Antimalarial drugs touted by the White House as possible COVID-19 treatments appeared 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—ended. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm.
Then, the Lancet results have began 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.
The Lancet issued an Expression of Concern (EOC) saying “important scientific questions have been raised about data” in the paper and noting that “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.”
The New England Journal of Medicine (NEJM) issued its own EOC 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 appear to increase the risk of death among COVID-19 patients, as some researchers had suggested. (Several studies analyzing other groups of COVID-19 patients support the NEJM results.) “Recently, substantive concerns have been raised about the quality of the information in that database,” an NEJM statement noted. “We have asked the authors to provide evidence that the data are reliable.”
A third COVID-19 study using Surgisphere data has also drawn fire. In a preprint first posted in early April, Surgisphere founder and CEO Sapan Desai and co-authors conclude that ivermectin, an antiparasitic drug, dramatically reduced mortality in COVID-19 patients. In Latin America, where ivermectin is widely available, that study has led government officials to authorize the drug—although with precautions—creating a surge in demand in several countries.
Chicago-based Surgisphere has not publicly released the data underlying the studies, but today 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.”
MJM says
Well of course SOME of the negative response to the suggestion of this use of this medicine is political. There are too many people in this country that are in influential positions that think their opinion and agenda are more important than actually helping people.
The fake news press loves to deny Pres. Trump a single good idea or success. They are motivated to replace him and deny him good deeds regardless of right or wrong.
Then the democrat party, seeking the recovery of more power, does the same thing.
Then you can toss in the sad attitude of big pharma, fueled by lobbyists peddling influence and the drive for higher corp. profits. 60 year old medicine that is cheap doesn’t do that. Research and grants and years of looking for another answer produce costs that get reimbursed and higher profits. DUH ? No, hydroxy is not a cure but apparently can help many. TOUGH. Let more people suffer and die to create more emotional interference and the need for expensive profit driving meds. Which creates more lobbying $ and more control. The weak lose ang big biz digs in deeper. UNCONSCIONABLE PROFIT.
3 bad actors all creating a united front that promotes what’s best for them and ignores what people want and need. Simply medicine that works.
It all quickly becomes a large malignant tumor plotting against the President instead of combining forces to discover what is best for Americans and all of mankind.
IF that’s not a blatant demonstration of how THE SWAMP functions, I don’t know what is.
Donald Trump is not a perfect man, as none of us are. Against this entire SWAMP he has shown the investigations to be false, found a way to wave a magic wand to bring jobs back, got us a great Wall St while our country is burning which will fuel the recovery, is showing the communist Chinese gov. their corporate bullying will stop, got us back into space, and has created areas of this country where minorities get tremendous help to open businesses and make real money in opportunity zones. Lots of this was going on while Joe Biden was hiding in his basement with his son’s ill gotten gains.
I don’t know what “truth” you all are watching, but I think you hear what I see.
And sure you can go ahead and fire away at Trump’s imperfections, many of which are created by those that twist his imperfect words, but there is no one else in our political sights who could improve all the things he has in these conditions.
Paul Plante says
Here’s the lengthy list of the known side effects of that **** as of September 2019, long before COVID came around and Trump started pushing the ****, so this is hardly a political hit or conspiracy against poor, picked on Donny Trump, the poor baby, and if anyone wants my share of that ****, they are welcome to have it:
Drugs.com
Hydroxychloroquine Side Effects
Medically reviewed by Drugs.com.
Last updated on Sep 13, 2019.
Check with your doctor immediately if any of the following side effects occur while taking hydroxychloroquine:
• Blistering, peeling, loosening of the skin
• blurred vision or other vision changes
• chest discomfort, pain, or tightness
• cough or hoarseness
• dark urine
• decreased urination
• defective color vision
• diarrhea
• difficulty breathing
• difficulty seeing at night
• dizziness or fainting
• fast, pounding, uneven heartbeat
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, and sex organs
• loss of hearing
• lower back or side pain
• noisy breathing
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• severe mood or mental changes
• sore throat sores, ulcers, or white spots on the lips or in the mouth
• sticking out of the tongue
• stomach pain
• swelling of the feet or lower legs
• swollen or painful glands
• trouble with breathing, speaking, or swallowing
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual behavior
• unusual bleeding or bruising
• unusual facial expressions
• unusual tiredness or weakness
• yellow eyes or skin
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
• Continuing ringing or buzzing or other unexplained noise in the ears
• feeling of constant movement of self or surroundings
• irritability
• nausea
• nervousness
• nightmares
• sensation of spinning
• shakiness and unsteady walk
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination
• vomiting
Cardiovascular
Cardiomyopathy (can result in fatal cardiac failure), biventricular hypertrophy[Ref]
Dermatologic
– Pigmentary changes in skin and mucous membranes, bleaching of hair, and alopecia are usually reversible when therapy is discontinued.
