The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that raised alarms about the safety of the experimental Covid-19 treatments chloroquine and hydroxychloroquine amid scrutiny of the data underlying the paper.
Just over an hour later, the New England Journal of Medicine retracted a separate study, focused on blood pressure medications in Covid-19, that relied on data from the same company.
The retractions came at the request of the authors of the studies, published last month, who were not directly involved with the data collection and sources, the journals said.
“We can no longer vouch for the veracity of the primary data sources,” Mandeep Mehra of Brigham and Women’s Hospital, Frank Ruschitzka of University Hospital Zurich, and Amit Patel of University of Utah said in a statement issued by the Lancet. “Due to this unfortunate development, the authors request that the paper be retracted.”
The retraction of the Lancet paper is sure to add fuel to contentious arguments about the potential of chloroquine and hydroxychloroquine, two old malaria drugs, in Covid-19, the disease caused by the novel coronavirus. President Trump has touted them as valuable treatments, despite a lack of rigorous data showing they have a benefit.
Meanwhile, on Wednesday, researchers reported the results of the first gold-standard clinical trial of hydroxycholoroquine in Covid-19, concluding that it did not prevent infections any better than placebo. Other clinical trials, including some looking at the drugs as treatments, are ongoing.
The Lancet study gained so much attention because it went further than other observational studies that had similarly found the drugs were not associated with improved outcomes for patients. The study, which was purportedly based on patient data from 671 hospitals on six continents, reported the drugs also corresponded to higher mortality.
The findings led to the pause of some global clinical trials studying hydroxychloroquine so researchers could check for any safety concerns. Outside experts, however, quickly raised concerns after noticing inconsistencies in the data. They asked the company that compiled and analyzed the data, Surgisphere, to explain how it sourced its data.
As scrutiny grew, the authors on the paper not affiliated with Surgisphere called for an independent audit. In their Lancet statement Thursday, they said that Surgisphere was not cooperating with the independent reviewers and would not provide the data.
“As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process,” the researchers wrote.
Outside experts raised similar concerns about the New England Journal study, which found that the blood pressure medications were safe to take for people with Covid-19. It was also based on data from Surgisphere.
In the New England Journal retraction statement, the study authors wrote, “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article.” They apologized “for the difficulties that this has caused.”
Concerns about the health risks of chloroquine and hydroxychloroquine were based on evidence beyond the Lancet paper. Earlier, the Food and Drug Administration warned the drugs should not be used in Covid-19 outside a clinical trial or beyond hospitalized patients because of the risks to heart health.
The drugs are safe for people to take for malaria, rheumatoid arthritis, and lupus, for whom they are shown to have benefits, experts stress.
Does this mean hydroxychloroquine CAN be used safely in patients in COVID-19
Chris, you are so right. I still don’t understand why we need “beyond meet” to “save the planet”. Just eat less in general, and especially less meet. The money and the research efforts would do more good in other areas. This is another example of less is more, they don’t know what to come up with so we can buy. I’m eating my spinach, and zucchini, broccoli.
Sapan Desai, one of the coauthor of the Lancet paper on HCQ, is the former founder of Surgisphere, the society ‘collecting’ the clinical data, as reported today by an italian newspaper (https://www.ilfattoquotidiano.it/2020/06/04/coronavirus-the-lancet-avvia-uninchiesta-sullo-studio-che-bocciava-lidrossiclorochina-preoccupati-gravi-questioni-scientifiche-sono-state-portate-alla-nostra-attenzione/5824478)
You can bet these “studies” are up to their necks with big pharma. The CDC, NIH, and all the others are primarily being funded by big pharma. Just like the beef, dairy, and other agri industries. Hate to admit it but Colbert was right when he said “eat your spinach”. Whole food, plant based diet would wipe out big pharma. That’s why there are “agg-gag” laws passed by congress. People don’t realize it takes 10 times more energy to produce a calorie of meat protein. People are not allowed to “talk about” diet truthfully. Almost 90% of chronic illness (heart disease, cancer, diabetes, high blood pressure, etc. would go away in a generation. If the public would SLOWLY start eating less beef and dairy.
View “Forks over Knives” on Netflix for an eye opening show!!
“Almost 90% of chronic illness (heart disease, cancer, diabetes, high blood pressure, etc.) would go away in a generation.”
I’d like to see the actual research that supports that conclusion. Forks Over Knives was more of a policy statement.
Just a note to say that CDC and NIH are not funded by big pharma or any other corporation or person. They are funded (100%) by Congress. Not to say that pharma would not corrupt them if they could. But they can’t.
