The pandemic's first major research scandal erupts

Kelly Servick, Martin Enserink

Science  05 Jun 2020:

Vol. 368, Issue 6495, pp. 1041-1042

On its face, it was a major finding: Antimalarial drugs touted by the White House as possible COVID-19 treatments looked to be not just ineffective, but downright deadly. A study published on 22 May in The Lancet used hospital records procured by a little-known data analytics company called Surgisphere to conclude that COVID-19 patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and more likely to die. Within days, large randomized trials of the drugs screeched to a halt. Solidarity, the World Health Organization's (WHO's) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm.

But just as quickly, the results have begun to unravel—and Surgisphere, which provided patient data for two other high-profile COVID-19 papers, has come under withering online scrutiny from researchers and amateur sleuths. They have pointed out many red flags in the Lancet paper, including the astonishing number of patients and details about patient demographics and dosing that seemed implausible. “It began to stretch and stretch and stretch credulity,” says Nicholas White, a malaria researcher at Mahidol University in Bangkok.

As Science went to press, The Lancet issued an Expression of Concern, noting “serious scientific questions” about its paper. Hours earlier, The New England Journal of Medicine(NEJM) issued an Expression of Concern about a second study using Surgisphere data, published on 1 May. The paper reported that taking certain blood pressure drugs including angiotensin-converting enzyme (ACE) inhibitors didn't increase the risk of death among COVID-19 patients, as some researchers had suggested. The journal asked the authors “to provide evidence that the data are reliable.”

A third study using Surgisphere data is also under fire. In an April preprint, Surgisphere founder and CEO Sapan Desai and coauthors concluded that ivermectin, an antiparasitic drug, dramatically reduced mortality in COVID-19 patients. In Latin America, where ivermectin is widely available, that study led some officials to authorize use of the drug, creating a surge in demand.

Chicago-based Surgisphere has not publicly released data underlying the studies. On 2 June, Desai told Science through a spokesperson that he was “arranging a nondisclosure agreement that will provide the authors of the NEJM paper with the data access requested by NEJM.” And in a 29 May statement, Surgisphere defended the integrity of its research and said it was pursuing “an independent academic audit” of its results in The Lancet. The journal and non-Surgisphere authors also said data reviews were underway.

The episode has left leaders of halted hydroxycholoroquine trials weighing whether to restart. “The problem is, we are left with all the damage that has been done,” says White, a co-investigator on a halted trial for COVID-19 prevention. It will now be hard to recruit people to key studies, he says. “The whole world thinks now that these drugs are poisonous.”

Desai co-authored the Lancet paper with cardiologist Mandeep Mehra of Harvard University's Brigham and Women's Hospital (BWH), cardiologist Frank Ruschitzka of University Hospital Zürich, and cardiac surgeon Amit Patel, who listed affiliations with the University of Utah and HCA Research Institute in Nashville, Tennessee. (Mehra and Patel referred inquiries to BWH. Ruschitzka did not respond to requests for comments.) The authors describe an analysis of electronic health record data from patients already treated for COVID-19 at 671 hospitals on six continents—nearly 15,000 people prescribed chloroquine or hydroxychloroquine, alone or in combination with an antibiotic, and a control group of 81,000 other patients. After adjusting for potentially confounding factors, the researchers found the risk of dying was 9.3% for the control group versus 23.8% for those getting hydroxychloroquine alongside an antibiotic.

In a 25 May media briefing, WHO Director-General Tedros Adhanom Ghebreyesus cited the results in announcing a “temporary pause” in Solidarity's hydroxychloroquine arm. Regulators in France and the United Kingdom also instructed investigators, including White's team, to halt enrollment in trials. And Sanofi said it would temporarily stop recruiting patients to two trials of its hydroxychloroquine formulation.

Other researchers immediately took issue with the analysis. The study does not properly control for the likelihood that patients getting the experimental drugs were sicker than the controls, says Matthew Semler, a critical care physician at Vanderbilt University. And White notes anomalies in the data. Although 66% of the patients were reportedly treated in North America, the reported doses tended to be higher than the guidelines set by the U.S. Food and Drug Administration. And the authors claim to have included 4402 patients in Africa, but it seems unlikely that African hospitals would have detailed electronic health records for so many patients, White says. The study also reported more deaths in Australian hospitals than the country's official COVID-19 death statistics, The Guardianreported. On 29 May, The Lancet issued a correction saying a hospital assigned to the study's “Australasia” group should have been assigned to Asia and updating a supplemental table. “There have been no changes to the findings of the paper,” it says.

