Category: clinical study retractions

The “regression to the mean project:” What researchers should know about a mistake many make

David Allison, via IU

The work of David Allison and his colleagues may be familiar to Retraction Watch readers. Allison was the researcher — then at the University of Alabama, Birmingham, now at Indiana University — who led an effort to correct the nutrition literature a few years ago. He and his colleagues are back, this time with what might be called the “Regression to the Mean Project,” an attempt to fix a problem that seems to vex many clinical trials. You may have noticed some items in Weekend Reads about letters to the editor that mention the issue. Here, Allison explains.

•Retraction Watch (RW): First, what is “regression to the mean,” and what does it mean for clinical studies? Continue reading The “regression to the mean project:” What researchers should know about a mistake many make

“Sufficiently serious” issues in study prompt company to yank drug approval application in China

The maker of a leading over-the-counter antacid has withdrawn its application for approval of the drug in China because a clinical trial of the product in that country was marred by “major protocol deviations.”

Researchers for the company, Reckitt Benckiser, maker of Gaviscon, had published a report on the study in 2015 in the journal Alimentary Pharmacology & Therapeutics. But the journal has now retracted the article, “Randomised clinical trial: The clinical efficacy and safety of an alginate‐antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China,” at the behest of the drug maker.

According to the notice: Continue reading “Sufficiently serious” issues in study prompt company to yank drug approval application in China

Harvard and the Brigham recommend 31 retractions for cardiac stem cell work

Piero Anversa

Retraction Watch readers may be familiar with the name Piero Anversa. Until several years ago, Anversa, a scientist at Harvard Medical School and the Brigham and Women’s Hospital, was a powerful figure in cardiac stem cell research.

“For ten years, he ran everything,” says Jeffery Molkentin, a researcher at Cincinnati Children’s whose lab was among the first to question the basis of Anversa’s results in a 2014 paper in Nature. Continue reading Harvard and the Brigham recommend 31 retractions for cardiac stem cell work

Japanese university revokes PhD following a retraction

Tokyo Women’s Medical University has stripped a researcher of her PhD, following the retraction of a paper — for data duplication — that was based on her thesis.

The August 30th announcement notes that a degree was revoked on July 20. The announcement does not name the researcher, but refers to degree number 2881, which corresponds to Rika Nakayama’s PhD. The university describes carelessness and errors, but not misconduct.

Here’s a rough Google translation of the announcement: Continue reading Japanese university revokes PhD following a retraction

When it comes to retracting papers by the world’s most prolific scientific fraudsters, journals have room for improvement

Journals have retracted all but 19 of the 313 tainted papers linked to three of the most notorious fraudsters in science, with only stragglers left in the literature. But editors and publishers have been less diligent when it comes to delivering optimal retraction notices for the affected articles.

That’s the verdict of a new analysis in the journal Anaesthesia, which found that 15% of retraction notices for the affected papers fail fully to meet standards from the Committee for Publication Ethics (COPE). Many lacked appropriate language and requisite watermarks stating that the articles had been removed, and some have vanished from the literature.

The article was written by U. M. McHugh, of University Hospital in Galway, Ireland, and Steven Yentis, a consultant anaesthetist at Chelsea & Westminster Hospital in London. Yentis was editor of Anaesthesia during the three scandals and had a first-hand view of two of the investigations. He also is the editor who unleashed anesthetist and self-trained statistician John Carlisle on the Fujii papers to see how likely the Japanese researcher’s data were to be valid (answer: not very likely). Continue reading When it comes to retracting papers by the world’s most prolific scientific fraudsters, journals have room for improvement

Distraction paper pulled for clerical error

The authors of a 2018 paper on how noisy distractions disrupt memory are retracting the article after finding a flaw in their study.

The paper, “Unexpected events disrupt visuomotor working memory and increase guessing,” appeared in Psychonomic Bulletin & Review, a publication of the Psychonomic Society. (For those keeping score at home, psychonomics is the study of the laws of the mind.)

The article purported to show that an unexpected “auditory event,” like the sudden blare of a car horn, reduced the ability of people to remember visuomotor cues. Per the abstract:

Continue reading Distraction paper pulled for clerical error

Researchers pull Nature paper over first author’s objections

Researchers have retracted a 2015 Nature paper about the molecular underpinnings of immune function after discovering they could not replicate key parts of the results.

The first author, Wendy Huang — who started working as an assistant professor at the University of California, San Diego, only months after the paper appeared — did not sign the retraction letter, published last week. The research was conducted while Huang was working as a postdoctoral fellow at New York University, home of last author Dan Littman (also an investigator at the Howard Hughes Medical Institute).

What happened appears to be a case of “he said, she said:” Littman asked to retract the paper after his lab couldn’t reproduce it, and Huang insists the data remain correct, saying the process had been “unfair and done without due process:”

Continue reading Researchers pull Nature paper over first author’s objections

A university went to great lengths to block the release of information about a trial gone wrong. A reporter fought them and revealed the truth.

Jodi S. Cohen

Here’s a story that shows the lengths a public university — The University of Illinois at Chicago — went to block the release of information about a child psychiatry trial gone wrong, and how a reporter — Jodi S. Cohen of ProPublica — fought them effectively at every turn to reveal the truth.

Earlier this year, ProPublica “revealed that the National Institute of Mental Health ordered the university to repay $3.1 million in grant money it had received to fund [Mani] Pavuluri’s study.” This kind of clawback is very, very rare.

We tipped our hats to Cohen then, because we had been trying for years to obtain documents that would tell the full story of the Pavuluri case, which we had been covering since 2015 when a retraction appeared. In particular, we’ve been trying to get the university to release their report of the investigation into Pavuluri’s work. We have been making a push for such reports, as we noted earlier this week in a roundup of more than 16 of them. Continue reading A university went to great lengths to block the release of information about a trial gone wrong. A reporter fought them and revealed the truth.

Fecal transplant paper pulled for “personal issue”

Last month, the Journal of Pediatric Gastroenterology and Nutrition pulled an article on fecal transplantation for a reason that, well, doesn’t pass the sniff test.

The paper, by Sonia Michail of Children’s Hospital Los Angeles, appeared online in October 2017 and described a randomized controlled trial of fecal transplants to treat kids with ulcerative colitis. (If you’re interested, here’s an overview of how fecal transplantation works.) The trial, or one awfully like it, is listed on ClinicalTrials.gov, and shows Michail as the lone investigator on the study, which is aiming to gather more than 100 participants.

But the journal retracted the article — which was the subject of a laudatory editorial in the journal pointing readers to the findings — with an entirely opaque statement, saying that the work   

Continue reading Fecal transplant paper pulled for “personal issue”

Journal holds firm on decision not to retract Macchiarini paper, despite outside pressure

Earlier this year, the president of the Karolinska Institute, Ole Petter Ottersen, contacted the journal Respiration, saying KI had conducted an investigation and determined that a 2015 paper co-authored by once-lauded surgeon Paolo Macchiarini had been tainted by misconduct. Please retract the paper, Ottersen said. When the journal said no — opting to publish correspondence from KI and the authors’ response instead — Ottersen posted some of their correspondence online, in an attempt to pressure the journal to do the right thing. It’s not going to work, according to Thomas H. Nold, publication manager at Karger, which publishes Respiration. We spoke to Nold about the journal’s plans for the paper.

Retraction Watch: How do you feel about KI’s decision to publish your correspondence?

Continue reading Journal holds firm on decision not to retract Macchiarini paper, despite outside pressure