Lessons from the Diovan scandal

Problems surrounding the blood pressure-lowering drug Diovan have shed fresh light on opaque and sometimes questionable ties between medical researchers and pharmaceutical firms. More facts behind the alleged clinical data falsification of the drug sold by Novartis Pharma K.K. could be exposed through criminal investigation now that the health ministry has filed an accusation with prosecutors against the Japanese unit of the Swiss pharmaceutical giant, saying that the firm engaged in exaggerated advertisement of the drug, generally known by the name Valsartan, using scientific papers based on falsified data.

The root of the problems lies in the industry practice in which drug makers give a huge amount of money to researchers at universities and medical institutions in ways that are not always transparent. The practice itself needs to be scrutinized, along with other fundamental problems including why research papers with falsified data were published without internal checks by the institutions in question.

Doctors at universities and hospitals receiving donations from pharmaceutical companies use drugs sold by them for their patients in clinical research to study the effects of the products. In the Diovan case, it was discovered that an employee of Novartis Pharma took part in the data analysis of the research conducted at universities in and after 2002 while hiding his employment status.

Studies by Kyoto Prefectural University of Medicine and Tokyo-based Jikei University School of Medicine concluded that the drug was more effective in preventing angina pectoris and strokes than other high blood pressure drugs of rival pharmaceutical makers, and papers based on the studies were used by Novartis Pharma to promote the sale of the drug, which generates more than ¥100 billion in annual sales in Japan. The studies were later found to have contained falsified data.

The prosecutors, once they officially take up the case, will be investigating the criminal responsibility of the parties involved. The probe by the health ministry so far has not been able to determine who falsified the data and how. Novartis Pharma has denied that the employee, who has since left the company, was involved in the data manipulation or that the firm knew the data had been falsified.

According to data made available by the pharmaceutical industry, drug makers in Japan provided a total of ¥470 billion to universities and people in the medical profession during fiscal 2012. The amount far exceeds the roughly ¥200 billion that the government plans to annually spend on large-scale medical research and development projects beginning in fiscal 2014.

The money from pharmaceutical companies includes research subsidies, compensation for doctors who give lectures at meetings to promote drugs sold by the firms, as well as other forms of donations. Laboratories at many universities find such donations a useful source of funding for their research, while pharmaceutical companies apparently hope that such funding will ultimately lead to higher sales of their products.

Novartis Pharma, which competes with other makers in the estimated ¥400 billion domestic market for high blood pressure drugs, provided about ¥1.1 billion in such donations to the five universities that engaged in clinical research on Diovan in the 2000s. Such ties highlight the key role the pharmaceutical industry’s funding plays in Japan’s medical research. They also raise questions about whether research on drugs that affect the health and lives of people should be guided by the interests of drug makers.

The flow of funds from the pharmaceutical industry to researchers should be made open and transparent, as should the research. Clinical studies using drugs on patients should be financed either by public research funds or through formal funding contracts between pharmaceutical companies and the research institutions involved — rather than by donations whose use is not specified. Such efforts will be essential if clinical studies by Japanese institutions are to regain their credibility in the wake of the Diovan scandal.