In March 2016, researchers in Switzerland and Canada published a meta-analysis in The Lancet, exploring the optimal painkiller and dose for treating pain in knee and hip osteoarthritis. Soon after, the authors were informed of an error that would change “all numbers” in a paper that may influence clinical practice.
The latest news is only one step in a long-running saga about former star surgeon Macchiarini, who was dismissed from KI last year. To read more, check out our timeline.
KI announced it was asking the journal to pull the paper late last year, after concluding that four authors — including Macchiarini — were guilty of scientific misconduct. The paper had already been flagged by the journal with an expression of concern, noting the data presented in the paper may not be “fully representative” of the experiments.
Today, the journal issued a retraction notice, saying the authors wanted to retract the paper. All of the authors who could be reached have agreed to the retraction, including Macchiarini.
A tribunal in the UK has rejected an appeal by Queen Mary University of London, who sought to reverse a previous order that they release data from a controversial 2011 paper in The Lancet about chronic fatigue syndrome (CFS).
The decision is one in a long series of judgments about the so-called PACE trial, which reported that two treatments — known as cognitive behavioral therapy and graded exercise therapy — helped alleviate the symptoms of the condition. But ever since The Lancet article and follow-up papers have been published, patients and critics have questioned the conclusions and clamored to see the raw data.
The main criticisms: The findings may prompt some to believe chronic fatigue is a mental, not a physical, disorder, and the PACE program could actually be harmful to patients by encouraging too much exercise. These criticisms were recently bolstered by a re-analysis of the evidence by the Agency for Healthcare Research and Quality, which downgraded its original conclusions about the effectiveness of cognitive behavioral therapy and graded exercise therapy.
Surgeon Paolo Macchiarini did not apply for the necessary ethics approval to perform the pioneering transplants he’s known for, according to the Swedish Research Council.
Chief Legal Counsel Anna Hörnlund, who wrote a letter in this week’s The Lancet, says Macchiarini’s work needed to obtain ethical approval from one of six regional ethical review boards, as required by Swedish law — and neither Macchiarini nor his former employer, Karolinska Institutet, did so:
Since we reported Friday that multiple authors had asked to remove their names from a high-profile 2011 Lancet paper about a risky transplant surgery, a few readers have wondered: Should this be allowed?
To recap: The same day the journal announced it was tagging the controversial paper with an expression of concern, it issued a new erratum about the paper, removing three author names (one had already asked to be removed earlier). The highly cited paper has been under scrutiny ever since the last author, Paolo Macchiarini, has been facing allegations of misconduct, which most recently led to Macchiarini’s dismissal from the Karolinska Institutet. (Here’s our timeline of events to keep you abreast.)
The Lancet has tagged an expression of concern onto a seminal 2011 paper by Paolo Macchiarini, the Italian surgeon whose work and conduct outside the operating room has earned months of heavy criticism that recently culminated in his dismissal from the Karolinska Institutet.
Ben Goldacre has been a busy man. In the last six weeks, the author and medical doctor’s Compare Project has evaluated 67 clinical trials published in the top five medical journals, looking for any “switched outcomes,” meaning the authors didn’t report something they said they would, or included additional outcomes in the published paper, with no explanation for the change. The vast majority – 58 – included such discrepancies. Goldacre talked to us about how journals – New England Journal of Medicine (NEJM), JAMA, The Lancet, BMJ, and Annals of Internal Medicine — have responded to this feedback.
A new project does the relatively straightforward task of comparing reported outcomes from clinical trials to what the researchers said they planned to measure before the trial began. And what they’ve found is a bit sad, albeit not entirely surprising.
As part of The Compare Project, author and medical doctor Ben Goldacre and his team have so far evaluated 36 clinical trials published by the top five medical journals (New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, Annals of Internal Medicine, and British Medical Journal). Many of those trials included “switched outcomes,” meaning the authors didn’t report something they said they would, or included additional outcomes in the published paper, with no explanation for the change.
Here are the latest results from the project, according to its website: