Two days after issuing expressions of concern about controversial papers on Covid-19, The Lancet and the New England Journal of Medicine have retracted the articles because a number of the authors were not granted access to the underlying data.
The Lancet paper, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” which relied on data from a private company called Surgisphere and had concluded that hydroxychloroquine was linked to a higher risk of death among some COVID-19 patients, has been dogged by questions since its publication in late May. Some of those complaints led to a correction about aspects of the data, but at the time the authors stood by their conclusions — namely, that hydrochloroquine and chloroquine do not to appear to be effective against the viral infection.
That correction was followed earlier this week by the expression of concern, and now three of the four authors of the article have decided to pull it entirely. The abstaining author, Sapan Desai, is the founder of Surgisphere, whose mission statement declares that the goal of the company is to:
relentlessly pursue advancements in machine learning, artificial intelligence, and big data with the intention of developing industry-leading tools that empower healthcare providers to make better, faster, and more accurate decisions.
Desai, as Medscape reports, wrote two papers about research misconduct in 2011 and 2013.
The Lancet on Thursday issued a statement about the decision, noting that the retraction wasn’t unanimous:
Today, three of the authors of the paper, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis”, have retracted their study. They were unable to complete an independent audit of the data underpinning their analysis. As a result, they have concluded that they “can no longer vouch for the veracity of the primary data sources.” The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study. Following guidelines from the Committee on Publication Ethics (COPE) and International Committee of Medical Journal Editors (ICMJE), institutional reviews of Surgisphere’s research collaborations are urgently needed.
The retraction notice goes into a bit more detail:
After publication of our Lancet Article, several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication. We launched an independent thirdparty peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.
Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. 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.
We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibi,lity we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.
We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.
*Mandeep R Mehra, Frank Ruschitzka, Amit N Patel
The publication of the study had prompted the World Health Organization (WHO) to halt a study of hydroxychloroquine, but the WHO resumed that trial once the expression of concern appeared.
The New England Journal of Medicine retraction followed a little more than an hour later, with Desai agreeing to the move:
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, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.”1 We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.
Updated at 2015 UTC, June 4, 2020, with news of the NEJM retraction.
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I’m not a medical researcher of particularly familiar with medications, but I do read a lot of science publications. I didn’t bother to finish reading this article, it was obviously rubbish from the start. Another valuable contribution to science from post publication peer review, but the Lancet will still get a boost to its Impact Factor. One can only wonder what the editors were doing even sending it out for review.
> namely, that hydrochloroquine and chloroquine do not to appear to be effective against the viral infection.
To be a little more specific: aside lack of efficacy, the Lancet paper argued that the use of HCQ and macrolides caused a significant (HR 1.35, if I recall) increase in risk of death. That’s why the trials were stopped (but not all of them: the RECOVERY UK trial ran their own analyses, did not find any indication of grave cardiotoxicty, and continued).
Thanks for the head’s up, there has been quite a discussion about this paper raging. There’s a good analysis of many shady aspects of the study here: http://freerangestats.info/blog/2020/05/30/implausible-health-data-firm
What I wonder is: how on EARTH could any scientist believe that they could publish this study without anyone else being able to look at the data and verify its provenance? And why didn’t peer review catch at least a few of the problems mentioned at PubPeer (https://pubpeer.com/publications/71DA593B9943638F1ADE6F80696914)?
>>I wonder is: how on EARTH could any scientist believe that they could publish this study without anyone else being able to look at the data and verify<<
Fraud done by intelligent people is nothing rare or surprising; however, _stupid_ fraud done by intelligent folk always shocks, not as a fraud, but as a seemingly non-explainable act of stupidity. That's really puzzling but this nevertheless does happen, also in science, actually with some regularity. Take Dr Haruko Obokata – what was the chance of her staying on the surface form more than a few months? What were her motifs?
Personally I find this phenomenon fascinating. Had I been a psychiatrist or a psychologist, I would embark on studying it 🙂
Being a pathologist, I go back to my slides…
“Personally I find this phenomenon fascinating. Had I been a psychiatrist or a psychologist, I would embark on studying it”
I find that too. Maybe that is because we are not intelligent in everything.
Too focused persons also can have glaring voids in their capabilities outside their area of expertise.
They based their study on the research available to them at that time. Like everybody else’s studies.. Privacy laws make their finds not verifiable NOT accurate.. Again , not verifiable but accurate.. To help people.. Again , to help people.. What is your motive.??
Perhaps they are scientists w/ a political view? Shocking;(
“And why didn’t peer review catch at least a few of the problems mentioned at PubPeer (https://pubpeer.com/publications/71DA593B9943638F1ADE6F80696914)?”
