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Surgisphere and Their Data (Updated)

Update, and this one needs to be at the top of the page. As you will see from the additions to this post, the entire Surgisphere story has collapsed. None of their papers can now be regarded as valid – vide infra.

So we have a very strange situation with some recent publications, one that deserves a closer look. The ones I refer to are the recent Lancet retrospective study on hydroxychloroquine use (blogged about here), one of the hospital data studies on the effect of anti-angiotensin therapies on the outcomes of coronavirus patients, and a preprint about the use of Ivermectin against the coronavirus (mentioned at the end of this blog post). All three of these rely on a large amount of multihospital patient data from a company called Surgisphere. Update: the Lancet now has an Expression of Concern out too. Update II: it’s more than that – the NEJM anti-angiotensin paper has now been retracted and so has the Lancet one – see below,

Note that the link there to the Ivermectin preprint no longer works, because it has been withdrawn, for unknown reasons. The ACEi/ARB paper has had an “Expression of Concern” attached to it by the editors of NEJM. And the Lancet paper has come under fire from a number of commentators. All of this is because the source(s) of all of Surgisphere’s clinical data and the way it’s been handled are a lot more obscure than they should be, and definitely more obscure than they appeared to be at the start. It’s worth noting that these papers go both ways about the efficacy of these treatments: the Ivermectin one suggested that it was a useful treatment for coronavirus patients, while the hydroxychloroquine one suggested that that drug wasn’t.

Here’s a Twitter thread that goes into some of the concerns, from someone who’s worked with such large hospital databases before. As you’ll see from Joshua Niforatos’ posts, there are a lot of sources for such numbers, each with their own complications, degrees of detail, degrees of disclosure, and legal/regulatory issues. He believes that Surgisphere could indeed have the data that they’re referencing, but he’s puzzled about how this was done and finds their disclosure about such issues to be severely lacking. For more, here’s a post at Free Range Statistics that goes into still more concerns – at the very least, Surgisphere is an opaque company. And there are enough questions raised to make you wonder if the situation isn’t a lot worse than that. Looking at the company’s employees, at the software they claim to be using, and at many other features of the story does not inspire confidence, and that post is a lot less hopeful that the underlying data really exist. Here’s another statistics site (latest post, I believe) with plenty of problems as well. As it notes, the underlying conclusions of these papers could still be correct, but that they do not do a sufficient job of making that case. This one’s also worried that the underlying data may not even be there, which would be awful. There’s a large open letter on these issues as well, specifically asking (among other things) about how so many patients could have so much cardiovascular data available.

Update: more on the story at Science. It isn’t getting any better looking, I’ll say that.

For their part, Surgisphere has responded here, promising an independent audit of their numbers and how they were obtained. That had better take place with all due speed, and it had better be good. If the company really has access to this volume of electronic health records around the world, and can really do the sorts of retrospective analyses that they’ve published, then good for them. At the very least, they need to do a lot better when they publish such work. But otherwise. . .well, a bad study isn’t just a zero. It’s a negative number; bad medical papers can do actual harm, and in the case of coronavirus therapy recommendations that harm can be immediate. So let’s have some answers as fast as we can get them.

Update: so much for the independent audit! As the two retraction notices added in the first paragraph above make clear, this isn’t going to happen. The authors now say that they are unable to access the raw data used for their own study and are thus unable to have it confirmed by anyone else. Accordingly, the papers have been retracted – the authors say that they “can no longer vouch for the veracity of the primary data sources”, and if that’s not a reason for retraction I don’t know what is. What a debacle.

117 comments on “Surgisphere and Their Data (Updated)”

  1. T Boyer says:

    There are things in Surgisphere founder’s Desai’s resume and background that probably should be kept in mind before taking his statements too seriously. There is a lot out there that people have found; I’ll just list a few examples with source links.

    Raising money for a wearable “human augmentation system” a “neural induction device” … “Amp your brain to achieve total clarity” “Revolution in human evolution” etc…
    https://www.indiegogo.com/projects/neurodynamics-flow-a-revolution-in-human-evolution#/

    Claims 165 publications but hasn’t had great jobs.
    https://www.researchgate.net/profile/Sapan_Desai

    Two malpractice cases filed against him last November, followed by him resigning from his job at a suburban Chicago hospital in February (and I’m not saying one is the cause of the other, but…..) :

    In one of these cases, the plaintiff is an estate, indicating that the patient died.

    http://www.cookcountyclerkofcourt.org/CourtCaseSearch/DocketSearch.aspx
    Docket numbers:
    2019-L-013108
    2019-L-012354

    A history of rather hyperbolic claims for products he’s be selling. Latest example in this press release dated 3/16/20:
    “Since becoming operational last week, Surgisphere’s diagnosis decision support tool has already been used by over 45,000 people in 59 countries. With an overall accuracy of 99.99%”

    https://www.businesswire.com/news/home/20200316005459/en/Surgisphere%E2%80%99s-COVID-19-Response-Center-Online-Physicians-Patients

    And to me the biggest obstacle to believing Surgisphere is real is that it lists only 5 employees, and no technical/scientific staff other than Desai (who we know had a full time job until recently).

    Is that an entity that is capable of selling some kind of software product to 600 hospitals on 6 continents, and that software tool also manages to extract patient level data basically in real time (which would be an unprecedented achievement in the whole field of patient record acquisition).

    And that data is all cleaned up, analyzed and ready for publication in a couple of weeks after the data was created?

    You combine all of this circumstantial evidence with the crowdsourced analysis of the Lancet and NEJM papers and I think there’s only one conclusion that can be reasonably drawn.

  2. DerekzHigh says:

    ‘Tell me again why anyone should be advocating such treatments. But your reasons had better stand up to 14,888 patients versus 81,144 comparators. Make it good.’ -DL

    1. Hein says:

      The difference between a scientist and an online conspiracy theorist is that the former **always** considers the unpalatable possibility that he might be wrong and uses any new evidence to evaluate and verify his own opinion. While the latter considers being wrong the ultimate failure.

      1. jz78817 says:

        and that the conspiracy theorist always demands proof of the negative. i.e. if you can’t prove it didn’t happen, then that means it likely did.

