A mysterious company’s coronavirus papers in top medical journals may be unraveling

[dufus]

 

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 coronavirus patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and were more likely to die in the hospital.

 

Within days, some large randomized trials of the drugs—the type that might prove or disprove the retrospective study’s analysis—screeched to a halt. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm, for example.

 

But just as quickly, the Lancet 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 involved and details about their demographics and prescribed dosing that seem implausible. “It began to stretch and stretch and stretch credulity,” says Nicholas White, a malaria researcher at Mahidol University in Bangkok.

 

full article

[tennis]

10 hours ago, dufus said:

 

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 coronavirus patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and were more likely to die in the hospital.

 

Within days, some large randomized trials of the drugs—the type that might prove or disprove the retrospective study’s analysis—screeched to a halt. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm, for example.

 

But just as quickly, the Lancet 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 involved and details about their demographics and prescribed dosing that seem implausible. “It began to stretch and stretch and stretch credulity,” says Nicholas White, a malaria researcher at Mahidol University in Bangkok.

 

full article

Immediately went to read the full source article.  It was interesting to find it was published by Science news.  Many, many years ago, Science  this was the quick and only source, for me, for topics of general interest in the broad area of science.  Honestly, I have not referred to the sourced internet website, for many many years, until today.  Reading the article recalls my early interest in these things that are scientific.  I actually head here to Nsane everyday.  I eagerly review the posts in this forum,  as well as the responses members provide.  The forum does help me keep aware of a great range of interesting topics.  Today, we have a conflict with what was published in Lancet and Science.  Interesting post.  

[dufus]

its not the only source ....

 

WHO to restart hydroxychloroquine study as risk data questioned

 

An international trial using hydroxychloroquine to treat COVID-19 patients will be restarted after questions arose about a study linking the antimalarial drug to increased death and heart risks.

The World Health Organization said Wednesday that it will resume recruiting patients for the hydroxychloroquine arm of a global trial called Solidarity. The agency had paused the branch of the study, which compares the impact of a number of treatment regimens, after the drug was linked to heart risks in a study published in The Lancet, a medical journal.

The move adds to the confusion that’s erupted since more than 200 scientists began questioning the study published May 22 in The Lancet. Scrutiny has focused on Surgisphere Corp., the Chicago-based firm that provided data for the study, from which scientists have demanded more transparency about its sources and methods of analysis.

The WHO paused the hydroxychloroquine arm of its study as a precaution “because of concerns raised about the safety of the drug,” Director-General Tedros Adhanom Ghebreyesus said in a press briefing. After a safety panel review “the members recommend that there are no reasons to modify trial protocol.”

source

 

 

[ghost]

I wonder how many covid-19 deaths were actually chloroquine or hydroxychloroquine deaths.

[dufus]

who know,s what,s really going on  !

[Karlston]

Doubt looms over hydroxychloroquine study that halted global trials

Researchers are skeptical of a data analytics company that has not shared data.

Enlarge

Aurich Lawson / Getty

117 with 68 posters participating

The Lancet medical journal on Tuesday issued an “expression of concern” over the validity of a recent study suggesting that the anti-malarial drugs chloroquine and hydroxychloroquine raise the risk of death and heart complications in hospitalized COVID-19 patients.

More than a hundred outside experts have raised questions and skepticism about the data and analysis, even as researchers halted clinical trials in light of the study's findings.

 

The two drugs at the center of the controversy have had a high profile during the pandemic, with many prominent figures—most notably President Donald Trump—promoting them as effective against COVID-19. On May 18, Trump even told reporters that he was taking the drugs himself to prevent infection from the new coronavirus, SARS-CoV-2.

 

Despite the publicity, there’s little evidence to support the efficacy of chloroquine or its analogue, hydroxychloroquine, to prevent or treat COVID-19. Small studies done so far have only provided mixed and inconclusive results in COVID-19 patients. The two drugs are only approved for use against malaria and autoimmune diseases, such as lupus and rheumatoid arthritis. They have also long been linked to risks of heart complications.

