How Bad Science Gets Published Again and Again and Again
Pamela A. Popper, President
Wellness Forum Health
According to Marcia Angell, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
Indeed, approximately 95% of what is published in medical journals is not reliable due to conflicts of interest, poor study design, and even outright fraud. An incident that took place last year concerning treatments for COVID-19 is a good example, and since this episode there have been no significant changes that would prevent this type of thing from happening again.
The Surgisphere Debacle
On May 22, 2020 The Lancet published a study reporting that hydroxychloroquine and chloroquine (the older version of the drug) were linked to increased deaths in hospitals all over the world. The paper was authored by Dr. Mandeep R. Mehra of Harvard Medical School, Dr. Amit Patel, and Dr. Sapan S. Desai of Surgisphere, an Illinois-based company that claimed to have gathered data on tens of thousands of patients in over 1000 hospitals worldwide.
According to this paper, one in six patients taking one of these drugs alone died; one in five taking chloroquine with an antibiotic died; and one in four taking hydroxychloroquine with an antibiotic died. The death rate for patients not given these drugs was one in eleven. Additionally, serious arrhythmias were reported, with most occurring in the group taking hydroxychloroquine in combination with an antibiotic (8% versus 0.3% in patients not given any of these drugs or combinations).
The mainstream media was thrilled, and this became a big story. Then-President Trump had made positive comments about hydroxychloroquine during at least one of the daily White House press briefings and had also reported taking it himself. The article appeared to provide evidence that Trump had misled the country concerning HCQ.
Anthony Fauci also appeared delighted; he had repeatedly made negative remarks about the drug. On May 27, 2020, just days after the Lancet study was published, Fauci made this statement on CNN, “The scientific data is really quite evident now about the lack of efficacy.”
Dr. Birx (AKA the scarf lady) chimed in “…it clearly shows that co-morbidity that puts individuals at more risk. And I think it’s one of our clearest studies because there were so many, tens of thousands of individuals involved; that the doctors clearly annotated who had heart disease and who had obesity. And you could see dramatically the increased risk…”
The Lancet paper had a major impact on both policy and research. The WHO stopped the hydroxychloroquine arm of its clinical trials. Research studies using hydroxychloroquine in the UK and France were also halted. The COVID-19 storytellers repeatedly reported that the issue was settled. Science showed that hydroxychloroquine was a dangerous drug, and not appropriate for the treatment of COVID-19.
The Guardian was one of the first media outlets to question the Lancet article. According to the article, data from five Australian hospitals with 600 COVID-19 patients and 73 deaths were included in the analysis. But at the time the data was collected, there had been only 67 deaths recorded throughout Australia. The Guardian was able to confirm that the National Notifiable Diseases Surveillance System in Australia was not the source of the information. Health departments in New South Wales and Victoria, two of Australia’s most populous states, stated that the reported data did not reconcile with their data and that they had not provided any data to the researchers who claimed to have gathered it.
Guardian investigative reporters also looked into Surgisphere and reported that one of the firm’s science editors appeared to be a science fiction writer and fantasy artist. One of the company’s marketing executives also had a career as an adult model and events hostess. The company’s LinkedIn page showed only three employees as of June 3, 2020, making it highly unlikely that the company had the resources to gather and analyze such a large data base, which consisted of 96,032 patients who were admitted to hundreds of hospitals on six continents by April 14, 2020. Additionally, Guardian reported that until June 1, 2020, the “get in touch” link on Surgisphere’s website led to a cryptocurrency website.
Researchers and writers at The Scientist also reported concerns about the study. The Lancet article reported that Surgisphere’s registry included data from over 63,000 COVID patients admitted to 559 hospitals in North America by April 14, 2020. But Surgisphere CEO and founder Sapan Desai refused to provide the names of any of the hospitals when asked. The Scientist contacted some of the larger health systems in states reporting the most cases and deaths and did not find any who confirmed that they provided data to Surgisphere.
Other researchers interviewed by The Scientist had doubts about the African data, noting that the quality of electronic health records in Africa made it highly unlikely that records for 4402 hospitalized patients could have been obtained from African countries by April 14, when at the time only 15,738 cases had been reported on the entire continent.
At the same time, another article published by the same authors in the New England Journal of Medicine reported that patients with COVID-19 and with cardiovascular disease and treated with HCQ had an increased risk of dying in the hospital. This article reported data from 346 COVID-19 patients hospitalized in Turkey by March 15.
Letters signed by over 140 scientists and physicians were sent to both the Lancet and the NEJM. The letter to the NEJM states that “countrywide, the first COVID-19 case was diagnosed at Istanbul Faculty of Medicine on the 9th of March. The second COVID-19 patient in that hospital was not seen until the 16th of March. The Turkish Ministry of Health reported a total of only 191 PCR positive cases by the 18th of March.” In other words, the NEJM article reported more COVID-19 patients in Turkey than had been diagnosed at the time.
The letter to the Lancet expressed “both methodological and data integrity concerns” and listed, among other issues:
- The study’s authors did not indicate the “severity” of the disease being treated. Was it early in the COVID-19 progression or late in the process? The dosages of HCQ or CQ used were not disclosed.
- The authors have not adhered to “standard practices in the machine learning and statistics community. They have not released their code or data. There is no data/code sharing and availability statement in the paper.”
- The countries and hospitals from which the data were obtained were not disclosed, and the authors have denied requests for that information.
- The numbers of cases and deaths as well as the detailed data collection from Surgisphere-associated hospitals in Africa “seem unlikely.”
- Reported ratios of HCQ to CQ are “implausible.”
On June 4, 2020, three of the authors of the Lancet paper retracted their study, claiming they were “unable to complete an independent audit of the data underpinning their analysis”…and “…that they can no longer vouch for the veracity of the primary data sources.” The NEJM article was also retracted.
The World Health Organization then resumed its research on the use of hydroxychloroquine for the treatment of COVID-19. But the retractions received far less attention than the original articles, which galvanized many doctors against treatments that were later proven to be effective. It is almost certain that more widespread use of these drugs could have saved the lives of many patients who died.
How Could this Have Happened?
Desai founded Surgisphere in 2008 while he was a surgical resident at Duke University. He spent 12 years working as a vascular surgeon in several states. According to an article in The Scientist, former colleagues of Desai stated that he routinely misrepresented his achievements and regularly provided inaccurate information about his patients. He even reported taking care of patients when he had not; and he was deemed so unreliable that staff members had to check with others to verify anything he said in order to protect patients. When asked why this was tolerated, staff stated that they feared retaliation and damage to the institution’s reputation. Some said that they did complain to their superiors, but nothing was done. Desai was accused of medical malpractice in at least three lawsuits, one of which involved a patient death. Colleagues also stated that Desai was likely unemployable at a medical institution in the future based on his track record.
Most of Desai’s co-authors reported that they had never seen the raw data and only reviewed summary data. Mehra was a co-author on three Surgisphere studies, including the two covered in this article, and handled all of the correspondence concerning the data. When questioned by scientists about data for one of the studies, he replied that he shared their skepticism about the “implausibly high” effect size. He passed their concerns on to Desai and Patel, but no response was ever issued. Mehra took no action until after the fraud was made public. Independent auditors also were not given access to the raw data, and they signed off on the articles anyway.
Timothy Henry was a co-author on the New England Journal of Medicine article and acknowledged that he had not seen Surgisphere’s data before the article was submitted to the journal. In an interview with The Scientist, Henry stated that this was a common practice.
According to Stefan Eriksson, director of the Centre for Research Ethics and Bioethics at Uppsala University in Sweden, the scientific community is unclear about what to do with coauthors of researchers accused of fraud or other misconduct.
Editor in chief of The Lancet, Richard Horton says that “peer review is not an effective system for detecting fraud.” He also says, “…you don’t want to impose another layer of bureaucracy on science that actually makes it more difficult either to do science or to publish science.”
Anthony Fauci remains head of an NIH agency and continues to insist that HCQ is an ineffective drug for the treatment of COVID-19 and instead promotes an expensive drug, Remdesivir, which had already been determined to be ineffective for treating viral infections in a study funded by his agency.