        You can’t reason a man out of something he didn’t reason himself into.

    2. Bill says:

      It would be a mistake to imagine this positively helps HCQ proponents. At best we’re back where we were before: at best mixed to bad data on efficacy, with known side effects. If this hadn’t been prematurely promoted by a President casting about for an easy, quick solution to the pandemic, we wouldn’t be hearing nearly as much about it.

      1. cabezoney says:

        What are the serious side effects for an early stage COVID patient?

        HCQ is safer than tylenol by far. If you want to claim side effects as a reason not to use it then you should show evidence that it has any serious side effects to a reasonable healthy person.

        They should probably stop giving it to sick people in the hospital. It won’t help and might make things worse. They can probably stop doing studies on that now too.

        RCTs on early stage ambulatory patients have always been needed, as anybody familiar with how HCQ is used in much of the rest of the world can tell you.

  3. loupgarous says:

    Thanks for trotting out the issues with SurgiSphere. Some of the indictments of their 671-hospital study of the chloroquine drugs in COVID-19 therapy (like the allegation that SurgiSphere’s director of sales was an adult model in her spare time) don’t speak to the reliability of the analysis – but that’s just their sales effort, and sexy women models with medical credentials are a commonplace in medical marketing (wander the poster presentation area of any major medical society meeting, if you doubt me). Others are more troubling.

    It IS interesting that 671 hospitals delivered data to an outfit whose credentials are in any way cloudy. HIPAA may have been violated unless US hospitals involved deleted patient-identifiable fields from the datasets BEFORE they got to SurgiSphere, or SurgiSphere had credibly undertaken to do so themselves.

    As you say, “So let’s have some answers as fast as we can get them” so we can either pitch this study out, or tease out and isolate relatively minor issues with the provenance of the data. If there are non-trivial issues with the data or analysis, it’s really too bad for anyone wanting to make informed decisions regarding use of HCQ/CQ in COVID-19 treatment.

  4. EugeneL says:

    One more trouble with Surgisphere is that no hospitals came forward and admitted that they provide data to them.

    Also I believe that Surgisphere did not provide country breakdown of the information, but only continent breakdown, as an attempt to make it harder to spot the inconsistency in the data, such as implausible smokers uniformity.

    1. Harry Houdini says:

      >>>>One more trouble with Surgisphere is that no hospitals came forward and admitted that they provide data to them.<<<<

      What is the possibility that the hospitals didn't "provide" the data and in a few weeks we'll have reports of data breaches? Just thinking on the 3rd side of the coin….

    2. loupgarous says:

      CDC rounded every US county equivalent’s number of deaths in each category of death up to n=10 in their WISQARS database of reported deaths. Their stated reason for doing so was to prevent identification of individual patients in datasets.

      Europe, South America and Asia comprise many more countries than North America, so that a statistician might choose breakdown by continent for several reasons.

      1. EugeneL says:

        There can be a mundane reason for not giving country breakdown, such as saving article space, but specifying data on a country level surely does not breach any patient privacy.

        1. loupgarous says:

          I wasn’t thinking about patient ID so much as keeping close as possible to an “apples to apples” comparison of the datasets across the world.

          I agree with those here who wonder who the project statisticians were on the big HCQ/CQ experience report. However, it’s not that uncommon for only the lead statistician to be named on papers drawing even on global datasets. It’s possible a separate CRO was retained for that part of the project, I guess (implausible, but possible).

  5. john says:

    The health care worker HCQ prophylaxis study now has been published in the IndianJ Med Res.

    Consumption of four or more maintenance doses of HCQ was associated with a significant decline in the odds of getting infected (AOR: 0.44; 95% CI: 0.22-0.88);

    http://www.ijmr.org.in/downloadpdf.asp?id=285520;type=2

    Here is the citation and abstract.

    Indian J Med Res, Epub ahead of print
    DOI: 10.4103/ijmr.IJMR_2234_20

    Healthcare workers & SARS-CoV-2 infection in India: A case-control investigation in the time of COVID-19

    Pranab Chatterjee1,#, Tanu Anand7,#, Kh. Jitenkumar Singh2, Reeta Rasaily3, Ravinder Singh4, Santasabuj Das8, Harpreet Singh5, Ira Praharaj6, Raman R. Gangakhedkar6, Balram Bhargava† & Samiran Panda9

    Background & objectives: Healthcare workers (HCWs) are at an elevated risk of contracting COVID-19. While intense occupational exposure associated with aerosol-generating procedures underlines the necessity of using personal protective equipment (PPE) by HCWs, high-transmission efficiency of the causative agent [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)] could also lead to infections beyond such settings. Hydroxychloroquine (HCQ), a repurposed antimalarial drug, was empirically recommended as prophylaxis by the National COVID-19 Task Force in India to cover such added risk. Against this background, the current investigation was carried out to identify the factors associated with SARS-CoV-2 infection among HCWs in the country.

    Methods: A case-control design was adopted and participants were randomly drawn from the countrywide COVID-19 testing data portal maintained by the ICMR. The test results and contact details of HCWs, diagnosed as positive (cases) or negative (controls) for SARS-CoV-2 using real-time reverse transcription-polymerase chain reaction (qRT-PCR), were available from this database. A 20-item brief-questionnaire elicited information on place of work, procedures conducted and use of PPE.

    Results: Compared to controls, cases were slightly older (34.7 vs. 33.5 yr) and had more males (58 vs. 50%). In multivariate analyses, HCWs performing endotracheal intubation had higher odds of being SARS-CoV-2 infected [adjusted odds ratio (AOR): 4.33, 95% confidence interval (CI): 1.16-16.07].

    Consumption of four or more maintenance doses of HCQ was associated with a significant decline in the odds of getting infected (AOR: 0.44; 95% CI: 0.22-0.88); a dose-response relationship existed between frequency of exposure to HCQ and such reductions (χ2 for trend=48.88; P<0.001). In addition, the use of PPE was independently associated with the reduction in odds of getting infected with SARS-CoV-2.

