Non-Profit Trusted Source of Non-Commercial Health Information
The Original Voice of the American Academy of Anti-Aging, Preventative, and Regenerative Medicine
logo logo
Infectious Disease Drug Trends Infection Protection Medications

Medical Journal Receives Its Own Expression Of Concern From World Level Specialists

3 weeks, 3 days ago

1488  0
Posted on Sep 01, 2020, 1 p.m.

For those that may not be aware “expression of concern” is a term from medical journals to make it clear that there is good reason to believe that a paper it has published may be biased or based on erroneous data. While this statement is not always followed by retraction of the problematic article, it does amount to an admission of unscientific handling. 

Along with 3 of his colleagues from the University Hospital Institute IHU-Mediterranee Infection, Dr. Didier Raoult, who is a world-level specialist of infectious disease and proponent for the hydroxychloroquine-azithromycin treatment for COVID-19 posted an expression of concern on the IHU’s website regarding recent papers that were published in the distinguished medical journal called the New England Journal of Medicine. In their statement, the team is seeking to publicly underscore the unheard-of sloppiness of methods that are being used for possible treatments for this disease, for which the results are being not only inexplicably accepted but also published by one of the leading major scientific medical journals in the English language. 

The 4 authors titled their short paper “Quousque tandem abutere, patientia nostra,” offering the English translation of the Latin text: “How long will you abuse our patience?” They write: “We ask the same question to the NEJM: how long will you abuse our patience? The biases shown in the studies on COVID-19 have gone beyond, as in the Lancet, for example, everything that has been seen so far. Please give us back a journal that we can use for medical education, that does not contradict all principles we have used for so many years.

NEJM is not the only medical journal facing criticism, in June 2020 another distinguished journal, The Lancet, was forced to place an expression of concern regarding a study discrediting the well known and widely used drug hydroxychloroquine that was published several days prior. This statement admits that the paper had potentially used fraudulent data in order to make the treatment appear as being useless and accompanied by serious side effects. At that time Raoult and his associates retorted that they were using HCQ in combinations with a macrolide antibiotic, azithromycin, over 3,000 times while keeping patients under close observation, without ever observing any dangerous side-effect; in contradiction patients at the IHU did better than the rest of France to boast that lowest COVID-19 death rate in the country. 

Raoult and colleagues Lagier, Brouqui, and Parola are now accusing the NEJM of similar bias, but this prestigious medical journal is refusing to publish their expression of concern, which prompted the team to post a reprint version on the IHU website for the general public to view. It is worth mentioning that all of the authors are well-established professors of infectious diseases or microbiology, and they have highlighted their respect for the publication, that is up until now, the NEJM was referred to as a reference journal for a long time. 

The team writes: “However, it appears that for the teaching of infectious diseases, in the context of COVID-19, the NEJM no longer corresponds to the minimum standards that we teach students from the 3rd year of medicine onwards.

The team speaks of the bewildering evidence of acceptance of unscientific articles that have been published by the journal, and they quoted the fact that in some of the research patients are being qualified as being infected with the virus without the support of a positive diagnostic test, remarking that: 

“For COVID-19 therapeutic trials, several publications in the NEJM have reported analyses where patients were not tested but included in the analyses. We teach our students not to do that. In some cases, this reaches extraordinary levels. For example, about hydroxychloroquine as post-exposure prophylaxis, when 821 asymptomatic participants were enrolled through social media to receive hydroxychloroquine or placebo, the analysis was based on self-report of an illness that was “considered to be consistent with COVID” (13%), with less than 3% supported by PCR assays. In JAMA [Journal of the American Medical Association], other studies have been published in which the dosage and duration of the prescribed treatments are not indicated.”

Recording the side effects is another notable problem with studies on HCQ, which can, in theory, be serious, mild, life-threatening, or not bad enough to stop a treatment that could prevent death. The team suggests that the NEJM is publishing papers that are not differentiating among the degree of side effects, rather lumping them together in a way that makes a treatment appear to be largely harmless. Before all of this controversy, hydroxychloroquine was touted as being safe enough for even pregnant women to take, with studies not finding an increased chance for birth defects when it was used to treat rheumatic diseases. 

