Category: disputed data

Released FDA docs reveal details of agency’s (failed) attempt to retract paper

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 a lawsuit shed light on the attempt — and show how tricky it can be to correct the official record.

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.

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….”

According to the documents, the authors of the Annals article did, in fact, agree to correct the article.

On November 9, 2016, Clifford Saper, Annals‘ editor in chief, wrote to Califf and Unger:

Continue reading Released FDA docs reveal details of agency’s (failed) attempt to retract paper

Controversial CRISPR paper earns second editorial note

Against the authors’ objections, Nature Methods has added an expression of concern to a 2017 paper that drew fire for suggesting a common gene editing technique could cause widespread collateral damage to the genome. The latest note — the second to be added in two months — alerts readers to an alternative interpretation of the findings.

When “Unexpected mutations after CRISPR–Cas9 editing in vivo” was published May 30, it immediately drew criticism from many of the top scientists working with CRISPR, including those associated with companies seeking to develop CRISPR-based therapies for humans. Share prices for the two largest companies pursuing CRISPR therapies, Editas Medicine and Intellia Therapeutics, dropped following publication of the article.

On June 14, the journal published a notice to alert readers to “technical criticisms” of the paper. Apparently, that wasn’t sufficient, because the journal is now providing more details on the nature of the criticisms, despite the objections of the paper’s authors:

Continue reading Controversial CRISPR paper earns second editorial note

Are there foxes in Tasmania? Follow the poop

Stephen Sarre, based at the University of Canberra in Australia, has made a career out of collecting and analyzing poop.

It’s a tough job, but someone’s got to do it. Part of his work is designed to answer a multi-million dollar question: Is Tasmania home to foxes, a pest that carries rabies and other diseases and can ravage local wildlife? According to the Australian news outlet ABC, the Tasmanian and Australian governments have spent $50 million (AUD) on hunting foxes on the island since 2001 — even though many have debated whether they are even there.

In 2012, after analyzing thousands of fecal samples, Sarre published a paper in the Journal of Applied Ecology which boldly claimed that “Foxes are now widespread in Tasmania.” But many outside researchers didn’t buy it, and quickly voiced their criticisms of the paper, namely that there may be problems with false positives and the methodology used to analyze the samples. Recently, the journal issued an expression of concern for the paper, citing an ongoing investigation into the allegations.

Here’s the expression of concern (paywalled, tsk tsk):

Continue reading Are there foxes in Tasmania? Follow the poop

Journal alerts readers to “technical criticism” of CRISPR study

A Nature journal has posted a editor’s note to a recent letter on potential unintended consequences of CRISPR gene editing, after an executive at a company trying to commercialize the technology said the paper should be retracted.

The original article, published on May 30 as a correspondence in Nature Methods, suggested that using CRISPR in mice can lead to unexpected mutations. But last week, the journal added an “Editorial note” online. Nature Methods says the notice is not an expression of concern, which would be a stronger suggestion that the paper is problematic; it simply wants to alert readers to the fact that, as the note states:

Continue reading Journal alerts readers to “technical criticism” of CRISPR study

Despite author’s protest, journal removes paper on emergency department prices

A journal has temporarily removed a paper showing the dramatic differences in the cost of providing emergency care that caught national attention (and some criticism from emergency care providers), despite the first author’s claims that the results are valid.

The paper, published online in February by the Annals of Emergency Medicine, showed that it can cost significantly more for patients to be treated at emergency departments than at urgent care centers, even for the same conditions. Soon after the paper was published, first author Vivian Ho at Rice University was told by the American College of Emergency Physicians, which publishes the journal, that there were some errors in the appendix, and they wanted to reanalyze the entire paper.

Ho told us:

Continue reading Despite author’s protest, journal removes paper on emergency department prices

Updated: Science fish-microplastics paper retracted

Despite continuing to vigorously defend their work, the authors of a controversial paper about the effects of human pollution asked Science to retract the paper last week.

According to a release from Uppsala University issued today, authors Peter Eklöv and Oona Lönnstedt submitted their request to Science last week, noting they wanted to withdraw the paper “as long as a suspicion of misconduct remains.”

The release — which echoes a statement that was also provided to Nature — notes:

Continue reading Updated: Science fish-microplastics paper retracted

A diabetes researcher sued his former employer for defamation. Here’s the story.

Franck Mauvais-Jarvis

The last decade hasn’t exactly been drama-free for Franck Mauvais-Jarvis, head of the Diabetes Research Program at Tulane University.

