Panel: 'Serious Faults' In Novartis Clinical Study
TOKYO (Kyodo) -- Novartis Pharma K.K. violated Japan's personal information protection law and ethical guidelines in a clinical study, led by the University of Tokyo, of a leukemia drug, the university's investigation panel said Tuesday.
Following release of its final report, the university will consider punishing those responsible, a university official said.
The clinical study led by Professor Mineo Kurokawa involved research on side effects of the leukemia drug Tasigna sold by the Japanese arm of the Swiss pharmaceutical giant. Kurokawa apologized in a statement, saying "we have caused great concern and trouble."
According to an interim report released in March by the University of Tokyo Hospital, Novartis employees were deeply involved from the planning stage of the clinical study, though patients were told the study would be conducted mainly by doctors.
Doctors also gave to Novartis information from a patient questionnaire, such as numbers allotted to the patients, their sex and initials, according to the report.
The final report said that violated a law requiring such personal information be kept confidential, as well as ethical guidelines for clinical studies.
The report also found that Novartis employees were involved inappropriately in four other clinical studies of other drugs, leading to the resignation of then Novartis Pharma K.K. president Yoshiyasu Ninomiya and other executives in April. All of the studies have been aborted.