    Interpretations & conclusions: Until results of clinical trials for HCQ prophylaxis become available, this study provides actionable information for policymakers to protect HCWs at the forefront of COVID-19 response. The public health message of sustained intake of HCQ prophylaxis as well as appropriate PPE use need to be considered in conjunction with risk homoeostasis operating at individual levels.

    I think this was part of the basis of the Indian governments policy to offer HCQ to healthcare workers with potential exposure to COVID patients.

    1. Sbabo David says:

      “The first part of the dose-response relationship
      curve showed an apparent increase in the odds of
      acquiring SARS-CoV-2 infection in HCWs who had
      taken 2-3 doses of HCQ prophylaxis. ”

      When you have some much biaises and make sub-categories, well you often get this kind of result.

  6. Grumpy Old Professor says:

    This is a great lesson for us all, thank you, D.

    The post on the “Freerangestatistics.info” blog says: “Previously, I had more or less gone along but thought there was exaggeration when people said “peer review is broken” but now I really believe it.”

    Well the early reliance of the general coverage of CoV-2 on assorted Rvix servers can’t have helped. See also PMID: 27273827.

    Good peer review is such an important part of the scientific process and as scientists, it behooves us to be cautious.

    GOP

    1. Another Guy says:

      There has been so much pressure to hear any news whatsoever on possible treatments and vaccines for COVID-19 that we have been reduced to reptile-brain level of thinking and now take press-releases on phase I data and leaked study monitor conversations at face value. That’s how scams of any kind flourish. Fear, greed and a customer who wants to believe. Nobody wants to hear that drug and vaccine discovery takes time to do it right, and the cost to human health is very high if we do it wrong.

  7. Jeff says:

    I notice that a publication called “NS Medical Devices” published a piece on March 13, 2020 entitled, “Surgisphere rolls out rapid diagnostic test for COVID-19”. They seem to have deleted it from their website, but I found a cached version of it: https://webcache.googleusercontent.com/search?q=cache:IjxOHv9zO5sJ:https://www.nsmedicaldevices.com/news/surgisphere-coronavirus-test/+&cd=10&hl=en&ct=clnk&gl=us

    In case the cached version disappears, here is the text:

    [Subheadline] Surgisphere has developed the advanced diagnostic tool leveraging its research network and advanced machine learning capabilities [end of subheadline]

    US-based healthcare management services provider Surgisphere has commercialised a new rapid diagnostic tool for testing novel coronavirus disease (COVID-19).

    The advanced diagnostic tool has been developed leveraging its research network and advanced machine learning capabilities, said the company.

    Surgisphere president and chief executive officer Sapan Desai said: “Surgisphere exists to help make the world a better place. This tool is the first effective weapon in the fight against this global pandemic. Early diagnosis means faster treatment, which means more lives saved.”

    The tool has been designed to use only three common laboratory tests to identify patients likely to have coronavirus infection. The tool is said to be highly precise, with 93.7% sensitivity and 99.9% specificity.

    In addition, the test would help control the transmission of coronavirus by rapidly identifying and isolating affected patients, mobilising public health resources, and prevent delays in current testing.

    [Subheadline] Surgisphere used its cloud-based QuartzClinical platform for COVID-19 diagnosis [end of subheadline]

    Surgisphere said that it has used its cloud-based healthcare data analytics platform QuartzClinical to identify patients diagnosed with COVID-19 in five countries.

    To develop the decision support tool, the company created a machine learning model using decision tree analysis with clinical and lab data from infected patients.

    Surgisphere is seeking data sharing collaboration with physicians and healthcare systems to increase the sample size of COVID-19 patients.

    Established in 2008, Surgisphere is engaged in developing complete, comprehensive, and accurate healthcare databases, to advance care for kidney failure, aneurysms, lymphedema, peripheral artery disease, colon cancer, and cardiovascular disease.

    The company’s data analytics system has access to point of care data from over 1,200 international partners.

    1. loupgarous says:

      That begs to be checked out, claim by claim and handwave by handwave.

      1. Lappan says:

        It lacks only “blockchain” for a full bingo card of investor-stampeding gibberish.

        1. EugeneL says:

          No, the “blockchain” buzzword was not missed by Surgisphere. This fruitful venue has been explored.

          “Until Monday, the “get in touch” link on Surgisphere’s homepage redirected to a WordPress template for a cryptocurrency website, raising questions about how hospitals could easily contact the company to join its database.”

          1. Lappan says:

            Just, “wow” – and a good thing I don’t try swimming with these professional sharks…

  8. Sunyilo says:

    Slightly off-topic, but looking at the authors’ list of the Lancet paper and mining the authors’ expertise it struck me, who might have done the data analysis? Somehow none of the resumes (all of them “MD celebs”) struck me as their owners being able to generate a statistical model or run an R or SAS script. Why wasn’t a single statistician or epidemiologist on the authors’ list (or even in the Acknowledgement section)? Maybe this is typical in the realms of medical publications but I find it highly unethical to leave technical contributors off the paper. Frankly, I wouldn’t this whole thing blowing up in the authors’ face. It all reeks of a science scam – like the “cold fusion” if folks care to remember.

  9. Jeff says:

    Is it possible that the real end game for Surgisphere is to create a demand for the rapid testing they claim to have developed? If so, is this the second (and far worse) coming of Theranos?

    Here’s a currently active version of the same piece about rapid testing on Businesswire: https://www.businesswire.com/news/home/20200312005647/en/Rapid-Diagnostic-Test-Coronavirus-COVID-19-Surgisphere

    1. EugeneL says:

      “a rapid diagnostic tool for novel coronavirus. Leveraging the power of its global research network and advanced machine learning, Surgisphere has developed an intelligent tool that uses as few as three common laboratory tests to identify patients likely to have coronavirus infection. With a sensitivity of 93.7% and specificity of 99.9%, this highly accurate test can help limit transmission of this deadly virus by identifying and isolating affected patients sooner, mobilizing public health resources, and avoiding delays associated with current testing. ”

      To me this sounds like a random mix of buzzwords. What the heck does the test have to do with machine learning? How does it mobilize public health resources?

      It’s a classic bullshit company.

