Archive for the ‘jama’ Category
Ben Goldacre has been a busy man. In the last six weeks, the author and medical doctor’s Compare Project has evaluated 67 clinical trials published in the top five medical journals, looking for any “switched outcomes,” meaning the authors didn’t report something they said they would, or included additional outcomes in the published paper, with no explanation for the change. The vast majority – 58 – included such discrepancies. Goldacre talked to us about how journals – New England Journal of Medicine (NEJM), JAMA, The Lancet, BMJ, and Annals of Internal Medicine — have responded to this feedback.
Retraction Watch: When you discover a published trial has switched outcomes, what do you do? Read the rest of this entry »
A JAMA study on an inexpensive treatment for osteoporosis has been retracted because the first author falsified or fabricated data. We’ve been expecting this one: An investigation at Women’s College Hospital in Toronto, the bone researcher’s former workplace, had already revealed issues with the paper.
An internal memo sent to staff (available in full here) in October explained that the investigation had found “unequivocal evidence of systematic data manipulation” by Sophie Jamal, who had already resigned from her positions at WCH and the University of Toronto.
The study appeared to show that nitroglycerin ointment could have a small positive effect on bone mineral density in postmenopausal patients. It’s been cited 30 times, according to Thomson Scientific’s web of Knowledge. (That’s two more times than when we last reported on the paper: It was cited once by the investigation, and once by a paper that was published earlier in October, but had not yet been indexed.)
A new project does the relatively straightforward task of comparing reported outcomes from clinical trials to what the researchers said they planned to measure before the trial began. And what they’ve found is a bit sad, albeit not entirely surprising.
As part of The Compare Project, author and medical doctor Ben Goldacre and his team have so far evaluated 36 clinical trials published by the top five medical journals (New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, Annals of Internal Medicine, and British Medical Journal). Many of those trials included “switched outcomes,” meaning the authors didn’t report something they said they would, or included additional outcomes in the published paper, with no explanation for the change.
Here are the latest results from the project, according to its website:
A heart researcher who fabricated trial participants has notched a second JAMA retraction. The retraction comes at the request of her co-authors, after an investigation by her former employer wasn’t able to confirm that this study was valid.
In September, we learned that Anna Ahimastos, who used to work at Baker IDI Heart and Diabetes Institute in Melbourne, Australia, had “fabricated [records] for trial participants that did not exist” in a JAMA trial for a blood pressure drug, according to principal investigator Bronwyn Kingwell. That trial was retracted, along with a sub analysis.
An investigation by the institute found problems or sufficient doubt in several more publications. This second JAMA retraction is number 5 for Ahimastos, of 8 total expected.
A bone researcher manipulated data in a 2011 JAMA study about an inexpensive treatment for osteoporosis. That’s the conclusion of an investigation at the researcher’s former workplace, the Women’s College Hospital in Toronto, the Toronto Star reports.
The study — led and manipulated by Sophie Jamal — followed 243 women over two years, as they applied nitroglycerin ointment once a day. The ointment is currently used to prevent chest pain and treat anal fissure pain by relaxing blood vessels; Jamal’s study concluded it could help patients with osteoporosis, too:
Among postmenopausal women, nitroglycerin ointment modestly increased [bone mineral density] and decreased bone resorption.
But even the modest effect was too good to be true. Read the rest of this entry »
A JAMA clinical trial that suggested a blood pressure drug could help patients increase their physical fitness, and a sub-analysis of those data, have been retracted after “an admission of fabricated results” by the first author on both papers.
The three-year clinical trial was published in JAMA in 2013. It was retracted this morning.
The trial found ramipril helped patients with artery disease walk longer and with less pain, according to the abstract:
Among patients with intermittent claudication, 24-week treatment with ramipril resulted in significant increases in pain-free and maximum treadmill walking times compared with placebo. This was associated with a significant increase in the physical functioning component of the SF-36 score.
The retraction note explains how the fabricated data came to light:
A JAMA letter published in April on data breaches accidentally included some data that shouldn’t have been published, either — specifically, “wording and data errors” that affected five sentences and more than 10 entries in a table. One result — a reported increase in breaches over time — also went from statistically significant to “borderline” significant, according to the first author. (So yeah, this post earns our “mega correction” category.)
According to an author, an “older version” of a table made it into the letter, “Data Breaches of Protected Health Information in the United States,” which was corrected in the journal’s June 23/30 issue.
The letter and table in question detail 949 breaches of “unencrypted protected health information.” The letter says the number of breaches has increased from 2010 to 2013; the original article claimed that the P value on that increase was <.001, but the correction says it’s really 0.07. The original says 29.1 million personal records were affected in those breaches; the real number is 29.0. And so on.
In this Japanese population with a high baseline fracture risk, combined treatment with folate and vitamin B12 is safe and effective in reducing the risk of a hip fracture in elderly patients following stroke.
In the wake of Harvard’s gritty performance in the NCAA men’s basketball tournament — they were eliminated Saturday — a pair of faculty members at the Ivy League institution are calling foul on two controversial journal articles that have already been corrected.
Walter Willett, an oft-quoted Harvard nutrition expert, is calling for the retraction of an eyebrow-raising article earlier this month challenging the relative health benefits of fats from fish and vegetables over those in meat and butter.
The article, which appeared in the Annals of Internal Medicine, quickly came under fire and the researchers — from the University of Cambridge — ended up making several corrections. Despite the changes, the authors have stood by their work, according to a piece this week in Science.
But that hasn’t stopped Willett from urging a retraction. Per Science:
JAMA journal quietly replaces diabetes drug commentary after learning co-author is working for drugmaker
JAMA Internal Medicine has replaced a commentary they published last week on the risks of two diabetes drugs, but you wouldn’t know the new version was a replacement.
One change is a correction about whether Byetta and Januvia carry so-called “black box” warnings from the FDA. The original sentence:
Because both drugs already carry US Food and Drug Administration (FDA) black box warnings for the risk of pancreatitis, why is this study important?
It now reads: Read the rest of this entry »