Clinical trial results for well-known blood pressure drug ramipril that were published in major journals contained fabricated data, a high-profile Australian scientist has admitted, according to the BBC.
The research at Melbourne's Baker IDI Heart & Diabetes Institute was first published in 2013 and said the blood pressure drug eased vascular disease pain. Researcher Dr. Anna Ahimastos "had oversight of data collection and integrity," the BBC said, citing a statement from Institute's Professor Bronwyn Kingwell, who oversaw the retraction of the articles.
Ahimastos has admitted responsibility and resigned. The two articles about the three-year clinical trial into ramipril have since been retracted, Kingwell told the BBC, all of which followed anomalies in the trial that were identified internally, sparking an investigation in June. Kingwell told the BBC there was no risk to patients.
"At no point were participants in the trial exposed to risk or harm," Kingwell was quoted as saying in the statement. "This was an isolated incident confined to the actions of one researcher."
"The Institute takes such matters very seriously and every effort has been made to correct the record with all affected parties as quickly as possible in-keeping with our obligations and our commitment to being a center of research excellence."
A statement sent by Baker IDI to FiercePharmaAsia said that the misrepresentation of data required the retraction of two papers--one in JAMA and one in Circulation Research.
"The affected trial commenced in 2008 and concluded in 2011," Baker IDI said in the statement.
"In the interim, and prior to discovery of this research misconduct, we have 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."
In June 2011, India's Aurobindo Pharma got the FDA nod to manufacture and market ramipril, a generic version of the King Pharmaceuticals drug Altace.
Other companies also make and sell the drug, including Ranbaxy Laboratories. The generic version was also involved in a high-profile recall by Canada's Apotex several years ago over one lot of Apo-Ramipril 5-mg capsules for high blood pressure when some were found to be empty. Because the capsules were not transparent, patients could not tell they didn't contain any drugs.
- here's the BBC story