After being accused of falsifying three figures in a submitted manuscript, Mauvais-Jarvis sued his accusers and officials at his former employer — Northwestern University — for defamation and conspiracy in 2011.

In 2014, a judge dismissed the suit. We wish we could tell you more details about it—such as what the university’s misconduct investigation found, or how the lawsuit was concluded—but they remain shrouded in mystery. What we know is based on court records from the lawsuit, which we recently obtained through an unrelated public records request. Even without all the details, it’s a long, sordid tale, involving a lot of finger-pointing and allegations of misconduct.

In 2008, a former research technician in the lab of Mauvais-Jarvis, then an associate professor of medicine at Northwestern University, raised concerns of fabrication in two figures in a paper on the regulation of insulin synthesis that had been submitted the Journal of Biological Chemistry. An inquiry committee at the university unanimously concluded that research misconduct charges against Mauvais-Jarvis were not credible.

But then a third figure in the manuscript was found to be “inaccurate,” and the university initiated a second inquiry. That’s when Mauvais-Jarvis — whose papers have been cited more than 2,000 times, according to Clarivate Analytics’ Web of Science, formerly part of Thomson Reuters — initiated a lawsuit. Continue reading A diabetes researcher sued his former employer for defamation. Here’s the story.

Group whose findings support video game-violence link loses another paper

Last July, Joseph Hilgard, a postdoctoral fellow at the Annenberg Public Policy Center at the University of Pennsylvania, saw an article in Gifted Child Quarterly that made him do a double take. Hilgard, who is studying the effects of violent media on aggressive behavior, said the results of the 2016 paper “caused me some alarm.”

The research—led by corresponding author Brad J. Bushman, a professor of communication and psychology at The Ohio State University (OSU)—showed that gifted and non-gifted children’s verbal skills dropped substantially after watching 12 minutes of a violent cartoon. The violent program had a greater impact on the gifted children, temporarily eliminating the pre-video verbal edge they displayed over their non-gifted peers.

To Hilgard, the results suggested that violent media can actually impair learning and performance. But the effect size was huge — so big, Hilgard thought it had to be a mistake. This, plus other questions, prompted Hilgard to contact the authors and the journal. Unfortunately, once he got a look at the data — collected by a co-author in Turkey who became unreachable after the recent coup attempt — the questions didn’t go away. So the journal decided to retract the paper.

Bushman’s body of work has continually supported the idea that violent media increases aggressive behavior, including a controversial 2012 study “Boom, Headshot!” that was retracted earlier this year.

What first struck Hilgard as odd about the 2016 paper was how large the effect of the violent cartoon was: Continue reading Group whose findings support video game-violence link loses another paper

“Strange. Very strange:” Retracted nutrition study reappears in new journal

In an unusual turn of events, a nutrition paper has come back to life a year after being pulled from its original publication.

After the paper was retracted from the journal Obesity, the authors revised it and republished it in another journal, Pediatric Obesity. Both journals are published by Wiley. The second version of the paper doesn’t mention the previous retraction. Indeed, the journal editor told us he didn’t know the paper had been retracted. Still, he stood by his decision to publish it.

The authors told us the paper was retracted after editors at Obesity raised concerns over the authors’ methodology. The authors revised the paper, adding some analysis and explanation of their methodological approach, and said the new version was accepted by peer reviewers before being published in Pediatric Obesity.

However, an outside expert who reviewed both papers for us said he thinks the authors didn’t change enough. According to Patrick McKnight, head of the Measurement, Research methodology, Evaluation, and Statistics group at George Mason University and a Statistical Advisory Board member of STATS.org:

Continue reading “Strange. Very strange:” Retracted nutrition study reappears in new journal

Headline-grabbing Science paper questioned by critics

When zoologists at the University of Oxford published findings in Science last year suggesting ducklings can learn to identify shapes and colors without training (unlike other animals), the news media was entranced.

However, critics of the study have published a pair of papers questioning the findings, saying the data likely stem from chance alone. Still, the critics told us they don’t believe the findings should be retracted.

If a duckling is shown an image, can it pick out another from a set that has the same shape or color?  Antone Martinho III and Alex Kacelnik say yes. In one experiment, 32 out of 47 ducklings preferred pairs of shapes they were originally shown. In the second experiment, 45 out of 66 ducklings preferred the original color. The findings caught the attention of many media outlets, including the New York Times, The Atlantic, and BuzzFeed.

Martinho told us:

Continue reading Headline-grabbing Science paper questioned by critics