Research Scandal Shows Need for Rules

The Daily Yomiuri (Toyko, Japan), May 28, 2013 | Go to article overview

Research Scandal Shows Need for Rules


The recent revelation that a pharmaceutical company employee participated anonymously in the analysis of clinical research for one of his company's drugs has shocked the nation's medical circles over a conflict of interest.

The case points to the need to establish clear rules on clinical research, observers said.

The scandal involved an employee of Novartis Pharma K.K. who took part in conducting clinical research on Diovan, a drug for high blood pressure. He quit the firm earlier this month.

Novartis used the research findings for promotion of the drug, which has annual sales of about 100 billion yen.

The Health, Labor and Welfare Ministry conducted a hearing on the firm about the case Monday and required it to compile measures to prevent a similar incident from taking place.

The opaque relationship between doctors and the drugmaker, which came to light over the issue of Diovan's clinical research, is threatening to tarnish the public's confidence in the nation's medical treatment system, observers said.

"[Hiding the employee's identity] was apparently a mistake and unreasonable from a viewpoint of social ethics, too," said Fumimaro Takaku, president of the Japanese Association of Medical Sciences. "It will result in a huge disadvantage for Japanese medicine. Such an incident should not occur again."

The research in question was part of a comparative clinical study of drugs for high blood pressure that was conducted by Kyoto Prefectural University of Medicine, involving about 3,000 patients.

The findings claimed that Diovan could reduce the risks of stroke and angina by 45 percent compared with conventional drugs, although there was no difference in the effectiveness of lowering high blood pressure.

The research results were published in academic papers without identifying the Novartis employee who was involved in analyzing principal data. The findings were used for advertisements, which could affect patients' choice of drugs.

Three problems could be behind the fiasco: ambiguous domestic rules for clinical research, unlike those in Europe and the United States; the university's sloppy research procedure; and the reciprocally cozy relationship between doctors and pharmaceutical firms.

Findings of large-scale clinical research involving a huge number of patients, like the study done by Kyoto Prefectural University of Medicine, are used in clinical guidelines compiled by academic medical societies, and therefore hold significant sway over doctors' choice of drugs. Such large-scale clinical research is distinct from clinical trials used in the approval process for drugs.

The university launched the research in 2004 to collect data on Japanese patients, drawing tremendous attention as a pioneering study in Japan along with similar research started two years earlier by Jikei University.

But unlike in the United States and Europe, where clinical trials and research are in principle conducted in line with the same standards, rules in Japan on clinical research remain vague.

As for clinical trials, strict rules are in place based on the Pharmaceutical Affairs Law. In line with international standards, the rules call for mandatory reporting to the state, triple checking of data and the keeping of records of the process of data corrections, among other measures. …

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