A heart researcher has notched her third retraction, a small 2006 trial in Annals of Internal Medicine which seemed to show that a blood pressure drug could help people with artery disease walk further with less pain.
Earlier this year, Anna Ahimastos, formerly a researcher at Baker IDI Heart and Diabetes Institute in Melbourne, lost a larger clinical trial in JAMA and a subanalysis in Circulation Research after it was discovered she’d fabricated patient records. As principle investigator Bronwyn Kingwell told us in September:
Specifically, records were fabricated for trial participants that did not exist.
Now, following an investigation by the institute, her co-authors are proactively retracting papers, with more to come. The Annals of Internal Medicine paper, “Ramipril Markedly Improves Walking Ability in Patients With Peripheral Arterial Disease,” is being pulled due to an “inability to adequately validate primary data sources.” According to the note, Ahimastos “maintains the integrity of the data and validity of reported results:”
Following admission of data fabrication by the first author, Anna Ahimastos, in a similar study of ramipril for patients with peripheral arterial disease (1), Baker IDI Heart and Diabetes Institute conducted an independent investigation of the trial, published in Annals in 2006 (2). Based on that investigation and our own analysis, we, the undersigned authors, wish to retract this article due to an inability to adequately validate primary data sources. Dr. Ahimastos maintains the integrity of the data and validity of reported results and has declined to answer additional questions. The investigation did not find culpability on our part, and we apologize unreservedly to the editors, reviewers, and readers of Annals of Internal Medicine. Given the clinical indications for ramipril and other angiotensin-converting enzyme inhibitors, we believe there is no risk that these possibly invalid trial data harmed trial participants or patients with peripheral arterial disease taking ramipril.
The paper has been cited 54 times, according to Thomson Scientific’s Web of Knowledge.
Currently, ramipril (Altace) is indicated for lowering blood pressure and, in high-risk older patients, reducing the odds of cardiovascular events such as heart attack or stroke.
A summary for patients on the trial has been retracted as well:
For years, scientists have debated the benefits of ramipril for physical activity, with some data conflicting those presented in the Annals of Internal Medicine paper. An editorial in JAMA that accompanied the 2013 publication of the now-retracted larger JAMA trial notes that there have not been clear results as to whether drugs like ramipril can help patients walk further. The editorial mentions the Annals of Internal Medicine trial:
Prior trials of ramipril therapy to improve walking performance in patients with intermittent claudication have yielded mixed results. A previous randomized controlled trial of ramipril vs placebo by Ahimastos et al involving 40 patients with symptomatic infrainguinal PAD and no history of diabetes or hypertension demonstrated gains in painfree and maximum walking distance of 227 and 451 seconds, respectively, compared with placebo. However, a recent meta-analysis by Shahin et al of 4 randomized trials involving 137 patients with PAD, including the 40 participants in the prior trial by Ahimastos et al, demonstrated no association between use of angiotensin-converting enzyme (ACE) inhibitors and improved walking performance.
It was a topic that is worth investigating, the editorial notes, stating that lower extremity peripheral artery disease is “a global health problem that will become increasingly prevalent as the world population lives longer with chronic disease;” 1 in 16 Americans over 40 have it already.
The Baker IDI Heart and Diabetes Institute provided a statement from director Garry Jennings, which noted that more papers will be retracted:
In September 2015, Baker IDI Heart and Diabetes Institute publicly advised of the retraction of two papers –one in JAMA and one in Circulation Research – due to misrepresentation of data in the relevant study. At the time, the single researcher responsible for data anomalies (Dr Anna Ahimastos) conceded the allegation and co-operated with the Institute’s investigation.
The finding of research misconduct triggered additional investigations into similar studies that the researcher was associated with. These investigations identified irregularities in two other intervention studies. These irregularities were similar to those previously admitted by the researcher involved. In response, the article co-authors have proactively retracted the relevant papers as there is insufficient confidence in the validity of the studies to allow them to remain on the public record. Five papers and one letter are in the process of being retracted.
While data integrity was compromised by the aberrant behaviour of a single individual,the authors apologise unreservedly to the editors, reviewers and readers of the respective journals. Ms Ahimastos’ supervisor, Prof. Bronwyn Kingwell, wishes to acknowledge the serious nature of this finding and offers her sincere apologies to all stakeholders affected by this matter.
According to the statement from Jennings, the institute has taken preventative measures against misconduct:
Prior to discovery of this research misconduct, Baker IDI has developed more effective levels of oversight and governance in relation to human research. This has included the formation of the Baker IDI Clinical Research Support Unit, a service that is facilitating the implementation of Institute-wide initiatives relating to clinical research reporting and monitoring and researcher training to ensure all our research adheres to international best practice. We anticipate that these additional frameworks and processes will ensure that potential issues are identified sooner and quickly rectified.
We’ve reached out to Ahimastos, and will update this post if we hear back. A spokesperson at Baker IDI told us that they’re not sure where she works now. We’ll continue to follow this story as more retraction notes are posted.
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