      1. Lappan says:

        Neural networks produce results without a comprehensible explanation of the factors that propelled the match. This amazing innovation also lacks a comprehensible explanation. So, “machine learning”?

        [actually I have a comprehensible explanation, just not one that’s printable in polite society]

  10. Neil says:

    It’s unclear if the requisite concentrations of ivermectin (roughly 2 uM) can be achieved with typical dosages of 12 to 18 mg. However, atovaquone has a similar efficacy against coronavirus in vitro, and sufficient concentration can be achieved in humans at the typical dose of 750 to 1500 mg.

    The problem with atovaquone is the price. At roughly $250 (USD) for a course of treatment, it’s out of the price range for many people.

    1. psoun says:

      Atovaquone? As in the Malarone combo? A malaria treatment dose using Malarone is four pills each over three days (four times the prophylactic dose), and a standard Malarone pill is 250mg of atovaquone. As it is now off-patent, the price per pill is about $1, so this is a $12 treatment if done like malaria. I scanned some press reports on a trial in progress but no idea where you are getting $250/treatment. I know malaria options and pricing cold living in Africa.

      I have a lot of Malarone hanging around the house in Dakar so would be very happy for that as an option.

      1. Neil says:

        Yes, the same drug used in the malarone combo, but sold under brand name mepron, without the proguanil. Proguanil does not have any known antiviral activity.

        $250 is roughly the price of a 210ml bottle in the United States.

        https://doi.org/10.26434/chemrxiv.12003930.v4 is the in vitro study mentioned. The clinical trial is listed at clinicaltrials.gov

        1. psoun says:

          Interesting. I understand that proguanil has no anti-viral effects, but would its inclusion negatively influence that of atovaquone (in other words, why not just use Malarone?)? There’s been recent malaria research suggesting synergistic effects of the combination that make it potentially amenable to less frequent dosing for prophylactic use (see work by Lachish et al. on this).

          1. Neil says:

            The anti-folate effect of proguanil is responsible for the majority of the side effects with this combination. However, assuming that it is tolerated by patients this could be a reasonable approach to prophylaxis.

  11. Thomas Munro says:

    The Lancet paper now has an expression of concern, apparently not yet up on the journal site:
    https://marlin-prod.literatumonline.com/pb-assets/Lancet/pdfs/S0140673620312903.pdf
    For people wanting to analyze the data themselves, I have converted all the tables into a spreadsheet. Available on Zenodo: https://doi.org/dxdp

  12. Simon Auclair the Great and Terrible says:

    As Fritz Zwicky would say, spherical something!

    Derek, I beg you to never do a post again on the halogenated antiplasmodial agent which Must Not Be Named!

    1. EugeneL says:

      spherical bastards

  13. Simon Auclair the Great and Terrible says:

    The Zwicky quote was spherical a holes cause any way you looked @ them they were.

    1. loupgarous says:

      So they’re like black holes in that regard. Asking for a friend.

  14. Forte says:

    The CEO left his doctor job in January and concluded data privacy agreements and system integration projects with 670 hospitals by March. All done With 4 employees who started in February. None of them IT or legal people. He then wrangled data on 90k patients. Some man for one man.

  15. EugeneL says:

    Data inconsistencies in another article based on Surgisphere data:
    https://mobile.twitter.com/Arkancideisreal/status/1267209709863362561

  16. john says:

    Something may be up. Hope it’s good news!
    David Boulware, MD MPH
    @boulware_dr
    2h
    Tomorrow.

    1. john says:

      The U Minn Boulware study is now out. Completely negative. It has limitations (low event rate, and no confirmation of infection by laboratory testing). Still, it seems to be the best one could do under the circumstances. At first I was worried about the inclusion of diarrhea to indicate possible COVID, given that this was the #1 side effect of HCQ, but on looking at the supplemental tables, I don’t think diarrhea could have influenced the results in a major way. The patients were young (average age 40). Zinc did not seem to make a difference. Very nice work. Still in press, somewhere, apparently, or still under review, is the completed early symptom treatment study by the same group.

  17. john says:

    Interesting (to me, anyway) thread on statistical issues with Mehra’s NEJM paper on coronavirus. I’m not promoting other threads on this particular blog.

    https://twitter.com/Arkancideisreal/status/1267209709863362561

  18. john says:

    By the way, some of the (non-coronavirus) threads on the arkancideisreal blog are pretty racist (I should have guessed from the title!). I’m not aligned with that in any way — I just was citing the one thread about the stats problems in the NEJM coronavirus paper.

  19. Andrew Novak says:

    Hoo boy, this does NOT look good at all. The biggest thing I can’t get over is the timetable. This software only seems to have started to exist in Late 2018, less than two years ago. Getting it into 671 hospitals, around the world, in that timeframe? Impossible. Massive data integration like that isn’t plug and play, it can take YEARS because everyone’s using something different, often very outmoded. It’d take an army of software and database devs to tailor make the software for different situations. Theoretically, you could outsource that, but still, you’d need an army of compliance people looking over their shoulders. The company never seems to have raised money, which would be a must for such a massively fast buildout, and it’s utterly implausible that such an enormous operation only has 5 guys on linkedin. I mean c’mon. The only thing I can say in their defense is that the massive balls and chutzpah required to fabricate this defies belief… but it’s happened before. They need to release everything to an external auditor, IMMEDIATELY. Or at the very least, I’d love to hear from SOMEONE that’s actually used their software before.

  20. Tom A says:

    Starting to sound like a 2020 version of Elizabeth Holmes and Theranos. Glad there’s a lot of knowledgeable skeptics examining the company.

    Derek, thanks for posting this. I’m satisfied your blog can be self-correcting. Some aren’t. They just double down on the nonsense.

  21. Glen L Weaver says:

    This is much more a problem with The Lancet than a problem with poor research.

    1. Jeff says:

      Glen, this looks more like outright fraud than merely poor research. Still, you’re right: how did this get through the Lancet’s editorial process without anyone wondering how such an overwhelming amount of recent data had been collected?

      1. Robert Clark says:

        The lead author and the Lancet editor had strong bias against HCQ. That may have led them to look the other way in regards to red flags about the data.

