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a blood pressure drug could help patients increase their physical fitness, and a sub-analysis of those data, have been retracted after “an admission of fabricated results” by the first author on both papers.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 It was retracted this morning.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:
To the Editor We wish to retract the article “Effect of Ramipril on Walking Times and Quality of Life Among Patients with Peripheral Artery Disease and Intermittent Claudication: A Randomized Controlled Trial,” published in the February 6, 2013, issue of JAMA.1 A recent internal subanalysis of these data revealed anomalies, which triggered an investigation and an admission of fabricated results by Anna A. Ahimastos, PhD, who is both the first and corresponding author and was responsible for data collection and integrity for the article. No other coauthors were involved in this misrepresentation. In particular, the data collected at the Townsville and Brisbane sites remain valid. Given the current indications for ramipril, we do not believe that patients have been adversely affected. All authors recognize the seriousness of this issue and apologize unreservedly to the editors, reviewers, and readers of JAMA. A system of good clinical practice was in place; however, clinical governance and audit procedures will be reviewed and strengthened to minimize the chance of possible recurrence of such behavior. We are also in the process of examining other studies for which Dr Ahimastos had oversight of data collection and integrity.
We sincerely regret that this study has been compromised. We feel deeply disappointed and let down by this situation and are committed to rapidly correcting the public record and implementing practices to prevent recurrence.
According to JAMA, the paper has been cited 35 times.
Currently, ramipril — brand name 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.
The sub-analysis, “Potential vascular mechanisms of ramipril induced increases in walking ability in patients with intermittent claudication,” was published in Circulation Research, and retracted last week. It’s been cited three times, according to Thomson Scientific’s Web of Knowledge.
Its retraction notice is similar to that of the clinical trial:
A recent internal sub-analysis by Baker IDIHeart and Diabetes Institute (“the Institute”) of the data presented in this article revealed anomalies that triggered an investigation, which resulted in an admission of fabricated results by Dr Anna Ahimastos. Dr Ahimastos is both the first and corresponding author of this article, and was responsible for data collection and integrity. According to the Institute’s finding, no other co-authors were involved in this misrepresentation. In addition, no data from the Townsville and Brisbane recruitment centers were included in this publication, and data from those centers remains valid. All authors recognize the seriousness of this issue and apologize unreservedly to the editors, reviewers, and readers of Circulation Research. Although a system of Good Clinical Practice was in place, the Institute vows to review and strengthen Clinical Governance and audit procedures to minimize the chance of possible recurrence of such behavior.
In accordance with the policies of the Baker IDI Heart and Diabetes Institute, the authors have requested to retract this article.
Principal investigator Bronwyn Kingwell, the head of Metabolic and Vascular Physiology at the Melbourne, Australia-based Institute, noted the main results from the JAMA trial have been corroborated by a “small clinical trial,” and provided more details about how the misconduct was discovered:
The sub-analysis was done to investigate a new research question. Specifically whether indices of glycemic control were related to walking time.
The sub-analysis revealed anomalies, which triggered an investigation and an admission of research misconduct by Dr Anna Ahimastos who was both the first and corresponding author.
Dr Ahimastos admitted to fabrication of patient data. Specifically, records were fabricated for trial participants that did not exist. The records of valid participants were not affected and the data from the Brisbane and Townsville sites remain unaffected.
Unfortunately these actions compromised the overall findings of the study and so we followed due processes and moved quickly to correct the public record by retracting the relevant papers.
It is important to note that while this study has been compromised, there have been no adverse effects for patients and that the main findings reported from the clinical trial have been corroborated by others in a subsequent small clinical trial (Shahin et al., Br J Surg, 2013: 100 (Suppl 2): 1-8.
She told us the key points of the investigation:
An investigation was conducted in accordance with the Australian Code for the Responsible Conduct of Research and while we are not able to provide a copy of the report, we can advise that the key findings were as follows:
– This incident was isolated to the actions of one researcher
– At no point were participants in the trial exposed to risk or harm
– The research group otherwise followed all standard procedures for investigator-initiated trials in-keeping with Good Clinical Practice as well as the Institute’s standard operating procedures
– Journal articles published on this study to be retracted due to invalid data
She also told us:
Dr Ahimastos has resigned from the Institute.
Since the incident, oversight has improved, Kingwell added:
The affected trial commenced in 2008 and concluded in 2011. In the interim, and prior to discovery of this research misconduct we have developed more effective levels of oversight and governance in relation to trials as well as appointing a clinical research governance officer to ensure our work is in-line with international best practice.
We anticipate that our additional frameworks and processes will ensure that potential issues are identified sooner and quickly rectified.
Kingwell and Ahimastos are co-authors on a number of papers together.
We reached out to Ahimastos, and we’ll update this post if we hear back.
Editor’s note 12:41 p.m. eastern 9/15/15: Due to a glitch in our content management system, comments posted yesterday on this story have temporarily disappeared. We are working to resolve the issue.
Hat tip: Kerry Grens
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Isn’t this white collar crime? Is it acceptable for the offender to simply resign and walk away?
If there was grant funding, this act might meet the bar of criminal fraud as respects the funding agency. Otherwise, it’s usually only academic dishonesty. The consequence for academic dishonesty is usually the loss of a position and the loss of ability to obtain funding for academic projects. Few would or should consider hiring such a person for any academic job. That’s a severe enough a penalty in my book.
The most important point was the evaluation by an external agency of the fraud. All have seen examples of young persons’ being fed to wolves when a more senior individual was very likely responsible. The senior persons have a great deal of power in the institutions in which they are performing the research.
What about the senior author of most of the Ahimastos papers, Kingwell – is there any responsibility on their behalf for the misconduct?
Hello.
I am writing this mail to find some information about the process of whistleblowing on medical research fraud in Australia.
Is there an official agency to which one can approach in Australia?
It would be really nice if you could give me some pointers.
Best Regards
Hrishikesh Kulkarni