The two highest-ranking international medical journals, New England Journal of Medicine (NEJM) and The Lancet, retracted yesterday simultaneously two papers on COVID-19. The reason is obvious fraud committed by the coauthor Sapan Desai, Chicago-based surgeon and businessman, whose analytics company Surgisphere claimed to have stored clinical data from thousands of patients of hundreds of hospitals all over the world. Which was apparently all a big fake.
This fraud case is being presently discussed in all the international news, literally every media is onto Desai’s shady past and the details of his Surgisphere fraud, some even figured out it might have been wrong to slam preprints as dangerous poison, while it is the peer reviewed papers in the two most highly ranking medical journals in the world which served us the biggest fraud and caused the biggest damage.
This is why I want to discuss some other aspects proper journalists would never touch. Are the heart surgeons and principal investigators of those two high-impact studies, the Harvard professor Mandeep Mehra of Brigham and Women’s Hospital, and Amit Patel of University of Utah, really the innocent victims of Desai’s fraud here?
And would the NEJM paper be retracted if the fraud was not exposed by mass protests against its Lancet counterpart, which claimed a suspiciously high rate of mortality from hydroxychloroquine (HCQ) therapy against the coronavirus infection?
How sausages are really made
Another point which gets overlooked: it was not the valiant journal editors who pulled the two papers. Desai’s coauthors initiated the retractions because they rightly panicked that nothing will remain of their highly lucrative reputations if they don’t distance themselves from their own fabricated garbage immediately. This was the Lancet paper, I discussed it in an earlier post:
Mandeep R Mehra, Sapan S Desai, Frank Ruschitzka, Amit N Patel Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis 2020 DOI:10.1016/S0140-6736(20)31180-6
In a bizarre course of events, the French chloroquine guru Didier Raoult previously claimed that paper to be fraudulent, and here Raoult was proven right, like a broken cuckoo clock which still shows exact time twice a day. Which doesn’t mean Raoult’s accusations of fraud towards all other chloroquine studies which disagree with his claims, are also correct. Neither does it mean that chloroquine and HCQ are now vindicated as COVID-19 therapy and prophylaxis drugs, quite the opposite. The rest of published research literature either clearly proves chloroquine drugs useless against the coronavirus, and those which still promote it, are either Raoult’s own self-peer-reviewed papers, or other works of abysmal quality.
Like that Indian preprint Raoult celebrated, which was coauthored by the same governmental official Balram Bhargava, who previously decreed HCQ to be used nation-wide for COVID-19 prophylaxis, and then ran a study to prove his vision as correct.
That Lancet paper caused the suspension of big randomized controlled clinical trials on COVID-19 worldwide aimed to determine chloroquine efficiency or the absence thereof, including the WHO clinical trial Solidarity, which was resumed when the Surgisphere data was questioned. Now that the paper is gone for good, clinical research will resume, but the damage is done. Because every chloroquine critical paper will now be dismissed as fraudulent by association. While Raoult cannot be a cheater despite his past and present, because he is now painted by the chloroquine cult as the genius who saved millions with HCQ and the hero who single-handedly exposed the Surgisphere fraud.
Alternative explanation: scientific publishing is broken, journal editors are either crooks or incompetents, all suffering from media obsession, elite scientists don’t care about anything other than their own academic elite status and the industry money flowing into their pockets. Hopefully COVID-19 might expose and end this farce.
The Lancet paper was corrected just some days ago, its conclusions declared unaffected, and now it is retracted. From the retraction notice, dated 4 June 2020:
“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.”
Strange is that the three authors Mehra, Patel and Ruschitzka now suddenly declare to have never had access to the data behind the paper they published as principal investigators. Because this is what their original paper declared on authors contributions:
“The study was conceived and designed by MRM and ANP. Acquisition of data and statistical analysis of the data were supervised and performed by SSD. MRM drafted the manuscript and all authors participated in critical revision of the manuscript for important intellectual content. MRM and ANP supervised the study. All authors approved the final manuscript and were responsible for the decision to submit for publication.“
Basically, Mehra and Patel designed a study and then asked Desai to provide them some results out of thin air, which his Surgisphere really is. Apparently, this is perfectly normal and reasonable approach in clinical research. How do we know Mehra and Patel did not specifically order some hydroxychloroquine adverse effect results, because they knew exactly which kind of story will be most credible, given the available published literature on chloroquine? Actually, why did Mehra and Patel write this in their original paper then:
“The corresponding author and co-author ANP had full access to all the data in the study and had final responsibility for the decision to submit for publication.“
They doubled down in a correction on 29 May, where Mehra, Patel and Ruschitzka clearly indicated to have access to Desai’s fictional raw data:
“One hospital self-designated as belonging to the Australasia continental designation should have been assigned to the Asian continental designation. The appendix has also been corrected. An incorrect appendix table S3 was included, originally derived from a propensity score matched and weighted table developed during a preliminary analysis. The unadjusted raw summary data are now included. There have been no changes to the findings of the paper.“
That was dishonest. Also, what exactly was the contribution of the cardiologist Frank Ruschitzka, from the scandal-plagued University of Zurich in Switzerland? None whatsoever is listed. What did he contribute then? A phone call to the Lancet editor Richard Horton? To Swiss media, Ruschitzka freely admitted to have not only have contributed nothing, but to not even have read the manuscript properly. How much did Ruschitzka contribute to his other papers then?
