PLOS ONE issues editor’s note over controversial chronic fatigue syndrome research

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After a request for the original data was denied, PLOS ONE editors have flagged a 2012 sub analysis of a controversial clinical trial on chronic fatigue syndrome with an editor’s note.

The editor’s note — which reads like an Expression of Concern — reiterates the journal’s policy that authors make data and materials available upon request, and notes that staff are following up on “concerns” raised about the study.

There have been numerous requests for data from the “PACE” trial, as the clinical trial is known, which the authors say they have refused in order to protect patient confidentiality. On November 13, James Coyne, a psychologist at the University Medical Center, Groningen, submitted a request for the data from the PLOS ONE paper to King’s College London, where some of the authors were based. According to Coyne’s WordPress blog (he also has a blog hosted by PLOS), the journal asked him to let them know if he “had any difficulties obtaining the data.” He did — KCL denied the request last Friday (the whole letter is worth reading):

The university considers that there is a lack of value or serious purpose to your request. The university also considers that there is improper motive behind the request. The university considers that this request has caused and could further cause harassment and distress to staff.

Last author Peter White at Queen Mary University of London, UK, told us the journal had not asked them to release the data, but he would work with PLOS to address any questions:

We understand PLOS One are following up concerns expressed about the article, according to their internal processes. We will be happy to work with them to address any queries they might have regarding the research.

Here’s the editor’s note for “Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis,” in full:

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Authors lied about ethics approval for study on obesity, depression

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Obesity has retracted a study that suggested overweight people may be less depressed than their slimmer counterparts in cultures where fat isn’t stigmatized, after realizing the authors lied about having ethical approval to conduct the research.

The authors claimed their research protocol had been approved by Norwegian and Bangladeshi ethical committees, but, according to the retraction note, part of the study “was conducted without the required approval of the university ethics board.” The journal’s managing editor told us that there is no evidence that there was harm to the study subjects.

Here’s more from the retraction note for “In Bangladesh, overweight individuals have fewer symptoms of depression than nonoverweight individuals:”

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University finds “preponderance of evidence” of misconduct by child psychiatrist

JPN39_2_CoverAn investigation at the University of Illinois at Chicago has found “a preponderance of evidence” that a psychiatrist who has received millions of dollars in federal funding has committed misconduct.

One paper co-authored by Mani Pavuluri, the director of the Pediatric Mood Disorders Program, has been officially retracted so far, from the Journal of Psychiatry & Neuroscience. UIC has requested that two others be retracted as well. None of the child participants in the three papers received medication as part of the research, but the Journal of Psychiatry & Neuroscience paper was pulled after the investigation found that Pavuluri had misrepresented how much medication some children had taken outside of the study.

On Tuesday, after we’d learned of the first retraction, Pavuluri told Retraction Watch that she didn’t “want mountains made out of molehills,” but admitted to “a bit of an [Institutional Review Board] infraction.”

The retraction note from the Journal of Psychiatry & Neuroscience lays the blame squarely on Pavuluri’s shoulders:

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Journal retracts — and republishes — small study on gamma rays for OCD

Screen Shot 2015-10-28 at 8.40.00 PMJAMA Psychiatry has retracted and republished a paper on a cutting-edge procedure for patients with obsessive compulsive disorder.

In the original paper, the authors claimed that three out of eight patients who underwent a procedure that used gamma rays to kill brain cells showed improvements 12 months later (versus zero in the group who underwent a “sham” procedure). But after a reader noticed an “inadvertent” error in the calculation of how many patients had improved, the authors realized that only two of the patients had responded meaningfully to the procedure.

The new results “did not reach statistical significance,” the authors write in a “Notice of Retraction and Replacement.”  JAMA Psychiatry published it yesterday, along with a new version of the articlea letter from psychiatrist Christopher Baethge pointing out the error, and an editorial. The original article is available in the supplemental material of the new version, with the errors highlighted.

