Retraction Watch

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Bone researcher manipulated data in JAMA study, says investigation

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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.

Paula Rochon, vice president of research at WCH, told the Star:

The findings were made to look more positive than they were…

In an internal memo sent to WCH staff yesterday (which you can read in full here), President Marilyn Emery said:

The investigating committee concluded that there is unequivocal evidence of systematic data manipulation by Dr. Jamal.

Jamal resigned from her position at WCH during an investigation into the paper. JAMA is considering a retraction of “Effect of nitroglycerin ointment on bone density and strength in postmenopausal women: A randomized trial,” the journal’s Editor in Chief Howard Bauchner told the Star

JAMA is aware of the concern of Women’s College and will make a decision about (a) retraction in the coming weeks.

The paper has been cited 28 times, according to Thomson Scientific’s Web of Knowledge.

A 2011 Nature Reviews Rheumatology paper used it as supporting evidence that nitroglycerin ointment is an effective treatment. But the review noted that Jamal’s data on the ointment conflicted with a 2009 study in the Journal of Clinical Endocrinology & Metabolism, “Transdermal nitroglycerin therapy may not prevent early postmenopausal bone loss.” Here is the review’s description of the conclusions of the two studies, starting with Jamal’s:

A 24 month randomized, placebo-controlled trial in 243 postmenopausal women with baseline lumbar spine T-scores between 0 and –2.0 showed increased [bone mineral density, BMD] and decreased bone resorption when treated with nitroglycerin ointment 15mg, applied once daily at bedtime, compared to placebo. However, another randomized controlled trial, conducted over 3 years in 186 postmenopausal women with baseline T-scores between 0 and –2.5, showed no BMD benefit of daily nitroglycerin ointment 22.5 mg compared to placebo.

The review suggests that the reason for the “discordance in findings” was a problem with the study that suggested nitroglycerin therapy does not work:

The reason for the discordance in findings between these two trials is unclear, but might be partly attributable to poor adherence to therapy in the latter study. Further investigation is needed to validate the optimal dose, dosing interval, and potential skeletal benefits of nitroglycerin.

Jamal’s findings received some press attention after they were published, such as news stories from HealthDay and WebMD.

But the study started to unravel following an allegation of research misconduct brought to the University of Toronto, where Jamal was an associate professor of medicine, the Star reports. U of T passed on the allegation to the WCH, and the two institutions conducted an inquiry; the formal investigation began in June.

A spokesperson for the U of T declined to tell us the source of the initial allegation. A representative of WCH told us that the investigation also included two other unpublished studies:

JAMA was the only published study in the investigation.  Two other studies were also investigated, but the final results of these 2 studies were never published.

A search for “Jamal SA” on PubMed retrieves more than 100 results.

No other researchers are implicated, the WCH spokesperson added:

No other WCH researchers were involved in data manipulation.

In the staff memo, Emery said there was “no evidence” any of the research participants had been harmed during the JAMA study:

We have notified relevant research participants, via registered letter, that they may have received inaccurate information about this research. We have found no evidence to suggest that there have been negative outcomes for these participants.

Jamal has resigned from both her post at WCH and U of T. The Star reports that she has a new post treating osteoporosis patients:

Jamal’s public profile on the website of the College of Physicians and Surgeons of Ontario shows her now working for the Appleby Medical Group on Lake Shore Blvd. W. in Toronto.

A receptionist who answered the phone at the clinic said Jamal is in the process of moving her practice there and will be specializing in treatment of osteoporosis.

In 2012, Jamal received the Jody Ginsberg Young Investigator Award from the Canadian Society of Endocrinology and Metabolism.

We asked the WCH spokesperson how the hospital plans to prevent such incidents in the future:

The investigating committee found there to be no deficiencies in any institutional systems or processes at Women’s College Hospital. Despite the investigating committee finding no deficiencies in our systems or processes, we are reviewing them all and are working with our academic partners to raise the bar and learn from this experience….WCH ensured this investigation and the allegations were addressed promptly, thoroughly and effectively. We will continue to educate our staff about research misconduct.

We reached out to the editor in chief of JAMA, and we’ll update this post with anything else we learn. We were unable to find contact info for Jamal, who declined to speak to the Star via her lawyer.

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Written by Shannon Palus

October 27th, 2015 at 12:11 pm

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