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Most authors of clinical trials published in JAMA and NEJM in 2017 failed to disclose industry payments

Authors of papers published in JAMA and NEJMreceived millions in undisclosed payments in 2017, an analysis finds.

By Natalia Mesa – THE SCIENTIST – January 24, 2022

A new analysis finds that 81 percent of authors whose work appeared in [two of the world’s most prestigious medical journals–SB] the Journal of American Medical Association and the New England Journal of Medicine in 2017 failed to disclose conflicts of interest in the form of industry payments.

The analysis reviewed 31 clinical trial reports from each of the two journals that were published in 2017 and identified 118 authors who, in total, received $7.48 million dollars in industry payments. The payment information came from Open Payments, a US government website where drug and device makers must report payments to physicians and health care providers. The analysis was posted as a preprint on medRxiv on January 1 and has not yet been peer-reviewed.

Of the 118 authors on the included papers, only a dozen did not receive any payments, according to the preprint. Of the 106 researchers who received payments, the payments ranged from as little as $6.36 to as much as $1.49 million. Researchers received payments for travel, food, speaking, and consulting services, among other things, STAT News reports. The 23 researchers that received the largest payments received a total of $6.32 million, of which $3 million was undisclosed.

The International Committee of Medical Journal Editors (ICMJE) recommends that researchers disclose payments they received in the three years prior to submitting a study for publication, so the analysis included all payments made to researchers between 2014 and 2017.

When publishing in ICMJE member journals, which includes JAMA and NEJM, researchers are required to follow the disclosure guidelines promoted by the ICMJE—which include disclosing payments. But this expectation was not met by many of the authors of the papers included in the analysis. According to STAT, the authors of the preprint say that their results suggest voluntary disclosure may not be adequate for avoiding financial conflicts or ensuring transparency.

“I’m not surprised, but really, I’m saddened and disappointed,” says Brian Piper, a neuroscientist and medical ethicist at the Geisinger Commonwealth School of Medicine, and one of the authors of the preprint, to STAT. “These are high-impact and highly influential journals. For many Americans, these are the centerpieces of evidence-based medicine. Many physicians subscribe to them. Many journalists turn to them for information.”

An NEJM statement to STAT says that the journal “follows the disclosure rules set by the ICMJE. The editors do review all of the more than 5,000 disclosure forms received each year but do not have access to primary records on which the information entered in the forms may be based. We expect the disclosure forms submitted by authors to be accurate and complete.”

JAMA has not yet responded to a request for comment on the preprint, STAT reports. 

According to STAT, Piper notes that disclosures that continue to rely on individuals may be a failed approach. Instead, he suggests that journals review Open Payments and provide a link showing payments made to authors.

January 28, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , | 1 Comment

“Deadly” Hydroxychloroquine (HCQ) to treat Covid 19: How the World’s Top Medical Journals, The Lancet and NEJM, Were Cynically Exploited by Big Pharma

By Elizabeth Woodworth | Global Research | June 14, 2020

Abstract and Background

A publishing scandal recently erupted around the use of the anti-malarial drug hydroxychloroquine (HCQ) to treat Covid 19. It is also known as quinine and chloroquine, and is on the WHO list of essential medicines.[i]

The bark of the South American quina-quina tree has been used to treat malaria for 400 years.[ii] Quinine, a generic drug costing pennies a dose, is available for purchase online. In rare cases it can cause dizziness and irregular heartbeat.[iii]

In late May, 2020, The Lancet published a four-author study claiming that HCQ used in hospitals to treat Covid-19 had been shown conclusively to be a hazard for heart death. The data allegedly covered 96,000 patients in 671 hospitals on six continents.[iv]

After the article had spent 13 days in the headlines, dogged by scientific objections, three of the authors retracted it on June 5.[v]

Meanwhile, during an expert closed-door meeting leaked May 24 in France, The Lancet and NEJM editors explained how financially powerful pharmaceutical players were “criminally” corrupting medical science to advance their interests.

