Category: united states

Hey, that’s my case study: Another retraction after doctors claim rights to case write-up

A group of researchers have retracted their 2016 case report about a rare dermatologic disorder in the wake of disputes about authorship and institutional approval.

The paper describes a young boy with Job’s Syndrome, in which patients experience painful, itchy and frequently disfiguring skin lesions, along with a constellation of other possible symptoms. The condition is extremely rare, occurring in less than one in 1 million births.

This isn’t the first time a journal has retracted a case study after another group of authors claimed ownership of the case. Earlier this year, we covered a retraction from a neuro-ophthalmology journal after the doctors who treated a patient suffering from a gruesome eye trauma took issue with the fact that radiologists had already published their diagnostic images as a case study.

According to the notice for this latest retraction:

Continue reading Hey, that’s my case study: Another retraction after doctors claim rights to case write-up

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

Journal knew about problems in a high-profile study before it came out — and did nothing for over a month

In June, Gene Emery, a journalist for Reuters Health, was assigned to write a story about an upcoming paper in the Journal of the American College of Cardiology, set to come off embargo and be released to the public in a few days. Pretty quickly, he noticed something seemed off.

Emery saw that the data presented in the tables of the paper — about awareness of the problem of heart disease among women and their doctors — didn’t seem to match the authors’ conclusions. For instance, on a scale of 1 to 5 rating preparedness to assess female patients’ risk (with 5 being the most prepared), 64% of doctors answered 4 or 5; but the paper said “only a minority” of doctors felt well-prepared (findings echoed in an accompanying press release). On Monday June 19, four days before the paper was set to publish, Emery told the corresponding author — C. Noel Bairey Merz, Medical Director of the Women’s Heart Center at Cedars-Sinai in Los Angeles — about the discrepancy; she told him to rely on the data in the table.

But the more Emery and his editors looked, the more problems they found with the paper. They alerted the journal hours before it was set to publish, hoping that was enough to halt the process. It wasn’t.

Continue reading Journal knew about problems in a high-profile study before it came out — and did nothing for over a month

Recent finding of misconduct by federal U.S. agency sparks debate

Nasser Chegini

In 2011, the University of Florida assembled a misconduct report about one of its ob-gyn researchers, identifying falsified data in a 2010 paper. But when an investigator at the U.S. Office of Research Integrity reviewed the report, something didn’t feel right.

“I reviewed the data, and I thought [UF] didn’t do their due diligence,” said Kristen Grace, then an ORI investigator, now heading up the compliance department of the Office of Clinical Research at the University of Pennsylvania. “Because the extent of the the falsification was so great.”

So the ORI asked the UF to re-open its investigation, expanding it to include previous years of work by Nasser Chegini, now retired. The institution also hired a new director of research compliance, who oversaw the second investigation. That report, completed in October 2013, was significantly more extensive — it documented intentional falsifications or fabrications in nine papers published between 2003-2008. (Through a public records request, we obtained a copy of this second report, which you can read in full here.) But last month, the ORI issued a finding of misconduct against Chegini that focused on only one paper; the agency said it chose to take a “targeted approach,” since eight of the nine papers had already been retracted.  

The move has prompted a debate — while some argue it’s a pragmatic use of ORI’s limited resources, others (including Grace) are concerned:

Continue reading Recent finding of misconduct by federal U.S. agency sparks debate

What should journals do when peer reviewers do not disclose potential conflicts?

Peer reviewers, like authors, are supposed to declare any potential conflicts of interest. But what happens when they don’t?

Take this case: In a court transcript from Feb. 23, 2017, Bryan Hardin testified that he was a peer reviewer on a 2016 paper in Critical Reviews in Toxicology, which found that asbestos does not increase the risk of cancer. In the deposition, Hardin—who works at the consulting firm Veritox—also said that he has testified in asbestos litigation on behalf of automakers, such as Ford, General Motors, and Chrysler, but said he had not disclosed these relationships to the journal.

Last year, the first author of the 2016 review withdrew a paper from another journal (by the same publisher) which concluded asbestos roofing products are safe, following several criticisms — including not disclosing the approving editor’s ties to the asbestos industry. In this latest case, the journal told us it believes the review process for the paper was up to snuff, but two outside experts we consulted said they believed Hardin’s relationships — and failure to disclose them — should give the journal pause.

We obtained a copy of the transcript from Christian Hartley, who was representing a man suing a mining company because the man developed cancer after being exposed to asbestos at work. When Hartley asked Hardin whether he had told the journal about testifying for companies involved in asbestos litigation, Hardin responded:

Continue reading What should journals do when peer reviewers do not disclose potential conflicts?

Researcher who shot dean after being fired for misconduct sentenced to 28 years in prison

Hengjun Chao. Credit: Westchester County DA

A former researcher at Mount Sinai’s medical school has been sentenced to 28 years in prison for shooting the dean that fired him.