        Robert Clark

      2. T says:

        Well the Lancet certainly has form in this area. Even without the fraud later uncovered (and the Editor in Chief’s attempts to bury allegations to protect his friend the author rather than demanding a proper investigation, for which he somehow didn’t lose his job), it’s hard to understand how Wakefield’s MMR/autism paper got through editorial and peer review. How can you take an almost universal intervention like vaccination, which is given right about at the age when developmental disorders are likely to be noticed, note that a tiny handful of patients with a particular disorder, surprise surprise recently had the intervention, and conclude that the intervention causes the disorder? This is a problem with some very famous journals with “superstar” editors. The Editor in Chief is like an absolute monarch and the journal content can end up reflecting their personal views, connections, and desire for glory rather than focusing on good, rigorous science.

  22. john says:

    Science magazine has a good summary of the controversy here:
    by Kelly Servick and Martin Enserink

    https://www.sciencemag.org/news/2020/06/mysterious-company-s-coronavirus-papers-top-medical-journals-may-be-unraveling

    Also, here is the latest interview with Prof. Didier Raoult about the controversy, plus general comments about how the issue has been treated by the press and the French government which includes some interesting comments about jealousy in the scientific process!

    https://youtu.be/zUbiYhknaK0

    I had to look up what Pieds Nickelés meant:
    ——————————————————————-
    Les Pieds Nickelés (French for “The nickel plated feet”) is a French comic series, originally created by Louis Forton. The comic premiered on June 4, 1908 in the newspaper L’Épatant, published by Société Parisienne d’Édition.[1] It is considered to be one of the earliest French comics [2] and one of the longest-running.[3] it centers on a group of anarchist youth getting in trouble.[4] In French informal speech of the early twentieth century, “nickel-plated feet” was a moniker for slackers, workshy people.

    https://en.wikipedia.org/wiki/Les_Pieds_Nickel%C3%A9s

  23. tc says:

    The Scientist has reached out to some of the largest health systems in the states hit hardest by the coronavirus pandemic to inquire whether they participated, but could not find any that did.

    Instead, a number of hospitals confirmed that they did not contribute data, namely, New Jersey health systems RJWBarnabas Health and Cooper Health, NYC Health + Hospitals and NYU Langone in New York, and Illinois-based health systems Rush and Advocate Health Care.

    Northwest Community Hospital, which employed Desai as a vascular surgeon until February 10 this year, did not contribute data, it confirms in an email to The Scientist. Nor did coauthor Mendeep Mehra’s institution, Brigham and Women’s Hospital.

    In an interview last week, Desai told The Scientist that he would ask if any hospitals were willing to come forward voluntarily to confirm their participation, but has not provided any names yet.

    https://www.the-scientist.com/news-opinion/concerns-build-about-surgisphere-corporations-dataset-67605

  24. Ffggggfdeerfghhvhhhv says:

    Well fuck…..why doesn’t he run a lefyist special on racism or shit. The chemistry of racism lol. Should fit with the hydroxychloroquine stuff.

  25. In your previous post, you said: “Tell me again why anyone should be advocating such treatments. But your reasons had better stand up to 14,888 patients versus 81,144 comparators. Make it good”. Here it is: https://melwy.com/blog/lancet-paper-on-chloroquine-is-overhyped-real-world-data-should-not-be-a-black-box

    1. theasdgamer says:

      Nobody enjoys eating crow. Now back to HC…where again are the outpatient studies that show that it’s ineffective? Or maybe people don’t understand the difference between treating outpatients within 5 days of symptom onset versus hospitalized patients more than 11 days after symptom onset?

      1. Joe Psycho says:

        Crow meat supposedly is not that bad, from what I heard it is like tough and dry turkey.

  26. Lambchops says:

    The hyperlink to the Science article is currently pointing towards Twitter.

    1. Robert Clark says:

      Here’s the link to the Science article on the controversy:

      A mysterious company’s coronavirus papers in top medical journals may be unraveling.
      By Kelly Servick, Martin EnserinkJun. 2, 2020 , 7:55 PM
      https://www.sciencemag.org/news/2020/06/mysterious-company-s-coronavirus-papers-top-medical-journals-may-be-unraveling

      Robert Clark

  27. Georgi Momekov says:

    Unfortunately Surgisphere`s research has already led to strange COVID-19 related decision making. Their highly questionable preprint “Ivermectin in COVID-19 Related Critical Illness” co-authored by guess who – Amit Patel, Sapan Desai, David Grainger, Mandeep Mehra (now removed from the preprint repository SSRN) has been cited in a white paper advocating for the antiparasitic drug ivermectin to be included in the national COVID-19 treatment guidelines of Peru. The preprint is full of data discrepancies between the main text, tabulated data and the Kaplan-Meier curve. The issue is analyzed in more detail by a prominent spanish infectious disease expert Dr. Carlos Javier Chaccour at:

    https://www.isglobal.org/en/healthisglobal/-/custom-blog-portlet/ivermectin-and-covid-19-how-a-flawed-database-shaped-the-covid-19-response-of-several-latin-american-countries/2877257/0

  28. Robert Clark says:

    Further on the Surgisphere controversy:

    Governments and WHO changed Covid-19 policy based on suspect data from tiny US company.
    “Surgisphere, whose employees appear to include a sci-fi writer and adult content model, provided database behind Lancet and New England Journal of Medicine hydroxychloroquine studies.”
    Melissa Davey in Sydney and Stephanie Kirchgaessner in Washington and Sarah Boseley in London
    Wed 3 Jun 2020 06.54 EDT Last modified on Wed 3 Jun 2020 07.50 EDT
    “The World Health Organization and a number of national governments have changed their Covid-19 policies and treatments on the basis of flawed data from a 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.
    “A Guardian investigation can reveal the US-based company Surgisphere, whose handful of employees appear to include a science fiction writer and an adult-content model, has provided data for multiple studies on Covid-19 co-authored by its chief executive, but has so far failed to adequately explain its data or methodology.“
    https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine

    Robert Clark

  29. CrankyJoe says:

    I definitely want the paper audited, but let’s not miss the forest for the trees.

