Japanese Pharma Employees Inappropriately Involved in Clinical Study
TOKYO, May 16 (Kyodo) — Japanese pharmaceutical company Kyowa Hakko Kirin Co. said Friday two of its employees were inappropriately involved in a clinical study on an anemia drug, violating internal rules to secure neutrality.
According to the company, the employees were involved in analysis of clinical data and obtained personal information of patients covered in the research conducted between 2012 and 2013 by a doctor at Sapporo Higashi Tokushukai Hospital in Hokkaido.
The hospital separately said the same day its nephrology department manager was instructed to retire in March for seriously violating ethical guidelines by starting the research before obtaining approval from its ethics committee.
So far, no falsification of the data was found and the study results have not been used for advertising purposes or in research papers, according to the firm.
About 30 patients who cooperated with the research have not suffered any health hazards, the hospital said, but added that the manager provided their personal data including medicine dosage and weight to Kyowa Hakko Kirin without their consent.
The doctor had begun collecting blood samples from patients before the study was approved in December 2012.
Kyowa Hakko Kirin said the employees were also engaged in compiling the study plan from an early stage and the company provided the nephrology department of the hospital with research funds.
The company set up an investigative panel of lawyers to look into the case and announce the outcome in late June.