The opponents of hydroxycholoroquine have all been politically motivated. No one said it was a cure. No one said it was a vaccine. No one said it is a miracle drug to be used alone. There is evidence – lots and lots of real evidence that using this drug in combination with Z-Pac and other drugs decreases the severity.
It is infuriating that doctors, liberal media, and democrats are lying about this drug and killing people who could be saved if it was made available to them because they hate Trump so much they would rather have people die than agree with him on anything.
The President actually stopped taking the medicine, so he doesn’t seem to agree with him either.
Indeed, once and for all, politics is politics and science is science. The political interference hurts our health. If you insist wearing a mask, you get labelled as democrat wanting to kill the “free” society and anti-business. Why can’t we agree that easy, cheap measures like the face masks reduce the pandemic and make possible the return to normal sooner.
R Benson the President stopped taking it because he was on a limited prescription because of a direct exposure-2 weeks at 400 mg a day.
Mr. Stichter, another approach to the risk of direct exposure is to procure a $4 mask.
so I don’t think the fellow is really worried about direct exposure.
(Unless Forbes is too left-wing for our consideration.)
If the Hydroxychlorquine is only tested on hospitalized patients (who are advanced in their illness, or else they would not be hospitalized) then it is therefore administed too late to positively affect the outcome. Only the side effects would be relevent and therefore reported. This sort of test is rigged from the start.
HCQ needs to be given with Zinc and you don’t design studies to give it to people already in the ICU and then say it doesn’t work.
Someone should look at the COVID morbidity in Africa where so many take HCQ routinely.
There are other antivirals that are being ignored because they are off-patent, such as Nitazoxonide.
We need to look at therapies and nutritional support. There has never been a corona vaccine that actually worked. To think one is suddenly going to work and not have untoward issues at some point is greedy stupidity.
unfortunately, it is unlikely that we will ever get any serious data from any African country. most have very low capacity health systems, and almost all have little or no surveillance capacity (except by the army for political reasons). also, African (and other) people who are taking hydroxychloroquine (if they even use it) are also likely to be taking artemisinin-type drugs, and only if they have malaria. it is possible that South Africa, which has an organized health system and good research capabilities, will be able to come up with useful information, but that would probably be ‘too late.’
to comment on hydroxychloroquine as a treatment. with this, as with all proposed treatments, there are questions of when to use it, what dose to use, and how long. all these are valid questions and deserve answering. if the point is to modulate excessive immune reaction, there’s no a priori reason that it might not help very sick people in the icu (though someone who understands more about the proposed mechanism of action may think there is). in any case, if people are using a drug off label in a given situation, it is worth doing a serious trial to get good information.
I knew there was something fishy about all these rushed publications about HCQ in all these high impact journals. I am an African from Nigeria & HCQ is taken routinely even at the sight of a mosquito flying in the room. We never had the problems being claimed for using HCQ. There may be a need to research why Africans are less susceptible to COVID-19 despite the poor conditions of living there.
I am not saying using HCQ for treating COVID-19 would or wouldn’t work but researchers should be slow to respond with a politically/financially motivated hypothesis coupled borne with a biased study geared at validating such hypothesis.
I would support any article only if there is transparency on the study design & raw data generated and collected. In this crutial time with such high stake global and political issues surrounding COVID-19, researchers should be careful of rushed publications coupled with a rushed review process exhibited by some high impact journals. Just because some experts are well known to journal editorials & their reviewers doesn’t warrant a sloppy review process.
All these people saying HCQ needs to be given with Zinc and very early on, where is the research in humans to back this up? Or is this just conjecture / broscience? Sounds like placebo to me. Weve had one study that suggests it doesnt work to prevent Covid and still you harp on about it not being administered early enough! How early is early enough? Given a lot of people are asymptomatic anyway these untested claims are largely academic!
If the main benefit of HCQ is as a zince ionophere (carrier) it seems HCQ has been wildly overhyped as there are other ionopheres that can perform this role eg EGCG and quercetin! I remember when that conman Trump first started hyping HCQ, it was HCQ + ZPAC, what have you got to lose, game changer! Few months on he drops the ZPAC and prescribes Zinc + HCQ! What a load of bollocks from the leader of the free world
To build on the commentary of Dr. Abeles below, the OTHER study here about HCQ/cocktail as a preventive for Covid-19 is itself a biased study. HCQ with azithromycin and zinc is a treatment regime for the symptoms, administered early in the infection, to stop the progression of symptoms. NOT to prevent infection. NOT to treat someone already on a ventilator. The study above was constructed not to test the efficacy of the HCQ cocktail as it should be used, but to derive a negative result. Similarly, studies that rely on giving the treatment to inpatients already cascading towards collapse are similarly misplaced. Can’t we, as the Doctor says, simply rely on actual science and not try to prove political points just because Trump recommended it?