The brief response left some researchers frustrated. “This was very, very annoying,” says James Watson, a statistician at Mahidol who on 28 May published an open letter—now signed by more than 140 researchers—that calls for the release of Surgisphere's hospital-level data, an independent validation of the results, and publication of the peer-review comments that led to the Lancet publication. “The Lancet encourages scientific debate and will publish responses to the study, along with a response from the authors,” a journal spokesperson said in a response.

On 2 June, many of the same researchers and others published an open letter to NEJMand the authors of the ACE inhibitor study, citing similar problems in that paper. It notes inconsistencies including a discrepancy between the small number of hospitals in each country that are said to have shared patient data with Surgisphere and the high proportion of those countries' confirmed COVID-19 cases included in the study.

Oddities also appear in the ivermectin study, says Carlos Chaccour of the Barcelona Institute for Global Health. There's evidence that ivermectin, the key weapon in the global campaign against river blindness, also has antiviral properties. The 6 April preprint, co-authored by Patel, Desai, and Mehra, along with David Grainger of the University of Utah, used Surgisphere data reportedly collected at 169 hospitals around the world between 1 January and 1 March. It included three patients in Africa who received ivermectin—even though only two COVID-19 cases had been reported in all of Africa by 1 March, Chaccour and two colleagues note in a recent blog post.

Chaccour says after he inquired about the discrepancy, the authors posted a second, longer version of the manuscript on 19 April, containing data collected between 1 January and 31 March. The new manuscript reported that ivermectin reduced the need for mechanical ventilation by 65% and slashed the death rate by 83%. But the revision had other problems, Chaccour and his colleagues wrote in their blog post. For example, the data shown in a figure were wildly different from those reported in the text. (Grainger also did not reply to a request for a comment.)

In response to the ivermectin study the Peruvian Ministry of Health modified its COVID-19 treatment protocol to include ivermectin (as well as hydroxychloroquine) for mild and severe cases of COVID-19; demand for the drug in Peru has surged. In Trinidad, Bolivia, the city government aimed to hand out more than 350,000 free doses of ivermectin after the country's Ministry of Health authorized its use against COVID-19.

Surgisphere's sparse online presence—the website doesn't list partner hospitals by name or identify its scientific advisory board, for example—has prompted intense skepticism. Physician and entrepreneur James Todaro of the investment fund Blocktown Capital wondered in a blog post why Surgisphere's enormous database doesn't appear to have been used in peer-reviewed research studies until May. Chaccour asks how such a tiny company—LinkedIn lists only a handful of employees—was able to reach data-sharing agreements with hundreds of hospitals around the world.

Desai's spokesperson says the company has 11 employees and has been developing its database since 2008.

The potential of hydroxychloroquine for treating COVID-19 has become a political flashpoint. French microbiologist Didier Raoult, whose own widely criticized studies suggested a benefit from the drug, derided the Lancet study in a video posted on 2 June, calling the authors “incompetent.”

For scientists running randomized trials of hydroxychloroquine, an urgent question has been how to respond to the paper and the ensuing flap. A trial funded by the U.S. National Heart, Lung, and Blood Institute opted to keep running after its data and safety monitoring board (DSMB) reviewed safety data from already enrolled participants, says Semler, a co-investigator on the study. WHO's paused Solidarity trial is awaiting similar review from its DSMB, says Soumya Swaminathan, the organization's chief scientist.

The controversy is an unfortunate distraction, says Miguel Hernán, a Harvard epidemiologist and co-investigator on an ongoing trial of hydroxychloroquine in Spain and Latin America. “If you do something as inflammatory as this without a solid foundation, you are going to make a lot of people waste time trying to understand what is going on.” Chaccour says both NEJM and The Lancet should have scrutinized the provenance of Surgisphere's data more closely before publishing the studies. “Here we are in the middle of a pandemic with hundreds of thousands of deaths, and the two most prestigious medical journals have failed us,” he says.

Correction (4 June 2020): An earlier version of this story said one problem with the ivermectin study, according to Carlos Chaccour and his colleagues, was the strikingly low mortality rate, 21%, of COVID-19 patients who needed mechanical ventilation. It stated that a case series in the New York City area found that 88% of COVID-19 patients who needed ventilation died. However, that number was based on a paper in JAMA that was later corrected because the actual mortality for this group was much lower. The sentence has been removed from the story.

 

 

Read more:

Science  05 Jun 2020:

Vol. 368, Issue 6495, pp. 1041-1042

 

See also:

salivating MSM hopes russia will get worse...in Since Covid19, no-one died from cancer, heart attack, dementia, bus encounter and natural carkup in the UK...

