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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Swedish review board finds misconduct by Macchiarini, calls for six retractions – Retraction Watch (Alison McCook | October 2017)0

Posted by Admin in on November 1, 2017
 

An ethical review board in Sweden is asking journals to retract six papers co-authored by former star surgeon Paolo Macchiarini, after concluding that he and his co-authors committed misconduct.

One of the papers is the seminal 2011 article in The Lancet, which described the first case of a transplant using an artificial trachea seeded with the patient’s own stem cells, and now bears an expression of concern from The Lancet editors. Over time, multiple authors have asked to be removed from the paper.

The Expert Group on Scientific Misconduct at the Central Ethical Review Board has determined that concerns over that paper — and five others co-authored by Macchiarini, once based at the Karolinska Institutet (KI) — were justified. In a press release, it says:

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Also see
(29/09/2016) – Macchiarini scandal: overstepping the research ethics mark – Euroscientist
(01/09/2017) – Dr Con Man: the rise and fall of a celebrity scientist who fooled… – The Guardian

Released FDA docs reveal details of agency’s (failed) attempt to retract paper – Retraction Watch (Charles Seife | August 2017)0

Posted by Admin in on October 31, 2017
 

Earlier this year, a raging controversy regarding a new drug spilled into the pages of a leading medical journal: the head of the U.S. Food and Drug Administration and another official publicly called for the retraction or correction of a peer-reviewed article about the drug. They didn’t get their wish. Now, documents released by the FDA via alawsuit shed light on the attempt — and show how tricky it can be to correct the official record.

While a US case it highlights how hard it can sometimes be (even for the US FDA) to force a retraction.

The controversy surrounds the approval of eteplirsen, a drug approved last September to treat Duchenne Muscular Dystrophy, a rare but invariably fatal disease that strikes (mostly) young boys. Eteplirsen was approved over the objections of the FDA team that reviewed the drug, which determined that there was insufficient evidence to approve the drug.
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But the controversy didn’t end within the walls of the FDA complex. Ellis Unger, who led the review team, believed that one of the principal studies of the drug, published in the Annals of Neurology, was “misleading” because it was based on “unreliable data.” So in early November, Unger, joined by the then-head of the FDA, Robert Califf, took the extremely rare move of writing to the editor of the journal to “urge that the paper be corrected or retracted….”
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Investigation into motives behind science misconduct – University World News (Suvendrini Kakuchi | August 2017)0

Posted by Admin in on October 20, 2017
 

Experts often point to the link between embarrassing retractions and tough pressure on academics to produce result-oriented investigations, but recent scandals have raised concerns of a more widespread culture of pressuring subordinates and other issues that lead to misconduct.

A brief review of responses to major research misconduct cases in Japan

The University of Tokyo, the country’s most prestigious research institution, this month revealed the results of its year-long investigation into data falsification involving five papers supervised and published by the university’s Institute of Molecular and Cellular Biosciences between 2008 and 2015. The scandal rocked the country’s scientific community last year.

It showed that rather than being isolated cases, intentional enhancement of images was common in that lab. The supervisor, a renowned Japanese cell biologist, Professor Yoshinori Watanabe, was identified as being mainly responsible for putting pressure on the co-author, his subordinate.

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Evidence based medicine manifesto for better healthcare – The BMJ (Carl Heneghan et al | June 2017)0

Posted by Admin in on October 11, 2017
 

A response to systematic bias, wastage, error, and fraud in research underpinning patient care

Another item bemoaning the impact of poor research on clinical practice but it also points to an initiative to address this.

Informed decision making requires clinicians and patients to identify and integrate relevant evidence. But with the questionable integrity of much of today’s evidence, the lack of research answering questions that matter to patients, and the lack of evidence to inform shared decision how are they expected to do this?
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Too many research studies are poorly designed or executed. Too much of the resulting research evidence is withheld or disseminated piecemeal.1 As the volume of clinical research activity has grown2 the quality of evidence has often worsened,3 which has compromised the ability of all health professionals to provide affordable, effective, high value care for patients.”
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