On the morning of Aug. 29, 2016, Chao, 50, attacked Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai, with a shotgun outside a deli in suburban New York. In 2010, Charney fired Chao for scientific misconduct. Charney survived the shot, but was hospitalized for five days.

As reported by the Chappaqua-Mount Kisco Patch yesterday, Judge Barry Warhit sentenced Hengjun Chao to 23 years, each, for attempted murder and assault, to be served concurrently; the maximum sentence for the attempted murder charge that Chao faced was 25 years. The judge also sentenced Chao to the maximum for criminal use of a firearm — five years — which will be served consecutively, bringing the total to 28 years.

In June, a New York jury found him guilty of attempted murder and the two other felony charges.

Stewart Orden, Chao’s defense attorney, told Retraction Watch he was “shocked at the sentence:” Continue reading Researcher who shot dean after being fired for misconduct sentenced to 28 years in prison

Unearthed emails: Monsanto connected to campaign to retract GMO paper

A trove of internal documents from Monsanto, recently unsealed in a lawsuit against the agricultural biotech giant, has revealed the firm’s role in the knotty tale of a paper from the lab of a scientist known for his stance against genetically modified organisms (GMOs).

That paper is “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,” published in September 2012 in the journal Food and Chemical Toxicology (FCT) and retracted in January 2014. Gilles Seralini, a scientist known for an adversarial stance towards GMOs, was first author. The documents have also spurred the retraction of several pro-GMO articles on Forbes.com written by Henry Miller, a fellow at the Hoover Institution, a conservative think tank at Stanford University. Emails showed that one of the articles, which didn’t discuss Seralini’s paper, was ghostwritten by Monsanto.

The documents, posted last week by the law firm of Baum, Hedlund, Aristei and Goldman, show Monsanto engaged with a network of scientists and other commentators to spread the message that the Seralini paper was bad science and should be retracted. Seralini told Retraction Watch that this proves what he has been saying all along, that Monsanto led a concentrated effort to discredit his science and protect its bottom line. He said:

Continue reading Unearthed emails: Monsanto connected to campaign to retract GMO paper

Fearing “stigmatization,” patient’s father seeks retraction of paper on rare genetic mutation

The father of a boy with a rare genetic mutation has accused a scientist of exploiting his child by proclaiming the defect a “genetic syndrome” and naming it after herself.

At an impasse with scientists investigating, publicizing, and interpreting his son’s condition, the father seems willing to use any leverage he can muster to remove the “syndrome” entry in an online genetic disease database. Based solely on an email he obtained from the database director, the father became convinced that if the paper underpinning the entry were retracted, the syndrome would go down with it. So earlier this year, he withdrew his consent and asked the journal that published the paper for a retraction, based on improper patient consent. He has also threatened to lob accusations of research misconduct at the paper’s last author. Continue reading Fearing “stigmatization,” patient’s father seeks retraction of paper on rare genetic mutation

“The article must be retracted:” Journal pulls prostate cancer study

A 2016 paper exploring the biology of prostate cancer has been retracted due to figure manipulation.

According to the retraction notice, a reader contacted the journal Clinical Cancer Research in late 2016 with concerns that similar bands appeared multiple times in two images. The editors asked the paper’s corresponding author, Shahriar Koochekpour, about the issue and requested the raw data for the figures. But Koochekpour, based in the Departments of Cancer Genetics and Urology at Roswell Park Cancer Institute in Buffalo, New York, at the time of the study, could not locate the raw data.

Since the lab did not have raw data from such a relatively recent paper, the editors reached out to the research integrity officer at Roswell Park Cancer Institute to investigate. Indeed,  the research integrity officer contacted confirmed that two figures were problematic, and requested the paper be retracted.

Here’s the rather detailed retraction notice, published in July 2017, for “GRM1 is An Androgen-Regulated Gene and its Expression Correlates with Prostate Cancer Progression in Pre-Clinical Models:” Continue reading “The article must be retracted:” Journal pulls prostate cancer study

Newspaper series prompts CDC to correct paper on Legionnaire’s disease

Post-publication peer review isn’t just for scientists. Newspaper reporters can help correct the scientific record, too.

The U.S. Centers for Disease Control and Prevention (CDC) has corrected a journal article on Legionnaire’s disease after the Pittsburgh Post-Gazette revealed what seems to be efforts by the researchers to misrepresent their data.

In a series of articles last December, the newspaper raised questions about the CDC’s actions in the aftermath of outbreaks in 2011 and 2012 of Legionnaire’s that sickened 22 veterans, killing six. The Post-Gazette obtained emails from CDC scientists that appeared to reveal their disdain for the sterilization method the hospital had been using to suppress the growth of Legionella bacteria. That method, a copper-silver system, is widely considered to be effective. But according to the newspaper, the CDC investigators were so critical of the copper-silver disinfectant technology that the VA ultimately switched to a system based on chlorine.   Continue reading Newspaper series prompts CDC to correct paper on Legionnaire’s disease