Here’s the note in full for “Gamma ventral capsulotomy for obsessive-compulsive disorder: a randomized clinical trial,” which explains the error:

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Journal mistakenly publishes Parkinson’s case report twice

Journal of Movement Disorders

A journal has retracted a duplicate version of a case report about a patient with Parkinson’s disease after mistakenly publishing the paper twice.

The Journal of Movement Disorders initially published the report — which detailed the case of an elderly woman with Parkinson’s disease whose symptoms worsened during drug treatment — in 2010. But it ended up printing it again in 2011 because of “a mistake of the editorial office and the publisher.”

The notice reads:

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Investigation finds “careless data workup” in alcoholism drug paper

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An investigation at Karolinska Institute has led to the retraction of a paper about drug treatments for alcoholics, after concluding the article contains a “very careless data workup.”

The paper, “Memantine enhances the inhibitory effects of naltrexone on ethanol consumption,” found that the drug memantine (normally used to treat Alzheimer’s) enhances the effects of naltrexone in rats, which blocks the high of alcohol.  It was published in the European Journal of Pharmacology and has been cited 10 times, according to Thomson Scientific’s Web of Knowledge.

However, its conclusion is now “unreliable,” according to the retraction note:

Continue reading Investigation finds “careless data workup” in alcoholism drug paper

Re-analysis of controversial Paxil study shows drug “ineffective and unsafe” for teens

downloadThe antidepressant Paxil isn’t safe or effective for teens after all, says a re-analysis of a 2001 study published today in The BMJ.

The original 2001 paper in Journal of the American Academy of Child and Adolescent Psychiatry — study 329, as it’s known — helped greenlight use of the drug (generically known as paroxetine) in young people. But it’s faced accusations of ghostwriting, undisclosed conflicts of interest, and issues with data analysis since publication.

According to a BMJ feature, also published today: Continue reading Re-analysis of controversial Paxil study shows drug “ineffective and unsafe” for teens

“Our manuscript unintentionally failed to meet academic and publication standards”

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Authors of a 2014 review paper about the use of “as needed” medications by people with mental health diagnoses are retracting it, but we’re scratching our heads as to why.

The retraction appears in “The experiences of mental health professionals’ and patients’ use of pro re nata (PRN) medication in acute adult mental health care settings: a systematic review protocol of qualitative evidence,” published by The JBI Database of Systematic Reviews and Implementation Reports.

From the abstract of the paper:

Pro re nata is a Latin phrase meaning “for an unforseen need or contingency”…The authors of the systematic review found that although the practice of using “as required” medication is common there is no good evidence of whether this is the best way of helping people to be less agitated when compared to being given a regular dose of medication.

We’re not entirely sure what went wrong here. This is the full contents of the note:

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A mess: PLOS mistakenly publishes rejected ADHD-herbicide paper, retracts it

logoPLOS One has retracted a paper that links the most commonly used herbicide to ADHD, after it was “published in error.”

According to the note, the paper was “editorially rejected following peer review and consultation with the Editorial Board,” but ended up going through the production process anyway.

When we contacted the authors, they filled us in with more details.

Continue reading A mess: PLOS mistakenly publishes rejected ADHD-herbicide paper, retracts it

Former Wake Forest grad student fudged data for drug study

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Brandi Blaylock

A former graduate student at Wake Forest School of Medicine “presented falsified and/or fabricated data” in a government-funded drug study, according to findings released by the U.S. Office of Research Integrity earlier today.

The report was released in the wake of an investigation conducted by the university and the ORI. Investigators found that although Brandi Blaylock recorded responses of a dozen laboratory monkeys after giving them anti-abuse drugs, she hadn’t given them the compounds “per protocol.”

Blaylock then presented the data at “two poster presentations, several laboratory meetings, and progress reports.”

Some of her research was supported by a grant from the National Institute of Drug Abuse, “Dopamine D2 Receptors In Primate Models of Cocaine Abuse,” which examined the effects of novel dopamine D3 receptor compounds on drug addiction on monkeys.

However, according to the report, Blaylock presented the falsified responses from a dozen monkeys: Continue reading Former Wake Forest grad student fudged data for drug study