    I’d rather some credible research team(s) expend the energy instead to sort out whether HC is beneficial, and if so in what ways. It’s 3 (4?, 5?) months into this, and feels like lessons learned from those months can’t be written down (wtf?). Enough places have hopped on the HC bandwagon, surely some place has done so in away that produced meaningful data? And before people go on about XYZ hospital (e.g., Raoult’s (sp) place). There are plenty of places that haven’t done HC and have lovely numbers. The wide range of impact of Sars-Cov-2 seems to indicate that data need to be analyzed by people that know wtf they are doing to account/explain the crazy spread of severity observed.

    Bottom line – this isn’t the time for finger wagging to take stage. It’s time for credible research teams to rise to the call and put this shit to bed.

    1. Druid says:

      Good point. There are still plenty of new infections taking place around the world, many in places where intensive care is not available, and if a cheap drug could help there is still time to save some lives or perhaps just as important, get patients to recover faster. We can tar and feather the spivs later.

    2. Rob says:

      Absolutely. There’s a reason the FDA doesn’t permit observational studies to be the basis for drug approvals; they are inherently unreliable. In a politically charged atmosphere like this one, both sides cherry-pick the observational studies that support their position. Dr. Raoult started this frenzy by claiming that giving patients his three-part therapy very early in the disease course produced very good results. Where is the randomized controlled trial that tests that specific claim?

    3. Thomas says:

      There is a randomized trial still being completed in the Netherlands. Let’s hope for valid results.

  30. Tom B says:

    UK Guardian just nailed it. It’s over.

    “The Guardian has since contacted five hospitals in Melbourne and two in Sydney, whose cooperation would have been essential for the Australian patient numbers in the database to be reached. All denied any role in such a database, and said they had never heard of Surgisphere. ”

    Article here:
    https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine

    1. EugeneL says:

      The company audit should now be done by FBI and DOJ, not independent researchers.

  31. Amanda says:

    the science article link doesn’t appear to go where you intended (random twitter link)

    1. Derek Lowe says:

      Whoops. Fixed, thanks!

  32. Peter Seebach says:

    I’m just waiting for a new study to show some actual benefit as a treatment for late-term cases, without zinc, and then watching all the people who said it was only a treatment with zinc, and only early-term or prophylactic, to claim victory over this. 🙂

    This is certainly an utterly surreal situation; multiple fake studies, and no obvious consistent motive between them.

  33. cabezoney says:

    Thank you for writing this. I’m so glad to see this controversy being maintained in the mainstream science community. I was very afraid it was going to get swept out of the news cycle by everything else going on.

  34. Fred the Fourth says:

    Surreal?
    My wife once complained to me about some utterly unethical behavior among board members of companies involved in a possible merger.
    I said, You can get someone killed for $10000. Why are you surprised at this behavior when there are 10s of millions at stake?
    No.
    There’s big money at stake somewhere, or at least some folks who think they can make it so.

  35. cabezoney says:

    I guess now that I’ve read your previous article on the Lancet study I should not be quite so congratulatory considering you swallowed it whole. I’m a layperson and even I could see it was highly problematic.

    For future reference, studies on HCQ with hospitalized patients are next to meaningless. Anti-virals aren’t going to work at this stage of the illness, and all the data is confused with patients in various stages of very poor health.

    What we need before dismissing HCQ as a treatment for COVID, as you did in your article on the fraudulent Lancet study, is wait for randomized clinical trials. There are dozens currently ongoing in US alone, which you compromise when you make wild claims about lack of efficacy based on highly flawed studies.

    Odd I have to explain this to a professional science writer, yet here we are.

    1. Lappan says:

      Oddly Didier Raoult’s original study that kicked off the whole HCQ furor was precisely about treating hospitalized patients, and reportedly had a fabulous effect on patients in poor health. Was that in fact erroneous, but fortuitously HCQ proved otherwise effective?

      1. lk says:

        As far as I know his treatment protocol is to treat patients the moment they’re admitted rather than wait for a positive test or severe symptoms, which is about as early as you can get in a hospital setting.

        1. Athaic says:

          “As far as I know his treatment protocol is to treat patients the moment they’re admitted ”

          From what I read it’s pretty much that.
          Although after his initial study/announcement in March, he started proposing his treatment to anyone showing up at his clinic and tested positive.

          So there is a lot of fuzziness in the “hospitalized patients” category, depending on local policies, time, and of course, above all, local availability of beds. It could be anywhere from “shows earlier symptoms and is kept under observation/confined in hospital” to “needs to be immediately admitted in ICU”.

          Notably, once enough people pointed the risk of heart complications from CQ/HCQ, a number of hospitals implemented a protocol where electrocardiograms were used to monitor patients receiving HCQ. Making all these patients de facto “hospitalized patients”, as this couldn’t be done with patients staying at home.
          (although, to be fair, I don’t know if adding EKG measures did really move many patients from non-hospitalized to hospitalized status)

  36. InformaticsMD says:

    Just as there are “gibberish paper creator” apps, I fear there may also be formulaic “clinical data generator” apps.

  37. Sanjay Kaul says:

    Non-randomized and quasi-randomized studies often contribute to misinformation and research waste. Even if there is no evidence of malfeasance, drawing definitive conclusions based on these studies is like placing the cart before the horse. Randomized controlled trial are urgently needed to adjudicate the uncertainties around these drugs including hydroxychloroquine. Currently the quality and quantity of evidence is insufficient to either incriminate or exonerate hydroxychloroquine. The data are not reliable to inform any decisions regarding halting current investigations including the WHO’s Global Solidarity Project.

    1. KazooChemist says:

      The WHO study has resumed.

      1. Sanjay Kaul says:

        Great, but the point is that they should have never suspended the project to begin with.

        1. Marko says:

          I think it was useful to pause the trial , because the resulting mid-trial review by the DSMB provides further proof that the Surgisphere “study” is fraudulent :

          ” Advisory group of WHO Solidarity Trial recommends resuming the hydroxychloroquine arm WITHOUT protocol modifications.
          “On the basis of available mortality data [from the trial]… there are no reasons to modify the trial” – DrTedros ”

          https://twitter.com/HealthPolicyW/status/1268213982739017730

          1. Sanjay Kaul says:

            An unplanned review by DSMB should ideally be driven by credible and reliable data which rarely comes from non-randomized and quasi-randomized studies. The DSMB review might be reassuring, however, the negative publicity around what triggered the review can be potentially detrimental for trial enrollment and conduct. I would be very interested in the trajectory of enrollment pre- and post-pause.

