Benikoji Supplements: Quickly Reorganize Investigation System

It must be said that Kobayashi Pharmaceutical Co. has been lacking a sense of crisis over a problem that has endangered people’s lives. The drugmaker must urgently review its internal investigation system and work with the government to quickly clarify the actual damage its products have caused.

Amid the spate of health problems among people who had taken Kobayashi Pharmaceutical’s supplements that contain benikoji red rice mold, it was found that an additional 76 people are suspected to have died as a result of taking the products. The company said it is currently investigating a causal relationship in those cases.

Kobayashi Pharmaceutical announced in March that there were five incidences of death. But recent inquiries by the Health, Labor and Welfare Ministry found that the company had been contacted by the bereaved families of the 76 people. As this could represent a rapid increase in the number of victims, it is little wonder that the ministry found the revelation shocking.

Kobayashi Pharmaceutical explained that reporting to the ministry was delayed because it “had not yet finished confirming [the facts].” When it first became aware of the problem in January, the company took two months to officially inform the government, and it had just been asked to speed up its notification process. Why did the company repeat the same mistake?

This time, it was also revealed that of the five previously announced deaths, one person had no history of taking the supplements. It is a situation that shakes the credibility of Kobayashi Pharmaceutical’s own investigation. Just how many victims are there? There is a limit to the company’s ability to investigate on its own.

Kobayashi Pharmaceutical has submitted a plan to the ministry on how it will proceed with the investigation and collect information from medical institutions on the 76 new cases.

The delay in reporting this time may have been due to a lack of communication from the ministry side as well. In the future, the ministry needs to actively get involved in the issue, without leaving investigation and analysis of results up to the company.

If necessary, the ministry should consider including outside experts in the investigation.

Concerning the supplements in question, there has been a succession of people who took them and then exhibited symptoms of kidney disease. Several compounds, such as puberulic acid, a toxic substance derived from blue mold, have been detected in the ingredients.

It has also been confirmed that puberulic acid can cause kidney trouble. However, a causal relationship with the deaths and other details have not yet been fully clarified.

The Japanese Society of Nephrology announced that more than 80% of the about 100 patients who took the supplements have not fully recovered kidney function even after continued treatment. The damage is serious, and Kobayashi Pharmaceutical needs to move fast and provide compensation for the cost of treatment and other expenses.

Complaints of health problems are spreading overseas as well. In Taiwan, about 30 people who have complained of poor health will reportedly file a class action lawsuit for damages against a subsidiary of Kobayashi Pharmaceutical.

The situation is becoming increasingly chaotic. To get the situation under control, the prompt and accurate disclosure of information is indispensable.

(From The Yomiuri Shimbun, July 2, 2024)