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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

Curious: A paper’s acknowledgments harshly criticized Spanish gov’t funding. Now two authors object.

In 2014, researchers condemned the Spanish Government for “destroying the R&D horizon of Spain and the future of a complete generation” in the acknowledgment section of a paper about wireless networks.

Three years later, the two last authors of the paper are protesting that protest, issuing a correction to alert readers that they did not approve the language. Here’s the text of the corrigendum notice, which mentions Juan M. Górriz and Javier Ramírez, both based at University of Granada: Continue reading Curious: A paper’s acknowledgments harshly criticized Spanish gov’t funding. Now two authors object.

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

Lost citation snuffs out Aussie fire paper

A journal has retracted a 2016 paper on wildfires in Australia because the authors neglected to cite earlier work — an unintentional lapse, they said.

The article, “Projected changes in Australian fire regimes during the 21st century and consequences for Ecosystems,” appeared in the International Journal of Wildland Fire. The authors are Sandy Harrison and Douglas Kelley,  of the University of Reading, in the UK. Kelley appears to have done his share of the work as a PhD student at Macquarie University in Australia.

According to the notice: Continue reading Lost citation snuffs out Aussie fire paper

Genetic disorder gets name change, but patient’s father still not happy

Credit: Online Mendelian Inheritance in Man

The leading genetic disease database has chosen a new name for a genetic condition, following complaints from a man whose son has the condition.

On Aug. 11, 2017, two days after our coverage of the situation, the Online Mendelian Inheritance in Man (OMIM) database changed the primary name of the phenotype associated with mutations in the RPS23 gene. The new name describes a set of features: “Brachycephaly, Trichomegaly, and Developmental Delay,” or BTDD.

Brachycephaly describes a condition where the back of the head is abnormally flat and trichomegaly refers to extra length, curling, pigmentation, or thickness of the eyelashes.

Marc Pieterse, of the Netherlands, has a son with the rare RPS23 mutation, one of two known patients in the world. The mutation affects ribosomes, cell components involved in protein production. On Aug. 9, we reported on Pieterse’s crusade against OMIM’s original name for the condition, which dubbed it a syndrome. He has feared that calling it a syndrome would “stigmatize” his son’s condition and tried to get the paper underpinning the OMIM entry retracted. The American Journal of Human Genetics has said it will not retract the paper.

Continue reading Genetic disorder gets name change, but patient’s father still not happy

“The paper is extremely flawed:” Journal retracts article linked to vaccines

A journal has retracted a 2016 paper after receiving criticism from outside researchers who raised concerns about its methodology and data.

The paper shares multiple authors with another paper that linked the vaccine for human papillomavirus (HPV) to behavioral problems in mice. Last year, a journal removed the study; later that year, the authors published a revised version in another journal. The latest retracted paper focuses on the antibodies present in a form of lupus.

Yehuda Shoenfeld at Tel-Aviv University in Israel, the corresponding author on both this latest retraction and the HPV vaccine paper, recently edited a textbook that explored how vaccines can induce autoimmunity in some people.  He told us the 2016 lupus paper does have a link to vaccines [his emphasis]:

Continue reading “The paper is extremely flawed:” Journal retracts article linked to vaccines

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?

Journal corrects paper by researcher sanctioned for misconduct

A biology journal has issued a correction to a 2014 paper by a researcher with 11 retractions, citing “inadvertent errors” that don’t affect the conclusions.

The researcher, Rony Seger, was recently sanctioned by his institution (The Weizmann Institute in Israel) following a finding of “serious misconduct” involving data manipulation. Specifically, the institute barred him from supervising graduate students, even future ones; his lab is now dedicated to replicating his previous work, with the help of a technician.

Last month, Michal Neeman, vice president of The Weizmann Institute of Science, told us she wasn’t sure how many additional papers by Seger would need to be retracted or corrected.

Recently, one more was revealed — in the August issue of Molecular and Cellular Biology, the following correction notice appears:

Continue reading Journal corrects paper by researcher sanctioned for misconduct

JAMA tells readers: “Caution advised.” Here’s why.

Last week, JAMA issued some unusual notices, letting readers know they should use caution when reading an editorial and letters associated with now-retracted articles by a bone researcher in Japan.

The notices — for papers by Yoshihiro Sato, now up to 14 retractions — remind readers not to heed the results of the now-retracted papers, and alert them to read any associated materials (specifically, an editorial in JAMA and letters in JAMA Internal Medicine) with caution.

The text of the notices describes them as “formal correction notices;” we asked Annette Flanagin, executive managing editor at The JAMA Network, why they chose that approach, instead of an expression of concern or retraction:

Continue reading JAMA tells readers: “Caution advised.” Here’s why.