  38. MoMo says:

    This is abomination of Science all around.
    Lancetgate should be the subject of criminal investigations and the WHO, CDC and perhaps the Deep State exposed.

    They played everyone here like violins and Derek especially.

    In no one We Trust

    1. sgcox says:

      Lancet should be should down for criminal negligence after Wakefield paper in 98.

  39. Erik Dienemann says:

    Dr. Boulware’s paper was just published in the NEJM showing that HCQ is not effective for post-exposure prophylaxis in a randomized, placebo-controlled, double blind clinical trial (the gold standard). Results/conclusions are below.

    https://www.nejm.org/doi/full/10.1056/NEJMoa2016638?query=featured_home

    So we now know that HCQ is not effective in hospitalized patients as per many, many studies (even the now tarnished Lancet study might only mean it’s not deadly, in the best case, but it never implied efficacy) and now it’s not effective for post-exposure prophylaxis, as I expected.

    I suppose it’s theoretically possible it would be effective in mildly symptomatic patients or could be a true prophylactic (by the way, anyone putting stock in that Indian prophlyaxis study is nuts, as that’s the shoddiest “paper” I’ve ever seen), but it’s highly unlikely. I’d like to see us close the book on this failed experiment and start spending our precious clinical resources on treatments that might actually work.

    https://www.facebook.com/photo.php?fbid=10219241192414648&set=a.1481493251341&type=3&theater

    RESULTS
    We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was −2.4 percentage points (95% confidence interval, −7.0 to 2.2; P=0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.

    CONCLUSIONS
    After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure.

    1. Robert Clark says:

      There are some problems with the Boulware study as well. The key issue is that most subject’s results were only by self-reported observation of symptoms, not by actual COVID-19 test results. Indeed, only 17% of the study participants were tested.

      This could be a major problem because the Indian study that showed significant protective effect for HCQ, found that only 5% of symptomatic subjects actually tested positive for COVID-19:

      https://twitter.com/rgregoryclark/status/1268383797655076865?s=21

      The link to the Indian study in that tweet is now inactive. You can read the study here:

      Healthcare workers & SARS-CoV-2 infection in India: A case-control investigation in the time of COVID-19.
      https://drive.google.com/file/d/1cVjDgCrcsVai_EQNRsQyV9TUPAeB5qRK/view

      Robert Clark

  40. Erik Dienemann says:

    People bashing Derek Lowe over this are way out of bounds. There’s some level of trust we all have to place in peer-reviewed journal articles and nobody knew there might be data issues when it was published. Yes, some of the results looked odd, but the issues with Surgisphere weren’t readily apparent.

    Also, even if the Lancet study had never been published the recent NEJM and JAMA studies as well as a couple of meta-analysis papers were pretty convincing that HCQ wasn’t efficacious for hospitalized patients – and even the few that showed some efficacy showed weak efficacy.

    With mostly retrospective, observational studies of an ineffective treatment, this is what we’d expect to see and yet 60-80% of hospitalized patients in NY (and likely elsewhere) were being treated with HCQ based on the flimsiest of evidence (mostly the discredited original Raoult trial and HCQ hawking by Dr. Trump) – and during that time, case fatality rates doubled in NY and the US, so if HCQ was even moderately efficacious, I doubt that would’ve happened.

    With HCQ being ineffective in hospitalized patients and now as a post-exposure prophylactic as per today’s NEJM study by Dr. Boulware, it’s time to close the book on HCQ and to use our precious clinical resources on other treatments.

    https://www.nejm.org/doi/full/10.1056/NEJMoa2007621

    1. theasdgamer says:

      “nobody knew there might be data issues”? Seriously? It was patently obvious from the start.

      1. Seebs says:

        If everyone knew that, why didn’t anyone make any of the *relevant* comments about the problems with the data? Instead, they all claimed it was irrelevant because it didn’t use zinc, or because the only predicted behavior ever had been prophylactic. (The latter being totally false, but whatever.)

        Go ahead. Show me the comment you made, suitably dated/timestamped, showing that you were aware of, or noticed, *these* issues, back when the discussion about the study was going on.

        If you didn’t notice them, and comment on them, your claim now that they were obvious is sort of suspect…

        1. theasdgamer says:

          Umm, I commented about problems with the data. And I was correct that the article would be retracted. Because I studied the disease and saw the problems with the data.

          1. theasdgamer says:

            theasdgamer says:
            27 May, 2020 at 10:23 pm

            I’m also skeptical that the authors could have gotten all that data ethically, analyzed it, and published in 30 days.

        2. theasdgamer says:

          I replied, but you haven’t acknowledged. Your dish of crow has been prepared.

  41. Marko says:

    Island nations have an increased potential to “crush the curve”. Norway is going to extreme lengths to achieve this potential :

    https://twitter.com/marynmck/status/1268318619026558976

  42. Marko says:

    “With HCQ being ineffective in hospitalized patients and now as a post-exposure prophylactic as per today’s NEJM study by Dr. Boulware, it’s time to close the book on HCQ and to use our precious clinical resources on other treatments.”

    You’re closing the book as prematurely as Derek did. The prophylaxis study tells us nothing unless it tells us what the final clinical outcome was for treated vs untreated. The idea that hydroxychloroquine would prevent infection altogether never made sense. It is not a powerful direct antiviral. That has been clear from the outset. Who wants to bet that we never hear about final outcomes , or , if we do , that the study was underpowered to detect any difference?

    I’d like to see mud smeared on Trump’s face as much as anyone. What’s being done in the name of “science” to accomplish that sickens me , however.

    1. MoMo says:

      Agreed- CQ and HCQ have hundreds of publications touting anti inflammatory activity and in ARDS yet everyone is focused on the virus and replication.