*

On May 22, 2020, the time-honoured Lancet [vi]– one of the world’s two top medical journals – published the stunning claim that 671 hospitals on six continents were reporting life-threatening heart rhythms in patients taking hydroxychloroquine (HCQ) for Covid-19.

The headlines that followed were breath-taking.

Although wider access to the drug had recently been urged in a petition signed by nearly 500,000 French doctors and citizens,[vii] WHO and other agencies responded to the article by immediately suspending the clinical trials that may have cleared it for use.

North American headlines did not mention that HCQ has been on the WHO list of essential drugs since the list began in 1977. Nor did they mention an investigative report on the bad press that hydroxychloroquine had been getting prior to May 22, and how financial interests had been intersecting with medicine to favour Gilead’s new, more expensive drug, Remdesivir.[viii]

The statistics behind the headlines

As a Canadian health sciences librarian who delivered statistics to a large public health agency for 25 years, I sensed almost immediately that the article had to be flawed.

Why? Because health statistics are developed for different purposes and in different contexts, causing them to exist in isolated data “stovepipes.”[ix] Many health databases, even within a single region or country, are not standardized and are thus virtually useless for comparative research.

How, I wondered, could 671 hospitals worldwide, including Asia and Africa, report comparable treatment outcomes for 96,000 Covid patients? And so quickly?

The Lancet is strong in public health and surely suspected this. Its award-winning editor-in-chief, Dr. Richard Horton, has been in his job since 1995.[x]

So how could the damning HCQ claims have been accepted?  Here is what I discovered.

The honour system in medical publishing

To some extent, authors submitting articles to medical journals are on the honour system, in which cited databases are trusted by the editors, yet are available for inspection if questioned.[xi]

On May 28, an open letter from 200 scientists to the authors and The Lancet requested details of the data and an independent audit. The letter was “signed by clinicians, medical researchers, statisticians, and ethicists from across the world.”[xii]

The authors declined to supply the data, or even the hospital names. Meanwhile, investigative analysis was showing the statistics to be deeply flawed.[xiii][xiv]

If this were not enough, the lead author was found to be in a conflict of interest with HCQ’s rival drug, Remdesivir:

“Dr. Mandeep Mehra, the lead co-author is a director at Brigham & Women’s Hospital, which is credited with funding the study. Dr. Mehra and The Lancet failed to disclose that Brigham Hospital has a partnership with Gilead and is currently conducting two trials testing Remdesivir, the prime competitor of hydroxychloroquine for the treatment of COVID-19, the focus of the study.”[xv]

In view of the foregoing, the article was retracted by three of its authors on June 5.

How did this fraud get past The Lancet reviewers in the first place?

The answer emerges from what has remained an obscure French interview, although it has been quoted in the alternative media.[xvi]

On May 24, a closed-door Chatham House expert meeting about Covid included the editors-in-chief of The Lancet and the NEJM. Comments regarding the article were leaked to the French press by a well-known health figure, Dr. Philippe Douste-Blazy,[xvii] who felt compelled to blow the whistle.

His resulting BFM TV interview was posted to YouTube with English subtitles on May 31,[xviii] but it was not picked up by the English-speaking media.

These were The Lancet editor Dr. Richard Horton’s words, as reported by Dr. Douste-Blazy:

“If this continues, we are not going to be able to publish any more clinical research data because pharmaceutical companies are so financially powerful today, and are able to use such methodologies as to have us accept papers which are apparently methodologically perfect, but which, in reality, manage to conclude what they want to conclude.” [xix]

Doust-Blazy made his own comments on Horton’s words:

“I never thought the boss of The Lancet could say that. And the boss of the New England Journal of Medicine too. He even said it was ‘criminal’. The word was used by them.”[xx]

The final words in Doust-Blazy’s interview were:

“When there is an outbreak like Covid, in reality, there are people like us – doctors – who see mortality and suffering. And there are people who see dollars. That’s it.”[xxi]

The scientific process of building a trustworthy knowledge base is one of the foundations of our civilization. Violating this process is a crime against both truth and humanity.

Evidently the North American media does not consider this extraordinary crime to be worth reporting.