 

The limited evidence for use against COVID-19 and the known risks led the Food and Drug Administration to issue a safety warning that the drugs "should be limited to clinical trial settings or for treating certain hospitalized patients."

 

In the Lancet study—which was published May 22 and reported by Ars—researchers aimed to provide some clarity of the drugs’ effects in COVID-19 patients. The researchers claimed to do so using the largest set of data to date, involving more than 96,000 hospitalized COVID-19 patients from six continents. According to the authors, a thorough hashing of the data indicated that those taking either hydroxychloroquine or chloroquine had significantly higher risks of death and heart complications compared with COVID-19 patients who did not take either of the drugs.

 

The safety issues were concerning enough that on May 26, the World Health Organization announced that it was suspending the use of hydroxychloroquine in its global Solidarity Trial, which is evaluating several potential COVID-19 therapies. Regulators in the UK and France also changed their recommendations surrounding the drugs.

A closer look

Amid the global influence, outside researchers began closely examining the data behind the study—or at least tried to do so—and have been left concerned.

 

In an open letter sent to the study’s authors and The Lancet, outside experts outlined ten significant problems, ranging from inadequate statistics, data irregularities, and a lack of ethics review. The letter was signed by more than a hundred researchers.

 

At the heart of the problem is that the data used for the study was from a data analytics company called Surgisphere, based in Illinois. The company claims to have an enormous trove of data harvested from electronic medical records held by hundreds of hospitals around the globe. However, Surgisphere says it cannot share said data due to data use agreements it has with the hospitals.

 

This is problematic for critics, who are skeptical of the data the company claims to have and would very much like to see it themselves and confirm that the analysis is accurate. In the open letter, for instance, outside experts noted that:

 

In addition to a lack of transparency over the data, a report by The Scientist magazine also noted that Surgisphere’s founder, Dr. Sapan Desai, has a less than pristine past. The magazine noted that Desai, who trained in vascular surgery and founded the company in 2008, resigned from a hospital position shortly after three medical malpractice suits were filed against him in 2019.

 

Further, before Desai and Surgisphere focused on data analytics, their most public-facing activity was selling medical textbooks. According to The Scientist, the textbooks had fake 5-star reviews on Amazon from accounts impersonating actual physicians. One of the impersonated physicians, a breast surgical oncologist, told the magazine that she and colleagues eventually got Amazon to remove the reviews.

 

For several years, Desai also published a medical journal called the Journal of Surgical Radiology, which abruptly shuttered in 2013 despite its website claiming to have accrued 50,000 subscribers in short order.

Ongoing concerns

In response to criticism and skepticism over the COVID-19 data, Surgisphere issued a statement saying, in part, that it will submit to an independent audit of its data. On May 30, some of the minor data irregularities—including a mislabeled hospital—were corrected in The Lancet.

Surgisphere wrote in its statement that it is:

 

Nevertheless, on Tuesday, The Lancet issued an expression of concern over the study, saying that “although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information.”

 

Two other COVID-19-related studies involving Surgisphere data have also been called into question. The New England Journal of Medicine issued its own expression of concern on a Surgisphere-associated study. The research looked at the effect of preexisting use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) in COVID-19 patients. Researchers have also questioned a pre-print study (one that has not yet been published or peer reviewed) looking at the anti-parasitic drug Ivermectin for COVID-19.

 

 

Doubt looms over hydroxychloroquine study that halted global trials

 

[tennis]

18 hours ago, ghost said:

I wonder how many covid-19 deaths were actually chloroquine or hydroxychloroquine deaths.

There is an old saying,  "there is no such thing as a free lunch".  So, yes.  There may be risks associated with taking chloroquine or hydroxychloroquine, as with any medication.  To address a cholesterol issue, my physician has prescribed a statin medication - Atorvastatin.  If you query Atorvastatin, it shows there are associated risks.  Here is an excerpt from a web source, regarding use of Atorvastatin:

 

...Commonly reported side effects of atorvastatin include:

hemorrhagic stroke, arthralgia, diarrhea, and nasopharyngitis. Other side effects include: urinary tract infection, insomnia, limb pain, muscle spasm, musculoskeletal pain, myalgia, and nausea.

 

If my life depends on taking a medication, which only my physician will allow, then I might accept whatever risk there is, including hemorrhagic stroke.  Happily, I am here to share with you today.

[tennis]

On 6/3/2020 at 1:13 PM, dufus said:

its not the only source ....

 

WHO to restart hydroxychloroquine study as risk data questioned

 

(portion snipped to save space)

 

source

 

 

Yes. Thanks for adding the update.  At the time of my earlier response to your post, your source had already been edited and included this note:

 

 (Update: At a briefing on 3 June WHO announced it would resume that arm of the study.) 

 

For those that might not check the source hyperlink, your post is informative, helpful.

[dufus]

 the Lancet results have begun to unravel—and Surgisphere, which provided patient data for two other high-profile COVID-19 papers ", .....  it really has nothing to do with the drug or drugs being researched.

[ghost]

8 hours ago, tennis said:

There is an old saying,  "there is no such thing as a free lunch".  So, yes.  There may be risks associated with taking chloroquine or hydroxychloroquine, as with any medication.  To address a cholesterol issue, my physician has prescribed a statin medication - Atorvastatin.  If you query Atorvastatin, it shows there are associated risks.  Here is an excerpt from a web source, regarding use of Atorvastatin:

 

...Commonly reported side effects of atorvastatin include:

hemorrhagic stroke, arthralgia, diarrhea, and nasopharyngitis. Other side effects include: urinary tract infection, insomnia, limb pain, muscle spasm, musculoskeletal pain, myalgia, and nausea.

 

If my life depends on taking a medication, which only my physician will allow, then I might accept whatever risk there is, including hemorrhagic stroke.  Happily, I am here to share with you today.

First and foremost: I wish you all the best with your health and hope you never get those side effects. There have been numerous studies and reports of  chloroquine or hydroxychloroquine increasing the chance of death when used on Covid-19 patients. I was merely asking if there are any Covid-19 deaths that were caused by chloroquine or hydroxychloroquine. If so, how many?

 

 

[dufus]

Hydroxychloroquine researchers angry, embarrassed by dodgy studies  ........ who knows how many !

[jamesDDI]

It's a shame. Lancet has lost all credibility.

[tennis]

15 hours ago, ghost said:

First and foremost: I wish you all the best with your health and hope you never get those side effects. There have been numerous studies and reports of  chloroquine or hydroxychloroquine increasing the chance of death when used on Covid-19 patients. I was merely asking if there are any Covid-19 deaths that were caused by chloroquine or hydroxychloroquine. If so, how many?

 

 

Understood.  It's all good.  My presumption (my thoughts) are that most are taking chloroquine or hydroxychloroquine because they are beset with Covid-19, and their medical and mental state drives them to choose this option.  If they don't take the drug(s), they understand they have a higher likelihood of death, then if they didn't taken the drug.  

 

To your point.  How many Covid-19 deaths are caused by  chloroquine or hydroxychloroquine, in general ?  Me"  I don't know and note my use of the strike through feature where I mention Covid-19.  Is it important to use that term here?  I must believe there are studies that quantify the number of deaths due to these drugs, based on the studies that were performed and required to approve their usage.  Sorry, but I am not chasing those facts or conclusions, wherever they are published.

 

So, do I know what morbidity risks there are, in any event?  No.  I am not an epidimiologist, doctor, or research scientist as you would find peer reviewing studies that are published with the approval of The Lancet.  So take my thoughts as simple skepticism on one hand, with a shred of hope on the other hand - that there are alternates to doing nothing when faced with a positive Covid-19 test result.