EDITORIAL: Falsified drug-test data

Mitsubishi Tanabe Pharma Corp. and one of its subsidiaries illegally exchanged and falsified drug test data for an application for government approval of a new product.

Sixteen such violations were committed from 1999 to 2009 concerning the test data for the drug, which provides certain blood components to patients during surgery.

The Ministry of Health, Labor and Welfare ordered Bipha Corp., Mitsubishi Tanabe's unit that manufactured the drug, to suspend business operations for 30 days for violating the Pharmaceutical Affairs Law. The parent firm, which is responsible for supervising the subsidiary, has been ordered to suspend business operations for 25 days.

Behind the data falsification was a rush to develop a new drug that could lift the company's miserable earnings. This pursuit of profits at the expense of safety shows how badly confused the companies' priorities became.

The companies deserved to be punished for undermining public confidence in the safety and quality of medical products and creating a possible health threat.

Even more maddening is the fact that this is not the first serious offense involving Mitsubishi Tanabe.

Bipha was created in 1996 by Green Cross Corp., which produced tainted blood products that infected a large number of people with HIV, the virus that causes AIDS. Former Green Cross employees were involved in the latest violations.

In 2001, the now-defunct Green Cross merged with a Mitsubishi group drug company.

Mitsubishi Tanabe also faced a number of lawsuits filed by people infected with hepatitis C from its blood products.

In 2008, the company reached a settlement with the victims. It apologized and promised to ensure that it will never again cause such drug-induced suffering.

The latest scandal, however, has shown that even while the lawsuits concerning the hepatitis C infections were under way, the company committed unlawful acts that could lead to another health disaster.

What was the company's apology all about?

In 2009, Mitsubishi Tanabe set up an independent investigation committee after an insider revealed the latest data scandal.

The committee's report said the company's financial straits were caused by the huge damages Green Cross had to pay to people infected with HIV from the contaminated blood products.

The report concluded that it was hard to deny that the propensity of Green Cross to seek profits at the cost of safety had been behind the data forgery scandal.

The fact-finding committee also argued that the series of mergers among companies, including Green Cross, that formed Mitsubishi Tanabe in 2007 resulted in a dysfunctional system for governance and supervision.

It called on the company to enhance the governance of the entire group and grasp all risk factors concerning business operations, organization and personnel allocations of both the parent and subsidiaries.

Mitsubishi Tanabe should make exhaustive efforts in line with the committee's recommendations.

The company says there have been no reports of health damage caused by the drug in question. But it should make a swift and effective response if any problems do arise.

The health ministry, which also ordered Mitsubishi Tanabe to improve the way it operates, should reject any unconvincing business improvement report that is not backed by satisfactory efforts.

In Japan, the pharmaceutical industry is going through a series of mergers and alliances.

Japanese drug makers are also facing the so-called 2010 problem--expected drops in revenue due to the expiration of patents for many of their drugs.

Managing mergers well and developing profitable new drugs are two challenges facing the entire industry.

The latest scandal should also prompt other pharmaceutical companies to make rigorous checks on their own.

--The Asahi Shimbun, April 16