You are correct. I find it hard to believe Zinc is not used in many of the HCQ these studies that I have reviewed. I have seen the ole “some expert” says we have enough Zinc in patient/subject’s bodies already.”- Don’t need no stinkin’ Zinc! I say prove it! Prove you even read the research on the impact of larger doses of Zinc on prevention of cell replication, before planning studies. I do wonder what research they referenced before planning their studies!
Hydroxychloroquine (HCQ) is a zinc ionophore and effective anti-viral therapy depends upon early administration of the combination of HCQ with supplemental zinc. Meaningful clinical trials of HCQ for COVID-19 should be designed taking into account the mechanism of action, e.g. HCQ enhances intracellular zinc that inhibits viral replication.
The editors of The Lancet rushed to publish this study – are they politically motivated perhaps – contravening their traditionally rigorous standards
Worldwide press and media blared out the results- often with politically oriented commentary …
The latest study in the NEJM regarding using hydroxychloroquine as prophylaxis has also come under heavy fire after academic scrutiny and again the media trumpeted ( excuse the pun) the purportedly negative results, again with innuendo or even overt statements displaying their leftward leanings
Cannot science be allowed to be rigorous without the vociferous hubbub about whether or not a public figure talks favourably about it ?
If someone, anyone, could produce a well-designed study that shows evidence that these drugs are effective, then that would actually be convincing.
(More convincing than belief in a cabal of medical journals, worldwide media, and people with leftward leanings who want people to die.)
I think the journals rushed to publish the studies because the findings were of intense, immediate public interest. They may have “contravened their traditionally rigorous standards” to do so (although I wouldn’t make too many assumptions about their “rigorous standards”). They might not have thought a study showing the drugs were safe would be of as intense public interest. So there might have been bias for that reason. They strive for excellence but also for relevance. But I don’t see any evidence of “leftward leanings.” There might certainly be an inclination to publish papers refuting nonsense that is being noisily hyped by unscrupulous people. I don’t see why anyone would criticize them for that. The only “leftward leanings” I imagine would just be that the left leans toward facts (ie, the truth) and the right leans toward ideology (and, lately, racism), facts be damned. For scientific journals to lean toward truth — I personally think is a good thing. But that’s just my opinion. (Not a fact.)
Sorry, but “scientific” articles pushing a political agenda have become the new internet informericial. Real science probably has gone into hiding.
To the author:
The President NEVER TOUTED THIS DRUG. He mentioned he was taking it and was hopeful it would be effective. The media scooped up this moment and has been touting their remake of this well-televised moment. To hear their version, the President has become a drug rep, on the side.
Aside from political motivations, the last thing a biotech magazine might welcome is a non-biotech, no-glitz, “handme-down drug” that could be safely used for a threatening global pandemic. How absolutely ordinary for an elite group so addicted to hyperbole. My guess is that biotech companies, some featured in biotech magazines, would not welcome the boring generic in question, either. Global pandemics should demand only the finest, most advanced drug treatment. Is there a life lesson here?
I recognize STAT’s high aspirations to write for sophisticated readers. Congratulations on the partial success. We are sophisticated readers. The magazine would be better appreciated if it followed the Dragnet credo: Tell the truth, the whole truth and nothing but the truth.
Obsfucation will be obvious. If you have to take sides, present all of them.
Incredible times we live in. The American left desire for power stops from nothing. Just because Donald Trump mentions hydroxychloroquine as one potential anti-viral remedy for COVID-19, the media keeps producing negative “studies” about this drug.
As first reported in a Guardian investigation, Surgisphere, whose employees appear to include a sci-fi writer and adult content model (they used to call them pornstarts), provided database behind Lancet and New England Journal of Medicine hydroxychloroquine studies.
The World Health Organization and a number of national governments have subsequently changed their Covid-19 policies and treatments on the basis of flawed data from this little-known US healthcare analytics company, also calling into question the integrity of key studies published in some of the world’s most prestigious medical journals.
Dr. Finston, when the president called this drug a “game changer,” yes, he was promoting it.
Thanks, but I won’t take infectious disease advice from politicians (nor from psychiatrists like yourself).
I can see based on your twitter page at https://twitter.com/drpfinston that you have a definite point of view, and that’s fine; the intimidating “MD” on your comment doesn’t carry as much weight as you think.
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