Bone researcher manipulated data in JAMA study, says investigation

Screen Shot 2015-10-27 at 10.53.53 AMA 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. Continue reading Bone researcher manipulated data in JAMA study, says investigation

“Fabricated results” retract JAMA clinical trial, plus a sub-analysis of the data

Screen Shot 2015-09-14 at 11.00.11 AMA 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a blood pressure drug could help patients increase their physical fitness, and a sub-analysis of those data, have been retracted after “an admission of fabricated results” by the first author on both papers.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  It was retracted this morning.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: 

Continue reading “Fabricated results” retract JAMA clinical trial, plus a sub-analysis of the data

JAMA issues mega-correction for data breach letter due to “wording and data errors”

s_cover_jcv062315A 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.

Continue reading JAMA issues mega-correction for data breach letter due to “wording and data errors”

JAMA vitamin-hip fracture study earns Expression of Concern for integrity issues

jama coverJAMA has issued an Expression of Concern about a 2005 study of whether two different types of vitamin B could prevent broken hips in people who’d suffered strokes.

The original study concluded:

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.

Here’s the notice for the study, “Effect of folate and mecobalamin on hip fractures in patients with stroke: a randomized controlled trial:” Continue reading JAMA vitamin-hip fracture study earns Expression of Concern for integrity issues

March Madness? Harvard profs take shots at controversial studies, request retractions

harvardIn 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:

Continue reading March Madness? Harvard profs take shots at controversial studies, request retractions

JAMA journal quietly replaces diabetes drug commentary after learning co-author is working for drugmaker

jama int medJAMA 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: Continue reading JAMA journal quietly replaces diabetes drug commentary after learning co-author is working for drugmaker

JAMA’s first-ever Expression of Concern appears for hip protector study

JAMA has issued its first-ever Expression of Concern over a 2007 study of hip protectors in the elderly that came under scrutiny from Federal regulators.

As the Boston Globe was first to report yesterday, the journal’s editor and executive deputy editor wrote in a notice published online: Continue reading JAMA’s first-ever Expression of Concern appears for hip protector study

Coming clean: A major figure in cardiology publishes a lengthy conflict of interest correction in JAMA

Authors’ financial disclosures can be a thorny issue for scientific journals.  There’s often confusion over just what should be listed as a conflict of interest, and when relationships are revealed after papers are published, lack of disclosure sometimes leads to corrections.

For example, the Journal of Cell Science recently published this: Continue reading Coming clean: A major figure in cardiology publishes a lengthy conflict of interest correction in JAMA

Potti and colleagues retract 2008 JAMA paper

Anil Potti‘s retraction count is now eight with the withdrawal of a 2008 study in the Journal of the American Medical Association (JAMA).

Here’s the notice, which appeared online in JAMA sometime yesterday: Continue reading Potti and colleagues retract 2008 JAMA paper

No Potti retractions on the horizon from JAMA, NEJM

With the third retraction of a paper by Anil Potti this weekend, plus details of various investigations dribbling out, we decided to check in with the world’s two leading medical journals about whether they planned to retract the papers of Potti’s they’d published.

JAMA published two papers by Potti and colleagues: One, “Gene Expression Signatures, Clinicopathological Features, and Individualized Therapy in Breast Cancer,” appeared in 2008. It has been cited 51 times, according to Thomson Scientific’s Web of Knowledge, and was the subject of two letters. In one, a correspondent expressed concerns about the lack of information in the study about Continue reading No Potti retractions on the horizon from JAMA, NEJM