This Happens Every Day!
Not one person involved in this travesty has lost his job, been prosecuted for misconduct, or even acknowledged wrongdoing. While The Guardian and The Scientist did cover the story, none of the mainstream media outlets that reported to the public that Trump had actually been right about HCQ, or that the journal articles had been retracted. Not one change has been made in any of the sloppy procedures that led to this debacle. Fauci is still referred to as the world’s leading virologist and The Lancet and the New England Journal of Medicine are still referred to as “prestigious” journals.
Every day, poorly designed studies conducted by conflicted or incompetent researchers and academics seeking attention are published in journals. Almost anyone desiring to make almost any claim can find a study to support their point of view or agenda. This is how the government and its co-conspirators have been able to use “science” to promote the biggest hoax in the history of the world. There is so much garbage science that it is impossible to respond to even a small percentage of it, and the bad intentions of the government, the medical cabal, and the media have become so clear that the best option is to assume that all statements from these sources are false unless proven otherwise.
This has been going on for decades, and just accelerated and got a lot worse when the COVID debacle started. Government and health officials seem mystified that more and more citizens are following fewer and fewer of their instructions. After all, they say, they are “following the science.” Actually, I’m amazed that anyone even listens to these people at all. They make things up and then find something in the medical literature to support it, and it is remarkably easy to do. It’s not science, it’s criminal behavior. And it will only stop when most people stop paying any attention at all.
 Mehra MR, Desai SS, Ruschitzka F, Patel AN. “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.” Lancet May 22 2020 DOI:https://doi.org/10.1016/S0140-6736(20)31180-6 RETRACTED
 Zachary Brennan. Fauci: Hydroxychloroquine not effective against coronavirus. Politico May 27 2020 https://www.politico.com/news/2020/05/27/fauci-hydroxychloroquine-not-effective-against-coronavirus-283980 accessed 9.2.2020
 Large study finds drug touted by Trump is “not useful and may be harmful” for COVID-19 patients. CBS News May 22 2020 https://www.cbsnews.com/news/hydroxychloroquine-coronavirus-drug-study-not-helpful-harmful-heart-risks-trump/ accessed 9.2.2020
 WHO halts hydroxychloroquine trial for coronavirus amid safety fears. The Guardian May 25 2020 https://www.theguardian.com/world/2020/may/25/who-world-health-organization-hydroxychloroquine-trial-trump-coronavirus-safety-fears accessed 9.2.2020
 Melissa Davey. Questions raised over hydroxychloroquine study which caused WHO to halt trials for COVID-19. The Guardian May 27 2020 https://www.theguardian.com/science/2020/may/28/questions-raised-over-hydroxychloroquine-study-which-caused-who-to-halt-trials-for-covid-19 accessed 9.2.2020
 Offord C. “Concerns Build Over Surgisphere’s COVID-19 Dataset.” The Scientist Jun 2 2020 https://www.the-scientist.com/news-opinion/concerns-build-about-surgisphere-corporations-dataset-67605 accessed 9.2.2020
 Mehra MR, Desai SS, Kuy AR et al. “Cardiovascular disease, drug therapy, and mortality in Covid-19.” NEJM May 1 2020 DOI: 10.1056/NEJMoa2007621 RETRACTED
 Watson JA, Meral R, Price R, Simpson J on behalf of 174 signatories. An open letter to Mehra et al and The New England Journal of Medicine. https://zenodo.org/record/3873178#.XtmckdVKipr accessed 9.2.2020
 James Watson on the behalf of 146 signatories. An open letter to Mehra et al and The Lancet. https://zenodo.orgJames /record/3864691#.XthfzTpKhPb
 Retraction: “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis” https://www.thelancet.com/lancet/article/s0140673620313246
 Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. https://www.nejm.org/doi/full/10.1056/NEJMc2021225
 Catherine Offord. A Perfect Storm. The Scientist Oct 2020 pp 35-41
 Mulangu S, Dodd L, Davey RT et al. “A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.” NEJM 2019 Dec;381:2293-2303