 

 

Gus note (updated): in the graph, there is about a quarter of equivalent death to Covid19, attributed to the common flu (influenza) which kills around 500,000 persons a year worldwide. 

 

Seasonal flu death estimate increases worldwide

Press Release

Embargoed Until: Wednesday, December 13, 2017, 6:30 p.m. ET

Contact: Media Relations

(404) 639-3286

According to new estimates published today, between 291,000 and 646,000 people worldwide die from seasonal influenza-related respiratory illnesses each year, higher than a previous estimate of 250,000 to 500,000 and based on a robust, multinational survey.

The new estimate, from a collaborative study by CDC and global health partners, appears today in The Lancet. The estimate excludes deaths during pandemics.

 

“These findings remind us of the seriousness of flu and that flu prevention should really be a global priority,” says Joe Bresee, M.D., associate director for global health in CDC’s Influenza Division and a study co-author.

 

 

Please note that the world population (7.8 billion presently) increases by more than 81 million people per year... THIS NEEDS TO BE TAKEN INTO ACCOUNT in all the data...

We can say that since the covid panic started in China, 450,000 died from the virus and another 550,000 died from "other causes", including malaria. Meanwhile we can also say that 40 million new people have been added to the world population in the same period...

 

 

 

Now let's look at masks, according to some "physicist"...

 

...

Health professional told me back in March that face masks were ineffective but that respirators (the N95) were. Because of the source, I thought there must be validity to this. However, it seemed counterintuitive.

I reasoned that there would be differentials between using any type of mask versus no mask because no mask usage would allow aerosols to penetrate unabated, whereas a mask should capture much of the aerosol and reduce risk of spread to others and presumably should also function to mitigate breathing in viral-laden droplets. Because of the greater density of respirator material, the prophylactic would be reasoned to be greater.

However, what I had not considered was how extremely small the virion was in relation to the porosity of the material in the masks and respirators. I also had not looked at the scientific literature on the subject…until now.

Denis Rancourt, an eminent physics professor, former anarchist, and author, examined the scientific evidence for using face masks and respirators as preventative of contracting respiratory influenza-like disease, or respiratory illnesses believed to be transmitted by minuscule droplets.

What I have noticed is that Rancourt is wedded to the evidence, and he is unafraid to make known his conclusion even though it goes against the mainstream consensus. His article, “Masks Don’t Work: A review of science relevant to COVID-19 social policy,” is Rancourt at his iconoclastic finest. He concludes,

No RCT [randomized control trial] study with verified outcome shows a benefit for HCW [health care workers] or community members in households to wearing a mask or respirator. There is no such study. There are no exceptions.

 

The virions are super tiny, tinier than the pores in the respirators. Rancourt writes,

 

if anything gets through (and it always does, irrespective of the mask), then you are going to be infected. Masks cannot possibly work. It is not surprising, therefore, that no bias-free study has ever found a benefit from wearing a mask or respirator in this application.

 

Rancourt’s article is fascinating and anyone curious abut the efficacy of masks should read it.

 

Read more:

https://off-guardian.org/2020/06/15/do-masks-and-respirators-prevent-viral-respiratory-illnesses/

World No 1 tennis player Novak Djokovic has tested positive to COVID-19 and apologised for hosting a tennis tournament which has become the centre of a virus cluster.

The tennis star said sorry for “each individual case of infection” as it was revealed his wife Jelena and his fitness coach had also contracted the virus after three other players previously tested positive.

Social distancing rules were ignored at the charity event in Croatia and video footage later emerged on social media of the Serb star dancing in a Belgrade nightclub with other players.

Australian Nick Kyrios did not hold back with a withering condemnation on Twitter in which he retweeted the video of the shirtless players dancing.

“Prayers up to all the players that have contracted Covid- 19,” Kyrgios tweeted.

“Don’t @ me for anything I’ve done that has been ‘irresponsible’ or classified as ‘stupidity’ – this takes the cake.”

 

Read more:

https://thenewdaily.com.au/news/coronavirus/2020/06/24/coronavirus-novak...

 

 

Read from top.

From the outset of the Covid-19 pandemic, it was taken for granted that the virus spread via respiratory droplets in the air and through contact. It was on this assumption that we were advised to wipe door handles, wear a mask and observe "social distancing".

However, this mode of transmission was never proven.

