NEJM corrects 3 papers after prominent cancer scientist left off credit for breakthrough

Screen Shot 2016-03-15 at 12.04.43 PMThe New England Journal of Medicine has corrected three highly cited papers to credit researchers who played a role in the work.

The papers describe a treatment in which engineered T cells fight leukemia, originally hailed as a “major advance” in the New York Times. Since the first paper appeared in 2011, co-author Carl June at the University of Pennsylvania has received more than $7 million in grants from the National Institutes of Health, according to MIT Technology Review. But according to a newly published correction, the three NEJM papers failed to note in the acknowledgement section that an important component of the experiments was supplied by researchers at St. Jude Children’s Research Hospital.

The correction, made 11 months after a request from co-author and Penn researcher David Porter, explains the contribution of the St Jude’s researchers:

Continue reading NEJM corrects 3 papers after prominent cancer scientist left off credit for breakthrough

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

Should there be “data authors?” Q&A with NEJM editor Jeffrey Drazen

Jeffrey Drazen ©2011 Jon Chomitz Photography 3 Prescott street, Somerville, MA 02143 www.chomitz.com jon@chomitz.com 617.625.6789
Jeffrey Drazen ©2011 Jon Chomitz Photography

Would designating a set of authors as responsible for data production – separate from those who conduct the analysis – help boost the reliability of papers? That’s a question raised by the editor of the New England Journal of Medicine, Jeffrey Drazen. Along with many other editors of top medical journals, Drazen recently signed a proposal by the International Committee of Medical Journal Editors to require authors of clinical trials to share anonymous patient data within six months of publication. He talked to us about another way to make trials more robust: Create “data authors.”

Retraction Watch: What has been the reaction so far to ICMJE’s data sharing proposal? Continue reading Should there be “data authors?” Q&A with NEJM editor Jeffrey Drazen

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

NEJM pulls letter by heart researcher who faked patient records

Screen Shot 2015-11-30 at 10.08.23 AMA heart researcher who fabricated patient records has notched retraction number six — this time, for a letter in the New England Journal of Medicine. She has two more retractions forthcoming.

The retraction comes at the request of Anna Ahimastos’s co-authors, following an investigation into her work by her former workplace, the Baker IDI Heart and Diabetes Institute. The investigation was not able to verify the data referenced in the letter, which includes a citation for a recently retracted JAMA paper.

The retraction note is similar to others for Ahimastos’s papers:

Continue reading NEJM pulls letter by heart researcher who faked patient records

Here’s how to keep clinical trial participants honest (and why that’s a big deal)

NEJMAdditional lab tests, creating a clinical trial patient registry, and rewards for honesty are among the advice doled out in this week’s issue of the New England Journal of Medicine for researchers to help avoid the major issue of participants lying to get into clinical trials.

In the Perspective, David B. Resnik and David J. McCann, both based at the National Institutes of Health, address concerns raised by a 2013 survey of clinical trial participants that revealed “high rates” of “deceptive behavior.” Specifically: Continue reading Here’s how to keep clinical trial participants honest (and why that’s a big deal)

Researchers call for retraction of NEJM paper showing dangers of e-cigarettes

NEJMResearchers and advocates are calling for the retraction of a 2015 letter in the New England Journal of Medicine that suggested that e-cigarettes are as harmful – if not more than – traditional cigarettes.

The NEJM paper reported that e-cigarettes expose smokers to significant amounts of formaldehyde, which the authors calculated could raise lifetime cancer risk by 5-15 fold compared to the risk for regular smokers. Critics, however, have claimed that to obtain such high levels of formaldehyde, the NEJM authors superheated the vapor from the e-cigs to levels that would create a well-known, acrid puff called a “dry puff.” This sensation, they say, is so terrible that no self-respecting “vaper” would consider repeating it. In other words, allege the e-cigarette supporters, the conditions described in the Letter—which was widely reported—were not relevant to human health.

This week, Addiction published a letter from critics of the NEJM paper, along with extensive supplementary materials, a reply from some of the NEJM Letter authors, and a response letter from the critics.

In their first Addiction letter, “Research letter on e-cigarettes was so misleading it should be retracted,” authors Clive Bates and cardiologist Konstantinos Farsalinos write: Continue reading Researchers call for retraction of NEJM paper showing dangers of e-cigarettes

Critics of Poldermans’ work baffled by NEJM stance on DECREASE papers

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Don Poldermans

A pair of researchers who have been calling for the retraction of two papers by cardiology researcher Don Poldermans say the New England Journal of Medicine is  “not justified” “disappointing” in its refusal to pull the articles.

A little background: Poldermans resigned from Erasmus University in 2011 after having been accused of misconduct. Last week, we reported that the European Heart Journal had issued an expression of concern for a 2001 article on which he was first author.

The New England Journal of Medicine added editor’s notes to two of Poldermans’ articles. But as Larry Husten at Forbes reports, the journal has no intention of retracting the papers: Continue reading Critics of Poldermans’ work baffled by NEJM stance on DECREASE papers

NEJM paper on sleep apnea retracted when original data can’t be found

nejmThe authors of a paper in the New England Journal of Medicine are retracting it, after being unable to find data supporting a table that required corrections.

Here’s the notice: Continue reading NEJM paper on sleep apnea retracted when original data can’t be found

So how often does medical consensus turn out to be wrong?

In a quote that has become part of medical school orientations everywhere, David Sackett, often referred to as the “father of evidence-based medicine,” once famously said:

Half of what you’ll learn in medical school will be shown to be either dead wrong or out of date within five years of your graduation; the trouble is that nobody can tell you which half–so the most important thing to learn is how to learn on your own.

Sackett, we are fairly sure, was making an intentionally wild estimate when he said “half.” [See note about these strikethroughs at bottom of post.]  But aA fascinating study out today in the Archives of Internal Medicine gives a clue as to the real figuresuggests that he may have been closer than any of us imagined. Continue reading So how often does medical consensus turn out to be wrong?