- The Lancet retracted a study that erroneously concluded that the malaria drug hydroxychloroquine increased death rates when used for COVID-19
- The Lancet study was found to be based on a patient database that was fraudulent
- Soon after the study was published, 100 researchers sent a letter to The Lancet’s editor, Dr. Richard Horton, detailing their concerns about the origins and validity of the database
- The lead author, Dr. Mandeep Mehra of Harvard, and two other study authors asked The Lancet to retract the study
- Reacting to the study, the World Health Organization and national governments immediately deleted the drugs from their COVID-19 policies, but after the retraction reinstated them
The respected medical journal The Lancet was found to have published a study on the use of hydroxychloroquine for COVID-19 that was based on such shockingly fraudulent data it was retracted.1 The paper, which ran on May 22, 2020, concluded that the malaria drugs hydroxychloroquine or chloroquine had no benefit when used in COVID-19 cases and actually increased death rates.2
The retracted study, “Hydroxychloroquine or Chloroquine With or Without a Macrolide for Treatment of COVID-19: A Multinational Registry Analysis,” also concluded that hydroxychloroquine or chloroquine increased the frequency of ventricular arrhythmias, which are abnormal heartbeats that can cause cardiac arrest by interrupting blood circulation to the brain and body.3
Before its retraction, The Lancet study caused swift termination of hydroxychloroquine and chloroquine in the COVID-19 protocols of the World Health Organization and different nations and an end to the drugs’ trials. They have since been reinstated.4
Researchers Doubted the Study From the Beginning
Because of the study’s alarming findings, researchers carefully scrutinized its findings. Within a week of publication, 100 researchers sent a letter to The Lancet’s editor, Dr. Richard Horton, conveying their concerns about the origins and validity of the database that the study was based on.5 According to The New York Times:
“The experts who wrote The Lancet also criticized the study’s methodology and the authors’ refusal to identify any of the hospitals that contributed patient data, or to name the countries where they were located. The company that owns the database is Surgisphere, based in Chicago.”
According to the Times, the researchers wrote in the letter:
“Data from Africa indicate that nearly 25 percent of all Covid-19 cases and 40 percent of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording … Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.”
Other researchers also voiced doubt that Surgisphere, a very small company,6 could assemble the massive database it claimed to have in a short period of time including from countries where electronic medical records may not exist.7 According to the Barcelona Institute for Global Health, Surgisphere also used a fraudulent database to promote the anti-parasite drug ivermectin for COVID-19 in Latin America.8
A quick look at the retracted Lancet study verifies the concerns of the letter writers. For example, would records from countries with less developed health care systems like Africa and so few electronic records really include pre-existing conditions like cardiovascular disease, coronary artery disease, histories of congestive heart failure and arrhythmias like U.S. records would be more likely to do?9
Would such records show patients’ comorbidities like hyperlipidemia, high blood pressure, diabetes and chronic obstructive pulmonary disease (COPD) as The Lancet study displays, and even obesity and BMI data?10 It is also unlikely that patients living in poor countries with few drug supplies would have been given antivirals like lopinavir, ritonavir, ribavirin and oseltamivir as the paper says. As the letter writers suggest, the data look too good to be true.
Researchers Had More Concerns About the Study
Researchers who wrote to Horton had additional concerns besides the implausibility of the patient database. According to the Alliance for Human Research Protection (AHRP), researchers in their letter to The Lancet’s editor also cite:11
|A range of gross deviations from standard research and clinical practices, such as: Patients were prescribed inexplicably high daily doses of hydroxychloroquine — far higher than the FDA-recommended doses.|
|There was no ethics review.|
|The number of patients reportedly from Australia far exceeded the number of patients in the Australian government database.|
|Gross misrepresentation of the numbers of deaths in Australia.|
|Refusal to identify the hospitals that contributed patient data.|
|The ratios of patients who received chloroquine (49%) to those who received hydroxychloroquine (50%) are implausible; in Australia chloroquine is not available without special government authorization.|
One signatory of the letter, James Watson, senior scientist at the MORU-Oxford Tropical Medicine Research Unit in Thailand, said he doubted that any research organization could have obtained such detailed massive records that quickly. “I just find it very hard to believe,” he said.12
Dr. Anthony Etyang, a clinical epidemiologist with the KEMRI-Wellcome Trust Research Programme in Kenya13 and a signatory to the letter, also doubted the study. He noted that even private hospitals can have poor medical records making the data very implausible, according to AHRP.14 The Guardian confirmed that the hospital data contained major inaccuracies:15
“Guardian Australia revealed glaring errors in the Australian data included in the study … data from Johns Hopkins University shows only 67 deaths from Covid-19 had been recorded in Australia by 21 April. The number did not rise to 73 until 23 April [as the study states] …
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.”
The Lancet Study Retracted
The alarming findings of The Lancet study had an immediate chilling effect. WHO and national governments immediately deleted the drugs from their COVID-19 policies and drug trials were stopped.16 If a drug does more harm than good, a clinical trial would be immediately terminated.
However, the situation quickly changed when Brigham and Women’s Hospital, the institution of the lead author, Dr. Mandeep Mehra, issued this statement soon after the controversy began:17
“Independent of Surgisphere, the remaining co-authors of the recent studies published in The Lancet … have initiated independent reviews of the data used … after learning of the concerns that have been raised about the reliability of the database.”