If Covid-19 is indeed a respiratory virus, then it should be deduced that it can only be transmitted by aerosol like all other viral respiratory diseases. In such a case, it is absurd to be cleaning door handles, absolutely useless to wear masks or to slip on a jumpsuit, and utterly ridiculous to keep social distancing. The only prevention is to ventilate as much as possible.

This mode of transmission has also not been proven, but it is much more logical than the dominant assumption.

This theory has been supported by numerous researchers since the beginning of the epidemic, but they have not been given a voice. It was in light of this hypothesis that Thierry Meyssan was prompted to deride the use of masks comparing them to those worn by the plague doctors in the XVIIth century [1].

239 scientists have just published an open letter to this effect in the journal Clinical Infectious Diseases (CID).

 

Read more:

https://www.voltairenet.org/article210490.html

 

Read from top.

 

But see also:

https://watermark.silverchair.com/ciaa939.pdf?

https://academic.oup.com/cid/article/65/11/1934/4068747?searchresult=1

https://academic.oup.com/cid

Face Masks: A Danger to Our Planet, Our Children & Ourselves

Cory Morningstar

It seems like only yesterday that a massive campaign against single-use plastic straws was trending. The much forgotten anti-straw trend was based on astronomical numbers; a suggested 500 million straws used each day in the US alone, with more than half a billion plastic straws being consumed and discarded, every day around the entire globe.

An estimated 8.3 billion plastic straws had come to pollute the planet’s beautiful beaches. The backlash against the straws appeared to be driven by the horrific impacts on the marine environment in particular.

Personal protective equipment (PPE) in 2020, in particular face masks, have become a new genre of pollution. The majority of face masks being purchase and disposed of are single-use surgical masks made of melt-blown fabric manufactured from polypropylene, a type of thermoplastic. The vast majority of all disposable face masks being consumed have two outer layers with a filter between them (polypropylene), made from nonwoven plastic fibres.

The paper COVID-19 Pandemic Repercussions on the Use and Management of Plastics published June 20, 2020 warns that a “monthly estimated use of 129 billion face masks and 65 billion gloves globally, is resulting in widespread environmental contamination.”

194 billion face masks and gloves equates to well over 6 billion face masks being consumed and discarded each and every day.

Based on the aforementioned paper, six months of face masks alone – equates to seven hundred seventy-four billion, while 12 months of consumption, equates to a stunning one trillion five hundred forty-eight billion face masks.

Meanwhile, “Canada alone has ordered more than 153 million N95 respirators, almost 400 million surgical masks and 18 million non-medical face masks. That doesn’t include demand from the private sector.” As a new emerging market, trees (biological communities invisible to the humancentric eye) cannot only be sacrificed on the altar of “green energy”, we can also pulverize them into face “ecofriendly” masks.

What happened to all those who cared about our environmental crises? That of climate change, biodiversity and ocean pollution?

MICROPLASTICS & HUMAN HEALTH

Microplastics are tiny plastic fragments less than 5 millimeters in diameter, or about 0.2 inches. They are barely visible to the human eye.

A 2019 study showed that human microplastic consumption ranges from 39,000 to 52,000 particles per day. These estimates increase to 74,000 and 121,000 when inhalation is considered. This amounts to humans ingesting approx. 5 grams of plastic each and every week, 5 grams being the equivalent of a credit card or a US nickel. Earlier in 2019, the European commission’s chief scientific advisers stated:

The evidence [on both environmental and health risks due to microplastics] provides grounds for genuine concern and for precaution to be exercised.”

More recently, on August 17, 2020, researchers analyzed 47 human tissue samples. Traces of microplastics were found in all 47 samples.

We have detected these chemicals of plastics in every single organ that we have investigated.”
senior researcher Rolf Halden, director of the Arizona State University (ASU) Biodesign Center for Environmental Health Engineering

This begs the question, what will be the result from applying microplastic materials, that is face masks, directly and securely over our air passages?

“Flock” is defined as inhaled microfibers of the plastic. “Flock worker’s lung” is an occupational lung disease caused by exposure to flock in manufacturing processes. People who work in flocking manufacturing processes inhale small pieces of the flock fibers, placing them at risk of interstitial lung disease. 

Workers exposed to polypropylene flocking particles have developed flock worker’s lung. The presence of microplastics in human lung tissue was outlined by in a 1998 science paper, following the research of lung tissue belonging to cancer patients who had prolonged exposure to plastic fibers.

In addition to particle pollution causing damage to lung tissue and reducing lung capacity, it worsens other respiratory health issues such as asthma. In 2013, the International Agency for Research on Cancer, an institution belonging to the World Health Organization, concluded that particle pollution causes lung cancer.