– AGEP should be distinguished from psoriasis, although this drug may precipitate attacks of psoriasis; it may be associated with fever and hyperleukocytosis[Ref]
Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Pigmentary changes in skin and mucous membranes, bleaching of hair, alopecia
Urticaria, angioedema, bullous eruptions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP)[Ref]
Gastrointestinal
Abdominal pain, nausea
Diarrhea, vomiting
Hematologic
Bone-marrow depression, anemia, aplastic anemia, agranulocytosis, leucopenia, thrombocytopenia
Hepatic
Abnormal liver function tests
Fulminant hepatic failure
Hypersensitivity
Allergic reactions (urticaria, angioedema, bronchospasm), hypersensitivity myocarditis
Metabolic
Anorexia
exacerbation or precipitation of porphyria
Musculoskeletal
Sensorimotor disorders
Skeletal muscle myopathy or neuromyopathy (leading to progressive weakness and atrophy of proximal muscle groups), depression of tendon reflexes and abnormal nerve conduction studies
Myopathy may be reversible after therapy discontinuation, but recovery may take many months.
Nervous system
Headache
Dizziness
Seizure, vertigo, nerve deafness, ataxia
Ocular
Blurred vision
Retinopathy (with changes in pigmentation and visual field defects), corneal changes haloes (e.g., blurring of vision, photophobia)
Maculopathies and macular degeneration (may be irreversible), extra-ocular muscle palsies (reversible), nystagmus
– Blurring of vision is due to a disturbance of accommodation which is dose dependent and reversible.
– Retinopathy is uncommon if the recommended daily dose is not exceeded.
It is usually reversible if therapy is discontinued.
If allowed to develop, there may be a risk of progression even after treatment withdrawal.
– Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas, and abnormal color vision.
– Corneal changes including edema and opacities can be symptomless or may cause disturbances such as haloes, blurring of vision or photophobia.
They may be transient and are reversible when therapy is discontinued.
– Maculopathies and macular degeneration can occur from 3 months to several years of exposure to this drug and may be irreversible.
Other
Tinnitus
Hearing loss
Psychiatric
Affect liability
Nervousness
Psychosis, suicidal behavior
Respiratory
Bronchospasm
References
1. “Product Information. Plaquenil (R). (hydroxychloroquine).” Sanofi Winthrop Pharmaceuticals, New York, NY.
2. Cerner Multum, Inc. “UK Summary of Product Characteristics.”
3. “Product Information. Hydroxychloroquine Sulfate (hydroxychloroquine).” Prasco Laboratories, Cincinnati, OH.
4. Cerner Multum, Inc. “Australian Product Information.”
https://www.drugs.com/sfx/hydroxychloro … fects.html
Paul Plante says
As to the stock market’s rapid rise, MJM, scroll down to the thread “Get ready for the pain: Bankruptcy Tsunami is starting” on May 31, 2020 by Wayne Creed http://www.capecharlesmirror.com/news/get-ready-for-the-pain-bankruptcy-tsunami-is-starting/ and you will see that Trump had no more to do with it than did the Man in the Moon, or Bambi, or Superman or PeeWee Herman, for that matter.
Several TRILLION dollars of federal debt that the American people, most of whom gain no benefit at all from the stock market, are responsible for paying back, are responsible for that rise, because America is for the ONE PERCENT and the rest of us are mere dirt beneath their feet.
And by the way, MJM, China has steadily accumulated U.S. Treasury securities over the last few decades, and as of December 2019, the Asian nation owns $1.07 trillion, or about 5%, of the $23 trillion U.S. national debt, which is more than any other foreign country.
Uh, if I have my facts right, that is on Trump’s watch.
Oh, those nasty COMMIES.
Yeah, right – that’s BULL****!
If they are so bad, why are we doing so much business with them, so we have a trade deficit with them, and why do we American people OWE them interest on $1.07 TRILLION of American debt?
If they are such bad people, why is the Trump government turning to them to fund its operations?
And why are we ordinary Americans then forced by the Trump government to have to pay interest on U.S. debt to fund the bad COMMIES in China who Trump says are exploiting us?
Trump has at least two sides to his mouth and he talks out of all of them at once!
But hey, it’s America, and everybody gets to choose who their hero will be, and you are welcome to him.