© KyodoThe head office of Novartis Pharma K.K. stands in Tokyo's Nishiazabu district.
It is shocking to see how entrenched the collusive ties were between a pharmaceutical company and university hospitals during clinical testing of drugs.
An outside investigative committee commissioned by Novartis Pharma K.K. has released a report on the inappropriate involvement of Novartis employees in clinical trials of a leukemia drug produced by the drugmaker at the University of Tokyo Hospital and other medical institutions.
The report revealed that Novartis employees wrote research plans for conducting the clinical trials as well as documents explaining the trials to patients and consent forms for them to sign, showing their deep involvement in the research.
What is particularly disturbing is the fact that Novartis was aware of serious side effects from the drug but did not report them to the Health, Labor and Welfare Ministry - an act that could constitute a violation of the Pharmaceutical Affairs Law.
This is inexcusable and tantamount to covering up damage done to the health of patients.
Also, Novartis' acquisition of personal information regarding all patients who participated in the clinical testing is suspected to be a violation of the Personal Information Protection Law.
After the scandal surfaced, Novartis discarded survey papers written by the patients in an attempt to destroy evidence. This is unpardonable.
A criminal complaint has been filed against Novartis for tampering with clinical trial data for a hypertension treatment drug called Diovan. After this problem surfaced, Novartis decided not to allow its employees to participate in clinical research anymore, but the employees in question continued their involvement in the trial on the leukemia drug. We must say the firm lacks ethics.
Swiss finger-pointing
The firm's headquarters in Switzerland - Novartis AG - removed the president and two other executives at the Japanese firm from their posts, pointing a finger at the Japanese company's corporate culture as the backdrop of the problem. We wonder, however, if there was any problem in the corporate governance of the Swiss firm itself.
The university hospitals bear heavy responsibility for the problem. This research was supposed to be "clinical research led by doctors," meaning doctors were to independently conduct research on the drug. In spite of this, the research was wholly orchestrated by Novartis. This shows how shallow doctors' awareness is about the necessity of conducting research fairly.
Novartis donated ¥8 million over three years to the laboratory of the University of Tokyo Hospital professor in charge of conducting the clinical test.
The pharmaceutical company wanted to use the results of the clinical test for advertising the drug, while the university hospital wanted funding in return. Their interests could not have matched more precisely, sowing the seeds for inappropriate conduct.
The latest scandal is similar to Novartis' misconduct over Diovan and other research irregularities. The Health, Labor and Welfare Ministry stipulates ethics guidelines for clinical trials, but they are not legally binding. In the wake of this misconduct, the ministry will establish a panel to consider the advisability of legally regulating clinical trials.
It is hoped that the ministry will come up with effective measures to prevent misconduct. But at the same time, it should consider whether such regulations could stifle research.
The Science Council of Japan has suggested that a public institution be established to neutrally conduct clinical trials, a proposal that merits the ministry's consideration of its feasibility.
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