An informal survey of a small group of health care workers by myself found that about 50% of workers noted that their masks began to fray at the end of their shift, noting fibers that itched their face and nose.”
[source]

In occupational flock, “the cutting process results in formation of airborne particles or fibers in the respirable range.” . As facemasks undergo a continuous friction with breathing, talking, and facial movements, it seems likely, if not probable, that microscopic polypropylene microfibers, in some amount, are effectively being ingested into both the body and lungs. 

Particles that are not inhaled into the lungs (the vast majority) make their way into our waterways. To be more succinct, every single particle produced, that does not make its way into our bodies, will instead go in to our waterways. The particles are then ingested into the body by humans and non-human life (marine animals and fish), some of which is too, ingested by humans. Of course, in addition, we drink the water, as does non-human life.

…Is this how we protect biodiversity? Is this what we mean by protecting health?

CLOTH MASKS

To mitigate against this latest environmental and health nightmare, people have been encouraged to wear reusable fabric face coverings comprised of three layers of fabric.

On September 25, 2020, a University of California–Davis study found that the fabric of home-made cloth face coverings release a large amount of fibers into the air. The study underscored the importance of washing them. What is not discussed are the same fibres being inhaled and ingested.

Those in the West, and those who own or have access to a clothes dryer, will know what dryer lint is. Friction causes the fabric fibres to become loose and dislodge during the washing and drying process – resulting in sometimes little, and more often lots – of lint that must be removed after each cycle.

Consider this excerpt from the article, How damaging is breathing in microplastics? [emphasis added]:

Microplastics washed off from synthetic clothes contribute up to 35% of the plastic particles polluting our oceans. Every time we do our laundry, an average of 9 million microfibers end up in the wastewater treatment plants that cannot filter them, and because of that, these fibers end up in the ocean. Also, just by wearing synthetic clothes, plastic fibers are constantly being released in the air.

Up until now, all research was focused on microfiber pollution through laundry washing. However, a recent study shows how wearing polyester clothes pollutes the environment to a similar extent—wearing polyester clothes releases as many microplastic fibers in the air as through washing.

If microfibers are shedding off clothing, they are shedding off masks. Even cotton ones. In fact, cotton textiles (clothing, towels, etc.) often produce far more lint than other fabrics. Add to this, the inhalation of chemical laundry detergent and chemical fabric “softener” (liquid and sheet form) that many people continue to use in the process of washing and drying the masks.

It is safe to assume that those wearing masks for long periods of time are most at risk. The vast majority of this group would be minimum wage workers, who have no choice but to comply, people of colour, who are told they are more susceptible to the virus than white populations, and children in schools, where masks have been made mandatory.

OUR CHILDREN

In June 2020, the Children’s Sick Kids Hospital, perhaps the most prestigious hospital in Canada, advised that children, by and large almost completely unaffected by the virus, should not wear masks and added that physical interaction and play was essential for their well-being. 

We have suggested that masks not be required when children return to school.”
Michelle Science MD, MSc, FRCPC, Division of Infectious Diseases, The Hospital for Sick Children, Assistant Professor, Department of Paediatrics, University of Toronto

Close interaction such as playing and socializing is really central to child development and should not be discouraged…Overall we think it’s not realistic or in children’s best interests to completely avoid all close interaction and play.”
Dr Daphne Korczak, Pediatrics, Psychiatry

For children and adolescents, masks are an absolute no-no. Children and adolescents have an extremely active and adaptive immune system and they need a constant interaction with the microbiome of the Earth. Their brain is also incredibly active, as it is has so much to learn. The child’s brain, or the youth’s brain, is thirsting for oxygen. The more metabolically active the organ is, the more oxygen it requires. In children and adolescents every organ is metabolically active.”
Dr. Margarite Griesz-Brisson MD, PhD , Consultant Neurologist and Neurophysiologist [full transcript]

These recommendations were largely ignored by the media and, despite the warnings, the government and school boards made masks and social distancing mandatory for children. 

The hospital further reported that 1500 asymptomatic children were tested, none tested positive [see this Twitter thread.] 

In the following presentation, Professor Franz Ruppert explains the impact of the pandemic from a psychological point of view. Ruppert explains how and why people currently suffer when their essential needs are taken; why children in particular are extremely affected; how current “protective” measures achieve this effect; and whether these measures are justified. 

 

 

Read more:

https://off-guardian.org/2020/11/06/face-masks-a-danger-to-our-planet-our-children-ourselves/

 

 

See image at top.

 

See also: the spikes... in covid-19 — science...