“We teach students to differentiate between side-effects that have direct consequences and require special care, such as kidney failure, and those that have no consequences or for which accountability is difficult to define, such as insomnia or constipation. We were surprised that in the very favorable study published on Remdesivir, the side-effects of insomnia, constipation, and renal failure were pooled,” they wrote.

Raoult has been questioning the efficiency of Remsesivir as a treatment for COVID-19 repeatedly, as he points out the dangers of it due to renal toxicity in various videos about the sanitary crisis that is published on the IHU website. 

The team say that they are stunned by another medical trial that has been quoted by the NEJM called the RECOVERY study which assessed the use of dexamethasone without prior or simultaneous use of antibacterial or antiviral therapies, saying that “Even basic textbooks,” show that “under these conditions, it could be seen unethical not giving corticosteroids in routine care in such circumstances and that such a trial should never have existed.”

Basically, to phrase it differently, according to the team the NEJM is condoning potentially dangerous treatments, and accusing the journal of promoting the expensive W.H.O recommended Remdesivir treatment over the cheap HCQ treatment, they write that some studies “looked more like a Marx Brothers movie than science.”

Abstract:

“Several of us in our institute, being professors of infectious diseases or microbiology, have for a long time referred to the NEJM as a reference journal. However, it appears that for the teaching of infectious diseases, in the context of covid-19, the NEJM no longer corresponds to the minimum standards that we teach students from the 3rd year of medicine onwards.

"We consider that an infected patient can only be definitely categorized as such with the support of a diagnostic test confirming infection. For covid-19 therapeutic trials, several publications in the NEJM have reported analyses where patients were not tested but included in the analyses. We teach our students not to do that. In some cases, this reaches extraordinary levels. For example, about hydroxychloroquine as post-exposure prophylaxis, when 821 asymptomatic participants were enrolled through social media to receive hydroxychloroquine or placebo, the analysis was based on self-report of an illness that was “considered to be consistent with COVID” (13%), with less than 3% supported by PCR assays. 1 In JAMA, other studies have been published in which the dosage and duration of the prescribed treatments are not indicated.2

Also, we teach students to differentiate between side effects that have direct consequences and require special care, such as kidney failure, and those that have no consequences or for which accountability is difficult to define, such asinsomnia or constipation. We were surprised that in the very favorable study published on Remdesivir, the side effects of insomnia, constipation and renal failure were pooled. 3 The result was that the side effects were considered insignificant whereas acute kidney injury tested alone shows the renal toxicity of Remdesivir. Finally, the report of the use of dexamethazone in the RECOVERY trial can only leave one stunned. 4 Indeed, in basic reference textbooks or reliable sources, it is easy to see that glucocorticoids are recommended in the treatment of respiratory distress or severe respiratory infections together and/or after antiviral or antibacterial therapies. Under these conditions, it could be seen unethical not giving corticosteroids in the routine care in such circumstances and that such a trial should never have existed.

All in all, it appears that publications promoting Remdesivir or suggesting hydroxychloroquine with or without azithromycin failure 5 seem to be particularly favored, to the point of publishing studies that looked more like a Marx Brothers movie than Science, as was dramatically seen for the so-called LancetGate. 6 Cicero, in the dangerous circumstances of the evolution of the Republic and after Catilina’s attempts to destabilize it, said to him “Quousque tandem abutere, patientia nostra?”. We ask ourselves the same question to the NEJM, How long will you abuse of our patience? The biases shown in the studies on the COVID-19 have gone beyond, as in the Lancet for that matter, everything that has been seen so far. Please give us back a journal that we can use for medical education that does not contradict all principles we have used for so many years.”

It would appear that the debate on hydroxychloroquine for COVID-19 is far from over, rather as more scientists and experts chime in, it is heating up. 

WorldHealth Videos

WorldHealth Sponsors