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Possible Media Journals Biasness on COVID-19 Clinical Trials

Possible Biase exhibited on covid clinical trials

Some media houses seem biased on the pandemic issue. Learn about how two giant media houses reported “uncertain” information from the articles posted and had to apologize for it.

The Lancet made a massive announcement that it is withdrawing a high-profile study. The research had it that hydroxychloroquine could bring more harm than good to COVID-19 patients. Just a few hours later and another media house – New England Journal of Medicine – also announces retraction of an article by some authors on the same grounds.

The article by the New England Journal of Medicine discussed COVID-19 and heart disease issues. Lancet’s published article, “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” found its way to the online space on May 22. The other article by NEJM, “Cardiovascular Disease Drug Therapy, and Mortality in COVID-19,” was published on May 1.

The Lancet article authors Frank Ruschitzka, MD, Mandeep R. Mehra, MD and Amit N. Patel, MD, said that the retraction was a result of concerns raised on the authenticity of the information relayed. Raised concerns also included how Sapan Desai, MD, the study’s coauthor and the Chicago-based Surgisphere Corp carried out the analysis.

According to sources, data reported on the media outlet, The Lancet, showed an association between chloroquine and hydroxychloroquine. This was either with or without antibiotics, such as clarithromycin and azithromycin. The data also captured a dramatic surge in in-hospital mortality. The study indicated a rise in heart complications such as heart arrhythmias for COVID-19 patients that were treated using these agents vs those that were not.

Expression of Concern

The editors at The Lancet, therefore, released an “Expression of Concern” following the release of that report. It stated that vital scientific questions had been asked. An open letter followed the expression of concern, and it was formulated by over 200 ethicists, scientists and clinicians. 

The letter was posted on the 28th May questioning the clarity of the data and general ethics of the entire study, as Medscape Medical News reported.

The NEJM also published an “Expression of Concern” on June 2, claiming that there were “substantive concerns” on the quality of the information posted on May 1. As captured above, the article discussed cardiovascular disease and mortality in COVID-19 patients stating that there was no rise in the in-hospital mortality. That was even after the angiotensin receptor blockers and ACE inhibitors were in the COVID-19 setting. 

That statement was released in response to the open letter published on June 2 by New England Journal of Medicine, bearing 174 signatures.

James Watson, DPhil, who is a statistician, spearheaded the open letter signatures for both releases – May 28 and June 2.

The Lancet authors, however, tasked a third party to review the Surgisphere and examine the integrity of elements used for trials as well as replicating the article’s analyses.

According to the Lancet authors, “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.”

The reviewers were thus not able to accomplish the review, and they passed the message across to the authors that they were withdrawing from the review process. The issue released by The Lancet claimed that matters to do with scientific integrity are taken very cautiously and conscientiously. It said that institutional reviews were urgently needed on the research collaborations from the questions raised about the study by Surgisphere,

“We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted.

We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.”

Similarly, the authors also requested the pulling down of the NEJM article. “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, ‘Cardiovascular Disease, Drug Therapy, and Mortality in COVID-19.’ 

We, therefore, request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.”

Some media houses seem biased on the pandemic issue. Learn about how two giant media houses reported “uncertain” information from the articles posted and had to apologize for it.

Harsh Implications

Mehra et al. reported in The Lancet that the World Health Organization had stopped the infusion of hydroxychloroquine in the SOLIDARITY trial. SOLIDARITY trial is a randomized trial of treatments to curb COVID-19. 

However, according to the data on The Lancet, a committee monitoring safety issues on the matter examined the mortality rates on the RECOVERY trial and the SOLIDARITY trial – the RECOVERY trial is a study based in the United Kingdom, also looking at hydroxychloroquine. The committee recommended that there was no need to tweak the trial protocol. 

The chief scientist at WHO Soumya Swaminathan, MD, MBBS, said that an “urgent priority for all of us to do the needed studies, do the randomized controlled trials, to get that evidence as quickly as possible,” since there were several limitations and biases in the observational studies. 

The Executive Group, therefore, decided to endorse the continuation of the SOLIDARITY trial that is including hydroxychloroquine. That was following the recommendation by the committee.

Potential Treatments for COVID-19

A wide array of treatments has been suggested for trials in trying to treat COVID-19. However, no one is sure whether these treatments will prove to be more effective than the usual care given at the hospitals to curb the pandemic. The RECOVERY trial is looking to test some of the suggested medicaments like:

· Lopinavir-Ritonavir (used on HIV patients)

· Hydroxychloroquine

· Low-dose Dexamethasone (a steroid used in curbing inflammation)

· Tocilizumab (anti-inflammatory cure administered via injection)

· Azithromycin (an antibiotic)

· Convalescent plasma (it is plasma gathered from people who recovered from the virus, and it contains antibodies that fight SARS-COV-2 virus)

Paul Singh, MHA, BA

Covid Antibody Diagnostics​™

A Natures Body Wellness Corporation, Lake Mary FL 32746 

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