Kyoto Prefectural University of Medicine announced on July 11 that the data used in clinical research on Novartis Pharma K.K.’s blood-pressure drug Diovan were manipulated. It added that the key conclusion based on the research was very likely erroneous but that there is no question that the drug is effective in lowering blood pressure.
Both the university and the drugmaker should clarify what actually happened during the clinical research and who did what.
The research, involving some 3,000 high blood-pressure patients, was started in 2004 to find out which high blood- pressure drugs are effective in preventing cardiovascular diseases such as angina and stroke. It was carried out by a team headed by Professor Hiroaki Matsubara of the university, who resigned in February. The team published seven scientific papers in medical journals in North America, Europe and Japan from 2009 to 2012.
It concluded that when compared with other high blood- pressure drugs, Diovan was 45 percent more potent in reducing angina and stroke. But the scientific papers were withdrawn later.
Diovan, generically known as valsartan, generates just over ¥100 billion in revenue each year in Japan. It has been prescribed to more than 1 million patients.
Kyoto Prefectural University of Medicine’s investigation focused on 223 patients whose medical records were identified. In 34 cases, diseases either were not mentioned in the records but appeared in data believed to have been used in the clinical research, or were mentioned in the records but did not appear in such data. The university also said manipulation of data is suspected because the research team had a tendency to report fewer incidents of disease in groups of patients who were given Diovan and more incidents of disease in groups of patients who were not given Diovan.
An employee of Novartis took part in the research and is suspected of having analyzed and manipulated the data. The employee, who quit Novartis in May, failed to identify himself as a Novartis employee when he put his name among the authors of the scientific papers.
Novartis denies that this employee analyzed or manipulated data. But the very participation of a drugmaker employee in research on the effects of a drug from the same company invites suspicions about objectivity.
There is a suspicion that the same employee also took part in clinical research on Diovan at Jikei University School of Medicine, Chiba University, Nagoya University, and Shiga University of Medical Science. Novartis should not only question the employee but also make clear what instructions it gave the employee.
Professor Matsubara’s research team is also known to have received more than ¥100 million in grants from Novartis. People will likely regard this money as a reward from the drugmaker. In principle, offers of this kind should be stopped.
The professor denies that data were manipulated. Kyoto Prefectural University of Medicine should thoroughly investigate what he did. Other universities should take similar action.
Each university should strictly follow the principle of letting a third party analyze data collected in clinical research.