Because scientific publishing and so-called “peer review” has been compromised to such an extent by big money interests it is no longer a reliable indication of the quality of a scientific journal paper.
See also Michael Mann. The world of peer reviewed science has been mangled in the past few years in the name of “issues science”. They have done all of us a great disservice.
“…. a US president is inciting people to take drugs that could potentially be dangerous…”
1. “Inciting”? He mentioned that he’s heard good things about it, a Dem elected official in MI said it saved her life, it’s been approved and used for over 50 yrs., etc., etc.
2. How could so many “experts” comment NEGATIVELY about this drug / “study” without reviewing the underlying data?
Wonder if the fact that Trump’s name is involved played ANY role in the instantaneous condemnation of this drug? 🤔
Look forward to the July review. If it turns out the drug is helpful, I wonder if the MSM will report that as they did with the 24/7 NEGATIVE “coverage”?
I am not a medical researcher, i am a molecular ecologist. I am not an expert in medical sciences, but i know hot to do science mostly, and i have to say i am more than concerned about the role of scientists in this pandemic.
I guess the colleagues doing medical research are currently working their butts off, and they are all deserving our respect. Its a also good that the public now gets a feeling how science works: a slow, sometimes painful build up of accumulating evidence.
But i also wonder if science has been the competent advisor in this case of a global pandemic many people has declared it to be, sometimes being ridiculed as “science believers”. However, “Listen to science” is a well meant slogan, but does not always work out well, apparently.
Chloroquin, e.g., was a complete desaster, starting from the early recommendations of south east asian health agencies, via shady papers of Didier Raoult (who certainly is a brilliant infectiologist), its complete politicization by right-wing populist politicians (and a left backlash which was not always driven by evidence, but wishful thinking), to the recent slurry of contradicting papers.
The same is true for mask efficacy. Even though there was a plethora of data on influenza, many scientific authorities e.g. in Germany advised against the use of masks, mostly because they feared that hospitals were outcompeted for equipment.
Almost every day, a new candidate drug is suggested. Even basal supplements like vitamin C, D, Zinc and so on, all of which are currently trialed, are debated for their benefits. Now, its the old Tbc vaccine which gets a lot of attention (again; it was already in the news earlier).
Even at the coarsest level (lockdown vs. herd immunity build up) scientists on the level of national advisory boards could not agree on a strategy. In the end, the best we came up with were methods which were already known to people in the middle ages (social distancing), and even for that, scientific icons like Ioannidis expressed their concerns.
Then, there is the questionable role of preprints.
In Germany, we had a big, public clash of virologists over a scientifically bad preprint about the role of school openings, driven by yellow press. Later on, scientists tried their best in selling this as a normal scientific discourse, but that was far from normal.
The abuse of preprint publication, often disguised as a “quick, cooperative way to share data in desperate time”, seems merely a bypass of peer review. Peer review is also a lottery, admittedly, and post publication review might even a better way to evaluate science, but what is the amount of preprints which would likely not pass review or see submission, anway?
I would guess its rather high. Preprints were never meant to let others do your job. I would rather have the journals offer express peer review (with one mandatory review from a statistician!), for which reviewers would get compensation.
sorry for the rant. Science will inevitably prevail. But the way to victory is very tough this time.
HCQ was on the list of candidate treats from the off, due to work on SARS in early 2000s – recommended in the Lancet in 2006 for SARS-like diseases. It then popped up with positive in vitro results in Nature in February at the same time as Remdesivir.
Trump’s suggestion that it could be useful then turned half of the US against it.
The hysteria then turned HCQ into ‘a dangerous drug’ – yougov data say 60% of Democrats think it is dangerous. Yet, bizarrely people didn’t even do a literature search – just Trump said it, so it’s bad. If you went to the data and literature HCQ has 50+ year track record, 5.6m prescriptions a year in the US with a very well known low risk safety profile. One of the top 150 drugs in the US, in the WHO top 400. Billions of doses used globally. Due to HIV in Africa, there’s even good data for the use of HCQ in conjunction with anti-virals.
A mostly benign treatment, with known contraindications where use is not recommended, with at least an in-vitro chance of success. For non-cardiac patients, the worst would be that it acts like a placebo.
Instead, the world went bonkers against it because of Trump.
My worry is that there might be active research or commentary against HCQ from people who should know better, or who have links to companies with other treatments. A cure is going to be worth tens of billions if the treatment is on patent. A generic like HCQ, not so much.
My second concern is that HCQ has been on the radar since the beginning – a minimum of February – the Nature paper. The same time as Remdesivir. But Remdesivir had results from clinical trials a few weeks back now. Where are the trials for HCQ? They were both identified as candidates at the same time. This is urgent. Thousands of people are dying, how do we have trials completed for the on-patent drug, while we’re still waiting for the off-patent one.
