A pharmaceutical company has admitted that one of its former researchers falsified early data on a compound that’s designed to fight cancer, now in human trials.
The data, published as an abstract in August 2015 in the journal Cancer Research, reported a therapeutic benefit of acalabrutinib in a mouse model of pancreatic cancer. The compound, developed by the company Acerta Pharma, has also been the subject of additional trials published in the New England Journal of Medicine and Bloodin 2015. The 2015 NEJM study, which had several authors in common with the Cancer Research abstract, showed the agent had “promising safety and efficacy profiles in patients” with relapsed chronic lymphocytic leukemia.
But an investigation into the data underlying the 2015 abstract shows some were falsified, prompting the journal to retract the abstract.
Ed Tucker, senior vice president of Medical Safety, Quality and Compliance at Acerta Pharma, told us that in August 2016 the company identified an issue with the data in the Cancer Research abstract and started an investigation:
In a letter, Ad Kaptein, a researcher at the Leiden University Medical Centre, in the Netherlands, wrote to say that a review and meta-analysis published by the journal that month hadn’t adequately cited the relevant literature in the field, including seven studies co-authored by Kaptein himself. The authors of the original paper say they had considered citing Kaptein’s work but decided against it, for various reasons.
The journal considered Kaptein’s complaint valid enough to publish his letter. But the letter carries the title “Expression of concern” — a term usually reserved for editorial notices issued by the journal to warn readers about some aspects of an article. But in this case, the author supplied the term, not the journal — yet the letter is tagged as an Expression of Concern on PubMed, giving the impression the paper has received a formal editorial notice.
Two authors who had a paper retracted for fake peer review in 2015 have lost another for the same reason.
Elsevier recently retracted the second paper by the duo, a 2015 paper in a cancer journal, after finding evidence of fake peer review. The paper was submitted in October 2014 and accepted just a week before our piece on fake peer review appeared in Nature.
According to the notice, after investigating the paper, which appeared in Cancer Letters, the publisher concluded that it was accepted “based upon the positive advice of at least two faked reviewer reports.” The notice also explained that the identities of several authors “could not be confirmed.”Continue reading Fake peer review strikes again for pair of authors
May was quite a month forRik Torfs, the rector of a prominent university in Belgium. On May 9, Torfs lost his re-election campaign for rector of KU Leuven by a slim margin—out of more than 2100 votes, he lost by amere 48. And just 20 days later, on May 29, Torfs wrotehis final column for the Flemish daily newspaperDe Standaard — whom he believes was at least partly to blame for his election loss.
BMJ Global Health has pulled a paper that criticized U.S. research of the effects of cervical cancer screening in India over defamation concerns.
That’s not what the notice on the paper says, however — at the moment, it just reads:
This article has been withdrawn.
However, forwarded email correspondence between the first author and an associate publisher reveals the journal published the paper and planned a press release, then realized it should be reviewed by a legal adviser. When first author Eric J. Suba at Kaiser Permanente San Francisco Medical Center inquired about the status of the paper and any potential press release, he was told the journal could no longer publish it, out of concern they would be taken to court.
Suba told us that, when he learned the paper would be pulled:
Correcting for the error, according to the retraction notice, had a “dramatic impact on the original article data and conclusions.”
Quyen Chu, a surgeon at Louisiana State University Health Shreveport, told us that the problem appears to stem from a misunderstanding about the US National Cancer Database (NCDB). After the paper was published, the NCDB pointed out to Chu that a key data point had not been reliably or consistently collected during the timeframe relevant to the study. The database’s user’s manual says essentially the same thing; Chu said he and his authors read it, but misunderstood it.
The original Journal of the American College of Surgeons study looked at whether a 2004 National Comprehensive Cancer Network treatment guideline — which suggested some patients could avoid radiation on top of surgery and hormone therapy — led to an actual decrease in radiation therapy. But the error forced the authors to drop tens of thousands of patients treated before 2004, which had a severe impact on their ability to draw conclusions.
A high-profile pediatric oncologist quietly left his former institution in 2015 after it concluded his clinical trials had been affected by significant “administrative problems.” But now the results of the university’s investigations and what followed have become public, after a paper in Belgium published a series of news reports last month.
We’re still hazy on some details of the case. The recent news reports allege that Van Gool started some clinical trials without proper ethical approvals and informed consent, and may have misled patients and their families about the benefits and potential side effects of his experimental treatment. Meanwhile, the CEO University Hospitals Leuven (UZLeuven) told us that Stefaan Van Gool, who had appointments at both the hospital and the university (KULeuven), left the hospital in 2015 as a result of administrative problems, but did not disclose the specific nature of these issues.
For the past 15 years or so, Van Gool has been developing and studying a vaccine to treat various cancers, initially at UZLeuven and, after September 2015, at a private clinic in Germany. Today, patients travel to his private clinic from all over the world and pay tens of thousands of dollars to receive the vaccine. But according to Flemish daily newspaper De Standaard, several years ago, UZLeuven began investigating his research and patient care practices. The outcome of these investigations was kept private until last month, after De Standaard published its reports.
Marc Decramer, the CEO of UZLeuven, confirmed that Van Gool left the hospital in 2015 and the university in 2016,but did not provide the specific reasons for his exit:
When a group of authors decided to write up a curious case of a 35-year-old woman with a mysterious mass that took 11 years to be diagnosed, they tried repeatedly to contact the patient for her permission. When they couldn’t reach her, they published the paper anyway, removing any identifiable information.
But the report apparently included enough details for the patient to recognize herself — and when she read the paper, she asked the authors to retract it.
Researchers in China have retracted a 2016 cancer imaging paper because they introduced “a plethora of data errors” while preparing the article for submission.
Although the retraction notice provides no details on what these errors are or how exactly they occurred, it does point the finger at the researchers, explaining that the data errors happened as a result of their “negligence.”