Notes

[i] World Health Organization. “World Health Organization Model List of Essential Medicines, 21st ed.”, WHO, 2019, pp. 24, 25, 53 (https://www.who.int/medicines/publications/essentialmedicines/en/).

[ii] Jane Achan, et al., “Quinine, an old anti-malarial drug in a modern world: role in the treatment of malaria,” Malaria Journal,  24 May 2011 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121651/).

[iii] WebMD, “Quinine Sulfate” (https://www.webmd.com/drugs/2/drug-869/quinine-oral/details).

[iv] The Lancet, “RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, by Mandeep R. Mehra et al,” Lancet, 5 June 2010 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext).

[v] Ibid.

[vi] Famous weekly British medical journal, founded in 1823.

[vii] Lee Mclaughlan, “Covid-19 France: petition for wider chloroquine access,” 6 April 2020 (https://www.connexionfrance.com/French-news/Time-wasted-over-use-of-choroquine-coronavirus-drug-says-petition-by-former-French-health-minister).

[viii] Sharyl Attkisson, “Hydroxychloroquine,” Full Measure, 18 May 2020 (https://www.youtube.com/watch?v=zB-_SV-y11Y). Attkisson is a five-time Emmy Award winner (https://en.wikipedia.org/wiki/Sharyl_Attkisson).

[ix] See “Stovepiping,” (https://en.wikipedia.org/wiki/Stovepiping) (accessed June 12, 2020).

[x] Dr. Horton’s career, professionalism, and awards are shown at https://en.wikipedia.org/wiki/Richard_Horton_(editor)(accessed June 12, 2020).

[xi] The Lancet and NEJM editors could not be expected to comb through data from 671 hospitals to verify their accuracy – especially when submitted by four doctors.

[xii] The full-text letter and signatories appear  at https://zenodo.org/record/3862789#.XuQiNmYTGhM

[xiii] Melissa Davey, “Questions raised over hydroxychloroquine study which caused WHO to halt trials for Covid-19,” The Guardian, 28 May 2020 (https://www.theguardian.com/science/2020/may/28/questions-raised-over-hydroxychloroquine-study-which-caused-who-to-halt-trials-for-covid-19).

[xiv] Melissa Davey et al, “Surgisphere: governments and WHO changed Covid-19 policy based on suspect data from tiny US company,” The Guardian, 3 June 2020 (https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine).

[xv] 1. Alliance for Human Research Protection, “The Lancet Published a Fraudulent Covid-19 Study,” 2 June 2020 (https://ahrp.org/the-lancet-published-a-fraudulent-study-editor-calls-it-department-of-error/).

  1. Brigham Health, “Two Remdesivir Clinical Trials Underway at Brigham and Women’s Hospital,” 30 March 2020 (https://www.brighamhealthonamission.org/2020/03/26/two-remdesivir-clinical-trials-underway-at-brigham-and-womens-hospital/).

[xvi] Vera Sharav, “Editors of The Lancetand the New England Journal of Medicine: Pharmaceutical Companies are so Financially Powerful They Pressure us to Accept Papers,” Health Impact News, 5 June 2020

(https://healthimpactnews.com/2020/editors-of-the-lancet-and-the-new-england-journal-of-medicine-pharmaceutical-companies-are-so-financially-powerful-they-pressure-us-to-accept-papers/).

[xvii] Dr. Philippe Douste-Blazy, MD, is a cardiologist, former French Health Minister; 2017 candidate for Director at WHO; and former Under-Secretary-General of the United Nations.  See also: https://en.wikipedia.org/wiki/Philippe_Douste-Blazy.

[xviii] “(Eng Subs) Hydroxychloroquine Lancet Study: Former France Health Minister blows the whistle,” BFM TV, 31 May 2020 (https://www.youtube.com/watch?time_continue=2&v=ZYgiCALEdpE&feature=emb_logo).

[xix] Ibid.

[xx] Ibid.

[xxi] Ibid.

Copyright © Elizabeth Woodworth, Global Research, 2020

June 23, 2020 Posted by | Corruption, Deception, Science and Pseudo-Science | , , | 1 Comment