      You can’t trust anyone as all of Science are amateurs with this microbe. And who are these people?

      Meanwhile, Science is being flooded with bogus data (E. Bik) worthy of criminal charges, you can’t trust even established institutions and it seems everyone has an agenda.

      Meanwhile people are told trust us scientists?

      Everyone should shut up for a while.

      1. theasdgamer says:

        Most everyone here hasn’t bothered to actually study covid. I bet almost nobody here knows that in the moderate stage, covid patients are hypoxemic, but not adyspnic. Their pO2 may be 80, but they are experiencing no distress. Because their CO2 levels are near normal even though their O2 levels have cratered.

        1. theasdgamer says:

          should be “but not dyspnic”

    2. RoonDog says:

      Total layman here, but it seems odd to me that all of the clinical studies with HCQ utilize a much larger dose than the doctors who claim to be using it successfully are using. Some of them have, in fact, claimed that the reason for the failures in the clinical trials is they’re using way too high a dosage.

  43. Sanjay Kaul says:

    It is not clear to me what was the justification for the NEJM HCQ study to be powered to detect a 50% relative reduction in symptomatic illness. With such a large effect size (resulting in a sample size of about 900), the study was doomed to a type 2 (false-negative) error leading to an inconclusive result. No meaningful inference can be drawn, I am afraid!

  44. RA says:

    All this is super sketchy. I think the traditional method of peer review needs to go…open participation models where many, not just 2 or 3 invited reviewers, can weigh in on a candidate paper before given the imprimatur of official publication would go a long way to avoiding these disasters that make science just another variety of “fake news” in the eyes of the public.

    1. Hyperbole killed the scientist says:

      While I don’t disagree, I think the “fake news” aspect felt by the general public has a lot more to do with scientific journalists (commonplace publications) repeatedly taking in vitro studies studies (and other early stage development projects), and publishing their write-ups with flashy headlines like “Cure for all cancers found” and other hyperbolic sentiments. Ten years later, there is still no “Cure for all cancers” and the public is left wondering why… I understand their business model is based on traffic, so the article titles make sense for their business, but does grave injustice to the public confidence in the scientific process.

      1. RA says:

        Good point and I agree this is a problem too! I would then propose that the broader universe of people who review a paper through an open participation process stay engaged and “review” the headlines of coverage that emanate from a paper…the headline writers and science journalists should have accountability too. When the people who have the knowledge to convey accurate information stay muzzled by closed peer review processes, the voices of disinformation and sensationalization reign unfettered.

  45. Rahul Agarwal says:

    This could be a bigger deal given Desai’s past history and obviously false claims regarding his company and other products he touts. It’s possible that some pharma gave good money to promote other drugs.
    Someone rightly said Desai should now be audited by FBI
    Scamsters should not be allowed to get away peddling fake data playing with millions of lives

    1. loupgarous says:

      FDA would probably be the competent agency to investigate SurgiSphere, because it’d otherwise be difficult for nonspecialists to distinguish mere sloppiness from deliberate fraud or other misconduct. FDA’s CDER and their scientific advisors specialize in that.

      If they find actionable fraud or other misconduct, they could then refer that to FBI and/or the Department of Justice.

      1. FDA indeed has experience in investigating trials, but it would have difficulty claiming jurisdiction with respect to the study (if there was one) behind the Lancet paper. As far as I know, that work has not been submitted to FDA in support of an application.

  46. Gen says:

    Pics of Surgisphere director, you know which one. NSFW but ok for WFH.
    https://twitter.com/medicalfollower/status/1267122976127885312

    1. EugeneL says:

      She surely can drive sales, especially for things such as
      “next generation human augmentation device that can help you achieve what you never thought was possible”

      1. loupgarous says:

        The Swedish hyperemiator from Austin Powers?

  47. Georgi Momekov says:

    The endgame for surgisphere flawed study…

    https://www.thelancet.com/lancet/article/S0140673620313246

    1. Marko says:

      The proper endgame would involve a bunch of orange jumpsuits.

  48. john says:

    Statement from The Lancet

    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 is published today, June 4, 2020. The article will be updated to reflect this retraction shortly.
    ————————————-

    What bothers me is Dr. Mehra’s role in all of this. BWH needs to investigate the NEJM and Lancet papers, and also perhaps even his other publications.

    1. G.Momekov says:

      The peer review process has been as flawed as the study itself…

      1. Rob says:

        The stink from this article is going to attach itself to the Lancet editor for a very long time.

  49. john says:

    The NEJM paper has been retracted as well.

    https://www.nejm.org/doi/full/10.1056/NEJMc2021225

    Interestingly, Dr. Desai is a signatory to the letter.

  50. theasdgamer says:

    Retracted. Who called it again? [does victory lap]

  51. Stefan says:

    Forget The Lancet … worse is that the WHO & Co all of a sudden decided to discontinue the Golden Unbiased trials, because the answer they were looking for, was already provided in that article. How is that for Unbiased.

  52. john says:

    Interesting interview with Dr. James Todaro re Surgisphere and HCQ. (Todaro is an ophthalmologist who let medicine to invest in bitcoin, but who became interested in HCQ in January. He was instrumental in exposing Surgisphere).

    https://anchor.fm/tales-from-the-crypt/episodes/167-Dr–James-Todaro-ef1khs

    Starts at 5:00 into the tape.

    1. theasdgamer says:

      Todaro and a group of us random twits on the internet took a hard look at the Surgisphere data and determined that it was likely bogus. I focused on the error of conflating old data with new data for a novel acute disease where the understanding of the disease changes rapidly.It was an international effort involving US, France, and Australia.

      1. theasdgamer says:

        Mixing early data with late data impacts diagnosis. Lab testing speed accelerates producing quicker turnaround. Docs eventually realize that covid ARDS initially presents atypically and doesn’t require venting, reducing the impact of ventilator induced lung injury on covid patients later in the epidemic. Patients earlier in the epidemic are treated with medication later after symptom onset than they are later in the epidemic because of testing turnaround time. Patients at some hospitals are vented less aggressively later in the epidemic. Essentially, aggressive venting killed many if not most covid patients at some NYC hospitals.

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