Mehra stated that he “eagerly await[ed] word from the independent audits, the results of which will inform any further action” and that such information would be necessary “before any conclusions could be reached.”
Soon the researchers discovered that Surgisphere would not be forthcoming with the audits. That moved three of the paper’s authors — Mehra, Dr. Frank Ruschitzka of the University Heart Center at the University Hospital Zurich and Dr. Amit Patel of the University of Utah and HCA Research Institute in Nashville18 — to ask The Lancet for a retraction. They issued this statement.19
“After publication of our Lancet Article several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication.
We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.
Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements.”
After the Lancet retraction and the fraudulent database was exposed, WHO director general Dr. Tedros Adhanom Ghebreyesus said.20
“On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol. The executive group received this recommendation and endorsed continuation of all arms of the Solidarity trial, including hydroxychloroquine.”
The Solidarity trial, consisting of 3,500 patients, is investigating a number of possible COVID-19 treatments.21
Studies Show Malaria Drugs’ Promise Against COVID-19
The retractions restored hydroxychloroquine and chloroquine to a place in treatment protocols and investigative trials to determine their usefulness in treating COVID-19. Several scientific studies have suggested the value of the malaria drugs against COVID-19. A 2020 letter in the journal Nature states:22
“Chloroquine is known to block virus infection by increasing endosomal pH required for virus/cell fusion, as well as interfering with the glycosylation of cellular receptors of SARS-CoV.
Our time-of-addition assay demonstrated that chloroquine functioned at both entry, and at post-entry stages of the 2019-nCoV infection in Vero E6 cells. Besides its antiviral activity, chloroquine has an immune-modulating activity, which may synergistically enhance its antiviral effect in vivo.
Chloroquine is widely distributed in the whole body, including lung, after oral administration.”
A 2020 study in the journal European Review for Medical and Pharmacological Sciences states:23
“Chloroquine and hydroxychloroquine have antiviral characteristics in vitro. The findings support the hypothesis that these drugs have efficacy in the treatment of COVID-19.
People are currently using these drugs for malaria. It is reasonable, given the hypothetical benefit of these two drugs, that they are now being tested in clinical trials to assess their effectiveness to combat this global health crisis.”
A 2020 paper in the Journal of Clinical Medicine states:24
“[T]he mechanism of action of some antimalarial drugs, e.g., the antiviral function, suggests their potential role in the chemoprophylaxis of coronavirus epidemics, despite possible adverse effects (e.g., retinal toxicity).
All these data provide important insights to understand the spreading mechanisms of COVID-19, and to direct scientific research toward the study of some currently available medications.”
Antimalarial Drugs Are Not Without Risks
As the Journal of Clinical Medicine paper states, antimalarial drugs are not without risks. Chloroquine raises the pH of vesicles in the cells that are hijacked by the virus. The normally slightly acidic environment facilitates the viral infection.
Both hydroxychloroquine and chloroquine have the side effect of elongating your QT wave in an electrocardiogram. This means the electrical activity in the heart is altered. The most common symptoms of this condition can be seizure, fainting and even sudden death, so the drugs are certainly not risk free.
The Lancet Retraction Is Not an Isolated Instance
Retractions of scientific papers are not rare. According to Science magazine:25
“Nearly a decade ago, headlines highlighted a disturbing trend in science: The number of articles retracted by journals had increased 10-fold during the previous 10 years. Fraud accounted for some 60% of those retractions;
one offender, anesthesiologist Joachim Boldt, had racked up almost 90 retractions after investigators concluded he had fabricated data and committed other ethical violations … the surge in retractions led many observers to call on publishers, editors, and other gatekeepers to make greater efforts to stamp out bad science.”
Sometimes the retractions stem from medical journals publishing research revealed to have been funded and written by drug makers or authors they pay. Such publications carry a built-in bias because they are skewed toward positive results and are usually thinly disguised sales pieces.
Such Pharma-supplied studies can be lucrative to medical journals because they often sell reprints of the articles, which pharmaceutical salespeople use in marketing to doctors.26 A study published in a reputable journal provides instant credibility in sales efforts.
In recent years, journals have instituted disclosure policies wherein authors must reveal any financial links they have to drug makers, including stock holdings. Unfortunately, the disclosures are almost always hidden behind pay walls so that only subscribers to the journals can see them. Furthering the opacity, the authors are often only referred to by their initials and it is difficult to determine who is who.
What was the motive of Surgisphere in its deliberate and brazen tarnishing of possible hydroxychloroquine and chloroquine treatments for COVID-19 through a fraudulent database leading to The Lancet retraction? The Alliance for Human Research Protection speculates the Surgisphere scheme was all about money:27
“Why are very powerful corporate-government stakeholders so intent on killing a drug with a 70 year track record? Because the drug works against the pandemic; it is readily available, and costs very little.
Therefore, it poses a financial threat to both pharma companies and their partners in government and academia, those who are intent on profiting from the COVID-19 pandemic.”
The authors are no doubt right. A readily available, low-priced medication already approved and in use will not make the billions a new COVID-19 vaccine or treatment would — for example, Gilead’s answer to hydroxychloroquine, Remdesivir, can cost up to $4,460 per patient,28 while a generic version of hydroxychloroquine is around $20.29