Lancet retracts and replaces news story about controversial abortion drug

The Lancet has retracted a journalist-written piece about a controversial drug used off-label to induce abortions, and replaced it with a corrected version.

In the retraction notice, the journal said it “removed the information that we believe to be inaccurate.”

The article, first published Oct. 28, 2017, highlights Pfizer’s decision to withdraw the drug, misoprostol, from the French market in 2018, and explores the ongoing debate surrounding its uses and safety. Approved to treat ulcers, misoprostol is more often used off-label to induce labor or medical abortions, despite reports of serious side effects, including hemorrhaging and birth defects “sometimes associated with fetal death.” Continue reading Lancet retracts and replaces news story about controversial abortion drug

Lancet retracts (and replaces) paper a year after authors report error that changes “all numbers”

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 authors contacted The Lancet immediately, in July 2016, to inform them of the issue. Sven Trelle, the paper’s corresponding author, also told us: Continue reading Lancet retracts (and replaces) paper a year after authors report error that changes “all numbers”

Macchiarini blames Karolinska for losing data as he retracts 2014 paper

Ask and ye shall receive: A journal has retracted a 2014 paper by Paolo Macchiarini, upon request from the Karolinska Institutet (KI).

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.

Here’s more from the notice:

Continue reading Macchiarini blames Karolinska for losing data as he retracts 2014 paper

UK tribunal orders release of data from controversial chronic fatigue syndrome study

court caseA 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.

In March 2014,  Continue reading UK tribunal orders release of data from controversial chronic fatigue syndrome study

Macchiarini did not obtain necessary ethics approvals, says Swedish Research Council

lancetSurgeon 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:

Continue reading Macchiarini did not obtain necessary ethics approvals, says Swedish Research Council

Poll: Should co-authors of a scientific paper be allowed to change their minds?

lancetSince 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.)

It’s not surprising that a few of Macchiarini’s co-authors would want to distance themselves from this ever-expanding scandal, but should authors who originally signed onto a paper be able to change their minds? Let us know in our poll, below. Continue reading Poll: Should co-authors of a scientific paper be allowed to change their minds?

Lancet issues expression of concern for 2011 Macchiarini paper

Paolo Macchiarini
Paolo Macchiarini

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.

Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study,” which described the first case of a transplant using an artificial trachea seeded with the patient’s own stem cells, now bears an expression of concern from The Lancet editors, citing ongoing investigations. The journal has also removed three more authors from the paper, upon their request.

The expression of concern essentially presents the timeline of the controversy that led the journal to make this move:

Continue reading Lancet issues expression of concern for 2011 Macchiarini paper

Top journals give mixed response to learning published trials didn’t proceed as planned

Ben Goldacre
Ben Goldacre

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.

Retraction Watch: When you discover a published trial has switched outcomes, what do you do? Continue reading Top journals give mixed response to learning published trials didn’t proceed as planned

Lancet retracts 24-year-old paper by “father of nutritional immunology” after reopening inquiry

lancetFollowing questions from outside experts, a retraction of a related paper, a university investigation and a court case, The Lancet has decided to retract a 1992 paper by Ranjit Kumar Chandra, the self-proclaimed “father of nutritional immunology.

In a lengthy retraction note included in the January 30 issue, the journal explains that:

the balance of probabilities in our judgment is that the reliability of the 1992 Lancet paper by Chandra can no longer be assured.

Chandra is objecting to the retraction.

This retraction was a long time coming, so sit back and relax as we fill in the backstory. Continue reading Lancet retracts 24-year-old paper by “father of nutritional immunology” after reopening inquiry

Did a clinical trial proceed as planned? New project finds out

Ben Goldacre
Ben Goldacre

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:

Continue reading Did a clinical trial proceed as planned? New project finds out