Additionally, Ruschitzka declared in the original paper that “no personal payments were received in relation to these trials or other activities“, but in the retraction notice he now had to declare previous massive cash flows into his own private pocket from all the big players in pharma industry and even from chocolate manufacturer Mars.
Update 19.06.2020: University of Zurich now opened a research misconduct investigation against Ruschitzka because of this affair.
The other retracted paper was this, it was first published on 1 May, 3 weeks before the Lancet paper:
Mandeep R Mehra , Sapan S Desai , SreyRam Kuy, Timothy D Henry, Amit N Patel Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19 NEJM 2020 doi: 10.1056/NEJMoa2007621
Nobody at all complained. The utterly fake study with imaginary 9000 patients could have stayed in the annals of medical science for decades and gathered many hundreds of citations. All because compared to the one in The Lancet, that was a “boring” paper, in a sense that it did not make such media-effective claims and lacked scandal potential:
“Our study confirmed previous observations suggesting that underlying cardiovascular disease is associated with an increased risk of in-hospital death among patients hospitalized with Covid-19. Our results did not confirm previous concerns regarding a potential harmful association of ACE inhibitors or ARBs with in-hospital death in this clinical context.“
In fact, 2 more papers reporting similar findings appeared in the same top journal simultaneously. This is how you commit fraud successfully: fake something which others validated by solid science, to escape criticism and to avoid responsibility when caught on fraud. The Lancet paper was also fabricated “correctly” in this sense, no serious scientist (Raoult is not serious) supports its use for COVID-19 anyway. Problem was: chloroquine was a very wrong topic to cause a scandal on.
My own theory is: if the main authors Mehra, Patel and Desai stayed out of the chloroquine controversy, nobody aside of a handful of easily ignored and media-irrelevant peers would have given a flying toss about Surgisphere’s reliability and the NEJM cardiology study.
Mehra would still have his NEJM paper, something every clinical researcher dreams about. He would be able to translate it into (extra) millions of dollars in pharma payments to himself. The Harvard professor might even also have kept the Lancet paper if only it would have been on some other COVID-19 topic, not chloroquine. For all we know, the Lancet paper might have even survived if it showed HCQ in a better light. After all, if you invent data it doesn#t matetr which way you fabricate. But because of the worldwide chloroquine cult led by Raoult and supported by the fascistoid leaders like Trump, Bolsonaro and Modi, the affair had to explode.
This was the NEJM retraction notice, dated 4 June 2020 and signed by all authors including this time also Desai:
“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.”
For some reason, this highest-ranking medical journal in the world, NEJM, still does not list author contributions. But maybe one can extrapolate from the Lancet paper and assume that here again, Mehra and Patel designed a study and possibly even its preferable results, then tasked Desai to produce the data out of his Surgisphere black box. The other coauthor presumably just went for a ride like Ruschitzka did, maybe their real contribution was simply being friends with Mehra and Patel.
In parallel, two Surgisphere preprints from April 2020, authored by Patel and promoting the antiparasitic medicine Ivermectin as the magic drug against COVID-19, have been deleted by the Elsevier-owned preprint server SSRN completely. The links are dead, but there are backups on internet archive, as a Twitter user noticed. It was apparently same “study”, but presented slightly differently. Strangely, in between versions Patel removed his coauthor Desai and listed himself as the sole author of the slightly changed preprint. Because of those preprints, Ivermectin almost became national COVID-19 therapy in central Latin America. But why did Elsevier delete the preprints completely and without a trace or explanation, since a DOI is supposed to be a permanent hyperlink?
A friend of a friend
Now, it is rather obvious that several people put their names on those NEJM and Lancet papers without having contributed anything of scientific value. In fact, it seems to be even their official defence line, freely admitting that all data was produced, analysed and validated by Desai alone. Undeserved authorships are actually a form of research misconduct in itself, but what about Mehra and Patel? They do declare themselves to be principal investigators on those two papers, which by definition implies they must have had access to original data, or have at least verified that the data exists, and that the persons performing data acquisition and analysis are qualified and trustworthy.
Mehra and Patel did none of that, and this in itself is scientific misconduct by recklessness and gross negligence. But wait, here is Patel promoting Surgisphere since March 2020:
It is strange Mehra and Patel only asked Desai if the data existed after massive criticism in international media, a peer signature campaign of protest and public accusations of fraud (not just by Raoult). Why did they trust Desai before so unconditionally?
There are no other common papers with Desai and either Mehra or Patel on PubMed. But one NEJM coauthor, SreyRam Kuy, surgeon and “quality improvement researcher” at Baylor College of Medicine in Houston, Texas, is a regular coauthor of Desai’s. The oldest of 13 common papers dates to 2013. Incidentally, Science spoke to Mehra:
“In a personal statement, Mehra said he connected with Desai through a co-author, and that he personally reviewed the Surgisphere analyses for both the Lancet and NEJM papers”
Maybe they mean Dr Kuy? Science also suggests how Mehra’s role is to be understood, and cites an authority:
“Mehra is widely viewed as “one of the stars of the field,” says Daniel Goldstein, a cardiothoracic surgeon at the Albert Einstein College of Medicine who has collaborated with Mehra on several studies. “He is as straight an arrow as you can find,” Goldstein says. “I think he maybe was too trusting of this company, because [with] the amount of data that this database gave, it’s hard to believe someone would manipulate it.“
Thank you Professor Goldstein. This is the crux bigwigs in medicine have to bear, like the Harvard professor Mehra. People keep inviting you to put your name on their paper without any contribution, and you just cannot satisfy all, so you only go for top-ranked journals, like NEJM and Lancet, because those would bring you the biggest share of academic fame, political influence and personal financial enrichment. That is the most charitable explanation of what Mehra did, and it would only fit if he did not declare himself to be principal investigator.
Desai is sure well versed with databases as his publication record suggests (e.g, Dua et al J Vasc Surg 2014). It is very much possible the Surgisphere database is not entirely fake, but a mutated Frankenstein monster of various real databases he had access to and stole data from over the years. Which would explain why statistics experts struggled to find telltale signs of data fakery in the Mehra et al Lancet 2020 paper.
For example, what about the paper by Sapan S. Desai, Amy H. Kaji, Gilbert Upchurch Jr, Practical Guide to Surgical Data Sets: Society for VascularSurgery Vascular Quality Initiative (SVS VQI) JAMA Surgery 2018? Is the multicenter Vascular Quality Initiative database presented there reliable, since Desai had his hands on it? Especially because of this:
“Corresponding Author: Sapan S. Desai, MD, PhD,MBA, Performance Improvement, Northwest Community Hospital, 880 W Central Rd, Arlington Heights, IL 60005 (firstname.lastname@example.org)“
Or would you trust this database analysis paper: Sapan Desai, Two-Year Outcomes of Early Cannulation Arteriovenous Grafts for End-Stage Renal Disease Ann Vasc Surg 2019?
Nobody ever complained about those, at least there are no public records available. Which surely means those Desai studies are 100% reliable, trustworthy clinical science which will benefit many patients, right?
Let me close with this paper by Desai, back then affiliated with “Department of Surgery, Duke University, Durham, CA 27710, USA”. It was flagged by Laura Clemens on Twitter:
Bhavin Patel , Anahita Dua, Tom Koenigsberger and Sapan S. Desai Combating Fraud in Medical Research: Research Validation Standards Utilized by the Journal of Surgical Radiology MDPI Publications (2013) doi: 10.3390/publications1030140
The abstract goes:
“Fraud in medical publishing has risen to the national spotlight as manufactured and suspect data have led to retractions of papers in prominent journals. Moral turpitude in medical research has led to the loss of National Institute of Health (NIH) grants, directly affected patient care, and has led to severe legal ramifications for some authors. While there are multiple checks and balances in medical research to prevent fraud, the final enforcement lies with journal editors and publishers. There is an ethical and legal obligation to make careful and critical examinations of the medical research published in their journals. Failure to follow the highest standards in medical publishing can lead to legal liability and destroy a journal’s integrity. More significant, however, is the protection of the medical profession’s trust with their colleagues and the public they serve.”
Damn right, Dr Desai.
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