“What I wonder is: how on EARTH could any scientist believe that they could publish this study without anyone else being able to look at the data and verify its provenance? And why didn’t peer review catch at least a few of the problems mentioned at PubPee”
Lancet already lost much trust . They can bend the rules for political impact sometimes. Remember Iraq deaths “paper” that was clearly political.
In fact this is not a story of one Dr Desai, a dodgy company, doctored data, and a few days of ensuing chaos across the globe. This is a story about the current editorial standards in top medical journals implicated in this affair. What happened? Is this just another effect of the Covid-19 pandemic (like a flood of medical graphomania everybody can follow on PubMed) or a pathology on its own?
I do not believe it was just an incident; it’s rather a symptom.
The interesting question, of course, is how did such papers came to be published? Is “scientific” a label that can be monetized by Editors of scientific journals? Was the WHO just waiting for the paper to appear, its reaction being negotiated in advance?
Everybody around the world seems already aware that there is something going on that nor scientists like Raoult not even Trump himself can stop. Big Pharma is really Big.
Perhaps they are scientists w/ a political view? Shocking;(
The role of money and politics needs to be investigated.
Money: Did the authors gain or stand to gain from these results? Dr. Desai and his company definitely stood to gain. What about the others? Did they have interests in competing drugs or in Dr. Desai’s company? Some good investigative journalism can help here.
Politics: Was this a case of confirmation bias by the editors? Did the Lancet’s politics (ref the anti Trump editorial a few weeks ago) lead them to ignore the obvious flaws in the paper? Publishing the peer review comments will help? If all the reviewers also looked past the study’s issues, then it’s just a garden variety failure of peer review, which we’re all too familiar with. If the editors ignored critical comments from the reviewers, then we have yet a different problem.
I am a clinician but reading the paper what intrigued me was how could they get all the data to such detail while the pandemic was going on and more so as the Health services across the globe were struggling cope!.
It is easier to shift the blame on Sapan Desai from Surgisphere but what about Dr. Mehra from Brigham and the chief editor of Lancet. Are they not accountable to anything??
Goes on to show every thing published in high impact journals should not accepted as gospel of truth.
I am proud that the ICMR(Indian council of medical research) did not buckle under pressure and continued to use HCQ cautiously in certain patient cohorts.
Dr Srikanth, ICMR obviously knows not to trust people like Sapan Desai.
I am just an idiot but seems like a study with 96,000 patients from 6 continents is going to be lots of work and if one percent of data is flawed through translation or plain unintended errors that is 960 examples to declare it a hoax or fraud by those who do not like the results published.
All science is based on a lie, supported or not supported by evidence. Truth needs no proof and stands by itself.
Truth is these HCQ reports are going to get political scientific stinkbombs thrown at them whenever they pop up from both sides no matter what.
Doesn’t seem fair or logical because the hospitals cannot release the data again because of legal reasons, or they just do not want to, since they already did, that this makes the whole study invalid.
but what if none of the data ever happened?
the company doesn’t have the staff or the credentials to gather that much data, the hospitals cited as providing it cannot confirm that *any* of their staff participated, and some of the details are improbable medically. and the firm itself hasn’t allowed independent audit of its data set.
so if the data was made up, does that invalidate their conclusions? or were the lancet and nejm just in a hurry to publish, for clear political reasons?
This is not the only one paper published by the group.
There is another one, using the same database, about ivermectin (Usefulness of Ivermectin in COVID-19 Illness).
Be safe
The Problem:
Prior to 1970s clinical research was “qualitative”- case reports, case series..
No special skill sets needed to do or read research.
After the 1980s clinical research became “quantitative” ie RCT, cohort, DTA etc.
Special skill set needed to do and read research.
Data-science degree required.
Currently:
1) Clinical researcher-untrained
2) Medical Research Ethics Committee-untrained
3) Journal editor-untrained
4) Peer-reviewer-untrained
My complaints, in a local paper.
https://www.thestar.com.my/opinion/letters/2020/06/08/the-clinical-research-industry-is-a-mess-that-needs-cleaning-up#.Xt3auAVfLKo.facebook
The article in Breightbart said the authors of the Surgisphere information, a man and a women were, a science fiction author and a audio video sex preformer. How did it end up in Lancet?
I have not checked what Breitbart claims, but accrdoing to the Guardian, one employee of Surgisphere was a full-time SF author and another an adult model/event hostess. They were not authors on the paper.
Breitbart is a website devoted to politicised fabrications, so it has nothing to contribute here.
Indeed we must insulate ourselves from such a menace with scientific fabrications.
the headline could use a small tweak: the retractions were based on “questionable surgisphere data”.
as posted, it can be misunderstood to mean that surgisphere data was helpful, rather than the source of the problem.