food and Drug Administration (FDA) cautions against use of HCQ "outside of the hospital setting or a clinical trial," but does not approve the drug's use within the hospital setting, either. The FDA approved an Emergency Use Authorization (EUA) for the drug in late March, but withdrew it on June 15 after the Lancet study. The latter study has since been retracted and its data discredited; and now its conclusions have been explicitly contradicted by the Henry Ford study.

The study's findings that the drug is effective (that it reduces COVID deaths) may be overstated or confounded with other unknown variables (such as steroid use); I agree with the the Journal's call for clinical trials of the drug. Undeniably, though, the safety of the drug has been proven (it does not even correlate with any increase in deaths); that and the possibility of dramatically cutting the COVID death toll warrant the FDA restoring the medicine's EUA.